MEDICAL DESIGN & OUTSOURCING - November 2017

NOVEMBER 2017

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HERE’S WHAT WE SEE

Why the Medical Device Handbook matters Medical device suppliers are way beyond the times when they merely filled orders to spec for medtech OEMs. From incorporating steerability into catheters to getting validation and testing done right, the companies serving the medical device industry have become specialized experts.

Through our annual Medical Device Handbook, we seek to harness this expertise for the medical device industry. We requested articles from medical device designers, outsourcers and consultants that avoided marketing pitches and instead provided useful information for our community.

Whether medical device developers are new to, say, catheters, electronic components or rapid manufacturing, the nearly 50 articles in this issue should hopefully help them dip their toes into these areas.

Here are just a few examples of the expertise to be had in this year’s Medical Device Handbook:

Chris Newmarker Managing Editor Medical Design & Outsourcing c newmark er@wtwhmedia.com

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• Medical doctors “want better performance and improved functionality in the catheters and delivery systems they use,” said Anthony Appling, senior director of research and development at Freudenberg Medical, Minimally Invasive Solutions (Jeffersonville, Ind.). “One of the most important parameters is the ability to steer a catheter with confidence and ease through challenging anatomies and deflect the tip for precise placement at its final target.”

Appling lists seven principal factors that medical device developers should consider.

• Heraeus’s CerMet – an advanced ceramic and metal technology system – creates the potential for implantable devices with thousands of electrical channels. Think new options for treating blindness and neurological conditions.

• We have a review of the common adhesive materials and their reaction to sterilization processes, courtesy of Christine Salerni Marotta, the North American medical business and market manager for Henkel Corp.

• Patent protection is becoming increasingly important for mobile health developers as more devices and applications join the connected world, according to David Dykeman, co-chair of Greenberg Traurig’s global Life Sciences & Medical Technology Group. Dykeman provides insights about how to do that.

• Scaling to high-volume manufacturing requires companies to think ahead and prepare for the future early in the product lifecycle, according to Gavin Wadas, manager of strategic capital projects for B. Braun Medical, OEM Division. Wadas lists four things medical device companies should reflect upon before they scale up.

• “Using a virtual tubing model analysis – such as Integer’s proprietary Virtual Tubing Model software (VTM) – dramatically decreases the time and resources needed for physical prototyping,” said Michael Holt, technical solutions director at Integer (Frisco, Texas). Holt listed three ways the Virtual Tubing Model software helps speed up catheter design.

• We have a solid roundup of the growing assortment of 3D printing options available for medtech development, courtesy of Jon Eric Van Roekel, 3D printing process engineering manager at Proto Labs (Maple Plain, Minn.).

• Medical device makers have the opportunity to capitalize on the strategic priorities and transparency initiatives at FDA’s CDRH, according to Lisa Olson, president of medical device strategic consulting company RCRI. “When the totality of FDA actions and external communications are evaluated, the agency is still demonstrating a focus on the strategic priorities set out in 2016,” Olson said. M

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Medical Design & OUTSOURCING

medicaldesignandoutsourcing.com ∞ November 2017 ∞ Vol3 No6

E D I T O R I A L EDITORIAL Founding Editor Paul Dvorak pdvorak@wtwhmedia.com @paulonmedical Executive Editor Brad Perriello bperriello@wtwhmedia.com Managing Editor Chris Newmarker cnewmarker@wtwhmedia.com @newmarker Senior Editor Heather Thompson hthompson@wtwhmedia.com Associate Editor Fink Densford fdensford@wtwhmedia.com Associate Editor Sarah Faulkner sfaulkner@wtwhmedia.com Assistant Editor Danielle Kirsh dkirsh@wtwhmedia.com

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CONTENTS

medicaldesignandoutsourcing.com ∞ November 2017 ∞ Vol.3 No.6

INSIDE

the medical device handbook 04

HERE’S WHAT WE SEE Why the Medical Device Handbook matters

10

54

MACHINING Choosing the right toolholder

58

MANUFACTURING

CATHETERS Steerability; It’s all in the tip; Virtual Tubing Model

22

CONSULTING Get the most from design services

High-volume automation; Micro-MIM; Heart valves; Global footprint

68

MATERIALS Plasma treatments; Orthopedic coatings; Adhesives; Epoxy

78

26

MOLDING

ELECTRICAL/ ELECTRONIC COMPONENTS

Overmolding; Rapid injection molding; Gas-assist molding; Micromolding; Dip molding

CerMet; UVC LEDs; Stretchtronics; Advanced lithium batteries

90

40

FLUID POWER COMPONENTS LVADs

44

HIGHPERFORMANCE POLYMERS Sustainability; Liquid silicone rubber; PEEK formulations

MOTION CONTROL COMPONENTS Moving plastic components; Mitigating heating

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REGULATORY, REIMBURSEMENT AND IP Intellectual property protection; Global product registration; FDA; Europe; Deciding Class I or Class II; Protecting mHealth IP

116

SOFTWARE Multiphysics simulation software; Middleware

120

STERILIZATION SERVICES Sterile barrier systems; VPA sterilization

124

TUBING: COEXTRUSIONS, HEAT SHRINK, MULTILAYER, MULTILUMEN Kink-resistant tubing

128

NEEDLES AND SYRINGES

VALIDATION & TESTING BASICS

Drug-delivery system design

Validation and testing; Cybersecurity; Designing a successful trial; Torque auditing; Preclinical CROs

98

RAPID MANUFACTURING AND PROTOTYPING 3D printing; Prototyping

8

104

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CATHETERS

Incorporating steerability into your catheter: Here’s what you need to know Here are seven key design and development considerations you need to keep in mind for catheters with steerability.

Anthony Appling Freudenberg Medical

(ABOVE) Four-way steerable multilumen catheter Image courtesy of Freudenberg Medical

As medical technology continues to advance, physicians who specialize in minimally invasive procedures also have advancing expectations. They want better performance and improved functionality in the catheters and delivery systems they use.

One of the most important parameters is the ability to steer a catheter with confidence and ease through challenging anatomies and deflect the tip for precise placement at its final target.

Here are some of the principal factors to consider: 1. Understanding the clinical user’s needs Ask questions and vet the clinical user requirements up front. Be sure you understand the anatomical applications, including any necessary interactions with given structures or tissue. What will the catheter be used for? Where will it need to go in the body?

Understand the potential tortuosity and assess what may be the best approach for achieving optimal trackability and range of motion.

2. Shaft design The three key properties of shaft construction are flexural stiffness, longitudinal stiffness and torsional stiffness. The material chosen, and how it is engineered along the length of the catheter shaft, affects each of these properties and is an important factor in overall performance and functionality.

Composite shafts, for example, feature a graded

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stiffness along the shaft. They start at the proximal end with a relatively stiff design and transition to a more supple design at the distal end.

3. Reinforcement Good reinforcement along the catheter shaft is especially important in a steerable, deflectable catheter, because it needs to resist buckling or kinking during use. The following traditional methods have been used with success to balance steerability and deflection with the necessary reinforcement: • Axial pull wires or aramid fibers with distal anchors or bands • Coaxial rigid tubing that traverses axially • Compression coils to reduce or prevent foreshortening of the catheter Some non-conventional methods have also been developed using shape memory polymers, nitinol and electromechanical tips, but these methods are often cost-prohibitive.

4. Lumen vs non-lumen A lumened catheter may be constructed with a lubricious multi-lumen or multiple single-lumen layup. In either case, the lumens must be kept as straight as possible to maintain planarity. The goal is to minimize twist to prevent off-plane tip

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CATHETERS

deflection. In addition, the central lumen needs to maintain patency even in the deflection zone. This can be achieved using variable coils, braids or laser-cut hypotubes. Larger catheters are more difficult to keep round during deflection due to the higher force needed to deflect.

For diagnostic or therapeutic catheters that do not require a central lumen, other methods can be used to facilitate tip deflection. For example, for single-plane deflection, the catheter can be anchored to the actuation components and moved axially along fixated wires at the tip and proximal end. A rigid spine can be incorporated to maintain planarity.

5. Other catheter functions and their potential impact on design choices Steerable catheters often include advanced functionality, and components that facilitate other functions may impact your design choices. For example, consider whether the catheter has sensors, electrodes or other electronic components that may need shielding. Carefully select materials to ensure they do not interfere with integrated circuits or sensors.

Selecting a different metal alloy is one example. Dielectric materials and their locations must be considered as well.

6. Extrusion All good catheters start with highquality tubing. It is important to understand the compounds and additives in the tubing material, and how to process them, to ensure a stable, high-quality product that will stand the test of time. High-performing materials for the outer jacket include PU and PEBA-based thermoplastics or other thermoplastic blends. PTFE or coextruded PEBA/PU with FEP or HDPE are traditional materials used for sheaths or guide catheters.

7. Manufacturing To help prevent unpleasant surprises late in the process, it’s considered a best practice to use the same manufacturing technique and process technologies during design and development as you plan to use for 12

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final production. Changes in the manufacturing technique mid-point can adversely affect catheter performance.

A partner with in-house design and manufacturing capabilities is advantageous to ensure design for manufacturability. It is also important that your design partner knows the fundamentals of lean manufacturing. Optimal lean manufacturing techniques and design for manufacturability go hand-in-hand to deliver a best in class device.

Accessing and reaching the target anatomy accurately is one of the key elements of maximizing procedural success. To ensure the success of a steerable catheter system, it is critical to choose a partner with a full range

of experience and a deep understanding of different manufacturing technologies. Ideally, you want a company with comprehensive design, development and full device manufacturing capabilities as well as an understanding of proven methods. A partner with a wide range of innovative solutions can further “steer” you to a successful product launch. M Anthony Appling is senior director of research and development at Freudenberg Medical, Minimally Invasive Solutions (Jeffersonville, Ind.). He has 18 years of experience in product design, development and manufacturing with an emphasis in minimally invasive delivery systems and therapeutic devices.

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CATHETERS

How virtual tubing model analysis can accelerate complex catheter shaft design Virtual tubing model analysis optimizes catheter design to help engineers reach final design freeze faster and shorten time to market.

Michael Holt Integer

As medical procedures become more complex, engineers are challenged to develop smaller, thinner-walled catheters to keep pace with highperformance clinical demands. Conventional catheter prototyping relies on a manual, timeconsuming trial-and-error process involving multiple rounds of material procurement, prototype assembly and bench testing. A virtual simulator simplifies the catheter design process but is still time-consuming and has resource challenges.

Using a virtual tubing model analysis – such as Integer’s proprietary Virtual Tubing Model software (VTM) – dramatically decreases the time and resources needed for physical prototyping. With VTM, complex multilayer braided composite tubes can be modeled in minutes, compared to using 3D CAD modeling programs that may take hours and consume valuable time.

VTM is a fast, easy-to-use software modeling program that predicts the performance of catheter shafts for single lumen constructions with one or more material layers, and with or without braid reinforcement.

Here are three ways the Virtual Tubing Model software helps speed catheter design: 1. Rapid design modeling With VTM, engineers can quickly model design options to predict kink radius, bending (lateral) stiffness, linear stiffness, torsional stiffness and hoop strength. Various design options can be modeled and overlaid in graphical form for each performance attribute, allowing engineers to analyze the graphs simultaneously to determine which design delivers optimal performance and any tradeoffs.

For example, an engineer may want to maximize kink response, but doing so may greatly reduce the torque response of the shaft. Knowing the tradeoffs in advance is crucial to developing a catheter shaft that delivers optimal performance.

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Maximize kink response in a catheter by performing modeling analysis with Virtual Tubing Model software (VTM) Graph courtesy of Integer

Maximize torque response in a catheter by performing modeling analysis with Virtual Tubing Model software (VTM) Graph courtesy of Integer

Model different stiffness zones to see how the stiffness of the catheter changes along the length and make changes as needed based on the application Graph courtesy of Integer

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IT’S ALL IN THE DETAILS

ONE SOURCE – ENDLESS SOLUTIONS Freudenberg Medical goes above and beyond to help you create next generation products. From components – utilizing sophisticated materials and processes – to sub-assemblies and highly specialized catheters and delivery devices. We serve customers from design and development through mass production.

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CATHETERS

2. Adaptable design options VTM allows engineers to model up to 10 unique layers, both braided and non-braided. The model can accommodate almost any polymer and braid material, requiring only the tensile modulus, Poisson’s ratio and ultimate tensile strength as inputs.

Braid patterns from 4 to 48 wires can be modeled with almost any braid wire material, including stainless steel, nitinol, tungsten, platinum, non-metallic monofilaments and many other metals.

3. Design for Manufacturability (DFM) analysis Utilize VTM to run and graph a series of models at different pic counts to quickly determine which option delivers optimal manufacturability. In the flexural stiffness chart, check out how a catheter engineer created an initial design for a microcatheter and requested a pic count of 160 ppi to minimize the bending stiffness of the catheter shaft. A series of VTM models were run at different pic counts and graphed.

The data showed that a pic count in the 120 ppi range delivered optimal flexibility. This lower pic count took less time to braid and required less braid wire. It also enhanced overall manufacturability and helped save time and resources.

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A series of VTM models can be run and graphed at different pic counts to determine the best range for optimal manufacturability Graph courtesy of Integer

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Based on a 20-year history of optimizing catheter designs, Virtual Tubing Model software is one of the most effective tools available today to predict prototype performance. The ability to create and overlay multiple reports for different design iterations allows engineers to identify performance patterns and pinpoint an optimal design more quickly. The result is significantly fewer prototype iterations to reach final design freeze and enhanced speed of new product delivery to market. M

Michael Holt is technical solutions director at Integer (Frisco, Texas). Holt has more than 20 years experience in the design and development of complex catheter based devices. He holds a Bachelor of Science in mechanical engineering from the University of Tennessee.

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Medical Design & Outsourcing  17

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CATHETERS

Enhancing catheter steerability and deflection It’s all in the tip when it comes to making catheters with state-of-the-art steerability and deflection.

Andy Black Medical Murray Ta n n e r H a r g e n s Medical Murray

Steerable catheters Catheters often need to navigate tortuous anatomy with precise control of the catheter tip. Steerable catheters are often utilized for access into side branches from parent vessels to introduce guidewires and other devices into desired locations. The ability to steer a catheter is generally measured by how well torque is transferred from the proximal end of the catheter to the distal end while the catheter retains the desired shape.

Sufficient “steerability” can be achieved by reinforcing the catheter shaft with braided wire to enhance torque transmission and provide kink resistance. A common steerable catheter is constructed by braiding wire over a lubricious liner, which serves as the working channel, followed by melting and compressing an outer layer of thermoplastic onto the braided liner to create a single, fused composite.

Many steerable catheters have a preset shape at the distal tip. These preset tip shapes can be manipulated with guidewires and shaft rotation for access to challenging anatomy. There are a large variety of preset tip shapes including a slight angle, cobra, visceral, pigtail, etc.

Deflectable catheters Some catheters may be required to place the catheter tip very precisely for a prolonged

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period at body temperature. Examples include guiding catheters, endoscopy, imaging catheters and tissue ablation. For these more challenging needs, deflecting the tip into a defined curve can control the catheter tip location.

One of the most common ways to deflect the tip of a catheter is by pulling a wire that runs the length of the catheter shaft and anchors itself within the distal tip of the catheter. This type of deflectable catheter design usually has a relatively stiff proximal shaft and a softer distal tip, allowing the distal tip to deflect when the wire is pulled. Using various durometers of the thermoplastic outer layer, melted onto the braided liner, commonly alters the shaft stiffness.

Deflectable catheters incorporate a dedicated liner running the entire length of the catheter, to allow the pull wire to move freely between the soft distal tip and the stiffer proximal shaft segments when they are all joined together. The pull wire is typically anchored by welding the wire to a ring and then embedding the ring within the distal end of the catheter. The location of the embedded ring will dictate the deflected shape when the wire is pulled from the proximal end.

For catheters that need to deflect in two directions, two pull wires will be used. Separate liners will be dedicated to each pull wire, and the wires will typically be welded to the ring embedded in the tip 180° relative to each other. These pull wires can be connected to a levered bell-crank mechanism in the handle for simple and smooth control of the tip with two directions of deflection.

Advanced design considerations There’s an increasing need for more advanced design and material considerations to alter the steerability and deflection of the catheter.

For example, structural heart implant delivery

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CATHETERS

systems must navigate a tortuous path and then maintain the intended shape while a relatively large, rigid implant is advanced through the catheter.

These more advanced catheter systems often require varying degrees of deflection, such as slight deflection in one segment with a very tight deflection curve in another segment. Straight lengths of catheter shaft between these deflection segments can also be utilized to create “reach” for optimal tip location when deploying other devices through the catheter.

Multiple deflection zones can be integrated into the length of the catheter

by varying the outer layer materials, the shaft reinforcement and/or the pull wire anchor locations. Varying the outer layer materials typically involves changing the durometer of the material. The shaft reinforcement may be altered by changing the braid pattern, transitioning from braid to coil or encapsulating a lasercut hypotube. The pull wires can be anchored at different locations along the length of the catheter or be radially offset when welded to the same anchor ring.

All of the options above can be combined for a near limitless variety of desired results. Assembly of catheters that combine these features can require a surprisingly amount of subtle finesse.

Emerging technologies New methods of catheter navigation are emerging. Rather than utilizing a pull wire, force can be transmitted to the distal tip using concentric tubes or small hydraulic chambers positioned within the tip of the catheter. Force can be generated within the tip by electric or thermal energy.

Magnets can also be integrated into the tip and then controlled by external magnetic systems. Any one of these new technologies may ultimately displace the current methods of steerable and deflectable catheters. M

IMPACT CAN DESTROY AN OBJECT OR A SINGLE ELEMENT OF THAT OBJECT

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CONSULTING

How to best collaborate with a product design firm There are a number of things that medical device companies can do to ensure that their partnerships result in well-designed devices. Here are a few tips for successfully navigating a partnership with a product design firm.

S o n j a Ta k a t o r i Product Creation Studio

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So you’ve successfully interviewed, evaluated and selected a design firm to partner with on your next medical device product development project.

Congratulations on finding a team to bring your product to fruition! As a client, you are investing your time and money into the partnership, and you want ensure that working together results in a successful and fruitful product development effort.

SHP_1579.jpg Your job now is to make sure the combined team delivers value and meets your needs.

Here are four key factors that will help you ensure the relationship begins and ends on the right track.

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1. Communicate your product marketing strategy Share information about your products, business and marketing strategy with the design firm at the beginning of the partnership and communicate any changes in strategy as they happen. Understanding more about the business, the product and the market helps the design firm innovative and make better decisions throughout the engagement.

Design offers an effective way to differentiate a company’s products, often providing a competitive advantage. Empowering the design firm with information about your company and market will inform their designs and decisions, resulting in more effective product designs.

2. Understand your target user needs and desires to create better experiences Don’t rely on best guesses about your users to inform your product design team. You can find out how actual target users behave, how they might engage with the product you are developing and what you might do to improve that user experience so they will ultimately purchase your product.

The knowledge gap between the design team and the target users can be diminished by applying systematic usability techniques throughout the design and development of the product.

Usability data can provide objective evidence to use as the basis for making design decisions and as a way to decide which ideas are the most viable.

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3. Accept the uncertainty of product development, but be an active participant as the project unfolds Relatively few details about the desired product are known at the beginning of the project, meaning that a design firm’s estimates are subject to a degree of uncertainty. As the design firm engages in the project and the product development effort matures, more knowledge is gained and the uncertainty about the project and desired product typically decreases.

But financial and contractual commitments are agreed upon at the beginning, based on the proposal – at the period of highest uncertainty. Once the design team engages and dives into product development, creative ideas emerge that may not have been in scope of the original proposal. This limits the design team’s freedom to pursue a better product.

If not managed appropriately, this also can lead to contentious discussions between the client and their design partner. Working together, however, the client and design firm can actively and continuously strive to reduce the uncertainty level.

An adaptive project management approach – in which estimates and project plans are redone on a regular basis as new information becomes available – is one approach to dealing with the uncertainty. In an adaptive framework, all team members from both the client and the design firm accept that changes are inevitable, learn from discovery and update plans to reflect those lessons and – above all – work together in a transparent and trusting partnership.

4. Engage continually in the partnership At Product Creation Studio, we believe the consulting relationship is an amazing collaboration built on commitment and trust in which we become an extension of our clients’ team. For this to work, both sides must embrace open communication and be capable of giving and receiving frequent, honest, transparent feedback to avoid unpleasant surprises.

To get the relationship off to a good start, clients should be ready to set their idea free and transition from day-to-

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Medical Design & Outsourcing

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day involvement in the details to supporting your design partners as they execute on the day-to-day details. This means communicating what you need at a requirements level, rather than how to do it at an implementation level. Understand and identify the key decision-makers and make sure the design firm knows who they are.

As the project progresses, other behaviors become key to maintaining a successful, lasting partnership: • The client needs to be ready and available to make decisions to keep the team moving forward; • The design firm should provide the client with options and tradeoffs to help make these decisions; • Resist the urge to micromanage. Let the design firm do what it was hired to do and provide it with the information, background and support to do it.

• The design team’s dedicated project manager should also manage regular updates in the form of meetings and written status reports.

• The client will benefit from being available for the meetings as requested, reading the status reports to make sure the information is understood and asking clarifying questions.

Working together, the client and the design team can achieve results that are more successful and innovative than what either team could have produced working on their own. By keeping these four factors in mind, you’ll be on your way to successfully bringing your product to market with the power of a well-functioning, multidisciplinary team. M Project Manager Sonja Takatori has 29 years of product development experience in a wide variety of industries, including regulated medical devices, consumer products and web applications.

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ELECTRICAL / ELECTRONIC COMPONENTS

Bobbin-type LiSOCl2 batteries are commonly used in bone growth stimulators and AEDs, and can handle the extreme temperatures (-80°C to 125°C) of the medical cold chain and autoclave sterilization.

Image courtesy of Tadiran Batteries

Advanced lithium batteries enable medical devices to be miniaturized Lithium batteries are allowing medical devices to become smaller and more ergonomic without sacrificing power or performance.

Sol Jacobs Ta d i r a n B a t t e r i e s

Modern medical devices are become increasingly sophisticated and miniaturized, demanding more advanced batterypowered solutions.

Lithium batteries are paving the way by powering a wide variety of medical devices, including automatic external defibrillators, surgical power tools, robotic cameras, RFID asset tags, infusion pumps, bone growth stimulators, glucose monitors, blood oxygen meters and cauterizers. Lithium battery chemistry is preferred for delivering the highest specific energy (energy per unit weight) and energy density (energy per unit volume) of any battery type, along with nominal open circuit voltages ranging from 1.7V to 3.9V, enabling products to be miniaturized.

Understanding lithium thionyl chloride chemistry Bobbin-type lithium thionyl chloride (LiSOCl2) batteries are ideal for medical applications

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that require low average daily current along with extended battery life of up to 40 years.

Bobbin-type LiSOCl2 cells deliver higher energy density and higher capacity, along with a very low annual self-discharge rate.

Typical applications include bone healers, oxygen meters and glucose meters.

Due to the absence of water and the chemical and physical stability of the electrolyte materials, certain bobbintype LiSOCl2 cells can withstand high temperatures up to 125°C, enabling equipment to undergo routine autoclave or chemical sterilization without having to remove the battery.

A prime example is Awarepoint battery-powered radio frequency identification (RFID) real time location systems (RTLS) that continually monitor the location and status of medical equipment. Environmental tests performed by Awarepoint showed

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that the bobbin-type LiSOCl2 battery could withstand +135°C temperatures and work continuously for 500 steam sterilization cycles. The battery was compact, lightweight and powerful, delivering 0.55Ah capacity @ 0.5mA while also being completely safe, U.L.-recognized and considered nonhazardous when shipped.

Bobbin-type LiSOCl2 cells can also be modified to operate at -80°C for use in the medical cold chain, enabling the continuous monitoring of frozen tissue samples, transplant organs, medical supplies and pharmaceuticals during transportation.

However, be aware that LiSOCl2 batteries are not created equal. A superior quality cell can feature an average annual self-discharge rate of 0.7% whereas an inferior quality LiSOCl2 battery can have an annual self-discharge rate of up to 3% per year.

For automatic external defibrillators (AEDs) – which can remain idle for years but then need to perform reliably in a life-saving emergency – it makes sense to choose a superior-quality bobbin-type LiSOCl2 battery that features the lowest possible annual self-discharge.

Hybrid batteries power high-current pulse applications A hybrid version of the bobbin-type LiSOCl2 cell combines a standard battery with a patented hybrid layer capacitor (HLC) that acts like a rechargeable battery to deliver the periodic high pulses required by external defibrillators.

A similar technique is utilized to create lithium metal oxide batteries that can deliver high voltage and high energy density, along with instant activation and extended operating life, even at extreme temperatures. Lithium metal oxide batteries deliver an open circuit voltage of 4.0 V with high pulses of up to 15A and 5A continuous current at 3.2V for a limited time. Often utilized in hand-held surgical power tools and cauterizers, these powerful little 28

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Medical Design & Outsourcing

batteries enable hand-held devices to become lighter and more miniaturized.

For example, the BioAccess portable small bone drill was powered by an alkaline battery pack that performed well and offered excellent reliability. By substituting 6 AA-size TLM-1550HP lithium metal oxide batteries for the alkaline battery pack, BioAccess achieved a 36% weight reduction with only 40% of the volume. An equivalent alkaline battery pack would have required 3x the weight and 2.5x the volume (15 AA-size alkaline batteries vs. 6 AA-size TLM-1550-HP batteries). Use of a lithium metal oxide battery pack also

✓ ✓ ✓ ✓ ✓ Awarepoint medical RFID asset tracking tags utilize bobbin-type LiSOCl2 batteries that do not have to be removed prior to high temperature autoclave sterilization, ensuring continuous and reliable data.

enabled the surgical drill to deliver faster drilling speeds, more active drill time (30 to 40 seconds at a time for up to 20 to 30 cycles), more instantaneous power and greater stall torque, resulting in more efficient drilling cycles with less operator fatigue.

Industrial grade rechargeable Li-ion cells Numerous medical devices are currently powered by consumer-grade Lithium-

11 • 2017

www.medicaldesignandoutsourcing.com

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in

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ion (Li-ion) rechargeable batteries.

Consumer Li-ion cells have inherent drawbacks, including short operating life (maximum 5 years and 500 recharge cycles, a high annual selfdischarge rate (up to 60% per year) and a limited temperature range (0°C to 60°C) with no possibility of recharging or discharging at extreme temperatures.

Industrial-grade rechargeable Li-ion batteries are now available that feature up to 20-year operating life with 5,000 full recharge cycles, able to deliver high-current pulses (up to 5A) and offering a much wider temperature range (-40°C to 85°C) with the ability to be discharged and recharged at extreme temperatures (10-hour rate).

Industrial grade Li-ion batteries could see dramatic opportunities

✓ ✓ ✓ ✓ ✓

for growth with telematics and GPS tracking devices being coupled with heart rate, temperature and other advanced sensors used to monitor the health and location of patients in hospitals, nursing homes, assisted living quarters or remotely. These and other emerging medical technologies will benefit from reliable, long-term battery-powered solutions. M Sol Jacobs is VP and general manager for Tadiran Batteries. He has more than 25 years of experience in developing solutions for powering remote devices.

BioAccess surgical power drills use lithium metal oxide batteries to achieve a 36% weight reduction with only 40% of the volume of comparable alkaline batteries.

Image courtesy of Tadiran Batteries

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ELECTRICAL / ELECTRONIC COMPONENTS

Enabling micro-sensors for next-gen interactive implants CerMet – an advanced ceramic and metal technology system – creates the potential for implantable devices with thousands of electrical channels. Think new options for treating blindness and neurological conditions.

Chris Newmarker Managing Editor

Only a few years old, Heraeus’ CerMet is upping the game when it comes to sophisticated implantable electronic devices.

“Medical implants manufactured using the Heraeus CerMet technology can be smaller, more efficient and capable of integrating more functions,” Jens Troetzschel, VP of advanced technologies at Heraeus (Hanau, Germany; St. Paul, Minn.), told Medical Design & Outsourcing. “We can now utilize extremely fine circuit paths that are only 0.15 mm thick, as thin as a piece of paper.”

We asked Troetzschel to explain CerMet and the medical device advances it’s enabling; the following is an edited transcript of our conversation: MDO: What exactly is Heraeus CerMet technology?

Troetzschel: The Heraeus CerMet material is a strong, high-density and extremely robust ceramic and metal (CerMet) composite of tiny platinum and aluminum oxide particles. But ceramic and metal typically do not bond chemically. To manufacture a feedthrough, until now, individual wires were inserted manually into the ceramic and soldered with a high-temperature process, which is labor intensive and time consuming. However, when many electrical channels are needed, this process quickly reaches its limit, which prevents the development of sophisticated miniaturized devices applied in novel therapies. With CerMet it is possible to realize a density of more than 5,000 electrical channels per square inch, which is a substantial improvement compared to current technologies – and this is not the end of the development.

This CerMet technology offers developers and manufacturers of implants greater flexibility in designing new devices because the material system allows for the production of more complex three-dimensional structures. In the area of feedthroughs, it will now be possible to manufacture angled or branched circuit paths, thereby allowing unprecedented design flexibility for the medical implants of the future.

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Heraeus CerMet microcomponent with internal routing to simplify the design of medical implants e.g. implantable sensors

A future retina prosthesis, for example, could be equipped with a significantly increased number of channels, conveying signals from the implant to the optic nerve, which results in improved imaging.

MDO: Where is CerMet being used already?

Troetzschel: We have entered into various partnerships with leading companies and research teams to develop next generation micro-implants. For example, Heraeus is now working with research teams on new interactive microimplants for the treatment of tinnitus, functional disorders of the gastrointestinal tract, and multilocular muscle stimulation in the field of bionic implants as part of the [five-year, €13.5 million] INTAKT innovation program, which is sponsored by Germany’s Federal Ministry of Education and Research (BMBF) and led by the Fraunhofer Research Institute. This network of medical industry, research, science and clinics is now developing new interactive micro-implants to improve therapies for numerous medical issues and therapies. The INTAKT Program is using the Heraeus CerMet technology to enable a significant miniaturization of novel medical devices.

This program allows us to fine-tune our technology even more, and the close cooperation with medical professionals leads to a much deeper understanding of clinical needs.

www.medicaldesignandoutsourcing.com

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ELECTRICAL / ELECTRONIC COMPONENTS

Within the scope of technology studies, we developed technologies to connect Heraeus CerMet components to electronic circuit boards on the inside of medical devices and to lead wires on their outside.

Heraeus currently is developing technologies for the integration of CerMet composites in titanium housings.

We are also working with numerous medical device manufacturers worldwide to develop next generation enabling solutions in the fields of neuro stimulation, retina implants, hearing aids and implantable sensor applications.

MDO: What is the future of CerMet? Troetzschel: In general we see a major shift in technologies ahead of us.

Mathematicians and programmers have developed powerful algorithms and software to analyze huge amounts of data to derive information. We’ve got the computational power to handle these huge amounts of data in real time in this day and age. Neuroscientists and researchers are getting a better and more refined Higher channel count can give better resolution e.g. to improve the performance of next generation retina implants.

(Image a) Shows an 8×8 grey scale picture of an apple, illustrating a retinal implant with 64 channels, b) shows a 16×16 resolution equaling 256 channels, c) shows 36×36 channels equaling 1296 channels.)

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ELECTRICAL / ELECTRONIC COMPONENTS (LEFT) Example of a high channel count feedthrough element to enable high resolution therapy e.g. for retina implants

The Greatest Brains In Magnetic Assemblies picture of the processes that happen in the human body.

All this happening in parallel at the same time creates an enormous momentum which is used by an entirely new group of players in the field of medical devices. Elon Musk’s Neuralink is an example, as well as Apple’s and Google’s activities in this arena.

However, these innovations will require implantable, miniaturized devices able to interface with the nervous system or more generally with the tissue of the human body – and they will have to sense certain bio-signals (biomarkers), process the data and/or transmit to systems outside of the body – which will display the information to doctors or directly to the patients.

Heraeus CerMet technology can open entirely new design options for significantly miniaturized devices. At the same time, the CerMet technology can allow for a virtually unlimited number of communication channels to interface with the body, and thus can help feed this enormous appetite for data.

As a biocompatible and bio-stable material technology system, CerMet will serve as a means for encapsulation of tiny little sensors or stimulators – which can in combination with flexible electrodes be placed everywhere in the human body, exactly at the point where the signal should be sampled or stimulation is needed.

Hundreds of channels will be used to feedthrough signals in retina implants as well as in brain readers or wearable general purpose recorders for neuro signals – just everywhere where a higher resolution yields a better “picture.”

CerMet will enable a new quality of delivering the therapy to exactly the right point. M Jens Troetzschel, Vice President Advanced Technologies, Heraeus Medical Components 11 • 2017

Medical Design & Outsourcing 35

Electrical Components_10-17_Vs3.indd 35

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ELECTRICAL / ELECTRONIC COMPONENTS

Why Flex is betting on stretchtronics for medtech Stretchtronics is flexible circuitry that could be implanted into clothing and could offer both worn or implanted opportunities for body monitoring.

Heather Thompson Senior Editor

36

The wearable lab at Flex (formerly Flextronics) says it’s making strides when it comes to creating devices that are transparent and seamless.

“Usually when you think about healthcare, you picture a person in a bed with wires running all around. We think healthcare should be as easy as putting on a T-shirt,” John Carlson, president of health solutions, told Medical Design & Outsourcing.

In Flex’s San Jose innovation and early technology labs, Anwar Mohammed shared one of the most intriguing technologies with medical applications. Mohammed is senior director at the advanced engineering group at Flex and provided some insight into the technology during a press tour in September. (Note: None of the devices MDO was shown are FDA cleared or approved. They were strictly proof of concept.)

Stretchtronics is flexible circuitry that could be implanted into clothing and could offer both worn or implanted device opportunities for body monitoring. You might recognize the technology—

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USUALLY WHEN YOU THINK ABOUT HEALTHCARE, YOU PICTURE it was featured in U.S. Olympic A PERSON IN Athletes’ light-up clothing designed A BED WITH

by Ralph Lauren.

And it could go WIRES RUNNING even further, such as be threaded ALL AROUND. into conductive yarn, noted WE THINK Mohammed.

The stretchable HEALTHCARE technology has been used in SHOULD BE AS sweat monitoring cuffs in the NFL. In EASY AS PUTTING terms of medical ON A T-SHIRT. applications, Carlson said that the sweat cuffs monitor glucose levels, as well as lactate and electrolyte levels.

Those data could be practical for a therapeutic or diagnostic application. In orthopedics, the sensors could be embedded in shoes or socks to measure activity rates post-surgical patients.

Another valuable area of therapy the technology can be used in is wound care. Flexible electronics could incorporate antibacterial technology, with hydrophobic and oleophobic properties.

Sensors that measure O2 levels can play a role in monitoring the progress of a wound. Mohammed also mentioned a theoretical ability to predict pressure ulcers.

Wound monitors placed on at-risk areas of the body could contain sensors that warn caregivers of changes that could lead to ulcerative conditions.

www.medicaldesignandoutsourcing.com

11/3/17 12:26 PM

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Mohammad noted that the material has significant applications in implantable devices, because of its flexibility. The electronic components won’t rupture or delaminate even after hundreds of use cycles.

Devices that use the flexible electronics have a unique opportunity to function alongside tissue, rather than be isolated from it.

“When the bodies’ cells identify foreign objects, and start to reject them, one of the first indications [is that they push on them],” Mohammad said. “Thanks to work being done at MIT and Johns Hopkins, they’ve been able to show that it can take up to 19 days for the body to recognize stretchable electronics as a foreign object. That is 19 days in which you can monitor and treat severe trauma.”

Stretchable electronics in medical applications is still nascent, Mohammed noted. As the technology advances new applications could be revealed. M

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ELECTRICAL / ELECTRONIC COMPONENTS

Three ways to integrate UVC LEDs into medical equipment and devices Adding disinfection with UVC LEDs is a viable alternative to chemicals, according to Crystal IS. Here are three examples of how they can make a difference.

Rajul Randive Crystal IS

In 2017, the Centers for Disease Control & Prevention (CDC) reported significant progress in many areas commonly associated with hospital acquired infections (HAIs). However, on any given day about one in 25 people who visit a healthcare facility in the U.S. will still contract an HAI. Infection reduction depends on combating pathogens that are becoming increasingly resistant to chemical disinfection methods. Adding disinfection with UVC LEDs is a viable alternative to chemicals because it disrupts the DNA of harmful microorganisms and destroys their ability to reproduce, thereby eliminating the spread of MRSA, C. diff. and many other pathogens that have no known natural defense mechanism to UVC energy exposure. Although there are many ways to integrate UV disinfection with LEDs throughout the hospital, the following cases offer the most opportunity for near term impact on the rate of HAIs. 1. Preventing C. diff Infections on high-touch surfaces Clostridium difficile (C. diff.), one of the most-reported HAIs, causes nearly 500,000 illnesses per year. It’s a remarkably resilient pathogen that’s easily transported on high-contact devices including mobile phones, stethoscopes, workstations and diagnostic tools. These devices are usually cleaned with chemicals such as isopropyl alcohol – but alcohol wipes do not kill C. diff. UVC LEDs provide a method for a quantifiable and trackable UVC disinfection dose via handheld or countertop devices to combat the superbug. In addition, integration directly into portable workstations and diagnostic equipment allows surface disinfection as hospital staff transition between patient rooms.

2. Quantifiable hub disinfection for CLABSI reduction The CDC reported a 50% reduction in central-line-associated blood stream infections (CLABSI) between 2008 and 2014, but recent improvements have

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been less dramatic. Disinfecting the hub of a central line is a manual process that relies on friction and time. It takes up to 60 seconds when executed properly and there is no way to verify compliance. A handheld LED device attached to an infuser could be aimed at the hub and within seconds deliver a UVC dose capable of a 4-log reduction of common pathogens like MRSA. The result is that a consistent disinfection dose is applied to a common site of pathogen transport in far less time.

3. Preventing ventilator-associated pneumonia UVC LEDs can also be used to address ventilator associated pneumonia (VAP). Though it occurs in only 1% to 2% percent of patients using mechanical ventilators, VAP mortality rates are greater than 50%. Focused UVC energy from a LED-enabled device could disinfect complex passageways, in-vitro components and even nebulizer equipment in-situ without heating the target surfaces.

Considerations for selecting a UVC LED When working with LEDs, there are number of parameters designers need to consider. The primary factor centers

Graph courtesy of Crystal IS

www.medicaldesignandoutsourcing.com

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around the desired log reduction, or disinfection rate, of the specific target microbe in the application. This defines the UV dosage required which designers need to achieve while balancing the other variables like UV intensity, disinfection time and uniformity of the UV radiation pattern in the design.

Each target microbe has a unique radiation absorption, or “fingerprint,” meaning they absorb UV photons differently at different wavelengths based on their cell structure. The accompanying graph shows the absorption spectra for a few common microbes found in healthcare settings.

The absorption curves show that there is a significant drop in microbe sensitivity at wavelengths shorter than 255 nm and greater than 275 nm. To ensure maximum disinfection performance, design engineers select a UVC LED that offers the greatest overlap of the target microbes absorption spectra, most typically with a peak in the 260 nm–270 nm range.

Once an LED is selected with the optimal peak emission, designers then consider the amount of UV intensity

required over a given time to achieve the disinfection target – this is known as dosage. To achieve a high dosage in a short amount of time to address CLABSI, the application would require high intensity. For applications that have more time for disinfection like hightouch surfaces or VAP applications, lower intensity LEDs can be used.

Healthcare providers, medical device OEMs and disinfection equipment manufacturers have every reason to embrace smaller, portable devices that employ solid-state technology like UVC LEDs. Doing so will significantly bolster what’s projected to be a long and difficult fight against the spread of infectious diseases and the ongoing emergence of chemical resistant super bugs. M Rajul Randive is director of application development at Crystal IS (Green Island, N.Y.), responsible for designing, building and testing various prototype applications that use Crystal IS UVC LEDs.

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FLUID POWER COMPONENTS

Imagining the future of heart pump technology Since its introduction more than 50 years ago, the left ventricular assist device has evolved from being a temporary solution to a long-term option for patients recovering from heart failure. Now, companies are engineering the LVAD of the future to be smaller and more adaptable for individual patients.

For more than 50 years, left ventricular assist devices (LVADs) have helped to extend and improve heart failure patients’ lives by assisting their hearts in pumping blood. Originally, LVADs enabled physicians to save patients’ lives for only short periods of time – they were considered a temporary solution for those that needed heart transplants.

Now, advances in design and functionality allow LVADs to be used long-term. With an eye toward progress, clinical and engineering communities are exploring where the technology is headed over the next decade.

D r. J o h n O ’ C o n n e l l Abbott

Previous generations: Pulsatile pump to continuous flow First introduced in the 1960s, the LVAD was initially intended to support patients pending myocardial recovery, or heart failure reversal. Although they were huge advances, early LVAD models featuring a pulsatile pump had some limitations: Battery life (an hour or two at most) and patient mobility. In fact, the device was so cumbersome that patients struggled to eat a full meal because the pump encroached on their digestive space.

The next generation of LVAD devices, such as Abbott’s HeartMate 3 pictured here, usher in a new wave of patient care.

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FLUID POWER COMPONENTS

The second-generation LVADs, which debuted in the early 2000s, were continuous axial-flow devices that improved on the pulsatile devices but posed a risk of blood clot formation and driveline infection where the LVAD motor connects to its external power source.

Patients also exhibited nonphysiologic flow (minimal pulse pressure, if any); combined with the high shear forces generated, this played a role in increased GI bleeding. To combat these negative side effects, scientists and engineers worked to develop a pump that would not clot and would be more compatible with a patient’s natural bloodstream.

blood and allows variable speeds to generate a “pulse” of 30 beats per minute. This flushes the pump out to reduce stasis and the risk of thrombosis.

The latest model also extends battery life, reducing the patient burden of recharging and swapping out batteries.

WITH AN EYE TOWARD PROGRESS, CLINICAL AND ENGINEERING COMMUNITIES ARE CURRENTLY EXPLORING WHERE THE TECHNOLOGY IS HEADED OVER THE NEXT DECADE.

Today’s LVAD: Centrifugal pump What makes this generation unique is its centrifugal pump, which spins in a circular fashion, ensuring blood does not become static to reduce the chance of clotting. The rotor is suspended magnetically to ensure it remains centered regardless of speed. Due to its large gaps, magnetic suspension is less traumatic to the

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Medical Design & Outsourcing

Engineers are taking the next major step forward by creating a smaller pump that requires less wattage – allowing for total battery implantation and safer recharging, less-invasive implantation procedures and greater patient freedom – and that’s more compatible with a heart that has experienced failure.

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Looking ahead: Designing the LVADs of the future Engineers and clinicians envision a device that’s more invisible to the patient and adaptable to the unique physiologic demands of each person. This nextgeneration LVAD will be designed to be fully implantable (to reduce infection risk) on both the left and right sides of the heart, with multiple feedback mechanisms to automatically regulate pump functions.

Twenty years ago, helping an advanced heart failure patient live for more than a year was considered a medical feat. Today the majority of patients live an average of two years with an LVAD as they await transplantation. Thanks to the hard work of today’s clinicians and engineers, that number will continue to improve in years to come. M Dr. John O’Connell was named VP, Medical Affairs & Medical Director, Mechanical Circulatory Support for St. Jude Medical (now Abbott) as part of the Thoratec acquisition in October 2015. Prior to joining Thoratec in October, 2013, Dr. O’Connell served as a heart failure cardiologist for 33 years.

If point A is your design concept and point B your finished product, then you can consider this the straightest line for pumps and compressors.

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HIGH-PERFORMANCE POLYMERS

PEEK formulations for new implantable devices Since the late 1990s, polyether ether ketone has become a go-to material for companies that manufacture orthopedic implants, thanks to its radiolucent and anatomical properties. Now, custom formulations of PEEK are enabling new potential applications for the polymer.

Lawrence Acquarulo Foster Corp.

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Polymers have always played a role in modern implantable medical devices. But until the late 1990s, many suppliers limited availability for longterm implants due to potential litigation liability in an inherently low-material-volume market. As such, metals remained the materials of choice through the end of the century.

Several factors changed the implantable polymer paradigm, including passage of the Biomaterials Access Assurance Act in 1998, which limited the civil liability of material suppliers. Suppliers also began developing business models to provide adequate returns on low-volume sales. As a result, polymer supply and innovation for implantable medical devices surged in the 21st century. No polymer represents this dynamic growth more than PEEK – polyether ether ketone.

In less than two decades, PEEK has become the material of choice for some orthopedic implants, such as intervertebral fusion cages. This has been attributed, in part, to the anatomical compatibility of PEEK and its inherent radiolucency.

Many traditional orthopedic implants, including fusion cages, were manufactured from titanium and stainless steel. These materials are extremely rigid, with elastic moduli of 100 GPa (14,500 ksi) and 193 GPa (28,000 ksi), respectively.

By comparison, the elastic modulus of cortical bone is approximately 18 GPa (2,610 ksi). This disparity in rigidity can cause stress concentration on the skeletal structure adjacent to the implant.

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In contrast, unreinforced PEEK has an elastic modulus of 3.7 GPa (540 ksi) and a tensile elongation of 45%. This provides a semi-rigid, yet tough implant that reduces stress concentration on adjacent bone. Implants have also been developed that are made of PEEK compounds reinforced with chopped carbon fiber, resulting in device rigidity equal to that of bone for greater structural continuity.

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HIGH-PERFORMANCE POLYMERS

Furthermore, metal implants are inherently opaque to X-rays (radiopaque), which limits the postoperative visibility necessary for some procedures. A major advantage of PEEK over metal intervertebral spinal fusion cages is inherent X-ray transparency (radiolucency) for postoperative evaluations.

Success in intervertebral cages led to increased interest in PEEK for other applications, including orthopedic trauma fixation, spinal stabilization, dental implants and ligament anchors.

Whereas the inherent radiolucency of PEEK is suitable for spinal fusion procedures, some of these new devices must be radiopaque.

Radiopaque fillers can be compounded into PEEK to enhance x-ray visibility. Selection of the appropriate filler and loading is based on clinical requirements, component size and location within the body.

The most common additives used to enhance the radiopacity of medical polymers are bismuth subcarbonate, bismuth trioxide, bismuth oxychloride and barium sulfate. The high melt temperature of PEEK, which exceeds 335°C (635°F), limits several of these radiopaque filler options.

Bismuth subcarbonate is limited to melt processing temperatures up to 205°F (400°C), beyond which it becomes unstable and turns from white to yellow; bismuth trioxide tends to turn from white to brown at PEEK processing temperatures. Bismuth oxychloride can be processed at elevated temperatures, but it reduces the melt flow of PEEK, which can impact molding or extruding quality parts.

Barium sulfate is the most common additive for radiopaque PEEK formulations. It disperses well in the polymer and can withstand the processing temperatures without color change. Barium sulfate is also biocompatible and has been used in minimally invasive devices (<30 days) and long-term implants (>30 days), such as bone cements.

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implantable devices, the availability of custom formulations designed to enhance key properties will expand.

At the forefront of consideration for suitable additives will be the elevated compounding and component processing temperatures of the polymer. M Lawrence Acquarulo is the founder & CEO of Foster Corp., a developer and manufacturer of critical polymer compounds for medical devices and drug delivery.

Table 1: Typical Properties of Implantable Materials

Property Units

Stainless Steel Titanium (316) (Grade 4)

PEEK (30% carbon fiber PEEK reinforced) (natural)

Tensile ksi 125

80

37.7

14.5

Strength MPa 860

550

260

100

3,6000

540

Elastic Modulus

ksi 28,000 14,5000 GPa

Elongation %

193

100

25

3.7

12

15

1.7

45

Table 2: Common Radiopaque Fillers for Plastics

Specific Heat Particle Radiopaque Gravity Stability Size Characteristics Filler (gm/cm3) (°F) (μm) Barium 4.4 700 0.5-2 Sulfate

White powder, medium bulk density, compacts, semi-free flowing with assist

Bismuth 8.0 400-450 1-2 Subcarbonate

Pale white powder, free flowing, dusty, low to medium bulk density

Bismuth 8.9 400* 1-2 Oxychloride

Yellow powder, high bulk density, free-flowing *turns brown at approximately 400°F

Bismuth 7.8 500 2-12 Trioxide

White to light gray powder, very dusty, low to medium bulk density, semi-free flowing

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Liquid silicone rubber is great for medical device applications, but is the tooling worth the trouble?

Dave Theiss Robin Industries

Liquid silicone rubber (LSR) is a sought-after material for medical applications. But there are tooling challenges and expenses associated with LSR that need to be understood by medical manufacturers looking to use the material.

What’s so great about LSR? Many LSR materials are biocompatible, with some grades approved for implants. Devices made from LSR are temperaturestable and can withstand harsh cleaning and disinfectants. Further, LSR resists discoloration from UV exposure, is scratch-resistant and retains a cosmetic attractiveness throughout a product’s lifecycle.

The material comes in an array of durometers, available at 5–90 durometer, that can be mixed to match any color. It can also be made optically clear, and it is second only to glass in light transmission.

LSR has a low viscosity that can be molded into components with thin walls or small features. Once cured, the material is flexible and can be easily removed from a mold form, even with undercut shapes. Some grades of LSR materials will bond to specific substrates during overmolding, thus eliminating the prepping step required by other overmolded materials.

In addition, LSR parts can be fully cured in seconds rather than minutes, compared with HCR silicone, which speeds up cycle times.

Trouble with tooling LSR tooling is expensive and building molds requires high precision and expertise beyond what’s needed for rubber and thermoplastics.

The liquidity of the material means that the cavity inserts must be absolutely precise to prevent flash extension. For example, tooling for many LSR processes will flash with fits as tight as 0.0002–0.0003 in.

Ejector pins can be used in LSR molds, but they must have a tapered shutoff and can’t invade the parting-line shutoff area.

Typically, ejector pins are avoided because any amount of debris or rubber that builds on the ejector valve seat will cause flash.

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LSR molders will likely use a vacuum in most tooling to get rid of outgassing, because the venting used in other thermoplastic processes doesn’t work as well. LSR comes in two parts and must go through a chemical curing process before being injected into the mold. Depending on the final part needs, venting might need to be ten-thousands-of-an-inch deep to control flash for tight specifications.

Curing LSR also requires a precise hand.

The molds are usually heated to 270-360°F to cure and require strategically placed electrical cartridge heaters in the mold. Heating molds to these temperatures will start the cure process in seconds. LSR also begins to cure at room temperature once the reactive

Image courtesy of Robin Industries

components are mixed. Therefore, the process requires flowing coolant to control the temperature up to the cavity.

Shutting down an LSR process is timeconsuming and generates material waste.

The dosing system requires disassembly and each component must be cleaned with a solvent. The A and B hoses are removed and the static mixer completely disassembled and also thoroughly cleaned with solvent.

System clean-out can take up to four hours; disassembling and cleaning tools will take the rest of the work day.

Overcoming tooling issues Molders with LSR expertise are aware of these challenges and can adjust by simplifying mold

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construction. Some use cavity inserts that go into standardized mold frames.

These frames will have a hot or cold runner system that can adapt to the cavity inserts, eliminating the need to build a frame for each part.

Miniature material dosing systems can minimize set-up and material waste.

Table-top dosing systems use short hoses or attach directly to the injection unit to simplify priming and cleanout process.

A pressure pot is a sealed reservoir that uses air pressure to force the LSR into the injection unit. The pressure pot requires premixing the LSR as part of the set-up, but eliminates the need to prime and clean out static mixing units. Further, the pots are easily removed from the machine and can be refrigerated to extend the life of the pre-mixed LSR. These adaptations will not cut out all costs, but they do simplify set-up and shutdown procedures. Because of the need for a high level of precision, and the risks of waste, expenses can add up quickly. It is important to work with a molding house that has LSR experience and can offer part design consulting early in the process. M Dave Theiss is technical director at Robin Industries (Independence, Ohio).

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HIGH-PERFORMANCE POLYMERS

How to add recyclability and sustainability into medtech plastics Recyclability and sustainability have become very important across the medical device marketplace, and some companies are taking note.

Jason Middleton, Ray Products

Some implement sustainability to appeal to consumers; others look to cut costs or align their business practices with their company mission. Whatever the motivation, 13% of CEOs see sustainability as their top priority, while another 36% view it as a “top 3” priority.

What role does plastic manufacturing have in the realm of sustainability? Quite a large one – at least potentially. More than 300 million tons of plastic are manufactured every year and this number is growing significantly. Globally, it’s estimated that less than 3% of that plastic is recycled.

Picking the right process Planning for recyclability starts with the process you choose. Some processes, like thermoforming, are easily 100% recyclable. Other processes, like fiberglass or thermoset manufacturing processes such as RIM, are either non-recyclable or can only be downcycled into other materials.

Beyond sustainability, thermoforming is particularly popular in medical device manufacturing because its

sweet spot is making high-quality, aesthetically pleasing parts in quantities from the low hundreds to the midthousands.

Easily recyclable processes include pressure forming, vacuum forming, injection molding and blow molding.

Processes that are non-recyclable or impractical to recycle are RIM, fiberglass and other thermoset processes.

Recycled materials options in thermoforming The most sustainable plastic manufacturing process uses recycled materials and creates a recyclable product.

Thermoforming can check both boxes.

On the materials side, thermoforming projects can be made from any combination of virgin and recycled materials. It helps to think about it in terms of a percentage. A project could use any percentage of recycled materials — from 0% all the way up to 100%.

An experienced thermoforming engineer can help you balance your performance, aesthetics and certification requirements with the availability of recycled materials.

Zero-waste manufacturing Pressure-forming and vacuum-forming also offer a zerowaste manufacturing process. During the thermoforming process, after a part is formed and removed from the mold, the excess material is trimmed. However, none of that material need end up in a landfill. Instead, the material can be collected, ground and sent back to the plastic suppliers for reprocessing.

Image courtesy of Ray Products.

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HIGH-PERFORMANCE POLYMERS

Design considerations for thermoforming recyclability When you’re planning a thermoforming project, what you do after your parts are thermoformed has a lot to do with their recyclability. Every piece of thermoformed plastic is, by definition, recyclable, but the process can be made more challenging by additions such as bosses or other attachment hardware, painting, silk screening or other coatings.

These are not insurmountable obstacles, but they do require a more specialized and labor-intensive recycling procedure.

The future of sustainability in plastic manufacturing To the average consumer, the words “sustainability” and “plastics” might seem out of place in the same sentence. But the truth is that plastics manufacturing can play a critical role in creating sustainable products and product life cycles. As more and more companies embrace sustainability as a core objective and as more and more consumers demand sustainability, understanding and utilizing sustainable plastic manufacturing processes becomes more important than ever. M

Designing for a sustainable end of life It’s strange to think that the products we create today will someday be discarded, but nothing lasts forever. If you’re concerned about sustainability, you must consider and plan for the day your products are disposed of.

No matter what process you use, consider the following key factors when designing for a product’s entire lifecycle:

Jason Middleton is VP of sales & development at custom heavy-gauge thermoforming manufacturer Ray Products (Ontario, Calif.).

Key Design Characteristics

Consideration

Materials selection

Are your individual materials commonly recyclable, or can they only be downcycled or recycled through specialized processes?

Number of materials

Generally, the more materials that exist in a single piece of equipment, the more complex it is to recycle

Size

Smaller pieces of equipment can be more easily transported to recycling facilities

Ease of disassembly

Products typically have to be disassembled and separated into individual components before they can be recycled

Cleanliness

Under typical usage, will your product be contaminated with other materials that will need to be removed before the product can be recycled?

Design and technology cycle

How long do you expect this product to be on the market before it’s made obsolete by a new design or technology?

Durability

How long will this product last before it needs to be replaced?

Hazards

Does your product contain hazardous materials that will need to be dealt with in specialized ways?

Chart courtesy of Ray Products.

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MACHINING

Why high-speed machining demands a high-end toolholder In high-speed machining for medical equipment manufacturing, choosing the right toolholder is the key to greater precision, longer tool life and decreased machining costs.

Jeff Elliott C o l l i s To o l h o l d e r

As any machinist will tell you, when it comes to precision machining the importance of a toolholder cannot be overstated. The quality of the toolholder plays an even greater role when precision machining at higher speeds.

High-speed machining is typically utilized for medical equipment manufacturing, in which machinists often work with exotic alloys and harder metals like titanium.

However, with speeds reaching 20,000 RPM, 30,000 RPM or even higher, the precise and secure seating of a properly balanced toolholder in the spindle becomes even more critical. At these rates of speed, even minor flaws in toolholder manufacturing can lead to less-precise machining, reduced tool and spindle life and even damaged workpieces.

This is why it’s important to understand the crucial role of a quality toolholder, which for tapered varieties boils down to two key factors: Fit and concentricity.

Without any holding or locking mechanism, self-releasing toolholders must precisely fit within the spindle with only the smallest allowance to maintain accurate location, repeatability and proper hold.

The other factor, concentricity, refers to the amount of wobble that can occur when the toolholder is rotating or spinning. In machining, this is called “the whipping effect” and can lead to inconsistent results and out-of-tolerance parts.

Decreased tool life and damage to the workpiece Using a less-precise or imported toolholder for highspeed machining can also decrease tool life or cause damage to the workpiece.

“If the toolholder is not concentric or is a little off-center, you will have rubbing, wear and more friction, which decreases the life expectancy of the tools,” explained Bart Fellin of Fellin Industrial Sales (Flemington, N.J.), a company that represents a variety of machine tools and toolholders.

When machining exotic alloys and hard metals, cutting tools already must be changed out more frequently as they dull or break. The cost of tool replacement, not to mention loss of production time due to frequent changeover, can add up quickly.

THE HIGHER-END TECHNICAL CARBIDE INSERTS REALLY DEMAND A HIGH-PRECISION TOOLHOLDER. IF YOU END UP BREAKING A TOOL IT COULD CAUSE HUNDREDS OF DOLLARS’ WORTH OF DAMAGE.

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“The higher-end technical carbide inserts really demand a high-precision toolholder,” Fellin explained.

“If you end up breaking a tool it could cause hundreds of dollars’ worth of damage.

“Not only is the tool expensive, but you have to change it out more often, and that takes time,” he added. “So when you cost out a job, you may find you are over budget rather than making a profit. It can make or break a deal.”

Less-precise or imported toolholders can also cause damage to the workpiece, which would then have to be repaired or thrown out.

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MACHINING

Image courtesy of Collis Toolholder

e at Jos 36 s 6 e u an # Se d S oth e Bo oM -7! i B .6

“You could be spending hundreds of hours designing a tool and then find out that it’s cutting slightly oversized holes, as an example, because the toolholder could not hold the tool properly,” Fellin said.

Contact us to discuss your project, and request a free sample kit today!

Quality assurance Fellin cautions against purchasing lessexpensive, imported toolholders based on price alone.

“There’s a lot of competition from imports and a lot of misleading information where they claim their toolholder is just as good,” he said. “But ‘time is money,’ so when you have to get a quality part out and you don’t want it getting rejected, then you want to make sure the accuracy is going to be there.”

One way to ensure you’re buying a quality toolholder is to look for its certification, which should be “AT3 or better.” AT3 refers to the tolerances related to the fit of the toolholder in the spindle.

Collis Toolholder touts itself as the only manufacturer to certify products as AT3 or better. It also places special emphasis on accurate concentricity. To prevent the aforementioned wobble or “whipping effect” from occurring, manufacturers often specify the level of unbalance by a G number with units in millimeters per second (mm/sec). This is why machine-tool spindles and machinetool parts usually are specified with vibration levels of G2.5 and G6.3. This is also why Collis toolholders are balanced to the higher G2.5 standards.

By producing tapered toolholders with a superior fit and greater balance, their toolholders can run at higher RPMs with less fretting, resulting in more accurate work and better surface finishes.

According to Fellin, in the medical device industry, OEMs are looking for repeatability in each toolholder as well.

“Being able to know that from the first toolholder they purchase to the fifth to the 20th, they are going to get the same quality is very important,” he said. M

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Jeff Elliott is a Torrance, Calif.–based technical writer. He has researched and written about industrial technologies and issues for the past 20 years. Collis Toolholder (Clinton, Iowa) has been manufacturing high-quality products for more than 100 years.

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High-volume manufacturing: Four points to consider before you scale up

Using a "design for manufacturing" approach helps ensure your products can be manufactured efficiently over the entire product life cycle. You must consider the equipment and processes that will be required should a device be designated for highvolume manufacturing.

Image courtesy of B. Braun Medical

Scaling to high-volume manufacturing requires companies to think ahead and prepare for the future early in the product life cycle. Here are four points to reflect upon before your company scales up.

G a v i n Wa d a s B. Braun Medical, Inc. — OEM Division

High-volume manufacturing typically involves the introduction of automation into the medical device fabrication and assembly process. A number of benefits usually follow: Repeatability, higher quality and lower (and more predictable) long-term costs of operation. However, many medical devices begin their life cycle below the high-volume threshold, sometimes with manual procedures. Successfully scaling to high-volume manufacturing requires foresight and planning to streamline the production process and minimize changes that could make your move to high-volume manufacturing more lengthy and expensive.

Weigh these important considerations early in the product life cycle: 1. Design for manufacturing: Device design needs to encompass more than end-user specifications. It’s essential that devices are designed to be

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manufactured efficiently over the entire product life cycle. That means taking into consideration the equipment and processes that will be required should a device be designated for high-volume manufacturing. After all, the automated, high-volume processes could be slightly or significantly different than the benchtop or prototype equipment used for producing lower volumes. Early discussion with the manufacturing team is critical to understand how high-speed automation may affect the design so provisions can be made to avoid problems when scaling up.

2. Material selection: A crucial part of designing for manufacturing is ensuring that the materials selected are acceptable for high-volume processes. Devices with injection-molded components are a perfect example. Lower cavitation might be more

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MANUFACTURING

forgiving with a given material (such as a polycarbonate) than a high-speed system producing components in a 96-cavity mold.

Some materials that are suitable for manual assembly might be incompatible with automated processes such as sonic welding or mechanized high-speed clamping. The solution is to select materials that you’ve already qualified for manufacturing with different processes at various volumes.

Otherwise you’ll need to burn time and money adjusting and potentially updating regulatory applications.

3. Supply chain and procurement confidence: Given the importance of material selection – and the obvious need for higher quantities of materials when producing higher volumes – it’s important to work closely with strategic procurement to ensure that the suppliers selected at the outset of a device’s product life cycle will be able to continue supplying with the same quality and reliability when volumes increase. Will the suppliers be able step up when you ask them? Do they have a long-term commitment to producing the material or component? Will they have the financial resources and management stability to continue supplying you once you invest in automated processes? The time, expense and uncertainty of qualifying a new

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supplier can cut into the cost efficiencies of a high-volume, automated process.

4. Team approach to optimize efficiency: The move to high-volume manufacturing isn’t a once-anddone event. There are many opportunities to continue learning and improving after the process has been established. That demands involving the entire team, from engineers to machine operators; each brings a unique perspective. And with high-volume manufacturing, even a small improvement in cost or efficiency can be significant when extended over millions of pieces. The team approach should also incorporate suppliers critical to the capacity to upgrade to high-volume manufacturing, such as custom machine builders and mold manufacturers. The more they know about the long-term project expectations and objectives, the better they can supply equipment that will meet the design intent and match the product’s intended life cycle.

Overall, high-volume manufacturing requires a product life-cycle approach that looks beyond immediate needs

A crucial part of designing for high-volume manufacturing is ensuring your materials are acceptable for high-volume processes. Devices with injectionmolded components are a perfect example.

Select materials that you’ve already qualified for manufacturing with different processes at various volumes.

Image courtesy of B. Braun Medical

and anticipates future demand. After long-term volume parameters have been established to complement product specifications, the team can determine how to meet both short-term and longterm volumes – and have a road map to scale and realize the benefits of highvolume manufacturing. M Gavin Wadas is Manager, Strategic Capital Projects for B. Braun Medical, Inc., OEM Division. He has more than 15 years of experience in project and program management, operations, capital planning and product engineering within the life sciences industry and is involved in managing medical device product life cycles.

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MANUFACTURING

Best practices for selecting a micro-MIM supplier Smaller medical devices mean extremely tight tolerances. Here’s how to identify the best supplier and manufacturing method to meet them.

R a g h u Va d l a m u d i Donatelle

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With the development of increasingly smaller medical devices comes the challenge of identifying the best supplier and manufacturing method to meet extremely tight tolerances.

Millimeter-sized components with micron-sized features are pushing the limits of traditional machining methods. As tolerances become tighter, machining is less consistent and supplier costs increase. Suppliers understand that micro-metal injection molding (micro-MIM) is becoming a go-to process for micro metal parts.

Micro-MIM can be a viable manufacturing alternative for such parts as metal connectors in implantable pulse generators and gear pump components. It’s also an alternative for components for the cardiac rhythm disease management, dental, ophthalmic, orthopedic, drug delivery and surgical ablation markets.

As components become smaller, weighing less than a few milligrams, the challenge with conventional machining is maintaining the extremely tight tolerances necessary to efficiently produce high-quality medical components at high volume.

Machining processes are unable to consistently produce micro-features. Different types of cutting tools are needed to machine different features to produce a single part and there may be a need to use more than one machine tool – making the manufacturing process expensive and inconsistent.

When considering micro-MIM suppliers, be aware of the critical capabilities needed to produce quality parts.

Based on our work with medical device companies, Donatelle identified four areas in which micro-MIM suppliers can fail – causing delays, added costs and often the need for a new supplier:

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Image courtesy of Donatelle

1. Using scientific principles to develop manufacturing processes Perhaps the most important consideration in choosing a micro-MIM supplier is finding one who understands manufacturing process variability and the controls needed to minimize the variation throughout the manufacturing process. The process needs to be developed using data to understand the relationships between process inputs (e.g., material, melt temperature, mold temperature, hold pressure) and process outputs (e.g., dimensions, surface finish) to create predictable manufacturing processes.

This level of understanding the MIM process helps minimize the risk of releasing non-conforming product into the field.

2. Materials expertise Materials play a critical role in the success of microMIM. Understanding the feedstock composition determines the success of any micro-MIM project.

Metal particle size distribution and binder type are

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important variables in determining the manufacturing cost and feasibility of consistent feature production.

Material sourcing is often a challenge because of the limited number of material manufacturers for micro particle size in the United States. Selecting the right material for each part is critical.

In some cases, a unique material may need to be developed to meet the performance and visual requirements of the component. This requires a supplier with the expertise to identify needs and to work with material compounders to create the right material. If the correct material is not sourced, and if it doesn’t meet the requirements or standards, the resulting product will be inconsistent.

Donatelle has developed proprietary materials to produce parts with specific corrosion resistance and electrical properties, mimicking a commonly used material in the medical device industry.

3. Equipment and technology expertise In addition to material control, equipment selection plays an important role in producing parts with minimal variation.

With micro-MIM, building molds for part sizes of less than a millimeter is a challenge. It requires specialized machinery, innovative techniques, knowledge and experience in machining — all at the micro size.

The supplier should not only be able to identify the right size equipment to mold the micro components, but have expertise in designing the manufacturing process as a whole system. They need to consider downstream operations with the customer’s end requirements in mind.

As medical devices continue to become smaller, conventional metal cutting processes are limited in producing micro-features and meeting tight tolerances. If you have a highvolume product with tight tolerances or micro-features, micro-MIM may be a solution. Even though the initial investment cost may be high, microMIM offers better accuracy, consistency and cost advantages for high-volume manufacturing. M Raghu Vadlamudi is the chief research & technology director at Donatelle (New Brighton, Minn.). He has more than 20 years of experience in the medical device manufacturing industry managing process development groups.

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MANUFACTURING

Is this the key to rapidly manufacturing heart valves?

Harvard researchers developed a manufacturing method that could help create heart valves in a short amount of time, opening the potential for rapid manufacturing.

Danielle Kirsch Assistant Editor

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Nanofiber fabrication may be the key to rapidly manufacturing heart valves with regenerative and growth potential, according to new research from Harvard University’s Wyss Institute for Biologically Inspired Engineering.

A research team led by Kevin Kit Parker created a valve-shaped nanofiber network that replicates the mechanical and chemical properties of the native valve extracellular matrix (ECM). They used the Parker lab’s proprietary rotary jet spinning technology – essentially a rotating nozzle that thrust an ECM solution into the nanofibers. The nanofibers could then wrap themselves around any heart-valve-shaped mandrels.

“Our setup is like a very fast cotton candy machine that can spin a range of synthetic and naturally occurring materials,” Parker said in a press release. “In this study, we used a combination of synthetic polymers and ECM proteins to fabricate biocompatible JetValves that are hemodynamically competent upon implantation and support cell migration and repopulation in vitro. Importantly, we can make human-sized JetValves in minutes – much faster than possible for other regenerative prostheses.”

The JetValve method is similar to another method known as electrospinning.

“You take a polymer and put it into a controlled ionic field, you sputter this through a nozzle and it forms a long fiber and orients on the far side in a random orientation, and it creates a fiber-like mesh,” explained Stan Rowe, VP of advanced technology & chief scientific officer at Edwards Lifesciences.

The Harvard team tested JetValves in collaboration with researchers at the University of Zurich in Switzerland, led by Simon Hoerstrup, co-director of the recently founded Wyss Translational Center Zurich.

Hoerstrup and colleagues recently developed regenerative, tissueengineered heart valves designed to replace mechanical and fixed-tissue heart valves. He used human cells that

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directly deposited a regenerative layer of complex ECM on biodegradable scaffolds shaped as heart valves and vessels. The living cells were eliminated from scaffolds, leaving an off-the-shelf human matrix-based prosthesis that was ready to be implanted.

“That’s kind of taking electrospinning one step further,” Rowe said. “It’s a pretty cool technology, but it’s pretty far from being commercial-ready. It’s exciting nonetheless.

I think they’ve shown some early feasibility that’s encouraging, but remember that a lot of people want their heart valve to last a long time – like their [entire] lifetime.”

Normal heart valves can take anywhere from six to 12 hours to assemble, according to Rowe. Additionally, the valves that the Harvard research team developed were pulmonary valves. Aortic valves are more commonly replaced in heart valve replacement procedures.

“The pressures and the requirements of the aortic valve are substantially higher and more demanding than the pulmonic valve,” Rowe explained.

The current method for making heart valves involves creating a biomaterial through a process that’s been perfected over the years.

“You take a biological substance and process it into a biomaterial to remove proteins and cross link it to form an implantable material. That process has been around for 30 years and has been refined over 30 years to produce a really strong, biocompatible material that people trust,” he said.

The Harvard team implanted JetValves into sheep using a minimally-invasive procedure and were able to show that the valves could function properly and regenerate new tissue.

“In our previous studies, the Harvard’s Wyss Institute of Biologically Inspired Engineering has created a rotary jet spinning technology to spin nanofibers and create heart valveshaped mandrels.

Image courtesy of Wyss Institute at Harvard University.

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MANUFACTURING

cell-derived ECM-coated scaffolds could recruit cells from the receiving animal’s heart and support cell proliferation, matrix remodeling, tissue regeneration and even animal growth,” Hoerstrup said. “While these valves are safe and effective, their manufacturing remains complex and expensive, as human cells must be cultured for a long time under heavily regulated conditions. The JetValve’s much-faster manufacturing process can be a gamechanger in this respect. If we can replicate these results in humans, this technology could have invaluable benefits in minimizing the number of pediatric re-operations.”

The Wyss Institute and the University of Zurich recently announced that they’re also collaborating to create a functional heart valve replacement with the capacity to repair, regenerate and grow. They also intend to create a GMP-grade version of the manufacturing process that is already customizable, scalable and cost-effective – enabling the creation of a high number of prostheses.

“Achieving the goal of minimally invasive, low-cost

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regenerating heart valves could have tremendous impact on patients’ lives across age, social and geographical boundaries,” said Donald Ingber, Wyss Institute founding director. “Once again, our collaborative team structure that combines unique and leading expertise in bioengineering, regenerative medicine, surgical innovation and business development across the Wyss Institute and our partner institutions, makes it possible for us to advance technology development in ways not possible in a conventional academic laboratory.”

Although the JetValve technique is encouraging, there’s still a lot to be done to be able to test in humans.

“It takes a really long time to validate the durability of a heart valve,” Rowe said. “[Harvard] has done some of the early steps of that, which are really encouraging, but they still have a long way to go.”

The study was published online in the journal Biomaterials. M

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Why a global footprint is a business imperative, not a buzzword A global manufacturing footprint can help companies capture value by accessing talent and reducing costs. Here’s how to successfully execute this strategy without falling into a reactionary offshore initiative.

Oscar Ford Preh IMA Automation

In the last two decades there was an undeniable shift in the U.S. toward offshoring manufacturing for all types of goods, medtech and medical devices included. One of the primary drivers of that trend was the pursuit of increased profit margins by reducing operating costs; in many cases, specifically reducing labor costs.

Now companies seem to be making adjustments from the short-term benefit of offshoring to considering broader strategic plans that maximize resources and align the enterprise for long-term, sustainable goal achievement. Some companies have stopped chasing low labor rates, as lower-cost countries increase their middle class and labor rates increase. That leaves the enterprise with a manufacturing facility in a country far from its core team and market without the benefit of the once-disproportionately low labor rates.

The difference between a well-executed global manufacturing footprint strategy and a reactionary offshore initiative usually comes down to which global market drivers are being considered, how the risks-versus-benefits are analyzed and how frequently these drivers or trends are monitored. Trends must be monitored closely and forwardthinking decisions made when it comes to creating a global manufacturing footprint. For example, less than a decade ago executives were stressing the importance of the BRIC markets (Brazil, Russia, India & China). The emphasis on the BRIC markets as high-priority targets has changed significantly, driven by a variety of global market conditions: • The reversal of economic progress with multiple years of recession, as well as ongoing political corruption scandals in Brazil • The slumbering economy and general uncertainty regarding Russia • The impact of rising income levels of workers along with a slowing economy in China • Increased interest in manufacturing opportunities in countries including South Africa, Turkey, Vietnam, Poland and Saudi Arabia There are a variety of ways to achieve a global footprint, www.medicaldesignandoutsourcing.com

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depending on the speed with which companies decide to pursue that strategy and the market conditions that make one method more or less favorable. A global footprint can be achieved via internal growth, which could mean the creation of new facilities or expansion of current facilities.

It can be achieved via outsourcing, such as the utilization of contract manufacturers. It can also be achieved via joint ventures, partnerships, or mergers & acquisitions (M&A).

Each method has individual and unique pros and cons.

At Preh IMA Automation we have been on the offensive, taking a very aggressive approach toward achieving our global footprint goal, by acquiring complementary companies in strategic locations while expanding current facilities. Our keys to success include complexity reduction, clear allocation of responsibilities, enterprise-wide development and deployment of the plan – and, above all, communication.

As a manufacturing and assembly automation equipment builder, we must have the same thought process as the manufacturing companies with which we partner. For us, a global footprint is not only about being aligned geographically, but philosophically as well.

As we do business with multi-national companies with manufacturing facilities in many countries, we too must be able to address different regulatory environments and regulations, overcome the existence of cultural differences, navigate import/export obstacles and alleviate communication barriers, to name a few, all while operating and appearing as one company worldwide.

A good global manufacturing footprint strategy is executed pursuing cost reduction, incentives, improved logistics, access to talent, vendor/supplier alignment and any other pertinent opportunities to capture value for your business. All of these need to be analyzed, considered and balanced, instead of taking a singularly focused, reactionary approach. M Oscar Ford is Business Development Manager for Preh IMA Automation, responsible for the strategic direction driving customer diversification and market expansion, focused on the Healthcare/Medical market.

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MATERIALS

Repeat sterilization for adhesives in reusable and non-disposable devices Here’s a review of the common adhesive materials and their reaction to sterilization processes.

Christine Marotta Henkel

Loctite medical device adhesives offer strong and flexible bonds for a range of flexible medical devices.

Image courtesy of Henkel

Intricate medical devices are often constructed of thermoset and other engineered plastics, which require advanced adhesive technology. In addition to considerations of bonding, sealing, gap filling and manufacturability, developers need to consider the sterilization plan that all materials – including the adhesives – will need to withstand.

The challenge is high, particularly for reusables and non-disposables. These devices are often sterilized by steam autoclave, hydrogen peroxide and chemical immersion because these methods are conducive to quick turn around and are considered low toxicity.

Autoclaving, the sterilization method for a high percentage of these categories of medical devices, presents the greatest challenge to device manufacturers due to its combination of temperature, pressure and moisture. Manufacturers must seek substrates and joining methods that are versatile and easy to use, yet still hold up in the most rigorous environments.

Cyanoacrylate, light-curing cyanoacrylate, lightcuring acrylic, dual UV/moisture-curable silicone, 68

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epoxy and urethane adhesives are commonly used for the assembly of medical devices.

• Cyanoacrylate adhesives are polar, linear molecules which undergo an anionic polymerization reaction. A weak base, such as moisture present on essentially all surfaces, triggers the reaction causing the linear chains to form. The products are maintained in their liquid form via the addition of weak acids which act as stabilizers. A variety of cyanoacrylate formulations are available with varying viscosities, cure times, strength properties and temperature resistance. Cyanoacrylates form thermoplastic resins when cured.

Testing of cyanoacrylate adhesives with a number of sterilization methods has yielded varying results, depending on formulations.

In general, however, cyanoacrylate adhesives have been shown to withstand up to 50 cycles of liquid sterilization immersion as well as hydrogen peroxide. In addition, select cyanoacrylate adhesives have exhibited

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MATERIALS

moderate resistance to autoclave exposure – with some specialty ethyl grades maintaining nearly 100% of their initial strengths following exposure to 50 autoclave cycles. A critical factor in maintaining bond strengths with cyanoacrylate adhesives following autoclave exposure is the selection of substrates that offer moderate to high initial strengths as well as substrates capable of withstanding the rigorous temperature, pressure and steam environment of the system.

•

Light-curing acrylics cure via a free radical reaction to form thermoset resins when exposed to light of the appropriate wavelength and intensity. Like cyanoacrylates, light-curing acrylic adhesives are available in a range of viscosities. In addition, light-curing adhesives vary in final cured form from hard, glasslike resins to soft, flexible resins.

As with cyanoacrylate adhesives, lightcuring acrylics vary in bond strength retention following exposure based on formulation, substrates selection and initial strengths achieved. Testing has indicated that, in general, light-curing acrylic adhesives maintain from 50% to 100% of initial strengths following 50 autoclave cycles.

• Light-cured cyanoacrylates are ethylbased products with photo-initiators added to the formulation.

The end result is fast fixturing (like that of a traditional lightcuring acrylic) and cure in shadowed areas. Light-curing cyanoacrylates would be expected to perform similarly to standard ethyl cyanoacrylates following sterilization exposure including autoclave.

• Silicone adhesives are similar to polyurethane adhesives in that they form flexible polymers when cured. Silicones, however, possess no rigid segment and therefore exhibit lower cohesive strengths – the strength of the polymer itself. The sterilization resistance of silicone adhesives is typically measured on the bulk polymer rather than on assembled specimens due to the low cohesive strength of the polymers.

Testing of dual light cure/moisture silicone adhesives following exposure to fifty autoclave cycles indicated a slight effect on the percent elongation of the adhesives, but an approximate 60% drop in tensile strength.

•

Epoxy adhesives, like the previously mentioned light-curing acrylic adhesives, cure to form thermoset plastics. Like several previously mentioned chemistries, polyurethane adhesives form thermoset resins when cured, thus exhibiting good chemical and environmental resistance. It is important to note, however, that the overall thermal resistance of cured polyurethanes is less than that of cured epoxies.

•

Polyurethane adhesives are substrate versatile but do, on occasion, require the use of a surface primer to increase the reactivity of the surface to be bonded. Epoxy and urethane adhesives are often selected for applications due to their enhanced chemical and thermal properties. Such resistance makes the adhesives suitable candidates for sterile reusables and non-disposables. With the potential of repeated autoclaving exposure, it is critical that reusable/non-disposable device manufacturers select adhesives which have the ability to withstand high temperatures and high steam pressure conditions. M

Christine Salerni Marotta is the North American medical business and market manager for Henkel Corp.

Loctite medical device adhesives are used for high speed and high strength needle assembly Image courtesy of Henkel

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How plasma treatments are driving up the value of plastic labware By altering the surface properties of polymer labware through plasma treatments and coatings, manufacturers are improving the quality of test results while increasing the value of products they create.

Jeff Elliott P VA Te P l a A m e r i c a

Each year, billions of multi-well plates, pipettes, bottles, flasks, vials, Eppendorf tubes, culture plates and other polymer labware items are manufactured for use in research, drug discovery and diagnostic testing.

Although many are simple, inexpensive consumables, an increasing percentage are now being surface treated using gas plasma or have functional coatings specifically designed to improve the quality of research and increase the sophistication of diagnostics.

Surface modification can improve adhesion and/or proliferation of antibodies, proteins, cells and tissue and improve signal-to-noise ratio so testing is more precise with less target material or markers required.

Altering the properties of these devices can also make sense from a business perspective. In a market dominated by several large labware manufacturers, more specialized offerings can create a competitive edge and drive up the value of each consumable.

“With polystyrene or polypropylene labware, if you can add a functional coating or use plasma to alter the surface properties, you can turn a $2 item into a $50 item,” explained Mic Barden of PVA TePla America (Corona, Calif.), a leading system engineering firm that designs plasma systems for surface activation, functionalization, coating, ultrafine cleaning and etching.

Plasma treatment Plasma is a state of matter. When enough energy is added to a gas, it becomes ionized into plasma. The collective properties of these active ingredients can be controlled to clean, activate, chemically graft and deposit a wide range of chemistries.

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MATERIALS Image courtesy of PVA TePla America

Most plasma applications for plastic labware can be categorized as “simple” treatments, such as O2 or argon for cleaning the substrate at the molecular level. The use of plasma is also well established for surface conditioning to make polymers more hydrophobic (water repellent) or hydrophilic (affinity to water).

But in vitro diagnostic substrates may require more selective chemistries for the selective adhesion promotion and conjugation of bio active molecules.

This can be achieved by providing particular chemical functionality at the surface, allowing covalent coupling of biochemical species to occur. Amino, carboxylic, hydroxyl and epoxy functionalities are important examples of the chemistries that are readily obtainable using a gas plasma surface treatment.

Multi-well plates Multi-well, or microtiter, plates are a standard tool in analytical research and clinical diagnostic labs. Most plates come with 96, 384 or 1,536 sample “wells” that function as small test tubes.

Polystyrene is the most common material used to manufacture microtiter plates, because

using plasma to become more hydrophilic.

Treating the surface in this manner has many benefits, including improved analyte wetting of wells, greater proliferation of cells without clumping, reduced amount of serum, urine or reagents required for testing and lower risk of overflow and cross-well contamination.

Improved antibody adhesion for bio assays Microtiter plates are commonly used for bioassays such as the enzyme-linked immunosorbent assay (ELISA). Performing an ELISA involves at least one antibody with specificity for a particular antigen.

To improve the bond and function of the antibody, plasma coatings can be applied to orient the Y-shaped IgG proteins utilized in the majority of these types of tests. Failure to do so can mean some antibodies face down or deform and become essentially unavailable for bonding with antigens.

“With most uncoated polymer surfaces you can’t control how the Y-shaped ‘capture’ antibodies are oriented,” Barden said. “However, a functional coating can be used to favor the proper upward orientation so the entire surface is available for the assay. In this way, we can improve the signal-tonoise and dynamic range of an assay.

“Amine coatings are commonly used because they have a middle surface energy, with water contact angles of approximately 60 degrees,” he said. “So the coating is hydrophilic enough that the liquid disperses well and hydrophobic enough to facilitate bonding of the material.”

Other alternatives include linker molecules such as epoxides or carboxylic acids or applying a quartz-like surface using plasma-enhanced chemical vapor deposition. According to Barden, these approaches provide a similar surface energy, but have functional differences that may be important, depending on the application. The issues of adhesion that apply to proteins used for ELISA can also apply to cells and tissue cultures, he added.

THE COATING IS HYDROPHILIC ENOUGH THAT THE LIQUID DISPERSES WELL AND HYDROPHOBIC ENOUGH TO FACILITATE BONDING OF THE MATERIAL. it’s biologically inert, has excellent optical clarity and is tough enough to withstand daily use. Most disposable cell culture dishes and plates are also made of polystyrene.

Other polymers such as polypropylene and polycarbonate are also used in applications that must withstand a broad range of temperatures, such as polymerase chain reaction (PCR) for DNA amplification.

Untreated synthetic polymers, however, are extremely hydrophobic and so provide inadequate binding sites for cells to anchor effectively to their surfaces. This means they must be surface modified 72

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Pipette tips Pipettes are another common lab tool. Often constructed of high-density polyethylene or polypropylene that tends to be hydrophobic, pipettes can still have difficulties with liquids sticking to the surface – particularly on or around the tip.

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Some pipette manufacturers add fluorinated polymers within the polypropylene during the injection-molding process, but there can still be issues such as phase separation or leaching.

To ensure pipette tips “sheet” off any aqueous solution more effectively, companies like PVA TePla can utilize nanotechnology to create a superhydrophobic surface. One technique involves etching the surface to trap gases in the recesses, allowing the liquid to float on the top in a “lotus effect;” another involves applying a more hydrophobic coating to the pipette tip.

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Minimizing leaching Since plastic labware is susceptible to leaching from plasticizers, stabilizers and polymerization residues, plasma is sometimes used to coat the inside of the containers with a quartz-like barrier material. These flexible coatings are polymerized onto the plastic by plasma enhanced chemical vapor deposition.

The resulting coating can be very thin (100–500 nm), highly conformal, noncrystalline and highly flexible (180o ASTM D522) coating.

R&D assistance Plasma treatment is common enough that leading equipment providers are able to modify existing, mature tools and technology, complete with fixturing, to deliver what are essentially drop-in solutions, according to Barden.

Some even provide access to on-site R&D equipment and engineering expertise.

PVA TePla, for example, often invites labware manufacturers to visit its lab in Corona, Calif., to run parts and conduct experiments on inhouse equipment. These technical customer/ supplier meetings often produce the best experimental matrices and ideas.

“The elegance of these [plasma treatment] solutions is that they leverage existing technology and know-how, as opposed to creating something that is completely new,” Barden said. “Access to this knowledge base facilitates new entrants into the market.” M Jeff Elliott is a Torrance, Calif.–based technical writer.

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MATERIALS

What are orthopedic coatings?

Medical device designers need to know the facts about orthopedic coatings.

Image courtesy of Orchid

Danielle Kirsh Assistant Editor

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An orthopedic coating is used on implants to help improve the functionality of an implant. Usually, the coatings can help define the geometry and the mechanical strength of an implant, according to Orchid (Holt, Mich.).

Coatings can be applied to different implants for a number of applications. These applications can include hip components, knee components, shoulder components, cones, sleeves, wedges, extremities and spinal implants.

Orthopedic coatings are designed to last as long as the implant is in the body, which can be anywhere between 20 and 30 years. They are made of the same materials that an implant is made from, such as titanium or cobalt-chrome, and serve a variety functions.

Particles in coatings were much bigger 25 years ago than they are now, when sizes can range from 88 microns to 707 microns.

In the design process, coatings can be customized for specific needs. The particle sizes, number of coating layers, and whether a tight or loose pack is needed can all be configured, according to Orchid.

These functions include promoting bone growth, improving the anchoring of cells with porous structures, avoiding infection by using anti-infective coatings and reducing implant wear.

The different types of coatings include hydroxylapatite (HA), titanium plasma spray (TPS) rough coating, TPS porous coating, resorbable blast media

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(RBM), anti-wear and sintered. Each coating serves a unique function when applied to implants: • Proprietary HA coatings are bone-like coatings and can be applied to cobalt-chrome, titanium or stainless steel implants to accelerate bone growth.

TPS improves mechanical fixation with porous and rough coatings.

• TPS coatings, when applied to titanium or cobaltchrome substrates, allow the coating to exceed the ASTM requirement while eliminating cracking of the implant.

• RBM coatings create a rough surface without leaving embedded debris. On titanium implants, RBM coatings create a roughened surface that is comparable to a 100 mesh aluminum oxide finish without leaving embedded debris behind.

• Anti-wear coatings enhance the wear properties of implantable components. These coatings are a tough ceramic coating that has enhanced wear properties for implantable components.

• Sintered coatings create a smooth or rough surface that is porous enough to allow bone and tissue ingrowth.

There is still room for more innovations when it comes to implant coatings, including enabling increased the lifetime of an implant, avoiding implant loosening, use of cementless implants and hypoallergenic implants.

Having been used since the 1970s, orthopedic coatings have some limitations as well. Hightemperature sintering of coatings reduces strength. Also, specific metal coatings have to be used with specific metals. For example, a titanium coating can’t be used with a stainless steel implant.

A medical device company’s decision to coat an orthopedic implant is up to the needs of the doctors, patients and insurance companies involved in the procedure. M

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MATERIALS

How a versatile epoxy is enabling brain stimulation In but another example of how useful and critical epoxies can be, researchers in Israel used a twopart epoxy to construct a magnetic coil to stimulate animal brain neurons via a magnetic field.

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Magnetic coils for brain stimulation Transcranial magnetic stimulation (TMS) is a non-invasive way to stimulate the motor cortex and other parts of the brain. A coil energized by a pulse generator is placed near the head of a human or animal, creating a pulsed magnetic field which induces small electric currents in the part of the brain just under the coil. By observing the resultant motor activity of the patient or subject, medical professionals can assess the damage from a brain injury or disorder, such as a stroke or multiple sclerosis.

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Designers of medical electronics assemblies have many options to choose from when selecting one or more compounds for bonding, coating, potting and encapsulating components.

While manufacturers can control many of the properties of these compounds, the underlying polymer chemistry is a critical factor to consider.

Each family of compounds – epoxies, silicones and UV/ LED light curables – offers a different set of performance parameters and processing requirements.

Epoxies are among the most versatile polymer compounds used in medical electronics. They offer excellent cohesion and resistance to chemicals and adhere well to a variety of materials.

Some specialty systems can operate over a wide range of temperatures from cryogenic (4K) to more than 550°F. Because they are 100% reactive, epoxies produce no volatiles during cure and exhibit little or no shrinkage during polymerization.

Epoxies are also showing promise in the rapidly growing field of brain stimulation.

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Scientists at israel’s Bar-Ilan University designed a study to explore exactly how magnetic stimulation acts on nerve cells in the brain (their work is described in the June 3, 2014 issue of Frontiers in Cellular Neuroscience).

Thin slices of the somatosensory cortex of rats’ brains were prepared for use in the study. A common-used procedure for studying the electrical activity of neurons, known as the patch-clamp technique, was modified to facilitate magnetic stimulation of individual neurons. The main component of the modification was a custom-made magnetic coil.

Standard lacquer-coated copper wire was used to make the coil, consisting of 14 turns of wire in each of two layers.

The coil was constructed using a wet-winding technique, in which the coil is impregnated with an epoxy compound during the winding process. The researchers selected lowviscosity Master Bond EP29SPLP epoxy for the wet-winding process. The epoxy was mixed with 25 μm alumina particles to enhance heat transfer, increase electrical insulation and strengthen the coil. The magnetic coil was positioned below the neuron under test during the experiment, which gave researchers important insights into how TMS affects neurons.

In an earlier study – published in 2011 in volume 194 of the Journal of Neuroscience Methods – researchers at the same university fabricated a custom-made mini coil for use in a TMS experiment on an awake monkey. In this case, the coil was immersed in a saline solution and placed inside a chamber designed to record brain activity via multiple micro-electrodes attached to various regions of the monkey’s brain. A wet-winding technique was used to build the coil, which included 32 turns of standard copper wire. Again, the coil was impregnated with Master Bond EP29LPSP epoxy mixed with 25 μm alumina particles during the winding process. For this application, electrical insulation of the coil and its windings was especially important in order to minimize the risk of electric breakdown.

The insulated mini-coil was tested to voltage levels up to 1200V. The studies out of Israel once again demonstrate that the success of any engineered product depends on the performance of all its parts – and that includes any chemical compound/epoxy used to join or protect one or more parts. M Rohit Ramnath is a senior product engineer for Master Bond (Hackensack, N.J.), a custom formulated adhesives manufacturer.

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MOLDING

Dip molding medical device products: What you need to know When it comes to dip molding products with emulsions of liquid rubber, it is necessary to complete a series of process steps to assure proper formation, vulcanization and finish treatment to meet the customer’s needs in the final application.

Mark Agee Kent Elastomer Products

Coagulant

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Dip molding can enable the creation of durable medical device parts in a variety of shapes, sizes and wall thicknesses, including probe covers, bellows, neck seals, surgeon gloves, heart balloons and other unique parts.

Natural rubber has outstanding resilience and high tensile strength, but also carries a protein that can cause an allergic reaction in humans. Synthetic neoprene and synthetic polyisoprene, in contrast, are non-allergenic.

Neoprene stands up against a multitude of factors; it’s resistant to flame, oil (moderate), weather, ozone cracking, abrasion and flex cracking, alkalis and acids. Polyisoprene is a close replacement to natural rubber when it comes to feel and flexibility, with better resistance to weather than natural rubber latex. Polyisoprene, though, does sacrifice some tensile strength, tear resistance and compression set.

The term “dipping” is associated with the manipulation of the dip form. In fact, the forms are dipped into the materials as the sequence is performed. It is important to ensure rubber recipes meet FDA medical device guidelines and requirements.

Here’s what the process looks like:

Rubber Dip

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Cure or

The dipping process can be characterized as a conversion sequence: The rubber is converted from a liquid to a solid and then chemically converted into a vulcanized network of molecules.

More importantly, the chemical process converts the rubber from a very fragile film into a networked group of molecules that can stretch and deform – and still return to their original shape.

Coagulation: Changing a liquid to a solid The coagulation process is not always necessary for all “dip” processing but is critical to our processing sequence. The rubber can be allowed to change from a liquid to a solid through air drying, but that will take much time.

Some-thin walled parts are produced in this manner. The coagulation process uses chemicals to force this physical state change.

The coagulant is a mixture or solution of salts, surfactants, thickeners and release agents in a solvent, typically water. Alcohol can also be used as the solvent in some processes. Alcohol evaporates quickly and leaves very little residue.

Some water-based coagulants will require help from an oven or other means to dry the coagulant.

The main component of the coagulant is the salt (calcium nitrate), an inexpensive material vulcanization Finish that provides the best uniformity of coagulation over the dip form.

Surfactants are used to wet out the dip form and assure a smooth, uniform coating of coagulant onto the form.

Release agents such as calcium carbonate are used in the coagulant formula to aid in the removal of the cured rubber part from the dip form.

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MOLDING

Keys to coagulant performance include uniform coating, fast evaporation, material temperatures, entrance and retrieval speeds, and easy change or maintenance of the calcium concentration.

The rubber dipping step This is the stage in which the rubber is converted from a liquid to a solid.

The chemical agent which facilitates the solidification, the coagulant, is now applied to the dip form and is dry.

The form is “dwelled,” or held immersed in the tank of liquid rubber. As the rubber makes physical contact with the coagulant, the calcium from the coagulant causes the rubber to destabilize and turn from a liquid state to a solid state.

The longer the form is immersed, the thicker the wall will develop. This chemical reaction will continue until all the calcium is consumed from the coagulant.

Keys to latex dipping include entrance and exit speeds, temperature of the latex, uniformity of coagulant coating, and controlling pH, viscosity and total solids of the rubber.

What is removed? The leach process removes residual salts, surfactants and water based proteins.

Main material components include the coagulant (calcium nitrate) and rubbers (natural (NR); neoprene (CR); polyisoporene (IR); nitrile (NBR)). Inadequate leaching can result in “sweating,” a sticky film on the finished product, as well as adhesion failure and increased risk of allergic reactions.

The keys to leaching performance include water quality, water temperature, dwell time ad water flow rate.

Cure stage This step is a two-step activity. The water in the rubber film is being removed and the temperature of the oven along with time is activating the accelerators starting the cure or vulcanization process. Cure time and cure temperature are key when it comes to optimizing the best physical properties of the different types of rubbers.

Finish Several options are available to treat the surface of a dipped part so that the part does not stick to itself. Options include a powder part, urethane coating, silicone rinse, chlorination and soap wash. This is about what the customer wants or needs for their product to be successful. M Mark Agee, is Manager of Customer Dip Operations at Kent Elastomer Products (Kent, Ohio).

The leach dip The leach process is the most effective stage to remove unwanted, water-based chemicals which are not wanted in the final product.

The most opportune time to remove the unwanted materials from the dipped film is the leach before cure.

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What is micromolding?

Micromolding is a very specialized art form. It’s the tiny-scale molding form of injection molding that entails building a cavity to match the shape of the part you want to make, sort of like the plastic molding that makes Lego bricks.

Danielle Kirsh Assistant Editor

Very small, high-precision plastic molding goes into micromolding for medical devices, according to Aaron Johnson at Accumold (Ankeny, Iowa).

There are three different things to keep in mind with micromolding: 1. Micro means the size of the part. It’s the most common definition when dealing with micromolding.

2. Micro-features are the tiny parts of a larger piece. As a whole, the part can be big, but its components can be smaller micro-features.

3. Micro intolerance is how the parts are measured and how close to the needed measurement the part has to be to be considered a good or usable part. When a part is molded, it has to measure within the needed measurement (the tolerance), which could be as small as a thousandth of an inch. Small parts that are simple to make have tolerances that are not as tight and would be considered regular molding.

space is needed to get the plastic where it needs to go. The size of the runner system in relation to the size of the part is waste. According to Johnson, you don't want to make a tiny part and have a lot of waste. True micromolding is efficient in relation to the part size and the runner system.

Some companies have set their largest micromolding to half an inch and some have sizes as small as 800-by-300-by-380 microns.

Micromolded parts can also have a part volume of 0.005 cubic inches or less, according to Accumold.

The level of detail and expertise required for building microparts is unique. While the task of making a small part can be daunting, the parts can be simple to make as long as the company is equipped to build high-precision parts. The process of micromolding differs with each company. M

Micromolding uses a variety of commonplace thermoplastic moldable materials including polyether ether ketone (PEEK), polyether imide (PEI), liquid crystal polymer and nylon. Some micromolding parts can be made of durometer or elastomeric as well.

They can also be made of optical-grade and medicalgrade materials for medical device parts. The types of materials used allow for the size of molds to be smaller than the size of a dime.

To make a part, there is a runner system that is the vessel for plastic to get from its melting point to the cavity to make the desired shape. The runner can be really long in some cases; that extra

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MOLDING

Overmolding silicone onto thermoplastics: What you need for success Overmolding silicone onto thermoplastics can be challenging, but offers advantages over TPEs that include chemical resistance, tensile strength and compression set. Here are some best practices to maximize your success.

David Mulera MedPlast

Overmolding has become a fundamental technique for medical component manufacturers in recent years. It reduces assembly costs, improves quality and expands the limit of what’s possible for medical device designs.

The most common type of overmolding involves thermoplastic elastomers (TPEs) over thermoplastics.

However, a growing number of medical molders are expanding the use of overmolding for liquid silicone rubber (LSR) because it offers a number of superior performance characteristics.

LSR acts as a protective cover against dust, water, impact, heat and electrical shock. For implantables, silicone creates a bio-friendly barrier between the medical device and the patient.

Typical applications for LSR overmolding include: • wearable devices • mechanical reinforcement • gaskets • seals • fluidic components • medical catheters • medical implants In many applications, overmolding LSR onto thermoplastics offers advantages compared with TPEs, including better: • tensile strength • chemical resistance • compression set • heat resistance • extreme low-temperature flexibility • elongation • inherent lubricity Achieving good long-term adhesion can be difficult when overmolding TPEs onto rigid thermoplastic substrates.

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However, the challenge can be even greater with LSR. Here are some best practices to maximize your success: 1. Select your materials properly Many plastic substrates require glass transition temperatures lower than that of LSR to properly cure. When possible, select a substrate material with a glass transition temperature above 300°F to ensure proper curing. Also consider using newer “primerless” or “self-adhesive” grades of LSR. These are formulated to bond well to thermoplastics on their own.

2. Avoid resin additives and mold releases Steer clear of substrate thermoplastics that have additives or mold releases that can create an adhesion problem. External mold releases are a definite no-no because they can also interfere with adhesion. Avoid additives with sulfur or amines (including amine-based antistats), as they can inhibit the cure of LSR. 3. Test your material combination To understand how well your substrate material will bond to a particular grade of LSR, it’s a good idea to send a representative part or sample plaque to the LSR supplier for testing. Most suppliers will perform this testing at no or minimal charge and it’s a good insurance policy before you invest in molds.

4. Keep your thermoplastic substrates free of contamination Any contamination can interfere with adhesion, so it’s important to keep substrates clean before overmolding.

This is less of an issue if the substrates are molded with the LSR in a two-shot mold, rather than molded separately and transferred from one machine to another. This is why it’s better to use a two-shot overmolding technique over transfer overmolding when possible.

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MOLDING

5. Consider pretreating the substrate (transfer molding only) Preparing the substrate surface with chemical primers, plasma or a UV treatment can increase adhesion. This is typically not possible with a two-shot overmolding process but can be done on transfer overmolding if adhesion is a major concern.

6. Keep your substrates warm It’s vital for substrate parts to be hot because the bonding of LSR to the thermoplastic is a chemical reaction; it needs a combination of time, temperature and pressure. Typical mold temperatures for LSR are 300°F to 400°F. The hotter the temperature, the shorter the cure cycle. Temperature is less of an issue if the substrates are molded in a two-shot mold, because the residual heat left in the substrate from the first shot helps cure the LSR. If the substrate is molded separately

in a transfer overmolding process, it’s a good idea to preheat it in a conveyor oven or on a hot plate.

7. Design in a mechanical interlock when possible Even if you follow the recommended practices for optimal LSR adhesion, it never hurts to incorporate into the part design some form of mechanical interlock between the materials.

Allowing LSR to penetrate through-holes onto the back side of the part is a good example.

A rough finish on the overmolding interface area can help, but isn’t required with a good self-bonding material.

8. Avoid aggressive demolding Avoid pulling or stretching the LSR when demolding because it may not be fully adhered and cured. Consider a PTFE coating on the mold to help with demolding.

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9. Maintain a consistent cycle time With transfer molding using two machines, it definitely helps to use automated (robotic) transfer from one to the other. (This is not usually an issue with two-shot molding.) This will ensure that the substrate temperature is consistent for overmolding and also avoids any contamination from a human operator handling parts.

Overmolding LSR onto thermoplastics can be more challenging than overmolding TPEs, but the benefits in terms of device performance characteristics make this specialized process well worth it. Looking ahead, innovations such as UV-curable silicone will likely allow medical molders to further drive down cycle time and increase adoption of this overmolding technique. M David Mulera is corporate VP of engineering at MedPlast (Tempe, Ariz.), responsible for engineering, processing and new technology development.

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MOLDING

Expanding design horizons with gas-assist molding Gas-assist molding, the process of using nitrogen gas pressure to fully form a part, increases design and manufacturing options for injection molded components.

Scott Rishell Mack Molding

Traditional plastic processing brings design and manufacturing benefits through repeatable, high-volume and high-quality part production coupled with cost reductions, but its versatility can be expanded in certain scenarios by the introduction of gas-assist molding. There are two methods – external and internal – with both allowing for improved flatness and the packing out of atypicallythick geometry. The external process can also reduce press tonnage, leading to cost savings, while internal gas-assist can form a lighter part that may benefit the end application.

Examining external gas-assist In external gas-assist, a micro-thin layer of nitrogen gas is introduced during the packing phase on the non-aesthetic side of the part, after the part is filled with plastic but not yet fully packed out. This process packs the part evenly, replacing the more traditional holding phase. The gas is held at a high pressure, forcing the uncured resin onto the opposite side of the tool. The aesthetic side ends up with a clean, uniform appearance, while the gassed side will have a wavy or “sinky” appearance.

External gas allows designers to modify traditional molded-part design parameters, such as rib-to-wall ratio. Generally held below 50% to 70% to avoid creating sink marks on the aesthetic side, external gas designers can increase this ratio up to and even above 100% depending on the part and resin requirements.

This process also allows for thicker ribs, offering a key part advantage by reducing differential shrink – a primary culprit in causing part distortion – between the nominal wall and the ribs. In components with critical flatness specifications this can be a game-changer.

In typical molding the required pressure to fully pack a part out can be extremely high, due to pressure loss from gate to end of fill. Because external gas molding replaces some press work with evenly distributed nitrogen gas pressure, less clamp force is required – molding pressures of 1-2 tons/inches squared can be achieved leading to lower part costs. Some considerations, however, include the fact that sealing gas from the external environment requires more intricate tool and part design, leading to increased tool cost, and the gassed side of the tool needs to be unseen in the final application if aesthetics are a factor.

Investigating internal gas-assist Internal gas-assist, on the other hand, is used specifically to mold very thick sections in parts.

In general the process is similar to the external method, except the gas is introduced inside the part geometry – creating a hollow channel through

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the thick region of the part and forcing the resin against the external walls to create a packed-out appearance in the thick section.

When the resin is evacuated from the center of the thick section, it leaves a cavity that can be 20% to 30% of the cross section. This can result in significant part-weight savings that could be critical to product performance. Additionally, getting this resin out of the part means the cooling time can be reduced in comparison to molding the thick geometry as a solid.

Press cycle times are typically dependent on the thickest partâ&#x20AC;&#x2122;s geometry.

Internal gas-assist allows extremely thick sections to be molded with high aesthetics; however, as with external gasassist, the more intricate tool design and increased tool cost must be considered when determining the best course of action for the application. M Scott Rishell is the technical lead on several programs at Mack, developing part designs for production processes with a focus on diagnosing and implementing solutions for design for manufacturability (DFM) issues, as well as reduce manufacturing costs through part simplification and process improvements.

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MOLDING

Rapid injection molding: 5 things you need to know Here are five things you should consider when deciding to use rapid injection molding as part of your development process.

Roger Spurrell Va u p e l l R a p i d S o l u t i o n s

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As every custom injection molder will tell you, “There’s no such thing as an easy part.” When you add in the need for speed the trade-offs start to multiply, because you are now considering how close the part needs to be to production versus willingness to invest in tooling that might not be production-worthy.

Another factor includes working with supply chain – which ideally wants to qualify vendors that can help you with prototypes and transfer to production.

Rapid injection molding is more than just speed and cost; it is about the ability to deliver a part that meets your desired outcome.

With that in mind, here are five things you should consider when deciding to use rapid injection molding as part of your development process: 1. DFM has become DFx What was traditionally termed “design for manufacturability” (DFM) has evolved into “design for manufacturability, test, clinical evaluation, investor presentations or production readiness” (DFx). In other words, DFx is a comprehensive approach to design that requires consideration of both the product and the business objectives, including reliability, regulatory requirements, cost and supply chain.

To choose the right manufacturing technology to meet your DFx objectives, you must evaluate the cost, timeline and product output capabilities of each technology.

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Your development partner should have broad experience with injection molding of medical devices and should be able to conduct design reviews to recommend the best technology for your part. If you go into your DFx process with the bias that the parts needs to be molded, you might not consider alternatives that will meet your desired outcome that could be faster and less expensive.

2. Materials are important Material selection has an impact on everything from device performance, to testing and sterilization methods, to cost and profitability.

When designing a new device, manufacturers often prefer to use materials that they already have biocompatibility data for, since this simplifies the qualification process. In addition, the shrink rate of the chosen material is an important factor that should be considered when determining the manufacturing process for your product.

Coming back to DFx and how it relates to rapid injection molding, you still need to ask whether the product needs to be of the production material. Or can you accept a tradeoff of something that is close enough to quickly meet your user needs, for lower cost.

3. Change is expensive Design freeze is that mythical place that most “built-to-print” shops are looking for from a designer. But you cannot get to design freeze without building a few parts and, many times during this process, parts that are critical to function need to be built in the exact design and intended material of the final part. Of course, you want to do this inexpensively and have the flexibility to change when design inputs change, without breaking the bank.

One way to reduce the costs associated with changes is to adopt a “steel safe” approach to the mold design. “Steel safe” or “metal safe” refers to the practice of leaving a small amount of extra material on the mold – for example, an

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inner diameter that should be 0.250 in. might initially be left at 0.255 in. This allows the mold to be modified (removing material is generally easy; adding material is nearly impossible) as the mold and product design are evaluated and “dialed-in.”

4. Validation There is a lot of complexity to the decision of whether to validate a component or the entire assembly of a device. The decision is risk-based, depending on the criticality of the device and your FMEA (failure modes and effects analysis). It is typically prudent to consider the validation criteria or validation path for your product early in the development process.

If the use of the product does not require validation for component delivery or future use of the same tool, certain trade-offs can speed up the process. As part of the design review, knowing the intended use of components and whether there is budget to build production tools will allow your tool designer to offer trade-offs that reduce cost and speed delivery.

Surgical handle component with insert

5. How many parts do you need?

We started this article talking about DFx. One of the outputs of the effort should be whether your development project is far enough along to justify investment in injection molding. Injection molds are expensive and increase cost of change.

Understanding how many parts you might need allows your manufacturing partner to suggest tooling investment that is appropriate for the life of the tool and other technologies that might be a better fit.

There is a tipping point with every technology where the total cost of ownership, which includes the tooling and part costs, www.medicaldesignandoutsourcing.com

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Pipette tips that require injection molding with tolerances to +/- .0001 in.

becomes the limiting factor. Working with a vendor that can offer multiple solutions to meet your goals allows you to see and understand the tradeoffs. Technologies such as machining, cast urethane and 3D printing all have their place in the development of a plastic part based on how many parts you need.

Completing DFx on your project with product intended use and volume is critical in making a manufacturing decision. By having this clear understanding, the options available to meet your needs may expand significantly.

One of your goals should be to identify a product development firm that can help you make the right manufacturing choice for your product development needs. M Roger Spurrell has 20 years of experience working with customers to meet their time to market and technical needs for product development. He is currently senior program manager and tooling manager at Vaupell Rapid Solutions located in Hudson, N.H. 11 • 2017

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MOTION CONTROL COMPONENTS

How Igus moving plastic components are enabling medtech innovation Advanced plastic components maker Igus sees more medical sector opportunities. Here’s how its e-chains, bearings and linear systems are enabling innovation.

Chris Newmarker Managing Editor

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Igus – maker of advanced plastic components including e-chain cable carriers, bearings and linear systems – has its main medical customers in Europe.

But that could soon change.

The company plans to sell to more medical customers in the U.S., Harald Nehring, Igus’s VP and head of global industry management, recently told Medical Design & Outsourcing.

“At the moment, we have one industry manager on medical technology, and we are looking for more like that so we extend the range. We want to offer the special medical technology consulting worldwide [and] more in-depth,” Nehring said. (Igus hosted trade press on an October visit to its Cologne, Germany, headquarters and manufacturing facility – as well as side trips to highlight innovative uses of its products.)

When it comes to Igus’s e-chains, they can provide a customized solution for any moving piece of medical equipment (or medical device manufacturing equipment) attached to multiple cables. Think MRIs, X-ray systems and more. They reduce downtime because they increase the service life of cables and hoses, can be customized for various types of motions and installations and are cleanroom-suitable.

“Our e-chain systems you can find in every device where a big linear or rotary movement is needed. We have a big advantage because we are non-magnetic with all materials, compared to metal competitor products, which in MRI equipment is a big advantage,” said Nehring, adding the caveat that the company so far does not offer systems that come into contact with blood or tissue below the epidermis in the long term, e.g. implants.

Igus bearings and linear systems also offer advantages because they have smooth movement and are durable and self-lubricating – enabling easyto-adjust hospital beds, surgery tables and more.

They’re resistant to acid, alkaline and alcohol cleaning

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agents. They’re also easy to clean and can be produced with FDA and E.U. compatible materials.

Both Igus e-chains and bearings are also finding uses in 3D printers, with potential opportunities in medical device manufacturing.

Here are three ways Igus components are already enabling innovation in the medical sector: 1. Speedy robot arms to store and retrieve medications in seconds It’s not difficult to see hospitals and pharmacies challenged by dispensing thousands of drugs with speed and accuracy. As the number of drugs rises, so do security issues. To address both, the Rowa Division of BD in Germany has introduced two machines.

The Vmax robot arm with a gripper (not shown) takes scanned medication packages and places them where space is available. The arm is driven in this left and right direction by an Igus Dryspin nut on an Igus lead screw with about a 1-in. pitch.

Image by Paul Dvorak

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Off-The-Shelf-Custom

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MOTION CONTROL COMPONENTS

The Rowa Vmax provides for the automatic storage and retrieval of boxed pharmaceuticals while the Smart System can collect and blister-pack a daily dose of medications for individual patients.

The rapid storage and retrieval are possible because of an Igus lead screw and nut. Stefan Niermann, the Igus head of business unit dryline linear & drive technology, says BD engineers had looked for a lead screw with a long pitch and low friction and selected the Igus products in part because the nut operated with less than half the friction of competing products.

2. Wheelchair wheel with speedy shock absorption Softwheel (Tel Aviv) boasts impact-absorbing wheels for wheelchairs. Wheel designers used Igus Iglide W300 plain bearings 18 times because the plastic bearings had so many benefits.

The W300 bearings were robust, wear-resistant, lightweight, corrosionresistant, suitable for linear and oscillating applications and maintenance-free.

One would never know just glancing at the wheel that Igus plastic bearings were playing such an important role. “The problem with the bearings is that they’re always hidden,” joked Patrick Carl, head of international sales for Iglide bearings.

The Acrobat wheelchair wheel from Softwheel Image courtesy of Softwheel

3. Taking friction out of a mechanical gurney A and A Co. (Tokyo) had a mechanism for electrical gurneys used in operating rooms. But the mechanism had a problem: Friction from the rotating shaft created a metal powder that was unacceptable for hygiene regulations for medical areas. Igus’s Iglide plain bearings solved the problem. Plus, the bearings don’t require lubrication, further promoting hygiene. M

OUR E-CHAIN SYSTEMS YOU CAN FIND IN EVERY DEVICE WHERE A BIG LINEAR OR ROTARY MOVEMENT IS NEEDED.

Founding editor Paul Dvorak contributed to this report.

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FAST DELIVERY, PRECISION AND PROVEN RESULTS. MONOCARRIER™ QUICK SHIP PROGRAM Automated medical and diagnostic applications demand repeatability to achieve consistent, accurate results. Through NSK’s Quick Ship Program, Monocarrier™ actuators are available within 4 weeks. Customize your order and add accessories, such as K1™ Lubrication Units, covers, sensors, rails and brackets for select models.

This program is ideal for small volume purchases with quick turnaround needs.

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MOTION CONTROL COMPONENTS

How to mitigate heating in a handheld surgical tool There are two main sources of power loss, and hence heating, when it comes to hand-held surgical tool motors.

Urs Kafader Maxon Motor

Motors operated at the rated torque limit can get very hot. In continuous operation, the winding can reach 155°C, resulting in a housing temperature of some 120°C. No surgeon would like to operate with a hand-held tool at even half of that temperature! Neglecting friction, there are two main sources of power loss, and hence heating, in motors.

Source 1: Joule power and iron loss The Joule power losses are linked to the current, i.e. the required torque load. As is well known, these losses increase with the square of the current. High currents close to the nominal value will result in temperatures unbearable for humans to touch; running the motor at currents of about half the nominal current results in moderate temperatures (typically below 50°C) that match sensitive human skin.

For motor selection, this essentially means you should go for an oversized motor! Be aware, however, that we consider here continuous operation in which the maximum temperatures will only be reached after some 10 minutes. In hand-held tools, one usually has intermittent operation that can expand to 30 minutes and more. The heating is according to RMS average load including dwell times.

The iron losses are related to speed. Eddy current losses increase with the square of speed, heating up the motors simply when rotating – even in a no-load condition.

In hand-held tools, this can be a problem for grinders and

Image courtesy of Maxon Motor

drills that operate at several ten-thousand rpm. Such highspeed motors need special design precautions to limit eddy current heating. Typically, they are made with a low number of magnetic poles, a slotless winding and ultra-thin back iron foils made of special low-hysteresis materials.

Source 2: PWM driver and inductance It turns out that heating is not only a question of torque, speed and design, but also of the driver. Some users have experienced high motor temperatures (80°C and more) even when driven at no-load conditions. In those cases, the driver and supply voltage often have a major effect.

Slotless windings have a very low inductance, resulting in a very low electrical time constant. The current will react very quickly; that’s good for dynamic behavior. However, when driven with pulse-width modulated (PWM) power stage (as most controllers are) the motor current is able to follow these rapid voltage changes, giving rise to a considerable current ripple. Be aware that the PWM voltage and the current ripple have no effect on the mechanical response of the motor. The motor reacts according to the average current and voltage values.

The current ripple peaks, however, heat up the motor.

Counter-measures for minimizing the current ripple are: • Reducing the supply voltage of the PWM driver, if possible, by the speed requirements of the application; • Increasing the PWM frequency to allow less time for the current ripple to build; • Adding an extra inductance – a motor choke – in series to the motor lines in order to increase the electrical time constant and to dampen the current reaction.

Maxon controllers take the low inductance of Maxon motors into consideration. They work at high PWM frequencies of 50 to 100 kHz and are equipped with sufficient additional inductance for most motors.

The heating problem might be easily resolved by replacing the old over-dimensioned controller with a controller made for lower power with a larger built-in inductance that operates at a higher PWM frequency. The largest effect on temperature, however, is gained by reducing the supply voltage close to the minimum value needed. M Urs Kafader is head of training for Maxon Motor.

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maxon product range

The solution is always a matter of the right combination.

If versatility and intelligent drive solutions are called for, the maxon product range provides the answer: A wide range of brushed and brushless DC motors up to 500 watts complemented by gearheads, sensors, brakes, positioning controllers and accessories offer a consistent modular system to realize whatever you have in mind.

Maxon Motors 11-17.indd 56

maxon precision motors 101 Waldron Road Fall River, MA 02720, USA Phone 508-677-0520 info@maxonmotorusa.com, www.maxonmotorusa.com

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NEEDLES & SYRINGES

How to ensure patient centricity in drug-delivery system design Now more than ever, it’s critical for drug-delivery systems to address usability needs and patient safety. Here are three key takeaways to ensure that patients stay central to the development process for drug-delivery devices.

Kennedy Clark West Pharmaceutical Services

For the treatment of many chronic conditions, such as Crohn’s disease, diabetes, multiple sclerosis and rheumatoid arthritis, drug administration continues to move from a doctor’s office to self-administration in the patient’s home. As a result, the market demand for patient-centric delivery platforms has increased dramatically. If patients are not comfortable with – or have difficulty using – the technology, adherence levels can drop.

It’s more critical than ever for drug-delivery systems to address patient safety and usability needs. Therefore, drug-delivery platform providers are more vigorously exploring innovation and technology to build patient centricity into the design of self-administration systems and stay ahead of market demand.

This requires conducting extensive research into three patient-facing areas: Human factors, device usability and patient needs.

road maps and habits and ideal scenarios.

• Identifying ergonomics: Human error and risk analysis, usability testing and heuristic analysis (encouraging a person to use the device on his/her own).

Human factors To design a drug-delivery system that will truly resonate with patients, the first step is understanding their behaviors and motivations.

This requires conducting research that will drive innovation in the design and development processes, creating a solution that works in a variety of situations. Methods for pinpointing behaviors and motivations include:

• Physical abilities: Anthropometry (the measure of bodies, such as height or the size of hands), biomechanics (what can be accomplished physically) and sensory abilities (vision, hearing and tactile sense).

• Cognitive abilities: How people process information, the capabilities of memory, the manner in which humans learn new things and how habits are developed.

• State of being: The general health of the expected user, disease states and comorbidities, mental and emotional states and motivation for learning new things.

• Experiences: Educational background, knowledge of a particular disease state and lifelong experiences with objects that will guide behavioral interactions with any delivery system.

• Collecting qualitative data: Interviews, ethnographic observations, contextual inquiries and concept evaluation.

• Gathering quantitative data: Questionnaires, in-person surveys and userbased performance testing.

• Analyzing and synthesizing outputs: Affinity diagramming, product adoption 96

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Device usability Once human factors are identified, it’s crucial to gain a deeper understanding of how appropriate a drug-delivery platform is for patients. Typically, the most impactful data is gathered through interviews and observations in the proper context. Seeing the user in the midst of daily distractions – such as caring for an aging parent and interacting with children, pets, ambient noise, temperature and lighting – all help human-factors experts better understand how the patient will use a device.

Testing can be broken down into four major components:

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Patient needs A third critical aspect to developing a patient-centric self-administrative platform is defining what they need out of the technology, beyond successfully delivering the therapy. Research can uncover information that will personalize the system and help increase adherence.

Those needs include: • Expected needs: Meaningful to patients; direct observation inside the user's environment is an effective way to document them.

• Expressed needs: Simple for users to articulate; “think-alouds” and other narrative techniques are best to determine expressed needs.

• Exciting needs: Typically delights patients; they often do not think about the features as technically possible.

Taking human factors, device usability and patient needs into account is critical to designing delivery systems that patients can and want to use. In doing so, drugdelivery platform providers will not only meet the unique needs of pharmaceutical partners, but more importantly, also ensure the device’s user interface is safe and effective for the intended population and environments. M

NEW ENGLAND CATHETER

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Kennedy Clark is a Senior Director leading the Global Market Development team for West proprietary devices. He has earned both MBA and Bachelor of Science in Industrial Technology degrees.

www.necatheter.com 603.838.2261 11 • 2017

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RAPID MANUFACTURING & PROTOTYPING

Complete 3-D printing Form 2 package by Formlabs Image courtesy of Formlabs

How have company launches and prototyping evolved with 3D printing?

Here are three basic ways that 3D printing can help you get your medical device project off the ground.

Jim Medsker Keystone Solutions Group

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Additive manufacturing, commonly referred to as 3D printing, began to surface in the 1980s.

Since then, the technology has quickly become a valuable tool for creating plastic prototype parts in a rapid fashion. Like many emerging technologies, however, the early days of 3D printing had drawbacks.

The equipment and materials were prohibitively expensive for most companies, thus creating the initial demand for 3D printing service firms. Many of the first printers on the market came with a price tag close to $300,000.

Further, the parts created were primarily for visual purposes only and typically did not have the surface finish, strength or other properties necessary to make them a fully functional part.

Roll the clock forward to the present day and the technology is not only capable of creating fully functional parts in many applications, it’s also accessible for small companies and 11 • 2017

hobbyists. Today there are several 3D printer options in the sub-$1,000 range, and many in the $3,000–$10,000 range, that produce high-quality, structurally capable parts.

In the early days of the technology, materials were limited to specialized plastics with limited mechanical and thermal properties.

Today materials, processes and resulting parts are wide-ranging, including: • • • • •

Many plastic resins Elastic and dual durometer components Metals Fabrics Biocompatible scaffold materials to promote tissue growth • Synthetic food products This advance led to the capability to produce everything from organ tissue to full-size

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Propel your business into the future.

HP Jet Fusion 3D Printing delivers design flexibility fast. hp.com/go/3Dprint

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RAPID MANUFACTURING & PROTOTYPING

vehicles and just about anything one can imagine in between.

For medical device startups, this means additive manufacturing is now a key asset for not only creating parts, but also in launching companies. The following provides a few brief examples of how this technology can help you get your medical device project off the ground:

YOUR IDEA

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1. Design cycle frequency Many additive manufacturing processes produce parts with near net shape and physical properties that parallel components made with standard production processes. This allows the 3D-printed parts to go beyond boardroom presentation and into the lab for testing. At times, they can even go into the field for voice-of-customer and validation studies.

Data from the lab and feedback from the field can then be fed back to the design team and the next iteration design can be produced quickly. This means project schedules and budgets are minimized and design integrity is optimized.

2. Funding Funding is often the primary barrier for entrepreneurs and department heads when it comes to getting ideas off the ground. While PowerPoint presentations and detailed pro formas can be impactful in the fundraising effort, there is nothing like a production-intent product in the hands of investors to help close the deal.

With today’s additive manufacturing technologies, this is not only possible – it’s becoming an expectation in many cases. High-quality prototypes deliver the message effectively and increase investor confidence.

3. Production Moving to full-scale production often requires a significant capital outlay for tooling, fixturing and minimum volume commitments – potentially meaning months of lead time. The cost as well as the time required for custom tooling often puts the program’s finances and schedule at high risk. Fortunately, with the production quality output of many of 100

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MS1048

todayâ&#x20AC;&#x2122;s additive manufacturing processes and materials, many companies are forgoing the burden of expensive tooling and are now using 3D printing for production runs.

Depending on the product, using 3D printing for production may be limited to the initial pilot runs. However, it is becoming increasingly common to use this technology for long-term ongoing production.

accessibility will undoubtedly help an ever-increasing number of initiatives get off the ground. M Jim Medsker founded Keystone Solutions Group (Kalamazoo, Mich.) in 1998 with the vision of creating a turnkey resource for helping people and companies with product ideas get their products commercialized.

The exciting news is that the technology continues to evolve and progress at an amazing pace. As the quality of parts and variety of materials produced with additive manufacturing continues to improve, the equipment and material costs continue to fall. These combined advancements and improved

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RAPID MANUFACTURING & PROTOTYPING

How 3D printing options are growing for medtech development The new Multi Jet Fusion process out of HP is but the latest 3D printing technology to up the game for medical device development. Here’s a roundup of what’s available.

J o n E r i c Va n R o e k e l Proto Labs

The medical device industry continues to be driven by innovation. Some sources, including medical market research firm Kalorama Information, say that medtech companies this past year will have spent an average of 7% of revenue on R&D, which is higher than most industries.

As those innovations are brought to market in the form of new products and services, medtech companies will look to rapid manufacturing processes for prototyping, functional and regulatory testing and, ultimately, end-use production.

Fittingly, our manufacturing industry generally – and 3D printing specifically – is driven by innovation.

Indeed, key technological developments and new applications in industrial-grade 3D printing, or additive manufacturing, continue to advance this technology, which has only been around for about 30 years.

The technology uses an inkjet array to selectively apply fusing and detailing agents across a bed of nylon powder, which are then fused by heating elements into a solid layer. After a layer is built, a fresh layer of powder is distributed on top of the previous layer and the next phase continues until the build is complete. The process uses an engineeringgrade nylon 12 powder, so parts are durable and suitable for functional testing and end use.

Proto Labs was one of a handful of sites that tested the technology before it hit the market.

“As far as what we’re testing in, it is definitely becoming a faster way to build parts compared to some other 3D printing processes,” applications engineer Joe Cretella told Medical Design & Outsourcing.

Indeed, as a part of this testing, we worked closely

AS FAR AS WHAT WE’RE TESTING IN, IT IS DEFINITELY BECOMING A FASTER WAY TO BUILD PARTS COMPARED TO SOME OTHER 3D PRINTING PROCESSES. Medtech companies are already using 3D printing in an impressive variety of ways: Vertebra replacements for the human spine; prosthetic components; surgical instruments; operating room equipment; hand-held devices; clear (transparent) options for braces, aligners and retainers in dentistry; and so on.

Multi Jet Fusion joins the 3D printing lineup One notable additive manufacturing newcomer is Multi Jet Fusion (MJF), launched last year by technology giant HP and recently adopted by multiple 3D printing service bureaus. MJF is a production-grade 3D printing technology that builds fully functional plastic prototypes and production parts faster than comparable processes and with detailed precision and improved isotropic mechanical properties.

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with HP’s R&D team to fine-tune the process in order to consistently produce high-quality parts.

In August, following the testing phase, we added this process to our production capabilities. With the addition of MJF we offer five industrial-grade 3D printing processes that can produce plastic, metal and elastomeric parts and components. This array of platforms is a prime example of how additive manufacturing continues to advance and grow.

So what 3D printing technologies are available?

Designers and engineers can now choose from several distinct classes of 3D printing technologies. Your choice of “tool” just depends on what you’re designing and its final application. Here’s a brief roundup of some of the main industrial-grade 3D printing options:

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Image courtesy of Proto Labs

• Stereolithography (SL) uses an ultraviolet laser that draws on the surface of a liquid thermoset resin to create thousands of thin layers until final parts are formed. SL is used to create concept models, cosmetic prototypes and complex parts with intricate geometries.

• Selective laser sintering (SLS) uses a CO2 laser that lightly fuses nylon-based powder, layer by layer, until final thermoplastic parts are created. SLS produces accurate prototypes and functional production parts.

• Direct metal laser sintering (DMLS) uses a fiber laser system that draws onto a surface of atomized metal powder, welding the powder into fully dense metal parts. DMLS builds fully functional metal prototypes and production parts and works well to reduce metal components in multipart assemblies.

• PolyJet uses a jetting process in which small droplets of liquid photopolymer are sprayed from multiple jets onto a build platform and cured in layers to form elastomeric parts. PolyJet produces multi-material prototypes with flexible features at varying durometers and is often used to concept overmolding designs.

• Fused deposition modeling (FDM) works by feeding a filament or spool of plastic into a heated nozzle, which then extrudes successive layers of thermoplastics onto the workpiece. FDM offers a wide thermoplastic material selection and is leveraged for iterative prototyping. www.medicaldesignandoutsourcing.com

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• Continuous Liquid Interface Production (CLIP), used by a company named Carbon, builds parts from the top down, unlike other additive technologies that work from the bottom up. Final plastic parts exhibit excellent mechanical properties and surface finishes.

• Multi Jet Fusion (MJF) selectively applies fusing and detailing agents across a bed of nylon powder, which are fused in thousands of layers by heating elements into a solid functional component. Final parts exhibit improved surface roughness, fine feature resolution, and more isotropic mechanical properties when compared to processes like SLS. Ultimately, choosing the right process for your next project is a multi-faceted decision because it depends on project requirements and a multitude of variables. Our application engineering teams work with customers every day to help them determine the best 3D printing process for their particular needs. M Jon Eric Van Roekel is 3D printing process engineering manager at Proto Labs (Maple Plain, Minn.).

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REGULATORY, REIMBURSEMENT AND IP

Protecting intellectual property All companies begin with an idea. The details of protecting that intellectual property can be daunting, especially if your idea is in the field of medical technology.

N. Scott Pierce Alexander Adam Hamilton, Brook, Smith & Reynolds PC

Starting a medical device company requires a vast array of knowledge, including knowledge about almost every type of technology, an immense amount of regulatory requirements and intellectual property protection strategies.

So how can you establish a legal framework that fulfills the promise of an advance in medical technology while rewarding you for your contribution to society?

Medical devices and methods of treatment that employ them are protectable as intellectual property. The most advantageous type of intellectual property will depend on the exact nature of the technology. In any case, it’s imperative before any action is taken that at least initial steps are taken to protect their work.

Types of intellectual property Each form of protection has its own advantages and limitations: 1. Trademarks and service marks: These are intended to indicate the source of a product or service and generally take the form of brands or logos.

Trademarks and service marks can be registered with the U.S. Patent & Trademark Office (Patent Office) and are usually indicated by the symbol TM or SM or, if the mark is registered, ®.

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2. Copyrights: These offer protection for works of authorship and visual art. Copyright protects an expression of an idea in a tangible form, rather than the idea itself. In most medical technology-based startups, copyright protection applies to publications and other written materials, such as internal manuals, product literature and company announcements.

Computer software, such as the programming of robotic components, is also subject to copyright protection, often as an alternative to or in addition to patent protection.

3. Trade secrets: These can include almost any type of information generated within a company that’s not known or readily ascertainable by the public. Trade secrets can include technology generated by the company, employee know-how and customer lists and can be maintained indefinitely, usually through the use of employment agreements and confidentiality agreements with third parties.

Technology that is kept confidential, but can be reverse-engineered if disclosed, should be protected by patents before any public disclosure, such as during fundraising efforts or by the commercial launch of a product.

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4. Patents: These are by far the most common means for protecting innovative medical technology. Most relevant to medical technology are “utility patents,” which protect the way an article is used; less relevant are patents for a design or a plant.

Six things you need to know about patents: 1. Provisional patents: A common form of initiating patent protection for medical startups is to file a “provisional” patent application, especially for companies with limited funds – the cost of filing can be very low, typically only a few hundred dollars.

Provisional patent applications are not examined by the Patent Office and automatically expire after a year.

They never mature into enforceable patents and are maintained in secret by the Patent Office, unless used in a subsequently published “non-provisional application.”

2. Filing early is important: Filing dates for provisional and non-provisional patent applications are important because prior right is given to the first inventor to file a patent application, not the first person to invent to a system. Therefore, it’s critical to file a patent application, even a provisional application, as soon as possible – preferably before speaking to potential investors.

Many “seed” or “angel” investors require that a patent application be filed as a prerequisite to discussing a new venture based on any emerging medical technology.

3. Wording of claims: The intellectual property of any nonprovisional patent application or patent is defined by its claims, which appear at the end of any application or issued patent. Each claim includes a “preamble” and a “body,” wherein a combination of so-called “elements” of the body of the claim outline the exclusionary rights of the patentee. Any process, machine, manufacture or composition of matter that includes all of the elements of the claim is said to “infringe” the claim and the patent owner has the right to exclude the public for the limited period of enforceability of the patent from making, using, selling, offering to sell or importing the infringing subject matter. The wording of claims is extremely important and it’s strongly advised that medical technology startups use a patent agent or attorney registered with the Patent Office.

4. Inventorship: This is determined by the claims of a patent application; any individual who contributed to the complete mental conception of any claim must be named as an inventor. Inventorship should be assessed before any patent application is filed to mitigate issues over patent rights. In addition, if improvements are not described in an application or patent, a new patent

application can be filed on the improvement. Very often this is critical because the improvement may end up as the most important – or only – protectable IP. Startups should be sure to have any employees assign their rights to the company when they become employees, lest they independently license or assign their rights to a third party. Even if inventors agree to assign rights to the company, failure to record the assignment with the Patent Office may still allow them to assign the rights to a third party.

5. Multiple parties: Medical technology is often multidisciplinary and startups based on medical technology frequently collaborate with outside parties, meaning that patent applications and patents may be jointly owned. Assignments of rights by inventors with obligations to different companies will cause the resulting application or patent to be jointly owned by both companies.

6. Associated agreements: Medtech startups often use several types of agreement for their IP. Nondisclosure agreements can be important in protecting confidential information before patents are filed. It’s strongly recommended that, regardless of any confidentiality agreement, a patent application be filed before disclosing the invention to a third party; it’s not uncommon for vendors to file applications after meeting with inventors to discuss new technology. Another common instrument is a material transfer agreement, often associated with samples of proprietary subject matter sent to prospective customers.

Patents and patent applications can also be licensed, either exclusively or nonexclusively, with “exclusive” licenses for a single licensee and “nonexclusive” licenses for multiple licensees. In any enforcement action against a potential infringer, all parties, including licensees, must take part.

Intellectual property protection is vital in any medical technology-based startup and it is relatively easy and inexpensive to establish a filing date in the Patent Office for an invention. Obtaining an early filing date is often critical in enabling an organization to attract the capital necessary to become established and proceed with its vision. M N. Scott Pierce is a principal and Alexander Adam is an associate at Hamilton, Brook, Smith & Reynolds PC (Boston). Pierce practices in biotechnology, chemistry, chemical engineering, electronics, medical devices and pharmaceuticals. Adam helps startups advance their innovations in medical devices, computer systems, electronics, imaging software, control systems, mechanical devices, telecommunications and clean energy.

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REGULATORY, REIMBURSEMENT AND IP

Mobile health innovations need protection for success Patent protection is becoming increasingly important for mobile health developers as more devices and applications join the connected world.

David Dykeman G r e e n b e r g Tr a u r i g

The emergence of medical mobile device apps and wearables is revolutionizing healthcare. Home monitoring, big data, the Internet of things (IoT) and personalized medicine are putting mobile health (“mHealth”) apps at users’ fingertips. With connected health and point-of-care diagnostics becoming more common in clinical settings, patent protection is crucial for developers of mHealth innovations and wearables used to diagnose and monitor medical conditions, prescribe drugs or order laboratory tests. mHealth apps can be used on a large scale, such as the apps provided by the Centers for Disease

Graphics by Matt Claney

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Control to assist first responders during the recent Ebola outbreak. Other mHealth apps provide continuous blood glucose monitoring, nutrition analysis and personal fitness tracking to allow individuals to monitor their own health. Analysts estimate that there are approximately 259,000 health-related apps for mobile devices. Consulting firm PwC forecasts that mHealth apps will have been downloaded 1.7 billion times by the end of the year.

In this rapidly growing market, medtech companies need to maintain a competitive edge through a strategic patent portfolio that focuses on protecting core technology, exploring new patent areas and establishing worldwide patent protection.

Drive growth with strong patent strategy A strategic patent portfolio protects a company’s core technology, which in turn helps secure funding and establishes a competitive advantage in the marketplace. A recent study found that a startup has about a 2.5-times greater chance of achieving success within 10 years of venture capital investment if it holds patents before the investment.

Patents are extremely important for companies of all sizes with innovations in mHealth. For early-stage companies, patents are often the only way for investors to place a value on its technology. In this way, patents make up a significantly greater portion of enterprise value for early-stage mHealth companies. As a company grows, patents become the currency that secures financing through venture capital or private equity investment. Patents can also lead to collaborations, joint ventures and licenses with strategic partners.

For early-stage mHealth companies, the key is to develop a strategic patent portfolio that has comprehensive patent coverage around the company's innovations. The core technology must have adequate patent protection to provide flexibility and room to operate in a desirable market. To obtain broad patent protection, companies should file an initial patent application covering the core technology,

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followed by additional patent applications covering key improvements. A company should consider both current and future business objectives and analyze ways that competitors may attempt to design around its patents.

Navigating the patent thicket A major challenge for mHealth companies is the complex and often multifaceted nature of mobile technology. Many traditional medical device companies are now creating mobile apps for existing products.

Such innovations frequently incorporate or combine multiple technologies; each component of the device must be protected. Where applicable, patent claims should be directed to the entire device, key components, control systems, disposables, mobile applications, methods of treatment, manufacturing methods and any other aspects of the invention. Design patents can also provide protection for the ornamental features of mHealth products. As companies continue to improve their core technology, they should patent incremental changes to form a "picket fence" of patent protection around that core tech. By filing patent applications covering incremental improvements, mHealth companies can grow their patent portfolio and expand their presence in the market.

It’s important to work with a patent attorney who understands the interplay of programming, healthcare, detection and processing with hardware to ensure that the app qualifies as patentable subject matter. A patent attorney can also file copyright applications covering the software.

From innovation to market mHealth innovations present some unique concerns.

FDA is issuing new guidance on how to best regulate medical mobile apps. To limit potential liability, mHealth apps should include a disclaimer that the app does not provide medical advice.

Medical mobile device apps and wearables are changing medicine at the forefront of healthcare innovation. With strategic patents that focus on key innovations, medtech companies can maintain a competitive edge in the burgeoning mHealth industry. M David Dykeman is a registered patent attorney with more than 20 years of experience in patent and intellectual property law and co-chair of Greenberg Traurig’s global Life Sciences & Medical Technology Group. He can be reached at dykemand@gtlaw.com or (617) 310-6009.

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Protect IP ownership in developer agreements Medtech companies that outsource the development of apps to third-party developers need to protect the ownership of their intellectual property (IP), including software code. When an mHealth company hires an independent contractor to create and develop code for an app, the company must have a written agreement stating that any code the independent contractor creates is a “work-for-hire” under copyright law. In a work-for-hire arrangement, that mHealth company will own any code developed by the contractor. Including this specific language in a written developer agreement allows the mHealth company to retain ownership of the copyrighted source code that runs the mobile app.

As a practical matter, mHealth companies should also be sure that third-party developers transfer website passwords upon completion of projects. Thus, a company can access and improve mobile apps and websites even if the developer is no longer involved.

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REGULATORY, REIMBURSEMENT AND IP

How can sponsors respond to and benefit from the complex challenges the new EU regulations present?

Vicki Anastasi ICON

The new European Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) represent one of the most wideranging and disruptive changes to recently affect the world’s second-largest medical technology market.

With just a three- to five-year transition period before full compliance is required in 2020 for MDR and 2022 for IVDR, the scope and complexity of this legislation will require significant changes in areas such as product development, data reporting, quality assurance and manufacturing processes. Manufacturers will need to identify which of their products will be affected by the new classifications to ensure they remain compliant.

Additionally, the role of Notified Bodies (NBs) will be restricted by the European Commission to certifying only specific classes and types of medical devices and in vitro diagnostic devices (IVDs) for which each NB can demonstrate expertise. This will reduce the number of NBs available to certify many devices for some time and, in combination with the larger volume of clinical data that NBs will be reviewing for each device, we expect long delays in certification reviews as deadlines approach. Finally, IVD manufacturers will be particularly impacted, as NB review will be required for approximately 90% of products, up from about 10% today.

What steps should manufacturers take to prepare for the new EU regulations?

Early planning is key. As challenging as product testing and reporting requirements may be, the new regulations could present an opportunity to get ahead of the competition.

Complying with the new MDR and IVDR will require significant lead time, especially when preparing clinical studies to certify new devices – and to recertify existing ones. Moreover, you’ll need extra time for expanded NB reviews and any backlog that may develop.

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Graphic by Matt Claney

New regulations are coming to the European Union and it’s up to developers to implement changes that will help them thrive in the new environment

For IVD organizations that have not previously run clinical trials, developing this capability requires a lot of time and resources. In addition, review of certification applications by NBs will take time, since NBs must develop the capacity to review IVDs. So, for MDR and IVDR, early transition will give your products an advantage in the market by providing buyers with credible performance information. Also, it gives early movers an edge in squeezing out other manufacturers competing for the same limited NB resources.

Will it be worthwhile to conduct clinical testing on existing products?

Yes, it’s worth the investment. Developing strategies that demonstrate effectiveness will help you gain and press your market advantage.

The best way to know whether your products are worth the investment is to conduct a “gap analysis” of your pipeline and existing product portfolio. For each product, first determine the category under which it will be certified – MDR or IVDR – and what additional evidence, clinical testing, production process, technical file documentation or other changes will be required to conform.

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Five mistakes that can turn your product registration into a money drain

Next, estimate the cost of these changes, assess how they’re likely to affect profitability and reconfigure your portfolio accordingly. Your analysis may indicate it’s time to drop marginal products with a lot of competition and focus on preparing packages for new, more profitable medical devices where there are fewer marketplace competitors or IVDs with strong evidence showing they support clinically beneficial treatment decisions.

Clinical tests for IVDs differ from those of pharmaceuticals or medical devices primarily in their endpoints. Although drugs and medical devices generally can be evaluated based on how they directly affect a disease or condition, IVDs must be evaluated based on how the information they provide affects treatment decisions.

Consider that the new regulations require uniform performance data reporting to a central database, which will make it easier for health system buyers to compare product performance head-tohead. As a result, any product that shows a clear performance edge could gain a decisive market advantage.

CROs can help assess portfolios for product viability under the new regulations and in creating the real-world evidence needed to conform to the new regulations. M Vicki Anastasi is Vice President & Global Head, Medical Device & Diagnostics Research for ICON plc. She has more than 25 years of experience in the medical device industry, with more than 15 years specifically focused on global medical device strategic consulting.

Medical device registration may seem straightforward, but it’s actually prone to potentially costly mistakes.

Heather Thompson Senior Editor

Medical device organizations are required to register medical devices with notified bodies in all countries where they sell those products. This process is fairly well understood and expected.

However, there are pitfalls in the practice of compiling the dossiers to register; mistakes can end up costing a company money, according to Carl Ning, director of global solutions architecture for Sparta Systems (Hamilton, N.J.).

Ning highlighted the common errors medtech companies make in thinking about product registration and offered some solutions: 1. Your regulatory department is understaffed.

The global registration process is time-consuming.

For the most part, medical device organizations only keep a few regulatory professionals on staff.

That means that only a few people are dealing with the hundreds, if not thousands, of SKUs marketed globally. They are working lean and they can’t get ahead of the transactional volume.

2. You think of your regulatory department as being pigeonholed as a cost center, not a revenue generator. Regulatory folks are responsible for a wide range of tasks, spanning pre-market approval activities to post-market surveillance. But thinking that your team is only perceived as a cost center is an underestimation of the value of your regulatory staff.

The perception couldn’t be further from the truth.

Consider that if a product isn’t properly registered in a country, the cost to the company can be enormous.

Consequences could range from potential civil penalties levied against the organization to top-line revenue impact if the sales team cannot gain timely and lawful access to the product for sales execution.

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REGULATORY, REIMBURSEMENT AND IP

3.

Your regulatory personnel is using home-grown spreadsheets or even paper tracking.

The “cost center” misconception can lead to a lack of investment in the department.

As such, many regulatory staffers use homegrown spreadsheets to manage global registration. Tracking something as complex as global product registration with a spreadsheet is the regulatory equivalent of bringing a knife to a gunfight. These complex spreadsheets are often updated by multiple people, so the realtime accuracy becomes questionable as the staff continuously plays catch-up. Further, such “systems” do not integrate with enterprise resource planning solutions. Companies have often invested heavily in an ERP, but fail to make the connection for product registration. This non-integrated landscape perpetuates the operational redundancy organizations face today, but it doesn’t have to.

Image courtesy of istockphoto.com

4. You are in reactive mode all the time. Without a comprehensive (and integrated) registry system, the regulatory staff is reacting to information rather than getting ahead of it. That means that keeping up with changes takes longer than it should. And producing even simple reports for a leadership team – reports that could be generated in a few hours – can take two to three days.

How to fix or avoid these mistakes Of course, there are ideal situations. Regulatory leaders would love to have more staff, but adding technology may suit more organizations. An end-toend management system offers both scalability and cost containment.

To make internal changes, regulatory leadership can help to educate the C-level teams on investing in technologies that can integrate the product registration process into the other critical pillars within an organization’s technology stack – such as ERP systems for product holds or QMS by linking product registration process to quality processes; e.g., a systemic issue requiring a CAPA that leads into change management, which in turn initiates the necessary product (re-)registration process automatically.

One of the key tenets is data integrity. If your regulatory staff is using outdated solutions, a “single source of truth” may be difficult to reach. That means getting answers to simple questions takes too long.

A good tracking system will introduce data integrity, ensuring all users are consuming consistent and upto-date data across the organization.

The right technology also provides a way to manage registration schedules and (recurring) commitments, so that regulatory teams get ample lead time, and can work quickly to ensure deadlines are met. An organization can benefit tremendously by having a collaborative platform to enable sales, marketing, product management and regulatory to work in unison to define, build, launch and sell the product. Finally, do ensure that the solution provides the proper alignment to your organization’s IT strategy (cloud versus on-premises). M

5. Your regulatory department may be viewed as a new product introduction/sales launch blocker rather than an enabler. With outdated technology in hand and a lean team to boot, regulatory teams trudge on fighting the good fight. While they may be able to contain a blaze, the time it took to fix the problem was likely borrowed from impending sales launch efforts. Any delay in new product/sales launch puts the responsible party under intense scrutiny; no regulatory team intentionally protracts the launch timeline.

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REGULATORY, REIMBURSEMENT AND IP

How to work with the new FDA Here’s how medical device makers can capitalize on the strategic priorities and transparency initiatives at the FDA’s Center for Devices & Radiological Health.

Lisa Olson RCRI

Dr. Scott Gottlieb has now settled into his role as the FDA’s new commissioner and is putting his stamp on the agency.

Interestingly, Gottlieb started with some very specific points of focus that have bubbled to the surface in the political arena, including the drug approval process and tobacco and opioid addiction.

On the working level, Gottlieb’s appointment has not interrupted the momentum of the agency as a whole. When the totality of FDA actions and external communications are evaluated, the agency is still demonstrating a focus on the strategic priorities set out in 2016. Although the recently signed fourth iteration of the Medical Device User Fee Act (MDUFA IV) has several new points, all of the changes serve to support the 2016 initiatives.

Strategic priorities The initial priorities set forth in 2016 focused on three main topics: Establishing a national evaluation system; partnering with patients; and promoting a culture of quality and organizational excellence. For 2017, the agency went deeper by defining how they intended to support those initiatives with the Regulatory Science Priorities document. These priorities ranged from the use of Big Data in decision-making to the development of new evaluation tools. There are tactical points for safety evaluations and controlling the microbial risks in reprocessed and sterile devices. Notably, these are all externally facing initiatives.

However, the FDA is honoring its commitment to improvement, transparency and accountability through its highly detailed quarterly reports.

MDUFA IV commitments Important commitments that will fundamentally impact how the FDA works have been included in MDUFA IV. Laying out the pilot program for laboratory accreditation, as well as actually accrediting laboratories, may not be revolutionary but will dramatically impact how review of submissions are done (as well as how submissions are constructed). Furthermore, MDUFA IV formally commits the FDA to accepting third-party review.

Although the agency has been regularly reporting to Congress, the new requirement is far more explicit in linking performance and activities to monies appropriated.

Capitalizing on the information Basically, Regulatory Science Priorities and MDUFA IV are about measurable performance and accountability. With an understanding that the FDA is being driven by metrics,

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one can extrapolate that interactions with the agency may become more highly formulaic. Standardized evaluations, reliance on checklists and uniform responses from the agency are going to become common. This can present both a benefit and a challenge for the device industry. On the positive side, interactions with the agency should become far more predictable. Evaluating warning letters, blogs, Twitter feeds, inspection reports and quarterly reports to Congress will tell manufacturers a lot about FDA expectations. On the negative side, reviewers are going to be more stringent about exactly meeting guidances without deviation.

On the surface, this standardization should help expand the FDA’s capacity and provide a more uniform approach to review and feedback. Looking deeper, this could also drive the agency to be potentially less flexible in accepting alternative or novel approaches. Expect submissions to be closely held to the published requirements. Policies such as RTA, allowable interactions, number of review cycles, etc., will be closely followed. Pre-submission meetings will have more importance than ever to ensure that planned approaches will meet agency expectations.

Despite the drive towards metrics, there is a clear initiative to be accessible. Both the pre-submission meeting program and the interactive review process should be used to your advantage. However, every interaction with the FDA should be very carefully planned. When engaging in a presubmission meeting, have your strategy as well-developed as possible. Have a list of questions that are specific, detailed and designed to gather agency expectations. Submissions must not only be thorough, correct and detailed but also well-constructed to lead a reviewer through the review process to a clear and compelling case for device safety and efficacy. Any novel approaches in your submission should be well-justified and clearly defended.

We are in a time of complex and continual change.

However, the FDA is providing multiple indicators of their expectations. Use all of these indicators to smooth your regulatory pathway. M Lisa Olson is president of RCRI, a Twin Cities–based medical device strategic consulting company. Olson has more than 20 years of experience in the medical device industry providing contract research services to startup through Fortune 100 companies. She has extensive technical experience in preclinical research, including in vitro and in vitro biocompatibility, genotoxicology and toxicology models.

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Navigating the FDA for connected devices As connectivity features become increasingly prevalent, developers are tasked with accounting for regulatory implications in increasingly long-term plans.

Aidan Petrie Ximedica

Let’s imagine a product that dispenses a drug for eczema. At its most basic, the dispenser is little more than a package for the primary drug container and so falls under some medical packaging and labeling standards, with some scrutiny as to what materials or pathways are in contact with the drug.

But add intelligence to the product and now it knows how much was dispensed and at what time; perhaps it has a reminder function that lets the patient know when they should take the treatment. We could then send the use patterns to the cloud and have analytics compress the data so that a caregiver or physician could look at the patient’s adherence to the regimen and make proper recommendations.

Everything described in this scenario is already happening with some medications, providing real benefits to the patient and potential benefits to the health system as a whole. Although some of these features cost little to implement and bring to market, others will require years of development, validation, usability and cost-benefit trials – and cost an order of magnitude more to develop.

Preemptively planning and managing this process can give clarity to the entire team and allow development teams to effectively to meet deadlines, plan resources and budget accurately.

Connectivity and classification Connected medical devices offer huge value to healthcare systems and services with their ability to transmit and analyze data, remotely monitor patient conditions, manage multivariable disease states and more. Navigating feature sets that keep a device within the FDA’s Class I exempt designation or trigger a higher classification is critical, as it has vast implications on development cost and timeline.

Almost every device we work on now has some form of connectivity. Often, the classification on the device has been defined by the clinical purpose and risk profile of the device and the FDA has an existing categorization. Other times, determining the effect of connectivity on classification can make abiding by preexisting regulations difficult. As more digital products are being developed with capabilities, analytics and processing outside of the physical product, growing risks and ambiguity exist alongside the benefits.

Class I and Class II triggers From a development perspective, the cost and time variant between a Class I exempt and Class II device is huge. With the higher risk profile of Class II comes a mass of additional requirements for the development and manufacturing process. Device development now follows a process outlined by ISO 13485 and the FDA’s Quality System and cGMP regulations.

These rigorous standards incorporate user needs and requirements, specifications, hazards analysis and a full risk-management process, design history files,

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documentation practices and a myriad of other controls that ensure that the device is developed safely. The device or system must also demonstrate its efficacy through validation studies and predicate equivalency. The ISO and FDA quality system requirements call into play a plethora of general and specific product safety standards, including the IEC 60601 series, 62366, 62304 (software validation), ICH Q6 and Q9 and more.

Risk management (ISO 14971) cuts across all these standards, laying out a development process infused with attention to safety and risk mitigation.

Connected devices, particularly those used at home, draw from many already available or easily developed technologies to deliver value to their diverse users. But how does the entrepreneur know what features might trigger a benign product Class I exempt device to suddenly require adherence to a Class II standard?

It is also worth noting the advantages to pursuing features that will move the app into Class II or higher territory. These richer, more impactful features and functions enable a digital health product to separate itself from the pack. Class I apps are everywhere, are not distinct from each other and, although they offer some value, don't take real advantage of the power of digital devices.

Regulatory, marketing and development leads should work through a matrix set that ’line items’ individual features desired and then categorizes them as ‘no implication,’ ‘it depends,’ or ‘triggers a higher classification.’

Proper input from respective leads about whether a particular feature will affect the development schedule or regulatory considerations in this rapidly evolving area can help to ensure that a device is successful in its first market entry and make it easier to build in new features as they are ready. M

Evaluate each feature, present or future The ‘tail should not wag the dog,’ in that classifications should not determine the success of a product. To that end, we recommend an exercise that evaluates individual features against the regulatory implications and against the development consideration. This trifecta gives the developer the ability to offset the market value of features against the likely impact to cost and to take a strategic approach to deploying feature sets. Developing a multigenerational plan in which MVP meets FDA strategy allows a product to come to market with a low regulatory bar and introduce new features over time.

In 1985, Aidan Petrie co-founded an IP development firm today known as Ximedica. In his role as Chief Innovation Officer, Emeritus, Petrie drives innovation in Ximedica’s core markets of medical device development and consumer healthcare.

www.medicaldesignandoutsourcing.com

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SOFTWARE

Four ways multiphysics simulation can boost medical device design From the simulation expert to the device designer, itâ&#x20AC;&#x2122;s never been easier to access the power of multiphysics simulation.

Va l e r i o M a r r a COMSOL

Because the human body is such an extraordinarily complex system to model and such a hostile environment for medical devices, their design must push the limits of technology. The adoption of multiphysics simulation can help bring devices to the market more efficiently while promoting innovation and collaboration among specialists.

One of the key advantages simulation offers is the ability to reduce physical prototyping.

Challenging designs and new ideas can be built and tested in the virtual world of numerical simulation without having to be physically constructed. In an industry where safety is of paramount importance, the capability to investigate different scenarios by specifying boundary conditions, material properties and physiological mechanisms allows for early and harmless correction of design mistakes.

Additionally, simulation measurements of any variable, such as temperature or flow velocity, can be taken at any point in a model, enabling a better interpolation of available experimental data.

Especially for medical devices, the fact that simulation results can be accessed in locations where it would be impractical if not impossible to place sensors on

a physical prototype or in the human body is greatly appreciated. Design challenges can be surpassed with ease when thousands of ideas are tested and measured before the first physical prototype is built.

The human body is an inherently multiphysics system where multiple physical effects influence each other. Hence medical devices have to be designed in that context to function properly and effectively.

Multiphysics simulation allows for a high-fidelity modeling of devices and the systems they operate in.

A real-world example involves a tissue ablation problem. (See model above.) To successfully design such an ablation system, engineers have to take into account different electrical conductivities of tissues, optimize the delivery of electromagnetic energy within the radio frequency and microwave range, and include perfusion to predict the temperature distribution inside and around the tissue being ablated. Multiphysics simulation ensures successful device design by accounting for all of the important variables.

Designers, who have simulation expertise, often find themselves in unique positions. In addition to being able to simply adjust definitions of variables and values and rerun the simulation, they can also make

(ABOVE) Multiphysics simulation of tumor ablation. The localized heating of malignant tissue is achieved through the insertion of a four-armed electric probe. This model couples the bioheat and electric field equations, and models the temperature field in the tissue. Simulation example made using COMSOL Multiphysics software and provided courtesy of COMSOL. 116

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This packaged simulation application published through COMSOL Server allows users to calculate the trajectories of platelets and red blood cells in a blood sample as they travel through a filtration device. Results show the electric potential, fluid flow distribution in the filtration system, and the particle locations. App example created with the Application Builder available in COMSOL Multiphysics software and provided courtesy of COMSOL.

significant modifications to the model, even if they were to realize a phenomenon had not been included or a new material or condition needed to be specified. However, with the shortage of simulation specialists, often the designer is an expert in the device being designed but not in the numerical methods and software needed to run a multiphysics model.

Simulation specialists then find themselves creating a bottleneck for innovation.

To remove this bottleneck and foster a culture of collaboration, the simulation specialists could build a user interface that simplifies the use of a multiphysics model by including only the input and output fields and reports needed by the device designer.

Such a packaged simulation application, as shown above, would hide all of the modeling details and show only the inputs needed for the simulation to provide accurate results.

The app would only present the results and reports that the designer is interested in and could be shared with a large group of users within an organization or even customers worldwide. Such a group can go beyond the device designer and include, for example, www.medicaldesignandoutsourcing.com

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experts in other disciplines, like physiology and healthcare compliance.

Democratizing the use of numerical simulation software for anyone through the deployment of apps is another way multiphysics simulation helps achieve the best design possible. This lets specialists from a variety of disciplines share their perspectives and skills during the design process of the next breakthrough technology in healthcare.

Multiphysics simulation can boost your device design in many ways, the four we discussed here are: 1) reduced need for physical prototyping, 2) availability of measurements of any modeled variable at any point in a device and its surroundings, 3) high-fidelity modeling by taking into account any physical interactions as they happen in the real-world, 4) facilitating the collaboration between simulation specialists and experts in device design and other disciplines through apps. Multiphysics simulation has a lot to offer the medical device industry, especially through the adoption of simulation apps bringing its predictive power into the hands of simulation experts and device designers alike. M Valerio Marra is the marketing director at COMSOL in Burlington, Mass. He received his PhD in fluid machines and energy systems engineering and his MSc in nuclear engineering, focusing on numerical methods for CFD.

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SOFTWARE

How middleware is changing medtech Medtech developers can take advantage of middleware technology to gain a competitive advantage.

Tim Gee Medical Connectivity Consulting

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Two macro trends are affecting how medical devices and systems are designed: adoption of off-the-shelf (OTS) computing technology to extend the power and capabilities of traditional embedded system medical devices, and the evolution of software architectures that greatly extend the ability to reuse software. Both of these trends have driven adoption of messaging middleware in the design of medical devices and systems.

As medical devices are transformed into networked information appliances, medtech manufacturers look to these two trends when designing central stations, remote surveillance, data analysis & diagnostic report generation and information gateway products. Rather than design these products as embedded system devices, industry best practice is to use OTS hardware and commercial IT software architectures. A common architecture is messaging middleware.

Messaging middleware is an amalgam of various software modules that use an enterprise service bus (ESB) to integrate and manage the modules. Key modules include a messaging engine, rules engine, interface engine, database, a web server and a data acquisition module to integrate the manufacturer’s medical device data. The selection of specific modules – there are many to chose from – and the inclusion of any additional modules depends on the project’s market requirements.

A common example of this architecture is the Mirth Connect interface engine, which is designed around its own ESB and includes messaging, rules, database and web server modules. A competitive patient monitoring central station has been developed using messaging middleware architecture. This product was developed in less than 12 months with seven engineers and received FDA clearance in less than 100 days using mostly open-source software.

Both commercial and open-source modules are available for building this software architecture. Vendor support is available for most of the open source modules.

This approach impacts manufacturers in a number of important ways. By leveraging messaging middleware architecture, manufacturers can come to market in a much shorter period of time compared to conventional software

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development methodologies. This rapid time-tomarket translates to substantially lower overall product development costs.

By integrating feature-rich modules into an overall architecture, it’s possible to launch an initial product with a substantially greater set of features. Once the modules are integrated, virtually all product functionality comes from how the various modules are configured, rather than adding to or changing the source code of the underlying architecture. Consequently, product changes and enhancements require less time and skill.

The trade-off for these benefits centers on changes required by the manufacturer to effectively support the development of a product based on a messaging middleware architecture. These changes hit the engineering, quality and regulatory departments. The degree of these changes depends on how far along a company is on the journey to adopt commercial software development methodologies for their non-embedded system products.

The development tools and engineer skillsets differ substantially between embedded system software development and development using the commercial computing platform software approach required by messaging middleware. This change can require investment in tools, engineer training, and perhaps, bringing in engineering resources with new skills.

The quality department will see new verification testing requirements for messaging middleware compared to embedded systems devices. Due to the substantial functionality available in these types of architectures, automated software testing, commonly used for commercial software, will have a big impact on minimizing the common testing bottleneck for manufacturers’ product development process.

The final opportunity for change driven by messaging middleware lies in regulatory affairs. There are several potential levers where messaging middleware based products can foster competitive regulatory strategies, especially impacting sustaining engineering (development after initial product introduction).

Because messaging middleware is a mature technology, this transition is more about navigating successful organizational change across multiple departments than it is about the technology itself. M Tim Gee is principal and founder of Medical Connectivity Consulting.

www.medicaldesignandoutsourcing.com

11/3/17 1:42 PM

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STERILIZATION SERVICES

Comparing EO and VPA sterilization As medtech advances, device makers need to consider sterilization methods that won’t compromise electronics, drugs or biologics.

Matt Conlon REVOX Sterilization Solutions

The medical device industry has undergone an impressive transformation over the last several years, resulting in new and innovative devices and solutions. As companies continue to innovate, they are finding that commonly used sterilization methods impose limitations in terms of efficacy, quality or production processes of many of the newer device components (electronics), coatings (drug), or contents (drugs or biologics). New approaches have the potential to overcome the constraints of legacy sterilization methods.

The challenges of ethylene oxide Proper and thorough sterilization of medical devices is critical. One of the most commonly used sterilization methods is exposure to ethylene oxide (EO) to kill microorganisms.

Though other methods come with their own challenges, EO presents the greatest risk in terms of patient and worker safety – and costs associated with risk mitigation requirements.

The following three areas are where EO presents its most serious challenges to medical device manufacturers: 1. Materials compatibility New materials for medical device manufacturing, such as biosensors, bioabsorbables and electronics, are not able to withstand heat- and humidityinducing sterilization methods such as EO. Also, any chemical reactions that might occur at higher temperatures and with humidity could create adverse chemical reactions that speed up degradation and corrosion of the device. In situations where a drug or biologic is present during sterilization, such as with prefilled

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syringes or drug-coated stents, the drug is also at risk. Heat can affect the active pharmaceutical ingredient (API) or biologic and impact the stability or pH, which threatens its overall functionality.

2. Patient and employee safety The limitations outlined in the ISO 1099307 standard set guidelines on how much EO can be left on medical devices. This amount varies depending on the intended use of the device. There has been particular attention to this issue in France, where 85% of single-use sterile devices in neonatal wards are sterilized using EO. Because of this, stricter regulations are in the ISO proposal process to further discourage the use of EO by requiring that manufacturers provide documentation of the rationale for choosing EO for sterilization (as opposed to an alternate method) and quantifying and limiting aggregate (multiple products) potential exposure to special patient populations, such as neonates. Due to the difficulty of making these calculations (with potentially multiple products by the manufacturer being used on a single patient), most would prefer a “risk versus benefit” approach. This enables the continued use of EO sterilization processes on critical lifesaving devices for which there is no other commercially feasible sterilization method.

The other side of this issue is the danger of EO to the health and safety of the employees in the manufacturing facility using it for sterilization. OSHA has strict regulations around exposure to EO, which medical device manufacturers

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have to adhere to when using it in their facilities.

For example, EO chambers must use blastproof containment facilities and employees are required to take extensive health and safety precautions. While protective measures are standard operating procedures whenever a process/material presents danger to employees, these precautions can become costly. Few manufacturers that do not already have experience with the risk and cost of on-site EO processing are willing to take on the regulatory and safety hurdles it brings.

The REVOX 3000L VPA Machine could be an option for medical device products that incorporate sensitive electronics, drugs or biologics.

3. Manufacturing efficiency While the sterilization process time itself varies greatly in accordance with the product being sterilized, every EO process requires pre-sterilization conditioning and post-processing aeration periods. This can add significant time to the overall process, ranging from several days to weeks.

Because of the risks and costs associated with on-site EO sterilization, roughly 75% of medical devices are sent out to contract sterilization service companies.

Depending on the location of the sterilization facility and the distribution logistics of the product itself, this can also add significant transportation time and inventory requirements that will impact the cost of goods sold. On-site EO operations bring the associated costs of required risk mitigation.

Matt Conlon is vice president and general manager of REVOX Sterilization Solutions.

VPA as an alternative Novel methods of sterilization can include highintensity light/pulse light, microwave radiation, sound waves, ultraviolet light and vaporized peracetic acid (VPA). www.medicaldesignandoutsourcing.com

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If a manufacturer wants to switch to one of these novel methods, the change requires the product and sterilization process to be resubmitted for 510(k) clearance. However, it makes the most sense to consider these alternative methods if a company is designing a new product, is going through changes that will need to be submitted for FDA 510(k) clearance anyway or is planning new manufacturing processes/sites.

VPA can improve material compatibility and enable integration of less costly designs and materials by eliminating the use of heat for sterilization, which can damage newer, heat-sensitive materials such as sensors and biologics. Instead of using heat, a proprietary peracetic acid (PAA) biocide is injected into a vacuum chamber at room temperature (18°C to 30°C) in vapor form, gently sterilizing the product with a total processing time of two to four hours. The VPA process is noncarcinogenic, nonexplosive/flammable, requires no external ventilation and breaks down to H20, CO2, and O2 within hours.

Additionally, although newer sterilization methods, such as gas plasma and vaporized hydrogen peroxide (VHP), have proven efficacy and utility for various applications, they do not offer commercial feasibility in the industrial sterilization space in terms of their throughput capabilities. With chamber capacities of up to eight pallets and short processing times, VPA is now a commercially feasible alternative that may help manufacturers further reduce the risk in the risk versus benefit decision tree. VPA can also be used as a valuable tool for bioburden reduction for preterminal sterilization, eliminating pre-sterilization bioburden fluctuation and enabling lower terminal sterilization exposure to whichever method is being used. M

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STERILIZATION SERVICES

How to select a sterile barrier system for a reusable medical device Sterile barrier systems are key components in medical device sterilization, so selecting the right barrier is essential.

Jason Pope Nelson Laboratories

Reusable medical devices, prior to use in healthcare facilities, must undergo validation testing to demonstrate the effectiveness of the cleaning instructions and the microbiocidal instructions that will be provided to the health care facility. Often, the microbiocidal process that’s validated for a reusable medical device is a set of sterilization instructions. Those instructions tell personnel performing the reprocessing how the device must be processed to correctly sterilize the device. The sterile barrier systems that may be used to contain the device during sterilization and storage after sterilization are an important part of the sterilization instructions. Medical device manufacturers must choose an appropriate sterile barrier system (SBS) for the device prior to sterilization instruction validation testing to ensure that the highest level of patient safety can be built into the reprocessing instructions.

A sterile barrier system must allow for the following activities during reprocessing: • Achieve the appropriate sterility assurance level (SAL): The SBS chosen to contain the device must allow the sterilant to reach all areas of the device.

• Prevent microbes from reaching the product following sterilization: An SBS must allow for the device to be safely stored by the healthcare facility until the time when it is needed for use on a patient.

• Allow for residual sterilant removal prior to handling: Sterilant residues may be toxic (e.g. residues from ethylene oxide sterilization) or may compromise the barrier properties of the SBS (e.g. the resultant moisture of a steam sterilization process can compromise the SBS if not properly removed).

• Facilitate easy aseptic presentation: An SBS that allows for easy aseptic presentation reduces the possibility of contamination prior to patient contact.

Sterile barrier systems receive 510(k) clearance for specific sterilization parameters, making it important to choose an SBS with clearance for the sterilization set-point required for validating the medical device.

For example, an SBS cleared only for dynamic air removal steam sterilization would be a poor choice for a device to be sterilized in a gravity displacement steam sterilization cycle. Choosing a system that’s cleared for the sterilization cycle appropriate for the medical device

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takes advantage of the optimal sterilization offered by the barrier manufacturer; that’s because the manufacturer’s choice to include a 510(k)-cleared SBS in the medical device sterilization instructions means the packaging was subject to tests demonstrating the maintenance of sterility following exposure. That testing takes into account any degradation that may result from exposure to the damaging effects of the sterilization process (e.g. the high heat of steam sterilization or potential chemical reactions with a gaseous sterilization process).

When choosing an SBS cleared for the sterilization setpoints to be used in the validation of the device instruction for use, we also are ensuring the use of a barrier that will allow for effective residue removal or package drying. Being able to sterilize the device is not enough; to ensure patient safety we must also be able to remove all toxic residues left behind by the sterilant. In the case of steam sterilization, effective drying must be obtained to reduce the possibility of an event occurrence that may compromise sterility.

Finally, when choosing an SBS to contain a medical device during and after sterilization, it’s important to consider the needs of the healthcare facility and personnel who will use the sterile barrier. The medical device manufacturer can validate their sterilization instructions with an SBS that’s easy for healthcare personnel to use, which can improve the aseptic presentation of devices into the sterile field. Additionally, by talking with healthcare facilities and personnel, the medical device manufacturer can determine which barrier systems are cost-effective for the facility to use.

There are many types of SBS, including wraps, pouches, bags and rigid containers, so take the time to find one that’s the best fit for the medical device in question. By looking at these necessities and concerns, the medical device manufacturer, when selecting an SBS to contain the medical device during and after sterilization, can improve the safety to the patient and help contribute to positive health care outcomes. M Jason Pope is a certified quality auditor and specializes in providing consultations for clients about sterilization of reusable medical devices, endoscopes and pharmaceuticals and general sterilization validation process development.

He has over 19 years of experience working in research and development, validation, and routine control of various sterilization processing modalities.

www.medicaldesignandoutsourcing.com

11/3/17 1:30 PM

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TUBING

How to make kink-resistant tubing work in smaller medical devices Today’s implantable medical devices require bio-friendly silicone that keeps fluids flowing even when space is tight.

Dan Sanchez Tr e l l e b o r g S e a l i n g S o l u t i o n s

Combining highly biocompatible silicone with the elasticity and durability of nylon creates a class of durable, crush- and kink-resistant tubing that’s ideal for today’s small yet highly complex medical devices.

That’s because small is the name of the game when it comes to today’s implantable medical devices, and tubing has to shrink to fit them. The challenge is that silicone – the most biocompatible, durable and flexible material for tubing – tends to kink when produced in small sizes.

The solution is reinforced tubing, which allows significant reduction of the bend radius of small silicone tubes. This opens up design possibilities for longterm implantable devices, drainage tubes and tubes that resist collapse under higher vacuum pressures.

What is kink-resistant tubing (KRT), and how is it used in medical settings?

In the medical world, silicone tubes are made kink-resistant by reinforcing them with nylon 66 monofilaments in a doublehelix configuration. The monofilaments are embedded within the wall of the tube,

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adding radial strength and reducing the likelihood the tube will compress or kink.

KRT is ideal for long-term implantable devices, allowing fluid to flow from the device into the body regardless of bodily movement. The tube will stay open even when the body moves and muscles flex, keeping fluid transfer consistent in all positions.

The tubing is also very useful in implantable devices involving electrical connections, such as pacemakers. The wires that carry the electrical impulses can be safely placed inside the reinforced tube with no concern that the tube will become compressed at the point of connection with the device.

Tubes that deliver fluids such as drugs into the body – or remove them from the body (blood, spinal fluids, urine) – can also benefit from reinforcement. For example, cerebral spinal-fluid shunt systems involve a tube that must go straight into the skull but take a sharp turn after leaving the body. Reinforcement can ensure consistent fluid flow and improve the surgeon’s ability to push the tube into the cranial opening.

www.medicaldesignandoutsourcing.com

11/3/17 1:34 PM

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TUBING

Finally, reinforced tubes are an excellent choice for wound drainage involving a vacuum (negative-pressure wound therapy).

The same nylon configuration that creates kink resistance makes silicone tubes resistant to collapsing under pressure.

What design considerations are relevant to KRT? There are four main concerns when considering KRT in a small medical device: 1. Silicone is highly biocompatible, but the nylon used in KRT is not. In some instances, the manufacturer may need to prove that the reinforcement will not come into contact with the body in order for the tubing to be used.

2. The nylon monofilaments used to create KRT are encapsulated in the silicone walls but not chemically bonded to them. Thus, if the tube is unattached at one end, that end may need to be sealed (using a secondary process) to ensure the relatively sharp ends of the monofilaments don’t come into contact with the body.

3. Nylon can degrade when exposed to high heat, so KRT is not an option for devices that will be subjected to an autoclave or used during ablation procedures.

4. The potential length of reinforced silicone tubing depends in part on its diameter. Current technology allows reinforced silicone tubes to be produced in sizes from 1⁄16 in. to 1/8 in. inner diameter. The tube wall must be built on a mandrel while the nylon spiral is being created, after which the mandrel can be removed. This step is difficult for long tubes, particularly those with large inner diameters. The surface area’s contact with the silicone enlarges significantly as the mandrel increases in size, increasing friction and the difficulty involved in removing the mandrel.

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Combining highly biocompatible silicone with the elasticity and durability of nylon creates a class of durable, crush resistant, kink resistant tubing that is ideal for today’s small yet highly complex medical devices. M Dan Sanchez is a product manager for Trelleborg Sealing Solutions – with 19 years of experience in silicone component manufacturing for the healthcare and medical industry, specializing in process development of silicone extrusions.

Image courtesy of Trelleborg Sealing Solutions

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11/3/17 1:34 PM

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VALIDATION & TESTING

Validation and testing: What you need to know In an increasingly competitive medical device industry, it’s still important that validation and testing is done right. Here are four things to keep in mind.

James Woods Jordi Labs

Medical device industry leaders these days are driving results at an ever-increasing pace. Amid patent limitations, intense competition and acute regulatory scrutiny, there’s a rush to get results that demonstrate safety and efficacy.

Jordi Labs (Mansfield, Mass.) is a contract research lab that’s frequently tasked with meeting these needs while maintaining a high degree of confidence and scientific certainty. Here are four basic recommendations we have when it comes to validation and testing: 1. Understand the testing regulations and guidance

Validation and testing, particularly for regulatory studies, is best prescribed by carefully considering the regulations and guidance relevant to your test article.

Each project has unique requirements, whether the test article is a medical device, a bioprocess system or a combination device. Additionally, understanding the relevant background information is critical. Two key questions are 1) What is the test article composition? and 2) How is the test article going to be used?

Answering these enables you to conduct testing in a way that produces results representative of the

Image courtesy of Jordi Labs

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actual use conditions. It is also generally good practice to go a little on the stronger side of the simulated use condition with temperature, time or solvent to effect a greater margin of safety. Additionally, to simulate the use conditions, it may be necessary to design custom extraction equipment and validate novel analysis techniques to ensure results are the best in terms of accuracy and scientific certainty.

2. Pay attention to details

Sometimes simple things like the wet chemistry required for sample preparation are overlooked while using advanced instrumentation. Whether it’s digestion for ICP-MS, volatiles analysis or concentrating a sample, the steps immediately prior to the analysis often play a critical role in the veracity of results. What seems like a slight modification to the sample preparation may pivotally alter the accuracy of an assay. This is why any modifications should be validated for accuracy, precision and intermediate precision.

3. Choose your instrumentation wisely

Although sample preparation is the foundation of any good analysis, it’s also important to use the latest advanced instrumentation, such as high-resolution mass spectrometers.

High-resolution mass spectrometers, in conjunction with comprehensive compound libraries, allow unambiguous identification of chemical species. Once a chemical species is correctly identified, accurately quantifying the species is the next concern. Species like oligomers, reaction intermediates and process degradants can be particularly challenging to quantify – especially when they’re not commercially available. When they are commercially available, or when

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using a surrogate standard, consideration should also be afforded to selecting the right detector for a compound. When you’re trying to maximize a method’s accuracy, it is important to remember that there are tradeoffs between detectors like UV/Vis, CAD, ELSD, IC and QTOF or QqQ MS. These tradeoffs can drastically affect validations for parameters like specificity, accuracy and precision.

4. Understand the regulatory framework

Regulatory guidance providers – including ICH, the FDA, the EC as well as standards providers such as ISO, USP, and ASTM – have some general consensus on concepts. But there are frequently significant differences in details. One set of guidances could spell out minutia like the number of replicates, extraction ratios, and acceptable time, temperature, and solvents while another may leave them nebulous or open to selection. Navigating this guidance to determine parameters like precision, intermediate precision, accuracy and robustness frequently requires

a careful understanding of the applicable regulatory framework for a medical device.

In summary, there are a few key features we’d like to emphasize in a successful validated analysis.

Understanding the background information for your medical device is the foundation of study design. Pay attention to details as you perform your analysis because minor changes frequently have a significant effect on your results. Using advanced instrumentation can reduce unanswered questions, but it’s also important to understand the limitations of your instruments. A firm understanding of the regulatory guidance is required to avoid analysis pitfalls and potential costly regulatory delays.

Finally, a strong focus on patient safety should be the bedrock upon which all decisions are made. M James Woods is a senior research scientist at Jordi Labs (Mansfield, Mass.). He has a demonstrated history of working in the chemicals industry, with a PhD in chemistry from Carnegie Mellon University.

www.medicaldesignandoutsourcing.com

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VALIDATION & TESTING

How to work with a preclinical contract research organization When outsourcing medical device laboratory testing, knowing what the regulatory and business requirements are up front is critical to the success of your testing program.

Amy A. Schade Felice Randi LaMadeleine J. Heléne Andersson To x i k o n

Requests such as unusual application of technical or regulatory guidelines, shortened timelines, nonstandard study designs and custom reports are common reasons why medical device testing does not go as planned.

The sponsor can help minimize risk of deviations and delays by avoiding such requests and by fostering a collaborative relationship with the contract research organization (CRO) through open communication.

Here are five basic steps to apply to your outsourced testing programs: 1. Selecting the vendor To ensure that you select the right CRO, perform a thorough vendor audit before placing work.

Schedule a visit to discuss capabilities, meet critical staff, understand their quality systems and get comfortable with the new relationship. Ask to tour the facilities and review the CRO’s standard operating procedures in order to ensure their processes meet your requirements. Request copies of certifications and regulatory inspection history to support compliant testing.

2. Setting expectations Once you’ve selected a vendor, collaborate to set expectations. Be clear before starting work about items such as expectations for timelines, report style, data sharing and frequency of communication between sponsor and CRO. Request sample reports ahead of time to have visibility to report content and data interpretation expectations. If you have specific requirements for report formatting, analysis or other content, it should be communicated up front to avoid delays.

3. Sharing information Share as much information as possible with the CRO, particularly when it comes to the characteristics of your test materials, all communication you have with regulatory agencies,

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the intended use of the data (e.g. are you submitting to a regulatory body?), and reports and information from any previous studies performed.

Inform your CRO as soon as possible when there are any changes, particularly in regulatory timelines.

4. Fulfilling your own responsibilities Doing your part is an important element of ensuring success. The personnel who interact with the CRO should be trained in appropriate technical procedures and regulations. When information is requested by the CRO, be prompt and thorough in your replies. Provide information, materials and documentation quickly and as agreed. Make sure to review all documents thoroughly and ask for clarification if there are any concerns, before signing.

5. Listening to the experts you hired When hiring a CRO, take advantage of their expertise and experience. Allow the CRO to use their standard procedures as much as possible, as they have been developed to meet technical and regulatory requirements as well as industry standards. If you require a CRO to use customized processes, the likelihood of deviations and delays may increase.

In closing, the single most important thing you can do is to communicate well. Consider the CRO’s suggestions and recommendations carefully. Provide complete information promptly when requested.

Be clear with expectations of quality, access and deadlines. Good communication on both sides of the partnership will help to ensure the success of your outsourced testing. M Amy A. Schade (RQAP-GLP) is director of corporate compliance, and Felice Randi LaMadeleine (RQAPGLP) and J. Heléne Andersson (RQAP-GLP) are quality assurance managers at Toxikon (Bedford, Mass.).

www.medicaldesignandoutsourcing.com

11/3/17 1:38 PM

Simplifying product testing and validation with fastener torque auditing Capturing data during a product’s manufacturing process can help ensure the quality and consistency of that product. Here’s how that process plays out with fastener torque.

Thomas Moore FUTEK

Electric Nut Runner

One of the scariest phases of product design is testing & validation. That’s when any unknown flaws or manufacturing defects will see the light of day. As you’ll see, you can eliminate the unknowns by performing something as simple as measuring and recording fastener torque.

Ensuring that your product meets manufacturing standards, operates consistently and does not fail prematurely is no easy task.

Customers, regulatory bodies and internal quality control each have traceability requirements that must be satisfied. How do you satisfy the needs of these various groups? The answer lies in providing data that your product meets specifications.

Although there are many design aspects to focus on, for this article we’ll concentrate on the literal “nuts and bolts” of your system by addressing the effects of fastener preload and how to solve the problems that may arise from incorrect preload.

Why focus on the fasteners? Your product’s structure relies on its fasteners to distribute loads. An incorrect preload applied to a fastener can

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lead to the premature failure. For instance, a bolt that has too little preload applied will transmit less stress than its neighbors, overloading them and leading to premature failure. Bolts with too much preload, on the other hand, can damage structures or overly elongate. The latter effect results in an eventual loss in bolt preload over time.

An improperly torqued fastener also affects more than just load distribution; it can also affect seal integrity.

Gaskets and seals require sufficient bolt preloading on the fasteners holding them in place. This ensures the gasket meets the desired service life of your product; otherwise, failures can occur. For instance, too much preload will result in premature gasket collapse, while too little preload results in a weak or nonexistent seal.

How do bolts receive the incorrect preload? This issue can be traced back to unexpected friction in the assembly process and the incorrect application of torque.

Solving this problem requires you to measure the applied torque and fastener preload and use that to determine the friction in your system and calculate the correct amount of applied torque.

1. Capture bolt preload. A complete measurement solution requires two sensors, one to measure bolt loading and another to measure applied torque.

Measuring bolt loading requires a sensor that allows the bolt shaft to pass freely through the sensor while measuring the force the bolt head applies as the fastener is torqued down. These sensors go by different names, such as through-hole load cells, load washers or donut load cells. The sensors aren’t limited to bolt load auditing; they can also be permanently installed to monitor gaskets and seals. This enables the monitoring of the changes in preload due to gasket fatigue and hardening, allowing you to anticipate and replace the gasket before failure. With this in mind, the next step is to measure applied torque.

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VALIDATION & TESTING

2. Measure applied torque. Torque measurement can be as simple as using a torque wrench with a digital display or a strain gauge based reaction or rotary torque sensor. The latter can be connected to a digital display and data-logging solution to automatically capture the torque the operator is applying to each fastener, or integrated into automated assembly systems for live torque feedback and monitoring. The sensor that will work best for you will depend on the accuracy you need and demands of your application.

Once you have a torque and bolt-loading sensor selected, you can derive the friction in your system to make an accurate calculation of the torque you need to apply.

3. Derive fastener friction and determine appropriate torque values. Friction derivation is quite simple. You install the bolt-loading sensor between your structure and the fastener. The shaft of the fastener then passes freely through the sensor with the head of the fastener resting against the active sensor area of the transducer. You then torque the sensor down measuring both the applied torque and resulting bolt loading. These tests are repeated until you receive consistent torque and bolt loading values. To calculate friction for your system, you then input your torque and bolt loading values and use a torque equation such as the Farr Screwjack Equation or Motosh Equation.

Once you have friction calculated, you can then determine the necessary torque required to achieve your requisite bolt loading. You then combine this precision torque value with torque sensors during manufacturing to verify that each fastener has received the correct amount of torque and logging it. The captured data is used to ensure the quality and consistency of your manufacturing process to your customers, regulatory agencies and any standards bodies you may encounter. With the data in hand, validation and traceability will no longer be a nightmare. M Thomas Moore is an aerospace engineer working for FUTEK Advanced Sensor Technology. He has worked on multiple projects including a miniature CubeSat attitude control system and an air braking system for small-scale sounding rockets.

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Medical device cybersecurity – strategies for verification and validation Cybersecurity is becoming an essential pillar of medical device design, and it’s important to find the right strategies to validate and verify your products are secure.

M i c h a e l Ly n c h Delmar Howard Intertek

The growth of connected environments has put medical devices at the forefront of the cybersecurity and patient data movement. As more of these devices are brought online there is an increased risk of hackers looking for targets that have, in the past, had a very lax standard for security. As shown by several high-profile exploits, the industry appears to still be catching up when addressing security concerns.

Fortunately, there are many industry guidance documents available, but sorting through them and identifying the most effective can be daunting. Almost all directives from the FDA concerning cybersecurity are nonbinding, which can make it difficult to confidently identify the most effective way to implement a verification and validation process.

The exception is the premarket submission process, which requires documentation on how cybersecurity is implemented.

For many device manufacturers, the difficulty is not only in identifying standards to follow but which apply to their specific product. Ensuring the chosen framework can scale as the device is updated and changed is also a challenge. Updates – or a lack thereof – can be challenging because of the possibility of introducing new vulnerabilities.

Cybersecurity is rarely a rigid checklist that applies to all industries. In many cases, thirdparty help is required given the large number of complementary guidance documents available.

www.medicaldesignandoutsourcing.com

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Image courtesy of dreamstime.com

NIST Framework One of the most comprehensive guidance documents available is the Framework for Improving Critical Infrastructure Cybersecurity published by the National Institute of Standards and Technology (NIST). This is one of the most effective documents to lay the groundwork for cybersecurity implementation.

The “Identify, Protect, Detect, Response & Recover” framework core is referenced throughout the industry and allows device manufacturers to consistently identify gaps in their processes through risk-based implementation.

Utilizing an Information Sharing & Analysis Organization (ISAO) can help gather and identify industry threats and can be an effective solution for keeping a baseline of security throughout the design and post-market cycle by leveraging the overall knowledge of the group. Participating with an ISAO also helps meet the FDA guidance on postmarket cybersecurity.

Medtech regulations There are many regulations that medical devices must adhere to. The E.U.’s General Data Protection Regulation is one of the most stringent, requiring immediate action. Effective May of 2018, the GDPR will change from a directive to a regulation, which is a stronger form of legislation. Some of the key considerations for medical devices are breach notification – in which users must be notified of a breach within 72 hours – and privacy by design, requiring privacy considerations when a product is designed. Both requirements align with generally effective cybersecurity design practices and should be part of the ongoing validation and review process.

In its final premarket guidance, the FDA is now looking for a cybersecurity plan, as well as data to back it up. Specifically, device manufacturers must identify cybersecurity risks, provide a traceability matrix and give a summary of controls created in the design of the device.

Verification & validation After considering the applicable guidance and regulations for a device, it’s important to conduct verification and validation activities to illustrate security is in place. When running verification and validation on connected medical electrical equipment, it’s important to take a two-prong approach, examining both the software and hardware of a device: •

Software: Medical device manufacturers spend large amounts of time on hardware development, but software development is less structured. Manufactures should include robust requirements for validation. The adoption of IEC 62304 is a good start to ensure that software validation

•

has equal consideration in the design phase. While IEC 62304 doesn’t identify specific tools to use; it provides a robust framework for verification and validation throughout the software development process.

Ongoing cybersecurity risk assessments and static analysis are key ways to help mitigate zero-day-style exploits on hardware and software. This is especially important within environments using Software of Unknown Provenance (SOUP). When devices enter a hospital environment, they can be placed somewhere not specifically intended for them to operate. Testing within a mixed interoperability environment can help mitigate some of these issues through better understanding of various connections and network features common in a real-world environment.

For example, Intertek has created virtual offices that include several hundred unique devices that can emulate a live hospital environment. With large-scale emulated environments, it is easier to test patches and identify potential limitations without subjecting customers and patients to potential harm.

Hardware: Addressing hardware security during the design & development phase goes well beyond simply testing and validating. Hardware has the disadvantage of not being able to be updated easily once delivered to a customer.

To combat this, it’s essential to avoid activating ports that are not required to function and ensuring each piece of hardware has a unique ID and login implementation.

Additionally, it’s critical to make sure features not in use are either disabled or removed from the device, prior to it being introduced to a live environment, especially when outsourcing.

Some hardware chips can be activated using physical access and, in rare cases, can be activated through software.

The UL-2900 standards are a good starting point; however meeting all of the requirements requires already having an effective documentation and validation process; it’s a good guideline for internal teams to work toward before opening up for a third party audit.

Increased breaches revealing personally identifiable information have made designing security into medical devices and their accompanying software required for all 510(k) submissions to the FDA in the U.S. and through regulations such as GDPR in the E.U. Having an effective validation and verification plan during the design phase has been a requirement for bringing medical devices to the market for 20 years. Adding cybersecurity to that plan is essential for any connected device. M Michael Lynch is managing consultant and Delmar Howard is performance testing program manager at Intertek (London).

www.medicaldesignandoutsourcing.com

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How to design a successful embolic protection devices clinical trial

Claret Medical’s Sentinel device, cleared by the FDA this year, trapped micro debris in 99% of cases.

Embolic protection devices could reduce risks of interventional cardiac procedures such as TAVR, but their efficacy is hard to prove.

Image courtesy of Claret Medical

David Novotny Novella Clinical

The embolic protection device (EPD) market is expected to grow into a billion-dollar industry if the device becomes the standard safety protocol for transcatheter aortic valve replacement (TAVR) and other interventional cardiac procedures. However, EPD tech has found limited success in clinical trials.

One potential reason is that even with well-designed devices, efficacy is difficult to demonstrate. EPDs are engineered to catch or deflect debris loosened during TAVR procedures away from cerebral arteries. By and large, they do a good job: Claret Medical’s Sentinel device, cleared by the FDA this year, trapped micro debris in 99% of cases. However, in its pivotal trial, the data did not conclusively show it improved patient outcomes.

Transcatheter aortic valve replacement, a widely popular alternative to surgery for high-risk patients, carries a small but serious risk of stroke, cerebral lesions and increased risk for neurological complications associated with debris blocking a cerebral artery, according to a study published in November 2016 in the American Journal of Cardiology.

Deploying an EPD during the procedure should, in theory, reduce that risk. An estimated 300,000 individuals worldwide have received TAVR, according to Future Market Insights. The growth in the TAVR market has, in turn, grown the EPD market potential. As of August 2017, three EPD devices had E.U. market clearance and one (Sentinel) achieved FDA clearance.

To capitalize on this commercial potential, future devices must optimize their clinical studies to show their efficacy.

Here are a few best practices EPD manufacturers must apply to design a successful trial that demonstrates the lifesaving potential of these technologies: 1. Determine appropriate patient populations. TAVR has become a standard option for high-risk patients with severe aortic stenosis because it’s equally as safe as surgery and minimally invasive. But when determining which patients should be chosen for a TAVR-EPD trial, sponsors must bear in mind that recruitment procedures are more challenging than other cardiac device trials.

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Assessments of valve severity, comorbidities and mortality risk all must be done prior to the procedure. Knowing the dosing of certain medications or existence of carotid stenosis, for example, is necessary to determine later if these factors had a role in any post-procedure strokes.

TAVR-EPD study patients must also have had stable health for 30 days before undergoing the procedure.

2. Have committed site teams. Because EPD trials require more time and resources than typical device trials, manufacturers should select sites that have a history of dedication to patient enrollment and retention. One reason for this is the recent expansion in the U.S. and the E.U. of TAVR indication to include intermediate-risk individuals. Sponsors will need to document and evaluate patient health carefully to ensure that study participants match the characteristics included in the expansion. The team should include not only cardiology and imaging specialists, but also geriatricians, heart failure experts, stroke neurologists, electrophysiologists, anesthesiologists and behavioral specialists. The best patient outcomes are most likely achieved with a committed, organized and multidisciplinary team both in study settings as well as in post-approval commercial use of the devices.

3. Use precise definitions. In past trials, strokes were often determined based on clinical symptoms alone. However, the Stroke Council of the American Heart Association/ American Stroke Association (AHA/ASA) now provides instructions on how to address the inclusion of clinically silent brain lesions as endpoints and how to accommodate changes in imaging technology. Should a silent stroke that is captured by magnetic resonance techniques actually count as a stroke? Including such imaged events, the AHA/ ASA cautions, could “unnecessarily inflate the assessment of risk of those procedures without a measurable clinical advantage to doing so.” M David Novotny is SVP of the Medical Device & Diagnostics Division of Novella Clinical (Morrisville, N.C.).

www.medicaldesignandoutsourcing.com

11/3/17 1:39 PM

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