MDT Magazine, July/August 2015

MDTMAG.COM

| JULY/AUGUST 2015 INSIDE:

How Can It Be So Small Yet So Powerful?

The Medical Design Engineer’s Resource for Products & Technologies

A Look at Engraving and Laser Passivation for MedTech PTFE Coatings: Still the Gold Standard 3 Factors in Using Plastic over Metal

The Complexities of Designing

Surgical Robots

INSIDE:

July/August 2015 Vol. 19 No. 5 General Manager Nick Pinto nick.pinto@advantagemedia.com 973-920-7745

Editorial Director David Mantey david.mantey@advantagemedia.com

Editor-in-Chief Sean Fenske sean.fenske@advantagemedia.com

Associate Editor Sam Brusco sam.brusco@advantagemedia.com

Regional Vice President of Sales, Midwest Mike Francesconi mike.francesconi@advantagemedia.com 973-920-7742

20 Cover Story The Complexities of Designing Surgical Robots 14 24 30

Applying Tech: How Can Something So Small Be So Powerful?

Emphasis on Device Coating: PTFE Coatings: Still the Gold Standard Roundtable: Shrinking Medical Electronics Bring Assembly Challenges

32

Case in Point: 3 Factors in Using Single-Use Plastic Components over Metal

36

Emphasis on Laser Passivation: A Technical Look at Engraving and Laser Passivation for MedTech

DEPARTMENTS 6 From the Editor's Desk 6 Editorial Advisory Board 8 MDT Online 10 Perspectives on Supply Chain Consolidation

4 / July/August 2015

18 28 38

Current Report: Electronic Connectors Notables: Test Equipment Infographic: Reshoring in MedTech MDTmag.com

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From the

Editor’s Desk

BY SEAN FENSKE | EDITOR-IN-CHIEF sean.fenske@advantagemedia.com

Editorial Advisory Board Carlos Castillo, Biomedical Engineer & Research Biomedical Engineering Advisor, Loma Linda University Zhang Neuroscience Laboratory

3D Printing, Stem Cells Blur MedTech’s Lines O nce upon a time, long ago, identifying what we covered in the pages of MDT was a much easier task. There were essentially two “worlds” — the pharmaceutical “world” and the medical device “world.”

Sure there were other outlier technologies that weren’t exactly grouped in either, and there were also drug delivery technologies (or combination products, if you prefer) that brought the two worlds together in one drug/device solution. But for the most part, there was a clear division of medical technologies that made things very neat and clean.

In more recent years, those lines between types of technologies aren’t so crystal clear.

As such, you start to see these areas creep into the focus of MDT. That’s already been happening with technologies such as biologics, which have been combined with medical devices similar to how pharmaceuticals are being merged with them, a practice that only continues to grow. Another example of “recent” changes is the entire realm of in vitro diagnostics. These technologies are really their own “world,” not exactly matching the more traditional definitions for pharmaceutical or medical device.

While biologics and IVD were perhaps responsible for the beginning of the lines being blurred, there are even more emerging technologies that will really make an impact on the medical device industry as they become more common.

Stem Cells We’ve been hearing about stem cells for years now, but seemingly each day, there is mention of a new method or technology that leverages them for yet another medical breakthrough. The use (and manipulation) of stem cells seems to have become a much less debated topic than it once was, but it doesn’t mean that the challenges of using them have decreased (or my regular discussions with my associate editor Sam

6 / July/August 2015

on whether they are actually “medical devices” or if we should cover them regardless of any such label that’s put on them).

The one aspect that still rings true, however, is that they will undoubtedly continue to be researched and as such, new discoveries regarding their use will emerge. They may represent yet another “blurred line,” but they are also a wonderful opportunity to enhance healthcare and address an array of diseases.

Michael Drues, Founder & President, Vascular Sciences Marc Dubreuil, Vice President of Business Development, Farm Design Stephen Holloway, Associate Director, Medical Devices and Healthcare IT, IHS Jinny Lee, Vice President of Strategic Marketing, Advanced Technology, Edwards Lifesciences Tom O’Dwyer, Director of Healthcare Technology, Analog Devices Michael Pereira, Senior Vice President of Technology & Operations, Ximedica Alan Schwartz, Executive Vice President, mdi Consultants Inc. Thomas M. Tsakeris, President, Devices and Diagnostics Consulting Group Jan Wittenber, Member of IEEE and Fellow at the Center for Medical Interoperability Derek Young, Founder & CEO, i360medical Ltd.

Growing Human Tissue We’ve run news on a number of human tissues and organs being grown in labs around the world. Lungs, skin, ears, hearts, livers, and more have appeared in petri dishes that enable the testing of new drugs or diagnostic technologies. The applications for growing human tissue and organs are only in their infancy though. Obviously a major goal would be to have the ability to grow these “parts” for use in the human body. Eliminating the need for organ donor lists would virtually be the equivalent of a “miracle cure” for many.

But is a lab-grown human tissue or organ a medical device? It’s “manufactured” and implanted just as a mechanical pacemaker would be, for example, but it obviously doesn’t “feel” like the same thing.

Just yet another example of the lines being blurred in this wondrous industry of ours.

3D Printed MedTech Additive manufacturing (i.e., 3D printing) is a fantastic technology that’s already influencing and changing the way things are being produced. In the design and manufacturing realm, it offers great time and cost savings in the creation of physical prototypes, is being employed for molds, and is even being used to generate short run production ready parts.

Undoubtedly, advantages with this process will continue to be realized.

In the realm of medtech, however, 3D printing creates a conundrum. If a doctor

wants to print a part or tool in his or her office to use in a clinical procedure, what’s the FDA going to say about that? What about the patient’s insurance company?

Should these considerations stifle the innovation that 3D printing in the healthcare space offers? I doubt anyone would say yes, but there does need to be a review of how we can ensure this is being done safely.

Could 3D printed medical device designs be submitted to the FDA for approval, thus allowing them to be sold to doctors to print in their offices? Do 3D printing machines need to go for review to determine that they can ensure the repeatability necessary to generate the parts or tools to spec each time without fail? These are only a few of the disruptive questions that are brought up by 3D printing in healthcare.

This changing landscape of medtech, while making my job of determining what we cover a little more difficult, is actually a fabulous thing. The fact that revolutionary technologies that combine multiple aspects of medicine are emerging makes for overall better healthcare solutions. Whether it means being able to diagnose faster, replace diseased human organs, regrow skin, print surgical tools on demand, or just provide better overall healthcare in some way means that I’ll gladly accept the flip side of making labeling these “medical devices” a little harder.

MDTmag.com

MDT Online

VIDEO

The Pulse: Mini-Robotic Biopsies and Disease Fighting Drones On this episode of the Pulse, we’re taking colon biopsies with miniature star-shaped robots, watching an origami biosensor-bot fold itself, catching disease-causing mosquitoes with a drone, and regenerating skin wounds with an injectable hydrogel. www.mdtmag.com/august1501

BLOG

Star Trek-style Ultrasonic Tech Could Regenerate Skin Perhaps one of the most sought after medical technologies coming from the sci-fi world is the “dermal regenerator” used in Star Trek. For those of you not familiar with the device, it was a commonly used, easily operated medical ray gun to heal minor skin wounds like cuts and burns. Might ultrasound tech offer a similar solution? www.mdtmag.com/august1507 BLOG

MedTech Memoirs: Contraceptive Devices The MedTech Memoirs is an ongoing feature that looks at the history of medical technologies as far back as we have records of them being used.

There are always some very interesting (and sometimes frightening) devices featured with a brief description of how they were employed and the success (or lack thereof) experienced with them. www.mdtmag.com/august1506

8 / July/August 2015

BLOG

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Couples Are Being Paid to ‘Test Out’ New Condoms

Looks like Styrene, Quacks like Styrene, but not a Duck

Ever since the Bill and Melinda Gates Foundation’s challenge announced a year and a half ago, scientists and designers have been collaborating to develop a “next generation condom.” They offered a $100,000 grant to any team with an idea for a condom that significantly improves upon the pleasure factor of condoms, in order to increase regular use. www.mdtmag.com/august1503

Polystyrene is a pretty commonly used material for trays in medical device packaging, but should some sort of trauma occur, the material can crack, negatively affecting the sterile barrier. A collaboration of suppliers have devised a potential solution. www.mdtmag.com/august1508

BLOG

Medical Electronics that ‘Melt’ Away Inside the Body Recently, there was news of an electronic stent that could capture blood flow data, store it, transmit it, and then dissolve away when no longer needed. The advantage of having such a device is that while it can still transmit information electronically, it dissolves away to eliminate any potential complications associated with such a device being left in the body. www.mdtmag.com/august1505

BLOG

Might Micropumps Eliminate Sleep Apnea Masks?

Sleep problems created due to sleep apnea don’t seem to be much better when the solution to that problem causes a different set of sleep problems. Fortunately, there are those who are working on the problem and attempting to resolve the technology solutions available. But is the solution presented here a realistic one? www.mdtmag.com/august1504

NEWS

Miniature Heart Sensor Keeps Heart Failure Patients Out of the Hospital Cardiologists at The Mount Sinai Hospital have begun implanting tiny, state-of-the-art microchip sensors in patients with advanced heart failure to better monitor symptoms and reduce their chances of returning to the hospital. www.mdtmag.com/august1502 NEWS

First Wearable to Shift Your State of Mind A consumer wearable enables users to shift their mental states in minutes; feeling more calm or energized when needed most. The sleek and simple wearable is placed on the head and designed for lifestyle use at home, work, or while commuting. www.mdtmag.com/august1509

NEWS

Five Minute Test Determines if Chest Pain is a Heart Attack An EU grant will help a company produce the necessary clinical evidence to support the adoption of a 5-minute H-FABP True Rapid Test as a way for emergency medical workers to rule out heart attacks before they are required to admit patients to a hospital. www.mdtmag.com/august1510 MDTmag.com

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Perspectives On Supply Chain Consolidation

See more Perspectives at www.mdtmag.com/Perspectives

Q:

Is the consolidation of services within the supply chain best for medical device manufacturers and innovation?

David Cabral President, Five Star Companies

With the tremendous resources incurred today to validate and approve a supplier, the cost of cutting a purchase order is significant. With consolidation, these total costs reduce exponentially, due to the controls and quality systems already being in place and documented. This is the true reason for an approved vendor list!

So, yes, I agree that partnering with a “good” supplier, one focused on many facets (quality, delivery, reliability, creativity, visionary, etc.) is best for all parties involved. It allows the OEM to focus resources on their core competencies (sales, R&D, industry requirements, etc.) while partnering with suppliers who have other competencies that enhance the overall market need for advanced technologies and products.

The key to staying innovative and creative is to form partnerships with those companies that value these competencies and make them a part of your corporate strategies and cultural fabric. MDT

Herm L. Harrison Vice President, Foster Transformer Company Consolidation of services can be a double-edged sword. Whether it has a positive or negative impact on innovation and creativity depends on the approach taken by the device manufacturer and the “one-stop shop” chosen.

Manufacturers in all markets face resource limitations, which are brought to light when a new design is conceived. A “one-stop shop” familiar with the unique safety and compliance issues facing medical device manufacturers can be a major asset during these times. This allows a

manufacturer’s engineers to concentrate on the “big idea,” while taking advantage of the shop’s resources to work out the details, make sure compliance issues are met, present ideas from other industries, and ensure that the final design is one that can be manufactured efficiently.

Selection of the wrong “one-stop shop” can tie up a manufacturer’s resources fixing problems, babysitting, or being forced to modify a design to fit the shop’s capabilities. Selection of the right manufacturing partner is no different than hiring the right employee, except the results (good or bad) are magnified. The key is selecting the right partner. Choose well and enjoy the rewards! MDT

Mona Phaff VP of Design and Engineering, Logic PD Wade McDaniel VP of Solutions Architecture, Avnet Velocity Industries consolidate because at a certain point in the maturity of a market, continued growth requires greater efficiency, reduced cost, and, of course, accelerated innovation.

While there are obviously certain characteristics of the medical device industry that are somewhat unique — the time and cost of regulatory compliance, the life or death nature of quality control — on the whole the medical device market is like any other. Survival comes down to the most basic principle of adapt or die. On paper, one might be able to argue that the creation

10 / July/August 2015

of “one-stop shops” reduces competition, and therefore diminishes the urgency for innovation. But, this theory does not reflect the reality of capitalism or of the inherent competitive nature of pioneering inventors who strive for better, faster, and cheaper — not just to satisfy customer demand, but to feed their own curiosity and creativity.

Not all players in this round of consolidation in the medical device market will thrive or even survive. Soon enough, a new generation of product/ service pioneers will emerge and challenge the status quo.

And in due time, facing their own adapt or die decisions, this contingent will recognize that, in business as in nature, no one can elude the inevitable forces of progress and change. MDT

As we see an increase in the virtualization of medical device companies focusing on their core IP, we are finding these companies need help managing more aspects of the supply chain. Having the ability to work with service organizations that provide end-to-end support throughout the entire product lifecycle, from user understanding and product development to manufacturing and aftermarket support under one quality management system, will increase their ability to innovate while reducing their risk to launch and foster sustainability in the global regulatory landscape.

Ownership by a single partner ensures seamless hand offs, continuous communication, and optimized processes throughout the product lifecycle. In addition, there is a single point of accountability for audits and post-market surveillance and vigilance. More importantly, there is shared revenue risk by both parties to incent the manufacturability and reliability of the design, accelerate time-to-market, and ensure profitable, consistent delivery of products and services.

Innovation and creativity is more important than ever, especially where business, technology, and user requirements converge. Selecting a strategic supply chain partner supports increased focus and investment in innovation without sacrificing operational excellence.

Having a single partner that understands the evolving business opportunity for profitability, the user for adoption, and the technology for competitiveness can help create a seamless journey through the product lifecycle to compete in the global medical device market. MDT

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Perspectives On Supply Chain Consolidation See more Perspectives at www.mdtmag.com/Perspectives

Jacques Hoffmann President, InterTech Development Company The saying “jack of all trades, master of none” comes to mind.

Every day we see that testing to ensure that a medical device functions as designed can become a crippling cost if engineers without extensive experience in testing applications engineering are tasked with creating assembly lines. Sometimes it’s a matter of knowing how to customize fixtures. Knowing how to compensate for factors like temperature variations, or even which types of sensors are optimal for a given application, may not be apparent to those who don’t have the benefit of a deep bench of test engineering talent, and a testing knowledgebase developed over several decades.

Innovation? Recently our engineers developed leak test methods that are 50% faster than the traditional approaches to leak testing.

They know the select applications where this new approach will work and where it won’t. I seriously doubt that a one-stop shop would have had the technical insights to develop this new approach.

Medical device manufacture requires quite the reverse of “onestop shops.” You’ll be best-served by complementing your more generalist engineering teams with outside experts who think about topics like testing 24/7. MDT

Craig Scherer Co-Founder and Senior Partner, Insight Product Development Whether or not combining and managing a group of independent specialists has greater value than engaging with a onestop shop is a debate that has raged on for decades.

The reality is that this decision should be based on a well-defined problem statement.

Take for example, a medical profession analogy. When you have a medical problem, you typically begin by seeing your general practitioner who can often diagnose and treat simple problems. If the problem is more serious, however, they will probably

12 / July/August 2015

refer you to a specialist. At this point, you will, of course, want the best-in-class expert who addresses this problem on daily basis.

When there is a significant innovation problem to be solved, you need excellence in design and manufacturing.

These usually don’t come from the same place. It is unlikely that a contract manufacturer can provide the level of innovation required to solve more than a basic problem.

If you are looking for disruptive innovation or have a serious user-centered design problem, you probably need a specialist and should find the best-in-class for each major phase of your effort. You need a team of researchers and designers that repeatedly provides better outcomes. MDT

Ray Brock Division Supply Chain Manager, Parker Hannifin Corporation Having managed supply chain both as a medical device manufacturer and as a supplier to medical device manufacturers, I believe there are many considerations in making this critical decision. Given that the device manufacturer is responsible to meet regulatory agency requirements including quality and consistency, ensuring the stability of its supply chain is essential. As part of this supply chain you also share in this responsibility. The criticality of product application, cost targets, mitigating risk, and urgency - all impact this decision. For components or designs in non-critical applications, the

decision may be easier.

In critical applications, however, increased scrutiny may be required. There are many levels of outsourcing to consider in efforts to reduce cost, inventory, and resource drain. These could range from multi-step processes for a component to a complete “one-stop shop” with capabilities from design and development to manufacturing with full regulatory approval. At Parker Precision Fluidics, we are able to utilize the expertise of focused partnering suppliers with the necessary core competencies to meet today’s design challenges. This alleviates us of the vertical integration burden, while allowing us to retain and enhance our ability to create innovative solutions for our markets, as well as specific customer applications. MDT

Rizwan Dard Engineer, EG-GILERO The short, simple answer is yes. Medical device manufacturers thrive on consistency and customer familiarity. The creation of “one-stop shops” allows long-standing relationships with manufacturers, which facilitates the ease by which medical devices can get from concept to fullscale production. If manufacturers are bombarded with brand new customers that are not accustomed to their system, the medical device production grinds to a halt. New procedures need to be set in place, new guidelines, requirements, and the list goes on. Having a consolidated supply chain solves these problems and provides new ideas with a clear, streamlined path to manufacturing.

Innovation thrives when companies are quick to adapt to the market - when ideas can come to fruition in an efficient manner, rather than being backlogged in an inefficient timeline. How else can new products be improved upon if they haven’t reached the market yet, or new ideas be inspired if all the ideas are still stuck in design? The innovation is in the technology, not the process, and if the process is expedited, then innovation can be more easily fostered. MDT

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Applying Applying TechTech Cancer Power MedTech in Portable Healthcare

How Can Something So Small Be So Powerful?

By Sam Brusco, Associate Editor

in fitness and tracking applications, or in cases where a device continuously monitors a chronic/acute condition but is still small t’s nothing new that medical devices are becoming more portable — enough to be tucked away under clothing.

The biggest challenge is the size and life of the battery. We adthe explosion of wearables has proven that. But making these techdress that with a highly flexible and configurable hardware and softnologies smaller and smarter is a challenge for power management. ware power management architecture. As devices get smarter, more A sophisticated set of functions requires quite a bit of processing performance is expected while still keeping size and power, which must somehow be enclosed in devicpower in mind. Products that can efficiently manage es that are constantly shrinking. Batteries typically complex processing with both hardware and softtake up the most space in a portable device, so ware features are critical. Renesas offers embedded what can be done within the limitations of space to solutions for this level of processing power, including optimize power? To assess this, MDT spoke with low-power, high-performance RX MCU devices Kaushal Vora, senior manager of product marketing and our Synergy platform with features that support at Renesas Electronics America. Here’s what he had complex multi-sensor processing and sensor fusion. to say about powering portable healthcare: We have hardware blocks that can do complex math functions more efficiently, a floating point unit to do Brusco: What steps is Renesas taking in power complex math efficiently, a DSP library, as well as a source design for connected portable devices? highly efficient real-time operating system.

Vora: Renesas microcontrollers (MCUs) and Kaushal Vora microprocessors (MPUs) have a flexible power management architecture. The power source for a Brusco: What power considerations must be made connected portable/hand-held device is typically a battery – either a for different use cases? single charge, rechargeable lithium-ion (Li-ion) or Li-poly. Our soluVora: This depends on the use case. In a blood glucose meter, for tions make sure the power drawn from these sources is optimized, example, there are typically three modes of operation: Measurement resulting in extended battery life for the end product.

Mode, User Mode, and Stand-by/Sleep Mode.

The customer’s goals are typically to minimize the cost and size Measurement Mode is when the device makes the measureof the power source while making it last longer. Our MCUs and ment and runs the algorithm. In this mode, the system is going MPUs support that with the ability to operate in multiple power full blaze and the power consumption is the highest. This only modes, dynamically switch between modes intelligently, and turn happens maybe four to five times a day, so efficient processing in on/off blocks individually as needed to minimize power draw. The the MCU will help optimize the power consumption. new Renesas Synergy Platform also adds complementary software User Mode is an intermediate power mode, where processing that makes it extremely easy and efficient to manage power. is not heavy but the HMI (human machine interaction) functions like switch/button presses and LCD/LED display are consuming power, for example when the user presses a button and views the Brusco: What are the challenges in powering microcontrollers? result or history on the LCD screen, which happens maybe six to Vora: The challenge is not so much with powering the MCU eight times a day. An intermediate power mode in the MCU helps itself but the overall system power. Because the MCU has a conserve power by operating the machine at a lower speed and flexible power architecture, it usually has the intelligence to turning off subsystems that are not needed or used. put itself in a very low-power state, which can be >90% of the Systems typically spend >90% of their lifetime in Stand-by/Sleep time in a battery-operated application. The biggest culprits are Mode. To extend battery life, it is important to have a very efficient sensors that must be on all the time, LCD displays, fuel-gauge/ stand-by/sleep power mode that ensures very low leakage. Having battery management ICs, and high-brightness LEDs. The MCU is responsible for turning these subsystems on and off to optimize a good software and hardware power architecture centered around the MCU is critical. overall system power consumption.

I

Brusco: What are the challenges of powering smaller and smarter devices?

Vora: More devices are becoming wearable, for instance

14 / July/August 2015

Brusco: What are the advantages of using Bluetooth Smart?

Vora: Bluetooth Smart (a.k.a. Bluetooth Low Energy) is the most popular low-power, short-range wireless connectivity stanMDTmag.com

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When BioAccess set out to make a lighter, more powerful cordless bone drill they chose Tadiran TLM-1550-HP batteries over alkaline cells. The result was a 36% weight reduction, greater torque and faster drilling speeds for ergonomic benefits such as reduced fatigue and more efficient drilling cycles, plus the improved reliability of a 20-year battery. This is just one example of how Tadiran Lithium batteries are performing miracles for pacemakers, AEDs, infusion pumps as well as a variety of handheld medical devices.

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Applying Tech Power dard for IoT and healthcare applications. It continues to be popular and most trends indicate this will be the most dominant low-power wireless technology for healthcare.

BLE is ubiquitous — it has the highest handheld (smart-phone/ tablet) “attach” rate (i.e., most handheld devices now ship standard with BLE). This eliminates the need for a specialized gateway to enable connectivity to the cloud; the gateway is already in everyone’s pocket. This enables unique “user-interaction” scenarios as compared to any other technology. BLE is extremely low power and is designed specifically for applications that are battery operated. It is secure as it has 128-bit AES encryption built into the standard. Also, BLE combats interference from other technologies in the 2.4 GHz ISM band (in which many other technologies like Wi-Fi, commercial microwaves, etc. operate), which is typically very noisy. Due to its “adaptive frequency hopping” ability, it can combat interference from other technologies, making it more robust and reliable. MDT

Powering Portable Surgical Tools

By Louis Adams, Southwest Regional Manager, Tadiran Batteries

M

aking a cordless surgical power tool smaller, lighter, and ergonomic is a design challenge, as applications involving high pulse and high rate power are not ideally suited to primary lithium batteries. Moreover, consumer alkaline batteries add bulk due to their low power-tosize ratios.

Lithium metal oxide batteries can offer an innovative solution by delivering 4V of nominal voltage, up to 2Wh of energy, and a discharge capacity of 135 to 500mAh. In addition, they are capable of handling 5A continuous loads and 15A maximum pulses.

These cells can also offer a 20year shelf life, wide temperature range (-40 to 85°C), and hermetic seal.

This type of battery solution is being used to power Pro-Dex automatic torque limiting surgical drivers that neurosurgeons use to fasten titanium screws into titanium plates that cover portions of the skull removed during surgery.

Tadiran’s TLM Series batteries (www.tadiran.com) were chosen for their compact size, high pulse

16 / July/August 2015

amplitude, and high continuous current during active drilling cycles. Two AA-size TLM 1,550HP batteries deliver 8V variable current for drilling speeds up to 2,200RPM, while four cells deliver 16V variable current for drilling speeds up to 4,000RPM. BioAccess surgical screwdrivers offer TLM batteries as an upgrade over alkaline batteries, enabling faster drilling speeds, more active drill time (30-40 seconds per cycle for 20 to 30 cycles), instantaneous power, greater stall torque for more efficient drilling, and a nearly 40% reduction in weight and volume. In comparison, it takes 15 AA-size alkaline batteries to perform equivalently to six AA-size TLM 1,550-HP batteries, adding 3X the weight and 2.5X the volume.

The Pro-Dex automatic torque limiting surgical driver utilizes the size and power advantages offered by lithium metal oxide batteries.

MDTmag.com

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Sterilization-Friendly Connector The REDEL SP connector is designed using a plastic material that is friendly to sterilization processes. The latching system is now embedded in the shell for an increased impact resistance with a high contact density, making this an ideal solution for medical or measurement applications, from catheters to surgical instruments. Configurations range from four to 22 contacts. A variety of colors and an ergonomic grip to make it simple for surgeons and medical staff to mate and align the connection. LEMO is now ISO 13485 Certified to better assist medical device customers.

LEMO 707-578-8811 www.lemo.com/en

18 / July/August 2015

MDTmag.com

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Cover Story

Surgical Technology

The Complexities of Designing

Surgical Robots

By Kenneth A. Fine, President/Co-Founder, Proven Process Medical Devices

I

n the O.R., robotic technology is enabling less invasive, safer, and more efficient surgeries. Robotics often allow surgeons to operate through smaller incisions, improve accuracy in delicate maneuvering, and reduce the risks associated with traditional open surgery.

Rising demand for these improvements is driving continuous invention of new surgical robots for specific procedures.

Behind every invention is a team with very specialized expertise and development processes, merging robotics engineering with medical knowledge to offer safe, effective devices that will make their way through the FDA approval process and into surgical suites. The development teams navigate a range of challenges that are unique to the medical and surgical device field. And of course, the stakes are high.

Engineering the devices to work with extreme precision is just the beginning.

Medical concerns such as toxicity, radiation, and allergens must also be managed. Safety and regulatory concerns are absolute top priorities. In addition to being able to perform the necessary, delicate maneuvers, fail-proof safeguards have to be built in. And then there are practical and physical challenges.

All these issues have to be addressed holistically for the science to bring real advancements in medical care.

Sterility Surgical robots need to be designed for sterility. Unlike a surgeon, a robotic hand can’t “scrub in” before a procedure. This vital issue requires imaginative solutions.

Sometimes the mechanics are built so that there is a base positioned outside of the sterile field and it runs the arm and

20 / July/August 2015

tooling that work inside the operating arena. Some components may be designed to be disposable, requiring a thoughtful allocation of technology to preserve the financial feasibility of the total system. Hospitals can’t just throw away their expensive pieces Finding the right team of professionals is essential for of capital equipment, robotic technology, as seen in this controlled manufacturing so the functional build of a catheter insertion robot. requirements, cost, botic devices are easier to package and and technological possibilities require sterilize; the connections, electronics, size, equal consideration during the design and cost of robots are more complicated. phase. Ideally, a device is affordable, sterile, precise, safe, and provides new Technology advantages for patients and healthcare “Some device inventors come to us with providers. goals that are extremely challenging, Another method to keep robotic tools sometimes even incompatible,” said Ben sterile is with thermoformed, snap-on, Piecuch, senior mechanical engineer at shrouding pieces that can be used once Proven Process Medical Devices (www. and thrown away. Inventors are also looking at the possibilities for designing motors provenprocess.com). “For instance, they might want to create a device that and electronics that can be kept sterile, performs at a specific speed, with power, and used five or ten times before being size, weight, and other specifications that replaced. The engineering challenges in this type of innovative solution are tremen- are not currently possible in combination. Improvements are being made evdous, but so are the potential benefits. ery day, but the technology isn’t always Maintaining power and range of motion through a sterile barrier is another available to meet an inventor’s vision.”

Alternate motions can sometimes be significant challenge. The degree of devised using pneumatics, hydraulics, freedom and power required can test the and specific electrical circuits to create limits of current technology. Working the desired effect. Imagine, too, the with precise motion with a tolerance of complexity of designing a machine that one degree between two rotating parts, can perform the same surgical procefor example, would require an extremely dure on both an 80-pound female and tight snap-fit between the main driving a 300-pound male patient. The physical device, through the sterile barrier, and parameters are quite different. onto the disposable tool to interact in tight tolerances through multiple degrees Cost of freedom. Sterile packaging of relevant Disposable medical devices and tools are pieces can also be utilized to isolate the not new; disposable needles, pinchers, and machinery from the sterile field. Non-roMDTmag.com

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Cover Story Achieving SurgicalLike Precision in Device Design

By Arvind Ananthan, Medical Devices Industry Manager, MathWorks

S

urgical instruments have advanced significantly in the past few decades due to the advancement of electromechanical automation in handheld tools and the development of robotic surgical platforms that are making it possible to perform complex procedures through smaller incisions and more precise instruments — in some cases, even remotely.

This shift is forcing surgical device makers to confront new technical and business challenges, rethinking the design of these devices. Gone are the days when they could develop a basic mechanical design, create multiple prototypes before “getting it right,” and then test it with surgeons. Such approaches are not only expensive and time consuming, but run the risk of compromising robustness and safety of the final design with increased motorization of these devices. It is also challenging to design the more complex robotic surgical systems this way as it would take an unreasonably long time to get to a working design and prove it is safe and effective.

Developing control logic for a motor for a handheld endocutter or a six degrees of freedom robotic manipulation arm involves complex control laws and scenarios that are challenging to efficiently develop with a traditional software lifecycle approach.

Multi-domain modeling, detailed design simulation and verification, and automatic code generation and implementation — collectively referred to as Model-Based Design — is helping to address such critical challenges and mitigate design risk in developing next-generation surgical instruments.

Model-Based Design with MATLAB and Simulink (www.mathworks.com) enables a rapid-prototyping workflow where design iterations can be quickly completed and refined thereby reducing overall development time by months.

Using Model-Based Design with MATLAB and Simulink, Ethicon Endo-Surgery completed the first proof-of-concept for the Echelon FLEX Stapler in about three months.

Surgical Technology

other tools have been used for years.

Today’s new, robotically controlled instruments may be essentially the same, but what used to be a simple handheld tool operated with a surgeon’s gloved hand is now interfacing with a robot instead. Trying to match the price point of “dumb” handheld tools with robotically driven instruments presents yet another new challenge. The interfaces and motions are very different. The price point of introducing a much more expensive piece of capital equipment is significant, but hospitals can balance this out if the device is outfitted with affordable, disposable pieces that match the cost of lower-tech disposables. This can help win approval from insurance companies to move toward using the new, more sophisticated technology.

Precision Most surgical robots perform the work of human arms and hands. The complex engineering required to replicate human movement is a challenge in designing robotics for any purpose.

Manufacturers trying to automate various tasks and processes often face the same difficulty. For surgical robotics, the challenges are multiplied.

In addition to space constraints in the operating room, these machines are made to perform invasive procedures on, and in, the human body. Precision is more imperative than in any other application. Surgical robots can be made to function with greater exactitude than a surgeon’s hands, removing variables such as tremors for smoother point-to-point motion than is humanly possible.

Space Constraints A lot of ORs are outfitted with older furnishings and equipment. Older ORs are furnished with operating tables not designed to hold 50-100 lb. robots, or much more than a saline bag and an armrest for the surgeon. New and future beds will undoubtedly be designed with higher weight capacities; meanwhile, device designers need to be mindful of physical restrictions that could limit the marketability and usability of their new machines. Space is usually tight in surgical suites that were not designed to hold the increasing amount of technology now entering the room. Today, much of the technology and devices have to be cantilevered off the bed or wheeled in on a cart. Several pieces of equipment may be competing for the same spot in a very cramped area, where medical staff must also have the freedom to maneuver comfortably.

Every piece of equipment, including robotic machines, has to fit within this confined space without interfering with everything else going on.

Experience Finally, a team of professionals with dedicated knowledge and experience in medical device design, testing, validation/verification, and FDA approvals can bring critical benefits to the project. Reality checks are built into their processes. While pushing the limits of technology and aiming for the moon, these teams can also identify where compromises may have to be made, and conversely, where unimagined improvements to the original concept might be possible.

Size

Conclusion

Functionality of surgical and medical robots can also be greatly improved by down-sizing the devices. Portability can be important, and some of these robotic devices are even designed to be implanted within the human body. Demand is growing for smaller and smaller robots to contain higher levels of complex technology and operational capabilities.

Robotic technology has an exciting future in the OR, enabling major improvements in patient care, safety, and even long-term cost efficiencies. The technical challenges can be overcome with innovative engineering, exhaustive testing, thorough knowledge of the regulatory requirements, risks and opportunities, and pure vision. MDT

22 / July/August 2015

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Boyd Coatings Research Co., Inc. High-Performance Medical Coatings Boyd Coatings Research Co., Inc. applies high-performance medical coatings using either off-the-shelf or custom-developed coatings. The company is ISO 9001 registered and a licensed applicator of Chemours Teflon® (formerly DuPont), Whitford® fluoropolymers, 3M and other popular coatings providing non-stick, heat resistant, conductive, insulative, hydrophobic and other desirable properties.

We are experts in the application of high-performance coatings and can advise you on which brands offer the best performance, longevity and overall value for your particular application. Experienced with and knowledgeable of the unique characteristics of literally hundreds of brands, our coatings engineers can evaluate your product specification / project objective and recommend the ideal solution based on the proven strengths and weaknesses of each type.

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FEATURING:

COATED GUIDEWIRE

Fully-Validated, Zero PFOA PTFE Coatings

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Emphasis On

Device Coating

PTFE Coatings: Still the Gold Standard

By Donald M. Garcia, Director, Research & Development, Boyd Coatings Research Company Inc.

P

TFE coatings are highly popular in a vast variety of industries and in a myriad of applications.

Recently, PTFE has garnered much attention due to recent changes put forth by federal EPA protocols as well as some unfortunate medical product recalls. However, when applied by coaters with proper care and know-how, PTFE still emerges as the best coating in terms of low coefficient of friction.

PTFE (polytetrafluoroethylene) is a fluorocarbon-based polymer proven to be an essential coating that is used in virtually all industries. Best-known for its non-stick qualities, it can be used on a vast array of materials such as carbon steel, stainless steel, steel alloys, aluminum, brass, and magnesium, as well as non-metallic surfaces such as glass and some rubber materials. Additionally, a newly-developed process to apply unmodified PTFE to Nitinol without adversely affecting the properties of the underlying material has expanded the range for the popular coating.

PTFE coatings are part of a family of fluoropolymers, materials that are highly desirable because they can provide a low coefficient of friction or slipperiness.

They also offer corrosion, chemical, and heat resistance; dielectric stability; chemical inertness to the surface of base materials; and “low/no-stick” properties for easy release. In addition, PTFE coatings, along with some other fluoropolymers, are biocompatible.

PTFE can be combined with plastics, resins, or other materials to modify existing characteristics, imparting other specific and unique properties to

24 / July/August 2015

Due to the limited availability of colors of industry supplied PTFE coatings, Boyd has available additional standard and custom formulated colors made under controlled conditions in its ISO9001 certified facility. enhance compliance to user’s product to completely eliminate PFOA by 2015. needs, especially for advanced technoloIn the case of PTFE, some of the gies. Such properties commonly include PFOA used for manufacturing remained. hydrophobicity, special coloration, That meant that all U.S. companies would hardness, thermal or electrical insulation, have to develop new formulations of and conductivity. The exact combination products that would not utilize PFOA in of PTFE with other materials is driven the manufacturing process. EPA had set by the client’s particular application. up the transition into two phases: the first For medical devices, PTFE is comwas a 95% reduction, which was completmonly used to coat surgical instruments ed in 2010, and the second to be completas well as medical components, guideed by 2015. (It should be noted that while wires, devices, and implantables. the industry refers to the current materials as Zero PFOA PTFE for convenience, there is still the possibility of “trace” quanEPA Promotes Elimination of PFOA tities of PFOA. The proper technical term from PTFE Coatings is “manufactured free of PFOA.”) PFOA (Perfluorooctanoic acid) is a Since modification of coatings used on chemical substance that was used in the manufacture of PTFE (as well as hun- medical components is more demanding due to the paperwork and FDA requalidreds of other manufacturing and indusfication procedures on customers’ newly trial applications). After testing showed altered devices, enlightened companies that PFOA, a non-natural occurring began to reformulate their PTFE coatings substance, was showing up persistently and transition customers over early on in at very low levels in the environment, the game. Boyd Coatings (www.boydthe EPA began investigations into the chemical, and, ultimately, issued a request coatings.com), for example, developed its MDTmag.com

Emphasis On

Device Coating

new formulation of PTFE at the beginning of 2012, which allowed the company to bring to market a fully developed material in early 2013. After more than nine months of successful product testing and non-critical, real-world applications in the field, Boyd announced in February 2014 that it offered a fully validated, Zero PFOA PTFE coating and application process for use on medical guidewires and devices, offering “as good as” or better performance characteristics as legacy (pre2006) and low PFOA (phase 1) materials.

Zero PFOA PTFE and Guidewires While Boyd’s new formulation of Zero PFOA PTFE was successful in the coating of medical guidewires and devices, not all others enjoyed the same outcome. Some coaters had not undergone the exhaustive testing necessary to deem the product qualified for use within the human body, resulting in substandard replacement ingredients in their new formulation. As a result, some guidewires had to be recalled by the manufacturer per the FDA.

Due to its many desirable qualities, PTFE is commonly used to coat surgical instruments as well as medical components, guidewires, devices, and implantables. A new process now enables Boyd Coatings to apply pure PTFE to Nitinol medical guidewires, without adversely affecting the underlying Nitinol material.

Following the recall of two OEMs’ guidewire products, deep concern was expressed in the medical industry and aspersions were cast indiscriminately towards Zero PFOA PTFE. In fact, some manufacturers of medical guidewires were considering coating their guidewires with something other than PTFE, despite PTFE’s superior qualities. After the success of its new formulation of PTFE, Boyd Coatings

26 / July/August 2015

was understandably disappointed that such a wonderfully performing material with such great properties was inappropriately castigated.

“The medical PTFE adhesion failure discovered on certain guidewires within the industry is the result of poor planning and due diligence, and is no reflection on true viability of this advanced coating,” said Don Garcia, director of R&D at Boyd Coatings. “Medical device OEMs should neither overreact by casting aspersion on all applicators nor on the PTFE coating itself. PTFE is still the gold standard for coating for medical guidewires. Companies working within the medical field must practice all of the due diligence demanded by an industry where the penalty for failure is so high (i.e., a mistake could cost a human life).

Boyd Coatings did its methodical due diligence and exhaustive rigorous testing (including saline soaks) and, after two years, has not had any PTFE adhesion problems whatsoever. ” “We are aware of the adhesion problem discovered on some guidewires within the industry,” continued Garcia.

“But to be successful in this industry, one must be constantly aware of the law of unintended consequences. This means thorough planning using known tools such as DOE and FEMA and rigorous product and process testing to [ensure] that all of the problems have been anticipated and properly resolved. Companies who have been in the medical industry for many years know this and the recent recall should serve as a reminder to OEMs that they should work with experienced medical coatings applicators that understand medical requirements, apply appropriate science, and are thorough in the pursuit of product quality.”

Continued Development for PTFE Nearly a year later, the furor around PTFE-coated guidewires has settled and most medical OEMs have become more comfortable using them again.

Now, in addition to PTFE being PFOA-free, the coatings are available in six colors — all of which are created with new, fully-validated FDA and EPA-

compliant Zero PFOA PTFE formulae.

Colors include blue, black, green, white, yellow, and clear. And, additional colors can also be custom formulated to meet a customer’s particular needs.

The purposeful use of color on components within the medical device market is significant as colors serve to increase product functionality and precision, promote cleanliness, color code models that might otherwise be easily mixed, and identify corporate branding. When color is incorporated with the PTFE coating, medical device OEMs can increase manufacturing efficiency, thus making the component more cost effective. Prime examples of medical devices currently utilizing colored PTFE include guidewires, mandrels, and hypotubes.

Another recent development is a new process enabling pure PTFE to be applied to Nitinol medical devices, such as guidewires and stents, without adversely affecting the underlying Nitinol material.

Typically, pure PTFE requires temperatures of 700°F to cure. Because Nitinol materials cannot tolerate this high temperature without suffering adverse reactions, PTFE was previously applied using hybrid forms where a resin binder was added and it was the binder that cured at lower temperatures. This lower temperature binder was used to hold the PTFE in a matrix to preserve the characteristics of the Nitinol material.

Unfortunately, PTFE hybrids produce higher coefficients of friction, thus diminishing one of the most important characteristics that makes PTFE coating desirable. For example, the “slippery,” non-stick qualities of PTFE on a Nitinol medical device can be very significant toward that device’s success.

“We’ve developed a new process that allows us to apply high-temperature-curing fluoropolymer coatings, such as PTFE, to Nitinol in their pure form,” explained Garcia. “Hybrid forms of PTFE with resin binders are no longer needed to keep below the Nitinol transition temperature. Being able to use the pure form of PTFE on Nitinol is a major technical development for manufacturers of Nitinol devices.” MDT MDTmag.com

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We have full confidence in our products and so do our customers, that’s why our parts have been included in everything from sneaker design to space exploration equipment on Mars. We are the exclusive manufacturer of the industry-leading SpiroloxŽ Retaining Rings, an innovative design that features a no gap, 360° retaining surface without protruding ears to interfere with mating components. Smalley is also the originator of Crest to CrestŽ Wave Springs which save up to 50% of space compared to conventional coil springs.

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Notables

Test Equipment General Scanning Chart Recorder With the addition of General Scanning printer technologies, JADAK now develops and sells real-time chart recorder and thermal printer technology for time-based data logging. General Scanning chart recorders have a sharp data output with resolutions up to 800 dots per inch. By joining forces with General Scanning, JADAK is able to bring additional value to medical customers, many of whom also have a need for chart recorders. It gives them a ‘one-stop shop’ for their data collection, chart recorder, and thermal printer needs. Furthermore, this move demonstrates the company’s commitment to helping reduce medical errors, increase patient safety, and improve the efficiency of healthcare across a broad spectrum of applications and procedures.

JADAK 315-701-0678 www.jadaktech.com

Cadaver Labs for Medical Device Testing Surpass has more than twelve years of experience conducting cadaver labs for physician and clinical bioskills training, and product development testing of medical devices. Our research team can help prepare the cadaver tissues exactly as needed. This includes cannulating vessels and performing specialized specimen prep (e.g., enemas, suturing, and more). Surpass also assists with prescreen imaging for size or orientation of specific anatomical structures with fluoroscopy, ultrasound, OCT, CT, and more. The company can expose or isolate desired anatomy, develop customized positioning devices, create physiologically pressurized models, set up vascular flow loops, and excise deployed implants or tissues.

Surpass 650-938-3675 www.surpassinc.com

CW Test Transmitter The Cellular/WMTS PST is a CW test source capable of transmitting test signals on two channels simultaneously. The output from each channel can be enabled independently, and the power level can be adjusted between -10 and +12dBm in 0.1dB steps. Each channel contains two frequency bands, allowing the user to switch between cellular and WMTS test frequencies. The transmitter covers a frequency range of 608-614, 1,395-1,400, and 1,427-1,432MHz in addition to the cellular frequency bands of 698-960MHz and 1,710-2,170MHz. The USB interface allows users to control the transmitter remotely. The transmitter can be powered using the internal 6 AA rechargeable batteries for six to eight hours of continuous use or from the AC/DC wall adapter.

Praxsym 217-897-1744 www.praxsym.com

Optical Shaft Measurement System The MarShaft SCOPE 250 plus features a highly accurate matrix camera with four million pixels. The system measures parts up to 250mm in length and 40mm in diameter. An MPE (maximum permissible error) of less than 1.5 microns + L/40 when measuring diameter and 3.0 microns + L/125 when measuring length is significantly more accurate than other systems using line cameras. The high-resolution CMOS matrix camera with a live image field of view of 40 x 24mm enables it to capture an entire part diameter in a single view. MarShaft SCOPE 250 plus can be operated entirely on the integrated touchscreen, or via a keyboard and mouse if desired.

Mahr +49-551-7073-800 www.mahr.us

28 / July/August 2015

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Additive Manufacturing Our additive manufacturing service offers three rapid prototyping processes: stereolithography (SL), selective laser sintering (SLS) and direct metal laser sintering (DMLS). Whether small parts with precise geometries or large, highly detailed patterns are needed, 3D printing at Proto Labs provides another option during early prototyping.

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Roundtable Electronics Assembly

Shrinking Medical Electronics Bring Assembly Challenges

By Sean Fenske, Editor-in-Chief

A

s more electronic medical devices are made portable, wearable, or even implantable, medical device designers will struggle with the challenge of getting more functionality and longer lasting power into their creations. With this in mind, this month’s Roundtable approached the topic of electronics assembly and got key insights into new innovations, trends, and tips for aiding in what can present as a significant obstacle to overall success.

Beginning with the factors driving the electronics assembly landscape, Michael Allen, president of Z-Axis offered his view for the medical device realm. “The biggest trend continues to be making systems smaller and portable. Two main factors helping us do that are smaller, more integrated ICs and new battery technology.

For the ICs, component suppliers keep further integrating parts.

We can get more features in a single IC that replaces multiple ICs. At the same time, packages for transistors, ICs, and microcontrollers have continued to shrink. Twenty years ago, the SOT-23 was common; five years ago, it was the SC70 at half the size; and now, many parts are available in the SOT-523, a third of the size of the SOT-23. We also use a lot of micro BGAs. Speaking about the second factor, he continued, “Battery technology is the second main factor enabling portable medical systems. Today’s lithium ion batteries pack enough energy and last long enough so that we’re now able to use battery power for devices where just five years ago, we’d need to use line power.”

Also speaking to power related issues was Andy Kelly, IC/systems architect with Cactus Semiconductor, “Energy storage density presents the biggest miniaturization challenge for most of our devices.

Even though we have access to the latest energy storage technologies and employ ultra-low-power design techniques, the battery is still typically the largest single component in most of our devices.”

Undoubtedly, when it comes to electronic medical devices that are shrinking in size, that battery can seem like an even bigger component and, as such, challenge to optimizing the assembly.

While not addressing the issue involving the power source, Lars Uffhausen, senior director of technology trends, innovation, and investments with Jabil did share some insights on a relatively newer technology solution that can certainly alleviate the issue of getting all the necessary electronics into a shrinking footprint. He spoke to the innovation of metallizing circuits, which is the ability to “print” the electronic circuitry onto the device “shell.”

“By metalizing circuits, designers are able to reduce or eliminate the use of flexible circuits and adhesives to integrate electron-

30 / July/August 2015

ics on medical devices,” explained Uffhausen. “Thus, they are able to integrate functionality without adding interfaces (flex PCB) and reduce the size and weight of the product. It has also been recognized that it allows for some unique shapes and geometries that maybe are not possible with the use of traditional flex or FR4 PCB. While this has been successful in niche medical device applications, the technology needs to be adopted on a larger scale and for applicable designs.

Still enthused by the benefits of flexible circuit technology, Heather Andrus, Sr. VP & GM of product innovation at Radius Product Development shared her comments on that option to ease the challenges of medical electronics assembly. “We see size, weight, and cost impacts. Printed electronics allow most of a circuit to be printed onto low cost, light weight PU. In addition, the circuits are flexible, allowing for smaller, more ergonomic form factors. We also see the ability to integrate components such as sensors and heaters directly into the printed electronics, with dramatic increases in reliability and decreases in weight and cost.”

Another “tip” for medical device designers when it comes to using technologies that shrink the space requirements in assembly came from Kelly. “Die-stacking is a powerful technology used to reduce the footprint required for multiple ICs in a device. What is often overlooked by device developers is that a successful diestack requires the die sizes, aspect ratios, and pin configurations of all the ICs in the stack to work in concert. If the planned die-stack includes all standard-product ICs, it is very unlikely for all of these to align effectively. If at least one IC in the stack is a full-custom design, then that IC can be designed to accommodate the unique characteristics of the other ICs in the stack, and may result in a significantly improved die-stack system.”

Before some final words from Allen, readers should be aware that with every Roundtable feature in print, the participants’ full comments are provided on the MDT website as individual blogs.

Just search for this (or another) Roundtable article and find the links to all the comments made by participants.

In closing, Allen offered the following consideration for medical device designers, “If you don’t have first-hand experience in PCB assembly — and even if you do — you should involve your manufacturing partner early in your layout process. Many contract manufacturers have a layout designer on staff; some have electrical and mechanical engineers as well who can provide higher-level assistance. They will have a thorough understanding of their own specific manufacturing processes since they live it every day.

They can give you a shortcut to ‘learning from the mistakes of others’ since they’ve pretty much seen it all.” MDT MDTmag.com

ADVERTISEMENT

Setting the Standard for “Medical-Grade” Foot Controls

STEUTE … SPECIALISTS IN FOOT-OPERATED CONTROLS FOR MEDICAL DEVICES STEUTE Meditech, Inc. has been designing and manufacturing standard, modified-standard and customized cabled and wireless foot-operated controls for medical device manufacturers (OEMs) for more than 57 years. Each is developed with the following key objectives: • Optimal functionality • Aesthetically complementary to the OEMs medical device • Operator comfort & ease-of-use • Full compliance with IEC, UL, CSA and FCC requirements Surgical Microscope Control

SAFE WIRELESS OR CABLED DESIGNS …

In addition to conventional cabled designs, STEUTE has pioneered the use of wireless foot-operated control technology in the OR and other medical environments.

Our knowledge of BlueTooth™, Infrared, ZIGBEE, DECT, ENOCEAN, WLAN, and other wireless techniques enables us to select the safest, best-performing technology for the application.

Based on this experience, STEUTE also offers their proprietary wireless (frequency-hopping) technology optimally-designed for safe medical applications. This 2.4GHz radio-frequency system features: • Safe, noise-immune operation • Encrypted communication protocols • Low power consumption • Optional “sleep mode” • Fast wake-up time • Worldwide acceptance Cataract Surgery Control

STEUTE also offers “hybrid” designs capable of operating in the wireless mode, or with an optional cable for use as a conventional “hard-wired” unit.

TYPICAL APPLICATIONS …

• C-arm & other X-ray equipment • Urology tables • Cataract surgery systems • Examination tables • Ultrasonic diagnostic systems Electrosurgical Generator Control • Bone saws • Surgical shavers • Surgical microscopes • Electrosurgical generators • Endoscopic surgical systems • Dental chairs • Biopsy systems • Laser-based dermatology systems • Laser-based dental systems • Fluoroscopes • Laparoscopic surgery systems • Medical camera systems • CT Scanners • MRI Systems X-Ray System • Navigation systems Control • Ophthalmic surgery systems YOUR HUMAN INTERFACE PARTNER …

Our team understands your need to demonstrate your equipment’s superiority with an easy-to-use control designed for operator comfort and optimum functionality.

We’ll gladly share our ideas for realizing a “medical-grade” foot control that optimizes your device’s performance and appearance. For a free, no-obligation consultation, please contact us at: STEUTE Meditech, Inc. 901 Ethan Allen Highway, Suite 102 Ridgefield, CT 06877 Telephone: (203) 244-6302 E-Mail: info@steutemeditech.com Web Address: www.steutemeditech.com

Case in Point

Molding

3 Factors in Using

Single-Use Plastic Components over Metal

By Aiken Toon, Technical Director, Forefront Medical Technology

M

etal parts are typically used in invasive medical equipment because a machined metal part ensures a tight seal at joints. However, use of metal components can increase cost over the life of the product when sterilization costs are considered. Additionally, even with sterilization, reuse of components exposed to bodily fluids and tissue can increase risk of patient contamination. Single-use precision molded plastic components offer a potential option for mitigating the contamination risks and eliminating the need for a washing/autoclave process, but molding these parts with enough precision to achieve the same performance properties as their metal counterparts has been challenging. Forefront Medical Technology (www.forefrontmedicaltechnology. com), a specialty contract manufacturer with a focus in disposable diagnostic, drug delivery, and medical device systems, recently designed and molded a plastic valve set that was functionally equivalent to the metal valve set currently used in an invasive medical device.

This article looks at the challenges encountered and addressed in that process.

The design team identified three initial challenges in this project: • Identifying materials with the correct level of rigidity and strength to be functionally equivalent to the metal valve set • Ensuring that the plastic components performed identically and felt similar to their metal counterparts to a doctor

32 / July/August 2015

performing a procedure • Designing a complex mold that could produce parts with conformance to extremely fine tolerances

proved materials that includes a full range of medical-grade polymers. This allowed the team to consider materials that had already gone through biocompatibility testing.

Identifying Acceptable Materials The valve assembly to be replaced had Addressing Functional Requirements five separate components: a stem, end To better understand the functional recap, snap cap, gasket, and spring. Multiple quirements, the design team closely studmaterials were required. The design team ied a working unit in their lab. The plastic began with a brainstorming process to de- valve set not only needed to perform termine the likely best materials options. functions identical to those performed by Thermoplastic elastomer (TPE), polyprothe metal part set, it also needed to feel pylene, polycarbonate, and acrylonitrile the same to the doctors using the device. butadiene styrene (ABS) were tested as One area of concern was friction. As replacements for the stainless steel parts. mentioned earlier, there is an ABS part ABS offered the lowest cost and the best sliding against a metal part and that operlevel of rigidity. This was important beation needed to be as frictionless as poscause the ABS part was sliding against a sible. The team found that a lubricated metal component during procedures and ABS component would eliminate the fricthe plastic part needed to be able to withtion and was able to work with an ABS stand the friction of the sliding motion. supplier to specify a material with an oily Another benefit was the compatibility of property that met the requirement.

ABS with TPE. Components that would Design of experiments (DoEs) were come in contact with the doctor’s glove used to fine tune the design of the spring needed to be soft with no sharp edges that could tear the glove. TPE met that criteria and it also provided the best bonding properties with the ABS components.

Materials selection activities were enhanced by the fact that the contract manuForefront Medical Technology’s injection molding machines are facturer maintains highly automated to achieve both precise part dimensions and the a database of aptarget cycle times needed to achieve cost competitiveness.

MDTmag.com

Case in Point

Molding

used for a cushioning effect, in order to develop a spring that provided the same “feel” to doctors as the metal spring.

Designing the Mold The most significant challenge involved mold design. The design of plastic components is fundamentally different from that of metal components because the manufacturing process is different. Fabricated metal parts are formed through machining, which supports very tight tolerances, precisely formed groves, and sharp corners with 90 degree edges to achieve a tight seal. Conversely, plastic parts are formed via an injection molding process, which traditionally has wider tolerances and delivers a less precise cylindrical form.

The tolerance for the components used in the suction valve assembly was 5.0 microns, which gave a window of ±2.0 microns. When a part is injection molded, there is a possibility of non-centering. Additionally, cylindrical molded parts are typically not a perfectly shaped cylinder. The initial parts did not have the required tolerance, and as a result, there was leakage in the activation button.

The team decided to change the mold and the molding concept. The two-cavity mold was redesigned to include a slide-core mechanism for forming the cylindrical portion

Software modeling was critical in designing a tool, hot runner, and cooling system that met the project’s requirements. of the part. The critical dimensions of the part were machined inside of the slide-core mechanism during the injection molding process. A high speed computer numerically-controlled electronic discharge machine was used for final machining, since it can control tolerance to less than 3.0 microns.

The next step in the mold fabrication process was a testing and debugging phase, which incorporated a dry run and analysis of product first off the tool. Once parts that met the dimensional specification were molded, key process parameters were identified and logged to define the perfect process window.

Conclusion Following internal validation and functional testing, the parts were sent to the customer for their evaluation. The cost of the plastic valve set was near parity to the amortized life-time cost of a metal valve set. When the cost of the autoclave/sterilization process following each procedure was considered, the cost of the disposable, single-use valve set was lower than then per procedure cost of using reusable parts. However, the real value of the use of a single-use, disposable valve set was the contamination risks it mitigates for patients.

The primary challenge in this project wasn’t related to resources or technical capabilities. Instead, the challenge was cognitive. The contract manufacturer’s team needed to design an innovative approach that utilized existing equipment and tools in ways that eliminated the tolerance constraints found in traditional approaches to tooling design. Software modeling tools were critical in designing the tool, hot runner, and cooling system. Mold-flow analysis and DoEs were performed to optimize the design and molding parameters. Molding process simulations were also done to test design assumptions prior to tool fabrication and to enable the tool designers to easily demonstrate the likely performance of the tool to the engineering team during the design process.

Integrating design, design analysis, tooling, and injection molding expertise enabled the team to develop a viable solution applicable to invasive medical devices used in surgical and/or diagnostic procedures. MDT

34 / July/August 2015

MDTmag.com

&Žƌ DŽƌĞ /ŶĨŽƌŵĂƟŽŶ 'Ž dŽ

Emphasis On

Laser Passivation

A Technical Look at Engraving and

Laser

Passivation for MedTech

By Scott Sullivan, Business Development Manager, Electro Scientific Industries Inc.

U

ntil recently, passivation of stainless steel medical devices has been accomplished either chemically or electrochemically. However, the process is quite expensive. Fortunately, there is a new laser passivating process that passes the ASTM F1089-10 standard test method for corrosion of surgical instruments.

This breakthrough means that medical device manufacturers will reduce production and inventory costs.

Stainless steels are engraved for a number of reasons, such as for branding and functionality. Engravings are chosen over surface marks for their longevity and smoothness. The added depth of an engraving will often surpass the life of a medical device or instrument. A chromium oxide layer coats stainless steel, preventing it from corroding. The lifetime of the device or instrument is often determined by the robustness of the protective oxide layer. Once that oxide layer is breached and corrosion begins, the device or instrument must be discarded.

Rotary cutter and lasers can both engrave most metals including 304 stainless steel. The resulting machined surface from a rotary cutter has a bright, shiny appearance. By contrast, the surface after engraving with a laser will have a matte finish. For differing reasons, both the rotary and laser engraved part will need to go through a post-process to passivate the surface.

Stainless steel resists corrosion by building up a chromium oxide layer that grows on a surface free of oil, grease,

36 / July/August 2015

and contaminates in the presence of oxygen. Since the protective layer occurs naturally it is considered passive. A continuous protective chromium oxide layer is important on any medical device or instrument because a single site that corrodes will propagate undercutting the passivation.

A rotary cutter is made from steel harder than 304 stainless steel. As such, the cutter does not have the same chemical composition and will quickly corrode. During the engraving, small particles of the cutter become embedded into the surface of the stainless steel. If these particles are allowed to remain, they will corrode and inhibit the creation of the chromium oxide layer.

Laser engraving ablates the stainless steel. To minimize any thermal effect of the engraving, a short pulse duration laser is chosen. Chrome that was at the surface has been ablated away or pinned to the carbon in the grain boundaries, leaving free iron on the surface. As with the rotary process, the engraved surface will corrode. In order to fix this problem, two traditional and one novel methods were used to remove the nucleating spots for corrosion.

Nitric and citric acids are the most commonly used chemicals for passivating stainless steel. Hot nitric acid is a strong mineral acid that quickly dissolves iron compounds and most other trace metals on the surface. Additionally, nitric acid is a strong oxidizer that generates the passive chromium oxide layer at the same time. Citric acid is an organic acid and does an excellent job of removing iron from all surfaces. By

contrast, citric acid is not an oxidizer.

The passivating chromium oxide layer is grown by exposure to ambient oxygen.

Both chemical passivation methods result in a shiny engraved surface. A four to 10 percent citric acid passivation is capable of passing the ASTM F108910 but is often not used in aggressive chemical or physical environments.

The advantages for citric acid are that it is safer to use, is biodegradable, and produces fewer effluent concerns.

Times of up to two hours at temperatures of 70째C with a concentration of 20% to 50% nitric acid result in a more robust passivation layer. Autoclaving is both chemically and thermally aggressive to an oxide layer. Every autoclaving cycle will thin an oxide layer. Being thicker and denser means that the passivation layer created by a nitric acid passivation process will last longer than one produced using citric acid. Thermal cycling during autoclaving expands the metal more than the passivation layer expands. The denser layer is less likely to be damaged by the heating and cooling during sterilization.

Passivation uses strictly chemical energy whereas electropolishing uses electrochemical energy to strip away metals that may lead to corrosion. Often referred to as reverse plating, electropolishing uses a rectified current passed through the part, which is immersed in an electrolyte bath.

Electropolishing dissolves high points faster than the low points on the surface of the part. This process reduces the surface area and allows for a more uniform oxide layer to form. Preferential dissoluMDTmag.com

tion also occurs. The higher the amount of chromium in the steel, the higher the corrosion resistance. High chromium content also reduces the strength and workability of the steel. At the surface, strength is not an issue. By preferentially dissolving the iron, a ratio of chromium to iron can be as high as 1.5:1. The smooth and chromium rich surface readily oxidizes, which creates a thick protective oxide layer.

An in situ laser process duplicates all but one of the results of both passivation and electropolishing. Native stainless steel was created by dissolving the free iron back into the matrix. Surface roughness and, thus, area was reduced by flowing the engraved surface. Enrichment of the surface chromium using electropolishing was undetermined.

Materials have a laser ablation threshold that is a combination of wavelength, pulse duration, and fluence. Above the

threshold ablation occurs and the metal can be engraved. Below the threshold, the surface can melt. Just at the threshold, the iron can be pushed back into a solid solution and the surface smoothed. The new surface is now smooth, contains no free iron, and is of the correct composition to form the protective chromium oxide layer. To assist in the oxide formation, the laser heats up the metal.

Using the laser means that there is no added process step to lower yield or add costs. The move from engraving to passivating is done in the process recipe and the parts do not need to leave the laser engraver. Because passivation and electropolishing are wet processes, there is a limit to when they can be done in the manufacturing sequence.

A fully finished part can be laser engraved and laser passivated, which allows for the part to be engraved after sale and

with the branding or regulatory markings for that specific market.

Post-engraving processing is needed on stainless steel medical instruments and devices. Chemical passivation has the advantage of being the traditional low cost process. For single-use products, it is cost competitive with laser passivation.

Electropolishing, though the most expensive per part, produces the most robust protective chromium oxide layer.

Laser passivation can be integrated into the laser engraving process, adding very little to the per part cost, while at the same time, increasing yield due to fewer processing steps. In addition, the engraving and passivating can be done on a finished part, reducing the amount of product in finished good inventory. MDT For more information, www.esi.com.

ADVERTISERS INDEX The advertisers index is provided as a reader service. Although every attempt has been made to make this index as complete as possible, the accuracy of all listings cannot be guaranteed.

.steute . . . . . . . . . . . . . . . . . . . . . . . . 31, 39

Fluid Metering Inc . . . . . . . . . . . . . . . . 16

Proto Labs, Inc. . . . . . . . . . . . . . . . . . 5, 29

ATL Technology . . . . . . . . . . . . . . . . . . . 7

Interface Catheter Solutions . . . . . . . . 11

Smalley Steel Ring Co . . . . . . . . . . . . . 27

Bimba Mfg Company. . . . . . . . . . . . . . 40

J-Pac Medical . . . . . . . . . . . . . . . . . . 2, 33

Specialty Silicone Fabricators . . . . . . . 13

Boyd Coatings Research Co . . . . . . . . 23

Junkosha USA . . . . . . . . . . . . . . . . . . 9, 35

Tadiran Electronic Industries . . . . . . . 15

Clippard Instrument Laboratory . . . . 17

Maxon Motors . . . . . . . . . . . . . . . . . . . . 1

WuXi AppTec, Inc. . . . . . . . . . . . . . . . . 21

Data Image . . . . . . . . . . . . . . . . . . . 16, 34

Mean Well USA Inc . . . . . . . . . . . . . . . . 3

Dynaflo, Inc. . . . . . . . . . . . . . . . . . . . . . 25

Plastics One Inc . . . . . . . . . . . . . . . . . . 19

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Medical Design Technology®

July/August 2015 /

37

Reshoring in the Medical Device Development Space Manufacturing is seeing a shift in outsourcing where certain jobs are returning to the U.S. MDT was curious to see if our readers were participating in this trend or had opinions on topics related to it. As such, this issue’s infographic highlights our survey results.

By Sean Fenske, Editor-In-Chief

When selecting an outsourcing vendor, U.S. vs. international is a significant factor.

Part quality with international ona nal al n. vendors is a significant concern.

31% 31% 30%

32% Somewhat agree agree 24% Neither nor disagree

Strongly agree Somewhat agree Neither agree nor disagree

40%

Strongly agree

3% Somewhat disagree

6% Somewhat disagree 2% Strongly disagree

1%

Strongly disagree

Has your company transitioned outsourcing services from an international to a U.S.-based vendor?

Yes, more than 5 years ago

Yes, within the last 1-5 years

% 18% 5 12%

IP protection with international vendors is a significant concern.

2%

2%

Somewhat disagree

Yes, within the last year Yes

Unsure

4%

59% No

Currently making this transition

“Made in the USA” is an important factor in outsourcing decisions.

44

%

Strongly agree

28 28%

Somewhat agree

Neither agree nor disagree

Cost savings

Strongly disagree

21% Proximity to the international customer

13%

Access to supply chain

5% Somewhat disagree

2%

59%

%

Somewhat agree

Neither agree nor disagree

What is the most important reason for using an international outsourcing vendor today?

37%

Strongly agree

35%

17%

7%

Other

2% Strongly disagree Why are U.S.-based outsourcing vendors appealing?

35%

67%

Ease of Competitive communication pricing 3838/ July/August April/May 2015 2015 / July/August 2015

52%

40%

Higher quality

IP protection

46%

53%

2%

Lower Proximity They are shipping costs not appealing designed by Larry Corby, Digital Artist

designed by Larry Corby, Digital Artist

4% Other MDTmag.com MDTmag.com MDTmag.com

Why compromise your medical device with an “industrial-grade” foot switch ...

Surgical Navigation Control

Examination Chair Positioning Control

Electrosurgical Generator Control

when you can offer your customers the benefits of a “medical-grade” design?

As an OEM, you know that a product designed for the medical market is fundamentally different for one intended for industrial-commercial use. This is also true for the foot switch.

Critical design factors, typically not considered for non-medical applications, include: • Weight

• Usability

• Sealing

• Cleaning needs

• Aesthetics

• Stability-in-use

• Storage

• Tactile feel

Steute has satisfied medical device OEMs’ unique needs with thousands of applicationspecific foot controls… each functionally, ergonomically and aesthetically optimized to the OEM’s requirements. Most with no engineering design or tooling costs.

Contact us for a no-obligation design consultation, or to discuss receiving a complimentary sample for evaluation.

(203) 244-6302

www.steutemeditech.com

info@steutemeditech.com

– THE EXPERTS AGREE –

INTELLISENSE

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WINS THREE PRESTIGIOUS AWARDS FROM LEADING INDUSTRY TRADE PUBLICATIONS

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