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NOVEMBER 2016

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840-11201 THK Medical Ad(DW)

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CRITICAL MEDICAL

APPLICATIONS REQUIRE

THK QUALITY

D N A

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A N A LY Z E R S

G U I D E S

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A C T U A T O R S

THK offers consistent ultra-precision linear motion components and systems that deliver tight tolerances for our medical, lab automation and equipment manufacturing customers. The confidence our customers have in the reliability and quality offered by THK makes us work even harder to innovate and achieve the ultimate in precision and quality.

To learn more, give us a call at 1-800-763-5459 or visit www.thk.com.

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100 YEARS OF INNOVATION.

For 100 years NSK has been proudly designing motion and control products that not only help increase productivity but also help make the world a more safe, reliable and comfortable place. Here’s to celebrating the past, innovating in the present and setting the future in motion. 877.994.6675

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BIMBA MEDICAL

FLUID MANAGEMENT MECHANICAL MOTION LAB AUTOMATION STERILIZATION CLEAN ROOM DOSING

MECHANICAL MOTION COMPONENTS TO

BRING YOUR DEVICE TO LIFE. From the operating room to the manufacturing floor, Bimba offers a variety of pneumatic, electric and hydraulic solutions to help you tackle your medical device applications. Whether you are designing a new system or improving an existing one, learn more about how our investment in medical device components can support your medical device needs at bimba.com/medical

ORIGINAL LINE ® AIR CYLINDER Design enhancements to the Original Line have more than doubled the anticipated service life of this industryleading, non-repairable family of air cylinders.

COORDINATED MOTION

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Unique continuous belt provides coordinated motion for each axis resulting in an ideal solution for high speed medical, life sciences and laboratory applications, including pick and place, filling, inspection and sorting.

Robust, double-acting or single-acting grippers provide high-precision and seamless speed adjustment for the opening and closing of the gripping jaw. 

Featuring a NEMA 23 motor, encoder and sophisticated stepper drive in a single device, IntelliMotor® provides the ability to drive motion applications that include various control modes.

© Copyright 2016 Bimba Manufacturing Company. All Rights Reserved.

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CONTROLLER CHIPS

FIT FOR EVERY APPLICATION

Medical Design & OUTSOURCING

medicaldesignandoutsourcing.com  ∞  November 2016  ∞  Vol2 No6

Nippon Pulse manufactures a variety of servo/stepper controller chips, and they all have different strengths.

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 Nic Abraham nabraham@wtwhmedia.com @NicsMedTechNews Senior Editor Heather Thompson hthompson@wtwhmedia.com

Some are ultra high-precision with a variety of interpolation functions. Some are simple and low-cost for basic motion control. Some feature pre-registers for smooth, seamless and continuous movement. Any of them will ease the burden on your CPU and allow for smoother, faster, more complicated motion profiles than an FPGA or CPU alone. All of them will impress you.

Associate Editor Fink Densford fdensford@wtwhmedia.com Editorial Intern - Medical Abigail Esposito aesposito@wtwhmedia.com

Publisher Brian Johnson bjohnson@wtwhmedia.com 617.905.6116

DESIGN & PRODUCTION SERVICES VP of Creative Services Mark Rook mrook@wtwhmedia.com @wtwh_graphics Art Director Matthew Claney mclaney@wtwhmedia.com @wtwh_designer Graphic Designer Allison Washko awashko@wtwhmedia.com @wtwh_allison

Traffic Manager Mary Heideloff mheideloff@wtwhmedia.com Production Associate Tracy Powers tpowers@wtwhmedia.com

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Controller Brian Korsberg bkorsberg@wtwhmedia.com Accounts Recievable Jamila Milton jmilton@wtwhmedia.com

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MEDICAL DESIGN & OUTSOURCING does not pass judgment on subjects of controversy nor enter into disputes with or between any individuals or organizations. MEDICAL DESIGN & OUTSOURCING is also an independent forum for the expression of opinions relevant to industry issues. Letters to the editor and by-lined articles express the views of the author and not necessarily of the publisher or publication. Every effort is made to provide accurate information. However, the publisher assumes no responsibility for accuracy of submitted advertising and editorial information. Non-commissioned articles and news releases cannot be acknowledged. Unsolicited materials cannot be returned nor will this organization assume responsibility for their care. MEDICAL DESIGN & OUTSOURCING does not endorse any products, programs, or services of advertisers or editorial contributors. Copyright©2016 by WTWH Media, LLC. No part of this publication may be reproduced in any form or by any means, electronic or mechanical, or by recording, or by any information storage or retrieval systems, without written permission from the publisher.

Nippon Pulse Your Partner in Motion Control nipponpulse.com | info@nipponpulse.com | 1-540-633-1677

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MEDICAL DESIGN & OUTSOURCING (ISSN 2164-7135) is published six times per year: January, March, May, July, September and November by WTWH Media, LLC. 6555 Carnegie Ave., Suite 300, Cleveland, Ohio 44103. APPLICATION TO MAIL AT PERIODICALS POSTAGE PRICES AND ADDITIONAL OFFICES IS PENDING AT CLEVELAND, OH. POSTMASTER: Send address changes to WTWH Media LLC, 6555 Carnegie Ave., Suite 300, Cleveland, Ohio 44103

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HERE’S WHAT WE SEE

A major step toward 3D-printed organs There’s been a lot of hype around the promise of using three-dimensional printing to create human organs for implantation, but mimicking the complex functions of the human body is just as hard as it sounds. Researchers at Harvard University recently made a major advance in the field. Just last month, researchers at Harvard University announced the first entirely 3D-printed organ-on-a-chip to feature integrated sensing – a “heart-on-a-chip” manufactured by a fully automated, digital procedure that allows researchers to collect data for short-term and long-term studies. It’s a major step forward for one of the Holy Grails in medicine: Creating fully functional artificial human organs for research and, eventually, implantation into the human body. The team designed six different inks using piezoresistive, high-conductance, biocompatible soft materials. The inks allowed them to integrate soft strain gauge sensors within micro-architectures, which in turn facilitate the self-assembly of endothelial cells – the cells that line human blood vessels. “We validated that these embedded sensors provide non-invasive, electronic readouts of tissue contractile

Brad Perriello Executive Editor Medical Design & Outsourcing bperriello@wtwhmedia.com

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stresses inside cell incubator environments. We further applied these devices to study drug responses, as well as the contractile development of human stem cell-derived laminar cardiac tissues over four weeks,” the researchers wrote in Nature Materials. It’s an important step toward creating viable in vitro models to study biological processes as an alternative to conventional animal models. Although organson-chips have been around for a few years, they are expensive and laborious to produce. “Our approach was to address these two challenges simultaneously via digital manufacturing,” co-author Travis Busbee said last month. “By developing new printable inks for multi-material 3D printing, we were able to automate the fabrication process while increasing the complexity of the devices.” “We are pushing the boundaries of three-dimensional printing by developing and integrating multiple functional materials within printed devices,” added co-author Jennifer Lewis. “This study is a powerful demonstration of how our platform can be used to create fully functional, instrumented chips for drug screening and disease modeling.” M

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PICK YOUR

COLOR MPD m e m o ry p r o t e c t i o n d e v i c e s

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M P D i s a g lo b a l m o t h e r e l e c t r o n ic c o m p o n e nt s s h o u l i s w h y w e a r e a lw

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a n u fac t u r e r o f b at t e ry h o l d c o m p o n e nt s . W e b e l i e v e t h at d f i t e a s i ly i nto y o u r d e s i g ay s c r e at i n g i n n o vat i v e n e w

e r s a n d o u r n s , w h ic h p r o d uc t s .

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CONTENTS

medicaldesignandoutsourcing.com  ∞  November 2016  ∞  Vol.2 No.6

INSIDE

the medical device handbook 06

HERE’S WHAT WE SEE A major step toward 3D-printed organs

42

74

Balloon catheters

Laser-Swiss combinations, Precision laser machining, Ultrasonic welding

CATHETERS

MACHINING

44

10

80

MOLDING

CONSULTING

Insert molding, Overmolding, Micro Molding

Knowing when it’s time

50

14

MATERIALS

MOTION CONTROL COMPONENTS

Adhesives, Nitinol, Tribology testing, High-performance polymers

Brushless DC motors, Gearheads, Linear actuators, Linear motors

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MANUFACTURING 3D printing, Lowering product development barriers, Single supplier risks

36

TUBING Co-extrusion tubing, Ultra-thinwall heat-shrink tubing, Tubing compounds

FLUID POWER COMPONENTS Sourcing seals

60

NEEDLES & SYRINGES Ultrasound-guided fine-needle aspiration

62

ELECTRICAL / ELECTRONIC COMPONENTS

VALIDATION & TESTING Validating software, What is validation?

84

REGULATORY 10 keys to the U.S. market, Alternative pathways

MEDICAL in

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THE MEDTECH INDUSTRY IN 10 YEARS As Medical Design & Outsourcing’s parent company WTWH Media celebrates its 10th anniversary, we reflect on the medtech industry’s past success and look forward to the next decade.

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AD INDEX

Connectors, Position encoders, Power supplies, Sensors

70

STERILIZATION SERVICES Ethylene oxide

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CONSULTING

How do you know when it’s time to hire a consultant? Chris Schorre | Vice President of Global Marketing | EMERGO |

Has this happened to you lately? • You spent countless hours online trying to research a specific process, but still don’t have a solid understanding of how it works. • You are under pressure to get a project done, but don’t have the internal resources to complete it by the deadline. It’s okay to admit that you need help The most successful people don’t pretend they know how to do everything. They recognize early on that learning how to do something would not be a good investment of their time. At some point you may be faced with the same decision and you need to ask yourself these questions:

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1. If I tackle this myself and it goes badly or takes way more time than expected, how will it affect the company? 2. What kind of stress will I be under if #1 happens? 3. Will I ever need to do this type of project again? Is there a long-term benefit to me investing considerable time to learn it? Believe it or not, the Internet is not always right In the byzantine realm of global regulatory compliance, fallacies abound online. The biggest mistake we see made is that clients do their own research but find outdated or incomplete information and take it as fact. Most people do not use the ‘Search Tools” button in Google that allows filtering results by date posted. That results in assuming old information is up-to-date. Good consultants stay abreast of recent changes, and can steer you clear of potentially expensive mistakes. Companies, like Emergo, work in the field of international regulatory compliance for medical device companies. Needless to say, it’s a complex field. Without a doubt the best clients we have are the ones who “know what they don’t know.”

www.medicaldesignandoutsourcing.com

Photo courtesy of istockphoto.com

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Two heads are better than one. Your idea. Our design. Both working together from the start to make great things possible. That’s what happens when Nason partners with customers in the medical equipment industry to create cutting-edge, fully custom switches and cylinders — and that’s why we’re proud to be a small part of something big.

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CONSULTING

People remember the outcome, not the cost Yes, hiring a consultant costs money and it is appealing (sometimes necessary) to try to figure out how to achieve your goals using internal resources, but remember, your time is not free either! A mid-level regulatory specialist might easily cost a company $100,000 in salary and benefits. That’s $50 per hour. If it takes that person three times longer to figure out how to do something than hiring an expert, that’s $150 per hour. But here’s where the real costs add up: We serve 2,800 medical device and IVD clients worldwide, so I can tell you that we often get calls from flustered companies that have submitted a 510(k) to the FDA after struggling to prepare it internally for six months. The FDA then

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rejects the company’s submission because they did not realize they needed a specific testing report. Now, the company must to go back and get the testing done, delaying market introduction and sales by another two months. These situations are entirely preventable and, in most cases, the cost of recovering from them far exceeds the initial investment of hiring someone who knows what they are doing. As Red Adair, a legendary American oil well firefighter, once said, “If you think it's expensive to hire a professional to do the job, wait until you hire an amateur.” M

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I N T E R C O N N E C T C O m P O N E N T S & h a R d wa R E

Battery Clips, Contacts & Holders

Fuse Clips & Holders

Terminals and Test Points

Spacers & Standoffs

Plugs & Jacks

Multi-Purpose Hardware

It’s what’s on the InsIde that counts ® E L E C T R O N I C S

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MATERIALS

There’s a wide range of materials used in the medical industry. Today’s applications call for flexible, durable, sometimes rigid and efficient materials. For packaging, materials may also be required to block moisture. Materials affect a medical device’s performance, durability, cost and more. Several factors should be taken into consideration when selecting materials, including availability, design flexibility, cost per unit, performance properties, regulatory compliance, biocompatibility, aesthetics and usability, manufacturing efficiency, sterilization & cleaning and sustainability. Swiss researchers developed a composite material made from silicone and copper alloy that goes from being highly flexible to rigid as its temperature varies – a good fit for endoscopic procedures. Also, a global developer offers bioabsorbable sutures, yarns and resins for custom configuration to meet unique performance characteristics. What’s more, ePTFE is a flexible, biocompatible material, used to cover stents and stent grafts. The lubricity, strength, and durability of the material makes it valuable during stent deployment and in

situ. Additionally, to minimize friction, wear and abrasion in medical valves, plungers, caps and seals, Quniton is a new high performance lubricious product with permanent, low coefficient of friction surface properties. Lamination is the technique of manufacturing a material in multiple layers, so that the composite material is stronger, more stable and has sound insulation via the use of different materials. A laminate is often permanently assembled by heat, pressure, welding or adhesives. When an item is given a plastic coating, it becomes tear-proof and waterproof because the laminating film encapsulates the item completely. Adhesives are materials used to hold two surfaces together. An adhesive must wet the surfaces, adhere to them, develop strength after it has been applied and remain stable. Metalizing is a process that deposits a thin metallic film on the surface of a non-metallic object. Metalizing is a common coating process used to improve resistance to corrosion, wear and fatigue. M

What adhesives are a good fit for plastic substrates? Jason Spencer | Global Market Development Manager | Henkel |

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New developments in adhesives are helping medical device manufacturers produce devices that are more chemically resistant to the harsher cleaners and disinfectants used in hospitals. These prequalified, fast-cure adhesives demonstrate superior performance under challenging conditions, enabling customers to reduce the time and resources needed to evaluate assembly methods. This leads to shorter development times while improving operational efficiencies. Due to the aggressive materials in new cleaners and solvents, plastics suppliers are developing new polymer blends, such as co-polyesters and acrylics, to withstand the harsher environments that medical devices are exposed to. Suppliers such as Henkel– the manufacturer of Loctite adhesives–work closely with suppliers to test adhesives with these new plastics to provide a complete disinfectant-resistant solution. By evaluating and testing various adhesive and substrate combinations in its labs, Henkel helps suppliers reduce their overall R&D time and shorten the development process. Henkel also holds medical seminars and hands-on training sessions to help suppliers improve medical device designs through optimization of joint designs and adhesive selection.

Medical Design & Outsourcing

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COLLABORATION IS KEY!

PAD PRINTING

PROJECT STATISTICS TWO-SHOT COMPONENT SUB-ASSEMBLY

LIGHT PIPE

Molded Components

21

Two Shot-Components

2

Printed Areas

14

Sub-Assemblies

5

UNRIVALED EXPERIENCE UNRIVALED RESULTS

ISO 14644 Class 7 (10K) Cleanroom

When Natus® Medical needed their echo-screen® III infant hearing screener manufactured with tight deadlines and zero room for error they turned to AIM Plastics. The result was a collaborative project that produced the world’s first electronic medical device made from Eastman’s Tritan™ material. The echo-screen III is highly chemical resistant and BPA free. This project also resulted in Natus winning the R&D 100 Silver Award. To learn more about how AIM can collaborate with you call 586.954.2553 or visit aimplastics.com

Quality Lab

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MATERIALS

Light-curing acrylic adhesives For many plastic substrates, light-curing acrylic adhesives are a viable solution. These one-component adhesives cure in seconds when exposed to ultraviolet or visible light. Light-cure acrylics are easily automated and fluorescent versions allow in-line detection of the adhesive. Light-cure acrylic adhesives are resistant to harsh disinfectants and are ISO 10993 Biological tested for medical device use. These acrylics are suitable for assembling syringes, injectors, infusion sets, pressure transducers, drug delivery devices, IV sets, oxygenators, cardiotomy reservoirs, blood heat exchangers, hearing aids, anesthesia masks and blood filters. Cyanoacrylate adhesives Cyanoacrylates, or instant adhesives, are another good choice for bonding

plastic substrates. These are one-part, room-temperature-curing adhesives that provide excellent adhesion to most substrates and typically fixture within seconds. Cyanoacrylates can be easily automated on production lines and are available in a variety of formulations including toughened, low-odor/lowbloom, surface-insensitive and thermally resistant. Some suppliers also offer highly flexible cyanoacrylates for the assembly of flexible medical devices. Cyanoacrylates are widely used to bond components in blood pressure transducers, endoscopes, IV sets, infusion pumps, catheters, orthopedic devices, hearing aids, cast boots and diagnostic imaging equipment. Loctite cyanoacrylates are ISO 10993 biocompatible.

Producing safer, more comfortable devices Collaboration between adhesive suppliers and plastic suppliers helps develop innovative solutions that benefit customers, enabling them to reduce costs, shorten their development time, and produce safer, more comfortable devices for patients. M

Stainless Steel Machine Components

Look no further! We help engineers meet their specific requirements.

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MATERIALS

What should be considered when pursing nitinol-based products? Norman Noble, Inc. |

The nickel-and-titanium alloy known as nitinol is a super-elastic shape-memory alloy responsible for major advances in medical technology over the last 15 years. Nitinol is a highly elastic material that can be processed to maintain a desired geometry. These properties, combined with high fatigue resistance and its ability to provide constant force over a wide range of displacements, makes it ideally suited for use in numerous medical implants and devices, such as: • • • • • • • •

Vascular stents (Cardio, AAA, Peripheral, Carotid, Venous and Neuro) Transcatheter heart valve frames Vascular closure implants Neurovascular clot pullers Devices and flow diverters Vena cava filters Atrial fibrillation devices Orthopedic anchors

As well-suited as nitinol is for vascular implant applications, few manufacturers are able to produce finished goods with it. Some barriers to working with Nitinol are: •

Nitinol knowledge: Working with the alloy requires extensive knowledge of its mechanical properties and fatigue characteristics. Low machinability: As a raw material, nitinol is difficult to machine with conventional technologies. Multiple proprietary manufacturing processes are required to produce even the most basic nitinol-based device. Electropolishing and passivation: To protect against the harmful release of nickel into the human body, electropolishing or passivation are required to create a protective titanium oxide layer. Process validation: Nitinol implant manufacturing requires strict process controls and validation to meet the finished material specifications.

When pursuing a manufacturer to produce a new nitinol-based implant or device, it’s important to 18

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consider a number of decision factors, some of which are mentioned below. Raw material sourcing Before committing to any manufacturer, it’s crucial to know how they will source nitinol for a given project. An OEM’s ability to supply the market with product is directly dependent on the contract manufacturer’s ability to source the raw material required to maintain continuity of supply. A sustained disruption in supply is often catastrophic for OEMs. At a minimum, ensure the contract manufacturer will qualify and validate two sources of nitinol for production. Any disruption in the material quality from the primary source can be quickly resolved by increasing supply from the second. Equally important, the quality, type (sheet or tube) and characteristics of the nitinol supplied by any given raw material producer

www.medicaldesignandoutsourcing.com

11/23/16 9:36 AM


Medical Innovation From Start To Finish

Design & Development

Regulatory

Testing

Tooling

Manufacturing

Commercialization Strategy

We are passionate about medical innovation. Together, our highly skilled, agile team will accelerate your device timelines from concept to commercialization. As your trusted design and manufacturing partner, we are dedicated to your success. EG-GILERO Toll-Free: +1 844-EGILERO www.eg-gilero.com

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MATERIALS

is variable. The manufacturer who regularly sources material from many suppliers is able to best match the raw material to your design requirements and product application. Design for manufacturability (DFM) and finite element analysis (FEA) It’s also critical to evaluate product design specifications during the prototyping stage to identify opportunities to reduce cost without compromising the manufactured part’s intended function. Any cost-reducing design changes must be implemented prior to design freeze. For any prospective new device design, extensive design and testing services should be available to help the design engineer perform FEA. This ability to model and simulate mechanical behavior reduces the time needed between design iterations, a critical step in the race to bring products to market.

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Dedicated process engineering Each manufacturing step requires the contract manufacturer to custom design that operation for any particular product design. This is done by designing, testing and refining the step using the same model and type of equipment and conditions that will be used in

production. The capability to design and manufacture all shape-set tooling and fixturing for each process step in-house is essential to ensure the highest level of quality and process control. It’s important to understand whether the manufacturer does this testing using equipment, experienced engineering personnel and facilities dedicated solely to process development, so it does not compete for time with products already in the production-manufacturing stream. Manufacturing parts complete Producing finished nitinol parts is a complex, multi-phase endeavor requiring years of experience and numerous manufacturing and finishing process capabilities. It’s important to understand up front whether your supplier can completely manufacture your part in-house using special nitinol processing techniques. Can they handle all manufacturing and finishing required to produce a marketable product without outsourcing any steps? By handling all steps in the manufacturing process, the supplier can tune each step based on its knowledge of the upstream or downstream capabilities. This produces the highest level of quality assurance and process control. M

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MATERIALS

How does tribology test data aid in material selection for single-use drug delivery devices?

In an emergency situation, there is only one “shot” to use a single-use injection pen, safety syringe or other medical device. One of the key design challenges for single-use medical devices is ensuring the “stiction” free movement of the device on the first and only usage. Single-use medical devices with moving parts have a unique set of performance criteria that include low forces, a short movement path and low speeds. Many of these devices use a secondary external lubricant, such as silicone, for quiet and smooth operation. These secondary operations can add significant cost, have difficult clean-up procedures and require additional quality inspections to ensure lubricant is applied correctly. A more cost-effective and manufacturing-friendly alternative is introducing internal lubrication by compounding the lubricant within the plastic. This improves dispersion of the lubricant and eliminates the added cost of secondary operations. Although standardized thermoplastic tribology tests use conditions that are predictive for long-term wear performance, they don’t help in the selection of materials to eliminate the stick-slip phenomenon that’s critical to the performance of single-use medical devices.

Josh Blackmore | Global Healthcare Manager & Ben Gerjets | Product Development Engineer | RTP Company |

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Accurately predicting results To assist in the material selection process, a custom oscillation routine was created for a thrust washer machine, and was used to mimic the movements, pressures and velocities found in the moving parts of typical auto-injection pens and syringes. Using this test method, engineers explored base resins including polycarbonate (PC), acetal (POM), acrylonitrile butadiene styrene (ABS), polycarbonate/ABS Alloy (PC/ABS), high-density polyethylene (HDPE) and polybutylene terephthalate (PBT). These resins were tested in a variety of combinations with friction-reducing additives including polytetrafluoroethylene (PTFE), perfluoropolyether (PFPE) oil and a selection of silicones, along with RTP Company’s All Polymeric Wear Alloy, known as APWA Plus. The combination of two compounds, one on each side of the

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Small in size, big in performance The PITTMAN Difference 12.7 mm (0.5-in) diameter. Also available: 9.5 mm (0.375-in); 20 mm (0.8-in); 28 mm (1.1-in)

Many of today’s most sophisticated analytical and medical procedures require ultra-compact, high-performance DC motor platforms that deliver responsiveness, maneuverability and extreme precision. Following established stringent design criteria, PITTMAN has developed the micro-motor “BI Series” – slotless, brushless motors for designers, developers and manufacturers looking to achieve high-performance in a confined space.

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MATERIALS

assembly and tested against one another, is referred to as a “friction pairing.”

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The data tell a story For each friction pairing, engineers measured the Static and Dynamic Coefficients of Friction (COF), looking for the lowest and most consistent static COF values possible with a minimal difference between static and dynamic COF. The threshold representing the smallest delta between the two measurements has been coined by RTP Company tribologists as the “Glide Factor.” Consistent, repeatable tests showed that the ideal friction pairings exhibited low Static Coefficient of friction (< 0.15) and a Glide Factor of < 0.015. A low Glide Factor is an indication that the mating surfaces will perform better, with less sticking, slipping, and inconsistent sliding. By conducting numerous statistically valid tests and gathering performance data, engineers came to a number of conclusions regarding materials selection for single-use medical devices, including resin selection, internal lubricant selection and the challenges of factors such as pressure and load. Benefits of using tribology data The data collected let designers make informed choices, rather than spend valuable resources on a conventional trial-and-error approach to medical device design and manufacturing. Accurate, upfront data also reduces the cost per part and time to market. In addition, the data shows that costly external lubrication and processing steps can be reduced or eliminated by using an internally lubricated compound. Most importantly, concrete material data helps ensure optimal medical device performance and safety. M

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SURGICAL PRECISION RE-DEFINED Micro Series Lead Screw Technology

For extreme control in medical applications including infusion pumps, intravenous therapies, surgical robotics, radiology, opthalmic instruments, microscopes, and other instruments that require ultra-precise motion control in confined spaces. 2 mm (5/64-in) diameter Micro Series Standard Lead Screw Assembly

Micro Series ZBMR Anti-Backlash Nut Assemblies

Micro Series BFWB Barrel Nut Assemblies

Haydon Kerk Motion Solutions Micro Series lead screw products enable a whole new range of micro-solutions that facilitate big advances in medical technology. The Micro Series provides precise control, reduced power consumption, and weight reduction without sacrificing performance or reliability. Prototype kits are now available in our online store and shipments can be made in 24 hours. For custom, application-specific needs, Haydon Kerk offers in-house engineering and manufacturing including machining, mold making, and injection molding capabilities, strategically integrated to satisfy your needs for a hundred, a thousand, or a million assemblies. For more information: www.HaydonKerk.com > Lead Screws & Nuts > 2 mm Lead Screw www.HaydonKerk.com

Call 1 603 213 6290 hkapplications@ametek.com

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MATERIALS

What highperformance polymers drive growth in specialty healthcare applications?

Jeff Hrivnak | Global Business Development Manager – Healthcare | Solvay |

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Engineering polymers have helped make healthcare simpler, safer and more costeffective for decades, and together they helped to drive a global market that was valued at $9.69 billion in 2013, according to analyst firm Grand View Research. Further, Grand View projects that the versatility of medical polymers will fuel robust growth through 2020 to reach a market value of just more than $17 billion. Specialty polymers – a category of materials defined by markedly higher performance than conventional resins – will only help to fuel the growth of the overall medical plastics market. This especially applies to applications in which replacing metal with a polymer could potentially lower a part’s overall cost, reduce its weight or enable a more ergonomic design. Encompassing polysulfone (PSU), polyphenylsulfone (PPSU), polyaryletherketone (PAEK), polyetheretherketone (PEEK), polyarylamide (PARA) and other advanced polymers, this class of materials collectively offers better mechanical performance than engineering resins, as well as broader chemical resistance, higher thermal properties and often inherent flame retardance without the need for additives. These materials are also compatible with a broad range of sterilization technologies, such as steam, ethylene oxide, vaporized hydrogen peroxide

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and high-energy gamma radiation. As with all healthcare thermoplastics, specialty polymers offer all the benefits that injection molding provides over metal fabrication, such as the ability to consolidate parts, cost-effectively mold complex components and eliminate secondary operations. Moldable polymers can also minimize the number of surfaces that need to be sterilized. Representative applications of complex or hybrid instrumentation in which injection-molded specialty polymers are playing a role include endoscopes and minimally invasive surgical instruments. Yet specialty polymers offer more than the traditional processing benefits of conventional plastics. Their uniquely high-performance properties put them on par with many metals and often position them as a viable alternative. Metal has traditionally been the medical industry’s material of choice for components that require high rigidity and durability against heat, chemicals and sterilization. But specialty polymers are challenging metal on all of these points, while offering a more cost-effective, moldable alternative. This is evident in the trend toward metalreplacement in single-use and reusable instrument applications, such as retractors, impactors and other surgical instruments. PARA’s metal-like strength and comparatively low cost vs. metal has further helped pioneer lighter, more ergonomic pliers, rod benders, staplers and other instruments traditionally reliant on stainless steel. The greater compatibility of PSU, PPSU, PAEK, PEEK and PARA with chemical, steam

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and gamma-based sterilization methods is also helping to drive broader adoption. Reusable medical devices and surgical tools, for example, must undergo hundreds of steam sterilization cycles within their service lives, which exceeds the performance capabilities of commodity polymers and engineering plastics. Single-use instruments are typically designed for sterilization with a gamma radiation dosage between 40 and 100 kGy. But despite their single-use label and counter to their instructions for use, these instruments have the ability to undergo several uses and sterilization cycles before they are discarded. The potential challenges are not lost on OEMs, who are seeking ways to design single-use instruments that are robust enough to retain critical properties if they are properly sterilized with gamma radiation, but visibly change in appearance if incorrectly sterilized using steam. Only specialty polymers combine the necessary mechanical properties, sterilization compatibility and colorability to achieve this goal. The performance and versatility of specialty polymers will continue drive new applications and growth in the healthcare industry. Expect to see a growing number of examples in which these advanced materials expand design freedom through their stronger mechanical and physical properties, improved chemical- and heatresistance and their compatibility with a broad range of sterilization techniques. Expect also to see them adopted in more and more applications that once relied on metal. In short, look forward to seeing specialty polymers open up entirely new and unexpected pathways to future growth in the medical polymers market. M

Veriflow Technologies case study available upon request

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MANUFACTURING

Many segments make up medical device manufacturing, including implantables, instruments and tools, additive and contract manufacturing and many others. The industry continues to innovate and grow at a rapid rate, and manufacturing plays a big part. Below are some common segments. Disposable devices have become a hot topic as the industry looks to manage infections. Onetime or temporary-use apparatuses cannot transmit infectious agents to subsequent patients. Examples of disposable devices include hypodermic needles, syringes, applicators, drug tests, suction catheters and surgical sponges. Plastics are often used in the manufacture of these devices. Minimally invasive devices refer to surgical techniques that limit the size of incision or involve short recovery times. When a medical device is placed with a patient during such a surgery, it is a minimally invasive device. Many procedures involve the use of arthroscopic or laparoscopic devices and remote-control manipulation of instruments with indirect observation through an endoscope or large display panel. The surgery is usually carried out through the skin or through a

small body cavity or anatomical opening and can involve a robot-assisted system. A common term in medical device manufacturing is contract manufacturing, which is a process that establishes a working agreement between two companies. As part of the agreement, one company custom-produces parts or other materials on behalf of the client company. In most cases, the manufacturer also handles ordering and shipment schedules. As a result, the client does not have to maintain manufacturing facilities, purchase raw materials, or hire labor to produce the finished products. Electromechanical (EM) is almost any single device with electrical and mechanical components. A trend in the design of a few EM devices is toward miniaturization, to make them as unobtrusive as possible, either for healthcare settings or as wearable units. Consider a particular AC-powered electric actuator that operates from 100 to 240 Vac. It comes with positioning electronics that are UL Listed, which means that device meets UL safety standards. The actuators combine a brushless servomotor with either rotary or linear actuation and digital position control. M

What are the best applications for 3D printing in the medical industry? Leslie Langnau | Managing Editor | Design World |

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Will 3D printing, also known as additive manufacturing, ever reach the stage where you can print transplantable organs? Doubtful, but ever-hopeful proponents say anything is possible. Until that day arrives, though, there are a number of medical uses in which 3D printing is making a large contribution. The most frequent use of 3D printing is in surgical situations where 3D printers are used to print a model of the body parts that will undergo surgery. MRI and CT scan data can easily be converted into a 3D-printable file. The printer then builds a threedimensional version of that data, delivering an accurate model of a body organ or section of a body. Surgeons can then examine that 3D model and plan the best surgical procedure. The 3D printing industry has many examples of this application. One is that of a young child

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who suffered from a double aortic arch heart malformation, in which a vascular ring wrapped around the trachea and esophagus, restricting airflow. A 3D-printed model of the childâ&#x20AC;&#x2122;s heart enhanced the planning phase so the surgical team could visualize exactly what steps to take to correct the malfunction. The benefits of preplanning surgeries this way are shorter surgery times and higher chances for successful outcomes. Increasingly, 3D printing is used to develop external support structures, such as those that reduce the weight of paraplegic exoskeletons or casts for broken bones. One innovative example is the BOOMcast to support broken limbs. It was 3D-printed with embedded electronics so that a doctor can monitor the limbâ&#x20AC;&#x2122;s physical state from anywhere in the world.

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MANUFACTURING

Multi-Axis Communications Just Got Simpler. 1 READY. Use our free SMI™ software to auto detect motors. 2 SET. Set CAN addresses and baud rate. 3 GO. Send commands; start talking.

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The BOOMcast is programmed to deliver medical information to a doctor, map pressure and audio data into LED lights that convey information to the patient – and, by the way, play music from a wireless cellphone connection. BOOMcast includes four force-sensitive resistors that record the contact pressure along the leg to indicate whether the healing bone has exceeded the doctor’s recommended load-bearing conditions. The 3D-printed body and ratcheting straps (made from FDM Nylon 12 for impact strength and durability) were built on additive manufacturing equipment including the Fortus 900mc and Objet500 Connex3 from Stratasys. The cast enables the patient to maintain an active, enjoyable lifestyle without compromising the healing process. Probably the third most popular use of 3D printing in medical applications is in implants. Primarily made of metal, such as titanium, implants are either permanent or semi-permanent. In some cases, the 3D-printed material serves as a scaffold to promote bone or tissue growth. Some material will eventually be

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absorbed by the body. In other cases, the implants replace bone removed by injury or surgery and provide structure or support. 3D printing is also a popular tool in the dental industry. It has been used to build custom braces for years and also helps dentists model teeth for crowns and other replacements. The use of 3D printing for limb prosthetics is popular, but not necessarily functional. Stories abound about high school students creating a hand or foot prosthesis for a friend. Such a design boosts confidence in the wearer and perhaps all the attention will encourage professional prosthetic developers to look into the use of 3D printing for some parts of their designs. While the 3D printing of organs is years away, the use of 3D printing to develop skin or other tissues for medical testing is gaining ground. It is possible to use stem cells in a special support suspension and 3D print tissue. Lastly, research is underway to use the ability of 3D printers to precisely deposit chemicals to create medical drugs. M

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ng.com

Is a single contract manufacturer the best option? Eric Sugalski | President | Smithwise |

For medical device startups, entering the manufacturing stage can be a daunting, frustrating and time-consuming process. Often, medical device startups will meet no-quotes or show stopping quotes from contract manufacturing organizations (CMOs) for their pilot builds. This is often due to the economic realities facing CMOs. It takes a significant amount of up-front time to identify the right suppliers, procure quotations and build manufacturing processes that result in high quality medical devices. This up-front time investment incurred by CMOs simply may not be justified by the downstream manufacturing revenues for a low-volume pilot build. For medical device startups, a “divide and conquer” strategy may be the most logical one for pilot builds. Although this puts more of the

supply chain and manufacturing responsibilities on the product engineering team, it also presents a number of advantages that should be considered. Gaining component supplier insights Medical devices are typically comprised of various plastics, electronics, metals and fasteners received from numerous suppliers. Component suppliers, such as injection molders and machine shops, are often willing to engage in low-volume production orders. In addition to their production collaborations, component suppliers are often willing to provide material samples and feedback on designs in order to optimize manufacturing processes. Implementing this supplier feedback can often drive down costs and improve quality of a new medical device.

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MANUFACTURING MaryAnn mpdo

Reducing supplier risks Many times there are one or several components within a new medical device that require specific expertise of a particular supplier. These may be optical components, precision sensors, reinforced catheters or other specialty components. When the success of a new medical device heavily relies on one specific supplier, it is typically known as “supplier risk” and can present a challenging scenario for a medical device company. These suppliers may drive pricing, bottleneck timing and cause other issues during production. In these cases, it’s valuable for a medical device company to have direct communications with the specialty component supplier to address issues real-time. Additionally, knowledge of this “supplier risk” may lead a medical device company to seek alternative suppliers as back-ups for the critical components that may exist.

Ready. Set. Commercialize! Web Industries is a leading CMO providing automated production of LFI devices, IVD components, and medical consumables at commercial-scale volumes. Specializing in new product commercialization, our one-stop outsource services include high-capacity automated manufacturing lines, in-house precision converting of exible medical components, and full material and supply chain management solutions. Web Industries knows what it takes to get medical diagnostic devices right every time.

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Lean assembly methods After components and suppliers have been identified, the pilot products still need to be assembled and packaged. Having developed the supply chain fully, vetted component suppliers through sample rush and constructed a comprehensive Bill of Materials, a medical device company may be well-positioned to collaborate with a small manufacturing facility that focuses primarily on assembly to get through the pilot build. Alternatively, the medical device startup may opt for more of a DIY manufacturing strategy for the pilot build. Not only can a “divide-andconquer” strategy accelerate transfer into manufacturing for a pilot build, it can provide the product engineering team valuable insight that improves quality, lowers costs, and reduces supplier risk. After successfully navigating the pilot build process, the team will be well positioned to engage in conversations with CMOs to scale-up. M

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How do additive manufacturing technologies lower medical product development barriers? Daniel Anderson | Director of Emerging Te c h n o l o g i e s | NN, Inc. Precision Engineered Products (PEP) Group |

Additive manufacturing (AM) – also known as 3D printing – technologies can produce parts directly from CAD models, often reducing costs and lead times while making it possible to produce complex geometries that would be difficult or impossible to reproduce even with the most sophisticated CNC equipment. These technologies are changing how products are designed and manufactured. Technologies like direct metal laser sintering (DMLS) that use high-powered lasers to essentially weld metal powder into parts offer appealing benefits to the medical device market. We all know time is money in one way or another. With conventional metal-removal technologies, design for manufacturability (DFM) can chew up a lot of time with little ROI if the design changes. Using DMLS, parts can be created in a short time with considerable complexity, which is especially useful during concept development phases. Direct metal technologies allow the creation of metal parts that

www.medicaldesignandoutsourcing.com

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may not be machined practically and can produce a concept model quickly that may actually be used in a cadaver lab or other demanding environments to prove the merit of a design. Furthermore, product development cycles often contain miscalculations that may put a person, activity or phase gate in jeopardy. DMLS has been used in many instances to quickly make parts to salvage a wide variety of situations. With conventional metal-removal techniques, it generally takes a long time to make complex parts, as increased planning, tooling and operations are required. DMLS is basically indifferent to complexity; it can produce a complex part nearly as easily as a simple one. More and more people are expanding their design parameters, knowing that DMLS can be used to make complex components, not only for concept development and prototyping, but into production as well. Single parts can be produced with DMLS that otherwise would have had to be comprised of multiple components. DMLS results in cost savings on several fronts. It often removes all welding requirements from products, eliminates multiple ops and even reduces risk, while limiting material waste. There are different advantages, disadvantages and considerations for different metal fabrication options, including DMLS. For example, a part machined from wrought may have more predictable mechanical properties, while a casting may be more applicable for certain part features or business goals. With DMLS, part geometry, strength requirements, grain structure, quantity and cost must be considered. To be most successful, it’s critical to partner with an experienced group for DMLS applications, one that uses machines dedicated to their respective materials and has validated equipment and materials. The progress that has been made with additive manufacturing technologies in material options, part consistency and properties is impressive. DMLS is not a silver bullet that will eliminate all other metal fabrication techniques, but it’s a valuable tool to have in the toolbox that has many applications and great continued potential in the medical industry. M 11 • 2016

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TUBING

Medical tubing meets standards and requirements for the medical industry. Typically used for drainage and fluid management, medical tubing can also be used in respiratory equipment, pumps, laboratory equipment and catheters. Tubing specific to medical applications has a designation achieved through certifications or standards. These ensure that the tubes are safe and reliable for drug manufacturing and patient care. The International Standards Organization

sets a series of standards, along with the FDA and other organizations. Medical tubing is created using a variety of materials. Specific to the application, materials are selected by performance properties. If a manufacturer is looking for flexibility, a rubber, metal or plastic material must be chosen to meet these requirements. It is imperative to select the right material. A number of issues can arise from selecting incompatible materials. M

What is co-extrusion tubing? To m M o o r e | Te c h n i c a l S a l e s Manager | Raumedic Inc. |

Co-extrusion presses two or more materials through a single die, resulting in one piece. It requires two or more extruders, each providing a pre-measured quantity of molten plastics for the end product. Co-extruded tubing serves many purposes in the medical market, particularly with medical devices. Co-extruded tubes can contain internally hardened tubes within a flexible tube-wires, coils and cables embedded in plastics â&#x20AC;&#x201C; or multi-colored and x-ray contrast striped tubes. Three distinct areas of co-extrusion include multi-layer extrusion, extruding wires and fibers within plastics tubing walls, and the coating/extrusion of plastics over wires. Multi-layer extrusion Co-extrusion in its simplest form is the ability to offer a tubing solution in which the inner and outer layers offer different functional advantages. Multilayer tubing offers a modern, effective, and practical solution for various medical applications. This tubing provides a design solution for medical systems which require the use of inert materials for drug delivery applications or bondable outer tubing layers. A major benefit of multi-layer extrusion is to manufacture tubing with as many as four different materials within a single tube. One result is that multilayer solutions can transform key material properties to create distinctly different materials. Typical applications for multi-layer extruded tubing include drug delivery, insulin delivery, angiography, and pain therapy. Micro multi-layer extrusions also are a rapidly growing application.

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The trend to minimally invasive surgery demands increasingly complicated catheters to treat patients with care. Also in diagnostics, miniature tubes are increasing in use due to sample quantities and in small sizes previously unavailable. Internal diameters for these products range down to 0.3 mm with external diameters of 0.6 mm. Co-extrusion of wires Within the medical device industry, many

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TUBING

products have traditionally required hand stringing wires, cables, and coils through multilumen tubing. That is an expensive practice. To address this, tubing extruders have developed the processing capability to co-extrude a wide variety of metal wires and glass fibers within the plastics tubing walls. Metals that can be contained in the tubing include copper, stainless steel, nitinol, platinum alloys, nickel, and silver plated wires. Polymers available for the tubing exteriors include polyurethane, silicone, polypropylene, polyethylene, nylon, and highperformance resins such as FEP, PEEK, PPSU, PEI and PTFE Moldflon. The co-extrusion of wires eliminates the need to hand string wires, cables, and coils through multi-lumen tubing. Co-extrusion of wires within tubing walls cuts fabrication costs, reduces scrap

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rates, and improves the ability to meet tight tolerances. Co-extruded tubing can accept wires that are embedded or wires that are loose enough to resist kinks. Typical applications are lead systems, cardiovascular catheters and PTFE liners. Wire coating Co-extrusion also encompasses wire coating in which wires, cables, and coils are extruded in-line within a thin polymeric layer, rather than the traditional coating process. Wires with a polymer layer thickness between 0.05mm to 0.1mm and up to 1mm are readily accommodated. In some cases, technology has extended that capability to 0.02-mm thick. With these extreme capabilities, the extruded layer protects the wire against corrosion and can

influence friction (higher or lower) and assist with electric insulation. An extruded wire coating also provides a consistent wall thickness, while allowing for a more continuous process with greatly reduced variation. Potential applications include neurovascular, lead systems, neuromodulation and cardiovascular. M

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What are the best applications for ultra-thin-wall heat-shrink tubing? Mark A. Saab | C h i e f Te c h n o l o g y Officer | Ve n t i o n M e d i c a l |

Ultra-thin-wall, medical-grade heat-shrink tubing is used in a variety of catheters and minimally invasive medical devices. Polyester (PET) heat-shrink tubing stands out from other heat-shrink tubing due to its ultra-thin walls, high strength and insulative properties. It is 10 to 100 times thinner than other heat-shrink tubing and more than 10 times stronger. Walls as thin as 0.00015 in. make PET heat-shrink tubing applicable to a wider range of product designs in which it is left on the product to add strength or insulation while adding little to the device dimensions. Following are key examples of these applications.

Variable-stiffness catheters Because of its ultra-thin walls, PET heat-shrink tubing can add stiffness to catheters without significantly adding to the device profile. By using different thicknesses of heat-shrink tubing along the length of the catheter, you can achieve varying degrees of flexibility. For example, you could use heat-shrink tubing with a one-mil wall at the back end of a catheter, a half-mil wall in the middle, a quarter-mil wall near the end, and none at the tip for full flexibility. Protective covering PET heat-shrink tubing is often used to cover laser-cut hypotubes, braided catheter shafts,

Innovative solutions engineered to your specific requirements.

Realize your vision with the most experienced and dedicated team in the industry. MicroLumen.com

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TUBING

of heat-shrink tubing over the end of the balloon to reinforce the bond and help to support the balloon bond during inflation. In braid-reinforced tubing, PET heat-shrink tubing can contain the braid at the end and prevent it from unraveling or poking through the thermoplastic layer. Tube marking and printing To add depth marks and printing to catheters and metal shafts, simply order custom-printed PET heat-shrink tubing and apply it to the product. This avoids sending the actual devices to a printer for labeling or bringing printing inks and solvents into the manufacturing facility for in-house printing.

spring coils, and other parts that require a thin but strong outer layer. The tubing provides a smooth transition over sharp edges and can be sealed against fluid leakage. Reinforcement With its high hoop strength, PET heat-shrink tubing offers effective reinforcement. For balloon catheters, you can apply a narrow band

Electrical insulation Because of its high dielectric strength, PET heat-shrink tubing is an effective electrical insulation material that adds little dimension because of its ultra-thin walls. For example, you can use it over needles to protect the skin from being burned during electrical stimulation, or to insulate electrosurgical devices, electrical components and wiring on catheters and other devices. These are just a few of the many applications that take advantage of the unique properties of PET heat-shrink tubing. The ultra-thin yet strong walls of this tubing make it an outstanding material for medical device designers looking for ways to make devices smaller and thinner so they can build in more features without increasing device profile. M

What are the key considerations for choosing a tubing compound? Peter M. Galland | Vinyl Division Industry Manager | R o s s Va n R o y e n | TPE Division Senior Market Manager | Te k n o r A p e x Company |

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Medical tubing manufacturers have a variety of compound options, ranging from flexible plastics to TPEs to natural and synthetic rubbers. The most widely used material by far is PVC, which for decades has been employed in numerous types of tubing. More recently, TPEs have emerged as promising candidates and are in successful use by tubing manufacturers. Teknor Apex offers TPE compounds alongside its broad range of PVC products for tubing. Flexible PVC compounds cost less than any current or proposed alternative material â&#x20AC;&#x201C; a critical advantage for high-volume items such as IV sets. Theyâ&#x20AC;&#x2122;re available in a broad range of durometers, from soft to semi-rigid, and can be bonded to virtually all of the plastics typically used for molded connectors. The crystal clarity of PVC is obviously of great practical value in clinical use. PVC can be sterilized with all standard methods. Special gamma-stable formulations exhibit minimal color changes following gamma irradiation. While generalpurpose PVC compounds provide strength and chemical

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resistance for a wide range of applications, compounds are available for tubing requiring high tensile strength, abrasion resistance or kink-resistance at low durometers. To make PVC flexible, phthalate esters, such as DEHP, have been the most widely used plasticizers for medical compounds. While issues have arisen concerning possible effects of these plasticizers on human health, there is no evidence that phthalates have had adverse health effects on humans after 50 years of use in medical devices. Nevertheless the issues have led some device manufacturers to consider PVC compounds containing alternative plasticizers. As a result, there are now multiple non-DEHP- and nonphthalate-plasticized PVC compounds on the market,

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including high-heat-stable products. Another plasticizer-related issue is stress cracking in rigid connectors caused by the migration of plasticizer to the interface with the rigid component. It is most pronounced in the case of amorphous rigid materials like polycarbonate. Over the years tubing manufacturers have avoided serious crazing issues through appropriate design and other measures; it’s now possible to minimize stress cracking by using specially formulated, stress-crackresistant rigid PVC compounds in place of polycarbonate or ABS for connectors. The newest rigid PVC compounds for connectors are specially formulated to provide strength comparable to polycarbonate or ABS, along with excellent clarity, while reducing or eliminating the stress cracking that often occurs. Gammaresistant grades are also available. Among the alternatives to PVC for tubing, there is now a range of TPE compounds that mirror the clarity, haptics, physical properties, kink- and clamp-resistance of PVC while exhibiting enhanced gamma stability and flexibility. Unlike silicone rubber, they provide the processing ease and design freedom of thermoplastics, while avoiding concerns about extractables and curing agents. Compared with silicones and TPUs, the new TPEs offer an economic advantage. Teknor Apex has developed TPE tubing formulations for use in a variety of medical assemblies. TPE tubing sets can be assembled using commercially available UV curable adhesives. In addition, a specialty-grade makes solvent bonding possible. Sterile TPE tubing welds are readily achievable using a Terumo welder or other comparable systems. In developing TPEs for tubing, Teknor Apex worked with medical industry experts, processors and equipment suppliers to ensure that downstream processes like hole-cutting, tipping and printing would not be an issue. In addition, the company drew on decades of experience as a supplier of PVC compounds for tubing. Today, Teknor Apex takes a “polymer-neutral” approach to the medical tubing market, helping customers to select the right compound to meet a particular performance or regulatory requirement. M

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CATHETERS

A medical catheter is a flexible tube inserted through a small opening that delivers or removes fluids, gases or medications into the body for healthcare applications. Catheters range from thin and flexible to thick and hard, depending on medical needs. As tubes, medical catheters are inserted into a blood vessel, duct or body cavity. Catheters can be plastic, rubber, silicone or latex, and can be permanent if a patient requires long-term care. They can also be disposable or multiple use. Once considered only for urine drainage, catheters do more than just treat urinary issues. For example, catheters have played pivotal roles in other applications, including stenting and the treatment of brain aneurysms, and will continue to evolve.

A balloon catheter incorporates a small balloon that may be introduced into a canal, duct or blood vessel and then inflated to clear an obstruction or dilate a narrowed region to drain body fluids. Drugcoated catheters are design to deliver anti-restenosis compounds like those used in drug-eluting stents. A guidewire is a wire or spring that provides extra strength and stability during catheter placement and exchange during contralateral access and in carotid procedures involving the two main arteries that carry blood to the head and neck. A guidewire also aids in catheter delivery. Lastly, a stent is a wire mesh tube intended to prop open an artery. When made for stainless steel or nitinol, stents are intended to be permanent. Some stents are made of polymers designed to dissolve over a period of months. M

Balloon catheters: What are some key design considerations? Katie Karmelek | Product Manager | Ve n t i o n M e d i c a l |

Balloon catheters are used in a wide range of minimally invasive diagnostic and therapeutic procedures, including dilating vessels, opening blockages, delivering stents, and more. There are many factors to consider when designing a balloon catheter, including the application, type of balloon, type of catheter, and device performance requirements. Applications The application for which the catheter will be used is the primary driver of catheter design. Common applications for balloon catheters include: • • • • • • • •

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Renal denervation Cryoablation Balloon sinuplasty Transcatheter aortic valve implantation (TAVI) Drug delivery Stent delivery Balloon occlusion Balloon angioplasty

• • • •

Esophageal dilation Atherectomy Balloon carpal tunnelplasty Kyphoplasty

Balloon types There are three main types of balloons: • Noncompliant (high-pressure) balloons are typically made of polyester or nylon. They’re used for applications in which the balloon needs to expand to a specific diameter and exert high pressure to open a blockage or dilate the vasculature. • Semicompliant (midpressure) balloons are commonly made of Pebax or higherdurometer polyurethanes. They’re used in applications in which you need mid-high pressures but want more compliance than a noncompliant balloon and more flexibility to ease delivery. • Compliant (elastomeric) balloons are typically made of polyurethane or silicone. They are inflated by volume, rather than pressure. Able to stretch 100% to 800%, they are often used in applications that require the balloon to fully conform to or occlude the anatomy.

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FAULHABER IER3 Ultra Precise 3 Channel Optical Encoders Catheter types Most balloon catheters require support to achieve the column strength needed to insert and advance the catheter into position. There are three common types of catheter designs: • Over-the-wire (OTW) balloon catheters feature a guidewire that tracks along the full length of the catheter. • Rapid exchange (RX) balloon catheters have a guidewire along only a short section (about 25cm), saving time compared with advancing a guidewire through the full length of the catheter. • Fixed-wire (FW) balloon catheters have a wire core built inside the catheter, eliminating the need for a guidewire to advance the catheter to the treatment site.

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Performance requirements While there are many performance characteristics to consider in a catheter design, some key properties include the following: • Inflation/deflation is the time it takes to inflate and deflate a balloon. To minimize this time, design the catheter to maximize the cross sectional area of the inflation lumen. • Trackability is the catheter’s ability to advance through the anatomy to reach the treatment site. This is especially important for tortuous anatomy, such as in neurological applications. • Insertion profile is the space needed to insert the catheter into the

• Two channel quadrature signals and an additional index signal

anatomy. The the with insertion • FAULHABER motors cansmaller be positioned accuracy of 0.1 to 0.3 degrees profile, the smaller with the new optical encoder the incision site, patient’s healing • Opto which reflectiveexpedites system as a the single-chip solution

and recovery • Highest resolution in itsprocess. class (up to 10,000 lines per revolution) • Angular resolution of 0.0009 degrees with the evaluation of 40,000 edges per revolution

• These Combineperformance with FAULHABERcharacteristics coreless DC motorsare and brushless DC motors as well as other often interrelated. For example, canMotion Controllers V3.0 FAULHABER motion technologies, includingyou the new

minimize inflation and deflation rates by increasing the diameter of the tubing. However, this also increases the catheter’s insertion profile. The wide range of design considerations for balloon catheters can be can be daunting. An experienced contract manufacturing organization that specializes in the design, development, and manufacturing of balloon catheters can help guide you through the process of bringing your innovative technology to market. M

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MOLDING

Overmolding is the process of adding an additional layer of material over an already existing piece or part. For chemical attachment, the initial part is coated with adhesives before adding the overmolding material. For mechanical attachment, the primary piece is either scored or altered slightly with projections or recessions to better attach to the overmolding material. The final result is a single part that fulfills a custom function. This process is ideal for simplifying your end product design and decreasing the chance of moving parts breaking. The options that overmolding creates are extensive and can change the surface of a piece or product part by adding texture, color and incorporating necessary functionality components for the specific consumer. Consider that the overmolding process can make a surface smooth or spongy, in nearly any

color for branding and organization, to smooth out the corners of sharp metal instruments, and to protect parts from chemical exposure. Medical instruments might feature overmolding to improve ease-of-use for the physician or technician. Handles on instruments may need to be thicker than the internal metal structure for proper handling, or have a specific shape on the outer handling surface for ease-of-use or for connection into another instrument. Overmolding might also help streamline products by reducing the necessity for rings and sealing fixtures. By overmolding, the sealing ring can be directly incorporated and adhered to the part, reducing the number of overall pieces required in the final product. The rubberized plastic seal can be directly affixed to the part, ensuring a clean and leak free junction. M

How should I think about insert molding in medical devices? Justin Strike | Program Manager | Sil-Pro |

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Does your device have sufficient mechanical interfacing to meet performance requirements? Can plasma or corona treatments enhance product performance? Will mechanical surface prepping, chemical adhesion or a combination of both processes be necessary for your product? Overmolding or insert molding is ideal for projects with complex final molded component designs. Overmolding offers extended functionality and aesthetic enhancements that can differentiate your products from the competition. In medical devices, overmolding adds complexity and development time to new products. There is often an increase in up-front tooling costs and handling steps, but overmolding can be a more favorable solution with minimal impact to overall price. Overmolding is defined as the placing of a previously formed component (molded, machined, extruded, etc.) into an injection molding tool and the process to form a composite part assembly once both parts are removed from the mold. The forming methods for the inserts in overmolding applications are limitless. Typical overmolding uses machined metal, injection molded components or extruded components. Molders use many different materials for several different applications such as radioopaque inserts in silicone, glass-filled nylon

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over stainless-steel inserts, silicone over PEEK, polyurethanes over PC, silicone on PC and silicone over silicone. There are requirements to consider when identifying the materials and method of manufacture for the insert of an overmolded product. The requirements are defined by the secondary material and molding processes. These requirements include temperature of tool, structural deformation around shut-offs and deformation from secondary material shrink. Several bonding methods are less costly to develop but they each have their own challenges. Adhesive bonding often results in a compromise of aesthetic control versus quality of bond. Sonic welding can limit your choice of materials and restrict design

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SMARTER TOOLS START WITH SMALLER PARTS. RING AND SPRING SIZES NOW* DOWN TO 0.165" (4 MM) FOR NEW POSSIBILITIES IN MEDICAL DESIGN. Today’s complex medical devices demand precision components that offer high performance in extraordinarily small sizes. Using materials ranging from surgical 316 Stainless Steel to implantable Titanium, Smalley engineers create wave springs and retaining rings below 0.2"—and that’s just the start. Challenge us to go even smaller on your next design. Visit smalley.com/medical for 316 stainless samples to test in your next application.

Ask Smalley. Our world-class engineering team has deep experience helping medical equipment designers. Look to us for free technical consultation, downloadable CAD models or no-charge samples for evaluation and prototyping.

THE ENGINEER’S CHOICE™ * Small part manufacturing requires close collaboration when determining design criteria. Please consult Smalley on your next application.

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MOLDING

options. Bonding or sonic welding of silicone or soft/flexible polymers is very difficult to achieve. Overmolding with silicone or flexible thermoplastic materials is much more common. When designing for an overmold solution itâ&#x20AC;&#x2122;s important to understand that the second-shot steel does not move, so the shut-off surfaces of the first shot will need to be repeatable. For a successful overmold, you may need to design the second-shot tool and process first. Items to consider are the second-shot material, shut-off surfaces, areas of flash and gate location. There are benefits to increasing the surface area contact of the second materialâ&#x20AC;&#x2122;s flow

to minimize the steel-to-part interface. All surfaces should be clean and free of debris and chemicals. Cleaning with isopropyl alcohol (IPA) can enhance the overmolding process resulting in a repeatable bond. Other treatments such as media blasting, corona, plasma and priming have also proven effective in the cleaning process. Overmolding can add complexity to development, but it can be overcome with proper tooling and design. The proper selection of materials, gate locations, shut-offs and locating features in the second-shot tool design can help reduce the impact of variation of the first shot and reduce the variable stack up that delays product development. M

Can I use overmolding in prototypes? Becky Cater | Product Manager | ProtoLabs |

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Overmolding is the process of molding two or more materials together to create a single part. The process is used in medical devices, for example, to create soft-touch grip handles for surgical instruments. The technology can improve functionality and comfort for users. Overmolding can also be used to mold multiple colors on a given product for aesthetics or branding. One benefit of overmolding is that it eliminates manufacturing costs by removing the need for a secondary assembly step. If you need to have two or more materials molded together, overmolding is a good option to consider. The process of designing an overmolded part is very much like designing any other injectionmolded

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part. In order to produce a good over-molded part, you need to follow general molding guidelines, such as making sure to add sufficient draft to vertical surfaces so the part can be ejected from the mold. You also need to pay close attention to thick areas to avoid sink and watch out for thin areas that may make the part difficult to fill. An additional consideration for overmolding is ensuring that the design has adequate shut-off between the overmold and the substrate, in order to minimize potential for flashing. Overmolding typically uses an elastomeric material as the overmold and those tend to be more likely to flash, so it's a bigger consideration for overmolding than it is for general injection molding. Historically there have been very few options for cost-effective prototyping or low-volume production of overmolded parts. Typically what engineers have to do during prototyping is separately produce the substrate and overmold parts then use a secondary method such as adhesive or fasteners to join them together for testing purposes. They might also rely on urethane casting using RTV or silicone molds as an alternative.

www.medicaldesignandoutsourcing.com

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Plastic Part Validation Have You Buried? Let PTI Engineered Plastics Dig You Out. In this age of high-tech manufacturing, quality requirements have never been tougher. Thatâ&#x20AC;&#x2122;s why PTI Engineered Plastics has built their operations to support validations throughout their manufacturing and assembly processes. Our team is highly trained to define and implement all facets of IQ, OQ, PQ protocol validations, including many other quality standards required in the plastic injection molding industry.

To learn more, call 586.263.5100 or visit teampti.com Prototype | Design | Engineering | 3D CAD Modeling | Tooling | Molding | Manufacturing | Cleanroom Molding

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MOLDING

Although these methods give the engineer a general idea of how well the finished products will perform, the only way to truly validate the properties and functional performance of an overmolded part is to produce the prototype in the actual material and production method using rapid overmolding. With the introduction of rapid overmolding engineers can now resolve potential manufacturing issues much earlier in their product development process, and they can minimize the risk of unpleasant surprises down the road. In the past, designers needed to have tens of thousands or hundreds of thousands of parts in order for overmolding to be a feasible manufacturing option. But e-commerce practices and companies willing to focus on low-volume production have changed that.

For example, ProtoLabs has its clients upload CAD files via its website, using software automation that helps accelerate the frontend experience. It enables us to analyze parts very quickly and get our quotes turned around within a few hours, complete with manufacturability feedback. Because everything is automated, once the customer finalizes their order, everything flows through the system and ProtoLabs starts making that mold immediately. Software automation allows us to really speed up the process and also keep costs down, making overmolding for prototypes and lowvolume production a possibility. Designers can have finished overmolded parts in-hand in 15 business days or less, and companies can order as few as 25 and up to tens of thousands of parts. Engineers and designers now have easy access to overmolding so they can experiment with the process in a cost effective manner. M

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For more information, visit cpcworldwide.com/medical. Š2016 Colder Products Company

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What is micro molding? MTD Micro Molding |

When it comes to defining micromolding, size is not everything, but it is a good place to start. It starts with a part that has features you cannot see with the naked eye. You need a microscope to see the feature(s) and the fine detail. A precise mold is the first building block to any successful micromolding project. The smaller parts get, the more difficult this becomes – there’s less error that can be tolerated in a mold. The Qualifiers 1" x 1"

1.

Does your part fit in here?

2.

Does your design require one or more of these features? .004"

R.001"

Ø.002"

R.0002"

WALLS

EDGES/CORNERS

HOLES

RADII

(.102mm)

3.

APPROX. MAX PART SIZE

(.025mm)

(.051mm)

Have other molders said “No” to your designs? Come talk to

(5µ)

.

“The 1-Inch Rule” The high majority of micromolding applies to parts that fit into the 1” footprint, where a small percentage are parts that have a need for precision but may fall outside of that 1” box. Micro Features Does your design have wall stocks in the range of .002” to .004”? Does it have aspect ratios in the range of 250:1?

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Is your part weight so low that you can make 520 parts from a single pellet of plastic? All of these features can be accomplished with micromolding and are generally recognized by the industry as being micro and requiring specialized tools. Something to remember is that a part does not need to be microscopic to be considered a micro part. This has been proven to be one of the greatest myths of the micromolding industry. In many instances, micro features on a part you can see with the naked eye require more specialized tools and techniques than what’s required to create a microscopic part with simple geometry. Some of the most difficult parts to manufacture are larger parts with micro features. 6 Sciences of Micromolding 1. Micro Materials – Thorough knowledge of the material, whether it be Polypropylene, PEEK or a Resorbable material, is absolutely essential to success. 2. Micro Design – Understanding and knowing what can be tooled up vs. what can be manufactured in production volume is the key to being successful. In a simple word: “reproducibility”. 3. Micro Tooling – In-house micro tooling helps clients who are seeking high resolution features as devices and components are miniaturized. The mold is definitely the enabler to produce highly unique and precise components. 4. Micro Molding – Micromolding is not molding small parts with macro-molding techniques and tools. 5. Micro Metrology - Microsized parts do not lend themselves to “touching”, whether by a probe or by hand, so all measurements must be made by highly sensitive optical systems. 6. Micro Packaging – Similar to metrology, handling and assembling or packaging microsized parts is far more challenging, and the solutions are definitely different than those employed in making macro-sized parts. M

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MOTION CONTROL COMPONENTS

The following Motion control section will introduce readers to gearheads, linear motor, linear actuators, and a discussion of brushed and brushless motors. Of course, there are many more motion control components, but these provide a good introduction and a few of the essential building blocks of a mechanical system. Who should read these sections? Certainly those new to the topics and new to the design field and then, because they are mostly mechanical topics, those who spend most of their time dealing with electrical design issues. For example, in the gearhead section, the author reveals that a gearhead is a speed reducer or torque increaser for an electric motor. In medical applications, the motor is often small with low torque but turns a shaft at a high speed. Making those fractional inch-ounces do something useful requires trading shaft speed for sufficient torque that will move a necessary machine element. EEs might appreciate the pros and cons of spur gears versus helical gears when such a selection becomes their responsibility. In the linear motor section, readers will learn

that moving a machine component does not always call for a motor and ball screw. The action can be done with good accuracy by positioning a magnet with electrical signals. Of course the use of a linear motor will require a design study to weigh its advantages against those of a simpler system using a motor, gearhead, and other machine elements. Because motion is such a common requirement for any machine, self-contained linear actuators are available in a wide range of sizes. These are often called electric cylinders because they include a motor, ball screw or similar device, switches to limit a rod’s extension, and all housed to simplify mounting and wiring. The article on electric cylinders provides selection suggestions. Lastly, we consider the case for brushed versus brushless motors. A lot more happens in these fields than we report on here. Needless to say, the medical field and the related topics in this handbook change quickly. New products are introduced at a near bewildering pace. So, to stay up-to-date, it’s a good idea to frequently scan the recent posts to medicaldesignandoutsourcing.com. M

What are the pros and cons of dc brush and brushless motors? Micromo, a division of Faulhaber |

One advantage of dc motors is the linear relationship that allows for predictable operation. For instance under cold conditions, the torque constant KM is the approximate motor torque production per ampere of current (In metric units: mNm/A). This is also true under warm conditions, but the thermodynamic effects on the torque constant and motor performance are beyond the scope of this paper. So, plotting current versus torque for a brush or brushless motor demonstrates this directly proportional relationship. When the torque demand M increases, so does the current I. Without neglecting the friction torque MR the equation is divided by the torque constant as shown:

I = (M + MR) / KM)

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Also, if we apply enough voltage across the terminals of a dc motor and the output shaft spins at a rate proportional to the applied voltage. We first calculate the back-EMF constant KE from the torque constant KM:

KE = KM * (2π / 60) We then can subtract the product of the current I and terminal resistance R from the applied voltage Ua and multiply that quantity by 1,000 over the back-EMF constant KE to obtain the approximate speed n of the motor at the operating point (speed at torque) mathematically, like so:

n = (Ua - I * R) * (1,000 / KE)

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MOTION CONTROL COMPONENTS

Despite this simple relationship, selecting a dc motor for an application can still be a daunting task. There are other variables to consider including dimensions, load, duty cycle, environment, and feedback considerations. When an application requires high speed, a quiet operation, low EMI, and longevity, consider brushless dc motors (BLDC). There are many advantages to brushless motor technology and speed is just one. Higher rotational velocity is possible with brushless because there are no mechanical limitations imposed by brush and commutator system. Brushless motors also eliminate unwanted current arcing, an issue that could lead to electro-erosion or micro-welding. Both are often observed when precious metal brush motors are overdriven beyond their rated specifications. BLDC motors often possess higher efficiency, and normally generate less electromagnetic interference or EMI. This can be beneficial for EMI sensitive applications. Because the stator is constituted by the motor coil, the superior thermal characteristics of BLDC over brush motors make it a great choice for applications that demand high torque. With the stator in close proximity to the case, heat dissipation is more efficient (especially with a heat sink). As a result, little maintenance is required on a brushless motor. On the downside, BLDCs often cost more than the DC brush variety. It is possible to spend twice as much on a brushless system while at the same time sacrificing the simplicity of a brush commutated motor. In addition, control and drive electronics are required to properly commutate and drive BLDC motors. One may have to reserve additional space in their application for controls and drive electronics. This is only true when the drive electronics are not integrated into the motor, but it often is the case. Whether you implement brush or brushless, another item that

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1. Rear cover

7. Washer

2. Lead wires

8. Spring

3. Electronics

9. Magnet

4. Housing

10. External rotor

5. Coil

11. Shaft

6. Ball bearing

12. Front cover

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must be taken into consideration is the length of the motorsâ&#x20AC;&#x2122; leads that supply power and feedback. Long cable runs tend to introduce EMI into the system, so one may have to compensate by implementing shielded-twisted pair to bleed off noise. As previously mentioned, motors must overcome starting friction MR as well. This term includes both static and dynamic friction. Static friction C0 is the sum of torque losses not dependent on speed. For a coreless brush motor, that friction is simply:

MR = C0 But for brushless motors, that term must include the dynamic friction term CV multiplied by the speed n:

MR = C0 + nCV Dynamic friction is different from its static counterpart. It is essentially zero on coreless brush motors, but becomes a factor for brushless motors at high speed. Dynamic friction (In metric units: mNm/rpm), which is sometimes referred to as the viscous dampening term, is the only factor defining torque losses in proportion with speed. The term includes losses due to the viscous friction of the ball bearings, as well as eddy currents induced by the changing magnetic field in accordance with Faradayâ&#x20AC;&#x2122;s law of induction. Overall, expect the speed-torque curve to demonstrate excellent linearity for both brush and BLDC technology. Choosing the right motor for an application can make the difference between a successful development effort and a headache. Consider both cost and performance before making a selection. These are always application dependent for all motion control projects. M

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Maxon Precision Motors Inc. |

Comparing spur versus planetary gearheads

The two most common and readily available gearhead designs are the spur and planetary versions. Each has benefits and drawbacks depending on the particular application. Spur gearheads are designed in such a way that two gears (a single stage) work together to increase the torque potential of the driving motor. Each gear in the train of a spur gearhead bears the entire torque load. Therefore, these gearheads are used where lower torques are specified. Backlash is also a common concern when using a gearhead. Backlash depends on the shape and accuracy of the gear teeth and the accuracy of the gear wheel mounting arrangement. The same goes for efficiency. The interplay between these two—backlash and efficiency—is that an increase in mechanical play between gears is good for efficiency and bad for backlash. In general, spur gearheads are the simpler and least expensive of the two units.

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Planetary gearheads are more complex in design. The input shaft drives a central (sun) gear, which then turns the surrounding (planet) gears. This arrangement lets each planet gear deliver torque in perfect synchronization with the others. Planetary gearheads share their torque load over multiple ‘planet’ gears, which leads to greater torque output capacity, and takes the pressure off of each individual gear. Both types of gearhead are made from a variety of metals and plastics, including brass, steel, nickel-steel, and other alloys. Important design factors include the size of the gears and the number of teeth on each of those gears. This determines the gear ratios for output torque and the shaft speed. With proper machining, it is possible to attain the same backlash from both spur and planetary gearheads. For standard gears, backlash ranges from 1° to 2°. Planetary and spur gearheads can provide up to 90% efficiency for a single stage

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MOTION CONTROL COMPONENTS

unit. (All gearheads can include multiple stages, but that approach also adds to the length of the device.) Reduction ratios for both spur and planetary gearheads range from near unity up to several thousand to one. Generally, spur gearheads are quieter than planetary gearheads. On all gearheads, noise increases at higher speeds, but note that noise is a function of tooth shape, the interaction of the teeth, and the material used. Steel-cut gears are the most durable, making them ideal for high-torque applications, while porous sintered gearwheels are better at holding lubricants. (Lubrication is a factor when service life is a consideration.) Most often, the selection of which gearhead type to use relates to the torque capability of the gearhead, while the selection of the reduction ratio primarily relates to the input speed limit required for the application. Whether spur or planetary, speed depends mostly on what the device is designed for. Tooth shape design is an optimization and compromising process, which affects speed, torque, efficiency, and backlash, as well as noise levelâ&#x20AC;&#x201D;and all combinations of these factors.

M

What are linear actuators and how are they sized? Jim Mangan | Vice President Sales | Nook Industries |

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Linear actuators provide important functions to a range of medical devices such as medical beds, operating tables, and dental chairs. A linear actuator is a mechanical device that converts energy to create straight-line motion to either lift, tilt, or move mechanical legs in and out, depending on the application. The basic components of linear actuators consist of a motor, set of gears, and a screw.

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Linear actuators are driven by either ball screws or acme screws. However, ball screw-driven actuators are often not chosen for medical applications because of their need for brakes. Instead, most medical-equipment designers prefer acme screws for their ability to carry large loads at low speeds without requiring the installation of brakes. Linear actuators can be operated by either a footswitch or handheld pendant, depending on the application.

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Unlike other industries, designers of medical equipment using linear actuators must pay special attention to the human factor of the equipment. For example, linear actuators operate at a low voltage, typically between 12 and 36V. Linear actuators operate at low speeds to ensure a patient is not jostled or at risk of falling. Actuators are also designed to perform at lower sound volumes, usually less than 28 decibels, so the noise does not disturb the patient. Because of these applications, accuracy is not a major concern. Their equipment’s primary function is to safely move patients so a doctor can easily observe them. Consider these several steps when selecting a linear actuator for medical equipment:

Load First, find the required load capacity. This depends on the size of the apparatus. Load capacity for a single actuator can be anywhere from 100 to 9,000 Newtons. Medical beds for example, are intended to assist in the lifting of patients that may be too heavy for one nurse, so the designer must consider the amount of weight that will be resting on the machine. Speed Next, choose an actuation speed, which is given in either inches-per-second or inches-per-minute. While actuators come in a wide range of speeds, medical designers might choose a lower speed that will not require a braking system.

Voltage After determining the speed, choose an operating voltage. Low voltage devices may be preferable because higher voltages put patients at risk for electrical shock. Dimensions Finally, calculate the necessary dimensional space in which the machine will fit so the actuator fits and operates smoothly. Beyond their versatility, linear actuators hold a number of other benefits. For example, depending on the version, engineers often report that linear actuators are durable, self-contained, cost-effective, and reusable. M

Power Management ICs

Ultra-Low Power Consumption, Ultra-Small Packages Voltage Voltage Detectors Detectors

Low Dropout Linear Regulators

Step-Down(Buck) DC/DC Converters

Step-Up(Boost)DC/DC Converters

IXD5118 schematic

IXD1233 schematic

IXD3235 Schematic

IXD2135 schematic

IXD5118 Features

• Operating voltage range: 1V-6V • Detect voltage range: 0.8V-5V (0.1V increments) • Accuracy ±2% at Detect Voltage ≥ 1.5V • Detect voltage temperature drift: ±100 ppm/°C • Low power consumption: 0.4µA (detect at VIN = 1V) 0.6µA (release at VIN=1V) • Output configuration: CMOS or open drain • Adjustable release time • Packages: SOT-25, USP-4

Part Number

Accuracy(%)

IXD5118 IXD5120 IXD5121-24 IXD5126 IXD5127

± 2.0 ± 2.0 ± 2.0 ± 0.8 ± 0.8

IXD1233 Features

• Operating voltage range: 1.7V-5.5V • Output voltage range: 1.2V-3.6V (0.05V increments) • Output current up to 200mA • Dropout voltage: 240mV at 200mA • Output voltage accuracy: ±1% • Ripple rejection: 75dB at 1kHz • Stable with low ESR ceramic capacitor at output • Standby current less than 0.1µA (typical) • Current limit and short circuit protection • Packages: SOT-25, SSOT-24, USP-4 Current Consumption, (detect/release)(µA) 0.4/0.6 0.6/1.7 0.4/0.6 0.6/1.3 0.6/0.7

IXD3235 Features

• Integrated low resistance N- and P-Channel MOSFETs • Input voltage range: 1.8V-6V • Output voltage range: 0.8V-4V (internally set) 0.9V-6V (externally set) • Maximum output current: 600mA • Switching frequency: 1.2MHz, 3MHz • High efficiency: 92% • Packages: SOT-25, USP-6C, USP-6EL, WLP-5-03

Detect Voltage Range (V) 0.8 – 5.0 0.7 – 5.0 1.0 – 6.0 1.5 – 5.5 1.5 – 5.5

Output Configuration CMOS Open Drain Yes Yes Yes Yes No Yes Yes Yes Yes Yes

IXD2135 Features

• Input voltage range: 0.65V-6.5V • Output voltage range: 1.8V-5V (0.1V increments) • Integrated on-chip 0.2Ω N- and P-Channel MOSFETs • Output voltage accuracy: ±2% • Switching frequency: 1.2MHz ± 15% • PWM/PFM mode auto selection • Under voltage lockout (UVLO) and soft start • Overcurrent limit and thermal shutdown • Package: USP-10B

Additional Features Separated SENSE input, adjustable release time USP-3 ultra-small package: 1.2 x 1.2 x 0.6mm Watchdog, preprogrammed release time USPN-4B02 ultra-small package: 0.95 x 0.75 x 0.38mm Preprogrammed release time, manual reset

For more information about Power Management ICs, or to download product collateral, visit www.zilog.com Design With Freedom

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MOTION CONTROL COMPONENTS

Types of linear motors The following was excerpted from Aerotechâ&#x20AC;&#x2122;s Linear Motors Application Guide, which is available for free download from the Aerotech website. A linear motor can be flat, U-channel, or tubular in shape. The configuration that is most appropriate for a particular application depends on the specifications and operating environment. Cylindrical moving magnet linear motors In these motors, the forcer is cylindrical and moves up and down a cylindrical bar that houses the magnets. These motors were among the first to find commercial application, but do not exploit all of the space saving characteristics of their flat and U-channel counterparts. The magnetic circuit is similar to that of a moving magnet actuator. The difference is that the coils are replicated to increase the stroke. The coil winding typically consists of three phases, with brushless commutation using Hall effect devices. The forcer is circular and moves up and down the magnetic rod. This rod is not suitable for applications sensitive to the leakage of magnetic flux. Because the motor is completely circular and travels up and down the rod, the only points of support are at the ends. This means that there will always be a limit to length before the deflection in the bar causes the magnets to contact the forcer. U-channel linear motor The U-channel linear motor has two parallel magnet tracks facing each other with the forcer between the plates. The forcer is supported in the magnet track by a bearing system. The forcers are ironless, which means there is no attractive force and no disturbance forces generated between forcer and magnet track. The ironless coil assembly has low mass, allowing for very high acceleration. Typically the coil winding is three phase, with brushless commutation. Increased performance can be achieved by adding air-cooling. This design is better suited to reduced magnetic flux leakage due to the magnets facing each other and being housed in a U-shaped channel. Due to the design of the magnet track, they can be added together to increase the length of travel, with the only limit being the length of the cable management 56

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system, encoder length available, and the ability to machine large, flat structures. Flat-type linear motors There are three designs of these motors: slotless ironless, slotless iron, and slotted iron. Again, all types are brushless. To choose between these types of motors requires an understanding of the application. Slotless-ironless flat motors The slotless-ironless flat motor consists of a series of coils mounted to an aluminum base. Due to the lack of iron in the forcer, the motor has no attractive force or cogging, which helps with bearing life in certain applications. Forcers can be mounted from the top or sides to suit most applications. Ideal for smooth velocity control such as scanning applications, this type of design yields the lowest force output of flat-track designs. Generally, flat magnet tracks have high magnetic flux leakage. Slotless-iron flat motors The slotless-iron flat motor is similar in construction to the slotless-ironless motor except the coils are mounted to iron laminations and then to the aluminum base. Iron laminations are used to direct the magnetic field and increase the force. Due to the iron laminations, an attractive force is now present between the forcer and the track and is proportional to the force produced by the motor. As a result of the laminations, a cogging force is now present on the motor. This motor design produces more force than the ironless designs. Slotted-iron flat motors In this type of linear motor, the coil windings are inserted into a steel structure to create the coil assembly. The iron core significantly increases the force output of the motor due to focusing the magnetic field created by the winding. There is a strong attractive force between the iron-core armature and the magnet track, which can be used advantageously as a preload for an air-bearing system. However, these forces can also cause increased bearing wear at the same time. There will also be cogging forces, which can be reduced by skewing the magnets. M

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Design with the power of small.

The finest miniature encoders for the most demanding spaces. Renishaw offers class-leading position encoders for precision motion control the world over. With their exceedingly small dimensions and lightweight design this family of high performance sensors are ideal for applications with tight spaces and even tighter tolerances. ■

ATOM—The world’s first high precision, miniature optical encoder with filtering optics 20.5 x 12.7 x 6.7 mm RLC—PCB-level magnetic position encoder designed for high volume, low cost OEM integration

Fits almost any linear or rotary feedback design you can imagine

20 x 13.5 x 3.3 mm

Available in PCB-ready configuration or as stand-alone cabled option

RLB—A PCB-level magnetic encoder designed for high volume low cost OEM integrations with added flex cable option

Powerful magnetic and optical scale technology for uncompromising accuracy Exceptional dirt immunity and the highest signal stability

Explore the wide range of options, configurations and applications at:

www.renishaw.com/encoders

8 x 3.3 x 14 mm RoLin—An environmentally hardened, packaged miniature magnetic encoder for OEM system integration 12 x 8.5 x 5 mm

Renishaw Inc Hoffman Estates, IL www.renishaw.com

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FLUID POWER COMPONENTS

What are ways to maximize supplier value when sourcing seals for medical devices? Colin Macqueen Director Te c h n o l o g y Tr e l l e b o r g S e a l i n g Solutions

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Today’s medical devices require seals to contain fluids, exclude contaminants, protect electronics, and assist in metering doses of medication. It’s common for manufacturers to complete the design of a device, including the seals, and then seek several competing quotes to find the best possible price for the seals. But this might not be the best approach to using the seal supplier’s full capabilities when developing an optimal sealing solution.

supplier involvement in the design process allows for a better understanding of the entire tolerance scheme and a more reliable system. For example, instead of requiring tight tolerances on the plastic case of an insulin infusion pump and sealing it with an O-Ring or thin gasket, a taller gasket design will be self-retaining in the housing and accept a greater out-of-flatness on the plastic parts, thus reducing total cost.

Tolerancing If everything fitted perfectly in a static application, it is quite possible that no seals would be required. But things don’t always fit perfectly, which makes seals necessary. In addition, the right tolerances make the seal work. Early seal

Assembly The miniaturization of devices leads to the adoption of smaller seals which are harder to consistently install. For example, a recent request was for an improved gasket design on a battery pack for a cordless surgical hand piece. By replacing the homogeneous elastomer parts with a metal form carrying an edge-bonded elastomer gasket, the customer easily handled the rigid gasket and assembled it more accurately every time.

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Design for manufacture Liquid silicone rubber (LSR) has become a leading option for medical device sealing, due to its cleanliness, inertness, and capability to form complex, detailed shapes. An early consultation with the seal supplier’s engineering team can avoid overly complex manufacturing challenges and use the full potential of LSR. Allowance for mold-parting lines, features to aid in robotic demolding, avoidance of deep undercuts and other such details are best considered at the beginning of the design process.

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Reduced complexity Seals often form part of a sub-assembly prior to final device assembly. A capable seal supplier, especially one that produces rubber and plastic parts, can produce the whole sub-assembly and in many cases reduce the number of parts required by producing a single, co-molded component. For example, two-shot manufacturing can produce a nylon syringe pump piston with an LSR seal in a single molding operation and a single tool. This reduces:

Ergonomics As patients use more medical devices, it is vital to make them as easy-to-use and as foolproof as possible. For example, we recently worked closely with a supplier of an infusion pump for treatment of chronic disease. To ensure simple and secure tubing connections, the conventional EPDM O-Ring is now supplied with a friction-reducing ISO 10993/USP 1031-compliant coating that reduces insertion force and eliminates the risk of incorrect or incomplete connections.

• Tolerance stack-up and hence variation in friction • Additional handling steps • Potential leak paths • Potential failure modes due to misassembly

In summary Seals are critical elements in many medical devices and working with a supply partner who goes beyond “make-to-print” can truly pay dividends in the long run. M

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NEEDLES & SYRINGES

What is endoscopic ultrasound-guided fine needle aspiration?

Rich Lessig Product Manager EndoTherapy Olympus Corporation of the Americas

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First introduced in the early 1990s, endoscopic ultrasoundguided fine needle aspiration (EUS-FNA) has become increasingly widespread as a sampling technique for extracting tissue or cell samples from lesions for definitive pathology diagnosis. Uses for EUS-FNA include cases that require the needle to be inserted into difficult-to-access locations which only can be reached by bending the endoscope tip to a large degree. Challenging anatomy and endoscope positions can prohibit the needle from actuating smoothly and cause it to lose its shape. Maintaining needle straightness is critical to ensuring the same needle could be used to retrieve multiple samples. A recent ASGE study showed that EUS-FNA could provide added benefit over CT scans or MRI in treating branch-duct intraductal papillary mucinous neoplasms (BD-IPMNs), lesions that can turn into cancer in the pancreas. These lesions’ position in the branch ducts makes them difficult to access, which calls for more creative ultrasound and needle solutions. Endoscopic ultrasound (EUS) has gained ground as a valuable method for diagnosing pancreatic cancer and diseases of the GI tract. Today, the industry has moved from viewing and identifying disease to yielding better diagnostic samples and reducing cost. These developments translate into new challenges for needle design. The introduction of the Olympus EZ Shot 3 Plus

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EUS-FNA needle resolves the common concerns that enter into needle design. Designers of the EZ Shot 3 Plus needle were challenged on how to: •

Obtain better samples: Flexibility was critical here, given that a high degree of curvature is present at the endoscope tip when accessing a difficult spot like the pancreatic head. To address this flexibility challenge, EZ Shot 3 Plus was constructed with nitinol, a material with great elasticity and "shape memory," (meaning that the needle remains straight throughout the procedure). Reduced friction is also important. A multi-layer sheath construction ensures the needle travels freely and smoothly. 
 Ensure the best puncturability: The needle is intended to access different anatomical structures and various lesion types. The needle tip sharpness and cutting edges were optimized for a variety of applications so, whether puncturing through tissue to reach a lymph node or puncturing the head of the pancreas, extensive simulation was necessary to reach the best design. 
 Enhance visibility: Designers focused on maximizing echogenicity (how well the needle appears on ultrasound), which meant extensive research and testing into innovations in dimple design, for precisely locating the needle in a lesion or to avoid adjacent anatomic structures. 
 Incorporate ergonomics: The needle handle requires a robust grip, smooth action, and visual appeal. Designers from Olympus’ consumer products group developed an aesthetic and functional handle design. Striking contrast between the dark text and white handle color make the needle identity apparent to the user. 
With the advent of EUS, needle design has become more challenging and demanding. One thing is certain, when it comes to sampling from a tight spot, the value of good design can’t be understated. M

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Merit Medical OEM offers thousands of quality components and innovative devices to meet your needs.

Learn more at MeritOEM.com

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ELECTRICAL / ELECTRONIC COMPONENTS

Consider this section as an introduction or beginners guide to several electrical components, such as power supplies, medical sensors, connectors, encoders, and the oftenrequired task of validation. Most complex medical equipment will require a power supply. For that the electrical community has responded with a wide range of designs. However, selecting one requires more than input and output voltages. For example, electromagnetic interference must be considered because of the dazzling array of electronic devices that can occupy a hospital room. In this case, it is possible that one device could interfere with the signals of another, nearby device. Electrical connectors, another discussion here, come in vast array of possibilities. The number of off-the-shelf connectors is impressive enough, but the number of custom connectors is much larger. These latter items call for involving the connector manufacturer for a best solution to the design challenge. Medical sensors are eyes and fingers of any medical device. The challenge in this field is to

make devices small, sensitive and nonintrusive, and then measure things that have not been measured outside a hospital lab. This brief section covers recent pressure and mass airflow sensors, and a look at skin-surface sensors. There is so much to measure inside the body that would be useful to athletes, those recovering from operations and illnesses and the medical professionals guiding their recovery. Measuring, for instance, a person’s blood oxygen levels without taking a blood sample would be a great advantage. These latter devices will take some time but good research is underway in facilities around the globe. Such sensors will also allow development of new wearable medical devices. Bluetooth technology continues its evolution, letting wearables transmit signals to nearby receivers that relay them, for now, to human professionals who can make decisions as the medical data changes. But it’s not hard to see that a desktop doctor in the form of a Siri or Alexa might ask a patient, “How are you feeling this morning?” and, depending on the patient’s voice, response and their wearable sensors, make medical decisions for them. M

What guidelines will help select a best medical connector? Hank Mancini | Marketing Manager | Affinity Medical Te c h n o l o g i e s , a Molex Company |

When designing medical devices, engineers face challenging conditions and complex choices not found in many other industries. The devices need to provide durability and reliability in harsh conditions with fluids, sterilization, and physical and electromagnetic interference. High mating cycles also play a role. These medical devices rely heavily on the underlying electronic interconnects to be effective. Connector design is an integral part of the design process and specifying the right connector is critical. A quick look at options The first consideration for engineers is deciding between an off-the-shelf connector, a hybrid version or a custom solution. • Off-the-shelf connectors are commercially available in multiple configurations. While these typically require a smaller engineering and tooling investment, they often have long lead times and a higher per-unit cost.

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• Hybrid versions include custom overmolded features on a stock connector body. These provide improved performance and an aesthetic value over off-the-shelf products and lower design and engineering costs than fully custom connectors, but also have long lead times. • Custom solutions are designed and manufactured for a specific customer, device, or application. With custom connectors, it’s easier to integrate components or electronics and incorporate markings or logos. The initial investment in engineering and tooling fabrication is typically higher, but these solutions can be more cost-effective in the long run depending on volume. Consider each application In many instances a custom or hybrid solution is preferred to an off-the-shelf option, especially when there are unique considerations.

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SAB SPECIAL CUSTOM CABLES A CUSTOM SOLUTION FOR EVERY APPLICATION

SAB North America has been the proven leader in the development and manufacturing of superior flexible and continuous flex control cables. In addition to our wide variety of in-stock wire and cable, SAB's engineering team can help you create a custom cable design to solve your toughest problems for almost every application. .

To get the best preforming cable for your application, call 866-722-2974 or email info@sabcable.com. 344 Kaplan Drive, Fairfield, NJ 07004 866-722-2974 www.sabcable.com

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ELECTRICAL / ELECTRONIC COMPONENTS

For instance, medical personnel in a procedure room with a dozen or more different cables and connectors in use simultaneously, run the risk of connecting the wrong cable and device. Off-theshelf connectors can be outfitted with different colors over-molded to create a hybrid model that clearly identifies which connector goes to which device. Devices used on patients must often withstand a defibrillation pulse of 5,000 to 8,000 volts, should the patient go into cardiac arrest. In this situation, insulation, spacing, materials, and air gap can be customized to meet the specific application needs. Other examples of custom features include designing the connector to prevent incompatible mating. Or, due to ergonomics, the ideal medical interconnect should be large enough to

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be easily handled by the intended user and intuitively mated. Understand the process With hybrid or custom medical connectors, the design, tooling, and manufacturing process can typically take between four and eight months. Early in the design process, the team needs to establish detailed requirements that include electrical (voltage, defibrillation, bandwidth/data rates, and more), mechanical (cable diameter, ergonomic features, expected flex life, desired mate and un-mate force, and more) and environmental (sealing and ingress protection, cleaning, sterilization, and others). After the specifications are established, and design work is agreed upon (which includes solid models), fabrication of the prototype can begin.

When selecting a hybrid or custom medical connector, teamwork between all parties is critical. The result will be a medical device, including the connector and cable assembly, which meets all mechanical and electrical requirements and performs well in the field. M

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What is a position encoder and how is it used in medical devices? Renishaw |

A position encoder is a device comprising a precision graduated scale and readhead (sensor). The encoder determines the position of the readhead on the scale and outputs this signal, in either analogue or digital formats, to a machine controller. Modern encoders may use optical, magnetic, capacitive or inductive principles to meet metrological requirements. Optical encoders are among the most accurate compact encoders on the market today, making them a preferred choice for most medical-robotic applications. Robotic surgery and encoders Medical robots are widely used to assist surgeons in surgical tasks requiring dexterity. General surgical procedures such as prostatectomy, hernia repair, hip and joint replacement, and others such as neurological surgery and laser-eye surgery are now commonly performed or aided by robots. Wristed robotic arms hold endoscopes and interchangeable surgical instruments in place while the surgeon manipulates them remotely either through teleoperation or computer control. These robots are capable of precise movements with dexterity far beyond even the most capable human surgeons. This can radically improve outcomes for patients. A robotic manipulator arm comprises a series of rotational joints, each driven by a servomotor and precisely controlled using encoder feedback. In teleoperated robot surgery, the surgeon moves a master manipulator, also with servos and encoders, to command the slave manipulator or robot arm performing the surgery. This requires a complex control system to let the slave manipulators and

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their instruments precisely track the movements of the remote operating surgeon. Each motor-driven joint on the slave is controlled by a feedback loop that computes the motor command as a function of the difference between the current position and the target (set-point) position and as a function of the current velocity and target velocity. Rotary (angle) encoders on each joint may also provide some degree of force or torque feedback to the operating surgeon, via the master manipulator, as a function of the slave joint positions and velocity tracking errors so as to reflect the forces acting on the instruments. To better detect and control fine movements in the joints, high-resolution rotary optical encoders are preferred for position and velocity sensing. These encoders feature low-mass components, miniature readheads, large through-diameters on the rotary scale, higher accuracy and precision, good immunity to scale contaminants, durability and safety of operation. Encoders on the joints of robotic manipulator arms require the highest accuracy and resolution to deliver the improvements in operative precision promised by robotic surgery – up to several orders of magnitude improvement in sensitivity. The future of surgery As encoders evolve, new procedures will become possible due to developments in robotics and attendant advances in the accuracy, precision, and non-invasiveness of surgery. Encoder feedback is vitally important for the safe and effective control and operation of robotic systems. Many of the world’s leading manufacturers of medical robots use optical encoders, such as Renishaw’s family of optical encoders, in their control systems. M

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ELECTRICAL / ELECTRONIC COMPONENTS

What are the considerations for selecting a power supply? Lorenzo Cividino Director Global Applications & Support SL Power Electronics

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Power supplies are an essential part of all electronic equipment. They provide the regulated voltages and protection to the electronics, performing vital functions necessary to achieve a device’s intended purpose. Ac-to-dc power supplies, for example, serve as an interface and provide isolation between the power utility’ hazardous alternating current (ac) and the required, lower-voltage direct current (dc). Choosing the right power supply is imperative for an overall successful product. The ongoing goal of increased density, reliability, and efficiencies mean power specifications must be reviewed carefully. Product life, temperature, input voltage, load and cooling are vital considerations. So are meeting standards for safety, Electromagnetic Compatibility (EMC) and regulatory environmental impact compliance. Today’s power supplies must meet stringent safety requirements and performance testing, adhering to various standards as well as Electromagnetic Interference (EMI) and EMC standards. Medical equipment must meet medical equipment safety regulatory standards such as IEC/EN/CSA/UL60601-1 3rd edition. In most cases, power supplies for Information Technology Equipment (ITE) or commercial equipment do not provide the performance, in terms of product safety, reliability and product life, needed by medical devices. In addition to the safety regulatory requirements, EMI and EMC are specifically defined for medical equipment as a collateral standard to the safety standard for many countries (North America and Europe) by IEC60601-1-2. The standard defines EM emissions and immunity requirements. For immunity requirements, there are various levels of interference immunity which need to be considered as well

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as the acceptance criteria. For example, it may be acceptable for a product to momentarily lose power during an electrostatic discharge or ac mains surge, as long as it recovers automatically. In other cases, it is expected to continue to operate without impact from the event. Consequently, it is inadequate and not helpful to specify an immunity standard without defining a level and acceptance criteria. Defining a power supply requirement calls for thoroughness and detail, and knowledge of what type of power supply is best suited for the application. For example, is an external versus an internal power supply needed? An external is a stand-alone product with its own enclosure and ac input cord or connector and an output cord and connector. Internal power supplies are embedded in their equipment. There are pros and cons for each: Cost, size, convenience, and performance are all considerations. Further details regarding EMC standards are available at www.slpower.com. The type of ac input is also something to consider. A Class I ac input has three conductors (line, neutral and earth ground), while a Class II input has two conductors (line and neutral, or line two) and does not have an earth ground. Class II products may be more universally acceptable because some end uses may not have an ac source with an earth ground. However, Class II products require additional levels of insulation and EMI filtering. They may also cost more, due to the difficulty of achieving the required performance without an earth ground reference. Product life and reliability are related but different. Reliability is measured in terms of probability of operating, or failing. The measure of this is expressed by Mean Time Between Failures (MTBF) estimates and is a reasonable figure of merit when comparing products. The method used in estimating the MTBF is important to know to make a fair comparison. There are different estimation procedures (MILHDBK-217 and Telecordia SR-332 are examples) and within the procedures, there are different methods with varying complexities and assumptions. Product life, however, refers to component wear-out mechanisms and is not really reflected in MTBF estimation. For that reason, look for product-life data as well as reliability data. A computer power supply can be quite reliable, but is not designed to last more than a few years of continuous operation. Medical power supplies, on the other hand, are expected to last five to 10 years or more. M

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ELECTRICAL / ELECTRONIC COMPONENTS

What are some of the more notable and recent medical sensors? Medical sensors are a particular challenge to developers because human physiology more often calls for measuring small values and doing so outside the body. Small size and low power consumption are other critical characteristics. In this vein we examine three notable and recent medical sensors: One for media-isolated pressure, one for mass airflow, and one for blood oxygen levels. A media isolated pressure sensor comes from All Sensors Corporation. The first, SPM 401Series, is said to provide excellent performance in various applications, especially for low-pressure and smaller solutions. These media-isolated

4.5”

sensors are said to operate in hostile environments and yet, like a silicon sensor, have excellent sensitivity, linearity, and hysteresis. The pressure sensor is compatible with 316L stainless steel for increased corrosion resistance and improved resistance to pitting from chloride ion solutions. The steel also provides increased strength at high temperatures. A piezo-resistive sensor chip, housed in a fluid-filled cylindrical cavity, is isolated from the measured media by a stainless steel diaphragm and body. A mass airflow sensor, from Honeywell, works on the transfer of heat. Airflow is directed across the surface of the

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sensing elements. Output voltage varies in proportion to the mass air or other gas flowing through the inlet and outlet ports of the sensor package. Dual Wheatstone bridges control airflow measurement – one provides closed-loop heater control, the other contains the dual sensing elements. The heater circuit minimizes shift due to ambient temperature changes by providing an output proportional to mass flow. The circuit keeps the heater temperature at a constant differential (160°C) above ambient air temperature, which is sensed by a heat-sunk resistor on the chip. The voltage output of the device corresponds to the differential voltage across the Wheatstone bridge circuit. Adequate air or gas filtering in most applications is possible with a disposable five-micron filter in series on the upstream side of the airflow device. Advanced skin-surface medical sensors are close at hand, says GE researcher Anil Duggal. The slim, wireless devices, which the company is developing with the support of the Nano-Bio Manufacturing Consortium and the U.S. Air Force Research Laboratory, stick to the wrist like Band-Aids. The sensors analyze sweat, check vital signs, and even keep track of patients’ medical progress after treatment. “This will improve patient experience and get doctors better data about patients,” Duggal says, noting that the sensors will also be able to track heart rate, blood pressure and blood-oxygen saturation levels – and could potentially allow for wireless ECGs, allowing a doctor check heart activity while the patient is at work or play. To power the sensors, Duggal and team resurrected organic light-emitting diodes. Once the next big thing in lighting, OLEDs glow when electricity flows through specialized organic polymers. They could be embedded in printed rolls of flexible sheets. The sensors are being tested in clinical trials to monitor hydration levels of people during intense exercise. The research team is working to expand this testing to measure stress as well. M 68

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STERILIZATION SERVICES

Sterilization is the removal of all microorganisms and other pathogens from an object or surface by treating it with chemicals or subjecting it to high heat or radiation. The methods of sterilization used most commonly in the medical industry, including radiation (e.g., Gamma and E-Beam), chemical (e.g., Ethylene Oxide), steam, dry heat and plasma, have been available for decades and are well understood. And the standards and regulations for medical sterilization process control are straightforward and well tested. Sterilization innovations, although they are few in number, have succeeded in making the process easy to follow, inexpensive and safe. The processes, including safe, environmentallyresponsible clean up, for sterilization of medical and industrial products are familiar to OEMs. Many medical device OEMs even choose to

bring sterilization in house, with a supplier providing regular maintenance. For the most part, sterilization is efficient and inexpensive, and suppliers are continuously working to make the processes even quicker and more convenient. These sterilization suppliers have made quick turnaround and flawless service their utmost priorities. Nevertheless, the sterilization world is in flux. Currently, the needs of OEMs might be outpacing the technology. Sterilization supply companies are working to improve sourcing for radiation methods, for example. They are also working to improve applicability to combination products that may contain tissues or pharmaceuticals. These products are sensitive to various methods, either due to heat or chemical exposure, and cannot always be sterilized using traditional methods. M

Why use ethylene oxide (EO) for sterilizing medical devices? Gregory Grams | Annick Gillet | Mike Padilla | Sterigenics |

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Ethylene oxide (EO) sterilization is the most common industrial sterilization technique for medical devices. It is a relatively ‘cold’ sterilization technique and offers high compatibility with most materials used in the manufacture of medical devices, such as plastics, polymers, metals and glass. Its lethality is driven by a chemical reaction (alkylation) with the DNA of bacteria, viruses, molds, yeasts and even insects. Care is required when designing a cycle to ensure thorough consideration of any potential limitations in products, materials, coatings, bonds or packaging. Temperature is one of the key considerations in cycle design and it’s important to select the highest temperature that can be tolerated by product in order to provide the most efficient and cost-effective process design. However, a higher temperature set point might impact the product material or packaging, so this should be evaluated and some conservatism is advised. EO sterilization typically operates within the range of 90°F to 135°F. Generally, the rate of the lethality of the process is doubled with every increase of 18°F. So elevating temperature can provide benefits

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such as reduced product contact time with ethylene oxide, which may result in lower EO residue levels and hence shorter aeration times. Cold temperature may also provide sufficient lethality, but will require a longer EO exposure time. It’s this flexibility in operating temperature that makes EO sterilization a viable option for products with multiple devices, components and materials. Water vapor is also an essential element in enhancing the deactivation of bacteria. It can both increase material porosity, hence improving EO penetration, and also drive the alkylation reaction within the DNA of the bacteria to provide greater lethality. It’s important to limit exposure to steam, particularly for some moisture-sensitive materials (e.g. bioresorbable polymers such as PLA, PGLA, etc.). In summary, relative humidity levels of above 30% are advised in order to provide repeatable process lethality. The maximum specification for steam addition/RH should be assessed and determined based on any limitations in product and/or packaging. Depth of vacuum is another important factor and physical limitations in product

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and packaging design may dictate the cycle pressure profile. For effective EO sterilization, it’s important to displace air and replace with EO, so deep vacuum cycles tend to be more efficient in providing optimal EO penetration into product and packaging, particularly when product design includes a long lumen. There are conditions that will limit the vacuum depth that can be applied: • Sealed aluminum pouches containing sterile product that cannot be exposed to EO will not withstand deep vacuum (burst risk). • Plungers from prefilled syringes might be moved when applying deep vacuum. • Plastic containers may be deformed at low pressures. • Bags which are poorly vented and may inflate. In these cases, the vacuum depths of the cycle can be reduced to compensate, but this change will impact EO gas penetration and removal, typically resulting in longer cycle times and increased aeration time. The final critical element is the concentration of ethylene oxide. Typically, the operating range varies from 400 mg/l to 800 mg/l. For higher concentrations, the lethality no longer follows a linear behavior and brings only adverse effects, e.g. flammable cycles, higher residual content and limited improvement on lethality. Therefore the selection of EO concentration must be based on the compromise between attainment of the required conservative sterility assurance level and minimized EO residual levels in the product. After a potential cycle design has been identified, and before launching a formal validation of product sterility assurance, it’s important to verify that there is no significant adverse impact on final product and packaging design. In order to mitigate risk, it is strongly recommended to perform stability and

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functionality studies on samples that have been exposed to two or three test cycles using a ‘worst-case’ version of the proposed cycle design. By verifying product can withstand multiple sterilization processes, products can be re-processed in case of any deviation. Once the cycle design has been established, and verified to be appropriate for product and packaging, validation of the sterility of the medical device(s) should be performed in accordance with ISO 11135:2014. In addition, safe levels of EO in product should be verified in accordance with ISO10993/7:2008. In conclusion, the ability to vary, by design, combinations of process parameters results in ethylene oxide providing flexible solutions to sterilize a wide variety of medical devices and materials which has driven its continued growth as a major sterilization technology. M

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MACHINING

Medical Machining refers to all of the CNC machining need to make to surgical implants, orthopedic devices and medical instruments. There are challenges to the process, including small-scale or micro-machined parts, as well as hard-to-machine materials, such as titanium. Parts in the medical field can be complex and are often required in small batches. Because the category of machining is vast, editors chose to focus on a few hot-button topics. As minimally invasive surgical procedures continue to gain popularity, they tick all the painpoint boxes in medical machining. These projects require micron-level tolerances, as well as micronsized part geometries, and difficult-to-machine materials. Laser machining, primarily femtosecond lasers, could offer a solution. Laser marking is an increasing need for

machined parts, particularly in conjunction with unique device identification. Achieving the correct processes mode and desired characteristics requires a deeper understanding of cycle times, marking quality and an OEMâ&#x20AC;&#x2122;s budget Another new technology is the hybrid machine offering Swiss machining and laser systems in a single platform. By combining a Swiss-style lathe and a fiberoptic laser delivery system, suppliers can provide the capabilities on a single machine platform to reduce part handling and improve part accuracies. In addition, ultrasonic welding offers a singular option for welding plastic parts that may be too complex for a single mold. The process uses heat and pressure to create solid-state welds between plastic components. M

How do laser-Swiss combo machines work? Jim Cepican | Marubeni Citizen Cincom |

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Fiberoptic lasers offer highprecision, high-speed laser cutting. But for products that require multiple processes, significant time and quality challenges can arise. Combining a Swiss-style lathe with a fiberoptic laser delivery system, suppliers can provide the capabilities on a single machine platform to reduce part handling and improve part accuracies. Because this is a relatively new system, there are only a few companies providing such hybrid machines. In order to discuss the technology, this article examines the L2000 made by Marubeni Citizen Cincom. The L2000 uses the IPG Photonics 400watt, single-mode laser unit with 10 micron delivery fiber. IPG is a leading provider of fiberoptic lasers and offers support in the United States. Additional power units are available that address specific application requirements. One option is a QCW (Quasi Continuous Wave) 300-watt system that can provide power bursts to 3KW when needed. The laser head assembly mounts on the

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gang tool slide of the Cincom machine. The movements are programmed in the part program of machine control. The unit can also mount on the B-axis tool position, allowing

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MACHINING

for laser cutting at various angles for components that require angular laser cut features. The laser head assembly is liquid-tight and capable of operating while coolant is flooding the work piece during the machining process. Internal air pressure protects the lens and internal components. High-pressure coolant used during the cutting process also feeds coolant through the tubing material in the auto-loading bar feed system. This flushes the dross (chips) created during the laser cutting process. A CCD integrated camera for optical viewing and alignment is included for X-Y beam alignment to the nozzle. The live camera is visible on the included touch monitor to improve set-up time. The L2000 is completely interfaced to the Cincom control. Cutting path and offsets are fully controlled and edited in the machine control. Laser

power and gas type can be selected from the machine control part program and can be edited in the part program as well. An additional benefit of the L2000 is that it’s modular and not designed for a specific model of Cincom machine. A single system can be purchased and moved to other machines. The system can also be retrofitted to older Cincom models. In general, the benefits of a hybrid machine lie in combining conventional and laser machining onto a single platform. Machinists can create multiple operations in a single set-up, which reduces part handling. The system can improve process control and increase throughput without compromising accuracy. And the system is also suited for prototyping because machinists can create tubing from solid stock. M

What do you need to know about precision laser machining? Mark Dustrude | Portfolio Manager Medical Laser Te c h n o l o g i e s | TE Connectivity - Interventional Medical |

Laser machining for minimally invasive devices calls for the most demanding of design and engineering solutions. Minimally invasive devices are synonymous with low profile sizes, often a fraction of a human hair in width; tight tolerance specifications, down to +/- 0.0005 in. ( ±0.0127mm) and highperformance materials that are challenging to process, such as shape-memory metals, precious metals, dissimilar materials and thermoplastic polymers. There are a number of considerations for successful laser machining within these design parameters: • The primary objective when laser machining should be to minimize the heat-affected zone around the laser site. Advanced laser welding allows for precision joining of components with little heat input into the part. This creates less distortion than most conventional welding processes, resulting in higher accuracy and quality. Contact-free laser welding also helps prevent stress on materials. • Femtosecond lasers are ideal in micromachining applications for drilling and cutting high-precision holes and shapes free from thermal damage. Femtosecond lasers are ultra-fast laser systems that essentially vaporize matter without a heat-affected

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zone. This capability creates new opportunities for advanced micro designs, particularly for difficultto-process metals and composite materials not feasible for laser machining with conventional systems. There are significant cost benefits to femtosecond laser processing, as little or no postprocessing or cleaning is required. • Make a good start – always begin with the cleanest possible materials. When laser-cutting a material or if using a previously machined component, all foreign material must be removed in advance of processing. When joining two or more previously laser-processed components, laser-recast and heataffected zones (HAZ), also referred to as laser slag, must be removed in advance. It’s also imperative to remove all machining oils from previously machined parts – even the smallest traces of oil will be detrimental to the overall quality of a laser weld. For manual handling of parts, always wear gloves to avoid getting foreign material or finger mark residue on the materials to be processed. • Consider your design in terms of fit prior to laser processing, particularly when laser-welding components. When laser-welding two parts, they should fit together seamlessly without any gaps. A

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good rule of thumb is that the largest gap advised in a welded design should be half the thickness of the minimum material to be laser-processed. • Attention to basic considerations

such as drawings, tooling and measurements will assist in maintaining accuracy and quality between parts. Welldeveloped drawings are essential to producing quality components – weld symbols and callouts should be clearly outlined. Good laser processing begins with good tooling. Exacting tooling and fixturing will ensure that the materials to be processed are in the appropriate position prior to application of the laser, producing a part consistent with the intended design and maximizing yield. Consider how the part will be measured after laser processing, agreeing on measurement protocols in advance with all project leaders while

balancing the protocol to achieve overall success in manufacturing. • Biocompatibility – Laser processing ensures that no filler materials are added during the manufacturing process. Alternative processing methods often rely on filler materials, adding additional time and cost relating to biocompatibility issues during regulatory submissions. Laser processing is a superior fabrication approach for a myriad of device applications. Coupled with the expertise of an experienced supplier, product designers can deliver a highly effective design, achieve excellent product quality and reduce overall processing costs for the most complex of minimally invasive devices. M

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MACHINING

How can ultrasonic welding simplify medical products assembly? To m H o o v e r | Senior Medical Segment Manager | Branson Ultrasonics Corporation, a business of Emerson |

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Because the structures of many plastic products are far too complex to mold in a single piece, it might be necessary to assemble their components into a finished product using one of three joining methods: Mechanical fasteners, adhesives or plastic welds. Ultrasonic welding is a popular industrial assembly technique that uses heat and pressure to create solidstate welds between plastic components. Components are held in tooling, then subjected to high-frequency (10-70 kHz), low-amplitude (1-250 µm) mechanical vibration that generates intramolecular friction, melting the mating surfaces and creating a strong molecular bond. Ultrasonic welds are widely used to join thermoformed plastic assemblies because they eliminate the need for chemical solvents, adhesives, screws or additives. The ultrasonic welding process integrates into high-volume part production and automation because weld cycles are fast – typically less than one second – and do not require consumables. Typical plastic component designs require only minor modification to ensure repeatable, high-strength ultrasonically welded assembly. The most common (and typically “mold-safe”) modification adds a small “energy director” to the mating parts interface. The energy director melts and flows to join the two surfaces. Under ideal conditions, polymer

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chains from each side of the mating parts migrate across the interface and become indistinguishable from the parent material. Many thermoplastics, both amorphous (such as polystyrene) and semi-crystalline (such as nylon), can be ultrasonically welded. Ideally, both parts in a weld should be the same material. However, many combinations of dissimilar plastics can be ultrasonically welded if their melting temperatures (Glass Transition Temperature, Tg), are fairly close. Ultrasonic welding can offer significant advantages to the assembly of medical devices that must otherwise be joined by screws and solvents. Adhesives and solvents have much longer processing times, can introduce contamination and be challenging to accurately dispense. Minimally invasive surgical instruments such as catheters, cannulas, luers and trocars often utilize ultrasonic joining with great success. For applications in which the vibration used in ultrasonic welding could negatively impact microelectronic components or delicate part structures such as membranes or filters, other plastic joining technologies are readily available. One alternative is laser welding, a vibration-free process that produces clean and hermetically sealed welds between a wide range of dissimilar polymers. Benefits like these, together with exceptional aesthetics, have made laser welding the technology of choice for joining plastic parts used in many advanced medical applications, including everything from in vitro diagnostic test products to wearable technology for remote monitoring or microfluidic drug delivery. There are many choices, questions and challenges inherent in the design, development and production of reliable, repeatable joining process solutions. A material joining supplier provides expertise that can have a positive influence on everything from proof of concept to prototype development, scalability, data collection, regulatory compliance and more. Involving an experienced engineering expert in early stages enables a manufacturer to determine the best joining technology for their product. For medical device marketers who design and manufacture on multiple continents, it is also valuable to partner with a technology supplier with global capabilities that can provide local welding design and production expertise and support where the device assembly is performed. M

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VALIDATION & TESTING

What does the FDA say about validating software? Kevin Ballard | Director of Software Va l i d a t i o n | MasterControl |

Software validation is required by law for companies that operate under the purview of the FDA and EMA. Companies must validate their systems (such as those for quality management and compliance) to comply with a number of regulations including 21 CFR 11, 21 CFR 210-211, 21 CFR 820, 21 CFR 600, and 21 CFR 1271. Although it’s required, the FDA does not specifically tell companies how to validate. Companies are required to explain how they intend to validate their software and show evidence it has been validated the way it was explained. This lack of specifics from the FDA led to an excess of validation. At its core, validation is documenting that a process or system meets its pre-determined specification and quality attributes. In other words, software validation 1) ensures that the software has been installed correctly, 2) ensures that the product will actually meet the user's needs, and 3) confirms that the product, as installed, fulfills its intended use and functions properly. The FDA recommends that companies pursue the “least burdensome approach.” But how do they do that? Traditionally, companies implemented an Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ), essentially a series of tests and documented evidence of the testing. Installation Qualification (IQ): The FDA defines IQ as “establishing confidence that process equipment and ancillary systems are compliant with appropriate codes and approved design intentions, and that manufacturer’s recommendations are suitably considered.” For European companies, Annex 15 defines IQ as the “documented verification that the facilities, systems, and equipment, as installed or modified, comply with the approved design and the manufacturer’s recommendations.” Operational Qualification (OQ): The FDA defines OQ as “establishing confidence that process equipment and sub-systems are capable of consistently operating within established

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limits and tolerances.” Annex 15 defines it as the “documented verification that the facilities, systems, and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges.” Performance Qualification (PQ): The FDA defines PQ as “establishing confidence through appropriate testing that the finished product produced by a specified process meets all release requirements for functionality and safety.” Annex 15 defines PQ as the “documented verification that the facilities, systems, and equipment, as connected together, can perform effectively and reproducibly, based on the approved process method and product specification.” One way to achieve the “least burdensome approach” is to integrate validation into a change control process trigger, such as the installation of new software or an upgrade. When incorporating validation into such an event, effort is more likely to remain focused on verifying that the change meets user requirements and is less likely to experience the “scope creep” often associated with validation. A company’s validation strategy should also be risk-based. The FDA currently advises that the level of validation should be parallel to the level of risk potential. Taking a risk-based approach to validation ensures that critical processes are the focus, rather than testing areas of the software that have little impact or are in low-risk areas. This lets companies focus their time and efforts on their business activities. Proper risk-based validation can help companies remain in a validated state, even when faced with frequent software upgrades. Companies are also encouraged to leverage vendor testing efforts and audit the vendor where possible. This would let them use their vendors’ test methods and evidence as their own test evidence, and further streamline efforts. This validation approach will ensure that companies pursue the least burdensome approach, help reduce overall costs and ensure continuous compliance. M

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VALIDATION & TESTING

What is validation and why is it perceived as so complex? Oscar Ford | Business Development Manager | Preh IMA Automation Evansville Inc. |

Many perceive validation as complex, ill-defined, and fear-inducing. The question is, “Why?” Why does the mere mention of the word “validation” stimulate fear and anxiety for some people? The following might provide some insight into this perception: In many cases validation is not consistently described and understood because it depends on the interpretation of the person or entity considering the word. In other words, what validation means to one person (whether that person is a validation engineer, manufacturing engineer, quality engineer or someone else), can vary significantly based on that person’s interpretation of the guidelines. This inconsistency can certainly contribute to the perception of complexity; we can all relate to a task becoming more complex and more difficult to accomplish when it feels like you are “aiming at moving target.” Another issue is that the word validation is frequently used indiscriminately. For example, validation is used in reference to something that is probably better classified as testing or qualification, such as machine or equipment qualification. At other times it’s used when referencing process validation (which is typically achieved by conducting an IQ/Installation Qualification, OQ/ Operational Qualification and PQ/Performance Qualification); that is, if you don’t subscribe to process capability and control mode (P&PC) methods. It is sometimes used in reference to software validation; in fact, you can probably think of several additional activities implied when the word “validation” is used. Although this as the state of things regarding validation and the perception of complexity,

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from a medical device manufacturer, contract manufacturer,or another healthcare companies’ perspective, what should these manufacturers expect from their suppliers related to validation? The answer: Your supplier should be able to specifically address how they will assist you with validation activities by sharing their expertise, experience, and validation processes. Here are a few tips on how to make sure the automation company that builds your automated assembly system has the capability and ultimately delivers value for your validation needs: • Interview the company specifically related to validation capability, or deploy your company’s vendor or supplier evaluation or management program, up to and including audits when capable. • Understand how the company operates in accordance with validation requirements. The company should be able to demonstrate this with tangible examples of standard procedures, deliverable documentation and artifacts, as well as past customer examples. This should require more than “acronym alphabet soup” in which acronyms such as IQ/OQ/PQ, QSR, CFR 21, IAT/FAT/SAT, and GAMP are thrown around without the company demonstrating a real understanding of your validation needs. • Understand the company’s level of sophistication and infrastructure related to validation and qualification documentation. Device manufacturers, contract manufacturers, and other healthcare manufacturing companies should take precautions by rigorously checking potential automation company’s procedures, deliverables, sophistication, infrastructure, experience, and all around validation capability. M

www.medicaldesignandoutsourcing.com

11/22/16 6:28 PM


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REGULATORY

What is needed to break into the U.S. market? Jodi Scott Partner & Chris Casolaro Associate Hogan Lovells US LLP

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Although most medical devices enter the United States market by obtaining either 510(k) clearance or Premarket Approval (PMA), there are other paths available, which are less frequently invoked. Below are high-level descriptions of pathways available to device companies. 1) 510(k) notification Devices that present relatively low risk (i.e., such as class I or class II) require the manufacturer to seek 510(k) clearance from the FDA, unless exempted from this requirement by regulation. Such clearance is generally granted when a new device is “substantially equivalent” in intended use and technological characteristics to a “predicate device,” which is generally a legally marketed class I or class II device. Products that are exempt from 510(k) clearance may enter the market so long as they are within the parameters defined by its predicate devices within the classification. 2) Premarket approval (PMA) A medical device that does not qualify for 510(k) clearance is placed, by default, in class III, which is reserved for devices classified by the FDA as posing the greatest risk (e.g., life-sustaining or implantable devices, or devices that are not substantially equivalent to a predicate device). For these devices, the product must be approved via the premarket application (“PMA”), which requires that the safety and effectiveness of the device be established with valid scientific evidence, normally high-quality clinical data. 3) De Novo review FDA will consider the de novo pathway for novel devices when the de novo requester either determines that there is no predicate device (“direct de novo”) or has its device found not substantially equivalent. To be eligible, the device must be low to moderate risk, such that general or special controls would provide reasonable assurance of the safety and effectiveness of the device.

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4) Humanitarian device exemption (HDE) The HDE program encourages device companies to bring treatments onto the market for conditions that affect small populations. Humanitarian use devices (HUDs) are limited to treating or diagnosing conditions that affect fewer than 4,000 people in the U.S. per year. The approval process is similar to a PMA except that the application is only required to demonstrate safety and probable benefit of the therapy. 5) Investigational device exemption An Investigational Device Exemption (IDE) allows a manufacturer to provide an investigational device to be used in a clinical study in order to collect safety and effectiveness data. All investigational clinical studies, unless exempt, must have an approved IDE. An IDE can be obtained through submission of an IDE application, which includes, for example, a clinical protocol and informed consent documents. Some studies that present nonsignificant risk may proceed without an IDE if approved by the Institutional Review Board (IRB). 6) Expanded access – Compassionate use and emergency provisions The expanded-access option allows an investigational device to be used, outside of a clinical trial, where a physician determines that a seriously ill patient requires use of the device and there are no generally accepted alternatives. Under the Emergency Use provision, a device that is needed immediately is exempted from FDA approval. Under the Compassionate Use provision, FDA approval is still required. 7) Custom device exemption (CDE) The custom device exemption allows manufactures to provide a device(s) to meet a particular patient or surgeon need in treating a unique condition in the absence of a commercially available medical device. No more than five custom devices within a device type may be manufactured per year. M

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REGULATORY

What are the 10 keys to the U.S. pathway to medical device approval? Debra Grodt Director of Regulatory Affairs Medical Device & Diagnostics Novella Clinical

What is a regulatory assessment? A regulatory assessment is a comprehensive review of Food & Drug Administration (FDA) regulations and similarly marketed devices to establish a framework to design a safe and effective product. Assessments include: 1) a detailed rationale for product classification; 2) applicable regulatory agency consensus standards and guidance documents; 3) laboratory and preclinical testing requirements; 4) clinical study requirements; and 5) submission format, elements and recommended timing. A list of Design History File documents to support FDAmandated Design Control (21 CFR Part 820.30) should also be included.

and ease-of-use (human factors and ergonomic testing) before enrolling subjects to define preliminary safety and effectiveness. Data from these pilot studies can help companies modify devices, labeling and training methods to develop better products, as well as to better define endpoints, follow-up requirements and patient populations for subsequent clinical studies.

What is an Investigational Device Exemption (IDE)? An Investigational Device Exemption (IDE) allows unapproved devices to be used in a clinical study to collect safety and effectiveness data required to support a Premarket Approval (PMA) or 510(k) application.

What are pivotal clinical trials? Pivotal clinical trials are the equivalent of Phase III drug clinical studies and are intended to collect safety and effectiveness data required to gain regulatory and market approvals. These clinical studies require a significant number of patients to provide adequate statistical power and the design is generally randomized against another device for the same intended use, or against standard-of-care. In addition to meeting FDA requirements, results from these studies can help support public and private coverage determinations for device reimbursement.

What are feasibility clinical studies? A medical device feasibility study or pilot clinical study is used to validate device design and clinical study design by the intended users. These proof-of-concept studies are generally small, usually between 20 and 60 patients. They should be done in a staged process, measuring training effectiveness, device issues

What are post-market studies? Post-market studies may be required by the FDA or may be conducted voluntarily by the manufacturer to collect real-world, long-term performance data. Post-approval studies and post-market surveillance studies are studies mandated by the FDA for novel and/or high-risk devices to define long-term safety and effectiveness.

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What are Class I, II & III devices? FDA classifies devices by risk, which governs the design verification, validation and clinical testing required, and therefore, how long it takes to get a device cleared for market. • Class I are low-risk, e.g. surgical instruments, gloves and visual acuity charts. • Class II are moderate-risk, e.g. contact lenses, urologic catheters, vascular clamps and blood pressure cuffs. • Class III are high-risk devices that support or sustain human life or pose higher risk of illness or injury, e.g. vascular grafts, coronary stents, implantable pacemakers and artificial hearts. What is an FDA pre-submission? This voluntary program allows sponsors to obtain FDA feedback to help guide product development and/or application preparation prior to submitting a formal IDE, PMA or 510(k) application. What is a 510(k) application? A 510(k) is a premarket submission made to the FDA to demonstrate a device is safe and effective and similar in intended use, materials, components, operating principles and method of use (i.e. substantially equivalent) to a legally marketed device. The FDA’s review of the 510(k) application and notification of clearance is required before placing a moderate risk device on the market. What is a premarket approval (PMA) submission? A PMA submission initiates the FDA’s scientific and regulatory review process to evaluate the safety and effectiveness of Class III medical devices. The PMA must be approved prior to marketing the device. FDA generally requires the manufacturer of a first-of-a-kind device to pass an on-site quality audit and attend an Advisory Committee meeting prior to issuing an approvable letter. What is the de novo pathway? New devices, regardless of risk, that are not substantially equivalent to an existing cleared device are automatically classified as Class III by the FDA. The de novo or Automatic Class III Designation process allows manufacturers to petition the FDA to reclassify a device as a Class I or II. Submitters will provide justification on why the device should not be considered Class III, highlighting the risks and benefits of the device. M

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Sarah Faulkner Associate Editor Medical Design & Outsourcing

The future of medtech will be personalized, connected and data-driven, at least according to Minnetronix founder Dirk Smith. Consider a hypothetical future teenager with asthma as he’s on the way to a soccer game, Smith said at the 5th annual MassDevice.com DeviceTalks Boston event. “Fifteen years from now, when we send this soccer player out, on his calendar is his soccer game, so his phone tells him to take his inhaler,” Smith said. “He sticks it in his pocket, goes on his way. As he’s going to the soccer game, his smart device is looking at that data input – physiological, environmental, and cloud data – and it’s predictive. It can determine the likelihood that he’s going to have an asthmatic event, and give warnings to him, to his coaches, perhaps to his parents.” The smart inhaler would be able to control dosage to prevent overdosing and provide constant physiological monitoring for the patient and provider. “The system can get smarter and, over time, provide better data for the individual as well as for the broader population,” Smith said during a panel discussion on the future of medtech. The panel also included Tal Medical CEO Jan Skvarka and Jon Rennert, CEO of Zoll, and was moderated by Jim Reed, VP of business development & marketing at Minnetronix. Devices like the connected inhaler will result from continued and evolving partnerships between the technology sector and the medtech industry, Smith said, pointing towards collaborations like the one between Medtronic and Qualcomm. Skvarka echoed the theme of collaboration as a driving force of the industry moving forward. Growth in the industry is stagnant, he said, and major players will continue to see consolidation as the path to growth. “How do you restore the growth in an industry which is growing at two percent? The fastest and safest way is with mergers and acquisitions.” Growth will also be stifled by an innovation crisis in the coming years, Skvarka suggested, due to a lack of venture capital. “I believe we will see a crisis in innovation in the medical device industry,” he said. “Basically, VC funding in the medical device industry has been stuck consistently at $4.7 billion since 2009. Remember, 2009 was the year when we emerged out of the recession. It has not moved since. “VCs are not funding the innovation, and also the strategics, the big companies, big companies are not good at innovation and they are getting bigger, so they will be even worse at innovation,” he said. As the industry faces these challenges, Skvarka said, companies have to deal with the forces that will continue to guide the industry, including a challenging reimbursement structure. “It's a much longer road than you would have in drugs. The path to reimbursement is a hand-to-hand combat with payers,” he pointed out. To be successful in medtech, Skvarka argued, companies will have to prove their products have economic benefits apart from improved health outcomes.

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“The truly innovative products, differentiated products, they are able to hold the ground. I think what we will see going forward is the commoditization will be even accelerated given the pressure from the economic buyer,” he explained. Rennert echoed Skvarka, saying companies will need to collect significant data about the economic benefits of their devices, alongside data on improved outcomes. “Clinicians are increasingly looking to evidence, not just that your device is safe and effective, but that it works better than the next-best alternative, and that gets into this question of economic and the value of it,” he said. Data-driven and personalized medtech is certainly the direction in which Zoll Medical is heading, according to Rennert. Zoll has developed technology in its automated external defibrillators to give rescuers feedback on how they’re performing CPR – if they need to push deeper, harder, or if they’re doing a good job. Rennert envisions a future where data can tell us more about an individual patient’s needs and provide more exact guidelines for therapy. “I think over time, we'll be able to measure the physiological impact of CPR, which is fundamentally to move oxygenated blood to the brain and vital organs, and we'll be able to see how we're doing on that particular victim” he said. “We'll be able to guide CPR to each person as they need it. You can imagine a small, elderly woman might need a very different type of chest compression than a large man.” More personalized care and more data might mean removing the clinician from part of the equation, he added. Better technology may be able to help patients help themselves. Wearable and mobile health devices will explode in popularity, Rennert said, as mobile devices are ubiquitous among the general population. In 10 years, wearable defibrillators could use predictive algorithms to warn patients when they’re at risk of a cardiac arrest, what kinds of activities aggravate their heart health, and keep them on track with their medication regimen. “We have a huge database of ECGs that led to cardiac arrest and those that didn't,” Rennert said. “We think there's an opportunity to mine that database to give predictive algorithms that might warn patients when they're at an elevated near-term risk of cardiac arrest so they could take appropriate precautions.” It’s clear that technological innovation will play a critical role in moving the industry forward over the next 10 years. Smith cautioned the crowd that as technology becomes more and more advanced, the patient must remain the primary motivation for development. “As you put more sophisticated computers, more horsepower into devices, it's absolutely critical that the interface to the human is safe and effective and intuitive,” he said. “Technology doesn't do much good if patients and providers can't interact with it, so we need to make sure technology is in sync with patient adoption.” M

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Catheters - Paul Dvorak Catheters are essential tubes, some more complex than others, inserted into the body for a range of functions, such as to guide the placement of stents, allow the out flow of urine when necessary, and in cardiac evaluation procedures. Each area will see significant changes. For one, the Catheter lab has gotten a big upgrade with widespread robotic applications that take doctors out of radiations way. Radiation from X-rays is needed to let physicians see their progress as they place stents and other vascular treatments. Urinary catheters are used when blood clots or kidney stones inhibit fluid flow, but are also a source of infection. Within the next 10 years, urinary catheters will dispense drugs with focused

responses, such as to dissolve kidney stones and blood clots. Furthermore, the drugs will be formulated in the doctorâ&#x20AC;&#x2122;s office to accommodate the patientâ&#x20AC;&#x2122;s physiology and prepared into the catheter while the patient waits. Cardiac catheters will head to medical museums as developments make them unneeded. Current practice is to insert a cardiac catheter into a heart for procedures that determine how well the heart is working. The procedure will be made obsolete by external tests that make the same determinations from outside the body. Devices using a combination of short wavelength ultrasounds will let physicians watch a patientâ&#x20AC;&#x2122;s heart beat and make more accurate diagnoses without need for minor surgery.

Nanoparticles - Sarah Faulkner Nanoparticles will continue to be a heavily researched drug delivery vehicle over the coming decade. I predict they will begin to move out of the research stage and into development, especially for use with combination cancer therapies.

Traditionally, nanoparticles have had trouble making it to clinical trials in humans, but I think as different types of nanoparticles are developed and the industry comes to better understand the mechanisms by which they can target and infiltrate cells, we will see nanotechnology available on the market.

3D Printing - Nic Abraham 3D printing, also known as additive manufacturing, is changing the way businesses operate, and not just in the medical device world. 3D-printed products can be made more quickly and cheaply, at a lower cost, than items

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made with conventional techniques. With 3D-printed orthopedic implants and other products already on the market, the technology is sure to play an increasingly important role in medtech over the next decade.

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Vision for the future

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Neuromodulation - Fink Densford Highly addictive painkillers, such as opioids, will be seen a last-line defense against chronic pain, with neuromodulation and neurostimulation technologies taking up as ordinary a role as pacemakers. Advancements in neural interfacing, technologies such as transcranial magnetic stimulation and

improvements to current neuromod tech will give doctors the ammunition they need to fight the U.S.â&#x20AC;&#x2122;s opioid addiction epidemic. As chronic pain is reduced and managed regularly, health across an aging population will increase, and more focus will be paid to quality of life and long term healthy outcomes.

Payments - Heather Thompson Outcomes-based reimbursement in the form of bundled payments is poised to revolutionize healthcare. Effective use of bundled payments will require concerted efforts in data collection among all stakeholders. Within 10 years, bundled payments might include an option for

medical device companies to participate in the cost recuperation that is now possible for hospitals. It certain that bundled payments will spread beyond orthopedics and into neurosurgery, cardiovascular procedures, and possibly even chronic disease management, such as diabetes. Medtech better be ready.

Robots â&#x20AC;&#x201C; Brad Perriello Robot-assisted surgery, long dominated by Intuitive Surgical and its da Vinci platform, will see other entrants on the market and a shift

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to devices that incorporate machine learning other artificial intelligence technologiesâ&#x20AC;&#x201C;creating surgery robots in the literal sense of the word.

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Raghu Vadlamudi Chief Research and Technology Director Donatelle

Faster, Smaller, Smarter: The Future of U.S. Medical Device Manufacturing The medical device manufacturing industry

2. Advances in skilled workforce

will see major improvements by the year 2026, thanks to three significant trends leading the way:

As medical technologies progress, they will require more complex and intricate engineering expertise and industry knowledge to optimize device and component concepts for manufacturability through development to delivery at every stage. That means career opportunities for students in science, technology, engineering and mathematics will flourish. It also means manufacturers over the next decade will need to continue to evaluate, envision and enact best and next practices to compete for those talented graduates.

1. Advances in micro-manufacturing Long a global leader in macro- and nanomanufacturing, U.S. original equipment and contract manufacturers are focusing significant efforts on expanding micro-manufacturing capabilities. Just as Japan changed the size game for consumer goods, medical manufacturers are developing precise and reliable technologies to create tinier and tinier devices and components for specific and reliable uses within the human body. Miniaturizing devices and components will require even more precision and accuracy, as well as improvements in the automation operations themselves. As a result, we’ll see exponentially more advances in lasers, optics and sensors – the tools used to accurately make, measure, validate and troubleshoot products – in order to manufacture medical technologies on specification with absolute quality and economic efficiency for micro needs. In parallel, the industrial revolution of the Internet of Things (IoT) and other technologies is paving the way for “smart factories” to accurately and consistently produce the breadth of conceived miniature devices. To be competitive, manufacturers will need to stay abreast of these technologies.

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3. Advances in on-demand technology and delivery By 2026, major innovations will succeed in expediting access to medical technology products from the plant floor through to the healthcare provider site. Currently, manufacturers keep a certain amount of medical devices and components in stock to fulfill new orders. However, as the IoT continues its expansion into manufacturing, stock and inventory is becoming increasingly automated. Work orders will automatically go through a system and trigger production, secondary

operations, assembly and delivery without delay. This “just in time” manufacturing shift to automated order fulfillment will dramatically reduce costs and save footprint, enabling manufacturers to streamline financials and optimize space for increased productivity. Meanwhile, innovations underway in 3D printing will forever change physician access to medical devices in real time. Once fully realized, 3D printing will make the seemingly impossible possible – that is, “point of use” on-demand medical technology and delivery. For example, currently a tissue must be biopsied, cultured and then transported. This process can take a few days or more. Once 3D printing is fully realized, a physician will be able to print a tissue when need is determined. With the material gains already made in printing – metal, polymers, etc. – the medical industry can expect to achieve point-of-use 3D printing to take off in certain capacities by 2026. M

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Vision for the future Charles Cohen President Fotofab LLC

Fotofab Celebrates 50 Years of Serving the Medical Products Industry, and Looks to the Future Fotofab provides a wide range of high precision metal fabricating services to produce components with geometries from simple to very complex. Whether the mission is a quickturn prototype to a high-volume production run, Fotofab has been satisfying medical product engineers for five decades. And while our core competency has not changed over that time, the technology of our production tools continues to evolve. As we look to our next decade, we see opportunities for our customers to benefit from our unrivaled experience, while knowing that their parts will be produced with state-of-the art production methodologies and uncompromising quality standards. Today, Fotofab is highly regarded by our customers for being responsive to their needs for product quality, quick response times and highly knowledgeable customer service. Located on Chicago‘s Northwest Side, our main plant houses multiple etching machines, and a thoroughly equipped CAE/CAD department. Our tooling, forming and stamping facility is located in Elk Grove Village, a short drive from our main facility and very close to O’Hare airport. We are proud to have earned our ISO 9001:2008 certification and are diligently working on our AS9100 certification, which is projected for June 2017 implementation. What changes do we see over the next ten years? Fotofab will continue to invest in the latest technologies to continue our commitment to continuous improvement. Advances in CAD systems will help engineers simplify design tasks and shorten the overall project cycles. Gradual refinements on the manufacturing side will also help speed production, while maintaining the company’s well known tight tolerances. In the medical products field, we are also seeing greater customer emphasis on environmental issues. Fotofab had anticipated this growing trend and is well positioned to satisfy these customer concerns. We are particularly proud to have been commended by government regulatory agencies for our environmental compliance and cooperation. Fotofab

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believes that to achieve long-term growth, we must be good stewards of the environment. We constantly work toward making our manufacturing process cleaner, safer and even more respectful of our country’s natural resources. Looking forward to our customers’ applications – the trend in the medical electronics industry is for smaller, lighter and more efficient products with even tighter tolerances. For example, in order to make a power supply for an EKG machine smaller, it must operate at higher frequencies, creating a greater need for shielding and heat dissipation. Our processes can satisfy those needs without lengthening product development time. Be it medical, medical implantable or any other market, customer companies will continue to push out more new designs faster than ever. Fotofab takes pride in being able to stay a step ahead of our customers’ needs with affordable, quick-turnaround custom parts for prototypes. In addition, we are well equipped in moving prototypes to laser production runs. Another area of change is with the types of metals our customers are asking us to fabricate. Exotic metals are required for some medical applications, because of their unique properties. These same properties can be challenging when the metal is etched, stamped or formed. Fotofab has developed proprietary approaches to overcoming these challenges, so that we are able to deliver parts that are comparable to those made of more compliant metals. In summary, Fotofab will continue to maintain close relationships with our medical product customers and advance our capabilities to keep pace with their future needs. The longevity and professionalism of our staff ensures the highest level of satisfaction. M

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Andrew Dallas Founder Full Spectrum Software

For the past 20 years, as the president of Full Spectrum Software, I have had the opportunity to participate in technological advances in the medical device and scientific instrument fields. One of the areas we’ve worked on extensively is genetic analysis. We are now seeing this technology rapidly emerge for use in medical applications. Given the advances of the past 10 to 20 years, where might the use of genetics technologies take medical devices in the next decades? In 1997, my team worked on what was then very advanced genetic analysis software. The Eastman Kodak product was called 1D, an automated image processing of electrophoresis gels. This allowed several samples to be analyzed at the same time to determine similarities or differences in DNA – for example, this technology was used for the DNA testing in the OJ Simpson murder trial. The system’s camera resolution was 752x582 capturing 12-bit grayscale. That’s about a half megapixel in a box the size of a large microwave. Fast forward 10 years to 2007, when we worked with Applied Biosystems on their SOLiD (Sequencing by Oligonucleotide Ligation and Detection) System. This device quickly generated billions of small-sequence reads using a 4-megapixel camera. Compared to the imaging technology of the past, today’s iPhone7 captures full-color images at around 12 megapixels. Ten more years advances us to the present. Recently, Full Spectrum worked with Nabsys to create an analysis platform that performs whole-genome sequencing. Rather than using a camera, the Nabsys device uses solid-state detectors and is able to directly read about 100,000 bases per second, an enormous leap in throughput. Another innovator we are working with is Xagenic,

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whose genetic technology uses nanostructured sensors and an electrocatalytic system to generate amplified signals. This allows detection of nucleic acids from clinical samples without using enzymes, resulting in diagnostic assays that can be rapidly run by users without training in laboratory analysis techniques. This capability can accelerate simultaneous diagnosis of multiple diseases and will support detection of dozens, if not hundreds, of conditions at once. Reflecting on the evolution of DNA information usage, we once had the ability to provide only an overall probability of DNA matching. This was sufficient for applications such as paternity tests and criminal investigations. Technology advanced to provide further detail such that today we are able to not only sequence and analyze genetic material, but also to modify it using the CRISPR technology. Looking ahead 10 years, we can reasonably predict that millions of people will have their entire genome mapped. They’ll benefit from personalized molecular therapies, and maybe, if we are lucky, extend their lives by having primary care physicians directly modify individual genomes. Full Spectrum Software is excited to create software for these new medical applications. We also see ourselves continuing to adapt our software development and testing practices in order to be able to support this scientific progress. Have you considered how you will adapt to incorporate state-of-the-art genetics technologies for use in your medical devices? M

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MEDICAL in

Vision for the future Vicki Anastasi Global Head, Medical Device & Diagnostic Research ICON plc

Preparing for 2026: Transformation Ahead for Patients, Payors, Providers, and Pipelines A decade from now, value-based healthcare, enabled by wearable and electronic health record (EHR) technologies, will be revolutionizing medical device markets. Manufacturers will contend with a changing constellation of customers, from payors to clinicians and patients. It will be important to consider what outcomes they will value most. Anticipating these changes is necessary to ensure the relevancy of today’s development process — from product design through clinical trials, marketing strategies, post-marketing and product refinement. Several trends are clear:

Patient-directed care – Patients will continue to take a larger role in medical decision-making. Furthermore, the maturation of wearables, smartphone apps, and networked medical devices will grant widespread access to personal health metrics. Expect patients, armed with real-time data about their current care and potential options, to not only drive fundamental changes how clinicians deliver care, but also directly influence product specifications and marketing strategies. Technology ecosystems will enhance products and trial access – Many devices will come to market with companion apps and wearables to enhance outpatient outcomes, especially by monitoring symptoms and treatment adherence. Apps that integrate external datasets will augment many devices’ utility, such as high-pollen alerts for asthma

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inhalers. Most of all, interoperable networks of electronic medical records will enable instant trial feasibility modeling, exact patient identification, and direct recruitment of patients during normal physician visits — without the use of advertising. Social media analytics and patient-friendly informed consent will also contribute to making clinical trials a more regular component of clinical care.

Real-world evidence-defined value – Value will increasingly be defined in terms of meaningful outcomes, including clinical, financial and patient status. As regulators will require more real world evidence, payors will too, and perhaps even collect it themselves through smart watches and other wearables. Planning for real world evidence collection will become a core component of early development, particularly for manufacturers to continue to control a device’s value story.

Payer and provider cost constraints and consolidation – Insurers, hospitals and physician groups will continue consolidating to maintain margins and gain buying power. Capitation and other risk-sharing mechanisms will drive formulary decisions based on device impact on total costs, including both episode-related costs, such as length of stay, and broader measures, such as mobility and depression. Aging

populations will shift the device payer mix toward Medicare.

Outsourcing development partnerships – In the past decade, device manufacturers outsourced production to strategic partners who provided increasingly technical electronics, materials and precision fabrication expertise. In the next decade, manufacturers will outsource clinical development processes for similar reasons. Contract research organizations already are introducing critical innovations, such as adaptive trials and wholly owned site networks, to drive down development costs and timelines. This includes incorporating real-world data at every development step, including EHR-based feasibility and recruitment, remote site preparation, enrollment support, risk-based monitoring, and direct post-market data collection through EHRs and registries. Strategic partnerships with CROs to integrate these capabilities will be a key part of the future model for lowering clinical development costs, increasing success rates and – critically – meeting patient, physician and payer needs for evidence of real-world value. M

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11/22/16 5:40 PM


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MEDICAL in

Vision for the future Lih Fang Chew Quadion LLC Global Vice President Marketing

Medical Technology At Minnesota Rubber And Plastics… A Decade Into The Future Huge strides the last ten years have been achieved in the use of seal technology in medical applications. These gains have been achieved both with new seal material development and the design of the seals as well. In just the last year alone at Minnesota Rubber and Plastics, Quniton®, a low coefficient solution material and Qmonix®, a high performance EPDM material solution, have been developed and designed into medical applications. These two areas of innovation – material design and their application -- are just a beginning and set the stage for what’s ahead at Minnesota Rubber and Plastics ten years from now.

Market Needs Drive Innovation Minimally invasive surgery continues to grow as a better alternative to traditional surgical methods. Virtually every type of surgery has been impacted from heart and orthopedic surgeries to cranial and abdominal procedures. Driven by reduced costs, less pain, less recovery time and mandates from the insurance industry, new and better devices that make these minimally invasive surgeries possible will be adopted rapidly. Key to the success of the devices used in minimally invasive surgeries are seals, their design and the innovative materials that make them work effectively. At Minnesota Rubber and Plastics, there is a longstanding dedication to both seal material development and design, positioning it ideally for the needs of the medical

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industry 10 years from now and beyond. Beyond minimally invasive sealing devices, Minnesota Rubber and Plastics specializes in medical and pharmaceutical micro-molded parts for critical applications with tight tolerances and dimensions. These include implantables and non-implantables, surgical components and surgical tools, catheter and components, valves and seals, over-molding, and micro-seals.

Expanding Capabilities With A History Of Success For over 65 years, Minnesota Rubber and Plastics has led the industry as a trusted solutions provider to medical device manufacturers worldwide. It has accomplished this by enhancing device performance in demanding new applications. The company’s leadership is based on expertise in material science and engineering design, with ideal solutions for the future.

Material Science Solutions Minnesota Rubber growing R&D center is staffed with chemists and technicians with on-site technical support at each of its six global facilities. These capabilities are continually refined, upgraded and expanded and will continue to do so well beyond 2026. The company’s current custom formulation materials laboratory has over 1600 different rubber compounds on file in addition to high

performance plastic materials expertise, and hundreds of new materials on the horizon.

Design Engineering Minnesota Rubber and Plastics design engineers conceptualize and evaluate ideas by combining science and technology to create value. Fundamental in the past and present, this approach will continue to expand over time. Utilizing the latest CAD programs, FEA models and future software, the company’s designers will mathematically model and mold components and assemblies to meet future challenging requirements.

Program Management Minnesota Rubber and Plastics was among the first to manage complete multi-year, complex design, manufacture and assembly programs. Today, forward- acting customers require large scale capabilities supported by broad program management. They will continue to do so on an accelerated pace in the years ahead. Minnesota Rubber and Plastics is prepared with its global infrastructure, optimized resources and technologies to ensure customer needs and interests are always at the forefront of the entire organization. M

www.medicaldesignandoutsourcing.com

11/22/16 5:41 PM


We Turn Ideas Into Results. Advanced Material Technologies

Every day at Minnesota Rubber and Plastics we produce high tolerance medical components and assemblies for the most demanding applications. Our experience in advanced material formulation enables us to be compliant with FDA, ISO 10993 and ISO 13485 to meet your unique product requirements. Our over 60 year history in the design and manufacture Precision Molded Medical Components and Assemblies

1100 Xenium Lane North Minneapolis, MN 55441-7000 (952) 927-1400 Fax (952) 927-1470 e-mail: webmaster@mnrubber.com www.mnrubber.com

155 route de Paris 27120 Pacy sur Eure FRANCE Tel: +33 (0) 2 32 22 24 26 INDIGO +33 (0) 820 320 751 Fax: +33 (0) 2 32 22 24 27 e-mail: commercial@mnrubber.com www.mnrubber.com

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MEDICAL in

Vision for the future

Rich Nazarian President and Chief Executive Officer Minnetronix, Inc.

Leveraging Partnerships and Experience to Bridge the Innovation Gap The “Innovation Gap” is an increasingly important issue in the medical device industry. New, life-impacting technologies are not being developed in part because of the lengthening time required to bring new products to market (by some estimates over 5.5 years for 510(k) devices and 8-10 years for PMA products). Additionally, the number of deals and total dollars invested in seed and early stage med tech companies has declined by 45% from 2008 and 2016. A consequence of this decline is an increasing consolidation and concentration of technology in the hands of a few very large medical device firms. Once the Abbott/St. Jude merger is complete, Abbott and Medtronic will control 20% of all PMA devices in the US and this will likely impact the speed and frequency of medical product innovation. A further consequence of the increasing challenges in medical device development is that the needs of both the venture community and of these very large firms is understandably directed almost exclusively at very large markets, leaving many smaller yet important medical areas underserved. These factors are driving a need for new business models and new methods of bringing medical technology to market. At Minnetronix, we are creating effective solutions to address the innovation challenge:

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1. We provide infrastructure, technology, regulatory expertise, and seamless engineering to commercialization services for medical device companies. With decades of device development experience and a best-in-class quality system, we’ve helped hundreds of companies launch new products while contributing to client enterprise value. Our ability to reduce the operating burden for small firms that may have burn rates of $750k - $1M / month, has helped clients save millions of dollars off the cost of bringing their products to market. For large firms, Minnetronix has proven to be a fast and cost effective strategic partner that can quickly enhance and manufacture products or product portfolios while helping to manage operating costs. 2. Our portfolio of proprietary and licensable technologies is a cost-effective way for our customers to enhance their product value and increase speed to market. A few examples of these technologies include Minnetronix’ Cognita wireless communications and cloud infrastructure, our wireless energy technologies, and our integrated blood pump power and control systems. 3. At Minnetronix, we are developing unique and meaningful technologies and therapies for small, underserved markets. We are able to effectively address these smaller markets by leveraging our established infrastructure and deep device experience to pursue technology development without the need for a “standing army”. The Innovation Gap in medical technology is real and is calling for new business models. Minnetronix is responding to the call by providing services and technology solutions that benefit our medical manufacturing partners and serve the medical marketplace at large. M

www.medicaldesignandoutsourcing.com

11/22/16 5:42 PM


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MEDICAL in

Vision for the future

Dr. Gauri Naik Co-founder and CEO Optra Health

Q: What technologies and practices will most benefit medical device companies in the next 10 years?

Q: How do you foresee Big Data changing the way you do business?

A: The number one practice the medical device industry

can leverage to see widespread organizational results and that will impact the bottom line, is Value Engineering. In a nut shell, Value Engineering is the systematic engineering of a product or device to take into account Cost Optimization, Miniaturization of an older product and technology upgrades. Value Engineering audits every step of the process from Conceptualization and Prototyping, to Verification, Validation and Regulatory aspects, to extract the highest value over the product’s lifecycle. Companies can save upwards of 50% on their total costs to engineer, manufacture and maintain a product, if managed upfront through Value Engineering. Optra Health has helped worldleading medical device manufacturers save millions of dollars with Value Engineering.

Q: In 10 years, do you think the IoT/Industry 4.0 trend will have faded or will connected machinery have become a way of life for diagnostics, maintenance and overall machine health?

A: When thinking about IoT or Industry 4.0, I always tell my

clients to keep in mind that information generation and data exchange is really the basis of your device’s overall value. If you’re not keeping up with the pace of information exchange and connectedness of intelligent machinery—you will be left behind. The implementation of IoT and cloud computing is a means of building smarter devices that produce more value to the customer over time. Utilizing machine-learning, mobility and Artificial Intelligence, customers receive intelligent insights from their data, and can then store, manage and share information through the cloud, leaving behind the burden of segregated of data silos.

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A: Similar to the trend of IoT, is Big Data—analytics are increasingly

being used for more intellectual insights from machinery, which provides more value overall value. Big Data involves the integration and collaboration of unstructured data, and is interrupting how customers use data from all sources. The incorporation of clinical and genomic data, alongside the exponential increase of disparate data, is forcing medical device manufacturers to re-engineering devices to enable the use of this information through compatible interfaces and personalized analytics output.

Q: What have you learned about managing innovation in the past ten years? A: Optra Health prides itself first and foremost on innovation—

innovative devices for our customers, and innovating how we do business over the past ten years. It’s necessary to think about creating an innovative or disruptive device, but overall, organizations need to think about keeping their businesses innovative through smart device design and overall cost efficiency. Without the two, companies can languish quickly in this extremely competitive industry. Managing price per unit with cost-effective engineering is a must today, and without thinking in this strategic sense, companies cannot grow and reach optimal market share. Innovation is at the forefront of medical device design, and intelligent practices like leveraging smart engineering partners will become the mainstay for accomplishing these goals.

www.medicaldesignandoutsourcing.com

11/22/16 5:45 PM


What does it mean to Innovate in Medical Device Design?

Innovation in medical device design, means delivering a device that executes the needs of today, while providing solutions to support the needs of tomorrow. Optra Health provides Cost Effective, Innovative Engineering in the following areas:  Hardware and Software Design

Optra Health specializes in engineering and re-engineering through:  Market Research and Product

Conceptualization  Product design & engineering  Prototyping  Engineering simulation  Verification and Validation  Value engineering  Regulatory compliance

 Embedded Systems  Mechanical Design  Industrial Design  Product Process  Mobility

Learn why clients like Thermo Fisher Scientific, GE, Philips, BD, Perkin Elmer and Olympus continue to work with Optra to Engineer Digital Healthcare: www.optrahealth.com.

STAY CONNECTED

@OptraSystems

Optrasystems

Optra-systems-ltd

OPTRA HEALTH

A division of Optra Systems, Inc.

530 Lakeside Drive Sunnyvale, CA 94085 USA Tel : +1-408-524-5300 | Email : info@optrahealth.com | Web : www.optrahealth.com

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11/22/16 2:06 PM


MEDICAL in

Vision for the future

Joe Zuzula Vice President of Sales & Marketing Orchid Orthopedic Solutions

Q: What are the market factors that will most impact where your business is in 10 years? A:

• Increased scrutiny of the regulatory bodies in the medical device industry. We will deliberately and proactively pursue management of these aspects. • The payment structure for orthopedic procedures. In particular, cost pressures will trickle down through the value stream. We’re early on in the value stream and we are already feeling the impact. These changes will drive us to think differently about how we deliver to the market. • The Asian market. I believe the Asian market will continue to grow, and it will become a larger portion of our business. But the U.S. market will still play the dominant role. • Mergers & acquisitions. I believe there will continue to be consolidation, with fewer players in the contract manufacturing space and very few large orthopedic contract manufacturers – although there may still be a few niche manufacturers with new and unique technologies.

Q: What technological advances are you most excited by? A: • Disposable products have an advantage in cleanliness and mitigation of risk of infection, compared to reprocessed instruments. This gives OEMs a product that is a consumable, as opposed to instrument sets they can’t sell. It also benefits contract manufacturers that can deliver a full solution (sterile packaged on the shelf). • Stem cell research. Growing tissue, cartilage in particular, is interesting. Although I don’t see implants and instruments going away any time soon, advances in tissue engineering could offer the patient something that is less intrusive. They will still need a way to deliver the tissue so either way I’m excited to be a part of a solution that affects people in such a profound way.

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Q: What concerns you the most in the industry? A: I’m not excited about the increase in FDA regulations.

Combined with hospitals hiring more surgeons out of private practice, I think innovation is being limited. There have been fewer PMA submittals and more 510(k)s. I’m also concerned about the stance some of our customers are taking in response to cost pressures. The focus is on reducing piece price, instead of working with their suppliers to reduce real cost in how we conduct business together.

Q: What do you think a hospital looks like in ten years? A: I think hospitals will actually work with contract manufacturers to develop commoditized products. I also see them using off-patent, stable technology that they can make anywhere. 3D printing of implants right in the hospital is something that is around the corner.

Q: Where do you think your company will be in ten years? A: I see us doing more full solutions rather than just offering a-la-

carte services. We will continue to expand our capabilities on three continents, so that we have full value streams in local markets. I see us working with our customers earlier in the development process, with customers identifying a few strategic partners that they work with early on with sourcing decisions being made even before the design is frozen. We will remain as one of the top medical contract manufacturers in the world. M

www.medicaldesignandoutsourcing.com

11/22/16 5:46 PM


QUALITY OF LIFE ENERGY STRENGTH FLEXIBILITY NEW HOPE HEALING IMPLANT HAPPINESS FEELING WHOLE SLEEPING NORMAL AGAIN QUALITY OF LIFE ENERGY STRENGTH FLEXIBILITY NEW HOPE HEALING HAPPINESS FEELING WHOLE SLEEPING NORMAL AGAIN Why do we work so QUALITY OF LIFE hard to offer technical ENERGY leadership in implant STRENGTH coatings? To provide

an opportunity for people to live a better life. From our proprietary Osseomatrix® and Asymmatrix® formulations, to our custom coating capabilities, our leadership in advanced technology coatings and surface treatments for implant fixation is undisputed. Whether you want the clinical success of hydroxylapatite coating (HA), the high osseointegration capability of titanium plasma spray (TPS), the roughened surface of resorbable blast media (RBM) or composite coatings, you can count on Orchid to deliver the best technical solution. All with the mission to help others live a better life.

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11/22/16 2:07 PM


MEDICAL in

Vision for the future Thomas Burns CEO Resonetics

How Will Healthcare in 2027 Shape Medical Product Design & Manufacturing? Think how automotive care has changed over the past decade. The average car now has between 25 and 50 microprocessors on board with real-time diagnostics covering most systems. A “tune up” has been reduced to an electronic diagnosis with software directing the mechanic’s every move. Healthcare is heading in the same direction. Precision medicine and data analytics will drive improved risk management and preventative care to avoid acute illnesses and catastrophic events. New tools will be essential and traditional core competencies alone may prove inadequate for product companies and their suppliers. Successful companies will consider the impact of the trends discussed below as they plan for the future. Smart Devices With the adoption of semiconductor and MEMs technology, embedding electronics and connectivity into products will become standard practice, particularly as greater use of personalized medicine becomes the norm. Expensive stand-alone systems will be replaced by hand-held devices that will display real-time information and communicate wirelessly to centralized patient information systems. Devices may provide diagnostic information only, but more likely will integrate mechanical tools, drugs and gene therapy. More long term implantables will be available for treating chronic diseases and delivering palliative care. Passive or “dumb” devices will become relegated to procedures that are either very simple and routine or very complex, requiring the skill and judgment of a clinician.

Miniaturization, Personalization and Outpatient Therapy Diagnostics of the future will utilize non-invasive sensing and imaging, body fluid and gas analysis and gene sequencing extensively. Therapies will be much more patient-specific and less traumatic, mitigating collateral damage to return the patient to full function sooner. Large surgical incisions and cuts through bone, muscle and cartilage will be limited to large joint and

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trauma surgery where broad access is the only option. Catheter-based interventions will continue to replace open surgical procedures, with new materials and fabrication techniques enabling smaller, thin walled devices with the strength and maneuverability to access the targeted anatomy. 3D printing of organic and synthetic materials will become common place as mass customization of medical devices becomes a reality. Increasingly, procedures will be performed in clinics and physician offices. Larger hospitals will focus on complex procedures requiring expensive equipment and support staff.

Cost Appropriate To meet the growing needs of an aging demographic and the burgeoning global middle class, devices of the future simply won’t be approved without answering the financial challenge. Innovative companies will use technology to lower total costs to society. This may prove to be the biggest hurdle companies will face in the future. The high cost of product development, the need for clinical evidence and the investments necessary to scale up production all run counter to a low-cost requirement. The device industry will begin to mirror the pharmaceutical and biotech industries where big bets are placed on new therapies that will provide the benefits necessary to justify pricing that earns an attractive ROI. This trend could pose a serious challenge to small and mid-sized companies looking to survive in this high-stakes environment.

Summary While daunting to consider the impact of technology and societal needs on healthcare delivery of the future, companies that hope to be market leaders would be wise to be proactive. Few companies will have the requisite talents and financial resources to go it alone. So add collaboration skills to the requirements of the future! M

www.medicaldesignandoutsourcing.com

11/22/16 5:47 PM


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11/22/16 2:12 PM


MEDICAL in

Vision for the future J. Mark King President/CEO Tegra Medical

A Foundation of Trust The Outlook on OEM-CMO Relationships Relationships work best when they’re infused with communication and commitment. It’s not so different with OEMs and CMOs. Many things will change in the medical device market over the next ten years: evolving needs based on an aging population, new and updated product to meet these needs, and different manufacturing technologies to make them. But one thing will remain the same: the critical importance of people and relationships. Whatever happens with technology and products, the people who work in this industry and the relationships they form as OEMs and CMOs will be critical for success. The industry is already adapting to changes that will include an increased trend of outsourcing more manufacturing to CMOs. OEMs will be more driven by the need to get products to market sooner and more cost-effectively. Market trends such as greater life expectancies, increased healthcare spending, and better insurance coverage will fuel their growth, while at the same time they will be faced with growing pressures such as increased regulatory processes, threats from low-cost competitors and decreasing margins. Meanwhile, medical devices will grow more complex than ever. As OEMs continue to shift investment dollars from manufacturing to their core competencies (e.g., R&D, M&A, sales and marketing) they will seek out CMOs who offer a wide range of complex manufacturing technology, speed-to-market, a global footprint and efficient, cost-effective operations. This will necessitate forming relationships with a smaller number of CMOs who can handle a larger portion of the manufacturing role: end-to-end solutions providers. The end-to-end role will work best with deep OEM-CMO relationships. They will start working together sooner in the product development cycle, partnering in the development of products designed from the start to be manufactured and assembled in ways that reduce costs and increase quality – DFMA. As we have seen at Tegra Medical, this can even mean working

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together to invent brand-new processes to meet unique needs. OEMs are judged by their products; they essentially put their reputation into the hands of their CMOs. In the coming years, that relationship will need strong doses of:

Trust – that the CMO truly understands the industry and all its pressures, invests in and understands how to maximize the most advanced technology, and has the expertise and capacity to get products to market on time. Respect – for the intimate knowledge OEMs have of their own customers and the manufacturing expertise CMOs bring to the table. This includes actively listening. Flexibility – to adapt current technology to meet future needs, or to align resources for special requirements. Initiative –to know when to interject with new ideas and suggestions for enhancing a product or process. Patience – for understanding that emerging OEMs may have product ideas that will take years of experimenting with different materials and processes before they’re ready for production. Urgency – for when products are ready for production and simply need to get to market fast. Balance – of the right mix of capabilities, expertise, quality and total customer dedication. Close relationships give CMOs the insight to adapt to and accommodate changing OEM needs. At Tegra Medical, we believe that OEMs and CMOs that work well together also grow together. M

www.medicaldesignandoutsourcing.com

11/22/16 5:48 PM


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11/22/16 2:17 PM


MEDICAL in

Vision for the future

Uwe Meyer Director, Business Field Manager Medical Testing TÜV Rheinland

Medical Testing and Government Regulations follow trends based on demands and needs. But what are these trends? Nanotechnology, cloud connectivity, deep learning, smartphone access and personalized medicine are all rapidly integrating into consumer-oriented medical devices, applications and overall healthcare. While adoption of these devices is incremental, it will increase rapidly in the next five to ten years, changing the medical landscape. Regulatory departments and authorities will need to keep up with the changes. ‘Telemedicine’ is one such trend. With ‘Telemedicine,’ patients can use devices equipped with various sensors or cameras to monitor their own health stats and relay information to doctors. Video consultations and health apps as part of a prescription will become a regular activity. Medical device companies will likely also face new care delivery challenges and opportunities. The forming of “hospitals without beds,” where intervention occurs in the hospital and recovery takes place in the patient’s home or an alternative setting, will impact healthcare. The rise of virtual care centers— overseeing patients through an ecosystem of technology, diagnostic devices, and sensors to provide medical care decisionmaking—has a direct impact on data storage and security. The data, whether clinical, patient-specific and/or consumergenerated, holds tremendous value to researchers and doctors in monitoring and identifying of health results. But it also carries the likelihood of more frequent and costly security breaches. Consumer and regulatory attention will intensify regarding medical device security: how it’s collected and generated, and especially the evaluation and testing of cybersecurity. Device manufacturers and hospitals alike will require compliance with these new regulations, and certification of in-depth threat modelling and protection against hacking will carry significantly greater weight. Changes are also coming to hospitals. With the use of robotics for minimally invasive surgery increasing, doctors

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are able to perform more complex procedures with greater control and precision than is possible with traditional techniques. The minimally invasive nature of robot-assisted surgery is a key benefit and will lead to new developments for more comprehensive robotic surgical solutions for operating room professionals. Finally, medical applications for 3D printing can provide many benefits, including the customization and personalization of medical products, drugs, and equipment. Cost-effectiveness and increased productivity can be recognized in tissue and organ fabrication; creation of customized prosthetics, implants, and anatomical models; and pharmaceutical research regarding drug dosage forms, delivery, and discovery. As a test and certification body TÜV Rheinland anticipates an increase from manufacturers and clients seeking approvals for their products in the following areas: • Care in the palm of a patient’s hand – a transformation to consumer-oriented medical devices. Applications will represent the greatest challenge to the diagnostics industry in providing consumer-oriented solutions that meet health and clinical needs. Cybersecurity will be a big part of this. • Medical robotics - growth, innovation, and development of surgical tools and prosthetic trends continues to improve patient outcomes • 3D Printing - bioprinting is emerging in the medical field and offers potential for new organs It is required that advanced medical technologies should be designed to satisfy the requirements, needs and capabilities of their users. The benefits of a user-centered approach to design include improved patient safety, better treatment results and increased user satisfaction. Let’s be ready! M

www.medicaldesignandoutsourcing.com

11/22/16 5:49 PM


Where will wireless medical device technology lead us in the next 10 years?

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Make sure your wireless medical device is protected! We live in a SMART and connected world. As technologies evolve, so does the need for more stringent and comprehensive safety testing, especially when it comes to wireless medical devices. Manufacturers must be concerned with far more than traditional product safety testing. Have you considered cyber threats: • Security of patient data • Communication to devices • Control of devices TUV Rheinland understands the landscape medical device manufacturers are faced with and is well positioned to support their regulatory and compliance needs. TUV Rheinland is your one-stop-shop for regulatory compliance, offering bundled services to meet all your testing needs. You can combine wireless approvals with any other mandatory product safety services.

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11/22/16 2:20 PM


AD INDEX

Accu-Mold LLC.............................................. 75 AIM Plastics.................................................... 15 AllMotion........................................................ 86 AMETEK/DFS (Windjammer) ....................... 21 Anomet Products........................................... 31 Atlas Vac......................................................... 68 B. Braun Medical Inc..................................... BC Bal Seal........................................................... 73 Bard PV OEM................................................. 17 Bimba Manufacturing Co................................ 3 Binder USA, LP............................................... 67 Bird Precision................................................. 77 Branson Ultrasonics Corporation ................ 27 Cadence Inc. ................................................. 12 CGI, Inc..................................................... 34, 35 Cicoil............................................................... 79 Clippard Instrument Laboratory, Inc.............. 9 CPC - Colder Products Company................ 48 DATA IMAGE Corp. ...................................... 77 Donatelle........................................................ 91 Dunkermotoren, part of AMETEK................ 29 Eagle Stainless Tube & Fabrication, Inc....... 24 EG Gilero........................................................ 19 Fotofab........................................................... 93

Fluortek.......................................................... 85 Full Spectrum Software................................. 95 Groschopp, Inc......................................... Insert Haydon/Kerk.................................................. 25 HEIDENHAIN Corporation......................... IBC Helical Products Company........................... 81 Humphrey Products....................................... 59 ICON plc........................................................ 97 igus Inc........................................................... 20 Introtek Int’l.................................................... 64 IXYS/Zilog....................................................... 55 J.W. Winco, Inc.............................................. 16 John Evans’ Sons, Inc.................................... 53 Keystone Electronics Corp............................ 13 Master Bond................................................... 16 maxon precision motor, inc...................... Insert maxon precision motor, inc..........cover/corner Memory Protection Devices, Inc.................... 7 Merit Medical OEM....................................... 61 MicroLumen............................................. 38, 39 MICROMO..................................................... 43 Minnesota Rubber and Plastics.................... 99 Minnetronix.................................................. 101 Moog Animatics............................................ 30 Norman Noble............................................... 89

SALES Mike Caruso mcaruso@wtwhmedia.com 469.855.7344 Michael Ference mference@wtwhmedia.com 408.769.1188 @mrference David Geltman dgeltman@wtwhmedia.com 516.510.6514 @wtwh_david Jim Powers jpowers@wtwhmedia.com 312.925.7793 @jpowers_media

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Nason............................................................. 11 New England Wire Technologies................. 41 Nippon Pulse Americas, Inc............................ 4 NSK Precision America.................................... 2 Optra Health................................................ 103 Orchid Orthopedic Solutions..................... 105 PITTMAN........................................................ 23 Proto Labs........................................................ 5 PTI Engineered Plastics................................. 47 QOSINA......................................................... 83 Renco Electronics Inc.................................... 69 Renishaw Inc................................................... 57 RESONETICS........................................IFC, 107 Ruland............................................................. 51 Rutronik Inc. | Electronica.............................. 87 SAB North America....................................... 63 Servometer..................................................... 71 Smalley Steel Ring Co................................... 45 Sorbothane.................................................... 22 Tegra Medical.............................................. 109 THK America, Inc............................................. 1 TÜV Rheinland of North America............... 111 Web Industries............................................... 32 Zeus................................................................ 37

LEADERSHIP TEAM Tom Lazar tlazar@wtwhmedia.com 408.701.7944 @wtwh_Tom Courtney Seel cseel@wtwhmedia.com 440.523.1685 @wtwh_CSeel Neel Gleason ngleason@wtwhmedia.com 312.882.9867 @wtwh_ngleason Jessica East jeast@wtwhmedia.com 330.319.1253 @wtwh_MsMedia

11 • 2016

Mary Ann Cooke mcooke@wtwhmedia.com 781.710.4659 Mike Francesconi mfrancesconi@wtwhmedia.com 630.488.9029 Michelle Flando mflando@wtwhmedia.com 440.670.4772 @mflando Garrett Cona gcona@wtwhmedia.com 213.219.5663 @wtwh_gcona

Publisher Brian Johnson bjohnson@wtwhmedia.com 617.905.6116 Managing Director Scott McCafferty smccafferty@wtwhmedia.com 310.279.3844 @SMMcCafferty

VP of Sales Mike Emich memich@wtwhmedia.com 508.446.1823 @wtwh_memich EVP Marshall Matheson mmatheson@wtwhmedia.com 805.895.3609 @mmatheson

CONNECTWITH US!

Follow the whole team on twitter @WTWH_Medical

www.medicaldesignandoutsourcing.com

11/23/16 11:23 AM


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Linear Encoders

Contouring Controls

Subsequent Electronics

847-490-1191

www.heidenhain.us

Length Gauges

Rotary Encoders

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& Do you need a supplier that makes managing complicated projects look simple and speeds you to market?

&

How about one with world-class design chops and quality systems for ensuring excellence?

&

Or one that saves time and money with sterilization, packaging and regulatory capabilities all under one large roof?

If your answer is yes, then B. Braun OEM is the only supplier you’ll need. Beyond a full roster of capabilities, we offer a vast array of products. You’ll find parenteral pharmaceutical solutions in a variety of bags, a thick catalog of standard and custom valves, all the admixture accessories you’ll ever need, and the products and capabilities to build a custom kit for your device or drug. It all adds up to a singlesource supplier that goes far beyond being a vendor to becoming a true partner. Visit BBraunOEM.com.

B. Braun Medical | OEM Division | USA

©2016 B. Braun Medical Inc. Bethlehem, PA. All rights reserved. OEM 15-5024 7/15 LMN

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Medical Design & Outsourcing - NOVEMBER 2016