Medical Design and Outsourcing

JUNE 2015

www.medicaldesignandoutsourcing.com

Medical Design & OUTSOURCING CONSOLIDATION NATION: It’s a sellers’ market at all levels of the medtech industry

PREMI ER ISSUE

IS THERE AN UNSERVED MARKET FOR DEVICES IN PSYCHIATRY? Jan Svarka, CEO of medical device maker Tal Medical, thinks so.

MATERIALS THAT ARE

CHANGING MEDICINE STRUCTURES THAT DISSOLVE

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HERE’S WHAT WE SEE

Keeping pace with the galloping medical-device industry Nearly every day, it seems that significant news shakes and realigns the medical device industry – and that’s to say nothing about the incredible technology coming out of labs around the globe.

Consider these recent announcements: Bioabsorbable materials are finding their way into products ranging from vascular scaffolds to bone screws. These materials can do the work of nitinol and stainless steel before dissolving over a controlled period. Then there’s the socalled "repless" sales model, in which medical device companies take their sales reps out of the equation. Smith & Nephew, one of the world’s oldest and largest orthopedic companies, says its new “Syncera” model can save hospitals performing 700 procedures annually an average of $4 million over three years. If successful – a big if – this experiment could signal a tectonic shift in the business of medicine.

Even the FDA is showing a newfound sense of urgency, creating a new, fast-track “de novo” protocol for devices aimed at deadly or

Paul Dvorak Founding Editor Medical Design & Outsourcing pdvorak@wtwhmedia.com

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debilitating illnesses with no other treatment options. News like this moves markets. Our goal with Medical Device & Outsourcing magazine is to deliver more of it. The publishing company that brought you Design World magazine and its online features has teamed up with MassDevice in a unique endeavor. Here at MD&O, we’ll bring our technical expertise to bear on the medical device industry, offering discussion and insight, coverage of new materials and tubing, technical features, sizing and selection guides, to name a few.

Over at MassDevice.com, the team led by founders Brad Perriello and Brian Johnson will harness their comprehensive knowledge of the medtech business to bring you insightful discussion of the industry’s hot-button issues with the CEOs of medical device companies large and small.

The staff on this end includes our managing editor, Nic Abraham. She has three years of experience editing, posting, podcasting, and conducting webinars – not to mention her MBA training, which will come in handy as we plumb the intricacies of this fascinating space.

Then there’s me. I have a degree in mechanical engineering and worked on a medical magazine for several years, but more importantly, I had the foresight to marry a nurse who now teaches nursing.

She will unwittingly serve as a behindthe-scenes consultant.

There’s never been a more exciting time to shine our light on the medical device market, as the ever-growing complexity of the regulatory, reimbursement, legal and economic landscape keeps pace with accelerating innovation.

So welcome aboard. Let’s make this a great ride. M

www.medicaldesignandoutsourcing.com

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CONTRIBUTORS

BROWN

HOWARD

THOMPSON

PATEL-RAMAN

HOOVER

JIM BROWN is Business Unit Manager for Medical Markets at Colder Products Company. Jim has been customizing fluid connections for more than 20 years. His expertise includes applications for medical devices such as blood pressure monitoring, dialysis, and surgical equipment. He has a B.S. in mechanical engineering from the University of Minnesota, Institute of Technology.

TOM HOOVER has been the market segment manager for Medical & Business Consumer Electronics for Branson Ultrasonics Corp. in Danbury, Connecticut (a business of Emerson) since 2010. Tom brings a vast resource of understanding of the challenges confronting today’s medical device manufacturers and biotech firms. His indepth medical industry experience in all aspects of product development and regulatory compliance provides him the ability to assist in finding the innovative solutions manufacturers are seeking.

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DELMAR HOWARD is the mHealth Program Manager at Intertek. He helps to create and manage mobile application testing programs and has been directly involved in the design and implementation of several certification programs within the mobile and wireless industries. He is based in Intertek’s Blue Bell, Pennsylvania facility outside of Philadelphia.

SONNA PATEL-RAMAN joined Halloran Consulting Group in 2014. She has more than 14 years of experience in applying medical device regulations to product development, clinical trial design and conduct, and device research and development.

Sonna focuses on regulatory and clinical strategies for medical device, pharmaceutical, and biologic companies.

KYLE THOMPSON is the Global Product Line Manager for the Thomson Systems Group, which includes rodless linear units, rod-style precision actuators, and lifting column products. He has been with Thomson for nine years with previous roles as an Applications Engineer and Field Sales Engineer.

www.medicaldesignandoutsourcing.com

5/22/15 3:38 PM

Medical Design & OUTSOURCING E D I T O R I A L

S T A F F

EDITORIAL

NEW MEDIA/WEB/ BUSINESS DEVELOPMENT

MARKETING

Founding Editor Paul Dvorak pdvorak@wtwhmedia.com @paulonmedical

Web Development Manager B. David Miyares dmiyares@wtwhmedia.com @wtwh_webdave

Marketing Manager Stacy Combest scombest@wtwhmedia.com @wtwh_stacy

Executive Editor Brad Perriello bperriello@wtwhmedia.com

Web Development Specialist Patrick Amigo pamigo@wtwhmedia.com @amigo_patrick

Marketing Coordinator Carli Evilsizer cevilsizer@wtwhmedia.com @wtwh_carli

Managing Editor Nic Abraham nabraham@wtwhmedia.com @WPE_Nic Publisher Brian Johnson bjohnson@wtwhmedia.com 617.905.6116

Director, Creative Services Mark Rook mrook@wtwhmedia.com @wtwh_graphics Graphic Designer Matthew Claney mclaney@wtwhmedia.com @wtwh_designer Graphic Designer Margaret Schneider mschneider@wtwhmedia.com @wtwh_meg Graphic Design Intern Erin Cawthorn ecawthorn@wtwhmedia.com

Traffic Manager Mary Heideloff mheideloff@wtwhmedia.com

Integrated Media Specialist John Hansel jhansel@wtwhmedia.com @wtwh_jhansel Video Coordinator Joshua Jones jjones@wtwhmedia.com @wtwh_josh

Business Development Manager Patrick Curran pcurran@wtwhmedia.com @wtwhseopatrick Online Coordinator Jennifer Calhoon jcalhoon@wtwhmedia.com @wtwh_jennifer

Accounting Jill Steinbuch jsteinbuch@wtwhmedia.com

Director, Audience Development Bruce Sprague bsprague@wtwhmedia.com

2011, 2012, 2013, 2014

Marketing Coordinator Nicole Loepp nloepp@wtwhmedia.com @wtwh_nicole Social Media Specialist Jen Kolasky jkolasky@wtwhmedia.com @wtwh_jen Media And Events Coordinator Heather Centorbi hcentorbi@wtwhmedia.com @wtwh_heather Content Associate Lexi Korsok lkorsok@wtwhmedia.com @wtwh_lexi

CONNECT WITH US! Follow the whole team on twitter @WTWH_Medical

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P M lea D& s Bo M e vi ot Ea sit h st us # S a 15 ho t 75 w ,

MEDICAL DESIGN & OUTSOURCING does not pass judgment on subjects of controversy nor enter into disputes with or between any individuals or organizations.

5/22/15 11:23 AM

INSIGHTS

Consolidation Nation: It’s a sellers’ market at all levels of the medtech industry Ken Fine, co-founder and president of Proven Process, is a popular man these days. Not a week goes by without Fine entertaining flirtations from private equity investors or potential strategic partners, looking to see if he’s ready to cash out of his business after 21 years.

Proven Process is a Mansfield, Mass.-based contract manufacturer providing engineering and manufacturing services for companies in the implantable cardiovascular space. It employs 85 workers, has a great reputation, a solid book of business and is still run by its three founders. In short, to a new breed of investors looking to mine this subset of the medical device industry, Fine’s company is the equivalent of a pretty girl at the bar or the guy by the jukebox with the six-pack abs.

To private equity, medical device contract manufacturers like Proven Process represent a great opportunity for a “roll-up,” business-speak for the practice of combining 2 to 3 mid-sized companies to create a larger enterprise. For these investors, the sometimes quiet $50 billion industry represents a major opportunity.

Brian Johnson Publisher Medical Design & Outsourcing bjohnson@wtwhmedia.com

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“I think they still see medical device contract manufacturing as a growth opportunity,” Fine tells me. “The medical device market is still growing, it’s still relatively immature, and there’s still a lot of room there.”

Consolidation is the name of the game these days. In 2014, there were more than 57 mergers among medtech manufacturers, according to an analysis

by MassDevice.com. That’s 16 more buyouts than the 41 deals logged in 2013, a 39% increase.

For medical device manufacturers, the drivers for consolidation echo conditions in the larger market, not just favorable borrowing rates, higher valuations and pent-up demand from the recession. Starting in earnest in 2011, the hospital sector has been consolidating like crazy, and some say this is just the start. In five years, the hospital industry we know today could be dramatically different, according to Trish Hannon, president & CEO of Boston’s New England Baptist Hospital.

“Consolidation in the provider industry is growing rapidly, because the cost structures can’t be borne by the revenue streams,” Hannon said recently at the annual meeting of the Mass.

Medical Device Industry Council. “If you fast-forward five years from now, there are 4,000 hospitals in the country and that number will change drastically.

The only way to survive is through consolidation.”

Fine says investors are letting him know that the M&A market for contract manufacturers is just as frothy, reaching levels not seen since the 2007 recession.

In recent months, Fine says, he’s seen Proven Process contemporaries such as The Aubrey Group sell to Sparton Corp., and Rhode Island-based Ximedica enter into a recapitalization deal with SV Lifesciences.

www.medicaldesignandoutsourcing.com

5/21/15 10:37 PM

The facts bear out Fine’s anecdotal evidence: There is a great deal of activity in the space.

For the 10 largest contract manufacturers specializing in medical devices, there’s been an uptick in M&A activity over the past 24 months. The list of high profile deals in contract manufacturing space includes: • Jabil Circuits buying Nypro for $665 million in 2013; • Private-equity-backed Tecomet acquiring Symmetry Medical’s OEM business in 2014 for $450 million; • Accellent spending $390 million for Lake Region Medical (and taking the company’s name the process) in 2014; • And TE Connectivity Ltd. acquiring AdvancedCath for $190 million.

Other deals of note include Flextronics buying RIWISA and Stellar Microelectronics in 2013 and Creganna-Tactx buying Precision Wire Components in the fall of 2014.

In this kind of environment, it may be tempting for Fine to take a spin around the dance floor, but he insists that business is too good right now to sell.

That doesn’t mean he doesn’t listen, however, and he’s always paying attention to what’s happening around him. After all, there may come a day when a suitor appears whose offer is simply too good to refuse. M

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CONTENTS

medicaldesignandoutsourcing.com ∞ June 2015 ∞ Vol1 No1

DEPARTMENTS

ON THE COVER:

02 EDITORIAL: Keeping pace with the galloping medical device industry.

04 CONTRIBUTORS

44

Abbott Vascular makes its Absorb bioresorbable scaffold of Evonik’s Resomer.

06

PUBLISHER’S COLUMN: It’s a sellers’ market at all levels of medtech.

11

MANUFACTURING & MACHINING: Advances in lifting column technology to improve overall user experience.

14

LEGAL COMPLIANCE: Mobile apps could be more medical than you think – and the FDA will notice.

18

TUBING TALKS: How tubing innovators are changing the landscape around minimally invasive surgery.

22

CONNECTOR & CABLES CORNER: Ensuring safe power for medical equipment.

26

THE CATH LAB: PFOA-free PTFE is ready for catheter applications.

FEATURES 44

Materials and ideas that promise shake up medical device design

Imagine a material with the strength of steel but the density of plastic, or synthetic skin printed on demand in an OR for a badly burned patient. Materials like these may soon be ready for prime time – and more are on the way.

54

60

Finding the best way to join plastic components

In designing the assembly method for the plastic components in a medical device, stay process-neutral and weigh the advantages and disadvantages of the available methods.

Evaluating the risk of device misconnections: Designing for medical devices with ISO 80369 in mind

Beginning in the 1990s, concerns grew regarding the proliferation of medical devices fitted with luer connectors and the reports of patient injuries and deaths arising from misconnections. Thus began a many years process to develop new industry standards for the small-bore connectors used in medical device applications.

69

A few ideas for improving productivity in medical processes

Drive-based vibration and slosh control can help improve throughput in machines that assemble medical devices and products.

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28 REGULATORY: 7 step to a successful first date with the FDA. 30

PATENT PROTECTION: How strategic patents can strengthen your medical device innovation.

34

FDA NEW PRODUCTS: Some of the pre-market approvals the U.S. Food & Drug Administration granted in February 2015.

76

PRODUCT WORLD Diaphragm pump, Retaining rings, Heart monitor sensor, and more.

79

DEVICE TALKS: Is there an unserved market for medical devices in psychiatry?

84

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MANUFACTURING & MACHINING

How lifting columns improve patients’ experience Vertical lifts are required in a wide range of medical equipment where accessibility and comfort improves care and patient outcomes.

Applications such as wheelchair lifts, examination tables, dental chairs, adjustable nurses’ stations, and optician instruments all require vertical lifts to provide appropriate care and an optimal patient experience.

Designers of medical equipment need lifting columns that are cost effective and provide a positive-user experience.

Kyle Thompson | G l o b a l P r o d u c t L i n e M a n a g e r, S y s t e m s | Thomson Industries, Inc. |

Maximizing speed and extension-to-retraction ratio A lifting column must offer a combination of speed and performance. A competitive edge can be gained if equipment can handle a high-load capacity and provide a stroke length which meets the Americans with Disability Act’s legal height requirements while operating at a speed to maintain efficiency of operation. Innovative designs of lifting columns that are currently available make this possible by using a telescopic lead screw with a nesting three-piece extrusion for a surprisingly small minimumretracted length and great extension-to-retraction ratio. These devices are ideal for use in machines such as wheelchairs or examination tables as well as ergonomic workstations. This technology can handle up to 2,000 N loading with operation speeds of up to 25 mm/s.

High load capacity For bariatric and chiropractic applications, high-load capacity is of utmost importance. A load capacity of up to 3000 N with high moment loading in a compact frame size is achieved by using a ball screw with a three-piece extrusion, which has additional extrusion overlap to allow for extended-length bushings. The resulting lifting column can have a short retracted length and deliver the smooth, quiet operation required for medical or home environments.

Noise reduction Low, consistent, and smooth noise operation provides an ideal medical environment. High-performance linear actuators can be supplied with noise-deafening covers making them suitable for use in medical applications without the need to add additional noise attenuation. The use of a single motor and screw further ensures smooth operation and patient comfort, while also allowing for lower amp draw and longer life.

Enhanced ergonomics Telescopic lifting columns maximize the extension-to-retraction ratio and give the flexibility in range of movement required to Modern innovations in lifting column technology mean medical machine builders can design without compromise, taking advantage of easy installation and superior performance while reducing overall costs.

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MANUFACTURING & MACHINING

Thomson’s LC 2000 is an easy to install, low-cost ergonomic solution that is said to increase operator and patient comfort.

lifting force while handling potential moment loads of up to 400 Nm. To provide column moment loading capability, an engineered polymer slide bushing is used that slides along the extrusion as the column telescopes and is keyed to enable about 40% more moment load than alternate designs.

In applications where there is too much side load for a single column, designers may synchronize two to four lifting columns together.

The resulting system will offer more stability, load capacity and moment load capacity, as required. For all installed configurations, a loading brake is vital to ensure the load is held even on power failure to provide complete safety for the user.

Reducing overall machine and lifetime costs Making the outside of lifting columns aesthetically pleasing eliminates the need for additional covers or shrouds. This simplifies machine design and reduces manufacturing costs. Pre-drilled mounting holes allow for easy mounting and integration into a machine. The lifting column will automatically shut off at end-of-stroke because the limit switches are internally wired in series with the motor power. No limit switch wiring is required from the user.

Fully enclosed columns can use high-viscosity grease to prolong life. The Thomson LC series lifting columns, for example, provide 10,000 cycles at full load, giving reliable lifetime performance with no ongoing maintenance or greasing requirements to help reduce lifetime costs.

improve patient, doctor and operator ergonomics. For example, powered wheelchairs will feature a minimal retracted height making it easier for patients to get into the chair and also offers high extension which lets users reach high objects, such as wall cabinets. Equipment such as examination tables or dentistry chairs can be adjusted to let patients get on easily and then quickly and smoothly be moved to an optimum height to ensure physician comfort and reduce the risk of back injuries. Additionally, using a column that provides rapid movement further ensures comfort and safety without compromising equipment integrity.

Bearing the load Other innovative design features in modern lifting columns include the ability to handle increased moment loads. The use of stand-alone actuators provide 12

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Fulfilling application and budget requirements To meet application and budget requirements, the right balance between extension-to-retraction ratio, load capacity, speed and cost is necessary. For medical applications, quiet, smooth operation is an obvious benefit. Ease of installation, ongoing maintenance and footprint of a lifting column solution are also factors machine designers must consider.

Light weight, quiet operation for cost-sensitive applications.

For applications such as baby incubators, optician testing machines and mobile carts, the extension-to-retraction ratio is not as critical.

Stroke lengths of up to around 400mm and loading capacity of up to approximately 1,600 N are usually adequate. It is important to have competitively priced solutions with exceptionally quiet operation for these applications.

Meeting exact requirements. There are a vast range of lifting columns available–each with features and benefits that may make them more or less favorable for a given application. Most equipment can also be customized to meet exact requirements such as higher retracted lengths, mounting plates with customer specific mounting arrangements, special cable lengths and double or extended bushings.

Modern technological advancements mean that whatever the application, machine builders can get the features they need in a solution which is cost-effective and easy to install while providing a better overall equipment performance and user experience. M

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LEGAL COMPLIANCE

Mobile apps could be more medical than you think, and the FDA will notice

Delmar Howard | mHealth Program Manager | Intertek |

The infiltration of apps into everyday life – and everyday healthcare – has fostered many new opportunities for medical businesses. Apps are programs that run on cell phones and other mobile devices. There are many tantalizing prospects.

They range from being able to develop new and supportive app products that boost patient care to those that aim to help identify health issues before they become more serious problems. While these apps primarily exist to make increasingly complicated modern-day lives easier, they can also present challenges with issues of regulatory obligations, necessary testing and trials, correct usability, privacy, security, and more.

Mobile health apps – or mHealth apps – are those that monitor health-related readings. These include blood pressure monitors, heart-rate meters, and other measuring devices, as well as apps that help maintain and store data input by users to monitor readings taken on other devices or in other ways. It can be confusing trying to understand when a mobile app leaps from a general wellness to a medical device, even though the FDA recently published guidance to help industry navigate the regulatory landscape.

Apps that are medical in nature and directly or indirectly involved with the treatment of a person in medical care are governed by the U.S. Food and Drug Administration (FDA), under its 510(k) and Premarket Approval (PMA) regulations. When the FDA thinks an mHealth app has crossed into medical territory, the app and its development company are subject to all the required regulations under 510(k). A subsequent investigation can required the developer to pull the application from the marketplace.

Potential consequences For example, a urinalysis app created by a non-U.S.based company drew the FDA’s attention when it launched in the U.S. market in early 2013. The app claimed it could help users determine their risk for a variety of medical conditions by taking a photo of an associated urinalysis chemical strip and analyzing the photo to make medical color comparisons. By crossing into medical diagnostic territory, the FDA decided the app and its associated strips were in

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medical care territory and thus needed to adhere to and be evaluated according to the 510(k) process.

According to a letter from the FDA to the app’s development company, the dipstick strips associated with the app had achieved the proper FDA clearance, but: “…they are only cleared when interpreted by direct visual reading. Since your app allows a mobile phone to analyze the dipsticks, the phone and device as a whole functions as an automated strip reader.

When these dipsticks are read by an automated strip reader, the dipsticks require new clearance as part of the test system. Therefore, any company intending to promote their device for use in analyzing, reading, and/or interpreting these dipsticks need to obtain clearance for the entire urinalysis test system (i.e., the strip reader and the test strips, as used together).”

Consequent to this letter, the associated company pulled that iteration of the app from U.S. availability and launched an online crowdfunding campaign to help it gain capital and user data to support its work in achieving the proper FDA clearance.

How to assure proper steps are taken Typically, when the FDA makes a move that involves removing an app from the marketplace, they meet with the developer and urge them to put their product through the 510(k) clearance submission process, which aims to ensure the developer followed the proper guidelines in the development of a medical application. This typically requires the inclusion of third-party-conducted and -verified studies and data, as well as documentation on how the app shows substantial equivalence to a current medical device.

The urinalysis-app developer could have avoided its mishap by having a better understanding of the FDA’s regulatory requirements around medical apps. However, because few understand what makes an app a medical device (or what doesn’t), businesses looking to pursue these opportunities in the marriage of technology and medicine must work closely with regulatory advisors and testing partners. It’s true that the FDA publishes

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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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17651 Armstrong Avenue Irvine, CA 92614 (714) 546-0994 Fax (714) 546-7614 e-mail: globalexpress@mnrubber.com www.mnrubber.com 21-90-3320-50

For a project evaluation call : 952-927-1400.

Email requests to medical2@mnrubber.com Download our complete literature and design guide at mnrubber.com/medical2

Engineered to improve performance.

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MR&PRubber Medical ad Medical Minn 6-15.indd 15Design & Outsourcing.indd 1

of complex devices makes us the preferred partner for industry leaders throughout the world. The next time your component or assembly project seems impossible, there’s no one better to partner with than Minnesota Rubber and Plastics. We’ll make your tough application a reality.

Leader in Advanced Material Technologies

5/5/15 10:25 AM 5/21/15 4:11 PM

LEGAL COMPLIANCE

SINCE YOUR APP ALLOWS A MOBILE PHONE TO ANALYZE THE DIPSTICKS, THE PHONE AND DEVICE AS A WHOLE FUNCTIONS AS AN AUTOMATED STRIP READER.

ELECTROFORMED BELLOWS TECHNOLOGY

Medical Bellows

guidance about what does and does not constitute a medical app, but it’s also true that regulatory experts are needed to interpret that guidance.

This can include a gamut of trial and testing needs. Testing a medical app typically requires a regulatory expert to specify what and how much testing is needed based on their experience dealing with the FDA. Much of this testing is usually based on risk mitigation, but there can also can be extensive testing regarding the function and performance of the application. For example: • How it may or may not be involved in treatment therapies according to physicians; • How it compares to other medical devices that have achieved FDA 510(k) clearance; • How any Health Insurance Portability and Accountability Act (HIPAA) regulations apply; and more.

Applications:

ISO 9001:2008 Certified RoHS Compliant

• Catheters for Therapies • Infusion Pumps • Implantable Devices • Surgical Instruments • Blood Pump Circulators • Drug Delivery • Seals for Harmonic Scapels • MRI and Imaging Equipment • Intravascular Tubing

Contact us for Engineering Assistance Making the Impossible....Possible!

(973) 785-4630 | servometer.com Compliance_JUNE 2015_Vs5.indd 16

Creating a test plan according to FDA recommendations and guidelines is the smartest way to help ensure a product successfully makes it to market.

The number of mobile apps that have acquired FDA 510(k) clearance is still relatively low, due primarily to the much more stringent requirements.

Apps that obtain 510(k) clearance, however, often benefit from a heightened perception and marketability, although it does require a more significant time and monetary investment on the part of the app developer.

Government agencies continue to monitor this section – and intersection – of the mobile and medical businesses. For instance, the FDA and the Federal Trade Commission (FTC) recently imposed fines on two melanoma risk-detection apps. Medical app developers should be aware that more restrictions and requirements could be imposed onto these kinds of apps at any time.

In the development of a medically related app, companies should partner with regulatory and testing experts who know the FDA, are able to work within the system to meet all the needed requirements, and understand how to give a medically oriented app the best face in the medical marketplace. M 16

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5/21/15 11:00 PM

Peel it off.

Peel it ALL off.

Introducing FluoroPEELZ™ Peelable Heat Shrink

One simple linear tear is all it takes.

Groundbreaking FluoroPEELZ™ peelable heat shrink from Zeus offers medical device manufacturers the revolutionary way to increase yield and improve safety.

Visit Zeus at MDM East Booth 1703 for more information, contact us at support@zeusinc.com.

Request a sample today at www.zeusinc.com/fluoropeelz

US +1 (803) 268-9500 | Europe +353 (0)74 9109700 Asia +86 13922204986 | Latin America +1 (803) 268-9500 www.zeusinc.com

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5/21/15 5:01 PM

TUBING TALKS

How tubing innovators are improving minimally invasive surgery Josh Ridley | S e n i o r M a n a g e r, B i o m a t e r i a l s D i v i s i o n | Zeus |

Tubing as fine as a human hair provides an ideal example of how medical devices continue to decrease in size, thereby broadening opportunities for minimally invasive surgery techniques.

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It may not be trending on Twitter, but minimally invasive surgery (MIS) is one of the hottest areas in healthcare today. Since its inception in the mid-1960s, clinicians and medical technology leaders around the world have explored ways to employ MIS in a wide array of diagnostic and therapeutic procedures. Never has the need for advances in minimally invasive techniques been more important to industry and the clinical community.

Healthcare reform is driving – essentially mandating – efforts to reduce hospitalization time and re-interventions while improving patient care and clinical outcomes. Cost-reduction efforts have a trickle-down effect on medical device companies – and subsequently to their entire supply chain. The challenge is to forge a different path for accessing anatomy that was previously accomplished via open surgery procedures. This is driving the need for advances in polymer extrusion technology and other processes and components for minimally invasive devices.

Shrinking medical devices From an end-user perspective, MIS offers huge benefits in terms of cost (procedure time), recovery (hospitalization), patient comfort (reduced trauma) and improved clinical outcomes (efficacy). Better yet, the idea isn’t limited to the vascular procedures, such as stenting and balloon angioplasty, that are most often associated with minimally invasive, catheter-based procedures.

Percutaneous coronary intervention (PCI) has come a long way since Dr. Andreas Gruentzig performed the first procedure in 1977. New PCI devices and procedural approaches surface on a regular basis and in other fields of medicine; otolaryngologists, for example, may have taken a page out of Gruentzig’s book to treat chronic sinusitis sufferers. It wasn’t long ago when patients unresponsive to drug therapy were left with no other choice than an invasive and painful procedure to treat chronic sinus infections. Modeling coronary balloon angioplasty, most ENT offices now offer balloon sinuplasty procedures, a much less invasive, painful, and costly alternative.

Similar examples abound across disciplines. What were once complex and often dangerous procedures in GI/endoscopy, laparoscopy, structural heart repair, neurology, oncology, urology and women’s health, among others, are now routinely performed using percutaneous, catheter-based, minimally invasive devices. Patients benefit from reduced trauma, less scarring and postoperative pain, and speedier recoveries. Doctors and hospitals win as well – MIS affords them the ability to better control escalating costs via more efficient procedures, reduced hospitalization times, and lower risks for secondary infections or re-interventions.

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TUBING TALKS

A closer look at tubing with a peelable heat shrink Zeus’ FluoroPEELZ peelable heat shrink offers medical device manufacturers a simple way to remove the recovered FEP heat shrink over the outer shaft of a catheter.

This paradigm shift in approach from open surgery to minimally invasive access would not be possible without the co-evolution of polymer extrusion technology. Advances in device design that afford improved access require delivery catheters with lower profiles, i.e. smaller outer diameters, without sacrificing real estate inside the catheter.

These innovative product offerings in extruded polymer tubing let doctors and hospitals treat more patients, disease states, and challenging cases with unprecedented levels of improved safety and efficacy.

A leap forward for traditional interventions Minimally invasive techniques are being used in almost every anatomical area from head to toe. New successes are

FASTER RECOVERY, LESS PAIN, AND FEWER COMPLICATIONS

being announced on a regular basis. A recent study out of Ireland, reported in the March 25 online edition of JAMA Surgery, found that patients who 20

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underwent laparoscopic colon resections greatly benefitted from MIS when compared to patients who underwent traditional open surgery. The MIS procedure reduced patients’ hospital stays by almost three days (4.5 versus 7.4) and recorded a 23% cost-of-care reduction ($24,196 versus $31,601). Perhaps most significant in the findings – although the most difficult to quantify – are the implications for improved patient care. According to lead author Dr. Conor Delaney of University Hospitals Case Medical Center in Cleveland, MIS enables “faster recovery, less pain, and fewer complications.” (http://goo.gl/N9snoI) Although not cited in the study, other clinical benefits for MIS procedures will almost always include reduced incidence of hospital-associated infection (HAI) – also known as nosocomial infection – because of minimized hospitalization time.

The next generation of MIS – Bioabsorbables Attend almost any endovascular conference and it will become immediately apparent that the bioabsorbable revolution is upon us. Bioabsorbable polymers, namely polylactic acid or PLA and polyglycolic acid or PGA, have been used for decades in areas including orthopedics and closure devices. More recently, these materials have been used in increasingly sophisticated applications such as coronary scaffolds and tissue engineering. With customized absorption profiles, these extruded polymers perform their prescribed function for a pre-determined period, after which they are safely absorbed and excreted by the body. Fully absorbable coronary scaffolds – which start out as highly customized, finely tuned extruded tubing – are already on the market with refinements and new advances forthcoming.

The benefits of these next-generation extruded polymer offerings are of paramount importance.

When combined with minimally invasive procedures,

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bioabsorbable technology represents perhaps the greatest stride in medical device innovation witnessed in years.

Advances in polymer science and extrusion technology directly correlate to the evolution from surgical-based intervention to minimally invasive approaches and associated medical device design. The goal of reducing procedure and hospitalization times, and patient trauma, while improving outcomes has created a dependency on polymer and extrusion science to keep pace with clinical demands. Whether it’s the laparoscopic repair of a ventral hernia or the placement of a bioabsorbable scaffold to treat coronary artery disease, polymer tubing suppliers are harnessing their ingenuity to constantly remain at the forefront of emerging technology.

In doing so, they are helping change the landscape around minimally invasive surgery. M

Bioabsorbable polymers such as Zeus’ Absorv are capable of safely existing in the body for controlled lengths of time before absorbing without harm or adverse interactions.

Smart fluid handling to take you forward, faster.

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• Designs prevent misconnections • Thousands of proven standard product choices • Custom connectors, including hybrids that transfer signal and fluid in one step Download the white paper at cpcworldwide.com/medical.

Fluid/signal hybrid © 2015 Colder Products Company

Tubing_JUNE 2015_Vs6.indd 21

5/21/15 11:05 PM

CONNECTOR & CABLES CORNER

Safe power for medical equipment Chris Peters | Application Engineer | SCHURTER Inc. |

The application examples are for vario us mating connectors

Electrical equipment in the medical field must not place patients or medical staff in harm’s way. Designing safe equipment starts where power is supplied. New medical devices require that power connectors and power entry modules fulfill the base standard for medical electrical equipment, IEC/UL 60601-1. A short circuit or residual current can trigger a protective system upstream and in doing so possibly shut down other life-sustaining equipment.

Thus, it is necessary to pay special attention to how each unit is supplied with power. Recent ideas from our company for connectors and power entry modules comply with these standards and generally can be used in most equipment without additional testing.

Medical equipment is governed by IEC/UL 60601-1 and harmonizes with both North America and Europe safety requirements. An important recent addition to this basic standard for medical devices is IEC/UL 606011-11 for protection in a Class II environment.

Shorter hospital stays mean manufacturers of medical devices are being presented with new challenges to minimize the safety risks associated with the use of in-home medical equipment. Because these medical products are operated by laypersons with little medical training, regulatory requirements have been established to provide safety measures specifically for the patients and operators.

For instance, the IEC 60601-1-11 safety requirement places several restrictions on in home medical equipment, such as: • Altered ambient conditions (storable at -25 to 70°C and operation at 5 to 40 °C with RH at 93%) • Protection Class II (no protective earth connection is permitted) • Enclosure protection from water and dust must be at least IP 21 (light rain) • Stricter shock and vibration tests (30 min random vibration test per axis)

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www.medicaldesignandoutsourcing.com

5/21/15 11:10 PM

Providing High Speed Solutions... ...in a High Paced Market.

In this industry, the demand for new products can rise in a heartbeat. And if you’re not first to market, you may as well be last. That’s why more OEMs turn to PTI Engineered Plastics. We specialize in complex, low volume plastic injection molding. We can design, engineer and manufacture any part to your specifications and deliver it in record time — without ever missing a beat.

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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CONNECTOR & CABLES CORNER

SCHURTER’s DC12, Power Entry Module with Filter is approved for Protection Class II.

Devices certified to Protection Class II have double insulation between the main circuit and the output voltage or metal enclosure. Even when they have electrically conductive surfaces, they are protected against any contact with other live parts through the double insulation.

Our company offers various combination connectors that satisfy the IEC/UL 60601-1 requirements, as well as connectors that meet the stricter requirements from IEC/UL 60601-1-11 for Protection Class II. One such module, the DC12 power entry module with EMC filter and line switch, provides double insulation between energized components and exposed parts, and complies with equipment level standard 60601-1-11.

All company filtered connectors for Protection Class II design have been highvoltage tested to 4,000V. Every one of these manufactured components is tested before leaving the factory.

A must for medical equipment Protecting equipment operators and patients is paramount, so special attention must be paid to effectively suppress transients on the conductive lines. Most standard devices today are supplied with power by switch-mode power supplies.

These are suitable for the various main voltages around the world. Due to the fast-switching capability by ICs, they have a high efficiency.

These switching ICs, however, cause great interferences that can be measured on the power mains. EMC standards specify limits for conducted and radiated interfering voltages for medical 24

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The V-Lock Cord Retaining System prevents accidental power interruptions.

equipment. This is a precondition for compliance with the EMC standards, which in turn is necessary for CE conformity marking. The use of a line filter is recommended.

This can be a standalone block filter or a line filter in combination with the connector.

Because the ground connection is missing in IEC appliance inlets with Class I, medical M5 filters, and Class II configurations, the filter has to make do without ground capacitors. These so-called Y-capacitors are widely used in most filter circuits because they offer good attenuation in higher frequency ranges (≥1 MHz). The attenuation loss can be compensated by more inductivity or by attaching ferrites to the power cable. However, as this is not always practical or even possible it’s recommended to deal with interferences in this frequency range as close as possible to the source of the interference. A power entry module with filter meets this recommendation by providing a line filter directly on the mains. www.medicaldesignandoutsourcing.com

5/21/15 11:12 PM

YOUR DESIGN · OUR MOTOR

A PERFECT FIT CUSTOM MOTOR MANUFACTURING If the motor you need does not yet exist, we’ll bring it into existence. Nippon Pulse manufactures custom

Power cord retention for additional safety Medical devices can be connected directly to the mains or with a detachable power cord. However, mobile devices, such as analytical apparatuses, diagnostic devices, endoscopy equipment, or laboratory equipment work in environs with greater danger of an accidental power-cable disconnect.

Detachable plug connections must meet the requirements of IEC standard 60320. Depending on the application, it is recommended to include a mechanism to protect against any unintentional plug removal from the equipment’s power socket.

The most common type of protection against inadvertent disconnection is a cord-retaining bracket. However, it is critical to select the correct bracket shape because there are many variations depending on plug type and size as well as the equipment use.

The V-Lock cord retaining solution, a simple attractive and alternative system to brackets, provides a better solution. With the V-Lock solution, the power socket is equipped with a notch that interlocks with a special latch on the power cord connector. Unlike brackets, the system forces the user to lock the cordset to the connector for operation which ensures the cord from being unintentionally removed from the socket. The V-lock solution makes unnecessary an additional cordretaining system specific to a unit’s power socket or retaining bracket. M

• tin-can steppers • synchronous motors

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SYSTEM INTEGRATION Nippon Pulse offers other motion control products, including controller and driver chips and boards and encoders, so we can provide full system integration for your application.

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We deliver innovative products of the highest quality, and offer exceptional service and support.

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Asymmetric attenuation curves come from a 1 A filter with Y-capacitors (top line) and without Y-capacitors (bottom line).

6 • 2015

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

5/21/15 11:13 PM

THE CATH LAB

PFOA-free PTFE ready for catheter applications Don Garcia Director Research & Development Boyd Coatings

| | | |

Boyd Coatings Research Co. has six PTFE colors – all of which are created with the company’s fully-validated and FDA & EPA-compliant, Zero PFOA PTFE formula. Colors include blue, black, green, white, yellow and clear.

In addition, the company can custom formulate additional colors to meet any customer’s particular needs.

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PTFE coatings are widely used in a variety of industries and a myriad of applications.

In the medical field, PTFE is commonly used to coat surgical instruments as well as medical components such as catheters, guidewires, and implantables. Recently the material garnered attention due to changes put forth by federal EPA protocols as well as medical product recalls.

PTFE (PolyTetraFluoroEthylene) is a fluorocarbon-based polymer and, over the years, has proven itself an essential coating used in almost all industries. Best-known for its non-stick qualities, it can be used on a vast array of materials such as carbon steel, stainless steel, steel alloys, aluminum, brass, and magnesium, as well as non-metallic surfaces such as glass, and some rubber materials.

Here’s the problem: PFOA (Perfluorooctanoic acid), a nonnatural occurring substance used in the manufacture of PTFE and other manufacturing applications, was persistently showing up at low levels in the environment. The EPA began investigations into the chemical, and, ultimately, issued a request to eliminate PFOA by 2015.

In the case of PTFE, there remained some of the PFOA used for manufacturing PTFE dispersions. That meant that all U.S. companies would have to develop new formulations of products that would not use PFOA in their manufacturing. EPA set up the transition into two phases: The first was a 95% reduction which was completed in 2010 and the second to be completed by 2015.

(It should be noted that while the industry refers to the current materials as Zero PFOA PTFE for convenience, there is still the

possibility of “trace” quantities of PFOA. The proper technical term is “manufactured free of PFOA”).

After more than nine months of successful product testing and noncritical real-world applications in the field, our company announced last year, that it offered a fully-validated, Zero PFOA PTFE coating and application process for use on medical guidewires and devices having as good as or better performance characteristics as legacy (pre 2006) and low PFOA (phase 1) material.

While the new formulation of Zero PFOA PTFE successfully coated medical guidewires and devices, others were not so successful. One coater used possibly substandard replacement ingredients in its new formulation, and then mistakenly decided not to undergo the testing necessary to qualify the product for use within the human body. As a result, the FDA had some manufacturers recall their guidewires. This created doubt in the industry.

Following the recall of two OEM’s guidewire products, some in the medical device industry expressed concern and cast aspersions indiscriminately towards Zero PFOA PTFE. The medical PTFE coating industry suffered a loss of confidence.

In fact, some manufacturers of medical guidewires considered coating their products with something other than PTFE. The medical PTFE adhesion failure discovered on certain guidewires within the industry is the result of poor planning and due diligence and is no reflection on true viability of this advanced coating. Medical device OEMs should neither overreact, nor cast aspersion on all applicators or the PTFE coating itself. PTFE is still the Gold Standard for coating medical guidewires, and the zero PFOA material remains tested and FDA qualified. M

www.medicaldesignandoutsourcing.com

5/21/15 11:17 PM

Rapid Manufacturing That’s a Real Lifesaver Tech-driven injection molding, CNC machining and 3D printing for those who need parts tomorrow

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5/21/15 5:10 PM

REGULATORY

7 steps to a successful first date with the FDA ”His palms are sweaty, knees weak, arms are heavy...” Was Eminem talking about his first encounter with the Center for Devices & Radiological Health (CDRH) at FDA? Why does the anticipation of a first “date” with CDRH send your heart into overdrive? And what do you need to do to prepare adequately so you don’t feel like a hormonal teenager about to go on a first date?

Here’s what you can you do to ensure success on your “first date” with CDRH – from asking them out to that awkward goodbye.

1

1. First of all, ask yourself - do I really want to date CDRH? Yes! It’s free and easy. And you can get input into any aspect of your product life cycle, but to make ]a good impression on that date, you really need to be prepared so you are well regarded from the ]first interactions.

Sonna Patel-Raman, PhD | Consultant II | Halloran |

2. How should you ask them out?

Follow the CDRH pre-submission guidance. If you do, you are pretty much guaranteed that they will say yes. Meet the requirements outlined in the pre-submission guidance for a high quality submission (i.e., ensure that it’s organized, clear and concise, and you’ve identified your questions) and ask for a face-to-face meeting, a teleconference, or just a written response.

3

3. What are you going to talk about?

Identify your critical issues – these can vary depending on where you are in your product development cycle. Get early input from all of the appropriate stakeholders and plan to meet regularly with your team. Questions can range from those about device classification and the regulatory pathway to more specific questions about pre-clinical bench testing and animal studies.

If you are further along, you may be ready to discuss the design of your pilot or pivotal study. Your questions should focus on specific issues that result in an answer that provides value. Questions such as “How should we design our clinical study?” or “What CRO do you recommend?” can be seen as unprepared and unseasoned vs. “Do the clinical trial endpoints meet with the Agency’s expectations?” which will be seen as pointed and experienced. Don’t be seen as an awkward dater, knocking the potential out of the relationship before even getting to first base!

Questions should be specific, targeted, and not open ended in either time or intent. Open-ended questions are difficult for CDRH to give you concrete feedback.

4. Make like Nike and Just Do It! Ask them out.

Once you have organized your pre-submission with the right questions (according to the guidance document), send it in! If this is your first time making a submission, get an expert to look it over so it will be met with an understanding that you know what you are doing. Everyone likes to place their best foot forward and feel confident, and have intentions clearly articulated before heading out into the dark.

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www.medicaldesignandoutsourcing.com

5/21/15 11:28 PM

5

5. Pre-date ritual Put your heels on. While you wait for your date, you should be getting ready with your stakeholders.

Practice internally and identify questions that CDRH may ask with an articulate and plausible answer that provides the agency with the assurance that you have been around the bases before, even if it’s your first time. Consider obtaining an external perspective for complex issues - someone who can help you understand CDRH’s current thinking. Also consider bringing along experts (design engineers, clinicians, statisticians) who can answer questions from the CDRH experts at the meeting, kind of like a suave but highly respectable big brother who will watch out that you stay in the “safe zone”.

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6. THE BIG DATE Relax. You’re as prepared as you’ll ever be. Plan to achieve agreement on critical issues, obtain clear feedback, and determine next steps. For some of you, that may mean a follow-up pre-submission meeting, which doesn’t have to be face-to-face. As for the fake yawn/arm around the shoulders move?

Don’t necessarily try to make any big commitments right now, and for sure, you shouldn’t expect any either. Can’t hurt to be friendly, but don’t go too far and expect instant agreement with all of your questions. And never be confrontational.

part production.

7

7. After the awkward goodbye at the door...

You’ve met with CDRH and discovered it wasn’t so bad! If you think you have more questions about another issue, be sure to mention to CDRH that you might be interested in a follow-up meeting to discuss. Draft meeting minutes and summarize key points. Provide the documentation for CDRH to review. Determine if you need a follow-up meeting – i.e., a second date!

Stay tuned...

(By the way - this isn’t how I’d recommend ACTUAL dating...) M 6 • 2015

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precision cleaning technologies to meet the demanding needs of medical Learn how our technology-neutral approach allows us to deliver the best solution to meet your specific application needs. Our global resources and local presence enable us to quickly provide the support you require anywhere in the world.

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5/21/15 11:29 PM

PATENT PROTECTION

Strategic patents can strengthen your innovation David J. Dykeman | G r e e n b e r g Tr a u r i g | LLP |

In today’s innovation economy, a medical device company’s success depends on the strength and value of its patent portfolio.

Recent statistics from the U.S. Patent & Trademark Office (USPTO) show the issue rate for new medical device patents is exploding. In fact, the number of medical device patents issued by the USPTO has increased each year since 2009. While the number of issued patents is increasing across all technology sectors, the issuance of medical device patents is increasing at a much faster rate. According to Thomson Reuters, medical devices exhibited the strongest patent growth rate among 12 key technology areas. Indeed, medtech companies need to stake their claims in the medical device patent gold rush.

Patents Fuel Company Growth A strategic patent portfolio is crucial to a medtech company’s growth and survival and can provide numerous business advantages. Patents are extremely important for medical device companies in all life stages. For early-stage companies, patents are often the only way for investors to place a value on a company’s technology, as sales usually cannot begin until after regulatory approval from the U.S. Food & Drug Administration (FDA) or the European Medicines Agency (EMA). In this way, patents make up a significantly greater portion of enterprise value for early-stage medical technology companies than other startups. As a medtech company grows, patents become the currency to secure financing through venture capital or private equity investment. Patents can also lead to collaborations, joint ventures, and licenses with strategic partners.

Patents are equally important for later-stage companies that are generating revenue. Experts estimate that the average medical device and drug patent can have

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a net present value of almost $200,000. Simply put, patents are a source of enterprise value that medical device companies cannot afford to ignore.

In addition to their monetary value, medical device patents also hold great strategic value. A strategic patent portfolio can be used both offensively as a sword to strike out at competitors, and defensively as a shield to avoid competitor attacks. Offensively, patents can prevent competitors from making, using, or selling the patented invention. Defensively, patents can serve as bargaining chips against a competitor who threatens to sue for patent infringement of one of the competitor’s patents.

Develop a Strategic Patent Portfolio Developing a strong portfolio first requires comprehensive patent coverage for the company’s core technology. Companies should file one or a series of patent applications providing the broadest possible patent protection to cover the core technology. To obtain broad patent protection, a medtech company should consider both current and future business objectives and contemplate ways that competitors may attempt to design around the patents.

Where applicable, patent claims should be directed to the entire device, key components, disposables, methods of manufacturing, methods of treatment, therapeutic uses, combination therapies, and any other aspects of the invention. As the core technology evolves, incremental improvements should be patented to form a “picket fence” of patent protection around the core technology.

By filing patent applications covering incremental improvements, medtech companies will continue to expand their presence in the marketplace.

Impact of Patent Reform Patent reform has recently swept across the United States and Europe, and medtech companies must adapt their patent strategies to maximize intellectual property (IP) protection. In 2013, multiple new provisions of the America Invents Act (AIA), the first major reform to patent United States law in 60 years, changed the United States patent system from “first-to-invent” to “first inventor-to-file.” Thus, medical device developers should file patent applications early in the development process before any public disclosure. The dramatic revisions of the AIA along with Europe’s recent proposals for a Unitary European Patent and Unified European Patent Court are closing the gap between the two regions’ patent laws. Such fundamental alterations in IP protection have medtech companies reevaluating how to best protect and enforce medical device innovations. Developers of

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PATENT PROTECTION

medical technologies should work with strategic patent counsel early in the development process to maximize patent protection in the United States and around the world.

File International Patent Applications Filing international patent applications further strengthens a patent portfolio and expands a company’s presence in the global marketplace. While foreign patent applications can be expensive, filing in strategic countries can be critical to the commercial success of a product. A company should consider filing in specific countries with a large target market for the product, countries where competitors’ manufacturing facilities are located, and countries that export medical products to other regions through distribution

Patent_JUNE 2015_Vs5.indd 32

channels. While the United States, Europe, and Japan have historically been top patent filing countries, China and Brazil are rising up the list.

Watch Out for Patent Trolls With the growing success of new medical technologies, the unwanted attention of patent trolls will not be far behind. Also known as patent assertion entities or nonpracticing entities (NPEs), patent trolls are businesses that acquire patents for the purpose of collecting royalties from companies whose products or practices allegedly infringe patents owned by the NPE. In 2013, patent trolls invaded the medical technology industry by filing numerous patent infringement lawsuits against medical device companies. As the funding and profits in the medical

technology sector increase, so will the undesirable activity of patent trolls. By taking careful steps to protect medical technology innovations through patents, companies can reap the financial and legal rewards of a successful strategy, and minimize the potential losses caused by patent trolls.

Conclusion In the wake of a shifting medtech market and changing patent legal landscape, tactical medical device developers would be wise to review and assess their research and development programs and patenting goals. By working with strategic patent counsel, medical device makers can take advantage of the changing patent landscape to stake bigger claims in the medical device patent gold rush. M

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FDA NEW PRODUCTS

The U.S. Food & Drug Administration’s list of pre-market approvals granted in February 2015 Summary of PMA Originals & Supplements Approved Originals: 2 Supplements: 62

Summary of All PMA Submissions Originals: 4 Supplements: 78

Summary of PMA Originals Under Review Total Under Review: 62 Total Active: 29 Total On Hold: 33

Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 62 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 148.0 FDA Time: 116 Days MFR Time: 32.0 Days

Summary of PMA Supplements Under Review Total Under Review: 556 Total Active: 430 Total On Hold: 126

PMA Original Approvals APPLICATION NUMBER / DATE of APPROVAL

DEVICE TRADE NAME

COMPANY NAME CITY, STATE, & ZIP

DEVICE DESCRIPTION / INDICATIONS

P130023 2/3/15

TissuGlu® Surgical Adhesive

Cohera Medical, Incorporated Pittsburg, PA 15212

Approval for the TissuGlu® Surgical Adhesive. This device is indicated for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in abdominoplasty.

P140018 2/20/15

VenaSeal Closure System

Covidien, LLC Morrisville, NC 27560

Approval for the VenaSeal Closure System. This device is indicated for the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV), through endovascular embolization with coaptation. VenaSeal is intended for use in adults with clinically symptomatic venous reflux as diagnosed by duplex ultrasound (DUS).

PMA Supplemental Approvals

34

APPLICATION NUMBER / DATE of APPROVAL

DEVICE TRADE NAME

COMPANY NAME CITY, STATE, & ZIP

P850064/S027 2/13/15 180-Day

Life Pulse® High Frequency Ventilator

Bunnell, Inc. Salt Lake City, UT 84115

Approval for a new patient box for the device.

P860003/S077 2/3/15 Real-Time

THERAKOS® UVAR XTS® Photopheresis System Procedural Kits

Therakos, Inc. Bridgewater, NJ 08807

Approval for a change in the polypropylene material used for the effluent tube of the centrifuge bowls in the UVAR XTS® Photopheresis System Procedural Kits.

Medical Design & Outsourcing

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DEVICE DESCRIPTION / INDICATIONS

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FDA NEW PRODUCTS

PMA Supplemental Approvals (continued) APPLICATION NUMBER / DATE of APPROVAL

36

DEVICE TRADE NAME

COMPANY NAME CITY, STATE, & ZIP

P860004/S205 2/25/15 Real-Time

Synchromed II Infusion System

Medtronic Neuromodulation Minneapolis, MN 55432

Approval for Synchromed II Infusion System refill kit model 8555 and IsoMed Infusion System refill kit models 8555 and 8553.

P880006/S092 2/15/15 Real-Time

SENSOLOG/ DIALOG/ REGENCY FAMILY OF PACEMAKERS

St. Jude Medical, Inc. Sunnyvale, CA 94085

Approval for the Model 3330 version 20.0.1 software for use on the Model 3650 Merlin Patient Care System (PCS) Programmer.

P880086/S253 2/25/15 Real-Time

AFFINITY/ INTEGRITY/ VICTORY/ ZEPHYR/ ACCENT FAMILY OF PACEMAKERS

St. Jude Medical, Inc. Sunnyvale, CA 94085

Approval for the Model 3330 version 20.0.1 software for use on the Model 3650 Merlin Patient Care System (PCS) Programmer.

P900033/S026 2/5/15 135-Day

INTEGRA Dermal Regeneration Template

Integra LifeSciences Corporation Plainsboro, NJ 08536

Approval for the following changes: 1) Change in cleaning detergent for certain equipment; 2) Change in cleaning method for certain equipment, utilizing isopropyl alcohol; 3) Establishment of equipment Dirty Hold Time (DHT); and 4) Establishment of a method to test for residues.

P900033/S041 2/12/14 135-Day

Integra Dermal Regeneration Template

Integra LifeSciences Corporation Plainsboro, NJ 08536

Approval for changes to the bioburden testing protocol for the Integra Dermal Regeneration Template.

P910023/S352 2/25/15 Real-Time

ELLIPSE/FORTIFY ASSURA FAMILY OF ICDs

St. Jude Medical, Inc. Sunnyvale, CA 94085

Approval for the Model 3330 version 20.0.1 software for use on the Model 3650 Merlin Patient Care System (PCS) Programmer.

P930014/S077 2/17/15 180-Day

Acrysof® Toric IOL & Acrysof® IQ Toric IOL

Alcon Research, Ltd.\ Ft. Worth, TX 76134

Approval of the following changes to the post-approval study for the device: Update the targeted number of subjects to be implanted from 415 to 400.

P930029/S049 2/12/15 Real-Time

ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEMS.

Medtronic, Inc. Mounds View, MN 55112

Approval for design changes for cables and foot switches required to meet RoHS compliance.

P950037/S139 2/10/15 180-Day

Dromos DR/SR rate Adaptive Pacing System

Biotronik, Inc. Lake Oswego, OR 97035

Approval for the Inventra, Iperia and Itrevia ICD and CRT-D devices as well as updates to non-implanted components Renamic, PSW 1401.U and the Home Monitoring Service Center to support the introduction of the new ICD and CRT-D devices.

P960016/S051 2/2/15 Real-Time

Livewire TC Ablation Catheter Safire Bi-Directional Ablation Catheter

St. Jude Medical St. Paul, MN 55117

Approval for a change to the buckle force product requirement for the Livewire TC and Safire Bi-Directional Ablation Catheters.

N970003/S170 2/25/15 Real-Time

Ingenio 2 Pacemakers: Accolade, Proponent, Essentio, Altura 2; Ingenio Pacemakers: Formio, Vitalio, Ingenio, Advantio

Boston Scientific Corporation St. Paul, MN 55112

Approval for a programming application software change for selected pacemakers and cardiac resynchronization therapy-pacemakers.

P970013/S063 2/25/15 Real-Time

MICRONY Family of Pacemakers

St. Jude Medical, Inc. Sunnyvale, CA 94085

Approval for the Model 3330 version 20.0.1 software for use on the Model 3650 Merlin Patient Care System (PCS) Programmer.

P980022/S161 2/13/15 Real-Time

Paradigm RealTime System, Paradigm RealTime Revel System

Medtronic MiniMed Northridge, CA 91325

Approval for changes to the pump motor sintered bearing material.

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DEVICE DESCRIPTION / INDICATIONS

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FDA NEW PRODUCTS

PMA Supplemental Approvals (continued)

38

APPLICATION NUMBER / DATE of APPROVAL

DEVICE TRADE NAME

COMPANY NAME CITY, STATE, & ZIP

DEVICE DESCRIPTION / INDICATIONS

P980043/S048 2/25/15 180-Day

Hancock II Porcine Bioprosthesis Heart Valve

Medtronic, Inc. Santa Ana, CA 92705

Approval for a change to stent material from acetal homopolymer (AHP) to polyetheretherketone, PEEK i5R (PEEK) for the devices.

P990009/S039 2/26/15

Floseal Hemostatic Matrix

Baxter Healthcare Corporation.

Round Lake, IL 60073

Approval for a manufacturing site located at Baxter Healthcare Corporation in Cleveland, Missouri.

P990034/S031 2/25/15 Real-Time

IsoMed Infusion System

Medtronic Neuromodulation Minneapolis, MN 55432

Approval for Synchromed II Infusion System refill kit model 8555 and IsoMed Infusion System refill kit models 8555 and 8553.

P990064/S057 2/25/14 180-Day

Mosaic Porcine Bioprosthesis Heart Valve

Medtronic, Inc. Santa Ana, CA 92705

Approval for a change to the stent material from acetal homopolymer (AHP) to polyetherether- ketone, PEEK i5R (PEEK) for the devices.

P990074/S029 2/11/15 180-Day

NATRELLE SalineFilled Breast Implants

Allergan Irvine, CA 92612

Approval for a manufacturing site located at Pro-Tech Design and Manufacturing, Inc., in Arlington, Texas.

P990081/S030 2/19/15 135-Day

PATHWAY AntiHER-2/neu (4B) Rabbit Monoclonal Primary Antibody

Ventana Medical Systems, Inc. Tucson, AZ 85755

Approval for the addition of Sanmina built Nozzle Plate Assembly in the manufacture of BenchMark XT instrument used in the tests.

P000006/S044 2/23/15 Special

Titan Inflatable Penile Prosthesis

Coloplast Corporation Minneapolis, MN 55411

Approval to implement an additional in-process test during the manufacturing of the Titan Touch pump.

P000037/S037 2/9/15 180-Day

On-X Prosthetic Heart Valve

On-X Life Technologies, Inc. Austin, TX 78752

Approval for modified device packaging and an extension to the product shelf life.

P010030/S058 2/22/15 Real-Time

LifeVest Wearable Defibrillator

Zoll Lifecor Corporation Pittsburgh, PA 15238

Approval for 1) Adding a new section to the Patient Manual that addresses Environmental Considerations Related to Noise and Vibration; 2) Adding a new section to the Operator Manual that addresses Physician Information To Instruct Patient Caregivers; and 3) Adding a new section to the Patient Manual that addresses What Family Members Need to Know.

P010032/S087 2/12/15 Real-Time

St. Jude Spinal Cord Stimulation System/8-Channel Adaptor

St. Jude Medical Plano, TX 75024

Approval for minor labeling changes to the SJM 8-channel adaptor (models 2311 and 2316); specifically, to include the use of the adaptor with the SJM trial system.

P010047/S036 2/13/15 Panel-Track

ProgelTM Pleural Air Leak Sealant

Neomend, Inc. Irvine, CA 92618

Approval for the Progel Pleural Air Leak Sealant (PALS). The single use Progel Pleural Air Leak Sealant device is indicated for application to visceral pleura after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks incurred during resection of lung parenchyma.

P020055/S015 2/19/15 135-Day

PATHWAY AntiC-KIT (9.7) Rabbit Monoclonal Primary Antibody

Ventana Medical Systems, Inc. Tucson, AZ 85755

Approval for the addition of Sanmina built Nozzle Plate Assembly in the manufacture of BenchMark XT instrument used in the tests.

P020056/S025 2/11/15 180-Day

NATRELLE SiliconeFilled Breast Implants

Allergan Irvine, CA 92612

Approval for a manufacturing site located at Pro-Tech Design and Manufacturing, Inc., in Arlington, Texas.

P020056/S026 2/25/15 180-Day

Natrelle Siliconefilled Breast Implants

Allergan Irvine, CA 92612

Approval for a line extension identified as the Natrelle Inspira Silicone-Filled Breast Implants to add breast implant options to the Natrelle Silicone-filled Breast Implants.

P030005/S116 2/25/15 Real-Time

Ingenio 2 CRT-Ps: Valitude, Valitude X4 Ingenio CRT-Ps: Intua, Invive

Boston Scientific Corporation St. Paul, MN 55112

Approval for a programming application software change for selected pacemakers and cardiac resynchronization therapy-pacemakers.

Medical Design & Outsourcing

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FDA NEW PRODUCTS

PMA Supplemental Approvals (continued)

40

APPLICATION NUMBER / DATE of APPROVAL

DEVICE TRADE NAME

COMPANY NAME CITY, STATE, & ZIP

P030011/S030 2/12/15 Real-Time

SynCardia Temporary Total Artificial Heart

SynCardia Systems, Inc. Tucson, AZ 85713

Approval for a minor design change to the Freedom Driver AC Power Supply.

P030017/S209 2/12/15 Real-Time

CoverEdge 32 Surgical Leads/ Precision Spectra™ MR Conditional SCS System

Boston Scientific Neuromodulation Valencia, CA 91355

Approval for minor labeling changes to the Precision Spectra™ MR Conditional Spinal Cord Stimulation System; specifically, the addition of the CoverEdge 32 Surgical Leads (SC-8336-50 and SC-8352-50) to the system.

P030017/S210 2/13/15 180-Day

Precision Spinal Cord Stimulator (SCS) System and Precision Spectra Spinal Cord Stimulator (SCS) System

Boston Scientific Corp.

Valencia, CA 91355

Approval for the Precisio S8 Adapter that will be used to connect the Precision Implantable Pulse Generator (IPG) or the Precision Spectra IPG to the following St. Jude Medical (SJM) SCS Leads: 3283/3286/3268/ 3269 Lamitrode S8, 3280 Lamitrode 8, 3244/3262/3263 Lamitrode 44, 3245/3264/3265 Lamitrode 44C, 3208 Lamitrode Tripole 8, 3210 Lamitrode Tripole 8C, 3288 Lamitrode 88, 3289 Lamitrode 88C, 3214 Lamitrode Tripole 16C, 3219 Lamitrode Tripole 16, 3228 Penta, 3183/3186/3189/3191 Octrode, 3086 Octrode Trial Lead Kit, 2283 8-channel Adapter, 3341/ 3342/ 3343/3346 Dual 4 Extension, 3382/3383/3386 Single 8 Extension.

P030035/S131 2/25/15 Real-Time

FRONTIER/ FRONTIER II/ ANTHEM FAMILY OF CRT-Ps

St. Jude Medical, Inc. Sunnyvale, CA 94085

Approval for the Model 3330 version 20.0.1 software for use on the Model 3650 Merlin Patient Care System (PCS) Programmer.

P030054/S281 2/25/15 Real-Time

QUADRA ASSURA/ UNIFY ASSURA FAMILY OF CRT-Ds; MERLIN PATIENT CARE SYSTEM PROGRAMMER

St. Jude Medical, Inc. Sunnyvale, CA 94085

Approval for the Model 3330 version 20.0.1 software for use on the Model 3650 Merlin Patient Care System (PCS) Programmer.

P040004/S010 2/27/15 180-Day

ADVIA Centaur® HBc Total ReadyPack Reagents, ADVIA Centaur® HBc Total Quality Control Materials

Siemens Healthcare Diagnostics, Inc. Tarrytown, NY 10591

Approval for claims to test neonate and pediatric populations with the FDA approved ADVIA Centaur HBc Total ReadyPack Reagents and ADVIA Centaur HBc Total Quality Control Materials. The device, as modified, will be marketed under the trade name ADVIA Centaur HBc Total ReadyPack Reagents and ADVIA Centaur HBc Total Quality Control Materials and is indicated for: ADVIA Centaur and ADVIA Centaur XP systems: The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human neonatal, pediatric and adult serum or plasma (potassium EDTA, or lithium or sodium heparinized) using the ADVIA Centaur and ADVIA Centaur XP systems. This assay can be used as an aid in the diagnosis of individuals with acute or chronic hepatitis B virus (HBV) infection and in the determination of the clinical status of HBV infected individuals in conjunction with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. This assay can also be used as an aid in the differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown.

ADVIA Centaur CP System: The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human neonatal, pediatric, and adult serum or plasma (potassium EDTA, or lithium or sodium heparinized) using the ADVIA Centaur CP system. This assay can be used as an aid in the diagnosis of individuals with acute or chronic hepatitis B virus (HBV) infection and in the determination of the clinical status of HBV infected individuals in conjunction with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. This assay can also be used as an aid in the differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown.

P040046/S007 2/11/15 180-Day

NATRELLE Highly Cohesive SiliconeFilled Breast Implants

Allergan Irvine, CA 92612

Approval for a manufacturing site located at Pro-Tech Design and Manufacturing, Inc., in Arlington, Texas.

Medical Design & Outsourcing

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DEVICE DESCRIPTION / INDICATIONS

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PMA Supplemental Approvals (continued) APPLICATION NUMBER / DATE of APPROVAL

DEVICE TRADE NAME

COMPANY NAME CITY, STATE, & ZIP

DEVICE DESCRIPTION / INDICATIONS

P050023/S079 2/10/15 180-Day

Inventra 7 VR-T, Iperia 7 VR-T, Itrevia 7 VR-T, Iperia 5 VRT, Itrevia 5 VR-T, Inventra 7 VR-T DX, Iperia 7 VR-T DX, Itrevia 7 VR-T DX, Iperia 5 VR-T DX and Itrevia 5 VR-T DX ICD Devices; Inventra 7 DR-T, Iperia 7 DR-T, Itrevia 7 DR-T, Iperia 5 DR-T and Itrevia 5 DR-T ICD Devices; Inventra 7 HF-T, Iperia 7 HF-T, Itrevia 7 HF-T, Iperia 5 HF-T and Itrevia 5 HF-T CRT-D Devices

Biotronik, Inc. Lake Oswego, OR 97035

Approval for the Inventra, Iperia and Itrevia ICD and CRT-D devices as well as updates to non-implanted components Renamic, PSW 1401.U and the Home Monitoring Service Center to support the introduction of the new ICD and CRT-D devices.

P060022/S020 2/3/15 Real-Time

Akreos AO60 Intraocular Lens (IOL)

Bausch + Lomb Surgical Irvine, CA 92618

Approval to modify the labeling to include the Bausch + Lomb IOL Injector (Model VIS100) to the validated inserters list on the labeling of the Akreos AO60 Intraocular Lens (IOL).

P060040/S038 2/12/15 Special

Thoratec HeartMate II Left Ventricular Assist System (LVAS)

Thoratec Corp.

Pleasanton, CA 94588

Approval for implementation of an additional existing Electrical Continuity test during the manufacturing process of the HeartMate II Left Ventricular Assist System (LVAS).

P080012/S021 2/10/15 180-Day

Prometra Programmable Infusion Pump System

Flowonix Medical, Inc. Mt. Olive, NJ 07828

Approval for a new programmer device. The device, as modified, will be marketed under the trade name Prometra Programmable Infusion Pump System and is indicated for intrathecal infusion of Infumorph (preservative-free morphine sulfate) or preservative-free sterile 0.9% saline solution (Sodium Chloride Injection, USP).

P080012/S024 2/12/15 Real-Time

Prometra Programmable Infusion Pump System

Flowonix Medical, Incorporated Mt. Olive, NJ 07828

Approval for implementing a mixed load sterilization configuration for the Prometra Pumps accessory kits, which are ethylene oxide sterilized.

P090015/S002 2/13/15 Real-Time

BOND Oracle HER2 IHC System

Leica Biosystems, Newcastle Ltd Newcastle upon Tyne, United Kingdom NE12 8EW

Approval for introduction of BOND version 5.1 software for use on the BOND Oracle HER2 IHC System.

P090031/S003 2/4/15 Real-Time

Monovisc

Anika Therapeutics, Incorporated Bedford, MA 01730

Approval to expand the specification for residual methanol in Monovisc from < 0.05% to < 0.03% w/w to be in accordance with residual solvent testing limits under USP General Chapter <467>, to revise the stability testing protocol for Monovisc, and to extend the shelf life of Monovisc from 2 years to 3 years utilizing this revised stability testing protocol.

P100010/S046 2/27/15 180-Day

Arctic Front Advance ST Cardiac Cryoablation Catheter

Medtronic Cryocath LP Quebec, Canada H9R5Z8

Approval for two new models to be added to the Arctic Front family of Cardiac CryoAblation Catheters: Arctic Front Advance ST Cardiac CryoAblation Catheters Models 2AFAST23 and 2AFAST28.

P100014/S013 2/12/15 135-Day

Solesta

Salix Pharmaceuticals, Inc. Raleigh, NC 27615

Approval for an extension of the clean room used during the manufacture of Solesta.

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FDA NEW PRODUCTS

PMA Supplemental Approvals (continued)

42

APPLICATION NUMBER / DATE of APPROVAL

DEVICE TRADE NAME

COMPANY NAME CITY, STATE, & ZIP

P100025/S007 2/3/15 180-Day

BreathTek® UBT for H. pylori and pUHR-CA

Otsuka America Pharmaceutical, Inc. Rockville, MD 20850

Approval for Cambridge Isotope Laboratories, Inc. (CIL’s) amended Drug Master File (DMF) #11378 on behalf of OAPI’s PMA Application which uses the drug as a component of the BreathTek UBT for H. pylori Kit. This supplement requests the review of the following changes to the Drug Master File: 1. Process change to manufacturing scale to add 18kg process; 2. Update to specifications and test methods for 13C-Urea; 3. Changes in QC testing locations; and 4. Changes in manufacturing locations for 18kg process.

P100027/S019 2/19/15 135-Day

INFORM HER2 Dual ISH DNA Probe Cocktail

Ventana Medical Systems, Inc. Tucson, AZ 85755

Approval for the addition of Sanmina built Nozzle Plate Assembly in the manufacture of BenchMark XT instrument used in the tests.

P100046/S006 2/12/15 Real-Time

AtriCure Synergy Ablation System

Atricure, Inc. West Chester, OH 45069

Approval for updating the transformer in the ASU Generator.

P110002/S009 2/5/15 Real-Time

Mobi-C® Cervical Disc Prosthesis

LDR Spine USA Austin, TX 78750

Approval for modifications made to the Mobi-C Universal Inserter instrument, which included addition of material to increase the inner diameter and a change to the laser marking and passivation process.

P110009/S009 2/5/15 Real-Time

Mobi-C® Cervical Disc Prosthesis

LDR Spine USA Austin, TX 78750

Approval for modifications made to the Mobi-C Universal Inserter instrument, which included addition of material to increase the inner diameter and a change to the laser marking and passivation process.

P110016/S015 2/26/15 Special

FlexAbility Ablation Catheter

St. Jude Medical Plymouth, MN 55442

Approval for an additional manufacturing inspection step.

P110032/S010 2/3/15 Real-Time

Aorfix and Aorfix Plus AAA Flexible Stent Graft System with Aorflex Delivery Device

Lombard Medical Technologies Inc. Irvine, CA 92618

Approval for a line extension that would include two larger size stent grafts. The device, as modified, will be marketed under the trade name Aorfix and Aorfix Plus AAA Flexible Stent Graft System with Aorflex Delivery Device and is indicated for treatment of patients with abdominal aortic and aorto-iliac aneurysms having vascular morphology suitable for endovascular repair, including: 1) Adequate iliac or femoral access that is compatible with vascular access techniques, implants, and accessories. 2) Aortic neck landing zone diameters with a range of 19 mm to 33 mm. 3) Non aneurysmal proximal neck centerline length of > 15 mm. 4) Infrarenal aortic neck angulations including those up to and including 90°. 5) Common iliac landing zone diameters with a range of 9mm to 19mm. 6) Distal fixation length of > 15 mm.

P110041/S001 2/2/15 Real-Time

ADVIA Centaur® HBsAgII

Siemens Healthcare Diagnostics East Walpole, MA 02032

Approval for an additional surfactant to the Lite Reagent.

P120006/S015 2/2/15 180-Day

Trivascular, Inc. Ovation Prime Abdominal Stent Graft System, Trivascular, Inc. Ovation iX Iliac Stent Graft

Approval the to add a larger diameter iliac limb and iliac extension, a longer length iliac Trivascular, Inc. Santa Rosa, CA 95403 limb, and decrease the delivery system profile for each iliac limb and iliac extensions. The

P120010/S024 2/19/15 Real-Time

MiniMed 530G System

Medtronic MiniMed Northridge, CA 91325

Approval changes to the design and manufacturing of the needle for the Medtronic MiniMed 530G System Enlite Glucose Sensor (MMT-7008A, MMT- 7008B); the specifically proposed changes which influence the Enlite needle to introduce a bevel at the needle tip and increase needle sharpness.

P120010/S026 2/4/15 Real-Time

MiniMed 530G System

Medtronic MiniMed Northridge, CA 91325

Approval for replacing the Test Plug with two Watertight Testers in the MiniLink Kit.

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DEVICE DESCRIPTION / INDICATIONS

device, as modified, will be marketed under the trade name Ovation Prime Abdominal Stent Graft System with the Ovation iX Iliac Stent Graft and is indicated for the treatment of patients with abdominal aortic aneurysms having the vascular morphology suitable for endovascular repair, including: 1. Adequate iliac/femoral access compatible with vascular access techniques (femoral cutdown or percutaneous), devices and/or accessories; 2) Proximal aortic landing zone: a) with an inner wall diameter of no less than 16 mm and no greater than 30 mm at 13mm below the inferior renal artery, and b) with an aortic angle of < 60 degrees if proximal neck is 10 ≥ mm degrees if proximal neck is < 10 mm; and 3) Distal iliac landing zone: a) with a length of at least 10 mm, and b) with an inner wall diameter of no less than 8 mm and no greater than 25 mm.

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5/22/15 9:26 AM

PMA Supplemental Approvals (continued) APPLICATION NUMBER / DATE of APPROVAL

DEVICE TRADE NAME

COMPANY NAME CITY, STATE, & ZIP

P120010/S030 2/4/15 Real-Time

MiniMed 530G System

Medtronic MiniMed Northridge, CA 91325

Approval for changes to the sensor base which included; the addition of anti-rotation pins and snap arms, modification of the o-ring gland; width, position, and diameter, an increase to the bore size and addition of a bore taper, a sensor through-hole size increase, and connector pad surface height increase, on the EnliteTM Glucose Sensor (MMT- 7008) of the MiniMed 530G System.

P120010/S036 2/13/15 Real-Time

MiniMed 530G System

Medtronic MiniMed Northridge, CA 91325

Approval for changes to the pump motor sintered bearing material.

P130005/S002 2/12/15 180-Day

Diamondback 360 Coronary Orbital Atherectomy System (OAS)

Cardiovascular Systems, Inc. St. Paul, MN 55112

Approval for changes to the design of the orbital atherectomy system pump (OAS Pump Model SIP-3000) including the addition of a secondary motor feedback printed circuit board, the addition of a shroud over the AC power cord connection, the addition of a 100% inspection of Power Jack retention, and the selection of an alternate vendor for the Timer Component.

P130008/S002 2/5/15 180-Day

Inspire Upper Airway Stimulation Therapy

Inspire Medical Systems, Inc.

P130017/S001 2/2/15 180-Day

Cologuard

Exact Sciences, Inc. Madison, WI 53719

FDA_JUNE 2015_Vs6.indd 43

Maple Grove, MN 55369

DEVICE DESCRIPTION / INDICATIONS

Approval for an update to the tablet hardware and operating system of the Model 2740 Physician Programmer, and related changes to the Model 2740 programmer manual.

READ MORE ONLINE FROMMASS DEVICE VISIT:

dwo.me/1GmwevR

Approval of the post-approval study protocol.

5/22/15 3:45 PM

MATERIALS

S A E ID D N A S L IA R E T A M hake up that promise to s

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Imagine a material with the strength of steel but the density of plastic, or synthetic skin printed on demand in the ER for a badly burned patient. Materials like these may soon be ready for prime time – and more are on the way.

T

itanium and its alloys were once considered exotic materials in the medical device world.

Today they’re old hat – peek in a few labs and R&D facilities and you’ll the truly exotic, materials used in electronic fingers capable of detecting tumors as deep as 20 mm and as small as 5-mm diameter, and fracture repair putty that stimulates bone growth. Researchers are even developing a biomaterial that can be mixed with a drug, then injection-molded into anatomically useful shapes.

If that’s not remarkable enough, consider the cutting-edge research lab run by the U.S. Army, the Defense Advanced Research Projects Agency, or DARPA ,and its long wish list for medical innovations for the battlefield. These are just a few of the ideas finding their way into materials and manufacturing cleanrooms today. Here are some we found a few that deserve close watching.

Bioabsorbable materials This is the big news. Materials that are bioabsorbable – they’re absorbed and excreted by the body over time – would be noteworthy enough. But now let it carry a drug as well, and the combination becomes more potent.

THIS IS THE MOST EXCITING MATERIAL DEVELOPMENT WE HAVE EVER ENCOUNTERED Paul Dvorak • Founding Editor

n ig s e d e ic v e d l a medic www.medicaldesignandoutsourcing.com

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“This is the most exciting material development we have ever encountered,” says MTD Micromolding President Dennis Tully. His company provides the manufacturing expertise for small medical components. “The wide property range of the bioabsorbable materials and their ability to carry drugs opens a door to many possibilities. And the material properties can be adjusted, from stiff to flexible. These allow conquering problems that nobody has a solution to, until now.”

One such material, Resomer, a family of lactide and glycolide based bioresorbable polyester polymers, comes from material development company Evonik Industries AG. Using advanced techniques, these polymers are further formulated into medical devices and extended-release drug delivery systems.

Doctors and patients prefer an implant made from the fully resorbable polymer over traditional nondegradable biomaterials such as metals, ceramics, and composites when the therapeutic properties of the implant are only needed for a period ranging from weeks to months. Another plus: A resorbable polymer lowers costs and the risk of infection because there is no need to remove the implant in a follow-up procedure. Evonik says medical implants made from its bioresorbable polymers degrade completely and are excreted from the body, leaving no trace behind.

Typical applications include sports medicine, trauma, CMF, coronary stents, drug delivery, regenerative medicine and medical The four devices, made of Evonik’s Resomer polymers, coatings. are intended to replace some stainless steel screws used to A remarkable feature hold bone fragments together while they heal. As the screws of these materials is that are absorbed by the body over a period of months, bone the degradation period is regenerates to fill the holes once occupied by the screws.

Image courtesy of Evonik Coporation controllable depending 46

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upon application. “Degradation is controlled with the monomer ratio and other factors, such as microstructure of the polymers which controls the release of the drug, inherent viscosity ratios, molecular weight, or end groups of the polymers,” says Paul Spencer, head of Evonik’s Global Biomaterial Business. “In addition, it is possible to functionalize the polymers to do different things. So a lot of technology surrounds knowing how to tailor the polymers for specific medical device applications or to meet the needs of the drug and the release requirements from the client.”

According to medical device developer Abbott Vascular, one application for the material is a bioabsorbable polymer scaffolding – commonly known as a stent. Abbott Vascular says its Absorb bioresorbable vascular scaffold is the first drug-eluting, fully biodegradable scaffold on the market for treating coronary artery disease. The device is available in Europe, but not yet in the U.S. “The materials are also used as coatings on cardiovascular stents. A lot of products such as metal stents have a drug-eluting coating that is completely biodegradable.

The coatings can be derived from Resomer polymer products,” adds Spencer.

Developing a new material is just the first step. Next one needs a method for turning the material into useful shapes.

“Along with injection molding and extrusion, Evonik has the know-how to process and formulate the material into microparticles and nanoparticles with drugs to provide extended delivery, over weeks or months depending on the drug and the indication,” adds Spencer.

Microparticles average about 80 microns, but with nanoparticles shrink that figure to around 100 nm or smaller. The diameter can be controlled for the drug and application.

When microparticles are injected into muscle, the muscle encapsulates the spheres, which draw in moisture and swell to keep themselves in place, Spencer explains.

“And because the particles degrade by hydrolysis, the drug is released as they absorb water. What's more, utilizing Evonik’s FormEZE manufacturing process, they can be delivered by a narrow-gauge needle – and

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MATERIALS

Can you identify this? It’s the business end of a needle, loaded with Evonik’s drug-loaded particles.

Ordinarily, the particles would be carried in a fluid for injections.

Image courtesy of Evonik Coporation

that is significant because it’s less painful than larger needles, especially for patients who might receive injections on a regular basis,” he says.

Spencer says Evonik’s Resomer business has invested in a state-of-the-art facility to manufacturer these drugs and polymers for clients. These could be standard and high-potent drugs, cancer drugs, and the technology is really not therapeutically limited, he says.

FormEZE is the company’s proprietary process for combining the polymers with drug and make them into a microparticles or nanoparticles.

Historically, the particle technology came out of MIT in the late 1980s.

In a message to device developers, MTD Micromolding’s Tully suggests that smaller, specialized material companies can dial in properties that an application needs and provide test materials.

Larger firms are ready to help too, says Evonik’s Spencer.

In 2014, the company opened what it calls the MedTech Project House for developing new products suited for medical technology in Birmingham, Ala. Evonik opened the facility with 25 scientists and engineers and released them from day-to-day business with the purpose of designing and engineering the next

THE WIDE PROPERTY RANGE OF THE BIOABSORBABLE MATERIALS AND THEIR ABILITY TO CARRY DRUGS OPENS A DOOR TO MANY POSSIBILITIES

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MATERIALS

generation of materials and processes for the medical device industry.

“If a device company wants a high-strength Resomer for an orthopedic application, the Project House researchers would work on that, and develop the process to fabricate the material. So we can introduce a new material and provide processing directions,” says Spencer, noting that the research will focus on a range of products, such as adhesives, composites, stronger biodegradable materials, or materials with different features and properties.

BECAUSE THE PARTICLES DEGRADE

BY HYDROLYSIS, THE DRUG IS RELEASED AS THEY ABSORB WATER

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A fix for severed spinal cords?

Online reports of treatments for spinal cord injuries are not encouraging. It seems generally accepted that central-nervous-system breaks cannot be rejoined. That thinking makes the work of the company TissueGen all the more significant. The company reports that a U of Texas research team using a company development is working to overcome the limitations associated with incorporating 3D chemotactic gradients in nerve-repair scaffolds. Nerve guides are created using the company’s Elute BDL fibers that are loaded with neurotrophic agents (having an affinity for the nervous system) wound in a variable-pitched coil for what the company says are highly tunable, 3D neurotrophic gradients.

The team has demonstrated that these gradient nerve guides created longer axons (the usually long process of a nerve fiber that generally conducts impulses away from the body of the nerve cells) and more direct (linear) path of axons compared to similar nerve guides with linear

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MATERIALS

neurotrophic concentration in an ex vivo dorsalroot-ganglion model.

TissueGen is applying the technology to develop a medical device targeting treatment and recovery of patients with spinal-cord injuries.

Gradient scaffolds may eventually be surgically implanted into a severed spinal cord to entice motor and sensory axons to regrow, and may

W H AT P L A S T I C I S I M P L A N TA B L E ? M O S T O F T H E M , W I T H A C AV E AT One of the more surprising things, says MTD Mirco Molding’s Dennis Tully, is that when discussing new projects with clients and engineering groups, even those in large companies with huge R&D budgets, it usually comes as a surprise that almost any plastic material can be used in an implant.

“Most are shocked to hear this. However, qualifying a material for in vitro use calls for proper testing. And there is a lot of misinformation about whether or not a material must be tested for a new application, especially when the material has proven itself in another application. They ask, ‘Can we forego the testing?’ And the answer is most always, ‘No,’” says Tully.

“But most people don’t understand that trying to leverage someone else’s data does not work most times.

That is because it was not generated in the same process.

So there is a wide interpretation of the rules specified by the FDA regarding material.

“There is also a great misunderstanding about what predicated data can be used relative to materials and whether or not a new material can be qualified. When the material has the right fit for the application, most often you find you have to start from square one no matter what material you select,” explains Tully.

The hazard is that product developers discover the need for retesting when they are far into development and don’t want to consider starting over. His take-away thought: Most materials can be used, but they must be tested to FDA requirements.

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aid in the recovery of what were previously considered irreparable injuries.

Printed synthetic skin Printing replacement human organs, a research goal for decades, has become a reality in recent years. About nine years ago, the transparent image of a printed human heart adorned the cover of one medical magazine. The image suggested the possibilities of a functioning organ made of tissue, not hard plastic.

A few years ago, under the leadership of associate professor Axel Geunther, researchers at the University of Toronto devised a way to print an epidermal layer over a dermal layer, just like natural skin.

Apparently DARPA threw down a gauntlet about that time, seeking a ready replacement to help burned and wounded soldiers recover more quickly and with less scarring. The team tackled that problem by finding a way to modify conventional print reservoirs so they would jet skin cells. Cartridges were devised to carry either epidermal or dermal cells. Working with burn surgeon Dr. Marc Jeschke of Toronto’s Sunnybrook Research Institute, the team produced the specialized cartridges and fluid

This sample of synthetic skin was printed by a device developed by students and instructors at the University of Toronto.

to keep the skin cells alive. During printing, the cells gel into a biodegradable dressing.

So far, the team has printed portions of human skin that helped the wounds on immunecompromised mice heal. The next step would include experiments with pigs and larger sizes of tissue.

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MATERIALS

One test for Saraf’s tumor detector went like this: Touch pressure (blue arrow, upper left) is applied on the top through a glass slide to compress the palpable structure (human tissue) on the tactile device. A constant bias of 18V was supplied across the top (Al) and bottom electrodes (ITO). An N-shaped object (for Nebraska) 3-mm thick, was imaged. The green bar in the optical image is 12 mm.

The tactile image (the hazy N) at 80 KPa load clearly shows sharp features of <2 mm. The cross section of the film (upper right) of Au and CdS nanoparticle layers are 500 x 500 nm, and their insets (lower right), are 100 x 100 nm.

Source: Ravi Saraf

Electronic fingers Tumors can be difficult to detect by touch, but that’s a common initial discovery method. This is especially true of breast tumors, but there even reading a clear X-ray takes some experience.

A team of researchers at the University of Nebraska, led by Professors Ravi Saraf and Chieu Van Nguyen, have devised a sensitive film that can sense differences in tissue density in human breast tissue, which can be an indicator of tumors.

From their paper on the film’s capability, Saraf and Nguyen say their tactile device detects a 5- to 10-fold stiffer object imbedded as deeply as 20mm deep in a softer material. The light emitted from the film is linearly proportional to local stress. The thin-film tactile device is a multilayer composite made of nanoparticles and polymers.

The film is an analog electro-optical device that shows embedded stiffness as continuous variation in light emission that can be focused on a camera. So the pictures captured represent accurate shape of the denser volumes – the tumors. And because it’s an imaging technology, it allows for the creation of digital records of examinations, something notes and recollections do not provide. Saraf says the electromechanical characteristics of the flexible thin film are precisely tuned to obtain a tactile image of the denser “lump” for contact pressures from 4 to 12 psi, about that of human touch.

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HOW TO TEACH AN “OLD” M AT E R I A L N E W T R I C K S Titanium has been around a bit longer than recent polymers because inventive companies keep reinventing the material. Titan Spine, for one, has been developing titanium alloys for use in spinal interbody fusions since 2006. “We have developed the expertise to manipulate the surface to promote bone growth and fusion,” said the company’s VP of Marketing Andrew Shepherd. Surface technology, he adds, is the science of surface manipulation to create a desired biochemical response. “In our case, we select for osteogenesis,” he says. “Titanium is the only material that has a natural affinity with bone and can be roughened with the specific textures at the macro, micro, and nano scales that favor bone growth and fusion.

Over the past decade, the material polyetheretherketone (PEEK) has been marketed as a better material for interbody fusion devices because it has a lower modulus of elasticity than titanium and is closer to the modulus of bone. “Some asserted that PEEK devices would have lower rates of subsidence – collapsing in to the bone – than titanium devices,” he says. However, any biomechanical engineer knows the key variable in avoiding subsidence is the structural stiffness of

Titan Spine’s Endoskeleton devices are for use in skeletally mature patients with Degenerative Disc Disease and with or without grade 1 spondylolisthesis or retrolisthesis.

The roughened surface, a proprietary feature developed by the company, encourages bone growth.

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the device rather than the implant’s material modulus.

A recent study showed that one of Titan’s devices subsided at statistically reduced rates and overall amounts as compared to a commercially available PEEK device. He suggests that design engineers should let science guide the development of innovative and beneficial medical devices rather than fallacious marketing.

All Titan Spine devices are made from titanium alloys and feature a proprietary combination of roughened textures at the macro, micro, and nano scales created through a subtractive process. “It’s not a coating,” he says. “The macro roughness is designed to resist expulsion, while the micro and nano roughened features interact with stem cells to upregulate osteogenic (bone forming) and angiogenic (blood vessel forming) growth factors necessary for bone growth and, ultimately, fusion.

He adds that the company will be launching a next-generation surface, called nanoLOCK, later this year that features even more nano-scaled textures that improve the osteogenic response to the company’s interbody fusion devices. “nanoLOCK is the first nanotechnology cleared by the FDA for spinal applications,” he says.

Fracture putty Some nuts are tougher to crack than others.

One idea that easily captures attention came out of DARPA’s idea lab: Fracture putty.

Ugly battlefield wounds such as compound bone fracture are difficult to treat, often requiring multiple surgeries and long healing and rehabilitation times. Current standard procedures that use screws, plates, and rods can lead to further complications.

A few researchers have taken a crack at the problem. A multi-facility team lead

by Matthew B. Murphy at the Methodist Hospital Research Institute in Houston reports on a good start. Their idea is to provide a mix that includes a bioactive

sponge with a composite of platelet-rich plasma, nanoporous silicon-enclosed microparticles, and adult-bone stem cells. The team devised a gel carrier to deliver and retain the stem cells and microparticles in the porous scaffold that would promote cell growth. The material was implanted subcutaneously in rats to evaluate the formation of bone tissue. Good first step: They found one combination of the ingredients formed more bone and was more vascularized after four weeks than another combination. M

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CONTRACT MANUFACTURING

When designing an assembly method for the plastic components in a medical device, stay process-neutral and weigh the advantages and disadvantages of the available methods.

Finding the best way to join

plastic components Tom Hoover • Market Segment Manager

Medical & Business Consumer Electronics • Branson Ultrasonics Corp.

A

s the medical device industry continues the rapid development of complex, innovative products, the need for joining plastic components is keeping pace. These requirements range from micro-scale tubes to macro monitors and pumps. Choosing a best method of assembly for plastic applications is crucial when reliability, performance, quality, and regulatory compliance are essential.

When selecting a technique or supplier for assembly requirements, it’s imperative to examine and compare all options to determine which may be best for a given application. It’s necessary to understand the advantages and limitations of each process, and work closely with equipment or system providers with the technical expertise to develop an applicationspecific solution.

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Selecting a joining method can be overwhelming, so the best application choice is to enter the decisionmaking process with an open mind and be process-neutral. Working with a supplier who doesn’t favor one technology over the other at the outset can provide the advantages of reduced time-to-market, lower costs and improved product reliability.

Weighing the welding methods There are many joining technologies for medical devices. Although ultrasonics is the dominant technology, others, such as laser systems, open the door to new opportunities. For many applications, a combination of techniques provide the best solution.

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Choosing the best way to join plastics is the foundation for many medical products. www.medicaldesignandoutsourcing.com

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CONTRACT MANUFACTURING

Most application development calls for a process-neutral approach as the basis for selecting the right technology.

Technologies for joining plastics include ultrasonic welding, vibration welding, hotplate welding, spin welding, and thermal processing. In addition, clean-joining techniques, which include laser welding, infrared (IR) welding, and vibration-plus-IR welding, are specially designed to minimize flash and particulates.

Joining methods also can support ecological standards and requirements for waste management, eliminate the need for chemical solvents and adhesives, and be highly-energy efficient.

Ultrasonic assembly is a cost-effective and widely used technique with the benefit of speed â&#x20AC;&#x201C; most welds take less than a second, need no consumables, require minimal or no setup time, and offer low cost of capital equipment and easy integration into automation.

Ultrasound assembly uses a series of components, including power supply, converter, booster, horn (or stack), and actuator, to deliver mechanical vibration and force to the parts. This generates heat at the interface of the mating surfaces, melting the plastic and creating a strong bond.

Medical devices typically require high-precision, perfectly clean joints.

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Other joining methods have drawbacks: Adhesives, for example, have much longer set-up and processing times and can cause contamination during operation, especially at the micro level.

Ultrasonics can offer significant advantages for assembling surgical instruments that are typically joined by screws and solvents. The method uses the device material itself to form a bond and does not introduce glues or adhesives into the process, eliminating consumables. It also cuts time in production, compared to gluing.

Minimally invasive surgical instruments, as well as catheters, cannulas, luers, and trocars, use ultrasonic joining.

Clean laser technology. Laser welding of plastics is an innovative technique based on the principle of passing laser energy through one plastic component, the transmissive part, that is absorbed by the second component, the absorptive part. This absorption results in heating and melting of the interface. The parts are joined with the application of a controlled clamp force.

Laser welding is a gentle and clean joining process that enables welding of complex geometries and materials that are difficult to bond with other techniques. Laser welding ensures attractive, reliable hermetic sealing in a single step that only takes a few seconds.

Whatâ&#x20AC;&#x2122;s more, laser is the technology of choice for joining plastics for in vitro diagnostic devices, as well for as microfluidic devices. This includes those used in diabetes care, where fluidic pathways are small and a primary consideration is to have zero particulate or flash, and protect delicate structures.

Vibration welding is a proven friction technique capable of producing strong, pressure-tight joints in the thermoplastic parts.

The major advantage of vibration welding is in its application to large (up to 60-in.-long or 24-in.-wide), irregularly-shaped parts. Cross-ribs, which create separate compartments, can even be sealed. The process also works with multi-plane and curved surfaces.

Vibration welding can be used to weld more than one part at a time and also readily lends itself to automation.

Two motion path options are employed in vibration welding:

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CONTRACT MANUFACTURING

• Linear vibration welding uses transverse, reciprocating motion: The vibration occurs in only one axis. The vibration motion occurs equally in both the x and y axes and all axes in between.

• Orbital vibration welding uses constant velocity motion: A non-rotating, offset, circular motion in all directions.

The clean vibration method combines infrared and vibration processes, offering more options and applications for smart molding joint design. Pre-heating the surface with infrared minimizes particles generated during the vibration weld phases and produces clean, high-strength joints, which reduces residual stresses and material-specific friction and welding time.

This technology is typically used in manufacturing large, two-part systems such as patient monitors, infusion pumps, or fluid collection vessels.

Spin welding is a friction process that joins circular thermoplastic parts by bringing the part interfaces together under pressure with a circular, spinning motion. One part is held stationary in a fixture, while the other rotates against it under pressure. The frictional heat generated causes the part interfaces to melt and fuse together, creating a strong, hermetic seal. The lower-mass half is usually located in the upper spinning portion, but exceptions are made based on part geometry.

Surgical trocars – which function as portals for the placement of instruments such as graspers, scissors, or staplers – lend themselves to spin welding because of their ports’ round geometry.

Choosing the right process Even though the many options can make it difficult to determine which process is best for a joining application, here is a thought process that should work for a majority of applications: • The first consideration is material.

Some materials are more compatible with a given process. Polyolefins, for instance, are somewhat limited in ultrasonic welding,

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but are recommended for all of the other processes. Ultrasonics is not recommended for TPRs/TPEs and has limited capabilities in some applications, but is recommended for others.

• The second consideration is part geometry. Start with the size of the part.

One of the limitations of ultrasonics is the tooling size. The lower the frequency (15 kHz) used, the larger the tool (approximate maximum: 10 x 10 in. (25 x 25 cm). The higher the frequency (40 kHz), the smaller the tool (approximately 2.5 x 2.5 in. or 6 x 6 cm). If the parts are larger than these ranges, you’ll have to consider using either multiple hits with ultrasonics or another assembly process.

• Delving further into part geometry, we come to the complexity of the part and weld profile. Some assembly processes accommodate certain features easily and others cannot.

• Other considerations are wall thickness and internal walls. Vibration welding, due to its linear reciprocating motion, has difficulty welding long, unsupported walls, while other technologies do not have an issue with these features.

• Another important aspect is production volume. Some processes, such as ultrasonic, spin, and laser welding, will process assemblies in seconds or faster, while hotplate welding may take 40 to 50 seconds. In some instances, welding multiple parts in a single cycle improves throughput.

• Capital equipment cost should be the last consideration, although that may be easier to recommend than to put in practice. Keep in mind that if you select a process based on initial price, you may not have considered long-term product or application development. This includes time to market and processing costs such as scrap, downtime and mold changes.

Choosing a material joining equipment supplier with a broad portfolio of technologies, application engineers and experience is a valuable asset within an overall product development strategy. Also consider the total cost of ownership for the assembly process, including direct and indirect costs.

For new or modified medical devices, all parameters, including design, materials, prototypes, and product performance, as well as processing time and costs, should be thoroughly evaluated to ensure choosing an appropriate joining technique. The best way is to start by taking a process-neutral approach that considers all options. M

Cannula, luers, and fittings typically use ultrasonic joining as the primary plastics welding method.

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PRODUCT DEVELOPMENT

EVALUATING THE RISK OF DEVICEmis

connections: Designing for medical devices with ISO 80369 in mind Jim Brown • Business Unit Manager for Medical Markets • Colder Products Co.

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PRODUCT DEVELOPMENT

Where ISO 80369 applies to the human system ISO 80369 Parts 2 to 7 define small-bore connector standards for six application categories. Its goal is to prevent misconnections between unintended devices.

Beginning in the 1990s, concerns grew regarding the proliferation of medical devices fitted with luer connectors and the reports of patient injuries and deaths arising from misconnections.

Thus began a many-years process to develop new industry standards for the small-bore connectors used in medical device applications. © 2015 Colder Products Company. All rights reserved.

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he much-anticipated ISO 80369 series of standards for small-bore connectors seeks to address patient injuries and deaths due to device misconnections that can occur when incompatible applications use the same, common small-bore connectors.

Luers, by far the most frequently used connectors in medical settings, have contributed to the incidence of dangerous medical connections because they can connect with unintended systems. The Introduction to Part 1 of ISO 80369 (hereafter referred to as ISO 80369-1) describes the problem: “In a coronary care unit there are as many as 40 luer connectors on the medical devices used with a single patient. Therefore, it is not surprising that misconnections are made.”

Why are the new ISO 80369 standards significant for medical device

OEMs? The need to improve patient safety is the most obvious answer.

Another concern is that medical misconnections expose manufacturers and caregivers to potential liability. There are also growing regulatory and potential legal issues to deal with. California law (HB1867) specifically prohibits the use of IV, epidural, and enteral connections that fit into a connection port other than the intended type beginning in 2016. The European Device Directive, the U.S. FDA, and other medical regulatory agencies around the world are addressing medical misconnections. The release of the ISO 80369 series of standards provides connector clarification and guidance in relation to minimizing medical misconnections.

In spirit, ISO 80369 covers medical device small-bore connectors used to www.medicaldesignandoutsourcing.com

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make connections between equipment and patients. ISO 80369-1, published in 2011, lays out general requirements for small-bore connectors that facilitate the transfer of liquids and gases in healthcare applications. Parts 2 to 7, in varying stages of development, address six application categories that represent the greatest risks to patients should a medical device misconnection occur.

These application categories are: a) breathing system and driving gas, b) enteral and gastric, c) urethral and urinary, d) limb-cuff inflation, e) neuraxial, and f) intravascular or hypodermic applications.

An accompanying illustration shows were these parts apply on a patient.

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PRODUCT DEVELOPMENT

THE ABILITY OF CONNECTORS TO INTERCONNECT IS IDENTIFIED AS A ROOT CAUSE OF MISCONNECTION. the applications and the potential risk associated with misconnections. This work quickly showed that too many applications used luers and the widespread use increased the probability of connecting incompatible devices. The first step was limiting the use of the luer to a single application and thus the luer became the connector for vascular access and hypodermic syringes.

Limiting luers to intravenous or hypodermic applications provides clear direction to medical device designers. ISO 80369-7 defines the luer fitting and drives minor changes to the design, primarily defining additional dimensions previously undefined in the old standard, ISO 594-1 and 594-2. Luers made to the ISO 80369-7 standard will connect to luers made to the ISO 594-1 and ISO 594-2 standard, but connectors made to the old standards do not comply with the new ISO 80369-7 standard.

As a result of limiting the use of luers to intravenous or hypodermic applications, other applications such

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as enteral feeding or neuraxial, which also commonly used luers, needed new connectors designed. The result of this effort is nearing completion with defined connector standards for several of these other applications. Whether or not a current medical device uses luer connectors, or finds its application defined in this new series of standards, product designers should understand the role and recommendations of ISO 80369 in relation to any medical device using a small-bore connector. This article discusses what ISO 80369 defines or will define, and it provides an action plan for assessing the risks of connectors already in use or being considered for use on medical devices and delivery systems.

Beyond the luer â&#x20AC;&#x201C; implementing ISO 80369 Product designers working on devices used in the six defined application categories called out in ISO 80369-2 through 7 will want to become familiar with the general requirements outlined in the first part of the new standard. However, ISO 80369-1 also provides guidance for designers of medical devices for the hundreds of applications outside the categories defined in the new standard. Two sections of ISO 80369-1, in particular, will help designers whose product incorporates fluid handling and smallbore connectors: 1 The terms and definitions in Section 3 2 The mechanical test for verifying non-interconnectable characteristics in Annex B.

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PRODUCT DEVELOPMENT

A variety of small-bore connectors is available for medical device and system applications not specifically defined by ISO 80369. Shown above are product options from CPC that offer the performance and material attributes defined by ISO 80369.

First, Section 3 offers the following definitions that can help product engineers begin designs or select connectors for their medical devices in the context of ISO 80369: 1 Small-bore: inner fluid pathway of a connection with a less than 8.5-mm diameter.

2 Rigid material: material with a modulus of elasticity either in flexure or in tension greater than 35,000 kg/cm2 3 Semi-rigid material: material with a modulus of elasticity either in flexure or in tension between 700kg/cm2 and 35,000 kg/cm2 4 Non-interconnectable: having characteristics which incorporate geometries or other characteristics that prevent different connectors from being connected Whether devices in the six defined application categories must use a standard connector can be somewhat confusing. ISO 80369-1 permits use of alternative small-bore connectors as long as they consist of rigid or semi-rigid materials and provide objective evidence that they do not interconnect with standard connectors specified in the six high-risk application categories.

Annex B discusses how to test a connector to provide the required objective evidence that it will not 64

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interconnect with the defined, standard connectors. This section includes an assessment for non-interconnectable characteristics of small-bore connectors based on their inherent design and dimensions. There is an important consideration when testing a connector not defined in the standard: The testing will provide results for the defined connectors but does not address other connectors in the market, and other connectors or applications may be added to the series in the future. “Mechanical tests for verifying non-interconnectable characteristics,” from Annex B of ISO 80369-1, summarizes the steps as follows: a Condition the connectors for your device to be assembled at 23°C and a relative humidity of 50%. b Assemble the small-bore connectors to the test connector by applying an axial force at a rate of approximately 10 N/s – not to exceed 70 N – that does not visibly damage either connector and with a torque not to exceed 0.12 Nm to a limit of no more than 90°. c Rotate threaded connectors in a clockwise manner, if applicable. d Hold the maximum assembly force for no less than 10 seconds. e After 10 seconds of engagement, without activation of any latch or disengagement mechanism, apply

an axial force of separation to the assembled connectors to a maximum of 0.02 N. f Verify that the connectors disengage. g For threaded connectors, apply steps a. to f. by assembling connectors in a counterclockwise manner, if applicable. h Repeat procedures a. through b. for every potential assembly surface.

Regardless of whether a medical device falls within ISO 80369’s six defined application categories, device manufacturers will want to assess both the physical characteristics of their connectors (according to the terms defined in Section 3) and the non-interconnectable characteristics (according to Annex B).

ISO 80369 goes on to provide one additional type of guidance for assessing small-bore connectors with the performance test methods described in Part 20. This section delineates procedures and formulas for determining performance attributes, such as leakage, resistance to separation from axial load and resistance to overriding. The guidance defines how tests should be conducted but not what values should be achieved. These requirements are found in the documents that define the connector for the specific application

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PRODUCT DEVELOPMENT

A flowchart for risk management

application categories covered

by ISO 80369, that of enteral applications. In its final document titled Safety Considerations to Mitigate the Risk of Misconnections with Small-bore Connectors Intended for Enteral Applications, the FDA advises manufacturers to design and test their products based on standards that specify dimensions and requirements and test methods that support the performance requirements. In plain

(Parts 2 to 7).Even after conducting the assessments outlined above, however, the only connectors that can be determined to fully comply with ISO 80369 series will be those defined in Parts 2 to 7.

Connectors for other applications not specifically covered cannot claim compliance with ISO 80369 series because documented standards for those connector applications to demonstrate compliance with do not exist. However, undertaking a risk analysis provides the final and most important analysis for decisionmaking in relation to any connector change or a new connector selection, regardless of the application.

Risk assessment – the gold standard for mitigating misconnections The FDA recently published final guidance for one of the defined 66

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language, manufacturers must assess the risk of misconnections for their particular device, and then decide if the risk is acceptable.

As with many risk assessments, conducting one in relation to a device connector has three purposes: to determine usability, safety, and regulatory compliance.

In many instances, identifying possible hazards associated with the design in normal and fault conditions falls on the shoulders of manufacturers while, typically, the healthcare industry operates under the principle of “safety under single fault conditions,” meaning a single fault should not impose the risk of loss of life. The risk of associated hazards should be, when deemed unacceptable, reduced to acceptable levels by appropriate means. For the purposes of this discussion, the diagram below will guide the examination of risk

management as it relates to medical device connectors: 1 Start with the selected connector.

Risk mitigation begins by answering several questions. Are there any hazards inherent in the connector design or materials?

Is the connector easy to operate correctly by professionals as in a hospital setting, and intuitive enough for non-professionals, such as home healthcare providers or family members?

2 What other devices are being used in the same environment that may have an interconnectable connector? What is the likelihood of connections being made between these incompatible devices?

3 What is the function of the device or machine being connected? Is the fluid transfer under pressure or a vacuum? What type of fluid is being transferred?

4 How could a misconnection happen? How frequently is this likely to occur? It is important to consider the environment in which the device will be used.

For instance, a blood-pressure cuff in a doctor’s office or supermarket may present a lower risk of misconnection compared to a blood-pressure cuff used in hospitals with IV lines, enteral lines, and others immediately around the patient.

5 If a misconnection did occur, what are the possible consequences?

6 What level of risk is acceptable for the assessing organization?

Final thoughts The original CEN Forum Task Group that investigated medical misconnections and the role of luers followed the established medical device industry principle of “safety under single fault conditions” when it recommended limiting the use of luers to IV applications. 3 A later

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PRODUCT DEVELOPMENT

THE GOAL IS TO DEVELOP UNIQUE CONNECTORS FOR MEDICAL DEVICES FOR EACH DELIVERY SYSTEM SO THAT THEIR INHERENT DESIGN MAKES IT VIRTUALLY IMPOSSIBLE TO CONNECT UNRELATED SYSTEMS.

ISO document published in 2006 expanded on the principle with: “In selecting the most appropriate solutions, the manufacturer should apply the following principles in the following order: 1) Identify hazards and the associated risks arising from the intended use and foreseeable misuse; 2) Eliminate or reduce risks as far as possible (inherently safe design and construction).” 4 This emphasis on risk mitigation remains good advice today. Even with ISO 80369’s connector standards for six defined application categories taking shape, the deliberate and documented analysis of risk continues as the OEM device designer and manufacturer’s best guidance in relation to connector decisions for diagnostic, monitoring and drug delivery systems. M For further study: 1: ISO 80369-1:2010(E), Annex A, Rationale 2: FAQs About Small-bore Connectors and Tubing Misconnections, AAMI, Oct. 15, 2013 3: CEN Report CR 13825, 2000 4: ISO/TR 16142:2006, Essential Principle A.1.2

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ENGINEERING DESIGN

Bipin Sen • Ed Lasch Bosch Rexroth Corporation www.boschrexroth-us.com

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for improving productivity in medical processes

Drive-based vibration and slosh control can help improve throughput in machines that assemble medical devices and products.

Controlling vibration can improve quality and yield when handling fragile or sensitive components, such as electronic devices.

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increasing the speed of a system that assembles medical devices, or packages medical products, seems like an easy way to boost throughput – until unwanted vibration (either induced or parasitic) appears. That requires deceleration of key actuators to avoid damaging the device or product, such as liquid medications, catheter kits, or electronic devices.

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for throughput. The time required for the product to settle or for the machine to stabilize after a move limits the rate of production. Controlling these unwanted movements (oscillations and vibrations) offers an opportunity for productivity gains in medical manufacturing. Our company addresses this with motioncontrol technology that reduces oscillations in a wide range of applications, with the potential to increase process throughput by as much as 50%.

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ENGINEERING DESIGN

Controlling oscillations Common industrial problems include liquid medications that oscillate inside moving packages, and objects that vibrate or sway as they move through multiple process steps via robots or linear transport systems. For example, in automated diagnostic tools, samples can be damaged and test results compromised if actuators impart too much motion to the micro plates or tubes.

In these applications, vibration can be imparted to the object by movement of the object itself, as well as by machine resonance – the low-frequency hum or ringing inherent in mechanical systems. The typical solution is to set an upper limit on the speed of motion. However, longer transient times to dampen oscillations can reduce productivity, while quality and dimensional accuracy are limited by the mechanical effect of the oscillations.

When a mechanical system resonates, its frequencies can be captured by the intelligent drive system. Control functions for damping and avoiding can then be introduced to reduce resonance. Less vibration reduces dimensional variation and damage to the product and permits shorter stabilization and transient times. Another plus: reducing vibration lower mechanical stress on the manufacturing equipment itself, which extends machine life.

Drive-based Adaptive Systems technology provides the intelligence to apply vibration damping and avoiding control methods which can increase throughput and extend machine life in processes where sloshing and vibration cause problems.

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Controlling slosh When packaging contains fluid, acceleration or deceleration of the package induces motion – or slosh – in the liquid. Sloshing liquid negatively affects filling, sealing and measuring processes – for example, there are strict regulations governing the tamper-proof sealing of liquid medications (over-the-counter, prescription and those used in clinical settings), so automated filling systems must work along with the container design to ensure that every container is correctly sealed with the proper amount of ingredients. To combat slosh, more reserve space in the container, more wait time for the contents to settle and extra space to allow for package movement are commonly required in liquid handling applications.

Because package movement is controlled by servo drives, using adaptive technology to minimize slosh provides several benefits. For instance, it reduces reserve space required in the container, which allows container height to be lowered to reduce the amount and expense of packaging material. Greater stability in the fluid meniscus also allows the use of optical level sensors to provide feedback to further optimize motion control.

In the process, anti-slosh technology shortens stabilization times, which cuts down on transient (i.e., process pause) time needed to allow contents to settle. The result www.medicaldesignandoutsourcing.com

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ENGINEERING DESIGN

is faster filling and sealing rates and machine cycle times.

Packaging lines that implement anti-slosh motion control typically improve throughput from 10% to 50%.

Why oscillation occurs Vibrations or oscillations are simply motions that repeat over a period of time. Controlling slosh and vibration involves factors of wave physics. Oscillations in medical manufacturing systems and automated diagnostic and lab tools, for example, would typically take the form of asymmetrical sinusoidal waves that vary in amplitude and frequency.

Oscillations can be classified as free vibrations, in which objects vibrate on their own after an initial disturbance to the system (much like a tuning fork), and as forced vibrations, in which objects vibrate when an external force disturbs the system (such as an out-of-balance washing machine).

Oscillations that occur as smooth sinusoidal harmonic waves can be further classified as linear vibrations, which are typically observed in small amplitude vibrations of flexible shafts and long slender objects, and as non-linear vibrations

Controlling slosh can improve throughput in a bottle filling line.

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ENGINEERING DESIGN

When a production tool generates induced or parasitic vibrations, such as when grinding lenses, open-loop vibration avoidance can be implemented as standard on the servo drive. And when encountering non-linear, non-repeating disturbances, closed-loop vibration dampening can easily be added.

that are distorted sinusoidal waves propagated by interactions between the object being manipulated and the internal resonance of the machine itself.

The complex physics of waves often make traditional methods of controlling oscillations ineffective. For example, adding stiffness or mass to increase machine bulk can help reduce vibration, but it is costly and cannot completely eliminate machine resonance caused by servo drives and other components.

Increasing time to allow contents or objects to settle is a simple tactic that lets wave energy disperse, but from a production standpoint, causes waste in the form of waiting time.

Vibrations can be minimized by smoothing the motion with jerk-limitation or S-curve motion-control profiles that avoid abrupt acceleration or deceleration. But programming can be complex and can accomplish only a limited amount of correction. Too much limiting to create smoother motion will slow acceleration to the point that machine cycles are reduced, further limiting productivity.

A better way to control vibrations An alternative is to use a software-based motion control that can settle or filter vibration by adapting to changes in the material, the load, and

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ENGINEERING DESIGN

Handling liquids using anti-slosh technology shortens stabilization times, which cuts down on transient (i.e., process pause) time needed to allow contents to settle.

the environment. To control oscillations, motion-control programs can utilize two techniques: Avoiding and damping.

Avoiding technology filters the vibrations caused by high dynamic movements.

Damping technology uses external feedback to employ counteracting kinetic energy to settle vibration. This feedback can be provided by the motor, an external encoder, or an accelerometer.

These functions require high intelligence and rapid processing in the motion controller to mathematically model and apply the appropriate value to the servo axis control system. With vibration avoidance by filtering, openloop control is used without external feedback. The resonance frequency mode of the system is modeled, so all that is required is for the motion controller to send position commands to cancel vibration.

This is different from merely doing an S-curve or jerk limiting to the motion profile. This technique can be applied in assembly applications for catheters, needles and other â&#x20AC;&#x153;sharps.â&#x20AC;? For example: Catheters have a wire drawn from a spool to a precise length, then cut and inserted into the catheter sheath. The wire needs to be kept at a precise, constant tension, an application that can be improved with vibration avoidance techniques.

With active vibration damping, closed-loop control is employed with a position interpolator and sensor feedback to send force or acceleration signals to the motion controller. Then the drive generates the torque position or velocity offset to cancel the vibration and suppress externally induced vibrations. A selftuning, proportional-integral-derivative (PID) controller using adaptive intelligence, adjusts the drive based on interaction with the machine and the load.

Active vibration damping is highly applicable to most automated, highspeed pharmaceutical and medical product packaging systems. It can also be implemented on large-scale lab automation tools, which may utilize a pickand-place motion where a large number of samples in liquid form are being dispensed into wells on a microplate.

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ENGINEERING DESIGN

The plate can move in multiple directions (up, over, down, and more) and because the plate is often uncovered, preventing the samples from sloshing is essential to ensure accurate results in lab experiments and diagnostic procedures.

Through vibration damping, it can be possible to improve automated lab device throughput rates, or increase the number of microplate wells, achieving greater efficiency (and target accuracy) without comprising the results.

The two techniques – both vibration avoiding and vibration damping – can also be implemented together, which is a capability offered uniquely by Rexroth. M A Rexroth drive system with Adaptive System technology can implement vibration damping and avoiding together, with or without a PLC

O N E W AY T O L E V E R A G E D R I V E - B A S E MOTION CONTROL EFFICIENCY Because vibration damping requires a motion control system that can adapt quickly to changes in process, material and application, Rexroth developed its Adaptive System technology to operate at the servo drive level, rather than at the control level. Drive-based motion logic and command value processing speeds up event handling and avoids the delays inherent in a control system’s cycle and update times.

Rexroth Adaptive System motion control can handle high-speed inputs and deterministic events with closed-loop response times that are unsurpassed by any other solution. For example, current closure can be accomplished in 62.5 µs (microseconds), speed loop closure in 125 µs, and position closure in 250 µs.

Drive-based firmware also allows more flexibility in implementation. Firmware options are available that provide base performance and high-precision performance. If the packaging machine or production tool generates induced or parasitic vibrations, open-loop vibration avoidance can be implemented as standard on the drive; when encountering non-linear, non-repeating disturbances, closed-loop vibration dampening are easily added.

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In addition, development of Adaptive Systems for specific applications is simplified by Rexroth’s Open Core Engineering (OCE) automation software and programming platform that allows personnel unfamiliar with PLC/HMI programming to create and integrate highly customizable automation applications. OCE provides the software tools, function modules and libraries that allow programmers who know C++, Java and other high-level languages to translate applications development into ladder logic for motion control, including Adaptive Systems vibration damping sequences.

The Rexroth Open Core Interface also provides libraries for LabVIEW Software – the popular graphical programming platform – to provide data acquisition on a Rexroth human machine interface, thus eliminating the expense of a separate PC. The precision machine control and increased throughput offered by drive-based Adaptive Systems – such as vibration damping and anti-slosh – combined with easy-to-use programming tools provide great potential for productivity gains in medical applications.

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DEVICE TALKS

Is there an unserved market for devices in psychiatry?

Jan Svarka, CEO of medical device maker Tal Medical, thinks so.

Svarka, who cashed out of a lucrative gig at private equity giant Bain & Co. to follow his heart to Tal Medical, thinks there’s an untapped market for devices in psychiatry.

To date, that’s been the purview of the pharmaceutical industry and Freudian psychoanalysis.

Tal Medical, which recently raised a $14 million funding round, is looking to commercialize a non-invasive neuromodulation device to treat acute depression. Like all good medtech stories, the origin of Tal Medical goes back to a serendipitous discovery, a glaring need and the potential to help thousands.

Below is a snippet of our conversation, which you’ll be able to download at DeviceTalks.com. Svarka will also join us June 17 at our DeviceTalks Live event at Boston Scientific’s headquarters in Marlborough, Mass.

BRIAN JOHNSON: Jan, you’re working in the area of depression – your tagline is ‘Rebooting the approach to depression.’ Tell us a little bit about what that vision means to you.

JAN SVARKA: The ultimate vision is that, in almost every clinical area, we have four different ways to treat a patient. There is a natural way; there is surgery; there are drugs; and there are devices. If you think about it, for example, in atherosclerosis, the natural way would be exercise and diet.

Drugs would be statins. Surgery would be a bypass, and devices would be pacemakers, stents, and so on.

In psychiatry, we really only have two ways to treat a patient. There’s psychotherapy, which goes back to Sigmund Freud with the first formal school about 100 years ago, psychoanalysis; and we have drugs, antidepressants, which go back to the1950s. We do not have surgery, unless you count lobotomy as a good option, and we do not have mainstream devices. Now just to be clear, we do have devices; we have electroconvulsive therapy and transcranial magnetic stimulation, but they are used today as last-resort therapies. Our vision is to close the device gap in psychiatry and to really find the clinical part of that in psychiatry by introducing a mainstream device into the clinical practice.

JOHNSON: How is your device designed to treat depression?

SVARKA: It’s a neurostimulation device. We are using magnetic stimulation of the brain to modulate the brain circuitry and reduce depression symptoms.

That’s it, at the highest level. It is derived from functional MRI. JOHNSON: It looks almost like a tabletop MRI machine.

HONEY I SHRUNK THE MRI.

SVARKA: I call it, “Honey I Shrunk the MRI.” It is derived from MRI and it is a tabletop device. It really looks like a small MRI, into which you put your head for a 20 minute treatment. We still have to figure out the dosing regimen, but so far we have tested a 20-minute treatment.

JOHNSON: This goes back to something that was a serendipitous discovery at McLean’s Hospital here in the Boston area. I understand there were patients with bipolar disorder who had MRI scans, and they developed some unexpected side effects.

SVARKA: That’s correct. As with many treatments in psychiatry, or actually indeed in medicine in general, low-field magnetic stimulation, or LFMS, was discovered serendipitously. We’re going back about 15 years to McLean Hospital, which is the largest psychiatric research facility in the world. It’s part of Harvard Medical School, and they were running a bipolar drug trial.

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DEVICE TALKS

For research purposes, they had patients undergoing functional MRI scans just to see what was happening in patients’ brains after taking the bipolar drugs, and an interesting thing happened.

The patients were coming out of the functional MRI scan after 20 minutes saying, “What did you do to me? My four-month depression episode is gone.” The technician approached the principal investigator on the study to tell him about it, and at first, the PI was saying, “Don’t worry about it.

These are bipolar patients. It’s their mood swing.”

However, the effect was persisting, and eventually they came to a conclusion that there was probably something in the specific research

WHERE WE ARE TODAY, WHAT YOU CARE ABOUT IN TERMS OF THE TREATMENT, IS SAFETY AND ACCURACY protocol, in the sequence they were using in the functional MRI. They hypothesized, “Maybe there is something in this specific sequence we are using,” so they decided to construct the proper sham control to randomize treatment to confirm the effect in bipolar patients. They did a trial in 43 patients and confirmed the antidepressant effect of the functional MRI, of that specific sequence they were using in their research protocol.

JOHNSON: Let’s dig into that sequence, because you can’t just get an MRI when you’re depressed and suddenly feel better, right?

SVARKA: If you use the sequence which we are using, you could get the antidepressant effect with a functional MRI, but the sequence which is used today for clinical purposes is not the same as was used back at McLean.

We have IP over the sequence. It’s the IP that defines the specific parameters of the magnetic 80

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6 • 2015

field, in terms of what’s the shape of the wave form, the frequency, the strength, the pulse wave and so on. We have IP over the parameters of the magnetic and the electric field, which is induced by the magnetic field, and we have IP over the specific device we’re using.

JOHNSON: I’m curious to know what you’ve learned about depression that you didn’t know going in. You’re not a psychiatrist by trade, correct?

SVARKA: I have a business background.

I worked in finance in London, in corporate finance and audits, and I went to Harvard Business School and in ‘99, I joined Bain & Co. I was on the consulting side. The last seven years I was partner in the healthcare practice. I consulted to pharmaceutical and medical device companies. I had personal interest in bipolar and depression because of a family member, so I had some first-hand experience with depression.

You can feel really hopeless when you’re with a patient who just cannot get help from any medication or psychotherapy.

JOHNSON: We’re talking about acute depression now, but you’re really speaking about changing the paradigm of psychiatry in general.

What’s the vision for five years down the road?

SVARKA: Where we are today, what you care about in terms of the treatment, is safety and accuracy. In terms of safety, we are MRI-derived.

It’s a very safe treatment. We have not observed any major side effects. In all trials to date, we have non-significant risk designation from the FDA. In terms of efficacy, you care about three things: How fast, how strong, and how long the effect lasts.

How fast, we already talked about it. This is the big asset of low-field magnetic stimulation.

It’s the rapid onset of action. How strong? We observed a more than 30% response rate with a single 20-minute session, and it would be astronomical odds if a single 20-minute session, which we inherited from a diagnostic procedure, would be the optimal treatment regimen.

We are hoping, by finding the optimal treatment regimen, our response rate will go much higher, and just to put it in context, a single 20-minute session produced 30% response rate

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DEVICE TALKS

in refractory patients. Drugs have about a 20% to 25% response rate in refractory patients.

We believe, in optimizing the regimen, we can improve it further.

The third thing you care about is the durability of the effect – how long the effect lasts – and this is what we don’t know. This is our clinical risk; this is what, in the previous trials at McLean, they didn’t ask about the durability. Now enter the National Institute of Mental Health, two years ago. They had been so frustrated about lack of rapid-onset-of-action treatments in depression, so they came up with this so-called rapid program and then this program, LFMS, was selected as the first and one of the most promising treatments for a grant.

Now we have an ongoing trial in place, multi-site. It’s a randomized sham led by Mass.

General Hospital, 80 patients, which is testing for the treatment durability. This trial will read out, we are hoping, in the first quarter of 2016 and should provide the ultimate definitive proof of concept for LFMS in terms of the last unknown that we have, the durability of the treatment.

JOHNSON: You’re a clinical-stage company.

Give us a look at your regulatory pathway over the next couple of years.

SVARKA: We have this ongoing trial, which is testing for durability. It will read out in the first quarter 2016. From there we have two options; if the data is very good, we’ll probably take it straight to the FDA, with the de novo pathway.

If the data is good enough, then we’re going to pivotal trial, and then the expected product launch would be sometime in the 2017 to 2019 time frame, so there is still a ways to go. There are still technical risks to overcome, the risk being we have to validate early results in largescale clinical trials. We have to establish the durability and we have to find out the optimal treatment regimen. M

Behind the scenes.

Ahead of the curve.

Inside the corner office.

82

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6 • 2015

WE'RE BACK FOR ANOTHER SEASON OF INSIGHT FROM MEDTECH'S BRIGHTEST MINDS! DeviceTalks, the live interview series from MassDevice, returns in 2015 for another season of insight from the brightest leaders in medtech.

The season kicks off JUNE 17 with an indepth interview with MIKE MAHONEY, CEO OF BOSTON SCIENTIFIC. Since taking the helm of the Marlborough, Mass.-based company in the fall of 2012, Mahoney has seen Boston Scientific's fortunes turn around dramatically. We'll go inside the turnaround and more at this event, which will be held on Boston Scientific's new Marlborough headquarters.

Learn more about this event and stay tuned for more announcements on the rest of our 2015 season.

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