Medical Design & Outsourcing - MARCH 2016

MARCH 2016

www.medicaldesignandoutsourcing.com

TRENDS R IN MEDICAL TECHNOLOGY Catheters • Robot-assisted surgery • Bioresorbables • Cybersecurity • Prosthetics 3D Printing • Materials • Adhesives • Tubing • Batteries • Bearings • Motors

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HERE’S WHAT WE SEE

Improvements at the FDA The regulatory trend no one is talking about

As we readied our first issue covering the hottest trends in the medical device industry, I was lucky enough to sit down with Cohera Medical CEO Patrick Daly at our DeviceTalks Research Triangle event. Our chat brought to mind a trend we don’t hear much about but that’s certainly under way: The FDA’s vastly improved track record when it comes to reviewing medical devices.

The FDA’s own numbers reveal the shift: The time to decision for pre-market approvals improved 20 percent, to an all-time low of 209 days, during the first quarter of 2016; the time to decision for 510(k) clearances over that span fell 14% to 109 days, its lowest mark in a decade.

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

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Cohera’s TissuGlu is the first product ever approved by the agency to seal tissue inside the body, and its nextgeneration Sylys sealant was the first product the FDA selected for its new Expedited Access Program.

Daly surprised me when, in describing his 10-year odyssey to FDA approval for TissueGlu, he gave great credit to the federal safety watchdog, singling out a pair of leaders at the Center for Devices & Radiological Health.

“I do want to take a minute and really compliment Dr. Jeff Shuren and Dr. Bill Maisel,” Daly told me. “I give them a lot of credit. They are really, really trying to change the culture there.

“I interact with the FDA almost weekly. I will tell you that you have two great champions in those two,” he said.

Daly said one thing he learned in his dealings with federal safety watchdog is not to be shy about explaining your product to FDA reviewers.

“You’ve got to be really committed to providing that guidance to FDA. This is where I go back and give Dr. Maisel a lot of credit. We built a relationship though this process, and we’re pretty forthright,” he explained. “I think some companies tend to defer too much.

They say, ‘Well, FDA will get mad at us.’ I’m here to tell you, if you don’t stick up for yourself and point out the errors in the FDA, no one else will.” M

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CONTRIBUTORS

VANN

RANDIVE

DUFFY

DENSFORD

HENRY

ABRAHAM

DVORAK

HUSKINS THOMPSON

NIC ABRAHAM is Managing Editor of Medical Design & Outsourcing.

An experienced writer and editor with eight years of expertise in marketing and public relations, she received an MBA degree in marketing after a 10-year career in the U.S. Air Force.

FINK DENSFORD is Associate Editor of Medical Design & Outsourcing. He has a passion for covering science, engineering and tech development and has been engaged in the scientific research world for over 5 years. He received an M.S. in science journalism in 2014 from Boston University.

STEPHEN DUFFY is Business Development Manager at Proxy Biomedical, an Irish company that specializes in biomaterial solutions for medical implantable products. Proxy is a leading supplier of biomaterial coverings for stents and other implants, using materials such PTFE, polyurethane, silicone and resorbable biomaterials, and also provide comprehensive textile conversion capabilities for medical implantable products.

PAUL DVORAK is the Founding Editor of Medical Design & Outsourcing. He has more than 27 years of experience writing and editing technical articles and editorials covering a variety of industries.

JAMES HENRY leads the products team at Calgary Scientific and is a chief contributor to the vision for ResolutionMD and PureWeb. He has more than 20 years of experience providing software strategy direction to companies in the oil & gas, medical, telecommunication, geolocation, construction and 3D graphics industries.

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KOREN HUSKINS is with Smart Products, a custom check/pressure relief valve manufacturer. Huskins has a background in technical communication and has been featuring low-pressure, low-flow applications within the medical industry (and beyond) for more than six years.

RAJUL RANDIVE is responsible for the design, building and testing of various prototype applications that use Crystal IS UVC LEDs. He works closely with customers to develop applications and maps those to engineering requirements that result in a marketready product.

HEATHER THOMPSON is Senior Editor of Medical Design & Outsourcing. She has more than a decade of experience covering technology, regulatory, and business trends in the medical device and diagnostics industry.

TIFFANY VANN is the Marketing & Communications Manager in the Global Tools & Storage segment at Stanley Black & Decker.

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CONTENTS

medicaldesignandoutsourcing.com ∞ March 2016 ∞ Vol2 No2

DEPARTMENTS 02

HERE’S WHAT WE SEE: The FDA trend no one wants to talk about

ON THE COVER:

04 CONTRIBUTORS

31

08 MATERIALS:

Advances in biomaterials support innovation for next-gen vascular implants 12 STORAGE:

The benefits of proper healthcare storage

MDO takes a look at the trends shaping medtech, from robot-assisted surgery to wearables.

TRENDS

FEATURES 21

Reducing the impact of hospital-acquired infections with UV disinfection

Integrating UVC LEDs into a UVGI system, instead of mercury lamps, allows for continuous disinfection without causing harm to a patient.

As standards look to reduce HAIs, LEDs are likely to become the light source of choice.

27

Engineering the evolution of wound care

Bed-bound patients – who may be obese, in hospice care, or recovering from wounds or bedsores – often find relief on an airinflated mattress that spreads their weight over a larger area to

14

HEALTHCARE IT: Is 2016 the year of workflow transformation?

18

TUBING TALKS: Pressure relief valve improves removal of patient earwax

20

FDA NEW PRODUCTS: Some of the pre-market approvals of the U.S. Food & Drug

31 TRENDS: • Catheters • Robot-assisted surgery • Bioresorbables • Cybersecurity • Prosthetics • 3D Printing • Materials • Adhesives • Tubing • Batteries • Bearings • Motors • Digital Health • Pneumatics • Couplings • Connectors 60

PRODUCT WORLD: Proportional valves, gas pumps, stethoscopes

62

DEVICE TALKS: Former Medtronic CEO Bill Hawkins recaps his 25 years in the medical device industry.

66

AD INDEX

provide increased pressure relief than would be possible with a conventional mattress.

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MATERIALS

Innovative biomaterials and processing techniques for next-gen vascular implants

Materials and conversion processing techniques are advancing, resulting in more sophisticated vascular implantable solutions. Textilecovered endovascular grafts, tissue valves for aortic valve replacement and polytetrafluoroethylene (PTFE)-covered stents are just a few examples of the biomaterials that are widely used in minimally invasive vascular intervention. Next-generation devices are aiming to create more effective solutions in terms of treatment, biocompatibility, durability and delivery, thanks to new material grades, functional coatings and innovative processing techniques.

Stephen Duffy | Business Development Manager | Proxy Biomedical |

PTFE is being used for peripheral vascular stents as a method of inhibiting restenosis.

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The advantages of resorbable biomaterial solutions The vascular market, like many other medical indications, is moving toward greater adoption of resorbable implantable solutions for coatings, components, and finished devices. This has been made possible with the introduction of more advanced biomaterial processing techniques, which deliver performance improvements that make resorbable materials a more viable solution. Digitally controlled dispersion technology is facilitating the use of resorbable polymeric coverings on current-generation drug-eluting stents, resulting in a baremetal stent remaining after release of the drug. A considerable number of companies are also developing next-generation bioresorbable vascular scaffolds. This is enabling thinner struts, more comparable to metal stent dimensions, such as the Meril MeRes100, featuring 100Âľm strut thickness, made from poly-L-lactide (PLLA) material.

Other biological components, such as porcine and bovine valves, are widely used in structural heart devices. However, material supply, along with extensive post-processing for human implantation, add significantly to manufacturing cost. New materials, including reinforced biomaterials, along with novel processing techniques, are being explored to determine if a synthetic alternative can be developed with sufficient biocompatibility, mechanical performance and durability for long-term implantation.

Introducing implants into the vascular system that disappear once their therapy is delivered is an ideal outcome. That’s why resorbable materials are being considered more than ever for a diverse range of next-generation vascular devices. Trauma or perforation injuries can benefit from resorbable coverings and implantable solutions; devices designed for short-term embolic protection and occlusion could resorb into the body without requiring subsequent removal.

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MATERIALS

Resorbable materials help companies develop implants that disappear into the vascular system once their use is obsolete.

Supporting innovation via biomaterial coverings and fabrics Biomaterial coverings support a broad range of functions such as occlusion, embolic protection, flow diversion, inhibiting restenosis, containing tumor growth, maintaining vessel integrity or supporting heart function. The application of these devices has evolved far beyond traditional coronary and peripheral indications to include endovascular, structural heart, neurovascular, carotid, below-theankle and even venous indications. However, despite the wide range of device applications, biomaterial coverings typically function as porous or non-porous barriers.

Textiles are one of the most wellestablished implant coverings and have been used for many years in grafts and valves. The versatility of fabric enables it to be formed around diverse implant designs, while being thin and flexible enough to deliver through a catheter. Polyethylene terephthalate (PET) fiber is the most common material used in textile vascular applications, due to its proven biocompatibility and established clinical history. Although the fabric can be knitted, it is typically woven to ensure shape stability and durability, while minimizing blood permeability.

Advances in high-density, fine-woven grafts have helped reduce Type IV endoleaks resulting from low-level porosity. In addition, higher-strength braided sutures, using material such as UHMWPE, allow for lower-profile suturing, while supporting the introduction of increasingly lower-profile and durable graft systems. Although mechanical fixation and bonding offers support, suturing remains the primary mode for affixing fabric to vascular implants. It requires highly skilled technicians 10

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and is extremely time-consuming. As a result, many companies have sought to overcome this challenge with the use of other biomaterials, such as polytetrafluoroethylene. The completely hydrophobic nature of PTFE helps to reduce porosity, and subsequent risk of endoleaks, while the material is applied to a metal frame without the need for suturing.

PTFE is a well-established biomaterial stent covering for indications such as arteriovenous access treatment and renal stenting. New advances in material and processing technology are leading to greater adoption of this material in vascular indications, as exemplified by the Gore Viabahn stent to treat stenosis of the superior femoral artery or the Microport Willis stent for intracranial aneurysms. PTFE also offers a versatile covering option for balloon and self-expanding stent systems, and it’s likely that we will see greater proliferation of its use, not only in the peripheral vascular market, but potentially in structural heart applications.

Synthetic biomaterial coverings Synthetic biomaterials, such as polyurethane and silicone, have been used to cover implants for decades, primarily in non-vascular indications. But there are limitations to mechanical performance, including strength, durability and deliverability, and problems with protein adherence and biofilm formation post-implantation.

Theroplastic polymeric coatings and membrane coverings have advanced significantly in recent years. Robust polymeric coverings can be applied at several-micron wall thickness, with additional coatings applied to enhance biocompatibility and functional performance. Synthetic biomaterials, including grades of polycarbonate, polyurethane and silicone, are being reconsidered as implant coverings or membranes in the vascular market, offering low-profile solutions in areas including thrombus retrieval, occlusion and embolic protection.

Next-generation devices will increasingly be modified to lower their profile and cost of manufacture or improve invivo performance and durability. New biomaterials, including resorbables and functional coatings, play an important role in enabling the next generation of vascular implants and are being introduced to offer more effective solutions for an increasing range of potential applications. M

Covered braided stent designs provide flexibility for tortuous anatomy.

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STORAGE

Proper healthcare storage and design for ergonomics, speed of use, and maximized space

T i ff a n y N . Va n n | M a r k e t i n g & C o m m u n i c a t i o n s Manager | Stanley Black & Decker |

When selecting proper storage in the healthcare industry, it’s necessary to consider components that contribute to efficiency, cleanliness, and preservation of instruments. After all, these elements are most important to any healthcare provider, because they play a major role in improving procedures in the work environment, keeping medical tools sterile and patients healthy. Additionally, these elements reduce expenses, with fewer cases of damaged or malfunctioning devices caused by improper handling and ineffective storage.

With these factors in mind, what does proper healthcare storage look like? How can healthcare providers determine the effectiveness and efficiency of their current storage systems? Because productivity, sanitation, and maintenance are primary concerns in healthcare facilities universally, providers should take into account ergonomics, speed of use, and maximizing space when evaluating storage systems. Is it time to trade in your existing storage system for a new storage solution that satisfies all

THE PROPER HEALTHCARE STORAGE SOLUTION SHOULD BE DESIGNED TO IMPROVE WORKFLOW AND PRODUCTIVITY. your healthcare facility needs?

The proper healthcare storage solution should be designed to fit the work environment to improve workflow as well as productivity. More commonly than not, limited space or inadequate 12

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use of space may have a domino effect and lead to poor organization in healthcare facilities. To address this problem, emerging solutions are available to combat ineffective storage and unproductive processes and provide versatility and custom storing features.

For example, storing instruments in cabinets that are too long for them forces providers to unnecessarily stretch to reach the instrument. Ergonomically, this adds stress, increases the risk of injury in the workplace, and wastes time. Cabinets designed to accommodate instruments with extended lengths lets healthcare providers store long instruments at a reachable level with one hand, eliminating the risk of injury from extreme reaching.

Other storage solutions deliver high-level organization by containing and transporting medical devices as they move about the healthcare facility. Some storage solutions also feature keyless entry, cart access programming, and user management software. These solutions are designed for optimal ergonomics, resulting in a small footprint and the ability to move through narrow, crowded areas with little to no room to maneuver. These mobile storage solutions are comfortable, convenient, and easy to operate; some are equipped with an optional handle for gripping.

Standard shelving can make it harder to move products, causing a delays and lost productivity. One solution is storage cabinets that allow a quick reach or find.

This feature lets healthcare providers save time while searching for what is needed and store instruments safely and securely. Furthermore, adjustable shelving options provide comfort for a quick reach at any level and also optimize space for instruments of varying size.

Hanging systems for instruments that require suspension protect delicate tools, relieve stress, and prevent kinking of

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cords. Ultimately, the hanging systems save healthcare providers from untangling medical tools, correcting impairments caused by improper storage and the need for re-sterilization before use.

What’s more, some companies have designed racking with angled top-level racks to support easy access to items stored in high places. With these systems, healthcare providers can reach for needed medical tools without standing on foreign objects and risking injury. Racking also provides the ability to label tools and instruments for quick identification.

Among the many benefits of flexible storage solutions, optimizing and maximizing space is another key feature that improves environments in healthcare facilities. Modular inner-cell designs and versatile storage accessories allow healthcare providers to eliminate wasted space. Moreover, some inner-cell designs aid in reducing costs per linear foot of storage and allow healthcare facilities to gain additional space per foot. For example, when compared to a standard size cabinet (34w x 24d x 84h), an InnerSpace storage solution provides an extra 21 linear feet and 140 percent more storage capacity. Customized interior configurations, additional space, and modified cabinet interiors to accommodate unique product sizes are all available to optimize and maximize existing space.

Take the time to re-evaluate your current storage systems for efficiency, speed of use and accessibility, and the ability to maximize space. Are your current storage systems effective for workflow and do they meet the needs of your healthcare facility? If healthcare providers became more aware of their specific needs and were educated enough to identify ineffective storage and workflow processes, medical facilities and the employees who manage them would see an increase in storage space and a boost in overall productivity. M

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HEALTHCARE IT

Allowing data to be free flowing and accessed through smartphones, tablets, laptops and workstations creates a more efficient environment.

Mobile 2016: The year of workflow transformation

James Henry | CTO/EVP - Products | Calgary Scientific |

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Integrating health IT with effective and efficient patient care delivery has not been an easy process. As a recent Harvard Business Review blog points out, “[T]he [electronic health record], which was in part meant to liberate physicians from the drudgery of paperwork, instead became their chief oppressor.”1 Today, looking for notes in a patient chart and copying or faxing documents has been replaced with file searches among multiple information systems and emailing requests for access to patient documents, with fingers crossed that the document will open when it arrives.

In the opinion of many providers, the shift from analog paper to digital documentation has not been liberating, and has increased the amount of time spent processing patient information and decreased time spent with patients.

Unlike the growing consumer satisfaction with technology, providers’ overall satisfaction with health IT has declined over time. In 2010, 61 percent of physicians surveyed by the American Academy of Family Physicians reported being either “satisfied” or “very satisfied” with their EMRs. In 2014, that percentage dropped to just 34 percent.2 But with countless hours and millions of dollars already invested in electronic health records (EMRs), the healthcare industry has no option save a return to a paper-based system, and providers have been forced to adapt without any perceived benefit. As the authors of the study referenced above put it, “From the physicians’ perspective, it appears that the significant investment in EHR systems over the past few years ... is failing to offer significant returns.

Far from helping physicians to operate efficiently and have more time to spend with patients, the opposite appears to be the case.” Before, doctors took notes at the bedside with paper, pen and clipboard that were permanently saved in a patient’s file. Today, they still scribble notes on paper and then dash to a computer to type them in, sometimes losing important data in the process. www.medicaldesignandoutsourcing.com

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HEALTHCARE IT

Radiologists are similarly handicapped by multiple proprietary and specialty picture archiving & communication systems (PACS). Instead of hanging files in front of a light board and talking them over with referring physicians and patients, radiologists ply their trade alone in rooms populated with the hardware of dozens of PACS. They roll between monitors, opening a different user interface at each PACS to read images, write or record reports and send them to colleagues, a practice called “swivel chair workflow.”

The initial push to adopt EHRs has shown that it’s going to take more than technology to reap the benefits of digital health. Today, the industry’s focus is shifting toward adapting technology to physician workflows, instead of telling providers to adapt their workflows to technology.

Focusing on supporting the workflow needs of providers and eliminating time-wasting tasks may finally unlock the promise of digital health: Improved care coordination and lower costs.

One path to bringing health IT and efficient physician workflow together is liberating patient data from proprietary information systems and allowing it to flow freely across all types of devices, including smartphones, tablets, laptops and workstations, from any and all locations. Mobile access to patient data not only meets provider needs; it’s also essential for healthcare institutions to remain competitive. Simple, secure access to patient images, for example, eliminates the need for repeat imaging, saving both time and money.

Providing mobile interoperability and access is complex, touching on everything from security to data formats to networking technology. The right architecture for the changing care delivery environment must support oneto-many interactions. With the “one” as a healthcare provider’s image viewer, the “many” can combine:

ONE PATH TO BRINGING HEALTH IT AND EFFICIENT PHYSICIAN WORKFLOW TOGETHER IS LIBERATING PATIENT DATA FROM PROPRIETARY INFORMATION SYSTEMS.

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• Smartphone, tablet, laptop or workstation: Viewing needs to be supported across all platforms, whether fixed or mobile, because providers move between them depending on whether they are at the bedside or in the office working on a report.

• Internal provider networks or external access points to internal networks: Effective workflows need safe, secure access to patient images and data, both locally and externally, so providers can coordinate care with patient care teams and specialists.

• Any DICOM or non-DICOM file, including photos, PDFs, and videos: Customers need to access not only patient scans but also photos, reports and even videos associated with either the scans or the patient. By supporting multiple file formats, a mobile diagnostic medical image viewer improves efficiency by allowing providers to stay within a single system, eliminating context switching, logins, and other distractions.

• One radiologist writing a report, one non-radiologist accessing an image or report, or an entire care team viewing an image during a conference: Coordinated, patient-centered care requires teamwork, and teamwork requires communication. The above features allow teams to convene, communicate and share data no matter where they are, what system they’re using or what files they’re viewing.

The coming year will see a transformation in the way providers work alone and with each other. We’re excited to play a critical enabling role in this transformation, by making providers more efficient and effective with mobile solutions. M For further reading: 1. https://hbr.org/2015/12/how-to-makeelectronic-health-records-an-assetinstead-of-a-burden 2. http://www.aafp.org/news/ practice-professionalissues/20150825ehrsatisfaction.html

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3/24/16 4:17 PM

Haydon Kerk® Linear Actuators...

SOLUTIONS IN MOTION High performance, precision linear motion technology Size 17 43 mm2 (1.7-in)2 Double Stack external, non-captive, captive hybrid linear actuator stepper motors

25000 Series G4, can-stack captive, non-captive, external linear actuator steppers 25 mm (1.0-in) diameter

Size 34 87 mm2 (3.4-in)2 captive hybrid linear actuator stepper motor.

Non-captive and external linear also available.

Size 17 - 43 mm2 (1.7-in)2 non-captive hybrid linear actuator with programmable IDEA™ stepper motor drive Size 8 21 mm2 (0.8-in)2 captive hybrid linear actuator stepper motor.

Also available in Single and Double Stack, non-captive and external linear.

Haydon Kerk Motion Solutions hybrid and can-stack linear actuators continue to offer equipment designers new motion control solutions that provide unmatched performance-to-size ratios, patented technologies and thousands of configuration options, and a vast experience in customized solutions.

HYBRID actuators are available in six sizes from Size 8: 21 mm2 (0.8 -in.) to Size 34: 87 mm2 (3.4-in.) – capable of delivering up to 500 pounds (2224 N) of force. Travels per step range from .001524 mm (.00006-in) to .127 mm (.005-in), with micro stepping capability for even finer resolution.

An integrated, programmable IDEA™ Drive is also available for Size 17 hybrids.

The G4 Series represents the industry’s most robust and most powerful CAN-STACK linear actuators. The G4 Series offers diameters of 20 mm (.79-in), 26 mm (1-in), and 36 mm (1.4-in). The can-stack product line also includes motors with diameters of 15 mm (0.59-in), 20 mm (.79-in) , 26 mm (1-in), 36 mm (1.4-in) and Ø 46 mm (1.8-in), available with captive, non-captive or external linear lead-screws.

Haydon Kerk Motion Solutions continues to be an innovative motion control technology company with a global network of people, facilities and services dedicated to engineering and manufacturing the world’s most advanced linear motion solutions.

For more information: www.HaydonKerk.com > Linear Actuators

Call 1 8OO 243 2715

www.HaydonKerk.com 1500 Meriden Road Waterbury, CT 06705 U.S.A. Telephone: 203 756 7441

Haydon Kerk 3-16.indd 1

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TUBING TALKS

What’d you say?

Pressure relief valve improves removal of patient earwax

Koren Huskins | Smart Products |

A custom-manufactured pressure-relief valve has improved the operation of an earwax removal device. The valve Model #130 valve with 3/8-in. OD from Smart Products is customized with a plastic body, special O-ring material, and precise opening pressure. The customized components ensure the valve works precisely within the Earigator. Pressure control is critical, so the Model #130 valve is the first line of security within this system. Should the water pressure reach a certain point, the Model #130 activates to divert pressurized water back to the reservoir. For additional safety, a pressure switch shuts off the Earigator system completely if needed.

The original device was invented in the 1990s by otologist Dr. Irwin Ginsberg. He and others noted that too much earwax – cerumen – can lead to ear pain, ringing, itching, or loss of hearing. Because ears are delicate sensors, people are often advised to seek professional treatment. Formerly, this involved irrigation with a syringe. This manual procedure puts a stream of pressure from three to more than 110 psi depending on the applied force.

There is also a lack of precise temperature control, general messiness, and patient discomfort. Ginsberg noted several drawbacks, such as a risk of injuring the ear’s external canal or the eardrum itself.

Medical device manufacturer Nupur Technologies acquired rights to the unit and improved it in several ways.

“We have reengineered the Earigator to a stateof-the-art design, with improved features. We have also significantly reduced costs. The product today will sell at less than half of the previous design,” Nupur Technologies CEO Joseph Priest explains.

“Cleaning earwax is a common procedure, but no one ever thought about improving the control and speed with which the procedure could be accomplished,” adds Priest.

The

The Earigator's base unit houses the electronic control board, water reservoir, heater, and water delivery system. This assembly includes the pump, a pressure relief valve, pressure switch, and water delivery tubing.

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NO ONE EVER THOUGHT ABOUT IMPROVING THE CONTROL AND SPEED WITH WHICH THE PROCEDURE COULD BE ACCOMPLISHED.

The valve Model #130 is a part of the Series 100 Standard Cartridge line of products and comes in a manual relief bleed style, check valves, or pressure relief valves, and in sizes from 0.25 to 0.75in. and opening pressures from 0.09 to 20 psi.

newly launched Earigator controls the temperature of the irrigating solution at 98ºF (37°C) and holds the pressure at 10 to 12 psi. The design now combines the functions of an otoscope and irrigation device in one product. The otoscope lets users clearly view and pinpoint the cerumen buildup before and during the procedure.

The hand piece includes a flow control trigger, water nozzle, magnifying glass, and LED lights. A procedure usually lasts three to five minutes. The Earigator makes earwax removal safer, faster, less messy, and lessens patient discomfort. M

Medical Design & OUTSOURCING

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FDA NEW PRODUCTS

The U.S. Food & Drug Administration’s list of pre-market approvals granted in December 2015 Summary of PMA Originals & Supplements Approved Originals: 2 Supplements: 81

Summary of All PMA Submissions Originals: 3 Supplements: 92 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 81 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 163.1 FDA Time: 140.4 Days MFR Time: 22.7 Days

Summary of PMA Originals Under Review Total Under Review: 58 Total Active: 32 Total On Hold: 26 Summary of PMA Supplements Under Review Total Under Review: 599 Total Active: 423 Total On Hold: 176

READ MORE ONLINE FROM MASS DEVICE

VISIT:

dwo.me/1RcV8BN

PMA original approvals APPLICATION NUMBER / DATE of APPROVAL

20

DEVICE TRADE NAME

COMPANY NAME CITY, STATE, & ZIP

P140030 Astron 12/17/15 Peripheral Self-

Expanding

Nitinol Stent System

Biotronik, Inc. Lake Oswego, OR 97035

P150019 Paradigm Real- 12/7/15 Time Revel

System

Medtronic MiniMed Northridge, CA 91325

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DEVICE DESCRIPTION / INDICATIONS

Approval for the Astron Peripheral Self-Expanding Stent System. This device is indicated for improving luminal diameter in patients with iliac atherosclerotic lesions in vessel reference diameters between 4.3mm and 9.5mm and lesion lengths up to 105mm.

Approval for the Paradigm Real-Time Revel System. This device is indicated for: Paradigm REAL-Time Revel insulin pump. The Paradigm REAL-Time Revel insulin pumps (MMT-523/MMT-723) are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Paradigm REAL-Time Revel system consists of the Paradigm MMT-523/MMT-723 insulin pumps, the Enlite glucose sensor (MMT-7008), and the MiniLink Transmitter (MMT-7703).

Use of the Paradigm MMT-523/MMT-723 insulin pumps with the optional sensor and transmitter components is indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes in adults (ages 18 and older). Enlite Sensor: The Enlite sensor (MMT-7008) is intended for use with the Paradigm REAL-Time Revel insulin pump systems (MMT-523/MMT-723) to continuously monitor glucose levels in persons with diabetes. Glucose values provided by the Paradigm REAL-Time Revel system are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on the sensor glucose readings provided by the Paradigm REAL-Time Revel system.

www.medicaldesignandoutsourcing.com

3/24/16 4:23 PM

MANUFACTURING

Reducing the of hospital - acquired Rajul Randive • Director of Application Engineering • Crystal IS

infections with UV disinfection

Integrating UVC LEDs into a UVGI system, instead of mercury lamps, allows for continuous disinfection without causing harm to a patient. As standards look to reduce HAIs, LEDs will quite possibly become the light source of choice.

Infection control is a major focus in healthcare, owing to its enormous, worldwide financial and social burden. One in every 25 patients will acquire an infection while hospitalized. In fact, hospital-acquired infection (HAI) is the most common hospital complication, resulting in billions in excess healthcare costs. In 2014, the infection control market was estimated at $13.1 billion, including chemical and physical equipment solutions. The disinfection and sterilization equipment market, a $3.1 billion segment, has the highest growth rate, supported by an objective of the Affordable Care Act to promote quality improvement and encourage innovation in the field of HAI prevention.

Historically, hospitals were paid regardless of the reason for service, with no monetary pressure to improve quality. Today, public and private health plans are moving to change payment structures to reward better outcomes instead of mere service volume. This is driving innovation in HAI prevention technology, www.medicaldesignandoutsourcing.com

Manufacturing Feat_3-16_Vs4.indd 21

including disinfection of air and surfaces using ultraviolet light.

Methods for delivering UV disinfection Ultraviolet germicidal irradiation (UVGI) is one of the techniques that can be used to reduce airborne pathogens in healthcare environments. With this technique, light in the 250nm to 280nm wavelength range (also referred to as the UVC range) disrupts the DNA of harmful microorganisms and renders them unable to reproduce, eliminating the spread of infection. UVGI is primarily delivered with three systems: Portable, in-duct and upper-room.

Portable UVGI units are used in patient, surgical and ICU rooms, and other critical-care settings. Mobile units use high-power, pulsed UV light for intense intermittent room cleansing between patient stays or procedures, while portable in-room air purifiers equipped with UV are used for continuous air treatment in high-risk areas.

This allows facilities to bring disinfection to the patients and locations that need it most.

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MANUFACTURING

Stationary UVGI disinfection can take the form of either in-duct systems for airstream disinfection or upperroom installations to prevent infection transmission within a room. Unlike the portable units, both types of built-in systems are capable of treating large air volumes. In-duct UVGI centralizes disinfection using mercury lamps to treat air as it circulates through the building. Guidelines from standards committees such as ASHRAE define optimal lamp placement within an air handling unit or duct to optimize disinfection. These units are practical for preventing infections that are primarily recirculated within buildings, such as sick building syndrome.

Upper-room UVGI units eliminate airborne pathogens within a room and are especially advantageous when the source of infection is localized. This solution is effective in preventing the spread of influenza, SARs, TB and other airborne illnesses. In fact, this method of disinfection has been found to reduce rates of infection by 80 percent in controlled mammalian laboratory experiments published

by Ed Nardell, Associate Professor of Medicine at Harvard Medical School.

UVC LEDs: Redefining UVGI systems Light-emitting diodes that put out UVC light are an emerging alternative for all three types of UVGI systems.

Traditional UVGI systems use low-pressure mercury lamps, which emit at 253.7nm as a line source. Despite this particular wavelength not being ideal from a germicidal efficiency standpoint, the lamps have become an industry standard because they are easily accessible. With the introduction of UVC LEDs, emission of the light can be tailored to the action spectrum of pathogens – reported between 265nm and 267nm. There can be some variation in wavelength susceptibility between bacterial and viral strains, usually depending on the cell wall characteristics.

The wavelength specificity of LEDs makes them beneficial to systems created for a specific target, such as SARS or TB. In traditional mercury lamp-based upper-room UVGI systems, the lamps are left on continuously in occupied rooms and congregate settings. Prolonged exposure to UVC wavelengths can cause eye and skin damage, so the use of these systems requires the integration of safety measures to protect occupants. These include directing almost all of the UV light above eye level via reflectance baffles integrated into the lighting fixtures. Such baffles have an unintended consequence of reducing lamp efficiency. New solutions using UVC LEDs provide increased design flexibility and safety for room occupants while being an inherently unidirectional and efficient light source. This means that manufacturers can control the emission path away from occupants, without requiring additional baffles to redirect light allowing for continuous disinfection without causing harm.

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A.

This comparison of two upper room UVGI systems, one using mercury lamps (a) and one using UVC LEDs (b), shows that the more even dispersion of UV light reduces cold spots (represented in as blue areas). Also, the system using the UVC LEDs (b) has lower power consumption than the system using mercury lamps (a).

B.

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MANUFACTURING

Comparison of UVC irradiation pattern for two upper room UVGI arrangements using UVC LEDs.

The compact nature of UVC LEDs also allows for more uniform disinfection in a room – regardless of shape or size. Traditional fixtures are constrained in design due to the lamps’ long tube housing. Such fixtures are placed in corners or along the walls of a room for optimum UV radiant distribution. But hot spots and cold spots are typical, as seen in the image at left, especially in irregularly shaped rooms. Conversely, the compact nature of UVC LEDs allow them to be placed in a grid-like pattern to accommodate room shape for maximum uniformity, providing an overall more efficient germicidal system. An example of the two different optical patterns possible with the same set of UVC LEDs is shown in the image above.

requirements provide direction for the system designer. The images below show two examples of localized surface sterilization targets – a cylindrical vial and a small workstation. As UV disinfection is line-of-sight irradiation, the flexibility of the LED allows for a uniform dispersion of light across the entire surface.

In the first example, a cylindrical vial requires a dosage of 5mJ/cm2. When performing the simulation, the designer must consider the power and time required

Localized surface disinfection with UVC LEDs The design flexibility of UVC LEDs can also be leveraged for small-scale surface disinfection, particularly for irregularly shaped surfaces. The compact nature of UVC LEDs allows the sterilization unit to take the shape of the disinfection target.

Understanding the size of the surface, distance from the light source, and dosage

to achieve this dosage at the furthest point from the LED array – the base of the vial, which is 81mm from the light source. The irradiation would be higher on the sidewalls closer to the top of the vial, so achieving the minimum dosage at the base would ensure the entire vial surface is disinfected.

According to the model, the arrangement shown will achieve the required dosage after 10 seconds of exposure.

The second example shows the disinfection of a workspace surface 100mm

Arrangement of LEDs that can be used for disinfection of vials (A), the optical modeling of the irradiation of the vial (B), and the irradiation pattern at the bottom the vial (C). www.medicaldesignandoutsourcing.com

Manufacturing Feat_3-16_Vs4.indd 23

MANUFACTURERS CAN CONTROL THE EMISSION PATH AWAY FROM ROOM OCCUPANTS WITHOUT REQUIRING ADDITIONAL BAFFLES TO REDIRECT LIGHT ALLOWING FOR CONTINUOUS DISINFECTION WITHOUT CAUSING HARM.

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MANUFACTURING

wide (about 4 in.), requiring a dosage of 12mJ/cm2. To achieve this, the lights are arranged in a 100mm-wide strip of four UVC LEDs set approximately 25 mm above the surface. To achieve a uniform dispersion with the 100° viewing angle of the LEDs, they must be placed 25mm apart in the array. The target dosage in this application can be achieved by irradiating the surface for 60 seconds.

Arrangement for surface disinfecting bar that can move along the axis (A) and radiation pattern from the LED on to a surface in stationary mode (B).

The ability to arrange the LEDs to accommodate the surface allows designers to achieve uniformity while making the most efficient use of the light source. This allows disinfection of more high-contact surfaces – further reducing the risk of HAI for patients.

In addition to overall effectiveness, systems integrating UVC LEDs provide other advantages, including environmental friendliness, less-complex electronic systems, and compact design. These advantages offer tremendous design freedom and flexibility for mobile and stationary systems alike. As LEDs become the light source of choice, these systems will be reimagined and redefined to address the growing concern around HAIs and improved outcomes in healthcare facilities and congregate settings. M For further reading: http://www.health. gov/hai/prevent_hai.asp

䴀䤀䌀刀伀䴀伀 漀û攀爀猀 琀栀攀 眀椀搀攀猀琀 爀愀渀最攀 漀昀 栀椀最栀 瀀攀爀昀漀爀洀愀渀挀攀Ⰰ 栀椀最栀 瀀爀攀挀椀猀椀漀渀 氀椀渀攀愀爀 愀渀搀 爀漀琀愀爀礀 洀椀挀爀漀 洀漀漀漀渀 猀漀氀甀甀漀渀猀 愀挀爀漀猀猀 搀椀瘀攀爀猀攀 洀愀爀欀攀琀猀⸀ 䰀攀愀爀渀 洀漀爀攀 愀戀漀甀琀 琀攀挀栀渀漀氀漀最椀攀猀 愀渀搀 挀愀瀀愀戀椀氀椀椀攀猀Ⰰ 椀渀挀氀甀搀椀渀最 䴀䤀䌀刀伀䴀伀ᠠ猀 䔀渀最椀渀攀攀爀椀渀最Ⰰ 䴀愀挀栀椀渀椀渀最Ⰰ 愀渀搀 䌀氀攀愀渀 刀漀漀洀 䄀猀猀攀洀戀氀礀 挀攀渀琀攀爀猀Ⰰ 愀猀 眀攀氀氀 愀猀 洀愀爀欀攀琀 愀瀀瀀氀椀挀愀愀漀渀猀 愀琀 眀眀眀⸀洀椀挀爀漀洀漀⸀挀漀洀⸀

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3/22/16 5:48 PM

Medical Bellows

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WOUND CARE

Engineering the evolution of

Paul Dvorak • Founding Editor

WOUND-CARE AIR MATTRESSES The Selectair Max, from Moxi Enterprises, is one of several support surfaces offered by the company. This model comes with a quiet and portable mattress and control unit. One feature, Auto Comfort, takes the complexity out of programming. During set-up, the control sets the optimal pressure based on the patient’s weight distribution.

Bed-bound patients – those who may be obese, in hospice care, or recovering from wounds or bed sores – often find relief on an air-inflated mattress that spreads their weight over a large area to provide pressure relief than would not be possible with a conventional mattress. More than a mattress filled with air, this medical device boasts carefully placed air holes that keep patients cool and dry. The bed was invented in the 1950s in Europe, but since coming to America it’s been improved with new versions and materials, better blowers to keep it inflated, and clever controls to provide more than inflation.

“Patients who are bedbound develop pressure sores on their coccyx, the bone at midbuttocks, so we provide specialty air mattresses that replace a conventional mattress to provide pressure relief,” says Brian Emich, President of Galaxy Medical in Akron, Ohio. “One of the air

mattresses we use has an AMETEK blower in the pump that keeps the mattress inflated. This product has been around for a while. One reason the system is so durable is that blower inside the pump unit,” he adds.

The whole point of low pressure Sometimes called therapeutic air, the design has about 30 cells, each with three or four pinholes.

IT’S ALMOST AS IF THEY ARE FLOATING IN A POOL. The patient’s weight is distributed to minimize pressure on the body’s pressure points. “It’s almost as if the patients are floating in a pool,”

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WOUND CARE

Clinitron Air Fluidized Therapy beds from Hill-Rom are designed to provide an ideal healing environment for compromised skin, by minimizing the forces that cause tissue breakdown: Pressure, shear, friction, heat, and moisture. The system’s air fluidized therapy minimizes interface pressure while maximizing the surface’s immersion and envelopment properties to support healing.

Features support skin integrity by providing statistically lower interface pressure and superior microclimate management surfaces over traditional surfaces.

Emich explains. “This lets blood flow into the coccyx area and prevents the skin from breaking down.”

The point of a low air-loss system, says Gregg Garland, CEO of support-surface manufacturer Moxi Enterprises, “is to distribute the patient’s weight over the largest area possible, immerse that person, and wick away moisture to keep them cool and dry. When a patient spends long periods in bed, the escaping air helps remove humidity from underneath the patient, because heat and moisture can contribute to tissue damage. So, reducing the humidity lowers the risk of wounds,” notes Garland.

“Most equipment we distribute is for hospice patients throughout Ohio,” adds Emich. “People at end stages of life need medical equipment to get them through that journey as comfortably as possible. So we provide hospital beds, oxygen concentrators, wheel chairs, and air mattresses to patients in homes and nursing homes.”

Durability is important to Emich and his clients. When equipment is returned to the warehouse, it’s cleaned and restocked. “We have Moxi air mattress systems that are up to 10 years old and still in daily use,” he says.

Early bed designs used a compressor to stay inflated, says Moxi’s Garland. “We started using AMETEK blowers in the 1990s. The beds and surfaces have changed, mostly with new materials and features. We are sensitive to a couple more factors in 28

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wound care, and those are high friction and shearing forces. So the material should have a low-friction surface and low shear. The material must also be waterproof, because most patients are incontinent. And then it must also be durable and washable.”

In the last 10 years, moisture wicking has become a frequently sought feature; the medical industry was first to realize its importance. “I’ve been using the term ever since entering this business over 20 years ago, and now many consumer brands offer the feature in clothes for sports enthusiasts,” says Garland.

The industry is now focused on adding new features. “We understand the science, so now we compete on features.

For instance, we have an automatic setup mode. It uses algorithms to set up the system based on the patient’s weight distribution. Also, elevating the bed frame so the patient can sit up centers their weight distribution more around the trunk area of the body. The power unit will respond to that change by pumping about 25 percent to 30 percent more air into the trunk area of the mattress to prevent the patient from bottoming out,” Garland says.

The mattresses are sold through a nationwide network, so it’s not uncommon for someone to call and ask for a new feature or tweak. “For instance, safety is a great concern, especially regarding patients who might fall out of bed. For them, we provide an optional safety cover with foam bolsters on the surface to prevent the patient from rolling off. Two bolsters are in the shoulder area and two in the calf area. We can’t physically restrain patients, so we have to devise clever ideas to prevent falls without restraints,” he says.

A range of sizes is another feature.

“The designs include many widths, heights, lengths, and versions. For example, the bariatric world – for the morbidly obese – has a heavy-duty model. A standard mattress is 36 in. wide, but it can be had up to 60 in. wide. A full mattress depth is 8 in. to 10 in., but an overlay, a topper that goes on a standard

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WOUND CARE

feel comfortable offering that if not for that blower and its reliability. In fact, some competitive products still use compressors, not blowers, because they are less expensive, so their warranties might be one or two years at most.”

Windjammer variable-speed, brushless dc blowers offer compact size, low noise, and long life. The product line includes low-voltage and high-voltage (bypass and thru-flow) versions for a wide range of requirements.

Speed is adjusted internally with an onboard potentiometer or with an external PWM or dc control that actively varies blower performance.

Options include an IntelliGen II electroniccontrol drive integrating a factory-programmed digital signal processor and custom option cards for specific application demands.

foam mattress, is only about 3 in. to 5 in. deep. And there are about five different power options that depend on the features selected.”

Regarding the blower, Garland says his engineers prefer AMETEK’s because they’re durable and reliable.

“It’s a workhorse. It has safety features

A closer look at the blowers Blowers made by AMETEK Dynamic Fluid Solutions are used in a range of hospital and healthcare beds. “In those applications, most designers select 5 in. Minijammers and 5.7 in. Windjammer blowers,” notes AMETEK Application Engineering Manager Kevin Martin. The numbers refer to the diameter of the fan. The compressors used in other brands of medical mattresses resemble those used in ordinary aquariums, Martin adds. “For some beds, the issue isn’t just pressure. There are flow requirements, and that’s where the generic compressors don’t stack up.” Compressors on low-cost mattresses just blow up the topper as if it were a conventional air mattress.

Martin says his company provides more than hardware. “We can do custom work for companies that need assistance, such as particular performance from the blower.

For example, one high-end bed manufacturer asked for assistance making sure the mattress inflated at the right speed, provided the right pressure, and deflated as needed.”

the pressure at different areas of the mattress. That’s usually done by using a controller to open and close simple valves.

Another mattress pad uses the technique to inflate and roll the patient to avoid bed sores and provide climate control. This cannot be done with a compressor. It calls for a blower,” he adds.

Blowers are also considered more reliable than compressors, for at least three reasons, Martin says. “First, the company has been manufacturing blowers for more than 30 years. And we use brushless motors. Compressors use brushed technology, and brushes wear out. Hence, the blowers last longer. Also, in manufacturing, all bearing bores are machined to tight tolerances so fan alignment is better than on less-expensive, competing units. And rotor balancing makes for a quiet and long-life blower.”

Electronic controls on the high-end blowers allow fine-tuning of the operating parameters. “For one design, a team of engineers from our company and the customer’s worked together to perfect the blower operation. Our application engineering team tuned the software to the exact performance and response necessary. The task was to match the operating parameters, find the right signal level, and minimal noise on the system,” says Martin. “And we did.” M

TECHNICALLY IT IS AN AIR BED, BUT AIR FLOWS THROUGH GLASS FLUIDIZED BEADS TO PROVIDE ANOTHER LEVEL OF COMFORT AND SUPPORT FOR PATIENTS. to address overheating that make it unlike other blowers. The system is a little more expensive than some of the imported products, but we differentiate ourselves with a five-year warranty, which is unusual in this industry because the mattress works 24/7. We would not

Fluidized beds are an interesting variation on low-loss toppers, says Martin. “Technically it’s an air bed, but air flows through glass fluidized beads to provide another level of comfort and support for patients.”

“Another treatment tactic is to vary www.medicaldesignandoutsourcing.com

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TRENDS

WELCOME

to our Trends issue, in which we dive into the need-to-know issues of medtech design and engineering.

We've tried to cover the basics – materials, adhesives, tubing, batteries, bearings and motors.

We also took a look at the cutting-edge trends shaping the industry, including how advances in catheters and robot-assisted surgery have reshaped the surgical field, as well as the burgeoning of bioresorbable products, cybersecurity, prosthetics, and 3D printing.

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TRENDS MATERIALS

Optically clear silicone for medical applications Heather Thompson | Senior Editor |

GW Plastics has made something we’ve never seen – or rather, something we can see through. GW Plastics has been molding optically clear silicone that is starting to gain interest for applications such as wearable technologies, endoscopes, optical sensors and instruments, medical lasers, diagnostics, light guides, light pipes, secondary optics, and other medical devicerelated applications.

Still in its infancy within the medical device industry, optical silicone provides some intriguing opportunities.

We asked Jason Bassi, Business Development Manager for the silicones division at GW Plastics, a few questions about this emerging technology.

Q: How did the idea of an optically clear LSR originate?

JB: The idea for optically clear silicone actually originated in the lighting industry, where it is used within LED lighting applications. I first saw optical silicone being liquid-injectionmolded four or five years ago, but it still seemed to be in its infancy. With GW Plastics’ core business being in the healthcare space, we tried to determine if there was interest within our current customer base. As we started exploring and becoming more familiar with molding the material, the opportunities began to present themselves. Although it’s not clear if there is one application or niche that stands out for this material in the medical device market, we’re seeing various applications that are prompting us to invest further in developing our capabilities and expertise.

Q: What are some of the opportunities you seen in the marketplace?

JB: The most common application we’re seeing optical silicone being used for is to replace polycarbonate, PMMA, or glass in situations where the traditional optical materials are limiting the design or function of the device.

In one instance, we’re working to assist a customer in the development of a wearable device that needs to form to the body and direct light to specific areas. The detail in the lens is very intricate and needs to be exact to diffuse the light properly. This wouldn’t be possible with traditional optical rigid materials.

We’re also seeing applications that involve UV light transmission that have a negative effect over time on polycarbonate and PMMA. Because optical silicone has excellent UV light resistance, it becomes a better longterm choice. Overall, we’ve noticed a similar pattern developing for the use of optical silicone in the medical device market, as we’ve seen with liquid injection molding

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in general.

Our customers face challenges that require an optical surface, but are limited with the traditional materials. Most of the applications center on creating highly precise features or geometries that are difficult to fabricate with current methods and materials. The low viscosity before cure makes molding optical silicone into complex shapes easier than with either organic polymers or glass.

Q: What are the attributes that make the silicone most interesting?

JB: The programs we’ve been most successful with haven’t necessarily started with the intention of utilizing optical silicone. Often we’re getting involved because a customer has a challenge that they feel silicone can solve. The benefits of silicone include being bacteriaresistant, UV-resistant, biocompatible, low -viscosity for molding precise and difficult features, temperature-flexible from -180°F to 600°F, chemical resistance, and fatigue- and compression-set-resistant, and it initially meets a need beyond the optical properties of the silicone. The true benefit is the design flexibility, along with the great physical properties of

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TRENDS the material. Because the optical-grade silicones additionally have excellent optical clarity, light dissipation properties, and durability, the results have been very encouraging.

Q: What are some design considerations that OEMs should take into account when working with the material?

JB: I think design freedom and flexibility is the key here. Because of the low viscosity of the optical silicone and liquid silicone rubber in general, liquid injection molding of optical silicone allows for the molding of geometries that would not otherwise be possible with other organic polymers and glass. Thin walls, the reduced likelihood of sink allowing for thicker walls, precise features, varying wall thicknesses, small undercuts, negative

draft, and difficult parts to fill can all be achieved with optical silicone. Other areas that should be considered are combining multiple components into one molded component. We see this in cases where a lens is combined with a seal. By molding the lens with an optical grade silicone, the seal can be incorporated into the lens, reducing a component and an assembly step.

I think we’re just starting to see some of the areas optical silicone can be of value in the healthcare market. The one limitation I do see at this point is that there are no medical-grade optical silicones that I’m aware of. I don’t feel this is as much of a technical hurdle as it is a business decision. Once the demand surfaces, I think the material suppliers will take the next steps to provide what the market drives. M

MOTORS

Your next operation may be performed by a machine Brad Perriello | Executive Editor |

If you can call something that’s been on the market for 16 years a trend, then robot-assisted surgery is one of the hottest in medtech. Pioneered by Intuitive Surgical’s da Vinci abdominal surgery device, which hit the U.S. market in 2000, today almost no medical specialty lacks an entrant with a robot-assisted platform.

As with most robotic surgery systems, the da Vinci's motor-actuated technology allows a surgeon's hand movements to be scaled, filtered and translated into precise movements inside the patient's body.

The device uses DC servo-motors made

by Maxon Motor, which says Intuitive’s engineers have built more than 30 of its motors into their devices.

Today there are at least a dozen companies working on robot-assisted platforms.

Trend: Intravascular Seeing the technology’s potential in other applications, Intuitive Surgical co-founder Dr. Frederic Moll founded

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Hansen Medical in 2002 with an eye toward the intravascular space. (Moll, a serial entrepreneur, also cofounded Mako Surgical, acquired in 2013 by Stryker Corp.; Restoration Robotics and its Artas hair restoration platform; and Auris Surgical.)

Mountain View, Calif.-based Hansen has a pair of platforms on the market: The Sensei system for electrophysiology procedures and the Magellan system for peripheral vascular interventions.

Another EP player is Stereotaxis, with its suite of products aimed at cardiac ablations to treat arrhythmias.

Corindus Vascular Robotics is also developing an intravascular system, the CorPath, for percutaneous

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coronary interventions such as balloon angioplasty and stenting. Cleared in the U.S. since 2012, the CorPath platform won an expanded clearance last year for radial-access PCI procedures.

Trend: Neurosurgery Medtech, a French company, has its Rosa neurosurgery device on the market in Europe, the U.S. and Canada. Designed to replicate the movement capabilities of the human arm, the device also features haptics designed to improve the surgeon’s “feel” during neurological procedures.

Trend: Abdominal surgery Intuitive Surgical has a sizable lead in abdominal surgery, but a pair of upand-comers are readying to compete.

TransEnterix this year completed its response to the FDA for its single-port SurgiBot, designed to be wheeled to the bedside (rather than requiring its own surgical suite). Based in Research Triangle Park, N.C., TransEnterix has said the SurgiBot could win FDA clearance this year.

Toronto-based Titan Medical is gearing up for first-in-human trials of its Sport ‘bot, another mobile, single-port offering featuring 3D imaging and interactive instruments. Assuming all goes well with the trials, the Sport system could be on the market by mid-2017, Titan has said.

Trend: Orthopedics The orthopedic space is no stranger to robot-assisted surgical devices, with Stryker and Smith & Nephew entering the space via acquisition in recent years.

Stryker paid $1.68 billion for Mako Surgical’s Rio device for knee and hip replacement procedures. The system uses a 3D model derived from CT scans to customize the implant’s size, orientation and alignment before the operation. Now called the Mako arm, the platform is designed to be used with Stryker’s panoply of knee and hip implants.

British arch-rival Smith & Nephew put up $275 million for Minneapolis-based Blue Belt Technologies and its portable Navio system. Unlike the Mako device, which is solely used with Stryker products, the Navio system is designed to pair

with knee implants from eight different manufacturers, plus the London-based company’s Zuk and Journey Uni devices.

Mazor Robotics is also in the orthopedic space, with its Renaissance spine surgery system, designed for open, minimally invasive and percutaneous posterior thoracolumbar approaches. And Medtech, the French company that makes the Rosa neurosurgery system, also makes a Rosa Spine version for this space.

Trend: Large-caps late to the party Google and Johnson & Johnson grabbed headlines late last year when they joined forces to form Verb Surgical.

Details are scarce, but the companies have said the Verb Surgical platform will incorporate leadingedge robotic capabilities. Their Verily joint venture, headed by former Volcano CEO Scott Huennekens, is a collaboration between Verily (formerly Google Life Sciences) and J&J’s Ethicon subsidiary. Ethicon is on tap to develop the instrumentation for the as-yetunnamed Verb Surgical system.

Medtronic is another big name in medical robotics (along with seemingly

Company Intuitive Surgical Hansen Medical Hansen Medical Corindus Vascular Robotics Stereotaxis Medtech Medtech TransEnterix Titan Medical Auris Surgical Robotics Stryker (Mako) Smith & Nephew (Blue Belt) Google/J&J (Verb Surgical) Medtronic Virtual Incision

Platform da Vinci Sensei Magellan CorPath Multiple Rosa Rosa Spine SurgiBot Sport ?

Rio Navio ? ?

RASD

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Market Abdominal surgeries Electrophysiology Peripheral vascular Percutaneous coronary interventions Electrophysiology Neurosurgery Orthopedics Abdominal surgeries Abdominal surgeries Ophthalmology Orthopedics Orthopedics ? ?

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everything else). The world’s largest pure-play device maker brought on a significant robotics program when it acquired Covidien for $50 billion last year, with CFO Gary Ellis later telling analysts that Covidien was “farther ahead even than ourselves” on the road to a robotics offering. Fridley, Minn.based Medtronic plans to integrate some of the interventional surgical devices it got from Covidien with a robotics system developed in-house – although with billions to spend there’s always the possibility that Medtronic will buy its way into the space.

Trend: Inside the body Virtual Incision’s twist brings the robot inside the surgical cavity. The company reported 1st-in-human proof of concept in March, when its miniaturized robotically assisted surgical device (RASD) was used in a colon resection procedure.

Spun out from the University of Nebraska (the company is based in Lincoln, Neb., and Pleasanton, Calif.), Virtual Incision’s device is designed to be inserted through a single incision into the abdomen, to work entirely within the body of the patient. M

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© 20

CATHETERS

How catheters are driving healthcare innovation Fink Densford | Senior Editor |

The catheter is not the Hollywood starlet of medical devices. Hardly glamorous, it’s a tube that goes inside the body. Despite their diminutive size and seemingly basic function, however, catheters have become an integral part of the modern healthcare system and are driving innovation in the industry.

Navigating the human circulatory system can be a difficult endeavor, but modern technology has brought us from reeds and metal-jointed tubes to space-age polymers and microscopic sizes that can perform a plethora of tasks and tap the inner reaches of our bodies without painful, invasive open surgeries.

Catheters are a central piece in modern hospitals and healthcare facilities, treating life-threatening lesions, scraping calcified plaque off arteries,

reshaping our hearts, delivering new artificial valves and snaking into our brain to prevent fatal aneurysms.

The most basic and recognizable is the Foley catheter, designed to serve a basic function in the urinary tract. But it’s rather advanced compared to its ancestor, a tube made from jointed metal segments hinged together with wire developed by Benjamin Franklin in the 18th century.

Franklin credited the invention to Francesco Roncelli-Pardino, but the idea of using straw-like devices to create pathways into the human body can be traced back thousands of years. Materials then were less than ideal – reeds, palm leaves and straw.

New materials introduced in the mid-19th and early 20th centuries, in the form of rubbers and plastics, revolutionized the devices. In the

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TRENDS 1930s, Boston-based surgeon Dr. Frederick Foley devised the catheter we still see in use today. Foley, recognizing that urinary catheters had a tendency to slip out of bodies during use, designed a catheter with a small balloon on the end to hold it in place.

But catheters do more than just treat urinary issues. Catheters were pivotal in the development and deployment of the 1st coronary stents and scaffolds – now a standard of care for percutaneous coronary interventions. The first coronary stent was deployed in 1986; 13 years later, stenting made up 84.2% of all PCIs. Catheter-based stenting has come a long way since its initial, bare-metal introduction. In the early 2000s, drug-eluting stents were introduced to minimize restenosis and the reinterventions associated with early bare-metal stents. Unlike their simpler ancestors, the polymer-coated drug-eluting devices contained antiproliferative agents to prevent neointimal hyperplasia, reducing restenosis rates significantly.

Development of new materials, which could be absorbed into the body after use, has lead to the development of bioabsorbable stents. Over

approved in the European Union. Absorb is made out of a poly-l-lactide acid biopolymer with an everolimus coating and is designed to be entirely reabsorbed over a matter of months after it’s deployed with an advanced catheter-based delivery system.

Beyond deploying stents, catheters are the driving force in a number of newly developed procedures to repair the peripheral vasculature.

Diamond-tipped, pneumatically driven catheters are at the heart of orbital atherectomy, a new procedure designed to treat peripheral artery disease. PAD is a narrowing or blockage of vessels that carry blood from the heart and lungs to the arms and legs, primarily due to the buildup of fatty plaque in the arteries. Approximately 8 million people in the U.S. have the disease, according to the Centers for Disease Control & Prevention, affecting between 12% and 20% of all individuals older than 60.

In orbital atherectomy procedures, which are being spearheaded by St. Paul, Minn.-based Cardiovascular Systems and its Diamondback series of devices, a catheter tipped with a diamondcoated crown and powered by a pneumatic drive console is used to physically debulk and remove the plaque from within diseased arterial segments.

The system uses a larger guidewire than earlier rotational atherectomy procedures to advance more easily through tight stenoses while allowing continuous blood flow through the vessels.

CATHETERS WERE PIVOTAL IN THE DEVELOPMENT AND DEPLOYMENT OF THE 1ST CORONARY STENTS AND SCAFFOLDS – NOW A STANDARD OF CARE FOR PERCUTANEOUS CORONARY INTERVENTIONS. the last decade, major players in medical devices including Abbott, Boston Scientific, Biotronik and Reva Medical have invested heavily in developing bioabsorbable stents.

In the U.S., bioabsorbable stents have yet to cross the finish line with the FDA. The closest product to win approval here is Boston Scientific’s polymer-coated, bioresorbable Synergy device, which features a polymer coating that’s designed to dissolve after delivering its drug payload, leaving a bare-metal scaffold behind.

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Catheters have also been at the center of other heart treatments for more than 30 years. The first catheter ablation to correct atrial fibrillation occurred in 1981. The early procedure used high-energy DC electricity to cauterize the muscle of the heart, disrupting dangerous arrhythmias. Ablation has come a long way since then, with energy sources varying from lasers to cryogenic freezing, and newer devices are being designed to allow surgeons to see the tissue they’re ablating.

Cardiofocus, based in Marlborough, Mass., has developed a visually guided laser balloon designed for ablation procedures for treating

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THE SYSTEM INCORPORATES AN ENDOSCOPE TO PROVIDE PHYSICIANS WITH THE ABILITY TO SEE WITHIN THE HEART, FOR THE 1ST TIME EVER.

paroxysmal atrial fibrillation. The system incorporates an endoscope to provide physicians with the ability to see within the heart, for the first time ever, and visually direct the application of laser energy to achieve durable pulmonary vein isolation.

The device is already approved in the European Union and the company is on track for FDA approval after submitting an application with the agency last fall.

In addition to shaping the heart, catheters are helping surgeons add to it with micro-sized valve replacements. Through the use of catheters, surgeons are able to guide expanding replacement valves into place in patients too sick to undergo open surgery. Transcatheter aortic valve repairs have been around for nearly 20 years, but new developments are pushing the envelope with replacements designed for the mitral, pulmonary and even tricuspid valves.

Mitral valve regurgitation is a much more common problem that aortic stenosis, affecting nearly 10% of all people age 75 or older, meaning the potential market for TMVR could be two or three times larger than its older TAVR cousin.

But the mitral valve’s anatomy is much

more complex than the aortic valve’s, making TMVR devices and their delivery systems much more difficult to design.

The FDA cleared the first transcatheter mitral repair product, Abbot’s MitraClip, in 2013, though the device is not designed to replace worn-out or heavily stenosed valves.

Many big players in medtech are tilting at TMVR, having dropped more than $2 billion combined last year to buy early developers of the tech. Medtronic paid $458 million for TMVR developer Twelve Inc., Abbott dropped $250 million on TMVR developer Tendyne and Edwards LifeSciences spent $400 million to buy CardiAQ Valve Technologies and their TMVR tech.

Innovations in catheter technology have brought the devices into every part of our body, including our brains. New catheter technology is allowing for the minimally invasive treatment of brain aneurysms – dangerous bulging or weaknesses in artery walls. Normally, procedures to correct the life-threatening problem are carried out by physically clipping the base of the aneurysm, which requires intensely invasive surgery in which the patient’s skull or brow is opened to provide access.

Medtronic recently won approval from the FDA for its catheter-based Pipeline Flex embolization device (also a former Covidien product) to treat brain aneurysms. With the Pipeline device, a catheter is snaked into the delicate vasculature of the brain, where it deploys a flexible tube from the base to the end of the embolism to guide blood flow along the vessel and away from the possibly fatal vascular expansion.

Both Boston Scientific and Cordis have developed devices to treat the same problem through the deployment of coils – microsized cords that range from smaller than a human hair to twice its width, made of soft platinum metal and shaped like a spring. A microcatheter is fed into the brain and the coil is deployed to fill the aneurysm.

Innovation is continuing with catheters – they’re connected to new developments including leadless pacemaker deployment, repairing holes in the heart with the aid of biodegradable adhesives and filtering out dangerous blood clots.

Although small in stature, catheters are driving medtech innovations that reach into every corner of the human body. M

CYBERSECURITY

Designing software security into Linux-based medtech Heather Thompson | Senior Editor |

As medtech developers seek to reduce costs and improve patient monitoring and care, they’re introducing wireless electronics to the market. The pace of development is slipping past “steady” and is now better characterized as “frenetic.”

Embedded software is critical for collecting, managing, storing, and transmitting medical data.

But the security of these devices – and the patient data collected and stored in them – presents new challenges to the medical device industry. www.medicaldesignandoutsourcing.com

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Intensified exposure One challenge, says Bryan Gartner, senior technology strategist at SUSE Embedded, is that there are so many options for interaction.

“Some companies use middleware to connect to the hospital and some write their own code.

And this creates potential attack surfaces,” he says. Understandably, he explains, hospitals are hesitant to open portals for device data because of the risk to patients’ data.

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TRENDS Dennis Vetrano, sales and business development manager-medical for SUSE Global Embedded, agrees, saying more standards are needed. “Driving patient data to many areas in the hospital from varying devices and ultimately to the EMR has become very complex due to a lack of standards within the industry and internal hospital IT structure.”

Medtech security There are various ways for medtech companies to find themselves unprepared for cybersecurity: discovering Malware in medical devices; transmitting unencrypted data; or overcoming a lack of comprehensive incident reporting to combat breaches are just a few.

Gartner says when it comes to malware, Linux software is generally delivered in granular packages that can be checked any time to ensure they’re signed and delivered as expected. He also suggests that devices take advantage of detection software that can be run over and over until it finds something out of the ordinary. “With tools like that, you do your best to isolate and mediate those problems and their impact on the overall device’s functioning.”

For transmitting unencrypted data, Gartner says companies need to make sure it’s secure both at rest and in transit. That requires some understanding of the options available, along with sound authentication and authorization principles.

There’s a lot of freedom of choice in encryption technology, he says. “It really is up to the designer to choose the most appropriate one for the situation,” Gartner notes, adding that there’s a trade-off between compatibility and security.

Increasing connectivity increases cybersecurity risks. For most computer systems, explains Gartner, security concerns primarily revolve around the protection of the data or information and ensuring its integrity over time.

With medical devices, the scope expands further to ensure that functionality can’t be interrupted or changed beyond the intended purpose, since injury to users or operators is also a risk.

In a networked environment, each wireless device becomes a potential gateway to the overall ecosystem of other connected devices. The fundamental properties of confidentiality, integrity and availability must be addressed with all designs, architectures, and implementations.

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With Linux in general, and for SUSE Embedded specifically, Gartner says multiple tools exist at each of the layers of the OSI model to address these principles within a given design and set of constraints.

Making Linux secure Linux is an alluring option because of its reputation for resistance to cyber threats.

As Gartner notes, “The overall community of users, administrators and developers are quite knowledgeable on security, privacy and protection measures.” Many users select Linux specifically because of security concerns with other operating systems. “Developers often favor newer technologies and versions,” he says. “Given the culture of the overall Linux ecosystem around security and quickly addressing any issues, the confidence and respect for this operating system is well-earned.”

That said, Gartner emphasizes that security is a process, not a state of being.

“Nobody should be complacent about potential cyber threats.”

To better understand Linux security, Gartner explains that Linux was designed as a multi-user operating system, with “specific access control paradigms.

Because it is by nature open-sourced, security defects can be observed, traced to a root cause, and fixed by any interested party.”

Vulnerabilities are cataloged and fixes made available often before their public release, says Gartner. And Linux distributors, like SUSE Embedded, take a snapshot of a set of releases and run their own significant testing, including security, to ensure a quality, reliable and robust offering for their customers. Further, he says, distributors also track vulnerabilities to ensure customers receive timely updates to address threats and defects.

Prescriptions for risk management Regulations such as IEC 62304 are good prescriptive measures, notes Gartner, because they provide the framework for the documentation needed for the software artifacts of a medical device over its entire life cycle. By focusing on risk management throughout the process, the documents enforce a mindset to assess risk early and often,

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as well as mitigate risks consistent with the devices’ own criticality classification and exposure to use or injury.

These standards can vary depending on the classification of the software (as product, system, unit, SOUP), he says. But in general they provide supporting evidence to the device manufacturer of a mature, functioning process control over how the software is developed, tested, delivered and maintained.

Gartner says he’s been impressed that FDA has begun mandating timely device security updates as part of regular maintenance. But device companies may

product after development because of FDA requirements. “This is where education in the process is important,” Gartner says.

Vetrano agrees that’s a significant change for the business model. “It’s becoming clear that medtech can’t ignore bug fixes” even though it changes the resource allocation for medtech product development. “Medical device companies have to mentally get behind the idea that in addition to the significant development costs, they have to maintain security once a product is on the market.”

In the last 24 months, Vetrano says,

be tapped to assist.

“The key is that medtech companies can focus on validation of the device and desired functionality as a whole, rather than becoming OS engineers,” Gartner says.

Medtech can’t simply rely on FDA to prescribe security.

“We in the medical field look to FDA as captain of the ship. But sometimes you can’t just look at the documents,” says Vetrano.

“As well as the documents are written and as helpful as they are, your compliance is only as good as the people reading, understanding, and applying those principles. There’s good

YOUR COMPLIANCE IS ONLY AS GOOD AS THE PEOPLE READING, UNDERSTANDING, AND APPLYING THOSE PRINCIPLES. not be used to tracking and managing threats effectively, he says.

A significant challenge is fear of reporting. Gartner advises medtech companies against avoiding reporting as a defensive move. One of the benefits of working with a distributor, he says, is that it allows for a safer, protected platform for bug fixes and updates.

Some companies struggle to overcome the notion that they shouldn’t touch a

FDA has made clear that companies will be expected to issue bug fixes and security patches, although they won’t have to refile for those changes.

That doesn’t mean they won’t have to do the internal work. “They still have to document and test everything,” says Vetrano, “and that’s where some problems have risen.” Companies might not have the engineering bandwidth to retest and document. Here again, OS developers can

guidance and structure, but it’s up to the company to put it into practice.”

The future of security Long gone are the days when software could simply be deployed without security updates.

Notes Gartner, “It’s possible to address cyberthreats in a rational, yet not overly complex or expensive fashion. Using diverse levels of protection is the best way to prevent problems.” M

TUBING

Simple, yet essential: Innovation in medical tubing design Fink Densford | Senior Editor |

Like the human bodies they’re designed to treat, medical devices are often composed of disparate systems. Linking those systems, much like the vasculature of the human body, are systems of tubes.

Tubing provides passage for gas, fluid, electronics, and even microsized devices to travel seamlessly. With modern designs, tubes are often slated to play double-duty, housing multiple components through different lumens with various internal sizes and wall thicknesses.

Since tubing plays such an integral role in medical tech, designers continue to push the limits with new tubing solutions. Advances in material design, extrusion and production techniques are constantly being released, improving design and functionality across the board. www.medicaldesignandoutsourcing.com

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TRENDS Production improvements are vital for tubing innovation. Better techniques for extruding thermoplastic elastomer tubing have improved biocompatability and processing, and new extrusion technology offers synthetic materials with low extractible content. That combination improves biocompatability, either when used in the body or with pharmaceutical products.

Other improvements include bioresorbable tubing, designed with custom degradation profiles to allow materials to perform in the body for a fixed period of time. New materials also allow for improvements in radio-opacity,

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anticoagulation, lubricity and biostability.

Formulations can be customized to deliver unique properties for project applications, such as UV-cured silicone materials, which cure more completely and at a higher rate than traditional platinum-cured silicone for more cost-effective production. Antimicrobial modifications can be incorporated into the material to help reduce infections.

As devices become more complex, tubing must follow, allowing for more devices, structures and other important components to travel through them. Though single-lumen tubing can be useful for a number of simple applications, multiple-lumen tubing cuts down on the number of tubes required in tight, constricting spaces for more steady operation.

Multi-lumen tubing has become more complex alongside associated medical devices.

Newer multi-lumen tubing may contain various lumen sizes within a single shaft, which makes

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concentricity of each lumen more difficult to achieve along with the appropriate wall thickness.

In micro-catheters, wall thickness becomes even more paramount.

meet pressure testing, tolerances; and manufacturing repeatability to meet requirements.

Incorporating co-polymers of silicone and polyurethane delivers long-

electronics or sensors, or along a shaft assembly with thin-wall coating capabilities suited to microcomponents along with microcatheter shafts and delivery devices.

SINCE TUBING PLAYS SUCH AN INTEGRAL ROLE IN MEDICAL TECH, DESIGNERS CONTINUE TO DEMAND THAT THE LIMITS BE PUSHED BY THE DEVELOPMENT OF NEW TUBING SOLUTIONS. Micro-catheter designs require thin-wall thickness that can maintain accurate pressure and flow mechanics. A balance must be maintained between wall thickness specifications that can

term biological stability and flexibility along with thin-wall thickness, implantgrade long-term biostability, lubricity and hemostability. The copolymer can also be used for encapsulating

Whether they serve a function outside a device, inside a device or inside a patient, production and selection of tubing is a critical part of medical design. M

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TRENDS ePTFE

Exploring encapsulated ePTFE Paul Dvorak | Founding Editor |

Expanded polytetrafluoroethylene (ePTFE) is a flexible, biocompatible material, currently being used to cover stents. The lubriciousness, strength, and durability of the material makes it valuable during stent deployment and in situ. But as the manufacturing processes for it have improved, it’s seeing renewed interest in other vascular applications, including transcatheter heart valves.

Material Benefits in Clinical Use The material’s ability to collapse and expand repeatedly is critical for its use in vascular applications. ePTFE can cycle millions of times without breaking or coming off the device – making it valuable in the stent deployment process and resistant to wear in the body. It can adapt to blood vessels and their natural pulsatile action. Those pressure pulses create flexion that an encapsulated device must withstand. ePTFE features varying permeability, enabling outgassing while keeping blood cells flowing. It

overcoming slippage during application to the stent.

Encapsulation, rather than coating, solves the problem for cylindrical devices and more complex geometries.

The biocompatible material is applied via a batch encapsulation process, enabling quick manufacture plus quality and cost and time savings. The encapsulation process is suitable for stent structures and other long-term implantable devices.

One of the benefits of the encapsulation process is that it enables very thin coverage of the stent, down to .0005 in. The encapsulation process can accommodate conical shapes, flared shapes, and double-flared shapes. The ability to encapsulate complex geometries is a critical development in manufacturing. It avoids the need to suture material to the metal. ePTFE sticks to itself around the metal of the stent, without delaminating or tearing.

A key advantage in the process is the time and cost savings it offers over traditional manufacturing methods. These methods include hand-sewing bovine or porcine valves to polyester, for example.

IN THE TIME THAT IT TAKES FOR THREE HAND-SEWN DEVICES TO BE READY, THE EPFTE ENCAPSULATION MIGHT PRODUCE HUNDREDS OF UNITS THAT ARE SUBSTANTIALLY THINNER. is chemically inert and hydrophobic. Further, the microporous nature encourages tissue ingrowth.

Research has shown that the endothelial cells lining blood vessels can adhere and grow on the devices surfaces.

The material is also easy to work with because of its temperature stability and achievable thinness.

Internal and external layers of coating measure in the micron scale, meaning that when the structure is deployed, it enhances the ability to navigate the vasculature but does not add significant thickness or diameter to the primary device.

Meeting Manufacturing Needs One of the traditional challenges of ePTFE is

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That process is long and labor-intensive, and garners the appropriate premium pricing. Further, as skilled as a hand sew may be, it cannot achieve micronlevel accuracy or micron thicknesses. By contrast, in the time that it takes for three hand-sewn devices to be ready, ePFTE encapsulation might produce hundreds of units that are substantially thinner.

What’s Next As minimally invasive procedures advance in the vascular realm, we will see the catheter sizes used for valves and stents get smaller. Encapsulated ePTFE is poised to meet the needs of innovators looking to improve clinical outcomes, reduce costs, and reduce time to market. M

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TRENDS LASERS

From advanced lasers to advanced stents: Femtosecond lasers create the next generation of bioresorbable stents Fink Densford | Senior Editor |

Manufacturing medical devices has always been a tricky task. Unlike consumer technology, the impact of a poorly built medical device can be severe and life-threatening. Producing devices for the human body can require precision on a level that used to be science fiction, but the development of ultra-short laser technology is taking their development to a whole new level.

Boston-based Resonetics is a laser micromachining company that produces a variety of parts and devices for the medtech and life science industries, including delicately structured bioresorbable stents. The company knows how important quality is when it comes to these parts.

“When you look at scaffolds or stents, there are several parameters of quality,” explains advanced technology VP Sergey Broude.

“One, of course, is the fidelity of the pattern with respect to the design, which comes from the customer. The second one is the state of the edge of the material after you cut it, because in all laser micromachining, metals and polymers, there’s always some propagation of effect of your laser into the material which stays on the target,” Broude said.

The next parameter is the presence or

THE TROUBLE WITH EXCIMER IS IT’S QUITE SLOW. absence of debris such as burrs or recasts on the edge of the part. These issues may require post-processing and post-laser cleaning, Broude said, which can be tricky with the polymers and materials used in bioresorbable stents.

Resonetics had, for years, operated with excimer lasers using a mask projection approach, he said. Even after bioresorbable stents hit the scene, excimer lasers still seemed to work – but slowly, and the process wasn’t optimal for bioresorbable materials.

“The trouble with excimer is it’s quite slow – these lasers can only operate at the rate of about 200Hz. You can’t go to fast with 46

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them,” Broude said. “So, over the years, for this application and other polymers, bioabsorbable or not, there was a tendency – and we were part of this – to search for a new laser.”

Enter the ultra-short-pulse femtosecond laser.

Known as fsec, the technology produces pulses that leave no thermal fingerprint on the part.

Disk-based fsec lasers offer sub-400 fsec pulses, plus best-in-class beam quality and peak power well-suited for cold ablation cutting, rather than a melt-ejection process. The resulting cut requires minimal post-processing and the smaller beam size allows machining of minute details.

The process works especially well for production of catheters, heart valves, and stents, for medical and glass-cutting and marking applications, as well as for 3D-structuring of ceramic material for dental implants. But perhaps the most interesting potential use is on a whole new class of bioresorbable materials – polymers that can safely remain in the body for controlled lengths of time before absorbing, as an alternative to traditional polymer or metal components.

In the past, fsec lasers were considered too slow for commercially viable operations. But recent studies evaluating cutting time per part and post-processing steps demonstrated that the return on investment for a disk fsec laser can be less than 12 months, especially for high-value components.

“Short-pulse lasers are relatively expensive to buy but cheaper to run than excimer lasers, and don’t require the nasty gasses that excimer lasers require,” Broude said. “So in many cases it’s easier to integrate them into the clean room environment or into states where environmental controls are more strict than others.”

The femtosecond laser is a dry format – no water or heat is introduced in the part. The number of steps is reduced; the part is machined then undergoes an electro-chemical process to round the edges. The integrity of the part is improved, several time-consuming steps are eliminated, and yields can be closer to 95%.

The femtosecond laser is also the only technology appropriate for machining medical

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Medical technology also relies on our drive systems. They are used, for instance, in modern arm prostheses which enables the wearer to make precise movements.

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TRENDS products out of new bioresorbable polymers.

Next-generation advanced bioresorbables (also called aspirants) are designed to meet precise degradation rates and other specifications.

“These lasers are different from excimer lasers in the sense that this is a Gaussian beam laser and we use it in direct-writing mode, where the beam is taken from the laser then formed by some optics and focused on the target,” Broude explained. “We’re currently applying a number of ultra-fast lasers for making stents, scaffolds and bioresorbable stents.”

The bioresorbable material can be machined into any stent profile, but it must be machined correctly and without induced heat.

Failure to do so might lead to crystallization in the material, degrading its structure, lifespan and ability to dispense medicine at the correct rate. Because bioresorbables dissolve, they can’t be cleaned like most plastics, nor can they be touched with liquid solutions – another reason the fsec laser is a better choice.

Largely composed of polyesters, primarily homopolymers and copolymers of polylactic acid and polyglycolic acid, bioresorbables show promise for

a variety of uses, including cardio stents for patients who may have been stented numerous times and can no longer tolerate a traditional fixed stent.

With the faster, more functional lasers at work, Broude said Resonetics has the ability to explore new materials for creating next-generation bioabsorbables as well.

“We see, both industrial and academic, new publications where people are using ultrashort lasers for newer and newer sets of materials,” said Broude. “And we are following this trend.” M

DIGITAL HEALTH

How much does buzz matter?

In the medical device world, buzz is not traditionally something companies strive to achieve. A blood pressure cuff doesn’t need brand awareness beyond the hospital or pharmacy purchasing the equipment. But in the commercial digital space, brand awareness is the only way to survive.

Digital health lies somewhere in the divide. It’s important to pique healthcare providers’ interest, but health app developers and electronics companies mentioned in the New York Times or the Wall Street Journal certainly get a boost from positive press. But for those that fly under the radar it’s a different story.

A case in point is Opternative. Using a computer and smartphone, Opternative’s app enables a digital eye exam in about 25 minutes in a patient’s home. Within 24 hours an ophthalmologist reviews the results and can send a prescription for glasses and contacts anywhere.

The company is registered with FDA and has IRB clinical data to show the product’s equivalence to an in-office eye exam.

Heather Thompson | Senior Editor |

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WE WOULD LOVE TO BE IN BUZZFEED, THE NEW YORK TIMES, AND ON EVERYBODY’S FACEBOOK PAGE.

iMedicalApps, a physician-run site that publishes app reviews by physicians, cited Opternative’s technology as an example of big media’s focus on flashier, less practical or lessresearched technologies. The lament on the lack of publicity for groundbreaking technologies echoes sentiments I’ve shared with other colleagues.

“I share the frustration,” says Tim Gee, principal of Medical Connectivity Consulting. “Media pick up on projects like the tricorder because they’re cool.”

And these products are cool, but they don’t necessarily have regulatory approval, clinical data, or immediate applicability that really can make a difference in outcomes. When poorly performing selfdiagnosis apps hog the spotlight, products that deserve a little fanfare are ignored.

This raises the question: How

important is the hype to digital product developers?

“We would love to be in buzzfeed, the New York Times, and on everybody’s Facebook page,” says Opternative co-founder & CEO Aaron Dallek, cofounder and CEO of. “But we’re going to build a strong company, with or without viral marketing.”

Dallek says he sees immediate potential in appealing to online retailers who often lose customers because patients have to go into a retailer’s office to update prescriptions. He notes, however, that the secondary prong of the marketing campaign targets patients directly; in this, a viral media push would be of great benefit. “We understand

that only a small percentage of people need an eye exam at any given moment. Being there at the moment of need will help us get patient customers.”

Many digital health companies are doing very well without hype, according to Gee. He cites Cardiopulmonary’s 10-yearold enterprise management system. “By anecdotal accounts, they do incredible work, but it’s very unlikely that the public will ever hear of their technology,” Gee says.

Perhaps the best medical technology doesn’t need the high-profile media focus.

But digital companies shouldn’t pursue viral or big marketing at the expense of smart, targeted marketing.

“At the end of the day, companies are responsible for their own marketing,” notes Gee, adding that successful adoption in the marketplace doesn’t always require a big media push. M

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TRENDS WEARABLES

Designing wearables without battery constraints Heather Thompson | Senior Editor |

Battelle’s research leader, Steve Risser, shows me a picture of a Snickers bar and a 47g battery and asks an interesting question: Which holds more energy? Those of you schooled in energy and thermodynamics will immediately understand the answer. The candy holds 291 Watt-hours, versus the battery’s 11.

The challenge, says Risser, is that the battery is sitting at the top of the hill, ready to go, while the candy requires much more work to convert that energy to a useful form.

“If we can figure out how to take advantage of the other energy sources available to us, the potential is enormous. Because the candy bar is easier to carry, more available, and more powerful,” he explains.

What if that type of battery technology could be applied to wearable technology?

Could designers imagine wearables without a rigid and bulky rectangular box? By focusing on developments in sensors, electronics and power, designers would be free to create devices with unique, integrated functionality and form factors.

Risser says the first step lies in rethinking the battery.

“Batteries have improved significantly over the past two decades, with an approximate three-times increase in energy density.” But, he says, there’s still a long way to go. And in reality, Risser notes, batteries in medical technology follow advances in other markets.

“The consumer industry is driving smallformat batteries,” he says.

Battery chemistries vary widely, Ritter notes. For example, the lithium family alone can differ by 50% in performance, based on their chemistry. Risser says more than $100 million has been invested in the past few years in bringing alternate chemistries to market. Although the majority of those discoveries will go toward large-format battery technology, there are some technologies that could be used in wearables.

Lithium-air and lithium-sulfur Lithium-sulfur is a light-weight rechargeable battery known for its low cost and high energy

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density. Lithium-air batteries use oxidation at the anode and reduction of oxygen at the cathode to induce current flow.

“Li-sulfur has been under development for 20 years. Only now are we seeing possibilities,” Risser notes. However, he says, the selfdischarge is not great and variation in discharge voltage complicates the design. “The cycle life is still 100 cycles.”

Metal-air Metal-air batteries use an electrochemical cell with a pure-metal anode and an external cathode of ambient air, typically with an aqueous electrolyte.

“Metal-air is even more complicated,” says Risser. Discharge can change the mass and size of the battery, and we don’t normally design for this type of change. In addition, designers need to think about airflow, and how it will feed the battery.

“There’s a lot that still needs to be worked out.”

Flexible printed The most immediate opportunity, Ritter believes, lies in alternative physical forms, such as nonplanar, flexible, printed, embedded, or combinations with energy harvesting. Such physical forms, says Risser, can integrate a battery into curved shapes.

A few companies can make flexible batteries, that can be embedded into the packaging, says Risser.

“What if, for example, you got the battery out of an electric car and integrated it into the side panels and roofing? You could then make the interior space available for users, you save in weight and you are no longer limiting the shape of packaging,” he says.

This design freedom, says Risser, is really only five to seven years down the road. The key is energy harvesting, and this is not an easy task.

“We have to think about how we can grab energy from the environment,” Risser says. Imagine a glucose fuel cell, he says. Such technology could revolutionize implants.

“We are at the cusp,” says Risser. “We are no longer making devices to fit the battery; rather we can start thinking about how the power will fit the design.” M

www.medicaldesignandoutsourcing.com

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PNEUMATICS

Pneumatics trends focus on precision and less contamination

Nic Abraham | Managing Editor |

As trends in medtech have moved toward the miniaturization of new products, lighterweight and more portable solutions, pneumatics technology has been keeping pace by focusing on application-specific solutions. Reducing power consumption, particularly for battery-operated equipment, has become an important factor, along with the ability to leverage more precise control and innovations in electro-pneumatic control. But in general, the key has been the technology adapting to the challenges created by the next generation of design and industry advances.

The industry has moved toward proportional control and electro-pneumatics for more precise control solutions. With devices such as ventilators or respirators, the operation of units in the past has been on-and-off, pushing a breath in and taking a breath out. Manufacturers are, however, using pneumatics to profile the breath provided to the patient to be more natural and assist in the recovery process. Proportional pneumatic controls are also used in biomedical research.

Another reason the medtech industry uses pneumatics, specifically components, is because of the

BEARINGS

Bearing trends focus on reducing wear and improving quality Nic Abraham | Managing Editor |

Bearing trends mainly focus on extending bearing life and reducing issues with wear to achieve high performance levels and save energy. This could be for medical research, surgical and dental needs, or laboratory and diagnostic equipment.

Designers and engineers are tasked with designing bearings for high-speed devices, as well as simple and complex ones.

A Japanese manufacturer offers special-environment ball bearings that can be used in vacuum, clean room, corrosive, high-temperature, contamination or nonmagnetic environments. Each component is designed with advanced material, lubricant or surface treatment to meet high-performance standards.

Because manufacturers are always looking to improve bearing quality, the materials used in the design process are important. A high-purity material should be used, such as nitrogen-enhanced martensitic stainless steel. It must also be corrosion-resistant and have evenly dispersed, fine carbides for lower noise and vibration levels. Ceramic ball bearings can be used, but only for specific purposes. Wear can be combated with

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cleanliness of compressed air, unlike with hydraulic oils.

A manifold system or valve block allows for less system contamination. Integrating components through good design improves the appearance of the circuit, but also eliminates potential leak points and eases system assembly.

Control valves are a fundamental component of any pneumatic system. Selecting the right air valves to control system pressure, direction of flow and rate of flow is crucial when designing fluid power circuitry.

If the pneumatic valve is too big for your application, you will be wasting air and money. If it’s too small, the actuator will not function properly.

Another trend, considered Pneumatics 2.0, is a platform called IntelliSense, which enables users to be proactive about maintenance and system optimization.

A first in pneumatics, the platform combines sensors, cylinders, and software to deliver real-time performance data. It features predictive diagnostics, remote monitoring, machine efficiency and maximizes production.

One manufacturer also offers pneumatics accessories: A flow control to maintain a constant flow in one direction and full flow in the opposite direction; miniature filters designed to remove most contaminant particles from compressed air systems; and a filtered orifice restrictor featuring a stainless steel filter screen that protects the restrictor from most contaminant particles. Orifice restrictors also offer precise flow control and are precision molded of polysulfone. Models are available for inline and 10-32 threaded applications. M

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TRENDS thin-coated bearings, which are ideal for medical instruments. One manufacturer has developed a thin coating for extreme cleaning conditions.

Bearings for rotating applications prevent metal-to-metal contact. The low-friction, selflubricating bearings allow for a cleaner operating environment. They are mainly used in low-load, high-speed applications such as blood separators, diagnostic equipment, laboratory sample processing equipment, MRIs, and bioreactor applications in biotech processing equipment.

One manufacturer replaced its recirculating ball bearings with linear ones because the recirculating units required frequent maintenance and re-lubrication, which are time-consuming and expensive processes. The new bearings are dryrunning and do not require external oils or greases.

This feature is especially important for medical labs, where contaminant-free operations are vital.

The manufacturer’s products determine the physical characteristics of powders and solid materials related to pharmacology, nanotechnology, and polymer science. Its physisorption and chemisorption analyzers deliver consistent and reliable data related to surface area, pore structure, and active metals for quality control and R&D applications. They also control

and optimize material selections. The new bearings are specifically used in the analyzer’s elevator unit to facilitate the up-and-down motion of either the cooling bath or furnace during the sample analysis process.

Bearing preload is the process of adding a sustained axial load, independent of external loads, to the bearing.

An axial preload ensures constant contact between the ball complement and bearing races reducing or eliminating both modes of play. Spring preload uses single turn wave springs to add the necessary preload forces despite dimensional variation and thermal expansion. Properly preloading a bearing can increase its life and eliminate the vibration of noise that results from specified clearance, manufacturing precision, and wear. M

COUPLINGS

High-performance in a small package Nic Abraham | Managing Editor |

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In the medtech industry, couplings play an important role in producing machinery. They are used to connect, transfer power, provide misalignment, protect, and more. As the industry evolves, coupling manufacturers will be tasked with designing unique parts to meet the growing need.

With uniqueness in mind, bellows couplings have rare properties and are small – a plus for engineers. Their thin walls and ductile nickel give electroformed bellows just one-fifth to one-tenth the spring rate of hydroformed brass bellows of the same size. The force required to extend and compress their convolutions is low and stays consistent from part to part. The dynamic properties of nickel also give electroformed bellows an essentially infinite life of 1016 cycles,

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plus they can be manufactured leak-tight to 10cc to 9cc of helium per second.

“With advances to assay time and automation, bellows couplings are well positioned, so to speak, to deliver the reliability and high-performance requirements that this new technology demands,” says Lori Lyons, Marketing Manager of Servometer & BellowsTech, speaking on the benefits of bellows couplings for immunoassay equipment and automation.

Additionally, another distributor’s Miniature Fairloc bellows couplings are said to have zero backlash, be easy to install, and correct for angular and parallel axis misalignment. The miniature couplings dampen vibration and noise, making them well suited for medical device manufacturers.

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Because of its compact design and high-quality build, the miniature coupling is durable and allows connections in restricted spaces. Both inch- and metricdimensioned parts are offered and a variety of bore combinations are available, ranging from 1mm to 3mm and 0.0625 in. to 0.125 in. The hubs feature the unique Fairloc design, capable of maintaining shaft alignment when others fail. They are also offered in rigid and flexible designs, including modular bellows, beam, disk, jaw, Oldham and slit types.

One manufacturer recently released a series of enhanced polypropylene plastic couplings. The quick disconnect couplings with panel mount options allow OEMs to easily integrate flexible tubing connections directly into their devices or equipment. The series and its panel mount inserts are available in polypropylene for enhanced chemical resistance and are gamma sterilizable.

Because of their small, compact form factor, the plastic quick disconnect couplings with panel mounts are used for applications within in vitro diagnostics systems, including those handling reagents and buffers. They also operate reliably in printing and ink-handling applications.

The manufacturer also offers a quickdisconnect coupling designed specifically for use with dual fluid lines, designed to offer intuitive, simultaneous connections and disconnections with a single thumb latch. M

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TRENDS CONNECTIVITY

Electrical connectivity requirements: It’s more than the battery

Paul Dvorak | Founding Editor |

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Until portable devices are powered by the wearer’s movement, they will require batteries. The number of portable batterypowered medical devices has grown exponentially over the past five years and that trend will continue. The ever-shrinking power source is driving a few other big trends in medical device design, including shrinking devices, a greater variety of wearable monitors, and smaller batteries with correspondingly smaller holders and connections. Outside influences driving trends are environmental concerns such as selecting materials that are ROHS-compliant and more environmentally friendly.

“We design a lot of battery holders for medical devices,” says Keystone Electronics’ application engineer Joe Rosenblum. “The holders include a standard line that covers a wide array of battery shapes, such as cylindrical, coin cells, and 9V, and for different chemistries.

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Although the chemistries are changing slowly, battery sizes are getting smaller, especially for personal-use devices, so their holders must be smaller.”

No surprise then that lithium ion cells are used more often. They are rechargeable, improve on energy density, and provide a higher output than previous cells. In addition, battery shelf life has rapidly improved with the introduction of many battery variations with a range of lower discharge rates, as in the case of lithium-ion varieties.

Although component-connection companies have a place in the supply chain, they usually don’t influence the design of the medical device. “However, we have an engineering team that designs custom connectors. A development engineer’s initial comment while showing a new device’s specs is often, ‘This is what we want,’” says Rosenblum.

The connecting components that securely retain batteries regardless of shape or position, while easing cell installation and replacement, call for clever manufacturing techniques. Custom capabilities have accommodated the rapid growth of non-standard designs along with battery holders to include retainers, contacts, clips, snap-ons and snapins for coin-cell and button-cell batteries, as well as strap assemblies for dual and multiple holders.

Balancing battery strength and size is another concern. One solution is to combine the use of plastic and metal sub-components, which also answers space and cost considerations. Retainer clips lock-in batteries securely and withstand shock and vibration.

In addition, where low electrical resistance is critical, contacts made of alloys such as phosphor bronze and beryllium copper serve as battery contacts as well as interconnects.

Lastly, improving reliability and durability of connectors or contacts are of major importance. That puts an emphasis on plating, because its selection depends on factors such as galvanic reaction, conductivity, hardness, solderability, corrosion, and environmental effects. Galvanic reactions occur when dissimilar materials contact each other and corrode.

Plating dissimilar metals with compatible plating helps protect base metals. The development and use of proper connective plating is directly correlated with longer-term battery life. Instead of three or five years, certain cells can now be expected to last 10 years. M

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TRENDS ADHESIVES

Improved reliability and cool LED light-curing top the trends in adhesives Paul Dvorak | Founding Editor |

The adhesives area is expanding more than trending, as more and smaller electronics require bonding into wearable devices. The trend for wearables in turn is fuelling demand for increased reliability and the ability to withstand harsh sterilization environments. And new methods for curing adhesives are on the forefront.

More companies are dealing with electronic applications that call for bonding tiny printed circuit boards to different surfaces. That makes reliability a challenge for medical devices, which require the bonding of dissimilar surfaces, including plastics, metal, ceramic, and glass.

“So much of the adhesive selection is device-dependent,” notes MasterBond application engineer James Brenner. “It’s difficult to define generalities.”

One concern for designers is thermal stability and sterilization. When bonding two dissimilar surfaces, be aware that they involve two different coefficients of thermal expansion and contraction. The good news, says Brenner, is that there are adhesives that withstand such thermal cycles. The earlier

3D PRINTING

Health beyond hype: What’s real in 3D printing?

Heather Thompson | Senior Editor |

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designers seek the advice of an adhesive company, he suggests, the better off they’ll be.

The FDA is concerned that reusable devices can withstand multiple cycles of sterilization, including autoclaving, radiation, ethylene oxide, and cold chemical sterilization. For higherstrength and multiple sterilization cycles, oneor two-component epoxies work best, while silicones are good for flexible bonds, tolerate high temperatures and have a low shrinkage on cure. The standard to shoot for is USP class 6 certification, whether a device must withstand one cycle or multiple cycles, to show a strong indication the adhesive will not cause problems when submitted to the FDA for approval.

Biocompatibility is a key trend for designers of implantable devices, which must be compatible with blood and body fluids. There are two widely used – and stringent – tests for biocompatibity: ISO N 993-5, detailing a cytotoxicity requirement, and USP Class 6.

Perhaps the latest trend in adhesives is LEDcured material, as explained by Brenner.

“The advantages of it are that it is a one-part material – it requires no mixing, unlike expoxies – and the LED is a cool light, so adds no heat (as would a UV lamp) that would distort the substrates being bonded,” he says. “Just as with UV light curing, the parts must be transparent.” M

R. Scott Rader is frustrated with the overhyping of 3D printing.

Rader, who leads Stratasys’s newly-formed Medical Solutions Group, says his frustration stems from the fact that, as he puts it, “the potential is huge without the hype.”

As an example, Rader describes a very realistic scenario in prescription orthotics. Today, he says, that process begins with a patient seeing a doctor. The doctor takes a cast of the patient’s foot and sends the cast through the mail to a manufacturing site. Then the manufacturer sends the device to the office and, after a few weeks, the patient comes come back in for a fitting. This could all take up to a month.

In a practical scenario that includes 3D printing, the doctor sends a foot scan that’s been converted into a CAD file to the manufacturer, who then sends the finished device directly to the www.medicaldesignandoutsourcing.com

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patient. “There’s less need for fitting, because the scan is far more accurate,” says Rader. Furthermore, he notes, that process would take less than a week, and would likely be done within 2 days.

Rader also notes that some people have the aspirational goal to take the system even further, wherein the patient might obtain a prescription and go to a local pharmacy. The pharmacists would access the scan, and then, using the CAD file and a desktop printer, create a device within a matter of hours. That scenario, he says, is a great goal, but “Nothing for that ecosystem truly exists today.”

There are risks in such a system that would have to be mitigated, he adds.

“There are complex algorithms required to take your foot scan and print a medical orthotic. The quality systems to measure it and make sure that it’s good, as well as somebody to clean it once it comes off the printer – those don’t exist.”

Still, even without over-promising, 3D printing could potentially revolutionize certain parts of the industry, and many of those opportunities are still in their infancy. As SME’s Lauralyn McDaniels puts it, “Prosthetics and models have been around for 25 years, but some of the scaffolds and implants, are brand new, or are only 3 to 4 years on the market.”

McDaniels organizes the opportunity as follows: • Prototyping, which is already an established technology.

• Models used in educational, surgical planning, and testing.

• Instruments, including patient-specific cutting guides.

• Bioprinting scaffolds and tissues.

Of those four, McDaniels has personal knowledge of the benefit of patientspecific cutting guides. Her friend’s 17-year-old daughter had hip replacement surgery last year. Because of 3D-printed cutting guides, what is normally a daylong surgery took only 2 hours. She also says that, for implantable orthopedic devices, the manufacturing moves from a multi-step process to a 2-step process because the surface textures can be printed directly onto the implant.

MOLDING

MICRO-SCALE CLARITY Short lead times and design freedom have made 3D printing a trend at the macro level, evidenced by the recent FDA clearance of the Unite3D foot & ankle fixation device by Zimmer Biomet, made with the company’s proprietary OsseoTi porous metal technology.

But 3D printing’s advantages may not translate on a micro-scale product. Because it’s a 100% additive process, meaning that it converts engineering data directly into a three-dimensional product, no forming tools are used to shape the finished product.

Meeting location- and tolerance-based requirements depends on the accuracy and repeatability of the 3D printing process and material. That’s a tall order at the micro scale, where a large dimension is 0.05 in., as shown in the accompanying photos.

The top image is a 3D-printed prototype made using a highprecision printer capable of deposition layers at 16-µ thick and 25-µ offset. The bottom image shows the comparison micro-molded part, made using a combination of several processes, including injection molding, tooling, and materialscience evaluation.

Measuring matters Industry is working to overcome various technical challenges, and there are limitations to 3D printing in general. For one, says Rader, when you are working with a 3D-printed device, you have to be able to measure the internal cavity. But since each part is printed individually, you can’t use destructive or batch testing.

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with a challenging aspect ratio – they are a thousand times longer than they are wide.” How do you check the channel, which may be 50-100 microns wide?

“It seems like a complex problem,” says Rader. But there’s a solution, and Rader says quality assurance simply needs to be aware that the options exist. “You can do acoustic imaging, X-ray-based metrology, and CT scanning 3 • 2016

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PROSTHETICS AND MODELS HAVE BEEN AROUND FOR 25 YEARS, BUT SOME OF THE SCAFFOLDS AND IMPLANTS, ARE BRAND NEW, OR ARE ONLY 3 TO 4 YEARS ON THE MARKET.

TRENDS

to visually inspect the internal structures.” Rader says eventually he’d like to see a vision system monitoring part built while it’s in the printer.

“That’s where we are headed.”

For McDaniels, however, the real problem is not the engineering issues or the metrology challenges, but the need for consistent and better standards. “The biggest challenge right now is the lack of standards and common protocols.”

A question of language “There are at least five different standardsdevelopment organizations working to create these documents,” says McDaniels. “Our big challenge is going to be coordinate as accurately and as quickly as possible, to build evidence for printing in medicine,” she says.

“Right now, at most hospitals, protocols and standards are up to the physician,” she says. “We have no common language.”

Rader agrees. “Engineers and manufacturers speak a language of machines, materials, tolerances, engineering concepts for stress and strain. Doctors speak a language of, ‘Here is what I want to do and here is the problem that my patient has and I just want to fix it.’” Rader says it takes a tremendous amount of effort, regardless of the manufacturing technology, to bridge the language gap.

Building a case for outcomes In the grand scheme, Rader notes, only two things count: Economics and outcomes. “We have to make outcomes better and better,” and more

importantly, McDaniels points out, we have to be able to show it.

McDaniels also notes that data collection and setting standards for that data are going to be a challenge. “We need to answer the question of what data should be collected,” she says. For example, she says with the surgical cutting guides mentioned earlier, The Centers for Medicare & Medicaid Services will need to understand the cost and time savings, as well as the improved outcomes. Right now, she says, “the channels of communication are too distributed and there is not enough data for regulations or for reimbursement.”

This type of data collection needs to be specified for all finished devices, but Rader says that’s no different from any manufacturing process, such as injection molding.

McDaniels says she expects the radiology group to already have standards for data “but integrating that into software and printing recommendations is difficult.” McDaniels also mentions that there are 30 to 40 standards confirmed or in development from various organizations. “It’s not too much, because the technology area is so diverse,” she says. “There are multiple uses, materials, and functions.”

Both SME and Stratasys support collaboration with AmericaMakes, which has developed the Additive Manufacturing Technology Roadmap to identify measurable and meaningful challenges that, when met, promote inquiry, knowledge-sharing, and technical advances across the industry. M

PROSTHETICS

Today’s science-fiction prosthetic will be ready tomorrow Paul Dvorak | Founding Editor |

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You’ll find many prosthetic researchers who admit to drawing inspiration from the replacement hand Luke Skywalker received in one of the Star Wars movies. You may recall a light saber severing Luke’s hand in one scene. In the next, he’s flexing his new bionic fingers. The scene is science fiction for now, but prosthetic developers say such designs are not that far away.

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The real-world trends in prosthetic design are more down-to-earth: Recent designs employ microprocessors and actuators. Also, a wide variety of upper- and lower-extremity prosthetics are now available, depending on the recipient’s wishes.

And the application of 3D printing is just getting started.

U.S. military veterans are providing a lot of the push for advances in technology. And thanks to U.S. Defense Dept. funding, recent prosthetic designs are quite sophisticated. For instance, walking on flat ground is not difficult, but walking down even a shallow incline can present a challenge.

“But recent microprocessor-controlled prosthetics for the lower extremities could have active control,” says Kevin Caroll, VP of Prosthetics at developer Hanger Inc. “For example, the microprocessor would signal the prosthetic to stiffen the fluid in the knee by closing off ports to generate more resistance from fluid going from one chamber to another. So the user need not think about what they are doing as they walk. The onboard computer is doing that and making constant adjustments.”

Even the process of getting fitted for a prosthesis has improved. Just 15 years ago, a veteran suffering a lost limb would have a prosthetic selected for him.

“Today, that same veteran will have several Staff Sgt. Heath prosthetics to Calhoun sizes up choose from, the 5th hole. because more Photo: Hanger Clinic manufacturers make the devices. Amputees are not just limited to one prosthetic knee or foot,” said Chief Prosthetic & Sensory Aid Service Bill Jones at the Louis Stokes Cleveland VA Medical Center. “The first time vets come to the hospital, they get a basic prosthetic to start walking and healing. As they progress, their limb heals and changes, perhaps calling for a different device. There is no limit to the number. If the vet shows an interest in swimming and needs some alternative, as long as he is showing a need, it is likely he will receive the device.”

An initial conversation usually starts with: What would you like to get back doing with the

limb? “Some request a shower leg or sports adaptive legs that accommodate golfing, even mountain climbing.”

A multidisciplinary approach is another recent trend. “In the amputee clinic we’ll have a physician and podiatrist along with someone from physical therapy, and sometimes an occupational therapist.

Each vet is different, so each limb is custom,” says Jones. An upper extremity loss is usually more difficult to treat, because the hand is more complex than a foot. A functioning hand is hard to replicate – fingers articulate and provide tactile feedback. Myoelectric prosthetics provides some of that function, using embedded sensors to pick up electrical impulses from the muscles in the residual limb. “If the vet wants it and it is appropriate, he or she can get such technology. They don’t articulate the fingers instantly, but they’re getting better at grasp function,” Jones adds.

For now, connecting nerves to motor controls is a stretch goal. “Several VA researchers are attempting upper-extremity feedback, but not with each individual. It’s more of a research project and less application engineering,” says Beth Orzell, CPO/Chief Orthotic & Prosthetic Lab at the VA Center.

Three-D printing is also influencing prosthetic designs. For example, a 3D printer can help replace a missing a finger or part of a finger. “This is exciting because it allows more customization,” says Orzell.

Another example is 3D-printed arms for children born without them. As with adult amputees, the trends are toward customization, increasing sophistication, and much lower costs.

Dominique Courbin, Director of Production with Limbitless Solutions, says that about 3,000 U.S. children are born without an arm each year.

Courbin got involved with this effort when as a mechanical engineering student, when he landed a project to print a finger or two for a child at no cost. But when it turned out the child was missing an arm, changing the team’s focus, the 3D-printed arm worked so well that Courbin and his colleagues formed Limbitless.

“We wanted to give away the arm at no cost to a family, so it had to be fairly inexpensive,” says Courbin. “It had to be useful. We wanted the prosthetic controlled by the same arm it was servicing.” Limbitless produces the arms for just $350 each.

The arm is also designed with simplicity in mind, to help the child quickly adapt to its use.

A cable runs along the length of each finger and ties into a servomotor; electrodes on the upper arm muscles sense when the child flexes, signaling motors to open or close the hand. M

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PRODUCT WORLD

The Clarius ultrasound scanner for iOS and Android is world’s first Clarius Mobile Health has developed the world’s first handheld ultrasound scanner with a mobile application for iOS and Android smart devices. The Clarius ultrasound scanner is wireless and works with a mobile app that’s compatible with most smart devices. With automated adjustments and an intuitive interface, the personal ultrasound device is designed to be carried around for quick exams and to guide procedures such as nerve blocks and targeted injections. Compact ultrasound systems for use at the bedside have become the norm in most hospitals and many private clinics.

Clarius Mobile Health www.clarius.me

New nextgen touch buttons feature smart electric field sensing Banner Engineering introduces its next-generation touch buttons for its industry-recognized K30, K50 and K70 multicolor indicators and pick-to-light sensors. Employing smart electric field sensing, the next-generation touch buttons provide superior immunity to false triggering caused by the buildup of detergents, oils and other foreign materials, as well as exposure to direct water spray.

In addition to exceptional immunity, next-generation K30, K50 and K70 indicators are ergonomically designed to eliminate hand, wrist and arm stresses associated with repeated switch operation, requiring no physical force to operate. The indicators can also be easily actuated with bare hands or in gloves.

All models feature rugged, fully encapsulated IP67/IP69K construction for optimal performance in high-pressure wash-down environments.

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Foster introduces ProFlex SEBS polymers for soft touch medical devices Foster Corporation debuts ProFlex styrene-ethylene butylenestyrene (SEBS) for medical device applications. These polymers offer a low-cost alternative to other thermoplastic elastomers with superior elastomeric properties.

Soft-touch over-molding of ProFlex SEBS onto rigid thermoplastic or metal components provides a highfriction, ergonomically friendly surface. Vibration-damping and insulative properties make ProFlex SEBS ideal for over-molding of instrument handles and grips. And ProFlex SEBS polymers also have 20 percent lower specific gravity than other engineering thermoplastic elastomers, yielding more parts per weight.

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DEVICE TALKS

DeviceTalks: 25 years in the hot seat with Bill Hawkins

BRIAN JOHNSON: I knew you went to school here in North Carolina, but I didn’t know how much this area was home to you. Your father was the mayor of Durham for four years. What did your dad’s experience in politics teach you about leadership?

For nearly a quarter of a century, William “Bill” Hawkins sat in the corner office of medtech companies of all sizes, before he stepped down from Immucor last year.

But Hawkins is best known for his 4 years as CEO of Medtronic, where he served in the corner office from 2007 to 2011. His time at the helm of the world’s largest pure-play medical device company was not without drama: His first major decision as CEO was cancelling shipment on the company’s top product, the Sprint Fidelis pacemaker lead that was already implanted in some 268,000 patients, rather than stand pat and keep the potentially lethal products on the market. That decision, which he calls the toughest of his career, was a telling start to a tenure that spanned the Great Recession and the enacting of the medical device tax.

In this interview from our recent DeviceTalks Raleigh show, Hawkins opens up to Publisher Brian Johnson about the worst and best deals he ever made, trying the window if the door won’t open, and why he hopes his latest venture in regenerative medicine will help treat end-stage renal disease.

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BILL HAWKINS: I always admired his ability to connect with people in all sort of walks of life.

As a mayor, he had a diverse population, and his responsible to set the tone. I used to marvel at how he would give talks and connect with people on a one-on-one basis. He taught me really just to be yourself, to be a good person and recognize that we all have something to contribute.

I think he actually had hoped to be reelected, but it didn’t work out, but he didn’t stop. That was the thing that I think about even when I parallel my career at Medtronic, when I stepped down. I was in no way ready to retire, and he was no way ready to stop being a good citizen.

BRIAN JOHNSON:You’ve made a lot of deals over the years. What’s one that you really hold up with pride, and what’s the one that you sort of say, “I wish I had that one back”?

BILL HAWKINS: I can start with the one I wish I had back, which was when I was president of Medtronic, not yet the CEO. We acquired a company called Kyphon, which was a kyphoplasty business, and it was a company that had acquired a company.

We were really interested in the company they acquired, and I learned a big lesson, that you really need to do a lot of due diligence when you do a big deal. We didn’t have the opportunity to really do much due diligence,

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SHERI DODD

Vice President and General Manager, Patient Management Services, Medtronic LLC

LEE JONES

Founder, CEO, Rebiotix

JEFFREY A. MCCAULLEY President & CEO, Smiths Medical

Behind the Scenes. Ahead of the Curve. Inside the Corner Office.

JUNE 6, 2016 MEDTECH’S BRIGHTEST MINDS MEET AT DEVICETALKS DeviceTalks, the live interview series from MassDevice, returns to the Science Museum of Minnesota with leaders from some of the regions most exciting companies. Our program on June 6th includes insight, networking, workshops on clinical trials, mergers & acquisitions and product development.

WHEN: Monday, June 6, 2016 from 1:00 PM to 8:30 PM (EST)

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DEVICE TALKS

particularly on the company that we were really interested in, because they were now buried in the public company.

It was a disaster.

BRIAN JOHNSON: At least they never beat you over the head with that.

BILL HAWKINS: My board reminded me about that every single solitary board meeting for four years. They wanted to hear about Kyphon.

BRIAN JOHNSON: Let’s talk about the good one.

THE GOOD NEWS IS, THIS TRIAL’S GOING TO GET DONE, WHICH IS THE MOST IMPORTANT THING. BILL HAWKINS: My best friend is here, Kim Westmoreland; I share his company, a company called Keranetics. I’ve done a lot of different things in my career, and this is what I love about what I do, because there’s always something else that you find that you 64

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never thought you would be doing.

About a year ago, there was a company in Winston-Salem, N.C., called Tengion. Some of you may have known it. It’s a regenerative medicine company.

I first came across Tengion when I was at Medtronic, when I was CEO. We put $20 million into a program they had for chronic kidney disease, which is really kind of fascinating. For patients who have late-stage kidney failure, they essentially had developed a technique for biopsying that patient’s kidney, essentially taking that biopsy and isolating certain progenitor cells, and then putting them into a bio-reactor and then putting them back into the patient.

Fast-forward, I’d left Medtronic.

[Tengion] was doing another program in tandem with that, and at the end of the day, it was not well-managed, and they ran out of money. They ultimately went bankrupt, but this program for the chronic kidney disease had actually just completed their Phase I clinical study, and even though we didn’t have the results, everything looked like it was going to be really good. Kim came to me and said, “Look, this company’s just gone bankrupt,” and I said, “I know them very well.”

Anyway, we put together a group of North Carolina investors, and we bought the company out of bankruptcy, with the intent of raising $25 million to do the Phase II clinical study. We bought the company, and we were able to then harvest the Phase I data, and the Phase I data was just off-the-charts good. This looked like it could be a dramatic therapy for patients with chronic kidney disease.

By the way, there was $400 million of capital in this company, all put into a lot of basic research, and they had built a $15 million, Class I manufacturing operation. We bought all of this for $1.5 million, but with the idea of spending $25 million to do the Phase II study.

We had to then fund the operation while we were trying to find investors, so it wasn’t just $1.5 million. It turned out to be about $4 million or $5 million.

I was shocked at how hard it was to get capital. In fact, we didn’t get capital, and at the end of last year, I had to go to the investors one more time to just try to

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keep this thing on life support. And lo and behold, one of the groups that we were looking to lead the financing came out of the woodwork and said, “We don’t want to lead it. We want to buy it.”

At 6:15 tonight, we closed the deal.

That’s a true story. Kim, we’re going to have a glass of champagne after this. I can tell you that. The good news is, this trial’s going to get done, which is the most important thing.

BRIAN JOHNSON: I read that you really wanted to attend the [University of Virginia’s] Darden School of Business for your MBA, and you didn’t get in, but you wanted to get in so badly that you called the director of admissions on the to say they a mistake.

BILL HAWKINS: That’s true. After I graduated from Duke, I ended up going to work for a small medical device firm, great experience. But then decided after being a salesperson for three years in the field, I didn’t want to necessarily continue in my career as a salesperson.

At that point, Harvard had a reputation for the case management program; Darden, University of Virginia was the other program. I really liked Charlottesville, so I applied to Duke, Carolina and to UVA. You’re right. I sent them my application and by full admission, I have never really done that well on the standardized test, and I knew that was going to be an issue.

Sure enough, I get this nice letter telling me that I was not being admitted.

I said, “I’m not just going to let that go.” I called the director of admissions, and I politely told the lady, “I think you’ve made a mistake. I think I got the wrong letter.” I said, “I’d like to come down and tell you why I think you made a mistake,” and I guess, given the fact that I had the courage to do that, she said, “We won’t turn you away if you come down. You could talk to us.”

I did, and lo and behold, they got the letter right.

It’s a blessing, because I’ve always told people throughout my career that the analogy is, when the door is closed, you’ve got to find a window, and you never, never give up. M

WE'RE BACK FOR ANOTHER SEASON OF INSIGHT FROM MEDTECH'S BRIGHTEST MINDS! DeviceTalks, the live interview series from MassDevice, returns in 2016 for another season of insight from the brightest leaders in medtech.

Learn more about our events and stay tuned for more announcements on the rest of our 2016 season.

MINNESOTA JUNE 6, 2016

BOSTON

SEPTEMBER 28, 2016

DECEMBER 12, 2016

(BIG 100 RELEASE PARTY)

Read the full interview online! devicetalks.com www.medicaldesignandoutsourcing.com

Device_Talks_3-16_Vs3.indd 65

ORANGE COUNTY

Behind the scenes.

Ahead of the curve.

Inside the corner office.

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