MEDICAL DESIGN & OUTSOURCING - March 2018 by WTWH Media LLC

MARCH 2018

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CANCER DETECTIVES This new technology could help surgeons clear out leftover cancer cells during surgery

DISRUPTING CONNECTED HEALTH Here’s how a respiratory firm took control of the medtech digital revolution.

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Remote robotic surgery would be a major disruptor, but are the conditions right for it?

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Precision Positioners and Piezo Transducers

Medical Design & OUTSOURCING medicaldesignandoutsourcing.com ∞ March 2018 ∞ Vol4 No2

E D I T O R I A L EDITORIAL Founding Editor Paul Dvorak pdvorak@wtwhmedia.com @paulonmedical Executive Editor Brad Perriello bperriello@wtwhmedia.com

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Managing Editor Chris Newmarker cnewmarker@wtwhmedia.com @newmarker Senior Editor Heather Thompson hthompson@wtwhmedia.com Associate Editor Fink Densford fdensford@wtwhmedia.com Associate Editor Sarah Faulkner sfaulkner@wtwhmedia.com Assistant Editor Danielle Kirsh dkirsh@wtwhmedia.com

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HERE’S WHAT WE SEE

Is Amazon about to disrupt the medical device business? The word “disruption” is bandied about a lot. But if Amazon does to the medical supply and prescription drug businesses what it did to bookstores, the effects could be truly disruptive to medical markets. Think the commoditization of a wide host of medical products, including diabetes supplies, syringes, IV sets and much more. Investors seem to think it’s a possibility. Since Amazon, Berkshire Hathaway and JPMorgan Chase announced on Jan. 30 that they would “bring their scale and complementary expertise” toward providing better healthcare for their employees, the stock of healthcare logistics company Owens & Minor has fallen about 25% in value, and Becton Dickinson is down about 8% as of this writing in mid-March. The Dow Jones Industrial Average was down about 4% during the time period. The Wall Street Journal followed up in midFebruary with news that Amazon has been reaching out to U.S. healthcare executives to expand its business-to-business marketplace, Amazon Business, to hospital and clinic systems. Amazon is even testing out the concept at an undisclosed Midwestern hospital system, according to WSJ. There have also been reports of Amazon’s interest in the pharmacy-services business.

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

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Reports of Amazon’s plans are causing such a stir because it is never business as usual when the e-tail giant enters a new market. As Chris Holt, leader of global healthcare at Amazon Business, told the Journal about the potential medical supplies play: “Our goal is to be something new.” Holt spoke of rethinking safety and security for healthcare supply chains. No wonder major medical device suppliers’ stocks are taking a hit. If Amazon can ensure safety and security — while also providing competitive shopping versus the supply contracts and purchasing organization arrangements that hospitals presently use — prices are likely to drop. Granted, Amazon will likely avoid implants, complex cardio and orthopedic devices and other highly regulated items, according to Modern Healthcare. That still leaves many arenas in which Amazon might compete for hospital system dollars. Owens & Minor CEO Paul Phipps actually agrees that the medical device supply space is ready for disruption. “It needs innovation, it needs connectivity and it needs transparency,” Phipps said during a mid-February earnings call with analysts, according to a Seeking Alpha transcription. Although Amazon already has traction in the direct-to-consumer medical products market and sells into small physicians’ offices, according to Owens & Minor’s Phipps, the edge for already established players like his lies in intra-hospital logistics. “What we bring is the knowledge of how to get medical products and medical devices to a hospital, but not just at a hospital [but] all the way into the operating room, to the cath lab, to the point of care,” he explained. Phipps described Amazon as a force to be reckoned with. “But what we’re focused on right now is trying to unlock the value through the solutions that we’re bringing to the marketplace. I happen to believe that’s not too far off from what Amazon is talking about.” M

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CONTRIBUTORS

FERRERA

THAKORE

GLASSEN

WOODWARD

DAVID L. FERRERA is a partner and chairs the product liability litigation practice group at Nutter. Fortune 500 medical device and pharmaceutical companies rely on Ferrera’s expertise and experience in presenting complex product liability issues to lay juries and courts. KEN GLASSEN is VP of engineering at Kaysun Corp. (Manitowoc, Wis.) — a provider of custom injection molding and engineering services. Glassen shares and applies his technical plastics engineering expertise to help OEMs in a variety of industries including medical, automotive and defense develop complex injection molding solutions.

ASHIR THAKORE is global segment leader – healthcare for Riyadh, Saudia Arabia–based SABIC. During his career, Thakore has worked in multiple leadership roles for several companies, including Ford, Visteon and Kalypso. MELANIE V. WOODWARD is an associate in Nutter’s litigation department and a member of the firm’s product liability litigation, business litigation and environmental litigation practice groups.

CONNECT WITH US! CHECK US OUT ON ISSUU! 8

Medical Design & Outsourcing

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BRING US YOUR MOST COMPLEX CHALLENGES INNOVATING THE FUTURE OF MEDICINE Leading manufacturers of Surgical, Interventional and Patient Monitoring equipment call on Carlisle Medical Technologies (CarlisleIT) to help them solve their most critical challenges. For your high-volume applications, CarlisleIT also designs and manufactures innovative and cost-effective, single-use components and assemblies, including design for automation. Our deep expertise in cable design, fine-wire management and advanced processing technologies means we can offer innovative interconnect solutions that meet your unique device requirements. Contact us at Medical@CarlisleIT.com to learn how CarlisleIT can help you design, test and build the critical interconnect systems needed for your next Surgical, Interventional or Patient Monitoring application.

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CONTENTS

medicaldesignandoutsourcing.com ∞ March 2018 ∞ Vol4 No2

DEPARTMENTS

Does robotic telesurgery have a future? Are the conditions right for commercial companies to start making an investment in a remote robotic surgical future?

ON THE COVER:

FEATURES

HERE’S WHAT WE SEE: Is Amazon about to disrupt the medical device business?

08 CONTRIBUTORS

IP ISSUES: Medtech expert predicts more M&A, rise of product liability litigation in 2018

14 REGULATORY: FDA’s digital health plan is shaking up its review process 16 MANUFACTURING & MACHINING: How laser marking could solve the medical device industry’s UDI challenges 20

ENGINEERING 911: What you need to know about complex injection molding

TUBING TALKS: Could this new Guill extrusion crosshead enable medical tubing innovation?

52 5 women in medicine you should know X-rays on the battlefield, the American Red Cross, leprosy treatment and more can all be attributed to women who made their mark on health and medicine.

ROBOTICS: How does autonomous robotic surgery affect product liability?

56 5 black innovators who shaped medtech From cardiology to endoscopy to blood transfusion, African Americans have played an important role as innovators in the history of medicine and medtech.

WOMEN IN MEDTECH: This CEO thinks blockchains could empower patients and secure data

DEVICE TALKS: There’s a simple way to improve stroke treatment in the U.S.

AD INDEX

43 ResMed uprising: Disrupting connected health Here’s how a respiratory firm took control of the medtech digital revolution. 48 The cancer detectives This new technology could help surgeons clear out leftover cancer cells during surgery

59 Medtronic thinks these clinics could be the future of diabetes care The medtech giant singles out its work with Diabeter, a chain of diabetes clinics it acquired in the Netherlands, as evidence of how it’s delivering more value for patients.

Medical Design & Outsourcing

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IP ISSUES

Medtech expert predicts high acquisitions, possible bidding wars in 2018 M&A Look for another strong year for medtech acquisitions in 2018, predicts patent attorney David Dykeman.

Heather Thompson | Senior Editor |

The wave of mergers and acquisitions in the medical device industry should continue this year, both in terms of value and volume, according to patent attorney David Dykeman. “Many large medtech companies are sitting on cash that they want to put to work to build out product pipelines,” said Dykeman, co-chair of international law firm Greenberg Traurig’s global Life Sciences & Medical Technology Group. The firm is gearing up to host its fifth Medtech Partnering Day March 27, 2018, at its Boston office, gathering top innovators, investors and leaders from across New England’s medical technology industry. Dykeman said the international law firm hosts the event as a service to the medtech community to connect potential M&A candidates to large medical device acquirers.

MANY LARGE MEDTECH COMPANIES ARE SITTING ON CASH THAT THEY WANT TO PUT TO WORK TO BUILD OUT PRODUCT PIPELINES. The fevered M&A market of recent years could get an additional boost from the U.S. tax reforms passed at the end of last year, he added, noting that for medtech, acquisitions are still the most viable way to return value to stakeholders.

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“The number of medtech IPOs lags behind biotech, so M&A remains the most prominent exit path,” Dykeman said. Top players in the device space are likely to consider traditional acquisitions in the cardio, orthopedics and diabetes spaces, but are also looking to digital health solutions to build an ecosystem of connected devices, he predicted. “Companies that are behind in connectivity will be looking to make a splash in digital health, which could lead to premium pricing and possible bidding wars,” Dykeman said. Representatives from Baxter and Medtronic will present at Medtech Partnering Day March 27 before conducting introductory meetings with early-stage companies in the afternoon. Past Medtech Partnering Days have featured industry giants including Boston Scientific, Johnson & Johnson, Sanofi, Zoll Medical, Philips and Smith & Nephew. “Baxter and Medtronic are active M&A players who want to acquire innovative solutions, so this event is a terrific opportunity for early-stage medtech companies,” Dykeman said. Early-stage medtech companies can apply for the coveted one-on-one meeting slots until early March. But just meeting with the medtech titans isn’t enough, he cautioned. Potential companies should be prepared to discuss their readiness.

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“Companies will attract the most interest if they have an innovative solution for a large, unmet medical need, a strategic patent portfolio to block potential competitors, and have done everything they can to de-risk the technology, the path to market and the company for a potential buyer,” Dykeman said. Another trend that will be discussed at Medtech Partnering Day is the rise of product liability litigation that could impact all medical device companies. Evan Holden, a litigator with Greenberg Traurig’s Atlanta office, is slated to present on the risks medtech companies face as product liability cases are increasingly consolidated into large multi-district litigations with hundreds or thousands of cases from across the country – and what they can do to avoid these costly litigations.

“The rise of multi-district product liability litigations should concern all medtech companies regardless of size or stage,” Holden said. “It is becoming more and more common for medtech companies to face these complex cases, which are costly to defend and carry significant risk.” M

THE RISE OF MULTI-DISTRICT PRODUCT LIABILITY LITIGATIONS SHOULD CONCERN ALL MEDTECH COMPANIES REGARDLESS OF SIZE OR STAGE.

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REGULATORY

FDA’s digital health plan is shaking up its review process It’s about disrupting the traditional way FDA handles submissions, reviews and post-market data – at least for digital products. The FDA is asking questions about how to overhaul digital health product regulation and relying on expertise within the industry to do so, according to Bakul Patel, FDA’s associate center director for digital health, who recently spoke with Medical Design & Outsourcing. In late 2017, the FDA launched the Digital Health Innovation Action Plan. Within that plan is a recipe to shake up the traditional way FDA handles submissions, reviews and post-market data – at least for digital products. The plan lays out three courses of action: Heather Thompson | Senior Editor |

• •

•

Under the 21st Century Cures Act, the FDA will provide qualification and clarification of the policies for medical software. Second is building the right skill sets to prepare the FDA for a digital health future. Patel said the entrepreneurs-in-residence program will allow the FDA to add expertise in software design, process modeling, and evidence gathering, among other skills. Third is a drive to instill trust in digital technologies by providing regulatory oversight that will enable U.S. patients to get the products first in the world.

and can be converged with the principles that we have agreed upon with the international regulators,” Patel told us. The FDA’s plan is to move from a “product-by-product base towards a company base, to start relying on a company’s culture of quality and organizational excellence” and leverage that credit to streamline the FDA’s process, he said. The key is that the FDA is not looking to review digital products in a traditional sense, but instead aiming to streamline in an appropriate manner for the technology, Patel explained.

WE NEED TO MAKE SURE THAT DIGITAL HEALTH PRODUCTS REALLY KNOW NO BORDERS. The federal safety watchdog is considering how to align with how products are being made, how the agency responds to market timelines and how the products fit in a global market. “We need to make sure that digital health products really know no borders 14

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Such a system might look like this: A digital marketing company goes through a precertification program, which requires a comprehensive look at the systems and design. Once they complete that certification program successfully, low-risk digital products might go straight to market without review. In exchange, they would commit to collect post-market and real-world evidence data to substantiate further iterations of the product, he said. Patel was quick to note this scenario may not fit every product or every digital company, but it is an example of what FDA might deem “appropriate” and noted that it’s a new paradigm for the agency. Over the next several months, the FDA plans to explore the possibilities of this paradigm shift (as well as its limitations) with nine companies enrolled in a pilot precertification program.

The original nine companies, announced last year, were: • • • • • • • • •

Apple, Cupertino, Calif. Fitbit, San Francisco Johnson & Johnson, New Brunswick, N.J. Pear Therapeutics, Boston Phosphorus, New York Roche, Basel, Switzerland Samsung, Seoul, South Korea Tidepool, Palo Alto, Calif. Verily, Mountain View, Calif.

that the FDA is not only thinking about submissions but also focusing on how the organization will conceptualize such reviews. Once those are finished, the group will explore the expectations for post-market management. M

The FDA plans to start by examining how to set the yardstick for a “culture of quality and organizational excellence.” Patel said the process will be highly methodical, but right now, they are asking questions. Then the agency will turn attention to deciding what the streamline path will look like for review. Patel noted

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MANUFACTURING & MACHINING

How laser marking could solve the medical device industryâ&#x20AC;&#x2122;s UDI challenges Ashir Thakore | SABIC |

Here are five ways that laser marking could provide advantages to medical device companies when it comes to meeting permanent marking requirements under the FDAâ&#x20AC;&#x2122;s Unique Device Identification program. As the U.S. Food and Drug Administration (FDA) implements its phased Unique Device Identification (UDI) program across medical device classes, OEMs are considering methods for complying with the permanent marking requirement. The FDA does not specify a method, citing the wide variety of devices, use conditions and reprocessing methods. However, for multiple-use devices made from plastic parts, the most viable option may be laser marking. Under 21 CFR 801.45, any device required to carry a UDI on its label must also have this information directly marked on the product itself, if it is intended to be used more than once and intended to be re-processed before each use. UDI goals include improving device traceability and recall in the case of a safety risk or adverse event and reducing medical errors.

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Choosing a marking method Permanent marks, which must last throughout the device lifecycle, are also known as direct part marks (DPMs) and are used widely in industrial part tracking. They can be created using laser etching, electrochemical etching and dot peen. Attaching a permanent plaque or tag (e.g., an RFID tag) is another option, according to the FDA. Laser marking is potentially well suited for UDIs on thermoplastic device components, even those treated with a coating. The laser creates a permanent mark that can withstand repeated cleaning and sterilization cycles. Lasers can produce small or intricate marks with high resolution. As a digitally programmable system, laser marking can accommodate diverse part geometries and types of marks. Further, the process

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MANUFACTURING & MACHINING

is fast and can be cost-effective in the long term once the necessary equipment has been purchased. Potential advantages of laser marking for UDI 1. Permanence through the lifecycle Laser marking delivers an intense, directed beam of energy to the surface of the thermoplastic part. By converting a high percentage of light energy into heat, the laser permanently burns the marked area of the surface, making it difficult to tamper with or remove. Because the only way to remove the mark is scratching off layers of the plastic to a depth sufficient to obscure visibility, regular cleaning – even with harsh disinfectants – should not harm direct markings. Typical sterilization methods for reusable devices should not cause unexpected interactions with laser marks.

2. Flexibility through digitization Laser marking systems are digitally programmable, allowing easy customization. In the case of UDI, which is a unique numeric or alphanumeric code, the FDA stipulates only that a permanent mark contain all required information: • Device identifier (DI) – Mandatory fixed portion identifying the device and device labeler • Production identifier (PI) – Conditional, variable portion denoting data like batch numbers and expiration dates A UDI directly marked on a device may be in either/both of these formats: • Human readable – Easily legible, plain-text format

• Machine readable – Able to be interpreted by automatic identification and data capture technology The versatility of laser marking can help give manufacturers the freedom to create an FDA-compliant UDI mark based on the geometry, size and surface texture of the device, quickly mark products and release them for commercialization. The software-based system allows marked devices to be digitally coded and all information to be stored in a database for efficient tracking and recall. Manufacturers and the FDA can quickly isolate reports related to a particular device to identify any underlying problem and take corrective action. 3. High resolution and accuracy While laser marking is most effective when a flat, fixed focal point is used,

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LASER non-flat surfaces can also be successfully marked. In the first scenario, resolution can be as high as 1,000 dpi, and legible text can be as small as 0.5mm. As a result, laser marking can produce intricate details in tight spaces. 4. Speed and efficiency The laser marking process can help increase throughput, thanks to writing speeds of up to 2,500mm/sec. Because the machines do not use chemicals or solvents, manufacturers can avoid the expense of buying and storing them. Additionally, laser marking systems can be used by manufacturers in-house, making it an efficient process. 5. Simplicity Compared to affixing a plaque or tag to the device, laser marking does not require additional steps and materials, such as application of special glues and adhesives which need an additional compatibility assessment. Additionally, plaques and tags can potentially fall off during the device lifecycle.

Specialized thermoplastics can help drive success Material suppliers with a dedicated focus on healthcare can provide guidance on the suitability of specific thermoplastics for laser marking and advise on contrasting colors and equipment settings that help improve readability. Leading global suppliers, such as SABIC, offer thermoplastics for healthcare that are formulated to produce laser marks with high clarity and precision, as well as color customization and compliance with good manufacturing practices for consistency. In addition, they can perform testing to help ensure the thermoplastic and its color are likely to produce high-quality laser marks. M

Potential pitfalls Laser marking carries a few caveats. One is the need for a capital investment in equipment, if this is a new process for the device manufacturer. However, because UDI is a long-term requirement, this expenditure can be offset over time by avoiding the costs of third-party marking services. Another potential pitfall is inconsistency of materials and parts. Because laser marking is a precise, specialized process, achieving the highest resolution requires uniformity in resin composition and processing. It is important to work with a thermoplastics supplier offering good production control for lot-to-lot consistency.

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ENGINEERING 911

Complex injection molding: What you need to know With careful planning, complex injection molding can reduce costs, optimize functionality and improve aesthetics in medical devices.

As medical device design evolves to provide ever-improving healthcare outcomes, manufacturers are partnering with full-service, experienced complex injection molders to gain the increased design freedom and process efficiencies necessary to keep pace with medical device advances. This partnership is a consistent value-add, from part and tooling design through material selection and process control, empowering many medical OEMs to address issues before they hit production or the bottom line. Ken Glassen | Kaysun Corp. |

Where complex injection molding makes sense Injection molding gives medical OEMs the latitude to integrate disparate materials — from dissimilar polymers to lenses, fastener threading, metal components and other non-plastics — to facilitate assembly, optimize functionality and increase durability. The decision to use complex injection molding is commonly driven by several factors, including: • Aesthetics: Incorporating a uniquely colored polymer into a device can make it more patient-friendly (notably in pediatric applications) or help differentiate products within a manufacturing line. • Expedited manufacturing: Integrating an intricate part into the product leverages machine-paced production

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and reduces or eliminates worker involvement in assembly. • Compliance: Addressing design and production challenges posed by strict regulatory controls efficiently validates all physical, chemical and compositional aspects of medical devices, especially implants. Looking into part design Many of the crucial decisions involved in complex injection molding should be made as early as possible in the design phase and with molder input. At this stage, adjustments have a reduced effect on the total cost and product timeline. When engineers are mindful of medical component design, tooling functionality and materials at the project outset, they can generally prevent missteps in three key areas: • Aesthetics: Visible knit lines may appear on product surfaces if proper tooling design is overlooked. • Bonding: If the product requires multiple materials, compatible polymers must be identified and chosen carefully to ensure a strong, permanent bond. • Durability: Plastics selection is integral to producing robust medical parts that can withstand the wear and tear — or even abuse —of daily use, even when devices are routinely moved from room to room or from ambulances into hospitals.

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ENGINEERING 911

Getting tooling right Tooling development is at the heart of the injection molding process, the step from which everything else flows. The ultimate success of the part begins at the point when the engineering team selects the metal from which a tool is made, based on certain process criteria, including: • Durability: Medical device production varies in volume and complexity. If the yearly usage is under 10,000 parts, aluminum is the preferred tooling material. Yearly usage exceeding 10,000 demands harder steels. • Cost: Softer metals, such as P20 steel and aluminum, are easily machined and therefore less costly builds. The tradeoff for the lower cost, however, is that softer metals wear faster. • Corrosion: Given the priority placed on cleanliness in most medical applications, stainless steel is the appropriate tool steel to avoid corrosion. Material matters Ideally, choosing materials for the injection-molded part is a collaboration between the plastics engineer and the OEM to clearly define the project’s requirements and reach a mutual understanding of five defining factors: • Physical load: Can the part stand up to the conditions of everyday use without fatigue? • Mechanical function: Can the characteristics of the polymer meet the demands of the medical application? • Thermal conditions: Will the device be exposed to fluctuating and extreme temperatures, particularly if it functions outdoors? • Environment: Will the device be implanted or used in direct contact with bodily fluids? If so, the polymers must be biocompatible in accordance with FDA regulations. • Chemical compatibility: What exposure will the device have to chemicals, such as hospital-grade disinfectants? 22

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Due to the unique nature of medical environments, it’s not uncommon for medical applications to have additional considerations that factor into materials selection, such as:

A robot picks up threaded metal inserts and metal spacers that will be placed in the injection mold tooling. Plastic will then be molded over the various inserts. Image courtesy of Kaysun Corp.

• Sterilization: Many medical devices must withstand regular sterilization treatment by radiation, chemicals or the high heat and steam of autoclaving. www.medicaldesignandoutsourcing.com

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• Molding dissimilar plastics: Multishot technology, or overmolding, is one of the most common complex injection molding techniques used in medical device manufacturing. This process involves adding softer polymers for ergonomic and waterproofing features (such as keypads, grips, protective bumpers and seals) over a hard-plastic substrate, typically an impactresistant device body. The high-heat resins required to withstand autoclaving, such as polysulfone (PSU), have their own set of process considerations. These materials are more difficult — and therefore costlier — to work with, mainly due to their higher melting points, which complicates everything from safety compliance to the molding process. For instance, PSU has a melting point of 700°F, versus 500°F to 550°F for typical resins. These higher demands mean higher risks for both safety and deviation. Since the tooling itself can reach 325°F (as compared to 180°F for a water-heated tool) it is subject to higher levels of thermal expansion, which adds complexity to the overall tooling design process. Conclusion Complex injection molding can provide a medical device and equipment manufacturer with competitive differentiation in the progressive medical industry. Moreover, choosing to work with an experienced, full-service molder gives OEMs increased design freedom and process efficiencies that result in high-quality parts and devices that perform with optimum efficiency and at lower total production costs. M

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TUBING TALKS

Could this new Guill extrusion crosshead enable medical tubing innovation? Guill Tool & Engineering’s Micro Medical crosshead features a patented single-point concentricity adjustment that could enable greater extrusion automation.

William Conley, sales manager of the extrusion division at Guill, demonstrates the single-point concentricity adjustment of the MicroMedical crosshead.

Image courtesy of Guill Tool & Engineering

Chris Newmarker | Managing Editor |

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Officials at Guill Tool & Engineering (West Warwick, R.I.) think they could bring medical tubing extruders’ capabilities to new heights through their recently released Micro Medical crosshead. The Micro Medical crosshead — which Guill touted at MD&M West in February — is an extrusion crosshead with a patented single-point concentricity adjustment. Guill officials described the single-point adjustment as a unique innovation for the extrusion of thin-walled jacketing and precision ID/OD tubing. Unlike previous crosshead designs with four adjustment bolts 90° apart, there is one bolt that controls 360° of adjustment. The Micro Medical’s design prevents problems with downtime or 3 • 2018

quality that sometimes occurred with the standard crossheads, which had operators loosening one bolt and tightening an opposing bolt 180° apart, William Conley, sales manager of the extrusion division at Guill, told Medical Design & Outsourcing at the show. “If the operator decides to take a shortcut and not loosen the opposing bolt, often the bolt you are tightening will break in the die holder retainer. This will require the line to be shut down to repair the damage. Or if the operator does not inform his supervisor, you may run defective product for an extended period of time,” Conley said. The single-point adjustment, working in conjunction with a two-stage clamping system, solves the problem, Conley said.

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“The two-stage clamping system allows you to pre-load the tension required to move the die holder. The single concentricity bolt is rotated to the high spot in the wall, and a simple adjustment with a 4-in. wrench will resolve the issue,” he explained. “It’s much simpler for the operators,” Conley added. “There’s less downtime because you don’t have as many broken components.” The single-point adjustment system has an added benefit: Adjustments are no longer restricted to 90° increments, according to Conley. “You will have access with full 360° of movement,” he said. The Micro Medical crosshead also boasts additional benefits for extruders:

IT’S MUCH SIMPLER FOR THE OPERATORS. THERE’S LESS DOWNTIME BECAUSE YOU DON’T HAVE AS MANY BROKEN COMPONENTS.

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The crosshead uses micro-fine adjustment screws for precise concentricity adjustment during extrusion of thin-walled and precision ID/OD medical tubing. Concentricity precision reaches 0.008 in. or finer per revolution, according to Guill. The single-point crosshead includes a patented cam-lock deflector for quick changeovers. The deflector has a a residence time of 1 min. at 0.5 lb/hr material flow. It has optimized usage with extruders measuring 0.5 in. and 0.75 in., and a max die ID of 0.25 in.

•

The Micro Medical crosshead also offers great user flexibility, according to Guill. It accepts both vacuum and micro-air accessories and is also ideal for pressure and sleeving applications. Fluoropolymer designs are available upon request.

Because there’s now a single point to adjust concentricity, it could become much easier down the road to automate the extrusion process, Conley said. “Ultimately what we’re looking to do is at some point is get automatic

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feedback from the engaging system,” he said. “So basically what they’ll do is they’ll be able to extrude the product, it goes into the tank, you’ll see what the finished product is as it comes out of the tank, and it’ll tell you where the error is in concentricity, where the adjustment has to take those that can feed a signal back to an encoder in a servo motor, move that around to actually adjust concentricity per the engaging system. “It basically takes the operator 100% out of concentricity,” he said. M

Guill Tool & Engineering officials tout the Micro Medical crosshead’s single-point adjustment as a unique innovation for the extrusion of thinwalled jacketing and precision ID/OD tubing. Image courtesy of Guill Tool & Engineering

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ROBOTICS

How does autonomous robotic surgery affect product liability?

As more medical device manufacturers offer autonomous robotic surgery to their surgeon customers, traditional lines of legal defense most often taken by companies may change, according to experts from Nutter.

David L. Ferrera | Nutter |

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Robots in surgery are not new. Indeed, robots have been assisting surgeons for years, giving them more precision and control in the operating room. But medical innovation is on the cusp of a new development that would remove the surgeon from the operating room entirely: Autonomous robotic surgery (ARS). ARS is an advance touted as providing myriad benefits to patients, including superior accuracy, shorter hospital stays and faster recovery times. As more medical device manufacturers offer this technology to their surgeon customers, traditional lines of legal defense most often taken by companies may change. Medical device manufacturers should reconsider potential product liability defense approaches to protect against litigation risks associated with these types of procedures.

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What will be required to be communicated to patients? Traditional product liability law holds that doctors are uniquely suited to advise their patients of the risks and benefits of a surgical procedure in response to the patient’s individual medical history and future needs. Given the medical complexities involved, medical device manufacturers typically are not expected to warn patients directly about surgical risks and benefits. Instead, the surgeon stands between the medical device manufacturer and the patient as a “learned intermediary” responsible for adequate warnings, because the surgeon has unique knowledge of the patient’s treatment options and the associated risks and benefits given current surgical practice. ARS arguably would remove the surgeon from this traditional equation, eliminating the

learned intermediary. Without the learned intermediary defense, will companies who manufacture the robots now be responsible for communicating risks and benefits directly to patients? We would argue no. ARS should not shift the existing legal landscape this dramatically. Although surgeons may be physically removed from the operating room, they will not be removed from the decision-making process. Surgeons will still play an important role in recommending ARS, explaining the pros and cons and discussing alternatives. As the medical professionals responsible for helping patients make the decision about whether to undergo ARS, a surgeon should still be viewed as a learned intermediary, and ARS manufacturers should continue to receive this valuable defense in product liability litigation.

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What will be the FDA’s regulatory pathway to market? There are two regulatory pathways for medical devices to come to market following FDA review: so-called “510(k) clearance” for devices “substantially equivalent” to those already on the market; and “pre-market approval” for more innovative devices. Under traditional product liability law, medical devices that undergo pre-market approval obtain protection from many state law legal claims under a doctrine called “federal preemption.” In essence, preemption holds that a lay jury may not secondguess the safety assessments of FDA professionals. Although robotic-assisted surgery is not new, ARS is a significant technological advancement, likely to involve more complex hardware and software. Thus, autonomous robots are

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likely to be subject to the FDA’s premarket approval process, rather than 510(k) clearance. If that is the case, state law claims against manufacturers of FDA-approved ARS systems for defective design or inadequate warnings should remain ripe for early dismissal as preempted by federal law. What is the “product”? Because only “products” are subject to strict liability causes of action, defining the “product” is a key part of determining exposure to liability. Surgical robots are unique in that they require both hardware and software to operate. While hardware is certainly a “product,” most courts do not consider software to be a “product.” But, in 2016, the FDA issued draft guidance stating that software is a “medical device” subject to FDA regulation. Although this guidance is not legally binding, it echoes the holdings of some courts that software is a “product.” The debate about what components of ARS constitute “products” is not academic. Rather, it highlights an inevitable issue that manufacturers will face in defending against lawsuits: was the patient’s injury caused by a defect in the robot or in the software that powers it? If different manufacturers collaborated to create the final ARS system, this issue could lead to finger pointing if the co-defendant manufacturers do not collaborate to present a unified front at the outset of a litigation.

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Conclusion Traditional legal rubrics such as the learned intermediary, preemption and co-defendant cooperation may be turned on their head in litigation involving ARS. Medical device manufacturers would be wise to stay abreast of the changing legal issues along with the changing technology. M

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WOMEN IN MEDTECH

How blockchains could empower patients and secure data Blockchain is best known as the technology behind cryptocurrencies such as Bitcoin. Patientory’s founders think it could have another important use – securing health data and empowering patients along the way.

Danielle Kirsh | Assistant Editor |

Medical Design & Outsourcing

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Secure access to patient data is a major issue for the healthcare industry. Patients have a hard time accessing their records and hospital networks need to transfer the data between networks if a patient chooses a new provider. That process can take days to complete and, even then, the patient doesn’t own their own data. “The biggest burden we have is getting access to patient data,” Chrissa McFarlane, Patientory’s founder & CEO, told Medical Design & Outsourcing. Atlanta-based Patientory generated enough buzz in the blockchain community that it managed to raise $7.2 million over a three-day period last year via cryptocurrency crowdfunding. The 3 • 2018

crowdfunding resulted in 1,728 contributors who bought 70 million PTOY currency coins. The blockchain technology that the company is offering is similar to what cryptocurrencies like Bitcoin operate. Blockchains are troves of data and records, known as blocks, linked together and secured using cryptography. They’re designed to be secure and are part of a distributed computing system. Blockchains’ functions are decentralized – multiple computer systems possessing the same up-to-date ledger at the same time. The lack of a central point of failure (a vulnerable central point that can be easily hacked) makes blockchains ideal for securing medical records. Think of blockchains as a virtual wallet and ledger.

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McFarlane thinks blockchains could be the solution to the healthcare industry’s headaches around the Health Insurance Portability & Accountability Act (HIPAA) violations and cybersecurity concerns. Blockchains can store and protect patient data because they’re tough to hack. At the same time, health providers can easily integrate them into hospital electronic records to provide a more efficient way of care for patient data, according to McFarlane. “We’re basically solving the issue of siloed and centralized healthcare systems,” she explained. When it comes to care management, blockchains could secure patient data, with the patient able to access data through what would essentially be a virtual mobile wallet. Doctors and healthcare providers can save time and money treating patients with blockchains because it prevents them from having to go over and do duplicate tests for something when the information from a different provider can be easily accessed through a blockchain virtual wallet. “The big idea is having a central location where patients can actually own that data,” said McFarlane. “Right now, patients don’t own that information. It’s owned by a hospital. That’s the biggest step – more patient empowerment.” One of the biggest challenges when it comes to blockchain technology is the need to break down the silos in healthcare, according to McFarlane. Hospital system administrators, for example, might be reluctant to incorporate the technology because portable access to patient information might make it easier for a patient to go to another health provider. If Patientory and its patient information blockchain technology are to succeed, the company will have to find a way to bridge the gap between providers and patients. “We’re going to see a much more free market economy and more consumerism in healthcare, which is a drawback for healthcare systems because while they may think they may lose money short-term, eventually it’s actually good for their performance and incentivizes healthcare systems to actually perform better once there is a sense of competition where patients can choose where they want to receive their healthcare,” McFarlane said. Like cryptocurrency, people are either really in favor of blockchains or against it. It’s not going to be implemented quickly throughout healthcare systems. “Look at Bitcoin. It took Bitcoin 10 years to get where it is, and it’s still in its early stages. While [blockchains are] still in its early stages, we can still see mass adoption within that five- to 10-year mark,” McFarlane said. “It’s definitely not happening overnight because it’s an emerging technology.” M

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REMOTE SURGERY

remote: Does robotic telesurgery have a future?

Although many have experimented with remote “telesurgery,” are the conditions right for commercial companies to start making an investment in a remote robotic surgical future? Although the idea of telesurgery — performing specialized procedures with robot-assisted surgical tools from a remote location — dates back to the very first research into medical robotics, the technology has yet to make a significant commercial impact. Robotic surgery is one of the hottest fields in medtech, as a raft of new entrants expand the possibilities for minimally invasive surgery. But thus far, commercialized systems are operated in a same-room cockpit or nearby control room. Is a remote solution viable? Opinions vary, but experts agree on one thing – the hurdles are daunting. Corindus Vascular Robotics (Waltham, Mass.) is one of the more optimistic players in the field. In January, the company announced a joint project with the Mayo Clinic in Rochester, Minn., for pre-clinical testing of its CorPath GRX platform in “telestenting” procedures. Doug Teany, R&D and operations SVP, told Medical Design & Outsourcing that Corindus is optimistic that the tests are a significant step toward a viable telesurgery technology. 34

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“For us, technically speaking, we're very confident that this can be done,” Teany told us. “We're so confident that it can be done that we've actually already done it in the office through a local area network connection — where we've gone further than one room away, but across a building in our headquarters.” The remote simulation was performed by Dr. Ryan Madder of Spectrum Health in Grand Rapids, Mich., operating CorPath via telecommunication systems with no direct cable connection. “He was able to complete a procedure, communicating through video and audio with a technician in our demo room,” Teany said. “So we have the technology to do it today; [now] we have to figure out the commercial infrastructure to scale that technology to across buildings and across miles.”

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REMOTE SURGERY

FI N K DEN SFORD ASSOCI AT E EDI TO R

Corindus Vascular Robotics’ full CorPath GRX vascular robotic surgery platform. Image courtesy of Corindus, Inc.

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Others testing the waters Other players in medical robotics are also testing the telesurgery waters, but haven’t progressed past proving the concept’s basic feasibility. TransEnterix CEO Todd Pope told us that although his company’s Senhance platform can be remotely operated, the case for further investment hasn’t yet been proven. “The capability is certainly there. I think the benefits need to be weighed versus the investment. Right now, robotic surgery is still fairly limited in its penetration. Up until now there have been trade-offs that have needed to be made,

and we think we addressed a lot of those trade-offs, so our forseeable future is really invested in getting Senhance systems out into ORs, not only throughout the U.S. but around the world. I think remote connectedness is something that stays on our dashboard for future investments as needed,” Pope said. Titan Medical (Toronto) CEO David McNally told MDO that his company has also experimented with remote capabilities for its Sport robot-assisted surgical platform. “We have done some early experiments — and this was before my tenure with the company, which began a year ago — with the ability to operate the system from remote locations across the continent of North America,” McNally told us. “We were able to demonstrate to our satisfaction that technically it is possible to operate a workstation that is remote from the patient cart.”

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‘Telesurgery is a completely different ballpark.’ Creating a commercially viable telesurgery system is much more challenging than creating a nonconnected platform, according to Dr. Richard Satava of the University of Washington, a pioneer in medical robotics research with more than 30 years in the field.

The external control panel for Corindus’ CorPath GRX system. Image courtesy of Corindus, Inc

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A first-generation version of Corindus’ platform was used in a larger remote experiment as well, Tal Wenderow, Cordindus’ co-founder and international & business development EVP, told MDO. That study, also led by Madder, explored the use of the CorPath system during percutaneous coronary interventions controlled from a separate room within the same building. Results from the 20-subject trial, published last year in EuroIntervention, showed an 86.4% rate of procedural success free from conversion to manual operations and a 95% overall procedural success rate.

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Early work with NASA and at Standford University with Dr. Joseph Rosen involved a robotic system for microsurgery on blood vessels a millimeter size or smaller, Satava told MDO. After Satava took a more handson role in the project at the Stanford Research Institute, the program shifted its focus to laparoscopic surgery, eventually drawing the eye of the U.S. Defense Dept.’s Defense Advanced Research Projects Agency, he recalled. “Initially, the director at DARPA wasn't happy because this project was pretty straightforward and simple and they only do new, innovative things. But I convinced him that no one had actually put together local surgery and remote surgery,” Satava said. The proposal called for a workstation at a M.A.S.H. unit and a robot-assisted OR at the battle front, “so that when someone would get wounded, immediately the medic would be able to put him in the robotic operating room,” he explained. The DARPA project progressed as far as two phases, the creation of the remote surgical station and battlefield OR, Satava said. But the funding dried up after the second phase and the program shifted to the Army’s Medical Research Command, he said. Still, the surgical station technology from the project was later licensed to Intuitive Surgical and used in the da Vinci platform. “So that’s the basic beginning of robotic surgery,” Satava said. “Telesurgery is a completely different ballpark.” A number of hurdles would have to be overcome for telesurgery to become a reality, including latency – the lag between the operator initiating an action and the remote system actually doing it. Another, possibly larger hurdle is coordinating the logistics between the surgeon operating the system remotely and the necessary surgical site team. “You have to have a regular surgeon there, at the operating table, in case something goes wrong. You get a specialty surgeon that can do robotic surgery and they could theoretically do it through a smaller hospital in a smaller city, but there still has to be a surgeon right there in case something goes wrong with the robot, so

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REMOTE SURGERY

The robotic arm, drive and cassette unit on Corindus Vascular’s CorPath GRX system.

the local surgeon can take over and finish the operation,” Satava said. Others in the robot-assisted surgery arena echoed Satava’s concerns about telesurgery, including Medrobotics CEO Samuel Straface. Although supportive of the potential societal benefits, Straface wasn’t optimistic about its commercial potential. “There’s an economy-of-scale issue here, too,” he explained. “To set up a robot remotely requires not only the robot itself, but also requires the expertise of the team to be able to do it.” And there’s competitions from “verbal assist” procedures, Straface added, in which a surgically trained assistant performs the surgery under guidance from an experienced surgeon at another site. Because the remote procedure would still require at least one additional on-site physician, plus added infrastructure and device costs, remote procedures could prove to be less cost-efficient than verbal assist surgeries – or just flying patients to regional centers of excellence for robotassisted procedures, he said. “The law of economics — I think that’s what drives this more than anything else. From a technology standpoint, it can be done, we can do it, we have done it, it’s just, ‘Is there any huge advantage for the patient and operator by doing it?’” Straface said.

Image courtesy of Corindus, Inc

“There’s a whole support team required in the sterile field to prepare and assist with loading the specific devices that will be used in the surgery,” Titan Medical’s McNally agreed. “It doesn't provide the benefit of reducing costs and it may indeed increase the complexity of performing surgery.” Titan Medical still counts remote connectivity among its goals for the Sport platform, he added, but the focus is on a more realistic short-term goal: The ability to transmit data and images from the surgery to remote locations. Still, there are successful examples of remote procedures that overcame at least a handful of the hurdles. In one, a team of French surgeons in New York performed a remote surgical operation on a patient in Strasbourg, France, in 2001. Dubbed the “Lindbergh Operation,” it was the first to overcome the time lag inherent in longdistance transmissions.

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3 • 2018

Medical Design & Outsourcing 39

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REMOTE SURGERY

Dr. Mehran Anvari, of St. Joseph’s Hospital in Hamilton, Ontario, regularly performs procedures using the same platform used in the Lindbergh Operation.

A physician running Corindus Vascular Robotics CorPath GRX system from the remote control station. Image courtesy of Corindus, Inc

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Next steps Corindus plans to move toward remote operation in phases, setting its sights on “teleproctoring,” in which a single expert is connected to multiple machines to help guide – and if necessary, take over – procedures administrated by less-skilled operators. “Just like our technology pathway, the development pathway will be very progressive. We will walk our way up to the problem instead of going after a ‘Big Bang’ approach,” Teany told us, adding that an operating prototype is slated for animal studies within the next 30 to 60 days.

3/13/18 5:42 PM

REMOTE SURGERY

The plan is for Spectrum Healthcare’s Madder to operate the CorPath system from a remote site for a procedure performed at Calvin College. “We'll have successfully completed a remote animal procedure within the quarter. We have a series of animal labs planned with Mayo this year and next year that will go from that progression of a few rooms away up to metropolitan and wide area networks. And we have a goal as a company to leverage what we've learned for a proof of concept, first-inhuman PCI done remotely within the next 10 to 14 months.” The benefits of remote stenting could be huge, Corindus’ Wenderow noted, delivering an enormous boost to the availability of life-saving procedures the world over. “The city of Beijing has a population north of 23 million. The outpatient population at Beijing’s Buwai hospital is north of 100 million, so people are flocking into Beijing for

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DATA COLLECTION

RESMED

UPRISING: DISRUPTING CONNECTED HEALTH

Here’s how a respiratory firm took control of the medtech digital revolution. HEAT HER T HOMPSON SEN I OR EDI TOR

When you think powerful digital connected devices, the first thing to pop into your head probably isn’t a CPAP. Continuous positive airway pressure has been shown in numerous studies to be effective in improving sleep apnea and preventing a host of co-morbidities such as obesity, congestive heart failure and chronic obstructive pulmonary disease. But the buy-in from patients is notoriously lacking. Respiratory companies have been struggling with this challenge for many years. Designers and developers have made both iterative and innovative improvements, without demonstrably moving the needle on changing patient behavior. For the most part, compliance rates hover around 50%. One company, ResMed (San Diego), has taken on the challenge of helping users become more compliant, the ecosystem more costeffective and customers more loyal through a model of connected health.

The AirMini, the smallest PAP available, was released by ResMed in 2017. AirSense 10 was introduced in 2014. All of ResMed’s home sleep devices come cloud connected right out of the box.

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DATA COLLECTION

ResMed’s quest to improve patient compliance began over a decade ago, explained CEO Mick Farrell. “We started our first digital health experiments with UC San Diego in 2002 and learned a lot over a decade.” That work lead to a reinvention of the company in 2012, with 100% cloudconnected medical devices across all of its sleep apnea therapy platforms. “We’re first in the industry to put a cellular communication chip inside every sleep apnea device,” Farrell told Medical Design & Outsourcing. Since then, the company has made impressive strides. Berg Insight, an independent research organization, estimates that 7.1 million patients worldwide use remote monitoring products. Of those, more than 4 million are cloud-connected to ResMed’s remote

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monitoring platform. In 2016, Berg noted in its “mHealth and Home Monitoring” report that sleep therapy remote monitoring grew by 70%, surpassing cardiac rhythm management. The report noted that the growth was “driven by the vendor ResMed that has made connected healthcare a cornerstone of its strategy.” That success changed the thinking around connected medical devices, blazing the trail for other medical device makers to follow. Actionable insights Farrell called out two key acquisitions that helped ResMed make the transition: Umbian, a digital health provider for sleep apnea management, in 2012; and Brightree, a provider of softwareas-a-service for out-of-hospital care management, in 2016.

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Their combined technology led to ResMed’s release of the “world’s largest remote patient monitoring network, AirView,” said Farrell. AirView captures nightly sleep data from more than 4 million sleep apnea and COPD patients via the cloud. Umbian’s U-Sleep features have helped improve the AirView offering by introducing “AirView Action Groups,” in which patients are automatically grouped by therapy issue via smart algorithms, enabling clinicians to efficiently manage patients “by exception.” Brightree helps customers improve both the clinical and business performances of sleep disorder devices. Another part of Air Solutions is ResMed’s patient engagement app, myAir, which scores sleep apnea patients on a scale of 100 based on how well

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DATA COLLECTION

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they slept using CPAP therapy, plus personalized coaching to improve results. Worldwide, 1,300 new patients sign up for myAir every day, Farrell told us. Each signup represents a paver on the road to Farrell’s holy grail when it comes to data: actionable insights.

The AirView patient screen shows data capture for patient’s use, but only alerts a caregiver with “by exception” events.

“Leveraging deep neural networks and sophisticated virtuous feedback loops of learning to discern actionable insights is the key to success,” he explained. The AirView platform captures 1.5 billion nights of medical sleep and respiratory care data, enabling analysis of large patient populations to glean insights that influence standards of care and patient outcomes. Automatic user adoption Although data collection alone would make ResMed a stand-out organization, there are tricky issues at play when it comes to gaining access to that data. That’s where user-focused design comes into play. According to designers specializing in patient behavior, the key to user adoption of connected devices is really

not to give them an option. Bill Evans — founder and former innovation SVP at Bridge Design, a Ximedica company — noted that every moment a device maker puts a barrier in front of a patient presents a risk that the patient will abandon the device. “We tell our customers, ‘Don’t make it hard to get in the cloud, meet your users where they are, not where you want them to be,’” Evans told us. ResMed took this lesson to heart. “You lose health adopters every time you ask a patient or provider to perform a set-up step, select a network or flip a switch,” Farrell agreed. “You’re asking them to do something before they see the value. We flip that around and only ask them to do something after we’ve generated the value for them. We took all the work out of it.” Every Air Solutions device is cloud-connected out of the box. Data from the cloud can be seen the next morning by the patient or (with the patient’s permission) a doctor, enabling the monitoring and support of patients without an office visit. “All the patient has to do is go to sleep,” Farrell said. “[ResMed] has thrown every best design practice in the book” at helping patients get connected with their medtech devices, Evans said. And it appears to work. A November 2017 study of 128,000 patients published in the journal CHEST showed that sleep apnea therapy users whose nightly use was remotely and self-monitored via ResMed’s AirView and myAir platforms, respectively, were more than 87% adherent on therapy. A three-legged stool Evans and other device developers often talk about three-legged stools when discussing what makes a product successful: Cost, outcomes and loyalty. The decisions ResMed made on how to

ied

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DATA COLLECTION

best collect, store and share data with patients and caregivers led to better outcomes. And patients get immediate feedback from their device, including prompts to order new supplies or replace parts and assessments of sleep improvement. All that helps build loyalty. The third leg is cost, and that’s where ResMed solves one of the stickiest issues in the medtech space: Reimbursement. Although every payer is different, all want proof of compliance. For example, Medicare requires that a patient use CPAP for more than four hours per night on 70% of nights during a 30-day consecutive period during the first three months of use. Farrell said myAir and AirView improved that number to 87%. A connected future ResMed has plans to expand its connected health solutions worldwide,

leveraging data for actionable insights and, according to Farrell, “exploring ways where all this smart data can take us next” — particularly when it comes to using artificial intelligence models through machine learning and predictive models. And the CEO has his eye on therapeutic areas beyond sleep apnea and COPD; he’s asked his team to consider possible applications in cardiovascular disease, Type II diabetes and other severe chronic diseases. Nick Vassilakis, founder & CEO of remote patient monitoring company Astute, noted that integration of sensors and data into a unified platform, “to get a more holistic view of a patient’s overall wellness,” is a significant challenge. Farrell understands that realizing his vision will require an entire ecosystem, with the pharma, medtech and software industries combining to “bend the rising

healthcare cost curve together.” “Everyone wants healthcare data streamlined and in one spot,” he said, and he sees ResMed playing a role by giving patients a single app for sleep, exercise and nutrition. “We see big tech companies like Apple creating consumer facing health applications and Google/Verily looking to create an ecosystem. Most recently we have seen Amazon talking about getting into the delivery space,” he explained. ResMed’s Air10 sleep apnea devices and Astral and Stellar in-home ventilators can already connect to the devices’ builtin cloud connection, he added, noting that the company plans next to connect its portable oxygen concentrators to the cloud. And although Farrell wasn’t willing to discuss his plans beyond that, it’s clear that ResMed plans to continue to lead the connected space. M

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CANCER DETECTION

the

cancer detectives SARAH FAU LK N ER ASSOCI ATE ED I TO R

This new technology could help surgeons clear out leftover cancer cells during surgery

In some instances, as many as 30% of patients need repeat surgeries to get rid of cancerous cells initially left behind. The team from Lumicell wants to change that. After his wife died of breast cancer in 2003, David Lee stepped away from a decades-long career in the semiconductor industry and jumped feetfirst into the medtech arena. Fifteen years later, Lee is president and co-founder of a company developing a system that can detect residual cancer cells in real time during surgery. Lumicell has tested its drug-device combination product in 45 breast cancer patients and, so far, has identified 100% of the cancerous cells that linger behind on the walls of tumor cavities. Lumicell’s technology could represent a shift in how surgeons determine the success of their 48

Medical Design & Outsourcing

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tumor-removal procedures, Lee told Medical Design & Outsourcing. “For the last two or three centuries, [surgeons have] always depended upon pathology to tell them that they succeeded. But they’re only inferring whether it worked. They’re only looking at resected tissue and inferring whether they left tumor behind. Even with the best of our technology at the best of hospitals, it’s still an inference,” he explained. Lee told us that Lumicell’s technology can serve as a way for surgeons to scavenge for residual cancer cells during a patient’s first surgery, potentially saving them from needing a second operation.

www.medicaldesignandoutsourcing.com

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CANCER DETECTION

Image courtesy of istockphoto.com

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CANCER DETECTION

A ‘pan-cancer’ detection agent After a patient’s tumor is removed, surgeons using Lumicell’s handheld imaging device can scan the empty cavity to hunt for any remaining cancer cells. Thanks to a proprietary fluorescent optical contrast agent the company developed, any cancerous cells left behind will light up when scanned by Lumicell’s device. While the surgeon is scanning the patient’s body, Lumicell’s decision-support software displays an image to help guide surgeons to any cancerous tissue. Those three components — the imaging agent, the handheld device and the decision-support software — combine to create a system that recentlyappointed CEO Kelly Londy believes will give them a competitive edge as a platform technology. “We’re currently in five indications, looking to prove the technology for breast, prostate, colorectal, esophageal and pancreatic cancers,” Londy said. “In the near term, we expect to have FDA approval to move forward with brain and ovarian.” Lumicell has been able to move between cancer types swiftly, thanks in part to a decision made by Lee and his team when they first developed the Lum015 imaging agent. “I had two world-class imaging guys back in 2008 and we agreed that we were going to come up with an imaging agent that was pan-cancer in concept,” he explained. “Other approaches and traditional imaging agents require binding to very specific proteins on cells. The problem is that those are very specific to each indication, so they have to create a drug for each.” Lumicell’s imaging agent is designed to activate in the presence of particular proteases, enzymes that break down proteins. Cancer cells secrete more of these than healthy cells, giving Lumicell researchers something to target. In some cases, according to Lee, doctors and researchers have helped to push the company to pursue certain indications for the Lumicell system. “In esophageal cancer, they wanted to know whether we could detect the 50

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cancer. It turned out that we could not only detect cancer, we could detect the pre-cancerous condition,” Lee said. “So they’re very enthusiastic.” Lumicell is pursuing the combination product pathway for its technology with the FDA and expects to file a premarket approval application by the start of 2019. “In most drug-device combination products, one or the other has already been approved. In our case, neither has been approved. It’s a new drug, a new device and it’s a new methodology, a new standard of care,” Lee said. From pathology slides to the human body There’s a financial incentive for hospitals and doctors to adopt Lumicell’s tech, Lee argued. Helping one patient avoid a repeat surgery leaves room in the schedule for a new patient. But there’s also an argument to be made on behalf of pathologists, according to the company. “There are six breast cancer pathologists at Mass. General Hospital. There is only one for all of gastrointestinal. They would like nothing better than to take less tissue,” Lee said. “Surgeons don’t want to take the extra time digging around blindly, and pathologists don’t want to take extra

time looking at slides that have no tumor.” Traditionally, pathologists examine slides from a resected tumor, looking for a millimeter-wide margin of cancerfree cells to determine whether a repeat surgery is needed. There is much debate over what constitutes a clear margin. Lumicell’s team is positioning its technology as a way to move the mark of success from a pathologist’s slides into the patient’s body. “We're shifting the paradigm from looking at the resected tissue to looking at the cavity in the body, which is really want counts,” Lee said. Instead of asking surgeons to root around blindly, Lumicell’s technology could help inform them when they’ve removed just enough tissue to rid the patient of cancer, noted longtime medtech design veteran Bill Evans. "In some cancer-margin detection, particularly in difficult anatomies where there are lots of things going on, you are trying to remove cancers that are intertwined with extremely vital tissues,” said Evans, founder and former innovation SVP at Bridge Design, a Ximedica company. “So you want to remove the minimum tissue possible but yet, at the same time, you want to remove all the margins of the cancer. That's an area where there's a lot of interest."

Photo courtesy of Lumicell

www.medicaldesignandoutsourcing.com

3/13/18 5:51 PM

CANCER DETECTION

The technology could also help alleviate the burden of what many surgeons consider the hardest part of their jobs. “The worst thing that they have to do in their day is go back and tell a patient that they have to do another surgery, that they didn’t get all the cancer,” Londy said. It isn’t easy to convince surgeons to incorporate a new technology into their procedures, cautioned Dr. Tracey Stokes, a Florida-based plastic surgeon who specializes in breast reconstruction. “Surgeons are fairly set in their ways. Surgeons are used to being the captain of the ship, and we’re accustomed to getting the results we get by doing the same thing the same way, every time,” Stokes told us. “That being said, there are many surgeons,

CancerDetection Feature MDO 3-18 Vs4.indd 51

YOU WANT TO REMOVE THE MINIMUM TISSUE POSSIBLE BUT YET, AT THE SAME TIME, YOU WANT TO REMOVE ALL THE MARGINS OF THE CANCER. THAT’S AN AREA WHERE THERE’S A LOT OF INTEREST. like myself, who are early adopters of technology. If there’s something that I’m going to use differently in the OR, there has to be a reason that I’m changing from what I’m comfortable with and what I’m used to getting reliable results with. A new technology needs to be innovative, or time-saving or safety-enhancing.” The Lumicell system was designed to change as a little as possible in a surgeon’s routine, according to Londy. The device feels and responds like an ultrasound probe, which surgeons

are already familiar with. And the company’s imaging agent is given to the patient while they’re in the preoperative room, where they get an IV anyway. It’s not even an additional needle-stick. “The surgeons don’t have to change much of what they do and the way that it works, it’s like 30 seconds extra in their process, so it’s not a big process change,” Londy explained. “We are talking about a change to the standard of care, but it’s a dramatic shift that’s actually quite subtle,” Lee added. M

3/14/18 10:39 AM

WOMEN INNOVATORS

Marie Curie Marie Curie is one of the most notable women in science. One of the things she is credited with is creating mobile radiography units to bring X-ray services to field hospitals during World War I. Her other achievements include developing the theory of radioactivity, methods for isolating radioactive isotopes and discovering the elements polonium and radium. Curie was the first woman to win the Nobel Prize in Physics, in 1903. In 1911, she received her second Nobel Prize in Chemistry, becoming the first person and only

Wikimedia Commons

Alice Augusta Ball, a chemist, developed an injectable oil extract that was the only effective treatment for leprosy into the 1940s. Ball, recruited by Dr. Harry Hollman of Hawaii’s Kalihi Hospital, isolated the active chemical compounds in chaulmoogra oil, which had been used to treat leprosy with inconsistent results. Too sticky to be used topically, it was too painful to inject. Ball isolated ethyl ester compounds from

Medical Design & Outsourcing

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Alice Augusta Ball

Wikimedia Commons

fatty acids in the oil to create an injctable and bioresorbable compound. Ball earned her bachelor’s degree in pharmaceutical chemistry from the University of Washington and got a second degree in pharmacy two years later. She went on to pursue her master’s degree in chemistry from the University of Hawaii. She was able to do her research on chaulmoogra oil before her untimely death at the age of 24.

3 • 2018

woman to win twice, as well as the only person to win a Nobel Prize in two different sciences. After recognizing that soldiers could be best served if operated on immediately on the battlefield, Curie obtained X-ray equipment, vehicles and generators to create mobile radiography units, known as petites Curies. Under her guidance, 20 mobile radiological vehicles and 200 radiological units were installed at field hospitals during World War I, according to the American Institute of Physics.

Rosalyn Sussman Yalow developed the radioimmunoassay technique to study insulin levels in diabetics, as well as hormones, vitamins and enzymes, which were previously too small to detect. The technique involves isolating target antibodies and measuring their radioactivity. Concentrations of the substance being tested, such as insulin in the blood, can then be calculated.

Rosalyn Sussman Yalow Yalow graduated from Hunter College in 1941 after studying stenography. Following graduation, she was offered a teaching assistantship in physics at the University of Illinois at Urbana-Champaign. She went on to receive her PhD in 1945. In 1977, Yalow was awarded the Nobel prize in Physiology or Medicine for the development of the radioimmunoassay.

www.medicaldesignandoutsourcing.com

3/14/18 12:34 PM

WOMEN INNOVATORS

DA N I E L L E K I R S H A S S I S TA N T ED ITO R

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WOMEN INNOVATORS

Wikimedia Commons

Jane Wright was known as a pioneer of cancer research and is most notable for her contributions to chemotherapy. She is credited with creating a technique that used human tissue instead of laboratory mice to test how drugs would affect cancer cells. Wright is also noted for pioneering the use of methotrexate to treat breast cancer and skin cancer. Wright first attended Smith College, where she earned an art degree. In 1945, she obtained her medical degree from New York Medical College; residencies at Bellevue Hospital and Harlem Hospital followed. Wright became a researcher at New York

Medical Design & Outsourcing

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Jane Wright

Wikimedia Commons

University’s Bellevue Medical Center, where her work focused on studying the effects of drugs on tumors. She was the first person to discover that methotrexate was effective against cancerous tumors. The drug is now known as a foundational chemotherapy drug. Further work in chemotherapeutics, on administering sequential and varying doses to increase the effectiveness of chemotherapy rather than giving patients multiple drugs led to her identification of treatments for breast and skin cancer that increased cancer patients’ life expectancy by up to 10 years.

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Clara Barton is known as the founder of the American Red Cross. During the American Civil War, when the victims of the first bloodshed in the 1861 Baltimore Riot were transported to Washington, Baron went to the railroad station where the victims were set to arrive and nursed 40 soldiers. Barton learned how to store and distribute medical supplies and offer emotional support to the wounded soldiers while providing clothing, food and supplies. By mid-1862, Barton was on the front lines of the

Clara Barton war, distributing stores, cleaning field hospitals, dressing wounds and serving food. Mentally and physically exhausted after the war, Barton traveled to Geneva in 1869, where she met a doctor who asked her to be the representative for the American branch of the Red Cross. By the early 1880s, Barton had gained approval from President Chester Arthur to start the American Red Cross after explaining that it would be used for earthquakes, forest fires and hurricanes in addition to wars.

www.medicaldesignandoutsourcing.com

3/13/18 6:00 PM

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AFRICAN AMERICAN INNOVATORS

DAN I ELLE K I R S H AS S I S TAN T ED I TO R

Fromcardiology,toendoscopy, to blood transfusion, African -Americans have played an important role in creating of some of medtech most important innovations. To help mark African-American History Month, here’s a look at some of their greatest achievements.

black innovators who shaped medtech

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AFRICAN AMERICAN INNOVATORS

Frederick Jones Frederick Jones is credited with inventing a nonmedical device that revolutionized battefield care – a portable air-cooling unit for trucks carrying perishable items. The Jones technology, which he patented in 1940, was used during World War II to preserve

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Charles Drew, known as the pioneer of blood transfusions, was responsible for the first blood banks and what became the American Red Cross Blood Bank. Drew set up and administered an early program for blood storage and preservation in late 1940, before the U.S. joined World War II. His job was to collect, test and transport large amounts of plasma to be distributed in the U.K.; he went on to invent the bloodmobile — trucks with refrigeration units to store blood. Drew also invented what we now know as the blood bank — a central location for blood collection processes,

Charles Drew

blood, medicines and food for hospitals and the battlefield. A prolific inventor, Jones holds 61 patents, most for refrigeration equipment. Others cover portable X-ray machines, sound equipment and gasoline engines.

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where people could donate blood to tested and stored before shipping. This concept later became known as the American Red Cross Blood Bank. Throughout World War II, Drew criticized the practice of segregating blood donated by blacks from the overall blood supply. Drew went to medical school at McGill University in Montreal and later did graduate work at Columbia University, where he went on to receive his doctor of medical science degree. After a lengthy research and teaching career, he died at age 45 as a result of a car accident.

Patricia Bath helped pioneer the treatment and prevention of blindness, by inventing a device called the Laserphaco Probe that refined laser cataract surgery. Bath is also the first black woman to hold a patent for a medical purpose. A co-founder of the American Institute for the Prevention of Blindness in 1978, where she served as president, Bath earned a bachelor degree in chemistry from Hunter College in 1964 and went on to attend the Howard College of Medicine, where she received her doctorate in 1968.

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Patricia Bath

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During a trip to Yugoslavia in 1967 to study children’s health, Bath saw that the quality of eye care was uneven among minority and poor populations, which resulted in higher levels of blindness. Upon returning to the U.S., Bath convinced her professors at Columbia University to perform free operations on blind patients at Harlem Hospital Center, where she was an intern. She became a pioneer of community ophthalmology, a volunteer-based outreach that brings eye care to underserved populations.

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AFRICAN AMERICAN INNOVATORS

Leonidas Berry

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Leonidas Berry was a pioneer in gastroscopy and endoscopy who invented the first directvision instrument, better known as the gastroscope, to visually diagnose and remove diseased stomach tissue. The device was the first to use flexible, illuminated tubes to look into the stomach to view

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early cancers and ulcers. Berry earned his first bachelor’s degree from Wilberforce University in 1924 and a second from the University of Chicago. He went on to get an M.D. from the university’s Rush Medical College and an M.S. in pathology from the University of Illinois Medical School. Berry practiced at Cook County Hospital in Chicago, where he specialized in gastroenterology. He retired in 1975 as chief of endoscopy.

Samuel Kountz

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Samuel Kountz helped develop the Belzer kidney perfusion machine, which can preserve a kidney for up to 50 hours after it’s removed from a donor. The device is standard equipment in hospitals and laboratories worldwide. Kountz was also the first to perform

a successful kidney transplant between two humans who weren’t twins and discovered that large doses of methylprednisolone, a steroid, could reverse acute rejection of kidneys after transplantation. He started his surgical training at Stanford University School of Medicine, where he studied the field of organ transplantation and decided to specialize in transplant surgery.

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DIABETES CLINICS

The medtech giant singles out its work with Diabeter, a chain of diabetes clinics it acquired in the Netherlands, as evidence of how it’s delivering more value for patients.

SA R A H FA U LK NER A SSO C IATE ED ITO R

Photo courtesy of Medtronic

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Managing a chronic illness can feel like a full-time job. Between juggling multiple appointments with an array of specialists and following a meticulous care plan, patients dealing with conditions like diabetes have a lot on their plate. Medtech titan Medtronic wants to help change that. The company’s CEO Omar Ishrak has placed his faith in value-based care as the future of healthcare. And the company points to its work with Diabeter, a chain of diabetes clinics in the Netherlands that it acquired in 2015, as evidence of its progress toward delivering more value for patients. Sue Willman has been a part of Medtronic’s effort to boost patient outcomes and lower costs across the healthcare system. Over the course of her 25 years in medtech, she has learned that there are two key elements to promoting good health for a patient.

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“You really need a good care plan, which usually comes from the provider, and you need adherence to that care plan,” Willman, who is VP of global integrated care solutions for Medtronic Diabetes, told Medical Design & Outsourcing. “A lot of my career had been focused on adherence to the care plan without any real closed-loop processes back to the clinician. So what intrigued me about the Diabeter clinic solution is leveraging all the patient engagement activities I was using, like remote monitoring and behavior coaching, but also getting that information back to the clinician so they could adjust the care plan.”

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DIABETES CLINICS

Diabetes is a data-driven disease. But the way that doctors care for patients with diabetes in the U.S. is still largely divorced from the array of technologies available on the market, such as glucose monitors that can track historical trends.

you did what you were supposed to do — and there’s no evidence or insight.” In Medtronic’s Diabeter clinics, diabetes specialists collect data from patients’ connected devices continuously between visits. They feed the data through an algorithm that creates a profile for each patient, giving the doctor a dashboard with which to organize their patients. “That’s how they know, from a population perspective, which patients to pay attention to and how, whether it be a call or a text, to say, ‘Hey, you need to come into the office. This isn’t something we can manage over the phone,'” Willman explained.

YOU REALLY NEED A GOOD CARE PLAN, WHICH USUALLY COMES FROM THE PROVIDER, AND YOU NEED ADHERENCE TO THAT CARE PLAN. “Today, care is very episodic. A patient goes in, sees the doctor and that’s it. The doctor tells you what you’re supposed to do and then you come back 90 to 120 days later, and they ask you if

In most healthcare systems, patients with Type I diabetes are cared for by endocrinologists and patients with Type II diabetes are seen by their primary care doctors. At the Diabeter clinics, patients are treated by a multidisciplinary team of specialists who focus specifically on diabetes and related conditions such as hypertension and stress. And while patients in the U.S. have to coordinate scheduling appointments across multiple offices to see a psychologist or a nutritionist, Diabeter clinics have centralized those resources, so it’s all under one roof. The clinics across the Netherlands serve more than 2,200 patients with Type I diabetes, but the company envisions later expanding its services to include people with Type II diabetes.

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DIABETES CLINICS

“Our vision for Type II is that you would add things related to screening for cardiovascular problems, you’d have podiatry, you’d have screening for neuropathy and more,” Willman said. Medtronic’s Diabeter clinics have been in place in the Netherlands for 10 years, and since 2015, they’ve grown from two to five clinics. The company is in active discussions to bring the diabetes care model to other countries; Willman noted that most prospective partners are excited about the clinical results that the model brings for patients — but worried about reimbursement. “In most markets, you’re reimbursed for seeing the patients in the office. What they’ve developed in the Netherlands is a bundled payment for out-patient services to allow for them to manage the patients based on how they see fit and to support the cost of those in-between office visit contacts,” she said. “When we go to other countries, they’re all for the model. But the trick is, how do you take the model and ensure that you can cover your costs?” When angling to bring the model to a new region, Willman and her team use the region’s data to show that, although they may pay more money to manage each patient upfront, the healthcare system will ultimately save money thanks to decreased hospitalizations. David Kaplan, director of corporate ratings for S&P Global Ratings’ healthcare group, pointed out that focusing a health economics argument around preventive care doesn’t always pan out the way companies hope. “While preventive care is good for health outcomes, the expansion of preventive coverage to a broad group often doesn’t fully offset the cost savings on a system-wide basis, so that becomes a net increase in cost,” he said. Ultimately, Willman argues that the benefit to implementing this type of care model falls squarely on patients. “We say that 90% of diabetes is managed by the patients. They go to the doctor, sure. But they have to make hundreds of decisions every day of what

they’re going to eat, how it’s going to affect their schedule, etc. All that burden is placed on the patients,” she said. “This is a way to give them support with enabling technology between office visits, as well as a unique patient experience with 24/7 support so that they have that safety net while they’re outside of the office.” Medtronic has proven itself more willing to embrace value-based care compared to some of its medical device peers, Kaplan added. “Presumably because they view the shift as inevitable and they would rather be ahead of it,” he explained, “whereas the financial incentive in the near term would be to leave things status quo.” The medtech giant’s value-based focus is part of a trend, Kaplan added. “While these clinics are unique in terms of their focus on diabetes, there are many companies trying to coordinate the care of patients with chronic conditions, as it is widely recognized that the episodic nature of the healthcare system, especially in the U.S., is not adequately meeting patient needs,” he said. M

Photo courtesy of Medtronic

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DEVICE TALKS

There’s a simple way to improve stroke treatment in the U.S. Technology is already available to greatly improve outcomes for stroke, but the healthcare system stands in the way, according to Stacey Pugh, VP & general manager of the neurovascular unit at Medtronic.

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The most important thing that could boost stroke treatment is passing proper legislation about taking patients in emergency situations to comprehensive stroke centers for treatment, Medtronic’s Stacey Pugh explained during her keynote discussion at DeviceTalks West, held December 2017 in Orange County, Calif. Technology has changed but systems of care have not, according to Pugh. “The most important thing we can do today in stroke unfortunately isn’t innovation. It’s legislation,” Pugh said. A stroke occurs when blood flow to an area of the brain is cut off, resulting in a deprivation of oxygen to brain cells, which then start to die. When brain cells die during a stroke, the abilities of that area of the brain are lost. Nearly 800,000 people a year experience a new or recurrent stroke in the U.S., according to the National Stroke Assn.

“There’s a couple of reasons for that,” Pugh said. “Part of it is stroke systems of care. The underlying medical system hasn’t evolved with the technology.” The American Heart Assn. and the American Stroke Assn. help designate primary and comprehensive stroke care centers. Solitaire is generally only available at comprehensive stroke care centers; primary centers are limited to doing a CT scan to locate a bleed or blockage and administering clot-busting tissue plasminogen activator drugs, according to Pugh. Without legislation, an ambulance can drive past several comprehensive stroke centers that are capable of performing the intervention with Solitaire before arriving at a primary care center – even if the stroke sufferer is outside the time window in which tPA therapy is effective. “There’s nothing in 30 states that says you have to be transferred to a comprehensive center,” Pugh explained. Go to a primary center before a comprehensive center, and data shows that it’s a 90-minute delay on average, according to Pugh. “Ninety times 1.9 million [dead brain cells a minute] – it’s not a pretty sight,” Pugh said. “So, for every 30 minutes you’re delayed from getting intervention, you decrease the likelihood of a good outcome – not zero disability but what we would consider reasonable functional independence – by 10%.”

THE MOST IMPORTANT THING WE CAN DO TODAY IN STROKE UNFORTUNATELY ISN’T INNOVATION. IT’S LEGISLATION Medtronic has a sproduct on the market – the Solitaire revascularization device – that reduces stroke mortality. It goes through the groin and into the brain – integrating into a clot and pulling it out of a large vessel occlusion. But only about 10% to 15% of people in the U.S. who are eligible to receive the therapy get it. 62

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FOR EVERY 30 MINUTES YOU’RE DELAYED FROM GETTING INTERVENTION, YOU DECREASE THE LIKELIHOOD OF A GOOD OUTCOME

The present system of transport for stroke patients reflects a time when tPA was the only way to treat stroke – and the idea was to get stroke sufferers access to the drug as quickly as possible, Pugh said. Before there was device intervention, comprehensive and primary centers were not much different from each other. They could both administer tPA and determine if a patient needed a higher level of care – for bleeding in the brain, for example – and transfer the patient as needed. “We’ve been able to show in that study that you could drive a patient an additional 20 miles and take them to a comprehensive stroke center and they still get tPA faster. So the only reason to stop in the primary center was to get

WE'RE BACK FOR ANOTHER SEASON OF INSIGHT FROM MEDTECH'S BRIGHTEST MINDS! DeviceTalks, the live interview series from MassDevice, returns in 2018 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 2018 season.

Stacey Pugh (right), VP & general manager of the neurovascular unit at Medtronic, discusses how to improve stroke treatment in the U.S. with Medical Design & Outsourcing publisher Brian Johnson (left) at DeviceTalks West.

a patient tPA faster, but you can get it faster going to the comprehensive center, even with an additional 20 miles, because speed is everything in these centers,” Pugh said. The odds of getting treatment are better if a stroke patient is a trauma patient as well, according to Pugh. There is a system in the U.S. that states if a patient is having a massive injury, they are guaranteed a direct route of care. There are designated trauma centers that are well-known. That’s not the case with stroke. There is no designated pathway for getting stroke treatment. M

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