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SHOWW REVIE

HOW CONTINUOUS GLUCOSE MONITORS HAVE TRANSFORMED THE DIABETES LANDSCAPE

NEW iRhythm CEO MIKE COYLE HAS BIG PLANS TO MOVE THE COMPANY FORWARD

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SHOWW REVIE

HOW CONTINUOUS GLUCOSE MONITORS HAVE TRANSFORMED THE DIABETES LANDSCAPE

NEW iRhythm CEO MIKE COYLE HAS BIG PLANS TO MOVE THE COMPANY FORWARD

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HERE’S WHAT WE SEE

Medtech is finally going digital

he COVID-19 pandemic sped up developments that were going on before the virus jumped from bats to humans. Count the digitization of medtech among those trends. Electronics have become so miniaturized over recent decades that it seemed only a matter of time before anything used on human beings would have sensors collecting information. However, industries are slow to change when they are highly regulated — and sell to big health providers paid by big public and private insurers. Why remotely monitor a patient when it seemed to work just ﬁne for them to stop in at the clinic to get checked out? Plus, there was the bureaucracy involved in trying to get paid for the remote monitoring. COVID-19 shook things up because just stopping in to get checked out sometimes wasn’t logistically possible. People also wanted to limit their exposure to others. Health providers quickly shifted to doing many things remotely. It’s little wonder, then, that 2021 is the year that we’re expecting a major orthopedic device company to roll out a smart knee implant. Zimmer Biomet’s Persona-IQ is a next-gen version of its successful, personalized Persona Revision knee implants. It incorporates the Canary Health Implantable Reporting Processor (CHIRP), created by the startup Canary Health. The CHIRP is about the size of a triple-A battery and can transmit data to a base station in a person’s home for up to 20 years. Zimmer Biomet and Canary Health are seeking reimbursement decisions from the Centers for Medicare & Medicaid Services that could enable doctors to receive extra payments for monitoring CHIRP data. It’s little wonder that there’s so much buzz around the Persona-IQ: Doctors could get an extra steady income stream for years, and they’d be grateful for the extra data after a year of trying to evaluate knee Chris Newmarker patients over Zoom. Executive Editor Dr. Bill Hunter, the founder and CEO of Medical Design & Canary Medical, recently told Medical Design & Outsourcing Outsourcing that the Persona-IQ will be able to do c n e wm a rk e r@ wtwh m e di a .c o m even more in the future: “If we can identify problems early, then it really becomes a ‘why not’ therapy at that point in time.” Hunter had several more insights to share for our cover feature about smart knee implants. The Persona-IQ story is just one in our March issue that covers the digitization of medtech: •

Senior editor Danielle Kirsh, for example, “attended” the CES 2021 virtual trade show and reported back on a host of wearables and digital health tools — many with a potential use against the coronavirus pandemic.

Medical Design & Outsourcing

If we can identify problems early, then it really becomes a 'why not' therapy at that point in time. 3 • 2021

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HERE’S WHAT WE SEE

CONTRIBUTORS

Associate editor Sean Whooley meanwhile interviewed Mike Coyle, who left an 11-year career at Medtronic to take the helm of iRhythm Technologies. The Zio XT from iRhythm is an ambulatory cardiac monitor among a number of promising technologies that could supplant the Holter monitors that doctors have used for years to discover heart rhythm problems. Pharma editor Brian Buntz checks out continuous glucose monitoring systems, which have already made a major difference among many people with diabetes.

ROMAN FAYERBERG is a registered patent attorney at Greenberg Traurig. He focuses his practice on the development and management of strategic patent portfolios and counseling clients on patent issues.

As I write this editorial in late February, the U.S. has crossed the 500,000 mark for COVID-19 deaths; nearly 2.5 million are dead worldwide. It’s hard to feel optimistic about the future with those types of numbers, and yet here’s to hoping that the accelerated innovation that we have seen in pharma and medtech will genuinely make a difference and enable people to have healthier and happier lives in the future.

KAREN CULLINANE is a partner in the Toxic Tort & Environmental Law practice group at Goldberg Segalla, LLP, and is based in Goldberg's Manhattan ofﬁce.

•

Chris Newmarker Executive Editor Medical Design & Outsourcing cnewmarker@wtwhmedia.com

DAVID J. DYKEMAN is a registered patent attorney with nearly 25 years of experience in patent and intellectual property law, and co-chair of Greenberg Traurig’s global Life Sciences & Medical Technology Group.

MARK TOLAND is the CEO of Medical Microinstruments (MMI SpA), a surgical robotics company dedicated to improving clinical outcomes for patients undergoing microsurgery. MIGUEL ANGEL TORRES TELLO has more than 10 years of experience in the medical device sector. He is cofounder of Veraque Consulting, a ﬁrm with the mission to provide access to the medical device market by complying with local regulations.

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FAYERBERG

DYKEMAN

CULLINANE

TOLAND 10

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3 • 2021

TELLO

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CONTENTS

medicaldesignandoutsourcing.com ∞ March 2021 ∞ Vol7 No2

• • • • • THE ENABLING TECHNOLOGIES ISSUE

COLUMNS 8

HERE’S WHAT WE SEE:

CONTRIBUTORS

IP ISSUES:

PHARMA:

ON THE COVER

Medtech is ﬁnally going digital

ARE SMART KNEE IMPLANTS THE NEXT BIG THING IN ORTHO? Orthopedic industry watchers think so, and Zimmer Biomet appears set to be ﬁrst out of the gate this year through a partnership with Canary Medical.

3 ways to a strategic medtech patent portfolio

What’s next for pulmonary ﬁbrosis treatment?

FEATURES

22 REGULATORY:

Mexico offers speedier deviceequivalency approvals

24 ROBOTICS:

Supermicrosurgery could lengthen the reach of robotics

28 STERILIZATION:

Preparing for ethylene oxide lawsuits and stricter regulation

30 TUBING TALKS:

48 CES 2021: MEDICAL TECHNOLOGIES YOU NEED TO KNOW

36 WOMEN IN MEDTECH:

53 HOW CONTINUOUS GLUCOSE MONITORS HAVE TRANSFORMED THE DIABETES LANDSCAPE

The annual electronics show went virtual this year, with some of the medtech geared toward managing COVID-19.

Innovations to make duodenoscopes safer

How temporary neurostimulation can treat chronic pain long-term

•

62 DEVICETALKS:

Corza Medical’s Lucier shares company’s surgical tool sales playbook

Medical Design & Outsourcing

•

Plus, Pharma editor Brian Buntz shares what he learned from wearing a Dexcom G6 CGM for several days And a timeline of CGM development that spans two decades

60 NEW IRHYTHM CEO MIKE COYLE HAS BIG PLANS TO MOVE THE COMPANY FORWARD Coyle intends to keep a hold on iRhythm’s top spot in heart rhythm monitoring and draw on his experience at Medtronic.

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IP ISSUES

3 ways to a strategic medtech patent portfolio Protecting innovations leads to medtech success. Top Greenberg Traurig patent attorneys explain how. Image courtesy of Adobe Stock

Roman Fayerberg | G r e e n b e r g Tr a u r i g |

David J. Dykeman | G r e e n b e r g Tr a u r i g |

Medical Design & Outsourcing

strategic patent portfolio is key to a medtech company’s growth and success, but building a robust patent portfolio takes strategy, time and money. While there are no shortcuts to building a strategic patent portfolio, there are several ways medtech companies can get a head start on the competition. 1. Establish processes to identify and protect inventions Early-stage medtech companies should implement in-house processes and procedures to capture and protect innovations in a strategic manner. Many large medtech companies employ experienced in-house patent attorneys whose primary responsibility is building and managing their company’s patent portfolio. Without in-house patent attorneys, these decisions become yet another responsibility of the busy chief technology ofﬁcer or lead engineer. Even when they understand the importance and are familiar with the patent process, patenting can take a backseat to other priorities and responsibilities. As a

3 • 2021

result, patent decisions are reactive to the circumstances, with filings non-strategic and driven by last-minute choices amid failure to capture all inventive concepts. Best practices include a patent process that is proactive with clear strategic goals. To help develop and manage a strategic patent portfolio, a medtech company should have formal processes and procedures designed to efficiently gather information from inventors, identify potential patent filings, respond to patent application office actions and monitor competition. A company should have an easyto-use invention disclosure form to help capture and keep track of the inventive developments. It should have regularly scheduled discussions (monthly or quarterly) with its patent attorney to review and address potential application filings and United States Patent and Trademark Office (USPTO) actions in a strategic manner, rather than chaotically at the last moment. Smart medtech companies should monitor and review the patent landscape for competitors in their technology space.

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IP ISSUES

The knowledge of the relevant patent landscape helps medtech companies focus their product development and patent application filing strategy on the technology spaces with less patent coverage while avoiding the technology spaces with a crowded patent landscape. While establishing patent processes and procedures requires planning and time to set up, medtech companies will benefit from having them in place in the long run. Companies can protect their innovations in a timely and strategic manner, while minimizing the risk of potential patent infringement. 2. Utilize USPTO’s fast-track programs Medtech companies should consider utilizing USPTO fast-track programs, including Track One and the Patent Prosecution Highway. While the USPTO has made progress in reducing the patent application examination backlog, a typical non-provisional utility application still takes an average of about 15.4

months to receive the first action from the USPTO and about 22.9 months from application filing to patent issuance (28.3 months for applications with request for continued examination). To beat the USPTO’s wait time, a medtech company should consider utilizing the USPTO’s Track One program. While the USPTO charges an additional fee for this program, the Track One program reduces the time to the first action to an average of 1.8 months. It can result in an issued patent in about half the time of the regular examination, about 10 months from patent application filing to a patent. To fully take advantage of the program, the Track One application should be focused on the commercial embodiment of the product to get the application to allowance and issuance faster. Prior to the first application issuing as a patent, the applicant can file a continuation application with claims of different scope to form a “picket fence” of patent protection around the technology’s core aspects. Another popular method to accelerate USPTO examination is the Patent Prosecution Highway (PPH). Under the PPH program, the applicant can request an accelerated examination in the USPTO of claims deemed allowable in a corresponding international application, including a PCT application. The applicant may need to narrow the pending claims before the USPTO examination to correspond to the allowable claims outside the United States, but, similar to the Track One program, the applicant will be able to pursue claims with a broader scope of protection in a continuation application. It’s also possible to accelerate a USPTO examination based on the age or health of an inventor. For example, the applicant can request accelerated examination and review if an inventor is at least 65 years old. The USPTO fast-track programs are more expensive than regular examinations, but medtech companies can still utilize these programs for their key patent applications to build a patent portfolio faster.

Medical Design & Outsourcing

3 • 2021

3. License proven technology and patents A medtech company should consider supplementing its patent portfolio by licensing in third-party patents. Another benefit of monitoring the patent landscape in the relevant area is to identify potential licensing opportunities. The licensed patents can supplement the company’s patent portfolio to provide broader protection around the company’s technology and offer additional options for patented commercial products. Potential sources for licensing opportunities are academic institutions and research hospitals. Because the academic institutions and research hospitals are typically at the forefront of innovation, patents licensed from them can provide an earlier priority date than the patent applications developed inhouse. Even if the as-filed claims of the licensed patents do not directly cover the commercial technology, medtech companies can utilize the continuation application strategy to obtain more relevant claims with a priority date that predates the competition. If such an opportunity arises, medtech companies should consider licensing an already-tested, patentprotected technology to quickly establish their presence in the technological space. Conclusion While there are no shortcuts to building a patent portfolio, medtech companies can successfully develop a strategic patent portfolio by working with business-minded patent attorneys to implement formal processes and procedures, utilize fast-track USPTO prosecution programs and identify patent licensing opportunities. This article reflects the opinions of the authors, and not of Greenberg Traurig or Medical Design & Outsourcing. The article is presented for informational purposes only and it is not intended to be construed or used as general legal advice nor as a solicitation of any type.

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Medical Design & Outsourcing 17

PHARMACEUTICALS

What's next for pulmonary fibrosis treatment?

Image courtesy of Adobe Stock

Brian Buntz | Pharma Editor |

D r. J o y c e L e e | Pulmonary Fibrosis Foundation |

Medical Design & Outsourcing

n 2014, the FDA approved two medications for idiopathic pulmonary fibrosis (IPF) — nintedanib from Boehringer Ingelheim and pirfenidone from Roche. “That was a huge success for our community, but certainly, it’s the beginning of what we need to be doing for our patients,” said Dr. Joyce Lee, a senior medical advisor for the Pulmonary Fibrosis Foundation, a nonprofit dedicated to supporting research and medical advances related to the treatment of the condition. Idiopathic pulmonary fibrosis, which is associated with shortness of breath and a significant symptom burden, has no known cause or cure. But there is reason for hope, according to Lee, who is also a professor of medicine specializing in pulmonary sciences and critical care at the University of Colorado. “There is a lot of investigation to find new therapeutics,” she said. In the following interview, Lee shares her perspective on the pulmonary fibrosis research landscape and shares her hopes for treating interstitial lung disease in the future.

3 • 2021

The future of IPF treatment will probably be a combination therapy based on the diversity in what’s being studied, including tailored therapies.

MDO: How would you describe the clinical trial landscape for idiopathic pulmonary ﬁbrosis? Lee: The clinical trials in the space span a lot of different disease mechanisms. Some trials are looking at different types of dysfunction, such as alveolar epithelial cell dysfunction and immune dysregulation. Others are targeting ﬁbroblast proliferation and other kinds of biologic mechanisms. There are also a lot of new modes of delivery being explored. It’s not just oral medications that are being studied. Some interventions are intravenous, while others are subcutaneous. There are also inhaled therapeutics. If we think about the future of IPF treatment, it will probably be a combination therapy based on the diversity in what’s being studied, including tailored therapies. There’s a Precisions study that’s NIH-supported, looking at genetic risk factors and response to therapy. A lot of these studies will change how we care for patients down the line.

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MDO: How have things changed since the FDA approved two drugs for pulmonary fibrosis in 2014? Lee: Until 2014, several clinical trials were largely negative in our space. It was frustrating for sponsors trying to find therapeutics because nothing was sticking. With the FDA approvals in 2014, there were therapies shown to be effective. I hope that inspired a lot of people to reconsider therapeutics in the IPF space. There have been several promising Phase 2 studies that have led to active Phase 3 clinical trials in IPF. Now more than ever, there are many opportunities for patients to participate in clinical trials, and the Pulmonary Fibrosis Foundation plays a significant role in supporting those trials. Not only are our industry partners more engaged in this area, but we’re targeting patients and reaching out to patients more than we were 10 years ago.

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MDO: What has the impact of COVID-19 been for people with pulmonary fibrosis? Lee: We’re still trying to understand the impact of coronavirus infection in patients with pulmonary fibrosis. Certainly, we worry about the impact of the infection on people who have pre-existing disease. We also don’t know whether coronavirus leads to new forms of fibrosis that are progressive over time. MDO: Could you briefly describe how IPF was treated in the past? Lee: In the early 2000s, we really refined the diagnosis of IPF. A 2005 New England Journal of Medicine article suggested that prednisone, azathioprine and N-acetylcysteine should be used to treat patients who have IPF. And that became our standard of care therapy between 2005 and 2010 or so. Then, in 2012, the Panther study results were published in the same journal that compared the combination of prednisone, azathioprine and N-acetylcysteine for IPF to placebo. That study was stopped early because there was evidence of increased harm in terms of hospitalization and death in patients who were randomized to standard of care therapy compared to placebo. That made us aware that our standard of care therapy until that point was harming our patients who had the disease. It led to a paradigm shift in terms of treatment. 20

Medical Design & Outsourcing

3 • 2021

Now more than ever, there are many opportunities for patients to participate in clinical trials, and the Pulmonary Fibrosis Foundation plays a significant role in supporting those trials.

In 2012, after that publication, we stopped using immunosuppression in patients with IPF. And then, in 2014, thankfully, there was the approval of antifibrotic therapy, and we were able to offer patient treatments again. MDO: What is your work like with the Pulmonary Fibrosis Foundation? Lee: PFF has been around ever since I was a trainee. PFF’s role has grown tremendously since 2010 — their development of a care center network and registry put them on the map in terms of increasing awareness and advocacy for this rare patient population. I’ve been very impressed with the progress made through the efforts by the PFF, so it was a wonderful opportunity to join a fantastic team. A lot of people are working very hard to find better therapies. We need patients to participate in clinical trials to find better therapeutics — if not for this generation, then certainly the next. One of the great

things that the PFF has done is to increase education and awareness around clinical trial participation, helping patients locate clinical trials and answer relevant questions for patients. With patient participation and collaboration with these industry sponsors and investigators, I think we will impact this disease more than we are now. It will be exciting. We’re looking forward to patients living longer and better lives with this condition. MDO: What would you like to see in the future for interstitial lung disease patients?

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Lee: It’s my hope that we’ll be able to offer early identification. There’s a lot of risk factors for the development of interstitial lung disease. We have families who have several cases of pulmonary fibrosis affecting relatives. I hope some of the work that is being done will allow us to identify those at risk for developing interstitial lung disease and potentially even secondary prevention. Right now, once a patient has established disease, we rely on tertiary care for the condition. It would be wonderful to prevent the disease progression that we see now.

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REGULATORY

Mexico offers speedier device-equivalency approvals A new medical device regulation in Mexico oﬀers an accelerated approval timeline for certain devices, but time will tell how fast it really is.

Image courtesy of Veraque Consulting

Miguel Angel To r r e s Te l l o | Ve r a q u e C o n s u l t i n g |

Medical Design & Outsourcing

exico is known as a relatively complex market for medical devices in regulatory terms. Still considered the second largest market in Latin America, Mexico offers three different routes to request a sanitary authorization. In this article, we would like to describe the equivalency route, the fastest regulatory pathway at the moment. The standard timeframe to receive commercial approval for a medical device is around one year upon submission to COFEPRIS (Mexico’s medical device regulatory body, the Federal Committee for Protection from Sanitary Risks). No matter the classiﬁcation of the device (except in some limited cases), one year is what the industry has had to wait to have access to the country. But the demand for COVID-19-related supplies and a public healthcare sector pushing to improve prices have bolstered the need for unprecedented measures. On November 18, 2020, the Ministry of Health in Mexico established new, expedited timelines for medical devices and pharmaceutical supplies. 3 • 2021

In this case, the authority is requiring five working days to respond to any new registration request under the so-called equivalency agreement. If it is not resolved in that period of time, the submission must be considered granted. Timelines The equivalency agreement route is not new. This regulatory alternative was published in 2010, providing faster access to the market for those medical devices approved by the FDA and Health Canada. Two years later, Mexican regulators extended the equivalency agreement to those devices approved by the Ministry of Health, Labour and Welfare (MHLW) in Japan. When the first equivalency agreement was announced in 2010, submissions were approved within two to three months. The rate increased over the years to end up at six to eight months, probably due to high demand and the bigger workload for COFEPRIS reviewers. Although the latest equivalency agreement provides a five-day legal timeframe to resolve a request, the real timelines may increase over time. Key points to consider In addition to better timelines, there are other perks to requesting a sanitary registration through the equivalency agreement pathway — specifically, less technical and legal documentation compared with other regulatory routes, and reduced translation costs.

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However, the equivalency agreement route is not an immediate recognition of the approvals in the above-mentioned countries (U.S., Canada and Japan). Therefore, it is very important to carefully evaluate if the products are eligible for this route. These are some of the key points to consider: •

•

The equivalency route is not applicable for Class I medical devices approved by Health Canada or the MHLW in Japan. Even though Class I, II and III FDAapproved medical devices are eligible for the equivalency route, the Establishment Inspection Report (EIR) is a requirement. In our experience, this is not a document easily released to any type of medical device manufacturer. Nevertheless, COFEPRIS has expressed that ISO 13485 or MDSAP (Medical Device Single Audit Program) certiﬁcation is acceptable in case the EIR is not presented.

Finally, a common question from our clients is if this route is strictly intended for companies located in the U.S., Canada or Japan. The answer is no. No matter where your company is located, you are eligible for the equivalency agreement if you have approval in the U.S., Canada or Japan. A minor caveat is that you may experience some hurdles legalizing certain documents. For instance, FDA documents must be apostilled and notarized in the U.S. Therefore, we strongly recommend that you receive feedback from experienced regulatory specialists to tackle these and other possible requirements. Conclusions Even though the latest Ministry of Health announcement improves the timelines in COFEPRIS, you should be cautious in your projections. We are not sure how COFEPRIS is going to deal with the immediate demand.

The demand for COVID-19-related supplies and a public healthcare sector pushing to improve prices have bolstered the need for unprecedented measures.

Images courtesy of Medical Microinstruments

ROBOTICS

Supermicrosurgery could lengthen the reach of robotics Robotic microsurgery can not only improve care for existing procedures, but open new frontiers.

I M a r k To l a n d | Medical Microinstruments |

Medical Design & Outsourcing

n consumer technology, everything is getting smaller. TVs are now as thin as a notebook and early cellphones the size of a small brick have made way for slim devices that easily slide into our pockets. By making technology smaller, it becomes more agile and easier to use. The same is true for medical technology. However, the race to make technology smaller in medicine has life-saving potential, especially in medical robotics, a rapidly expanding field expected to reach $27 billion in value by 2027. I attribute much of that growth to the untapped potential in medical procedures in which robotics can improve outcomes, reduce readmissions and limit complications. Not only can robotic devices

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make existing procedures safer and more reproducible, but the evolution of smaller instruments and more sophisticated software and data integration enable procedures that have never been attempted and create entirely new fields of medicine. Evolving from micro- to supermicrosurgery Microsurgery is the manipulation and suturing of very small anatomy such as vessels, ducts or nerves, performed under high visual magnification. Until recently, the capabilities of human hands limited the size of the anatomy that could be addressed, and therefore, which procedures physicians could successfully perform.

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ROBOTICS

By making surgical instrumentation smaller, adding wrist-like mobility to the distal end and manipulating it with a robot, we can reduce physiological tremors and scale the surgeon’s hand movements to enable procedures that seemed unimaginable a few years ago. Interest in robotic microsurgery is growing because recent technological developments have brought new treatment options to conditions that affect broad patient populations across various disease states. For example, breast cancer survivors who suffer from lymphedema have no cure, only lifelong treatments with poor results. Thanks to the advent of supermicrosurgery, which enables surgeons to reconnect the lymphatic channels, patients can avoid permanent damage and the need for ongoing interventions. By advancing microsurgery with robotic assistance, more surgeons will be able to perform these complex and delicate procedures that afflict nearly 250 million people worldwide, including 1 million people in the U.S. In plastic surgery, robotic technology allows surgeons to treat trauma with a competency never seen before. They can reattach severed digits and rebuild limbs for victims of car crashes. Also, neurosurgeons have an opportunity to mitigate the risks associated with brain surgery through robotics by minimizing the size of the incision they need to make.

Interest in robotic microsurgery is growing because recent technological developments have brought new treatment options to conditions that affect broad patient populations across various disease states. Over the next few years, the robotics field will explore how small we can go and how far we can push the limits of surgical capability within microsurgery and supermicrosurgery, connecting vessels less than 0.8 mm in diameter. Even minor advancements will open the door for expanding areas of medicine such as pediatric surgery, particularly with newborns and infants, where precision is crucial. These emerging practices will allow us to repair the tiny vessels and nerves and address procedures that are well beyond the scope of manual surgery.

Medical Design & Outsourcing

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The golden age of robotics Since the outbreak of the COVID-19 pandemic, the public has scrutinized care delivery in an unprecedented way. The crisis has exposed many inefficiencies in healthcare, but especially the need to use technology more effectively. Providers are completing more robot-assisted procedures every year, and the pandemic has created an even greater appreciation for the technology’s ability to reduce morbidity and truncate the length of hospital stays. More than ever, patients want to spend as little time as possible in the hospital, and improved outcomes from robotic surgery may offer a solution. The pandemic also begs the question of how robotic platforms can limit the spread of communicable diseases. Robotic procedures inherently create physical distance between the physician and patient in a traditional model, but online robotic systems can execute remote procedures, in which the operating physician is in a different room or even in a different country. Additionally, many microsurgical procedures treat emergent conditions, and remote capability can empower surgeons to start treatment from home before they even arrive at the hospital. The number of companies in the robotic space also shows the industrywide belief in the technology. From the world’s largest healthcare companies, like Siemens Healthineers and Johnson & Johnson, to startups that have yet to enter the arena, the field has never been more crowded. Consumer technology will always move faster than the highly regulated medical device field, but this decade promises the introduction of more devices that are as sleek as a flatscreen TV. Particularly in microsurgical robotics, the confluence of the pandemic and emerging technologies will contribute to a better, safer healthcare system for patients worldwide.

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Medical Design & Outsourcing 27

STERILIZATION SERVICES

How EtO plants can avoid lawsuits, cope with stricter regulation If EtO industry actors take certain targeted steps now, they can minimize legal exposure, more eﬃciently manage litigation and be better situated for compliance once new federal regulations are established.

T Karen Cullinane | Goldberg Segalla |

he use of ethylene oxide (EtO) to sterilize medical devices came under renewed scrutiny after the Environmental Protection Agency concluded in 2016 that EtO gas was even more carcinogenic than previously thought. During the last few years, in particular, an explosion of lawsuits ﬁled against sterilization companies have alleged that regular exposure to the plants’ EtO emissions caused cancer in individuals who live or work in the vicinity. Sterilization plants have also faced state actions while the medtech industry has braced for more aggressive federal oversight and stringent regulation of EtO use and emissions. The COVID-19 pandemic gave rise to an urgent need for the rapid sterilization of medical equipment required to battle

the virus, delaying the expected increase in EPA regulatory oversight of EtO. With a new administration seeking to prioritize an environmental justice agenda, however, the prospect of renewed regulatory focus on EtO emissions is more likely than ever, even if the timeline remains uncertain. Accordingly, medtech companies and the facilities that produce and use EtO should undertake data-driven assessments to minimize risk, and work to create new regulations and adapt their operations to comply with more rigorous oversight. If EtO industry actors take certain targeted steps now, they can minimize legal exposure, more efﬁciently manage litigation and be better situated for compliance once new federal EtO regulations are established.

Image courtesy of Adobe Stock

Medical Design & Outsourcing

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MEDICAL

Know your neighbors Given the thousands of individual personal injury lawsuits and class actions already pending against EtO sterilization companies throughout the U.S., any given plant’s first priority is to preempt or diminish the costs of litigation. First, EtO plant officials should learn what the neighboring community is like and what it needs. Doing so makes it easier to eliminate immediately identifiable risks. For example, consider discussing options for early resolution with a community member with a particularly debilitating cancer diagnosis who otherwise would be an outspoken, visible opponent of continued plant operations and especially likely to attract media attention — and, therefore, a flurry of lawsuits. Here are some other questions to consider: • What are the demographics and history of the surrounding community? • Are there existing studies of latency illnesses and cancers in the area? • How do the community’s health statistics and cancer rates compare with those in areas that do not have an EtO facility in their midst? • Would it help to conduct an epidemiological survey of the surrounding community and cancer incidences in anticipation of litigation? • Is the plant’s owner or parent company a good corporate citizen that contributes to the community’s general well-being and profitability and communicates effectively and accessibly? • Can you offer creative and compensatory measures to affected residents to head off lawsuits that could snowball into litigation that is more visible? Knowing the answers to these questions may prevent a lawsuit or diminish its value later.

recommend practices and equipment that can lead to improved data, and evaluate systemic weaknesses that result in fugitive emissions that must be immediately mitigated. Also consider consulting with an expert on how existing equipment can be adapted or modified to increase efficiency and promote safety to meet the standards of tougher regulations and requirements. Be proactive Beyond taking stock of its own actions and their effect on surrounding communities, the EtO industry can better prepare for stronger federal and congressional oversight by being involved in the regulatory process. For instance, throughout 2020, there were a number of questionand-answer presentations, committee hearings and public comment sessions about new EtO regulations. These are not only opportunities to participate in developing new regulations and compliance measures, but can help industry efforts to educate both regulators and the American public about the life-saving value of medical devices, particularly in the shadow of COVID-19, and the difficulty in finding an alternative sterilizing agent as effective as EtO. It is critical for industry players to communicate what is practically feasible so the federal government can consider this before enacting new EtO regulations. These actions can also help EtO entities to develop a better idea of which new or modified regulations are most likely and to prepare best business practices and compliance and safety plans. EtO stakeholders would benefit from diligently keeping track of and participating in every agency or congressional event to have a more meaningful role in shaping a regulatory landscape that is safe, reasonable and fairly accounts for the risks and costly investments of industry actors.

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TUBING TALKS

Ambu’s aScope Duodeno disposable duodenoscope is one of two FDA-cleared disposable duodenoscopes. Image courtesy of Ambu

4 innovations to make duodenoscopes more single-use — and save lives Duodenoscopes are complex devices used to detect problems in the upper gastrointestinal tract. Diﬃculties in cleaning them for reuse have led to serious illnesses, but several medical device companies have stepped in to solve the problem. Danielle Kirsh | Senior Editor |

Medical Design & Outsourcing

uodenoscopes are ﬂexible, lighted tubes threaded through the mouth, esophagus and stomach into the top of the small intestine. They’re an important tool for spotting lesions and tumors in the bile and pancreatic ducts, but the complex devices have many small working parts. “Duodenoscopes — regardless of whether they are reusable or singleuse — are one of the most technically complex ﬂexible endoscopes to design and manufacture, as they travel deep into the body with a camera mounted on the side instead of the front,” David

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Pierce, EVP and president of MedSurg and president of endoscopy at Boston Scientific, told the MDO sister site Medical Tubing + Extrusion. “The device must be flexible enough to safely navigate tortuous anatomy, yet stiff enough to effectively deliver therapy to a patient’s biliary anatomy.” Reprocessing them is tough — a bad situation because reprocessing failure can result in one person’s tissue or fluid remaining on the scope and going into someone else. By 2015, there were numerous reports of deadly “superbug” infections associated with the devices. The FDA reported in 2019 that

the reprocessing problem was a lot worse than previously thought, with contamination rates around 5.4% for high-concern bugs such as E. coli and Pseudomonas aeruginosa. The FDA recommended in July 2020 that hospitals and endoscopy facilities consider using duodenoscopes with disposable components to lower the risks of infection. The agency also said it believes that the best solution for reducing the risk of disease transmission from duodenoscopes was through innovative device designs that make reprocessing easier, more effective or unnecessary. The FDA has now cleared several duodenoscope innovations, ranging from disposable duodenoscopes to disposable components that make reprocessing easier. Creating single-use scopes or scope components poses challenges, however. “In any single-use scope, the main challenge is to design an endoscope which is on par with the quality of a reusable while keeping the production costs low enough to make sense in hospital economy. A single-use scope must cost a fraction of a reusable scope and this is an innovation and manufacturing challenge,” said Rasmus Kümmel Holtze, Ambu’s director of global product management in gastroenterology. Here are four single-use duodenoscope innovations that Ambu, Boston Sci and other companies have come up with to reduce the risk of “superbugs.” 1. Ambu: aScope Duodeno disposable endoscope Ambu received FDA clearance for its aScope Duodeno single-use duodenoscope in July last year. Ballerup, Denmark-based Ambu says it designed the aScope Duodeno to streamline workflow with no reprocessing or repair. With no spare parts, the duodenoscope is ready to use by opening its packaging and connecting the duodenoscope to Ambu’s eBox Duodeno unit, which connects directly to medical-grade monitors to process the camera’s video image. “A key benefit of single-use versus reusable is the ability to do fast innovation — in months and not years. And the new technology gets in the hands of the doctor quickly because the next shipment can be of the latest product and there is no upfront capital investment,” Holtze told MT+E. “Ambu’s vision is to enhance patient safety, eliminate device-related cross-contamination, 3 • 2021

Medical Design & Outsourcing 31

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TUBING TALKS

and simplify the procedure set-up. Since aScope Duodeno is single-use, there is no degradation of mechanical performance over time. It is always a new scope, sterile straight from the pack and available.” The single-use duodenoscope offers high-definition imaging from a camera that connects to the accompanying aBox unit to give physicians a clear image of mucosa and anatomical structures in the upper GI tract. It also features dual LEDs in the distal tip with a 130º field of view; a rounded tip design; four-way bending angulation allowing distal end bends up 120º, down 90º, right 110º and left 90º; three programmable remote switches and a 4.2 mm working channel. “For the users, a single-use duodenoscope will feel different, more lightweight than a reusable, and doctors have to get used to a different sensation,” Holtze said. “However, those differences are minimal versus the ability to protect patients from cross-contamination, improve hospital efficiencies and add

convenience with full cost-transparency, no upfront capital investment, no repair cost and no time-consuming reprocessing that impact workflow.” 2. Boston Scientific: Exalt Model D disposable endoscope The FDA in December 2019 cleared the first fully disposable duodenoscope — the Exalt Model D made by Boston Scientific. “From a regulatory and payer perspective, we have seen a steady drumbeat of positive momentum since FDA clearance. Exalt Model D received CE Mark in Europe in January 2020. In the U.S., in June 2020, CMS also approved our application for a transitional pass-through (TPT) payment — a new payment category — for single-use endoscopes, including Exalt Model D, in outpatient settings,” Pierce told MT+E. “Securing this TPT was an important milestone as it increased healthcare providers’ access to the device for Medicare beneficiaries, particularly during a time of heightened awareness of the need to

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A key benefit of single-use versus reusable is the ability to do fast innovation — in months and not years. And the new technology gets in the hands of the doctor quickly because the next shipment can be of the latest product and there is no upfront capital investment.

Boston Scientiﬁc’s Exalt is one of the only fully disposable duodenoscopes cleared by the FDA.

eliminate infection risk,” Pierce said. Boston Sci designed the Exalt Model D single-use duodenoscope for use in endoscopic retrograde cholangiopancreatography (ERCP) procedures. At the time of FDA clearance, it was the ﬁrst single-use duodenoscope on the market and was granted breakthrough device designation. The Marlborough, Mass.–based company’s duodenoscope has four-way bending capabilities at the distal tip with a range of motion similar to reusable duodenoscopes. Its elevator is designed to deliver consistent performance while enabling guidewire locking at the distal tip of the duodenoscope. It can be used with the Exalt controller and is compatible with Boston Scientiﬁc’s single-use endoscope accessories. “We have and are continuing to invest voluntarily in clinical research by coordinating prospective clinical trials to drive further published evidence related to clinical use and performance of Exalt

Image courtesy of Boston Scientiﬁc

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TUBING TALKS

Olympus’s disposable distal endcap for duodenoscopes. Image courtesy of Olympus

Model D,” Pierce said. “We also continue to innovate based on feedback from our customers to ensure that our scopes remain state-of-the-art.” “From an environmental standpoint, we’ve partnered with industry leaders in medical recycling and waste management to offer sustainability solutions, including full device recycling or waste-to-energy. This may reduce waste deposited to landﬁlls, lower greenhouse gas emissions and destroy potential contaminants through incineration,” Pierce said. “We’re also in the pilot phase of a ‘recycle by mail’ program for the device, with approximately 20% of customers currently using the service. We’re assessing logistics, customer feedback, pricing and other factors for a full launch.” 3. Olympus: TJF-Q190V disposable distal endcap Olympus announced in February 2020 that it won FDA clearance for its TJFQ190V duodenoscope with a sterile, disposable distal endcap. The TJF-Q190V duodenoscope features a sterile, clear, single-use distal endcap cover. It also offers improved visualization of and access to the distal end for manual cleaning and disinfection. The distal-end ﬂushing adaptor enables cleaning of the elevator mechanism, and the sealed elevator wire channel port doesn’t require separate cleaning. “Adoption has been steady despite COVID-19 conditions. The endoscope’s performance has been well-received as well as the response from infection prevention departments regarding our enhancements to the reprocessing procedure,” Philip Doyle, executive director of marketing for 34

Medical Design & Outsourcing

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Olympus’s Core GI, told MT+E. Tokyo-based Olympus said the duodenoscope is designed to improve cleaning and reprocessing of the device to reduce contamination and eliminate deadly superbugs. “Single-use duodenoscopes incur a very high cost; this is particularly worrisome in the ﬁnanciallystretched hospital environment of the COVID-19 pandemic. Without much clinical evidence to demonstrate reliable performance of disposable duodenoscopes in non-expert hands, it will be difﬁcult to justify the costs that are inherent to single-use design, particularly in light of the low reported incidence of patient infections related to ERCPs with traditional duodenoscopes,” Doyle said. “We believe that by combining these new disposable and cleaning components with the trusted handling and proven outcomes of an Olympus TJF-Q190V duodenoscope, we can deliver an instrument that emphasizes all aspects of patient health relating to ERCP. And our planned innovations will focus on maintaining that balance while building on clinical performance, costeffectiveness and infection prevention.” Pentax’s DEC HD disposable elevator duodenoscope. Image courtesy of Pentax

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4. Pentax: DEC HD disposable elevator duodenoscope Pentax subsidiary Hoya won FDA clearance for its DEC HD sterile, disposable elevator duodenoscope in November 2019. The duodenoscope’s creators designed it with fewer parts that require cleaning and disinfection between uses. It has a lightweight, ergonomic control body and allows physicians to simply and safely dispose of the elevator with a sterile-disposable distal cap. Tokyo-based Hoya’s DEC HD device is designed to help diagnose, visualize mucosa in detail, identify abnormal tissue and locate papilla for cannulation. “Disposable endoscopes are still some way away from replacing conventional endoscopes. However, we predict that the presence of disposable endoscopes will rise in the mediumto long term. With patient safety and hygiene positioned at the forefront of our product design and development programs, we will continue to pursue how we can provide a breakthrough solution in infection prevention,” Kaori Kawashima, Pentax Medical’s GM of corporate communications and product branding, told MT+E.

WOMEN IN MEDTECH

How temporary neurostimulation can treat chronic pain long-term Stroke survivors often experience pain following a stroke, but temporary neurostimulation devices could alleviate the pain without opioids and permanent long-term devices.

Danielle Kirsh | Senior Editor |

SPR Therapeutics’s Sprint peripheral nerve stimulation system Image courtesy of SPR Therapeutics

A notion takes hold “We thought, ‘Wouldn’t it be a cool idea to activate these muscles of the shoulder and try to restore some movement in the shoulder for those patients and reduce the subluxation that occurs from those muscles being inactive? Wouldn’t that be kind of neat if we can set that shoulder back into place, so to speak, in those patients?’” Bennett said.

Maria Bennett | SPR Therapeutics | 36

Medical Design & Outsourcing

aria Bennett, co-founder and CEO of Cleveland-based SPR Therapeutics, has been studying pain relief using electrical stimulation for 25 years with the goal of treating the pain in the back and extremities using a non-surgical medical device. “The idea around the product actually started back in my graduate studies,” Bennett told Medical Design & Outsourcing. “I was working with a team of scientists and physicians that identified shoulder pain as a significant unmet need in patients following stroke. We had used electrical stimulation to stimulate nerves, which is the core piece of the technology to activate shoulder muscles and other muscles in the body — especially those that were inactive or unused for long periods of time such as those affected by a stroke or spinal cord injury.” Stroke survivors’ shoulder pain can result in a limited range of motion and subluxation, according to the American Heart Association. Shoulder pain is often treated with medication and range-of-motion exercises to maintain the shoulder joint’s correct anatomic position as much as possible. Nerve block injections with anesthetic and Botox have also been used for pain management following a stroke, according to the heart association.

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Bennett and her research team found that electrical stimulation could provide that benefit, reducing pain and improving patients’ quality of life. The initial neurostimulator her team produced could be used for a short period of time, up to 60 days, and it wasn’t implantable like other available neurostimulators. Bennett set out to develop that technology even further, joining a small, venture-backed, Cleveland-based startup that was based on helping patients who had suffered spinal cord injuries. Though the research was costly, she moved on to expand the clinical work behind the technology. She ultimately went to work at Boston Scientific but continued thinking about the product she wanted to create. After her stint at Boston Scientific, Bennett moved back to Cleveland to join former colleagues who founded the electrical stimulation company NDI Medical. NDI Medical sold its urinary incontinence-treatment product to Medtronic in 2008 for $42 million. Her

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colleague approached her after the sale and proposed the idea of getting back into pain management to build upon the work Bennett did in graduate school. “So, in 2009, I spent time validating the market and making sure there was an unmet need for a short-term neurostimulation device that could be used to treat different kinds of pain, specifically in the peripheries, but also low-back pain. I also did clinical validation and worked with some of my previous clinical colleagues,” Bennett said. “We had to think about this device going widespread commercially down the road.” Bennett officially founded SPR Therapeutics in 2010. “For the first several years, we focused on research and development of the technology and advancing it toward FDA clearance. We received FDA clearance in 2016 and then transitioned the organization into a commercial organization. Now we’re selling our device across nearly 20 U.S. territories and are continuing to execute on our commercial expansion strategy,” she said.

We thought, 'Wouldn't it be a cool idea to activate these muscles of the shoulder and try to restore some movement in the shoulder for those patients and reduce the subluxation that occurs from those muscles being inactive?

How the technology works The core device and product is called the Sprint peripheral nerve stimulation system. It’s a neurostimulator that activates a nerve that has been injured, either through trauma or disease, and now causes pain. “The nerves that feed the brain signals are hyperactive,” Bennett said. “They have all these pain signals that are communicating to the brain that you’re in pain. What electrical stimulation does is that it calms down that overactivity. It starts to reset it to a healthy state in which it starts to send positive signals to the brain that you’re no longer in pain or that pain has been reduced.” The technology is designed to treat everything from joint pain, such as in the

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shoulder or knees, to post-amputation pain. It uses a very fine lead the size of a hair-like wire strand that is placed through the skin near the target nerve that has been injured or suffered trauma. A physician, usually an interventional pain specialist, places the lead using a needle guided by ultrasound and turns on the device to deliver electrical stimulation. The physician can also see the activation of muscle and adjust the stimulation for the patient’s comfort. The rest of the wire exits the skin and is connected to an external stimulator, according to Bennett. Patients can also control the level of stimulation using a device that’s similar to a key fob. When placing the lead in an outpatient procedure, a clinician can program the neurostimulator device through the fob or through a separate program on a tablet. Commerically, SPR Therapeutics is approaching 4,000 patients who have used the device across the U.S., according to Bennett. Company sales reps are working with hospitals and surgery centers in about 20 U.S. territories. The company is focusing on chronic back, shoulder, knee and nerve-related pain. Keeping an elective procedure essential during COVID-19 Early in the COVID-19 pandemic, the Centers for Medicare and Medicaid Services released guidance recommending that healthcare providers postpone adult elective surgeries and procedures to preserve personal protective equipment such as masks and gowns while protecting patients and staff from exposure to the coronavirus. “I think, like [for] many other business owners, it was a very uncertain time,” Bennett said. “I was very fortunate to have our very supportive board of directors and our team that rallied very quickly to say, ‘How are we going to respond and how do we retool ourselves in a virtual environment while also keeping the strength of the organization afloat with our resources to ensure that we can continue to execute on our commercial strategy?’” In keeping with the pandemic’s telehealth and telework landscape, SPR Therapeutics provided educational webinars to customers and additional training for the company’s sales representatives in order to keep the brand top-of-mind with physicians and the internal team sharp during the slow down period. “The webinars were successful,” Bennett said. “It drove the opportunity for new customers coming out of the slowdown period. We were able to come out of May with our largest month of sales in the history of the company. We’ve grown month-overmonth steadily since then and are closing the gap of what we thought we could achieve for revenue for 2020. There will be a very small difference between where we thought we’d be.” The federal Paycheck Protection Program also enabled SPR Therapeutics to avoid layoffs or furloughs. “Being a medtech company is never a straight path. There are lots of twists and turns that we have to be prepared for,” Bennett said. “Now we’re almost 11 years old and have had a lot of twists and turns, but we’ve been able to adapt by having open and transparent communication amongst the team and plan for contingencies. I am very proud of what our team has accomplished and look forward to the many opportunities we have to continue to provide an opportunity for pain relief for the millions of pain sufferers.”

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Medical Design & Outsourcing 39

The Original Push-Pull Connector

CHRI S N EWMARKE R EXECUT I VE DI RECTO R

hat do drug-eluting stents and smart implantable medical devices have in common? It turns out it's a lot, at least according to Dr. Bill Hunter. The founder and CEO of Angiotech Pharmaceuticals from 1992 to 2011, Hunter saw that medical device companies had cardiovascular stents that could save lives but also caused inflammation problems, while pharmaceutical companies had drugs that could stop the inflammation. He helped bring the technologies together, playing a role in the invention and development of the Taxus drug-eluting coronary stent from Boston Scientific and the Zilver PTX peripheral drug-eluting stent from Cook Medical. Hunter started Canary Medical (Vancouver, British Columbia) in 2012 because he thought 42

Medical Design & Outsourcing

3 • 2021

that micro-electromechanical systems (MEMS), sensors, batteries and wireless communications had advanced enough — especially when it came to pacemakers — that one could package sensors with implantable medical devices. The company's name came from the idea that the resulting data stream could do for healthcare what canaries did for coal miners: Provide an early warning. "I used to say, 'We live in a world where your refrigerator's connected to the internet. Why are lifesaving medical devices not?’ There's some pretty valuable information we'd like to know," Hunter said in a recent interview with Medical Design & Outsourcing and MassDevice. "We were all from a cardiology background," Hunter said of the Canary team in the early days.

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SMART KNEE IMPLANTS

"We thought, 'Hey, we could do this almost by making a pacemaker.' We take a battery, we take telemetry, substitute sensors for the leads." The execution of the idea was still hard, according to Hunter. "You got to have consumer electronics to get it there. You got to do cloud storage and data analytics and user interfaces on the other end. None of the components is rocket science, but putting them all together is actually a bit bigger task than meets the eye. And so it's pretty exciting." The result was the Canary Health Implantable Reporting Processor (CHIRP). It's the size of triple-A battery and modular enough that Zimmer Biomet ofﬁcials in recent years saw the potential of embedding the sensor inside the tibial extension segment of a commercial knee prosthesis. The birth of smart knee implants Zimmer Biomet this year plans to launch the Persona-IQ, a next-gen version of its successful, personalized Persona Revision knee implants that will incorporate the CHIRP sensor. The Persona-IQ received breakthrough device designation from the FDA in October 2019. Zimmer Biomet and Canary Health are in the ﬁnal stages of a de novo 510(k) clearance process with the agency — as well as reimbursement decisions from CMS that could enable doctors to receive extra payments for monitoring CHIRP data. During a March earnings call, Zimmer Biomet CEO Bryan Hanson described Persona-IQ as an important piece of the puzzle to create a digital ecosystem around ZB's implants.

"We've had a signiﬁcant shift in our research and development dollars toward robotic storage, data informatics to build that ecosystem that's going to be meaningful for patients and for our customers alike. And I got to say, there's a lot of excitement around that in our organization, a lot of excitement from our customer base as well," Hanson said. Competitors are already working to catch up. Stryker, for example, announced in January that it had bought privately held OrthoSensor and its Verasense intraoperative sensor tech that could further enhance the ortho giant's Mako robots. "Smart devices and implants will play an important role in the future of orthopedics, and the addition of OrthoSensor will allow us to continue to innovate and advance smart sensor technologies, including intraoperative sensors, wearables and ultimately, smart implants," Stryker investor relations VP Preston Wells said during a January earnings call. Zimmer Biomet appears to be at the forefront of smart implants, and the PersonaIQ should start driving revenue growth in late 2021 and early 2022, SVB Leerink managing director Rich Newitter said during a DeviceTalks Weekly podcast in February.

CAN CORZA BUST UP MEDTECH’S SURGICAL SUPPLY MONOPOLIES? WHY ZIMMER’S SPIN OUT IS ONLY THE BEGINNING Rich Newitter, managing director of SVB Leerink, explains how Zimmer Biomet is grabbing share in the orthopedic space and building an enviable portfolio of digital sensors and systems. www.devicetalks.com/category/podcasts/

Medical Design & Outsourcing

3 • 2021

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Information from the CHIRP goes to a home base station that’s the size of a modem and uploads the data to cloud infrastructure powered by Microsoft Azure. Image courtesy of Canary Medical

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SMART KNEE IMPLANTS

The Canary Health Implantable Reporting Processor (CHIRP) can go inside the tibial extension segment of a commercial knee prosthesis, shown here. Image courtesy of Canary Medical

Information from sensors such as the CHIRP could decrease the number of times a patient needs to come back to a doctor's ofﬁce — and could even one day identify problems with an implant before they happen, according to Newitter. "I think that it is a pretty exciting time for what I think will be an important ﬁrstgeneration of sensor-based technology in orthopedics," Newitter said. Smart implants appear to answer the ortho device makers' question of how to further innovate and make procedures better, said Truist Securities managing director Kaila Krum. "Ultimately, I do think that that smart implants will play a role." Creating a 'knee-CG' The CHIRP sensor in its tiny package includes gyroscopes, accelerometers and a pedometer, enabling

it to measure and passively broadcast data on step count, range of motion and gait. A Home Base Station that's the size of a modem plugs into a home outlet and uploads the data to cloud infrastructure powered by Microsoft Azure. Health providers can use the data to track how well the knee implant performs and spot potential infections or failures. The battery technology is sufﬁciently long-lasting that a CHIRP implant could broadcast for up to 20 years. Its data could make it easier for doctors to do more knee patient checkups remotely — something they've been struggling to do amid the COVID-19 pandemic. "We can monitor a patient, see if they're active, do their range of motion, see how they're progressing," Hunter said. "That's a good product." Hunter thinks CHIRP could accomplish even more in the future, though, as artiﬁcial intelligence helps spot patterns that could provide early warnings of problems. One

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If we can identify problems early, then it really becomes a 'why not' therapy at that point in time. of the Canary team members even coined the term "knee-CG," a comparison to how an ECG measures the heart's electrical activity but tells so much more based on its data patterns. Imagine, for example, a stoplight chart in which most postoperative patients have green lights because the CHIRP data suggests that they are doing fine with their knee implants and probably only need reassurance. Meanwhile, a fifth have yellow and red lights, signifying they need to get back into the office for further work. "If we can identify problems early, then it really becomes a 'why not' therapy at that point in time," Hunter said. Beyond knees For now, Canary Medical remains focused on Zimmer Biomet's Persona-IQ launch. But Hunter sees the potential in coming years to package CHIRP sensors inside hip and shoulder implants. "It really is a modification of existing technology," he said. Looking farther into the future, Hunter envisions smart ortho screws that could run currents through bones to measure healing — and even tiny ring-shaped sensors in the cardiovascular space. "The sensor technology is so good that we have a sensor power source and transmitter that we can fit onto a 1-by1.5-mm chip,” he said. “So we're going to start to be able to get into smaller and smaller and more intricate devices as we go forward."

3 • 2021

Medical Design & Outsourcing

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2021 The annual electronics show went VIRTUAL this year, with some of the medtech geared DA N IE LLE K IR SH S E N IO R ED ITO R

toward managing COVID-19.

here were fewer mobile health devices and wearables to check out as this year’s CES went virtual — with a trend toward medtech to slow the spread of COVID-19. The annual electronics show featured 419 digital health and 219 wearable devices, down from 546 and 635 devices, respectively, presented a year before. CES 2021 included portable air purifiers, handsfree body temperature thermometers, EEG brain-mapping devices and more. Here are a few companies that exhibited digital health and wearable products at this year’s show.

Atlantic Therapeutics: Stress urinary incontinence treatment device Atlantic Therapeutics showcased its directto-consumer and FDA-approved device that delivers non-invasive pelvic floor stimulation through wearable technology. The neuromuscular electrical stimulation tech is embedded in a pair of shorts designed to strengthen and re-educate pelvic floor muscles, according to the company. "We are extremely proud to have brought this ﬁrst-in-world technology to market to alleviate this all-too-common condition, and we ﬁrmly believe that Innovo represents a paradigm shift in the $13 billion urinary incontinence market when compared to the current sub-optimal choices," CEO Susan Trent said.

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3 • 2021

Medical Design & Outsourcing

CES 2021

"As we accelerate momentum for Innovo in the U.S., participation in CES 2021 will ... raise awareness of this unique, groundbreaking technology for treating bladder weakness." Atlantic Therapeutics said results from a clinical study demonstrated that 80% of Innovo users experienced significant improvements after four weeks and 87% were considered “dry” or “near dry” after three months. Four-fifths of users also found Innovo significantly improved their quality of life.

Atlantic Therapeutics’s stress incontinence treatment device.

Image courtesy of Atlantic Therapeutics

Axion Research: Early cancer detection technology Axion Research touted its AXiR Engine early detection system that’s designed to predict cancer and detect early risks for Alzheimer's disease. The technology predicts a user's health through an analysis of all their disease risks and test results plus big data. It is capable of early cancer detection and its AI-powered engine can determine a user's risk for Alzheimer's and other diseases, according to Axion, which said it can also assess the risk of developing severe cases of COVID-19. AXiR boasts an easy-to-understand visual presentation of a user's disease risk and timeline of future health; risk analyses for chronic and other types of diseases based on several years of medical data and answers to screening questions; analyses of changes of test data and overlapping patterns of health transition maps to identify someone's immediate health risks; and individualized health programs based on risk factors.

Binah.ai’s artiﬁcial intelligence, vital signs monitoring smartphone app. Image courtesy of Binai.ai

Medical Design & Outsourcing

3 • 2021

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Binah.ai: Video-based monitoring tools Binah.ai showcased its artificial intelligencepowered video-based monitoring tools for health and wellness monitoring. Binah.ai measures vital signs like heart rate, oxygen saturation, respiration rate and heart rate variability as well as mental stress using a smartphone camera. The technology supports vital sign monitoring of anyone over the age of 18 of any gender and skin color. “Founded in 2016, Binah.ai established its mission to allow access to basic healthcare services to anyone, anywhere ... be in control of their own health and wellbeing. The Binah.ai vision is a world where access to telemedicine levels the playing field, facilitating remote healthcare in new locations, and giving healthcare professionals a smart tool to make data-driven decisions in any situation, while easing the burden of healthcare costs,” CEO and cofounder David Maman told MDO. “The COVID-19 pandemic has tremendously accelerated the need for innovative technologies in healthcare and RPM (remote patient monitoring) specifically, and they are here to stay even after the pandemic is over.” The technology applies a mix of signal processing and artificial intelligence to extract vital signs by analyzing signals from the upper cheek region of the face in under one minute with medical-grade accuracy, according to the company. The platform also includes tools for easy user management and enhanced reporting and analysis. “We are now not only focused on the upper cheeks, as Binah.ai has introduced a dynamic region of interest selection that automatically detects which part of the face extracts the highest signal quality for each specific scan, making it relevant for people wearing a mask or a beard. Vital signs can be measured by either the upper or lower cheeks, or the forehead, still without using any of the person’s identifiable features or demographic data such as age, height or weight,” Maman said. The technology also uses remote photoplethysmography (rPPG) and applies a mix of signal processing and AI technologies like computer vision to first detect the best skin region to take a signal from and then deep learning to analyze the changes in the reflection of light that returns to the camera, according to Maman.

CES 2021

GateDoc: Wireless Bluetooth body temperature scanner GateDoc’s technology is designed for use by the general public to reduce waiting lines at public facilities such as the gym, supermarket or restaurant. It uses touchless sensors to perform a body temperature scan within half a second with accuracy up to 0.2°F. To use the device, visitors place their heads 1–4 in. in front of GateDoc. The forehead temperature measurement scanning method illuminates a green or red light and sound to determine if someone can enter a building. “In just a fraction of a second, it becomes clear whether you should enter a facility or not,” cofounder Dennis Giezeman said. “We create fever-free zones.” The device is app-connected, which means managers and owners of facilities can receive alerts when someone with a fever is detected at the entrance. “We were among the first to be confronted with the protective regulations against COVID-19 at our office in Shenzhen (China). Entire cities went in total lockdown and temperature measurements at facility entrances became a new standard,” Giezeman said. “Our headquarters in the Netherlands also struggled with addressing the dilemma of whether it is responsible to go to the office or to the gym, supermarket or restaurant. That is how we came up with the idea of GateDoc, an objective and efficient process to increase safety and wellbeing.”

LuftDuo portable air puriﬁer. Image courtesy of LuftQI

iMediSync: EEG brain mapping device iMediSync (Seoul) touted its AI-driven electroencephalogram (EEG) brain mapping and LED-therapeutic device iSyncWave. iSyncWave is designed for the early detection and supportive care of neuropsychiatric disorders such as dementia, Parkinson's disease, TBI, PTSD, ADHD, depression and more. “iSyncWave was created to provide an integrated service for both healthcare providers and individuals who want to understand their brain health with our comprehensive EEG analysis solution,” founder and CEO SeungWan Kang said. It is a gel-free, portable EEG brain mapping device with LED photobiomodulators that allows individuals to prevent degenerative neurological disorders with regular checkups. The device works with iMediSync's iSyncMe mobile application that connects to the company's cloud platform for an AIdriven EEG analysis. The cloud-based program also works as a telemedicine platform to connect patients to online doctors and mental health specialists.

LuftQI: Portable air purifier LuftQI (Taiwan) showed its portable air purifier Luft Duo at CES this year. Luft Duo uses UVA LED and photocatalytic technology to eliminate dust, pollen, mold and pathogen molecules. The company claims that the device creates zero unnecessary waste with a replaceable and washable filter. The photocatalytic technology allows the device to decompose pollutants that are too small for HEPA filters, like formaldehyde, which measure 0.00001 mm in size, as well as molds, VOCs and pathogens. It purifies air in a 240 ft2 space and works by plugging in to a wall outlet and turning on with a single button. LuftQI said that through research conducted by third-party labs, the company found that the COVID-19 virus cannot survive in the air for more than one hour when near the Luft Duo device. The virus usually lasts for 21 hours when airborne.

GateDoc’s body temperature thermometer. Image courtesy of GateDoc

iMediSync’s artiﬁcial intelligence-driven EEG brain mapping device. Image courtesy of iMediSync

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3 • 2021

Medical Design & Outsourcing

CES 2021

Omron’s remote heart monitoring platform. Image courtesy of Omron

Omron: VitalSight remote heart monitor Omron launched its VitalSight remote patient monitoring system to track blood pressure from home. The system is designed for patients with high-risk levels of hypertension or those with heart failure. It comes with an Omron-connected blood pressure monitor and a data hub that are pre-set to securely share measurements with a patient's physician and care team. Doctors can personalize blood pressure thresholds to improve engagement with patients. Omron's system can be integrated with a clinician's electronic medical record system or through Omron's doctor dashboard for data analysis and automatic notiﬁcations to signal when patients may have a blood pressure reading that needs action. “We're seeking to help those struggling to manage hypertension and its risks, especially with comorbidities and complications associated with this COVID-19 pandemic," president and CEO Ranndy Kellogg

said. "VitalSight, our first remote patient monitoring service, and our new Omron Connect 2.0 app are designed to give consumers more power in managing their hypertension, give physicians more insights to evolve treatment, and to strengthen the patient-physician relationship via remote monitoring.” Philips: CPAP mask selector Philips showcased its CPAP sleep apnea Mask Selector 3D for the first time at CES 2021. The mask selector is a clinically validated, 3D facial-scanning device designed to help healthcare providers fit patients with the right-sized CPAP mask from home. The system is a telehealth solution for sleep apnea, reducing the need to be monitored for sleep apnea in hospital sleep studies. Mask Selector 3D works by capturing 150 pictures of the patient's face and gathers over 100,000 key data points of facial geometry from each picture. The data is run through the algorithm of thousands of facial scans from various ethnicities to identify the 46,200 points most critical to the maskfitting process. "We can have patients take pictures of their face and give them a mask that fits their face," said Philips chief innovation and strategy officer Jeroen Tas. The company can provide therapeutic devices following the remote monitoring through the mask and offer sleep apnea treatment at home, according to Philips. "We can dramatically improve the way to diagnose the disease," Tas said.

Philips’ Mask Selector 3D software for CPAP mask ﬁttings. Image courtesy of Philips

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3 • 2021

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BRIAN BUNTZ PHARMA E DITOR

Continuous glucose monitors (CGMs) are

The Dexcom G6 family of products.

among the most potent diabetes management tools to emerge in recent decades.

Image courtesy of Dexcom.

he FDA approved the ﬁrst professional CGM in 1999, and the technology has evolved swiftly since then. Current models beam data via Bluetooth to smartphones (plus the Apple Watch) and the cloud, enabling patients to explore their blood glucose readings in an app or via downloadable PDFs. “Decades ago, we were still checking urine sugars,” said Dr. Egils Bogdanovics, a Connecticut-based endocrinologist and advisor to diabetes device giant Dexcom. “In the early 1980s, ﬁngerstick blood glucose www.medicaldesignandoutsourcing.com

monitors came out. That was a big deal — a revolution in diabetes,” Bogdanovics recalled. But the fingerstick blood glucose monitor provides more of a snapshot than a moving picture. The first professional continuous glucose monitoring became available around the turn of the century. In June 1999, the FDA approved the first device to read blood glucose levels continuously. Known as the Continuous Glucose Monitor System from Medtronic, the device was intended to be used for three days. 3 • 2021

Medical Design & Outsourcing

CONTINUOUS GLUCOSE MONITORS

LOOKING BACK AT TWO DECADES OF CGM ADVANCES The rapid evolution of the continuous glucose monitor has brought flexibility and convenience to diabetes control. B R IA N B U N T Z P H A R M A E D ITO R Continuous glucose monitors (CGMs) have transformed how many people with diabetes manage blood sugar, but attempts to monitor blood glucose have a long history. Efforts to manage glucose kicked off in earnest when researchers began measuring glucose in urine in the mid1800s. Scientists’ ability to do so steadily improved over the years, but urine glucose testing wasn’t commercialized until 1908, establishing a foundation for diabetes care. Elkhart, Ind.-based Ames Company refined the process in 1945 with the introduction of Clinitest reagent tablets, which are still commercially available, albeit from Bayer. The company would introduce the first blood glucose test strip in 1965. The Dextrostixbranded strips were intended for use in doctors’ offices.

In the 1970s, Ames developed a device known as the Ames Reflectance Meter to measure reflected light from a Dextrostix strip. It was the first blood glucose meter and was intended for use in doctors’ offices. Home blood glucose monitoring became feasible in the early 1980s with the launch of the Ames Dextrometer. This electronic glucometer allowed people with diabetes to check blood glucose in about one minute. More affordable blood glucose monitors would follow that require less blood than the Dextrometer. While self-monitoring blood glucose technology continued to improve from the 1980s to the early 2000s, patient continuous glucose monitors didn’t become commonplace until the new millennium.

1999:

FDA approves ﬁrst professional CGM Known as a “Continuous Glucose Monitor System” from Medtronic MiniMed (Medtronic Diabetes, Northridge, Calif.), the device provided three days of glucose data meant initially for a physician rather than a patient to review. The device was intended to help

physicians establish patients’ glucose proﬁles and monitor insulin therapy. It took patient readings every 10 seconds while providing 5-minute averages. The sensor had a maximum life of 72 hours. Like many others that would follow, the device would require ﬁngerstick-based blood glucose calibration.

2001:

FDA approves ﬁrst real-time CGM The GlucoWatch Biographer from Cygnus Inc. won marketing approval for adults with diabetes. It was the only system to provide a stream of glucose readings to patients when introduced. While the armband-based device was noninvasive, it was

not widely successful because it tended to cause site irritation. Animas, which eventually acquired the rights to the GlucoWatch and its successor, the GlucoWatch G2 Biographer, stopped selling the technology in 2007. Johnson & Johnson acquired Animas in 2006.

(continued)

As professional CGMs evolved, so did the length of time patients could use the technology. Endocrinologists, however, remained the target audience, reviewing blood glucose data retrospectively. “We looked at the data to recognize patterns for people who were on insulin,” Bogdanovics said. Professional CGMs morphed into personal CGMs with the first hitting the market in 2001. The personal CGM market, however, didn’t kick off in earnest until Medtronic and Dexcom entered the market niche in 2004. It gained further traction in 2008 when Abbott entered the market. “Initially, the main emphasis was

For me personally and for many of my patients, CGMs are one of the most useful tools available in management of diabetes. to avoid hypoglycemia,” Bogdanovics said. For patients with type 1 diabetes, there is the risk of so-called “hypo unawareness,” where blood sugar levels fall to dangerous levels before a patient notices there is a problem. With a CGM, “an alarm would go off at 3 a.m. and you can avoid having a hypoglycemia emergency requiring glucagon,” he added. As CGMs have evolved and become more user-friendly and long-lasting, people with diabetes are using them not just for hypoglycemia but overall blood glucose control. “For me personally and for many of my patients, CGMs are one of the most useful tools available in management of diabetes,” said Dr. Gaja Andzel, chief of the endocrinology department at Beaver Medical Group in 54

Medical Design & Outsourcing

3 • 2021

CONTINUOUS GLUCOSE MONITORS

HOW CGMS CAN INSPIRE LIFESTYLE CHANGES CONTINUOUS GLUCOSE MONITORS CAN PROVIDE INSIGHTS AND RAISE QUESTIONS.

B R IA N B UNTZ P H A R M A ED ITO R AS AN EARLY ADOPTER of fitness trackers such as the Fitbit, I’ve long appreciated the power of health data. But my recent experience with a continuous glucose monitor (CGM) has done far more to inspire me to look after my health — even as a nondiabetic. I had heard about the potential of such technology before from the cardiologist Dr. Eric Topol, who serves on the board of Dexcom, and the entrepreneur Tim Ferriss, who has discussed using the technology as a non-diabetic to optimize weight loss and muscle gain. But I have only recently had the chance to evaluate CGM as part of Dexcom’s “Hello Dexcom” sample program that enables patients to try out the company’s G6 CGM at no cost. The goal of the program is to increase awareness among healthcare providers and consumers. The G6 device, pictured to the right, provides blood glucose readings every 5 minutes for 10 days via a smartphone app or dedicated receiver. Modern CGM technology enables users to see within minutes the impact of diet and exercise on their bodies. Within 30 minutes of eating something sweet, for example, I watched my blood sugar spike. Even though my blood glucose levels were generally stable and normal, the experience of seeing blood sugar spikes has inspired me to scale back on refined carbohydrates. Another intriguing aspect of using a CGM is getting tangible data on how specific foods affect your body. Certain foods — like brown rice, oatmeal and bananas — caused my numbers to increase more than expected. Others,

like 100% whole grain bread, led to more modest gains. Tea and coffee also seemed to cause slight increases. In some people with diabetes, even black coffee can cause large blood sugar spikes. The impact of exercise on blood glucose was also pronounced. Going for a walk up a steep hill after a meal seemed to cause a signiﬁcant blood sugar decrease. Conversely, jogging would cause a temporary blood sugar spike, while being sedentary for a couple of hours would cause a modest rise. It’s easy to see the beneﬁts of the technology for people with diabetes — and even prediabetes. My CGM experience also raised questions about the out-of-pocket costs for some patients. A month’s supply of CGM sensors can cost a few hundred dollars, depending on the model and brand. While some patients have CGM expenses subsidized by insurance companies or Medicare, current eligibility requirements for coverage tend to be restrictive. Then, there is the question of sustainability. While Dexcom has been exploring a recycling program for the one-button plastic sensor applicator, which is roughly the size of a computer mouse, the device’s blood-contacting components complicate that goal. Also, given my experience installing a range of connected devices, including smart speakers and

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home automation technology, I found the CGM app occasionally frustrating. But the potential to dig into blood sugar data and analyze data trends was motivating in a way that I have not found from other connected health devices, whether connected scales, ﬁtness trackers, blood pressure cuffs or smartphone-based ECGs. Dexcom recently found in market research that 75% of people with diabetes are unfamiliar with CGM technology’s potential. Given that the technology has inspired me to establish longterm diet and exercise goals as a nondiabetic, I can see how CGMs can be especially powerful for people with diabetes.

Image courtesy of Dexcom

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Medical Design & Outsourcing

LOOKING BACK AT TWO DECADES OF CGM ADVANCES

2004:

Medtronic wins FDA approval for its Guardian CGM System The Guardian CGM from the medical device giant could warn users when their blood sugar hits dangerous levels. The device provided glucose values every ﬁve minutes.

(continued)

Image courtesy of Medtronic

Dexcom introduces its first real-time CGM Known as the Dexcom STS (short for short-term sensor), the device shared glucose every five minutes. Like Medtronic’s Guardian device, the STS could also provide alerts when glucose levels dip or rise above predefined thresholds. The device was intended to be used for up to 72 hours. 2006:

Medtronic debuts ﬁrst integrated insulin pump and CGM system Medtronic received FDA approval for its MiniMed Paradigm REAL-Time system, which it described as a milestone toward the development of an artiﬁcial pancreas. The following year, the company expanded the indication for its CGMs to include patients aged 7–17.

2007:

Dexcom introduces the Seven CGM The device was the ﬁrst approved for up to seven days of use. A model with updated software known as the Seven Plus (shown here) introduced blood sugar trending arrows. The trend arrows can help people with diabetes anticipate in advance when blood sugars are starting to trend high or low.

Image courtesy of Dexcom

Medtronic launches the Guardian REAL-Time system with MiniLink transmitter The standalone personal CGM features a smaller transmitter than preceding models. The transmitter is waterproof to a depth of 8 feet for up to 30 minutes when connected to the glucose sensor. 2008:

Abbott launches FreeStyle Navigator CGM in the U.S. With a sensor life of up to ﬁve days, the Navigator provided patients with blood glucose values updated once every 60 seconds. Medtronic introduces its next-generation professional CGM Known as iPro, the physician-targeted device was smaller and lighter than preceding models.

2012:

Dexcom debuts G4 Platinum The G4 Platinum offered improved accuracy when measuring hypoglycemic blood glucose values. The device also could work for up to seven consecutive days. The device also featured a consumer-technology-inﬂuenced design. The company would expand its functionality in 2015 with the introduction of the Dexcom Share receiver that transmits G4 Platinum blood glucose data via Bluetooth to a smartphone or iPod Touch app. The functionality allows a patient to share data with up to ﬁve designated recipients. Dexcom won permission to use the device in pediatric patients in 2015. (continued)

Image courtesy of Abbott

CONTINUOUS GLUCOSE MONITORS

Medical Device Manufacturing From Concept To Market

The FreeStyle Libre 2 from Abbott has a 14-day sensor life. Image courtesy of Abbott.

Redlands, Calif., in a call with UBS analysts. Diabetes is “an invisible disease,” Andzel said. “You don’t feel it.” But CGM technology makes “an invisible disease visible,” she added. “It has a tremendous impact on patients’ compliance and patients’ understanding of the disease.” When patients use CGMs, their average blood sugar readings (measured using glycated hemoglobin, known as HbA1c or just A1C) tend to fall, according to Bogdanovics. One traditional challenge of A1C numbers — before CGMs were widely available — is that they only provide a long view of blood sugar. Two patients could have a moderately high A1C reading of 7, but one might have relatively stable blood sugar control while the other might have frequent peaks and valleys in glucose. “The metric in diabetes since CGMs came out is starting to change,” Bogdanovics said. “It’s not just A1C — it’s how much of that time is spent in that target range.” “That’s where this ‘time-in-range’ comes in,” he added, referring to CGMs’ ability to determine how often people with diabetes are in a speciﬁed blood glucose window. “We can avoid highs and lows and have the blood glucose average nice and tight.” 3 • 2021

Medical Design & Outsourcing

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LOOKING BACK AT TWO DECADES OF CGM ADVANCES

(continued)

2013:

Medtronic introduces second-generation integrated insulin pump/CGM Medtronic’s 530G Enlite was the ﬁrst integrated insulin pump/ CGM to offer a “threshold suspend” feature to manage hypoglycemia. When blood sugar values fall to a predeﬁned low level, the pump stops pumping insulin for two hours.

2015:

Dexcom launches G5 Mobile The G5 Mobile was the ﬁrst device that enables people with diabetes to manage glucose levels via a smartphone. The device was approved for adults and children as young as two years old. The device also supported the “Share” functionality of its predecessor.

2016:

Abbott launches FreeStyle Libre Pro A professional device, the FreeStyle Libre Pro has a lifespan of up to 14 days. As with other professional devices, glucose data are blinded to the patient. A physician using a FreeStyle Libre Pro reader can access multiple patients’ data. The sensor is water-resistant up to 3 feet for up to 30 minutes.

2017:

Medtronic wins approval for closed-loop device When the FDA approved the Guardian Sensor 3 in 2017, it was the first device to automate insulin delivery via a hybrid closed loop system with the Medtronic MiniMed 670G insulin pump. Other CGM/insulin pumps would follow, such as the t:slim X2 insulin pump integration with the Dexcom G6, which won FDA clearance in 2019. Abbott launches FreeStyle Libre for U.S. patients The device was the first to be factory-calibrated, meaning that it would not require fingerstick testing. The manufacturer referred to the device as a flash glucose monitor rather than a continuous glucose monitor as it required patients to scan the device before seeing data. The device also did not sound alarms for out-of-range glucose readings. The patient-focused device can be worn for 10 days.

2018:

Dexcom launches the G6 The FDA approved the Dexcom G6, which featured several upgrades over preceding models. First, its sensor has a 10-day lifespan like the Abbott FreeStyle Libre. It also does not require ﬁngerstick calibration, although such calibration is supported. The device also features more robust interoperability than preceding models, making it compatible with insulin pumps and mobile apps.

(continued)

Image courtesy of Medtronic

Image courtesy of Dexcom

Image courtesy of Abbott

LOOKING BACK AT TWO DECADES OF CGM ADVANCES

CONTINUOUS GLUCOSE MONITORS

(continued) CGMs also allow people with diabetes to be better-informed in their insulin use. “Regardless of how you get your insulin — insulin pumping or multiple daily insulin injections — the most important thing is CGM,” Bogdanovics said. “It’s markedly better control, and less time with [blood-glucose] lows than an insulin pump with finger sticks or multiple injections with finger sticks.” There is also a growing number of insulin pumps designed to work with CGMs. The Dexcom G6, for instance, supports the Tandem t:slim X2 insulin pump. “It gets real-time Dexcom CGM

Some type 2 diabetics, however, prefer to use the technology transiently for a couple of months as they adjust their diet, exercise and lifestyle routines. “I would say 70% of all type 2s I work with are on CGMs at some point, but 15% are long-term,” she noted. In the long run, though, Bogdanovics sees ﬁngerstick-based blood glucose monitoring gradually fading away for type 1 and type 2 diabetics. “I think CGM is here to stay, and it’s improving,” he said. The COVID-19 pandemic has also underscored the importance of technologies like CGMs, which enable people with diabetes to play a

2018:

FDA approves the Eversense CGM system The Eversense CGM from Senseonics provides glucose data every ﬁve minutes for up to 90 days via an implantable sensor. A transmitter and mobile app round out the system. The company’s Eversense XL system, which has a 180-day lifespan, is awaiting FDA approval. Image courtesy of Senseonics

Regardless of how you get your insulin — insulin pumping or multiple daily insulin injections — the most important thing is CGM. data, and it can anticipate that the blood sugar is actually going to drop below normal and slow down the rate of infusion.” Similarly, if a patient’s CGM glucose reading is above normal, the pump can increase the insulin infusion rate. Another example of a CGMinsulin pump combo includes the Medtronic 670G and the t:slim X2. Eli Lilly and Ypsomed are also partnering on automated insulin delivery. Insulet has partnerships with CGM makers Dexcom and Abbott. Bogdanovics would like to see broader use of CGMs. “In my practice, 85% of anybody on insulin has a CGM, but if you look across the nation, the device penetration is well below 50% — probably somewhere around 35%,” he said. “There’s still a lot of room to improve the use of it.” CGMs tend to offer more benefits for type 1 diabetics, according to Andzel. Many type 1 diabetics who start using CGMs end up using the technology for the rest of their lives, she said.

greater role in their treatment than in the past. While the number of people going to endocrinologists fell in the early days of the pandemic, it is not uncommon for newly diagnosed diabetics to have to wait six months to get an appointment with one, according to Andzel. “We have this problem with access,” she said. “There is no slowing down (in the number of new patient diagnoses) at all.” The integration with smart devices, in particular, is a powerful tool, Bogdanovics said. Smart devices make it possible for parents, for instance, to keep track of their diabetic children’s glucose levels to ensure they don’t trend too high or low. The technology is “taking off, but I think that we’ve just got to get the message out there,” Bogdanovics concluded.

3 • 2021

Medical Design & Outsourcing

2020:

FreeStyle Libre 2 wins FDA clearance Abbott’s FreeStyle Libre 2, which was introduced in the U.S. in 2020, is an integrated continuous glucose monitor rather than a flash glucose monitor. It notifies users when glucose levels are high or low without requiring them to scan the device. The device is the first patientfacing CGM to have a 14-day lifespan.

SEAN WHOOLEY ASSOCIATE EDITOR

iRhythm

The new head of iRhythm has his sights set on maintaining the company's position atop the heart rhythm monitoring space while drawing on his experience with Medtronic.

aking over as CEO of a medtech company in the midst of a pandemic doesn't seem ideal, but former Medtronic executive Mike Coyle was thrilled to take the helm of iRhythm Technologies in January 2021. The digital cardio health company had had a banner year in 2020, and Coyle believes it has a bright future in a space that continues to grow. "I always had an ambition to be a CEO of a public company and when this opportunity came along, I was really impressed with the team that's here," Coyle told Medical Design & Outsourcing recently. "This just seemed like the right time to make the move, and I couldn't be more excited about what's ahead, especially the fact that, despite the strong growth the company's had over the last several years, I think it's just on the front end of continuing to drive disruption in the U.S. market."

Medical Design & Outsourcing

3 • 2021

iRhythm displayed its strength in the cardiac arrhythmia detection and treatment space in 2020, as the company's stock nearly quadrupled in per-share value over the course of 365 days. The company's Zio XT, an ambulatory cardiac monitor that uses deeplearning algorithms, got a big boost in December when U.K. regulators recommended it as an option for those with suspected cardiac arrhythmias who would beneﬁt from electrocardiograph (ECG) monitoring for more than 24 hours. Still, the pandemic's push to virtual meetings made for an odd transition to CEO. "You'd love to get your team around the table and start the team-building, but a couple of things make it easier here," said Coyle, who had served as Medtronic's EVP & cardiovascular group president. "The company's in great shape with great forward momentum.

www.medicaldesignandoutsourcing.com

Images courtesy of iRhythm

iRHYTHM MONITOR

[Former CEO] Kevin [King] already put in place some of the most important nearand immediate-term strategies, which are perfectly positioned with what I would be doing anyway, so we don't have to change direction." Before his 11-year stint at Medtronic, Coyle provided leadership consulting services to private equity, venture capital and medical device ﬁrms. He previously served as a divisional president at St. Jude Medical, leading businesses including the company's global pacemaker, implantable cardioverter deﬁbrillator and cardiac resynchronization.

Coyle expects more competition to come into play, namely with Philips acquiring BioTelemetry. He subscribes to the theory of semiconductor industry pioneer Andrew Grove that "only the paranoid survive," and will put that into practice in an effort to stay on top of the space. "We're going to be watching closely to see what competitive technologies are being developed and make sure that we continue to stay ahead of it as the company has been able to do over the last

We believe iRhythm is well-positioned today with strong clinical data, patient-friendly products and a focused commercial strategy which we believe will win in that scenario.

The Zio system is designed to discover and analyze irregular heart rhythms.

Image courtesy of iRhythm

The graduate of Case Western Reserve University with an MBA from the University of Pennsylvania's Wharton School of Business also held leadership positions at Eli Lilly. Now, his attention turns to what is ahead at iRhythm. Coyle said the market opportunity for iRhythm is about $1.8 billion in the U.S. alone for the symptomatic atrial ﬁbrillation patient population, giving the company plenty of room to grow while seeking to broaden its offerings. Market watchers see the same space for growth. Truist analysts recently said that, following Boston Scientiﬁc's purchase of Preventice Solutions, iRhythm will be left as one of the only standalone players with real scale in the remote heart rhythm monitoring space. The market consolidation may offer more opportunities than risks for iRhythm as it seeks to accelerate growth for its Zio platform. Extended-wear monitoring looks to be "one of the fastest growth subsegments of cardiac monitoring," growing more competitive over time, they added. "We believe iRhythm is well-positioned today with strong clinical data, patientfriendly products and a focused commercial strategy which we believe will win in that scenario," the Truist analysts wrote. www.medicaldesignandoutsourcing.com

several years," Coyle said. Part of staying ahead involves dealing with pandemic-related circumstances such as working remotely from his team. However, COVID-19 has created new viewpoints on healthcare delivery and opened up avenues to advance remote monitoring and care. Those avenues are ones Coyle wants to explore from the helm of iRhythm. "The bright side of the pandemic is that it showed the ability to move between in-clinic treatments and home services," Coyle said. "If we could actually leverage the cloud and at-home diagnosis, we can serve more patients. We're expecting a snap back to some degree of how much at-home therapy we're seeing, but we expect certain accounts who are progressive to think about how to incorporate it into their normal workflow." Coyle's sights are set on maintaining iRhythm's position atop the cardiac arrhythmia space while drawing on his Medtronic experience in working with payor systems to establish value-based healthcare options. The new CEO hopes to find ways to get the Zio platform to patients who need therapy in more cost-effective and efficient ways than what's been done in the past with Holter monitors and other technologies. "I'm very excited about being here," Coyle said. "When the opportunity came along, I was really impressed with the team here. I couldn't be more excited about what's ahead." 3 • 2021

Medical Design & Outsourcing

DEVICETALKS

Corza Medical's Lucier shares company's surgical tool sales playbook

To m S a l e m i | D e v i c e Ta l k s E d i t o r i a l Director |

ith backing from private equity giant GTCR and leadership from executive chairman Greg Lucier, Corza Medical has the means and experience to enter the surgical tools space. “We believe there is an opening for a pretty good-sized surgical tools and technologies company to compete against the Ethicons and the Medtronics of the world,” said Lucier, who built the diagnostics giant Life Technologies which would be acquired by Thermo Fisher Scientiﬁc for $13.6 billion in 2014 — the largest medtech deal at the time. But how can a small company with approximately $350 million in annual sales hope to compete? In an interview with the DeviceTalks Weekly Podcast, Lucier opened up the company’s playbook. Establish a beachhead Corza was formed from the simultaneous acquisitions of Surgical Specialties Corp., a privately owned supplier of surgical

Medical Design & Outsourcing

3 • 2021

Born of a pair of acquisitions, the company could expand into multiple specialties.

sutures, needles and ophthalmic knives, and Takeda’s TachoSil ﬁbrin sealant patch. The $500 million Surgical Specialties acquisition closed in February, according to Lucier. Focus, focus, focus The former CEO of spinal implant maker NuVasive said the company will use a tighter focus to build a following, specialty by specialty. Through the acquisition of Surgical Specialties, Corza now has contact points across multiple specialties. However, Lucier says Corza will pursue “deep dives” into specialties as it’s done in ophthalmology by acquiring TachoSil. TachoSil will certainly ring a bell for Johnson & Johnson, whose Ethicon subsidiary agreed to acquire the product line from Takeda Pharmaceuticals almost two years ago. The sale was part of Takeda’s bid to shed the ophthalmology products it acquired through its $62 billion purchase of Shire in January 2019. TachoSil sales reached $155 million during ﬁscal 2018, Takeda said at the time.

www.medicaldesignandoutsourcing.com

Images courtesy of Adobe Stock

However, Ethicon abandoned the $400 million deal in April 2020 after regulators expressed worry that the company would sell both leading ﬁbrin sealant patches Evarrest and TachoSil. Corza stepped up in September, agreeing to pay a similar price. “You'll see us do more of that vertical excellence,” Lucier said. Build a global business The executive chairman described Corza Medical already as “geographically diverse.” Lucier and CEO Dan Croteau will lead a global team of more than 1,700 employees who work in 13 countries throughout North America,

believes want both choice and value. “You’re going to see us be very high growth because what we’re going to do is promise our customers that they can get essentially as good a technology [as competitors],” Lucier said. “But they can get it at an exceptional value without having all these restrictions of a bundle anymore.” Lucier added that Corza Medical will also have the methods to create customized surgical tools, including a digital infrastructure with customer-facing websites and technology for sales reps to help customers make special requests. “It's not going to be a one-sizeﬁts-all on our technologies,” he said. “We're going to be willing to modify

You're going to see us be very high-growth because what we're going to do is promise our customers that they can get essentially as good at technology [as competitors]. Europe and Asia, with manufacturing facilities in the U.S., Mexico, England, Germany and China. Capital from Surgical Specialties’ previous co-owner Vivo Capital and others enabled the company to acquire three companies and to build two factories in the U.S. and China, according to Vivo. “We already have a very fast-growing business in China, a very sizable business in Europe. And then of course, here in North America,” Lucier said. “We’ll be global just like the Ethicons are of the world.” Offer choice Lucier suggested that “bundling” by competitors — building multiple devices into packages created to save money — limits the choices for customers, whom he

that needle, create a special suture in a simple example, to allow that surgeon to get really, really what they want for the surgeries, how they do it.” Look for growth Lucier joined with GTCR in 2019 to form Corza. It took two years to build a platform. Now that it’s in place, Corza will be looking for additional companies to acquire. “While we're starting with sutures and needles and hemostatic patches, you're going to see us potentially spend billions of dollars to grow not only into those categories, but also to move to laparoscopic surgery, electrosurgery and a number of other categories that would be traditionally serving those particular surgeons,” Lucier said.

“I do hope that we are the acquirer of choice and the, you know, the, the appeal I can make to an owner, somebody who wants to continue on in the journey, is that we can provide them the resources, some particular expertise to allow them with their current business, to become global, to become even more competitive by being in combination with what we're building at Corza Medical.”

CAN CORZA BUST UP MEDTECH’S SURGICAL SUPPLY MONOPOLIES? Lucier discussed Corza Medical’s plans further during our DeviceTalks Weekly podcast of Feb. 5, 2021. Subscribe now on your favorite podcast player! www.devicetalks.com/category/podcasts/

www.medicaldesignandoutsourcing.com

3 • 2021

Medical Design & Outsourcing

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