Medical Design & Outsourcing – MAY 2022 by WTWH Media LLC

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Medical Design & Outsourcing

5 • 2022

NEW!

HERE’S WHAT WE SEE

4 AXIS SERVO from

Harnessing the power of cloud computing

2.25”

hen Johnson & Johnson and Microsoft announced a deal earlier this year to use cloud computing to support digital surgery, executives on both sides spoke with Medical Design & Outsourcing about how the partnership could advance medtech. That started a series of conversations with leaders at cloud computing giants Google, Microsoft and Amazon — and on the device side at Johnson & Johnson, Philips and GE Healthcare. We consistently heard that the COVID-19 pandemic accelerated cloud adoption not only for medical records and telehealth, but also for manufacturing operations, supply chain management and making new vaccines, therapies and devices. What’s most exciting is medtech’s cloud-enabled future, where increasingly connected devices with smarter, smaller sensors will collect and share more data than ever before — all through remote servers. Artiﬁcial intelligence and machine learning will yield new ways to predict, diagnose, manage and even cure diseases like cancers and other conditions once thought unbeatable. Perhaps even a once-in-a-lifetime pandemic like COVID can be tamed. Could the cloud power a test-and-trace effort to identify the latest variants and develop rapid vaccine responses to counter this fast-moving virus? Can we ramp up data collection to better understand and mitigate COVID’s immediate and long-term effects? Only if we try. Those who can pull it off will be greatly rewarded. Look no further than this edition’s ranking of the top-selling pharmaceuticals of 2021, three of which are helping reduce the risks of COVID before, during and after infection. This edition features other innovative technologies with the Jim Hammerand potential for wide-ranging applications. Managing editor Medical Design & Outsourcing You’ll read about a catheter-delivered jhammerand@wtwhmedia.com brain implant that lets paralyzed ALS patients control a computer with their thoughts and could open up a new way to tap our brains for other treatments and therapies. Another device developer just won FDA clearance for its proprietary plastic and coating formula to embed antibiotics in implants, which might lead to many more drug-device combinations in orthopedics and other implantable devices. Digital therapeutics is yet another area where groundbreaking advances seem closer than ever. Associate Editor Sean Whooley reports on the efforts of four medtech companies developing software-based products to help patients manage a variety of conditions. Many challenges remain as the medical industry explores and embraces cloud computing, but the opportunity is real. I can’t imagine an industry better suited to the task.

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CONTRIBUTORS

DALEY

FRIEDRICHS

JAKUCKI

KENNEDY

MOVAHED

NAGJEE

PREMRAJ

STEPHENSON

STULL

ZHANG

KATHLEEN DALEY is a partner at Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, and has significant experience in trial and appellate litigation. Her practice encompasses a wide range of technologies, such as mechanical devices, semiconductor devices, and pharmaceuticals, with a particular emphasis on medical devices. DANIEL FRIEDRICHS, PH.D., leads development engineering at Minnetronix Medical for commercialization of surgical energy devices including in vivo electroporation systems and other energy-based medical, surgical and drug-delivery therapies. He is named on over 35 patents and has worked with an extensive network of clients seeking to commercialize a wide array of technologies within multiple diverse clinical indications. MACIEJ JAKUCKI is a technical director for medical device testing at Element Materials Technology and has 15 years of testing expertise in the orthopedics and cardiovascular industries. ERIC KENNEDY is a staff engineer at Kaleidoscope Innovation based in Cincinnati, Ohio, and has over 14 years of global medical device experience leading large- and medium-scale concept-to-launch orthopedic, micro-surgical, cardiovascular and ophthalmic devices. 10

Medical Design & Outsourcing

SAEID MOVAHED, PH.D., consults with Minnetronix Medical on design, verification and manufacturing of reversible and irreversible electroporation electrodes and pulse generators. Minnetronix develops device-specific requirements for electroporation for various tumor cells, electroporation-specific safety systems, and real-time therapy monitoring architectures. VIK NAGJEE is the vice president of product at nference and serves as an advisor to Anumana Inc., a company created by nference and the Mayo Clinic. Previously CTO at several organizations, he was responsible for healthcare solutions, strategy and market development and oversaw product security and regulatory compliance to help ensure the security of information systems and patient health information. ANGELINE PREMRAJ is an attorney at Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, with a diverse patent practice in client counseling, prosecution, litigation, and post-grant proceedings before the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office. While her technical background is rooted in medical devices, she works with a broad field of technologies, including augmented and virtual reality (AR/VR), electrical and computer technology, financial and business systems, and manufacturing.

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KATE STEPHENSON is a fourthgeneration machinist and Stanford University engineering Ph.D. with medical device design and development experience spanning more than 60 products. Her research and private consulting practice focus on matching medical innovation with the manufacturing technologies needed to develop, test and manufacture them. RON STULL, power product marketing engineer at CUI, is an experienced engineer with knowledge and experience in analog power, digital power and ac/dc and dc/dc power conversion. He joined CUI in 2009 and has served in key roles across different facets of engineering (including application support), test and validation, and design. JASON ZHANG, M.D., is an attorney at Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, focused on strategic patent prosecution as well as inter partes review proceedings before the Patent Trial and Appeal Board of the U.S. Patent and Trademark Ofﬁce and district court litigation. He works primarily in the bioinformatics and digital healthcare technology areas and has prosecuted patent applications related to machine learning, computer vision, drug-related knowledge discovery, and therapeutics.

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CONTENTS

medicaldesignandoutsourcing.com • May 2022 • Vol8 No3

DEPARTMENTS 8

HERE’S WHAT WE SEE:

Harnessing the power of cloud computing

10 CONTRIBUTORS 14 CATHETERS:

Pulse ﬁeld ablation enables new precision cancer treatments

18 TESTING:

ON THE COVER

Top tips and tricks for feasibility testing

THE CLOUD IS TRANSFORMING MEDTECH

22 MANUFACTURING:

The promise and pain of startup customers: 3 ways to support early-stage innovators without becoming a high-risk investor

Leaders at Amazon, Microsoft, Google, J&J, Philips and GE Healthcare discuss payoffs and potential in device connectivity, product development and cross-industry partnerships.

24 IP ISSUES:

How to pass the patent eligibility test for Software as a Medical Device

28 SOFTWARE:

Making biomedical data computable

30 REGULATORY:

Power supply safety standards for home medical devices

32 PHARMA:

The best-selling pharmaceuticals of 2021

38 TUBING TALKS:

FEATURES

44 ORTHOPEDICS:

56 DIGITAL THERAPEUTICS OPEN UP

Catheter delivery could enable better brain implants Ariste Medical co-founder sees great potential for drug-coated orthopedics

NEW OPPORTUNITIES IN MEDICINE

Video games, software and apps are new tools for treating and managing medical conditions.

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CATHETERS

A Minnetronix engineer evaluates a control board for an electroporation system. Photo courtesy of Minnetronix

Pulse field ablation enables new precision cancer treatments Saeid Movahed | Minnetronix Medical |

Macro-scale electroporation energy manipulates cellular behavior for effective drug delivery.

Daniel Friedrichs | Minnetronix Medical |

Medical Design & Outsourcing

hen applied to tissue, electric fields can enable precise and selective ablation effects by manipulating cellular-scale electrical properties. One effect, called electroporation or electropermeabilization, has many therapeutic and diagnostic applications including tumor ablation and intercellular delivery of DNA, RNA, protein and other cargo. The intercellular space is separated from the outside environment by phospholipid bilayer (cell membrane), which is an electrically polarized membrane made of lipid molecules. Transmembrane potential (TMP) — the inherent difference between electric potentials on the two sides of the cell membrane — can be manipulated by external fields. This 5 • 2022

discontinuity in the electric potential is caused by the ability of the cell membrane to act as a capacitor, the difference between intracellular and extracellular conductivities, and the existence of an electric current in the cell membrane due to ion pumps and ion channels. Presence of an externally applied electric pulse near the cell will alter this transmembrane potential, which consequently affects the membrane structure. When the applied electric field is strong enough, it will significantly disturb the cell membrane, creating artificial nanopores. Nanopore creation The energy minimum principle can be used to explain nanopore creation in the cell membrane during the electroporation.

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CATHETERS

Based on this theory, the pores on the cell membrane can be either hydrophobic or hydrophilic. Thermal fluctuation will cause gaps in the lipid bilayer of the membrane (hydrophobic pore). These pores start to grow under the stress from the elevated TMP enhanced by an external electric field. There is a threshold value of the TMP (0.5 ~ 1 V) at which the hydrophobic pores start to be converted to the hydrophilic pores (or converted pores) by lining the water-attracting heads of lipid molecules with the walls of the pores to minimize their energy.

A Minnetronix engineer conducts board-level characterization of the output signal for an electroporation device.

Photo courtesy of Minnetronix

Following the creation of the first hydrophilic nanopore, the TMP remains constant near the created hydrophilic nanopores and further increases of the external electric field will no longer affect the TMP. In this stage, increasing the electric field will intensify the electroporated area of the cell membrane (the area with hydrophilic nanopores) as well as radius of the created nanopores. Five steps of electroporation The electroporation process can be categorized into five different steps: 1. Induction: In this step, the TMP increases by the external electric field until it reaches its critical value. This step usually takes less than one microsecond.

Medical Design & Outsourcing

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2. Expansion: The number and radius of the created nanopores continuously increase while the TMP is maintained constant above its threshold value. The time span of this step is affected by the shape and the duration of the electric pulses and is usually in the range of microseconds to milliseconds. 3. Stabilization: This step initiates when the external electric field, and consequently the TMP, decreases to a subcritical value while the nanopores still exist in the cell membrane. 4. Resealing: Upon removal of the external electric field, the resealing process of the cell membrane starts, which usually spans from seconds to minutes. 5. Memory: After the resealing step, some more resilient changes usually remain in the cell membrane for minutes to hours. Therapeutic and diagnostic applications of electroporation Nanopores created artificially in the cell membrane by electroporation can be permanent or temporary based on the intensity and the duration of the applied external electric pulse(s). For low and short-duration electric fields, the created nanopores can re-seal themselves by removing the applied electrical field, and hence, the electroporation process will be reversible. However, strong-intensity and longduration electric fields can generate permanent nanopores and cause irreversible damage to the cell membrane. In the irreversible electroporation, the expansion step continues until they permanently damage the cell membrane and consequently kill the cell, a property which can be beneficially harnessed for tumor ablation, as an example. These reversible and irreversible electroporation processes have numerous therapeutic and diagnostic applications. As an example, reversible electroporation can be used to deliver chemotherapeutics into cancerous cells. The resulting temporary nanopores in the cell membrane are an efficient pathway to transit drugs, ions or even futuristic nanosensors into cells. Irreversible electroporation can be used to permanently damage the membrane structure and kill cells such as malignant tumors. Here, the nanopores are permanent and cannot reseal themselves, which kills the cells and ablates the targeted area.

Electroporation device development Design and fabrication of electrodes and pulse generators, along with finding optimum arrangements of electrodes around the targeted area, are among the most challenging bottlenecks of cell electroporation device development. The effectiveness and safety of electroporation depends on both biological characteristics of the targeted tissues and the electric pulse properties. These properties have been continuously improved by developing more efficient electric pulse delivery methods. The optimum design of the electric pulse parameters (waveform, pulse shape, intensity and duration) and the arrangement of electrodes (location and number) not only improve the electroporation outcome, but also allow blood vessels and nerves to be spared during the electroporation process, which can reduce the required time for patient recovery and retain the targeted organ’s function.

5 • 2022

Medical Design & Outsourcing

TESTING

Top tips and tricks for feasibility testing

Eric Kennedy | Kaleidoscope Innovation |

Avoid unexpected failures and keep your project on time and on budget with these best practices.

Y Maciej Jakucki | Element Materials Te c h n o l o g y |

Medical Design & Outsourcing

ou’ve passed through your design freeze, parts are rolling in and everyone is excited as veriﬁcation testing starts. The ﬁrst few tests are underway and — uh-oh — your device’s performance is not meeting your requirements. Scrambling to root-cause analysis and rationalizing the poor results leads to no avail. The numbers don’t lie. You tell the leadership a redesign is needed, timeline is extended, budget is blown, sales forecasts and future company plans are delayed. If only thorough feasibility testing had been conducted, this could have been avoided. Best practices A successful testing strategy always begins with the foundation of good acceptance criteria, so at the end of the day we can say objectively how the design is performing. Understand your target throughout the process and answer questions about potential risks during development. Never assume that you won’t have an issue.

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Sources for good requirements include: your competition, experience of known performance, failures from the MAUDE database, FDA guidance documents, published literature, risk analysis, test lab consultants, biomechanical data, and human factors/user data. Next, how is the testing going to be conducted and who is executing it? Does your team have the necessary equipment and experience? Do you need to leverage an external vendor’s expertise? Digital simulation is a tool that can be used to evaluate several designs, eliminate some options and gain conﬁdence in the part’s performance. To highlight potential problems before they arise, pay attention to boundary conditions, how the design will be held in test ﬁxturing, how it’s clinically used, material properties, and whether a linear or non-linear simulation is needed. To understand how your design will perform, it is important to pay attention to all of regions in the model, not just the highest stress. Watch out — Un-validated simulations are not accepted by regulatory bodies.

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TESTING

Early feasibility testing is conducted on prototype parts that may have looser tolerances, built with non-representative manufacturing processes, and possess other characteristics (like surface finish) that may differ from the final product. Also, crude testing method setups are sometimes employed to save time and get data quickly. It may make sense to come up with a custom methodology to understand the performance of a particular part of the design, as opposed to the whole design. It is important to consider and balance the time/cost savings these lower fidelity parts and methods have on data confidence and reliability.

Optical tools can determine defects or voids in materials, coatings, or additive lattices. Identifying and understanding these failure locations or crack initiation sites can improve your R&D decision making. Photo courtesy of Element Materials Technology

Medical Design & Outsourcing

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Actual force testing may yield valuable learnings on methods that feed into both the design and future validation/verification testing. Using the appropriate force gauge is important to make sure sensor resolution isn’t a large contributor to measured values. In terms of sample size, the goal here is to gain confidence and learn about how the design is failing in an efficient matter. An n (sample size) of three is a minimum that allows some basic metrics to be calculated. ASTM standards usually mandate an n of five, and a sample size of six is often used with FDA submissions. Worst-case configurations are important to consider evaluating at this stage if your design is marketed in different sizes, footprints, or materials. You want to be sure the rest of the SKUs in your design family will exceed the performance of the test specimen. Additionally, several key factors may also be considered for inclusion in the worst-case definition. At a minimum, estimations of their impact can be added to the uncertainty of your feasibility results. Some of these factors could include sterilization, post-processing, distribution exposure (vibration, temperature, humidity) and shelf-life aging. www.medicaldesignandoutsourcing.com

Analysis Tests are in execution. How do we draw sound conclusions? What should we be paying attention to? In failure analysis, was the observed result what you expected in terms of failure mode and location? Did it match the model side by side? In addition to the post-mortem images, visual and audible cues during testing can be valuable in determining when conditions in the system are changing. For example, can you tell which strut failed ﬁrst, and is it consistent part to part? How did the graph look? Was it textbook force displacement or did it have spikes, and what can those be attributed to? Functional failure/ clinical failure is different than an engineering or mechanical failure. Cracks or bending may occur, but this doesn’t mean the device isn’t still doing its job. If there was a mechanical failure, what risks does that create with wear debris or long-term crack propagation? Test methods are not written in stone, certainly not at this stage. They can be iterated and improved, especially if observations question the clinical relevancy. Test methods also may change entirely. Some devices are known to perform differently in

a standardized test material such as foam than they do in actual tissue. Cadaveric testing may be warranted, particularly if a novel device or technique is involved. Testing may not be a singular event. It’s often conducted, repeated, and evolved over a long period of time.

MEDICAL

SOLENOID VALVES

"A successful testing strategy always begins with the foundation of good acceptance criteria, so at the end of the day we can say objectively how the design is performing." Banking historical test results/methods into a consolidated location will pay dividends when recall is needed. Following some of these guidelines can save your project and company time and money as you evaluate the best way forward for your design. Considerations

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for feasibility testing should be in your project timeline, especially if you have unique or new design components. There is nothing worse than getting your final parts, only to have an unexpected failure throw the entire project timeline into uncertainty.

TOP: Test frame capacity is an important criteria in lead time for testing. Some fatigue tests have frequency limitations and adding more capacity to the project can decrease overall project completion times. BOTTOM: Custom test setups, multi axial loading, or unique wear paths often require complex fixtures and equipment. While there are test standards available (in some but not all cases), designing the test to evaluate a critical feature of your part needs to be considered. Photo courtesy of Element Materials Technology

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MANUFACTURING

The promise and pain of startup customers: 3 ways to support early-stage innovators without becoming a high-risk investor Startups represent a highly lucrative opportunity for suppliers to get in on the ground ﬂoor of a whole new product line, but their low success rate and hightouch needs can make them a dangerous distraction from your main customers.

Photo courtesy of Adobe Stock

Kate Stephenson | Dyad Engineering |

Medical Design & Outsourcing

nthusiastic and highly committed to their cause, medical device startup founders speak with a deep passion about righting the wrongs of healthcare and the immense potential for proﬁt in doing so. However, they also tend to be overly conﬁdent, naïve about the sheer amount of work their idea represents and perennially underfunded. The risks and rewards of working with startups are constantly shifting. To mitigate the risks without resorting to a blanket “no startup” policy, there are three strategies every medical device manufacturer and OEM supplier can turn to. 5 • 2022

Help them help themselves Among the ways that startups frustrate manufacturers is the common bane of every sales funnel: spending too much time and effort on a lead that never converts into a lucrative customer. Startups are novices at what you are an expert at. Because of this, early conversations with startups tend to be around educating them enough for you to decide whether they are ready to work with you. These types of conversations are ideal for creating online content around. This content can include a readiness checklist to help potential clients identify what stage of product maturity you work with, along

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with what documents and information you will need to quote a project. General manufacturing education materials — either your own or links to credible sources — can be invaluable in familiarizing prospects with the processes and language you use. Bag up your scraps and overstock to hand out at trade shows and educational events. I use these heavily in educating my startup clients about available materials and manufacturing methods. Finally, if prospects self-disqualify using your content, make sure to offer links to trusted partners who may be more suitable. This will greatly improve the odds of them returning once they are ready for your services. Align on what they can offer you right now When startups pitch to investors or other potential business partners, the discussion focuses primarily on what future value the company can claim. As the service provider or manufacturer, you should focus on what the startups can offer your business today. This is a concept I’ve challenged many of my startup clients to think through as they are pursuing partners for their short-term needs. With odds of future success so difﬁcult to determine, startups can still offer value to your organization in other ways. There is the reputational advantage. With everything from cars to toilets being pitched as innovative, working with startups developing new products grants their partners a similar aura of creativity and novelty by association. Startups are also more willing to support publications of projects in exchange for pro bono services, allowing for more detailed case studies than might be acceptable to your cash-paying clients. Startups also allow for experimentation in your own product and processes, without the potential reputational repercussions of failing to deliver to a key client. Be selective and strategic Startups come in all shapes and sizes with varying needs, strengths and weaknesses. Just like you have a system for managing your main sales funnel, you need to a system to identify what startups work best for you. You might focus only on startups that are of interest to certain strategics, giving you an onramp into a selective supplier network. Startups that represent the ﬁrst use 5 • 2022

Medical Design & Outsourcing

of one of your products in an FDA-regulated device represent a major reputational boost. If your products ﬁnd use in a wide variety of devices, work with startups whose intellectual property strategy leaves you clear ownership of new manufacturing processes or techniques that you develop while working with them. On a practical note, you may choose to only work with startups that need the machines and equipment underutilized by your paid projects. Just like your ideal customer tends not to just fall in your lap, neither will the ideal startup: those that are funded, have a strong team and offer a major strategic value. If you really want to make startups part of your business development, you need to include startup outreach in your marketing and sales efforts. This does not need to be a major effort. Potential strategies include sponsoring startup pitch events, offering a few hours of consulting as in-kind services to a contest winner, or giving lectures at

incubator or accelerator programs. It could be as simple as crafting a brochure that explains your existing services, products or funding methods that would be of interest to early-stage companies. A ﬁnal thought Most successful businesses split their efforts between delivering excellence to existing customers and working toward the incremental improvements that will keep them competitive in the next 2 to 5 years. While this split will keep you competitive for now, it can leave you vulnerable to major disruptions in 5 to 10 years. In life science products, that longer-term future is exactly what startups are aiming for. Partnering with startups should not be part of your immediate growth strategy. However, the market information they bring to the table, and the new technology you develop with them, can be vital to ensuring your company’s relevance over the next decade.

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8/18/20 11:24 AM

How to pass the patent eligibility test for Software as a Medical Device There’s “signiﬁcantly more” to it than a good idea for an SaMD algorithm.

Kathleen Daley | Finnegan |

Angeline Premraj | Finnegan |

T Jason Zhang | Finnegan |

Medical Design & Outsourcing

echnology continues to change the practice of healthcare, and one area where this has become evident is the increasing prevalence of software aimed at healthcare applications. This can include software that is integral to a medical device, software used in the manufacture or maintenance of a medical device, or software that is itself the medical device, also known as Software as a Medical Device (SaMD). SaMD is an area of tremendous growth in the medical healthcare field. However, there is still significant unpredictability in the patent eligibility of SaMDs. This article provides an overview of the challenges facing the patent eligibility of SaMDs and examines potential strategies to achieve eligibility. The defining feature of an SaMD lies in its unique role as software that performs independent medical functions without the need for actual medical device hardware. As such, SaMD inventions are often characterized as an “abstract idea” by the U.S. Patent and Trademark Office and face patent eligibility challenges.

5 • 2022

SaMDs and the Alice test In U.S. patent law, patent eligibility is governed by 35 U.S.C. § 101, which defines the types of inventions and discoveries eligible for patentability as “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” This eligibility requirement is interpreted under the test set forth in 2014 by the U.S. Supreme Court in Alice Corp. v. CLS Bank International. Under the Alice test, the first inquiry is whether the claims are directed to an abstract idea. Since this is often the case with software algorithms, the relevant inquiry is whether the claims recite additional elements that amount to “significantly more” than an abstract idea, law of nature, or natural phenomena, three long-held exclusions to patent eligibility. If a claim passes this test, the claim is eligible for a patent. When it comes to SaMD, the innovation lies in its independent function as a medical device, disconnected from any medical device hardware or a physical device.

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Image courtesy of Adobe Stock

IP ISSUES

Examples include software that develops a patient treatment plan based on patient input data or image processing software for medical diagnoses. Thus, the biggest hurdle for these inventions is often that claims reciting a software algorithm are frequently characterized as encompassing an abstract idea. But a potential solution to this hurdle may lie in determining what can constitute “significantly more” than an abstract idea under the Alice test. Specifically, even if a claim is directed to an abstract idea, it can still be patent-eligible where the claim contains an inventive concept — that is, where the claim is based on more than “wellunderstood, routine, conventional activities.” One way to achieve this “significantly more” characterization is to demonstrate that the invention is directed to an improvement over the current state-of-the-art.

How SaMDs can pass the test So what does it take for SaMDs to be “signiﬁcantly more” from a patent perspective? Courts have found claims to be signiﬁcantly more than an abstract idea when they include improvements to

"The defining feature of an SaMD lies in its unique role as software that performs independent medical functions without the need for actual medical device hardware."

the functioning of a computer. Claims that improve another technology or technical field have also been found to be “significantly more.” Most relevant to SaMDs, courts have also found that meaningful limitations — more than merely linking the use of the software to a particular technological environment — elevate the claims to significantly more than the abstract idea. In one example, while the claims were directed to collecting and comparing data (similar to SaMDs) for optimizing immunization, the additional step of actually immunizing the patient based on the comparison was a specific application and practical use of the comparison. Thus, tying the data analysis to immunization by reciting an actual step of performing the immunization benefited the claims. By considering these and other examples, patent owners can streamline drafting patents and patent claims to overcome the hurdles that often stand

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in the way of patent eligibility for SaMDs in various ways. First, patent owners may focus on reciting the specific features of the invention that provide technological improvements or solutions. For example, it may be useful to recite diagnostic features that make the data from the measurement device more accurate. If a particular software implementation makes a diagnostic or therapeutic method faster or more efficient, that should be recited in the claim with support in the specification describing how that particular software makes the computer faster or more efficient. Second, it may be beneficial to avoid excessive reliance on terminology that reads on mathematical concepts, mental thoughts, or other excluded areas. Through these examples, patent applicants can improve the chance of successfully prosecuting patent applications directed to SaMDs.

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Medical Design & Outsourcing

SOFTWARE

Making biomedical data computable Cloud computing can power quantum leaps in human health.

state-of-the art platform that supports real world evidence (RWE) and health economics and outcomes research can enable breakthroughs at an unprecedented scale. This is achieved by making the de-identified, transformed information contained within the electronic medical record (EMR) available for data science and analysis at the aggregate and patient level. Add multi-modal data sources such as imaging and electrocardiograms as well as novel data assets like digital pathology and omics data to enrich the EMR data to provide a truly longitudinal view of the patient, and you have the beginnings of a world-class platform. The keys are privacy preservation, harnessing longitudinal data, data enrichment and a data science platform.

Data enrichment: harmonization and curation Information is entered into the EMR in diverse forms, from variations in the units used to record a given value (body temperature measured in Celsius versus Fahrenheit) to variations in labeling due to the integration of different coding systems or even typographical errors. In short, the raw EMR contains data generated by the interactions of fallible human beings with data storage systems whose organizational scheme designs have evolved over time and can differ across clinical sites. As a result, the same kind of information can be stored in many different locations, under different labeling or in different formats, within the same EMR. If we want to analyze one metric across all patients, we first need to gather all records of that metric and standardize the way results are stored. Harmonization is a broad-scale effort to pursue this kind of data organization across all metrics in the EMR data. The majority of EMR data exists in semi-structured or completely unstructured forms. Curation — transforming this data into structured labeled data — is a critical part of enabling artificial intelligence (AI) applications downstream.

Vik Nagjee | nference |

Medical Design & Outsourcing

Privacy preservation and harnessing longitudinal data (including novel data assets) In order to be able to perform medical device/drug design/clinical trials research, the most valuable data is based on RWE, which is harnessed from clinical data. Patient and data privacy is paramount and requires a robust de-identification platform including de-identification of unstructured data at scale. The cloud provides the ability to be able to perform best-in-class de-identification. To harness longitudinal data, the platform itself must be made complete with access to rich data across all modalities (clinical, molecular and imaging data). Addition of novel data types such as digital pathology and molecular biology helps provide an unprecedented, comprehensive 360-degree view of the patient’s story.

5 • 2022

www.medicaldesignandoutsourcing.com

Image courtesy of Adobe Stock

This visual shows the inverse relationship between data availability and value. Image courtesy of nference

"The majority of EMR data exists in semi-structured or completely unstructured forms. Curation — transforming this data into structured labeled data — is a critical part of enabling artificial intelligence (AI) applications downstream."

Coupling state-of-the-art technology with deep biomedical expertise to transform semi-structured data (augmented harmonization) and unstructured data (augmented curation) results in the largest labeled dataset in healthcare. This requires cloud-scale capabilities. Some examples include drug to phenotype, disease diagnosis, diagnosis date, disease location, and oncology biomarker status. Data science platform The cloud truly enables commoditization of algorithms to provide data science to the masses: •

Ready-made applications: Hyperscalers have added several AI capabilities specific to healthcare and life sciences that make it easy to consume these services without requiring deep knowledge of the science of AI/machine learning (ML)/deep learning. For example, Google Cloud Platform provides Cloud Healthcare API, a pathway to intelligent analytics and ML capabilities. The other two of the big three cloud service providers offer similar capabilities: Amazon HealthLake, and Microsoft’s Azure for Health. www.medicaldesignandoutsourcing.com

•

AutoML, also known as code-free data science: The rise of the citizen data scientist means we can, with minimal subject matter expertise, bring our own data and have computers tell us what algorithms are best to answer our speciﬁc question. These algorithms don’t discriminate between protected classes and, further, tell us which features we should use when trying to predict an outcome without having to start from scratch. Each of the cloud providers offer signiﬁcant advances in this space.

Scalable computing and advanced ML tools allow pioneers to keep pushing the envelope of what is possible. Innovators in this space favor a hypothesis-free approach to science over the status quo, hypothesisdriven approach. Instead of solving one problem at a time, we strive to develop generalizable and extensible models that can dramatically accelerate downstream hypothesis generation and holistic algorithm development. The cloud truly enables the scale and ﬂexibility of such an approach. The elasticity of the cloud provides the ﬂexibility and freedom to operate atscale, while being able to unabashedly experiment. 5 • 2022

Medical Design & Outsourcing

REGULATORY

Power supply safety standards for home medical devices Patients using blood pressure monitors and CPAP devices in non-clinical environments are protected by IEC 60601-1-11.

H Ron Stull | CUI |

ome medical devices can provide an excellent ﬁrst line of defense when dealing with health and medical issues, and there is an increased need for at-home care for patients released from hospitals and other healthcare facilities. The medical technologies used in nonclinical environments range in complexity from simple materials for administering ﬁrst aid to sophisticated devices for delivering advanced treatment. Complex at-home electrical medical devices must comply with the stringent IEC 60601-1 safety standards for medical patient protection. They must also adhere to additional requirements related to risks found in and around the home, like untrained equipment users and the uncontrolled at-home environment. Blood pressure measurements Blood pressure is a critical vital sign guiding acute and long-term clinical decision-making. Generally, blood pressure measurement collects systolic pressure and diastolic pressure. Systolic pressure is the peak arterial pressure during systole,

Medical Design & Outsourcing

5 • 2022

Internal medical ac/ dc power supplies and external medical ac/dc power supplies have 60601-1 certiﬁcation for 2 x MOPP (means of patient protection). Photo courtesy of CUI

when the heart muscle pumps blood from the chambers into the arteries. Diastolic pressure is the minimum arterial pressure during diastole, when the heart muscle relaxes and ﬁlls the chambers with blood. Mean arterial pressure (MAP) is calculated from systolic pressure (SP), diastolic pressure (DP) and pulse pressure (PP) using the following equations: MAP = DP + 1/3 (SP - DP), or MAP = DP + 1/3 (PP). A pressure sensor measures the patient’s systolic and diastolic pressures as the cuff deﬂates. For example, an acpowered, wheelchair-accessible blood pressure measurement device has a cuff and elbow sensor inside the unit that automatically adjusts to ensure the patient is in the correct position for highly accurate results every time. The blood pressure measurement system requires an ac/dc power supply that complies with the medical IEC 60601-1 electrical safety requirements and meets the requirements for home use laid out in the IEC 60601-1-11 collateral standard. An internal ac/dc power supply series or an external series of wall-plug adapters address those medical at-home power requirements and safety concerns.

www.medicaldesignandoutsourcing.com

IEC 60601-1-11 compliance requires that power supplies be rated with IEC protection Class II due to an assumption that the electrical environment has a poor protective earth conductor or none. Class II power supplies provide the proper level of protection without relying on protective earth ground by applying double or reinforced insulation. CPAP systems The gold standard for obstructive sleep apnea (OSA) devices is the continuous positive airway pressure (CPAP). The acpowered CPAP device provides consistent air support for night-time breathing difficulties like apneas, hypopneas and snoring. The machine connects directly to the patient in medical, clinic, hospital, or at-home environments. Automatic CPAP features are essential due to the expected use by untrained operators. The device reacts to the patient’s breathing breath-bybreath, and the machine’s reading of these reactions eliminates the need to adjust settings by at-home healthcare operators. In addition, the CPAP machine offers climate control, which automatically adjusts the humidity and temperature of the delivered air. Humidity and temperature measurements provide optimum comfort and protect the patient from condensation in the mask and tubing.

The at-home environment may contain a variety of electromagnetic noise emitting devices that could interfere with the functioning of medical equipment and sensors. Home medical devices must meet stricter requirements than traditional medical equipment to limit potential interference in their own emissions. For example, traditional medical equipment must meet CISPR 11 class A emissions, while home medical equipment must meet the stricter class B limits. CPAP machines can use cellular, Bluetooth Low Energy or Wi-Fi connections to upload data to a cloud service, but reliable communication requires minimal interference. Wireless CPAP device connectivity also enables telehealth/telemedicine help to address common CPAP performance issues like lack of comfort and usage difficulties. The CPAP device requires a power connection that meets the medical IEC 60601-1-11 safety standard. CPAP devices with wall power use an isolated ac/dc power supply complying with IEC 60601-1-11 standard. Some portable CPAP devices run on battery power while traveling. The CPAP system and other portable medical devices must meet harsher shock and vibration tests, and some added mechanical stress tests. With battery power, the ac/dc battery charger configuration still requires a connection that complies with the medical IEC 60601-1-11 safety standard.

www.medicaldesignandoutsourcing.com

The IEC 60601-1 isolated ac/ dc power must allow for a +10/-15% mains supply variation to account for the less predictable residential power infrastructure. This means an input range of 85 to 264 Vac for universal operation. The motor and sensor systems are underneath the battery charger and the non-isolated dc/dc power structure. The motor system has a blower assembly that pushes air in the nasal mask tubing. The sensor system uses several sensors to measure humidity, temperature and nasal mask flow. Conclusion Electronic home medical devices monitor and evaluate an individual’s health and provide data for early diagnostic and future treatment guidance. This article used the examples of electric-powered blood pressure and CPAP systems with the IEC 60601-1 power supply backbone and sensing technologies to demonstrate home diagnostic electric equipment. Due to the differences between the home and hospital, home medical devices must meet IEC 60601-1-11 safety requirements.

Electrical topology of a CPAP device, containing power, sensors, fan motor, and patient interface Illustration by CUI

5 • 2022

Medical Design & Outsourcing

PHARMACEUTICALS

The best-selling pharmaceuticals of 2021 COVID-19 vaccines generated tidy sums last year, along with two biologics and a blood thinner.

Brian Buntz | Pharma Editor |

Comirnaty COVID-19 vaccine

Image via Pixabay

rug sales in 2021 hit record heights, with a handful of pharmaceutical companies handsomely rewarded for creating COVID-19 vaccines and treatments. Pfizer alone raked in $36.9 billion in sales from the Comirnaty vaccine it developed jointly with BioNTech. Demand for the COVID-19 vaccine helped catapult Pfizer to be 2021’s top pharmaceutical company. Continued demand for the PfizerBioNTech vaccine is likely to keep Pfizer as the biggest pharma firm of 2022 as well. The second-best-selling drug of 2021 was AbbVie’s injectable biologic Humira, which generated $20.7 billion in sales. Next in line was Moderna’s COVID-19 vaccine, which drove $17.7 billion in revenue. Merck’s megablockbuster Keytruda rounded out the top four with $17.2 billion in revenue. Novartis and Roche have struggled to commercialize COVID-19 therapies, although the latter has introduced a series of SARS-CoV-2 diagnostics. The two companies thus dipped in the rankings compared with the previous year.

1. Comirnaty COVID-19 vaccine The meteoric rise of the COVID-19 vaccine from Pfizer and BioNTech has little precedent in the pharmaceutical industry. Generating more than $59 billion in cumulative revenue in 2021, the vaccine added $36.8 billion to Pfizer’s bottom line in 2021. The vaccine also catapulted once little-known BioNTech into the top tier of the pharmaceutical industry. In 2021, the company’s €18.9 billion in revenue surpassed that of Bayer’s pharmaceutical division. In addition, BioNTech announced a pact with Matinas BioPharma that could potentially result in an oral COVID-19 vaccine. Pfizer is also betting on the future potential of mRNA-based vaccines. “Although mRNA is not the holy grail, we believe the technology has the potential to have a game-changing impact on global health, which is why we have developed a robust mRNA strategy and are aggressively building our platform,” said Pfizer CEO Dr. Albert Bourla. 2. Humira (adalimumab) AbbVie’s megablockbuster Humira (adalimumab) surpassed the $20 billion mark for the first time in 2021, hitting $20.694 billion. The company has sought to offset the impact of Humira biosimilar competition outside of the U.S. in recent years through price increases. In 2003, when Abbott Laboratories launched Humira, the drug cost $522 in the U.S. per 40-mg syringe. Since then, Abbott and its later spin-off, AbbVie, have hiked the drug’s price more than two dozen price times. Humira now costs $2,984 per syringe, according to an investigation by the U.S. House of Representatives. A series of Humira biosimilars are poised to hit the U.S. market in 2023. The company seeks to reduce its reliance on Humira, which accounted for 36.8% of its revenue in 2021.

Medical Design & Outsourcing

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PHARMACEUTICALS 50 of the best-selling drugs from 2021 In its 2021 earnings call, AbbVie CEO Rick Gonzalez noted that the JAK inhibitor Rinvoq (upadacitinib) and the monoclonal antibody Skyrizi (risankizumab) will be “commercialized across all of Humira’s major indications plus atopic dermatitis.” “With the strong performance that we’re seeing in their initial indications and the robust data we’ve demonstrated across our broad development programs, we expect combined peak sales for Skyrizi and Rinvoq to exceed the peak revenues achieved by Humira,” Gonzalez said. “In hematological oncology, we’ve established a leading position with Imbruvica and Venclexta, which are both expected to remain important revenue contributors through the decade.” 3. Spikevax COVID-19 vaccine Moderna’s Spikevax COVID-19 vaccine generated $17.7 billion in revenue in 2021, making the drug the third-bestselling product of the year. Brisk sales of the vaccine have helped Moderna bolster its pipeline, which includes vaccine candidates for flu, respiratory syncytial virus, cytomegalovirus, HIV, Zika and others. But while the company saw meteoric growth in much of 2021, Moderna must now work to convince investors that the company is more than a COVID-19 vaccine company.

Spikevax COVID-19 vaccine Image via Wikimedia Commons

Medical Design & Outsourcing

5 • 2022

DRUG NAME

MANUFACTURER(S)

2021 SALES

INDICATION(S)

Comirnaty COVID-19 vaccine

Pfizer/BioNTech

$59,108,942,000.00

reduce the risk of COVID-19 infection

Humira (adalimumab)

AbbVie

$20,694,000,000.00

rheumatoid and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis

Spikevax COVID-19 vaccine

Moderna

$17,675,000,000.00

reduce the risk of COVID-19 infection

Keytruda (pembrolizumab)

Merck

$17,186,000,000.00

various cancers

Eliquis (apixaban)

Bristol Myers Squibb and Pfizer

$16,732,000,000.00

blood clots

Revlimid (lenalidomide)

Bristol Myers Squibb (Celgene)

$12,821,000,000.00

myelodysplastic syndrome, multiple myeloma, and mantle cell lymphoma

Imbruvica (ibrutinib)

Pharmacyclics (AbbVie) and Janssen (Johnson & Johnson)

$9,777,000,000.00

chronic lymphocytic leukemia/small lymphocytic lymphoma with 17p deletion, Waldenström’s macroglobulinemia

Eylea (aflibercept)

Regeneron Pharmaceuticals, Bayer

$9,244,294,000.00

Stelara (ustekinumab)

Janssen (Johnson & Johnson)

$9,134,000,000.00

plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease

Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide)

Gilead Sciences

$8,624,000,000.00

HIV

Xarelto (rivaroxaban)

Janssen (Johnson & Johnson)/Bayer

$8,039,505,000.00

reducing the risk of stroke in nonvalvular atrial fibrillation, deep vein thrombosis, pulmonary embolism, DVT prophylaxis following knee or hip replacement surgery

Opdivo (nivolumab)

Bristol Myers Squibb

$7,523,000,000.00

various forms of cancer

Trulicity (dulaglutide)

Eli Lilly

$6,471,900,000.00

type 2 diabetes

Dupixent (dupilumab)

Sanofi Genzyme, Regeneron Pharmaceuticals

$6,209,567,000.00

atopic dermatitis, asthma, chronic rhinosinitus with nasal polyps.

Darzalex (daratumumab)

(Janssen) Johnson & Johnson

$6,023,000,000.00

multiple myeloma

REGEN-COV

Regeneron Pharmaceuticals, Bayer

$5,828,000,000.00

reduce the risk of COVID-19 infection

Trikafta/Kaftrio

Vertex Pharmaceuticals

$5,697,200,000.00

cystic fibrosis

www.medicaldesignandoutsourcing.com

50 of the best-selling drugs from 2021 DRUG NAME

MANUFACTURER(S)

2021 SALES

INDICATION(S)

Gardasil/ Gardasil 9 (human papillomavirus 9-valent vaccine)

Merck

$5,673,000,000.00

various cancers caused by human papillomavirus

Veklury (remdesivir)

Gilead Sciences

$5,565,000,000.00

COVID-19 requiring hospitalization

Ibrance (palbociclib)

Pfizer

$5,437,000,000.00

HR-positive and HER2negative breast cancer

Januvia/Janumet (sitagliptin)

Merck & Co.

$5,288,000,000.00

type 2 diabetes

Prevnar family (pneumococcal vaccine)

Pfizer

$5,272,000,000.00

pneumococcal vaccine

Tagrisso (osimertinib)

AstraZeneca

$5,015,000,000.00

non-small-cell lung carcinomas

Cosentyx (secukinumab)

Novartis

$4,718,000,000.00

plaque psoriasis, psoriatic arthritis, ankylosing spondylitis

Ocrevus (ocrelizumab)

Roche

$4,622,292,000.00

relapsing or primary progressive multiple sclerosis

Enbrel (etanercept)

Amgen

$4,465,000,000.00

plaque psoriasis, rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis and ankylosing spondylitis.

Xtandi

Astellas

$4,173,232,862.57

treatment of prostate cancer

Invega Sustenna, Xeplion, Invega Trinza/Trevicta

Janssen (Johnson & Johnson)

$4,022,000,000.00

schizophrenia, schizoaffective disorder

Vaxzevria

AstraZeneca

$3,917,000,000.00

reduce risk of COVID-19 infection

Entyvio

Takeda

$3,908,309,048.65

ulcerative colitis, Crohn’s disease

Lynparza

AstraZeneca/Merck & Co.

$3,737,000,000.00

Ovarian cancer, breast cancer

Perjeta (pertuzumab)

Roche

$3,616,452,000.00

HER2-positive breast cancer

Gilenya (fingolimod)

Novartis

$3,548,000,000.00

multiple sclerosis

Pomalyst/Imnovid (pomalidomide)

Bristol-Myers Squibb

$3,332,000,000.00

multiple myeloma

Orencia (abatacept)

Bristol-Myers Squibb

$3,306,000,000.00

rheumatoid arthritis, juvenile idiopathic arthritis

Actemra/ RoActemra (tocilizumab)

Roche

$3,257,092,800.00

Rheumatoid arthritis, forms of juvenile idiopathic arthritis and giant cell arteritis as well as CAR T cellinduced severe or lifethreatening cytokine release syndrome

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4. Keytruda (pembrolizumab) First approved in 2014, the immunotherapy drug Keytruda continues to be a core business driver for Merck & Co. Since its initial approval for advanced melanoma, Keytruda has won scores of additional oncology indications. Biosimilar competition, however, will likely erode sales by the end of the decade. To reduce risk, Merck has ramped up investment in its oncology pipeline. Merck has “an expanding portfolio of commercial and developmental oncology assets beyond Keytruda, which offer meaningful growth opportunities beyond 2028,” Rob Davis, president and CEO of Merck, said in the company’s Q4 2021 earnings report. In addition, the company hopes that sales of the Gardasil vaccine for recombinant human papillomavirus can offset waning Keytruda sales in coming years. Davis anticipates that sales of Gardasil could “potentially double by 2030.” The company is also looking to vaccines, cardiometabolic, neuroscience and other disease areas to help fuel growth.

Merck has "an expanding portfolio of commercial and developmental oncology assets beyond Keytruda, which offer meaningful growth opportunities beyond 2028."

5 • 2022

Medical Design & Outsourcing

PHARMACEUTICALS 50 of the best-selling drugs from 2021 5. Eliquis (apixaban) Developed jointly by Bristol Myers Squibb and Pﬁzer, Eliquis continues to be a solid revenue driver. Generating $16.7 billion in total revenue, global Eliquis sales were up 20% in 2021. “In the U.S., fourth-quarter sales increased 22% versus prior year, driven primarily by total prescription growth of 13%,” Bristol Myers Squibb Chief Financial Ofﬁcer David Elkins said on the company’s 2021 Q4 earnings call. Eliquis remains the most popular oral anticoagulant in many countries. The COVID-19 pandemic helped stoke demand for apixaban given evidence that blood thinners could help reduce the death risk from patients with severe infections who are at risk for strokes and heart attacks.

Check out our full Pharma 50 report, including top R&D spenders, bestselling drugs and top pharma employers. Everything goes live by mid-June at www. drugdiscoverytrends.com.

DRUG NAME

MANUFACTURER(S)

2021 SALES

INDICATION(S)

Prolia (denosumab)

Amgen

$3,248,000,000.00

osteoporosis, low bone mass

Remicade (inﬂiximab)

Janssen (Johnson & Johnson)

$3,190,000,000.00

Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis

Tecentriq (atezolizumab)

Roche

$3,031,236,000.00

urothelial carcinoma, non-small cell lung cancer and triplenegative breast cancer

Farxiga

AstraZeneca

$3,000,000,000.00

Type 2 diabetes mellitus, heart failure

Lantus (insulin glargine)

Sanoﬁ-Aventis

$2,950,402,000.00

diabetes

Skyrizi

AbbVie

$2,939,000,000.00

plaque psoriasis

Genvoya (elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide)

Gilead Sciences

$2,879,000,000.00

HIV-1 infection

Avastin (bevacizumab)

Roche

$2,794,406,400.00

colorectal, lung, glioblastoma, kidney, cervical and ovarian cancer

Entresto (sacubitril/ valsartan)

Novartis

$2,787,000,000.00

chronic heart failure and reduced ejection fraction

Hemlibra

Roche

$2,763,316,800.00

hemophilia A

Symbicort (budesonide formoterol)

AstraZeneca

$2,728,000,000.00

asthma, airﬂow obstruction in patients with COPD

Triumeq (dolutegravir, abacavir and lamivudine)

GlaxoSmithKline

$2,590,384,800.00

HIV

Herceptin (trastuzumab)

Genentech (Roche)

$2,463,393,600.00

breast, stomach and esophageal cancer

Xeljanz (tofacitinib)

Pﬁzer

$2,455,000,000.00

rheumatoid arthritis, psoriatric arthritis and ulcerative colitis

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TUBING TALKS

Catheter delivery could enable better brain implants Synchron’s catheter delivery could make brain-computer interface technology simpler, safer and more accessible than the leading alternative: open-brain surgery.

O Jim Hammerand | Managing Editor |

fﬁcials at Synchron, developer of the catheter-delivered Stentrode brain-computer interface (BCI) implant, believe they’re the only BCI company tapping into blood vessels to capture signals from the brain. New York–based Synchron recently said four ALS patients with a Stentrode implant had no serious adverse events one year after their procedure. The implants allowed the paralyzed patients to control a computer for online shopping, banking and text communication without using their hands or voice for input. “BCI has been on a bit of a journey,” Synchron Director of Neuroscience Peter Yoo told Medical Design & Outsourcing. “It’s been in the making for a few decades now, but it hasn’t quite translated into the real-life patient setting yet. It’s largely been an engineering problem because people need to pave the way of getting into the brain or getting inside the skull to record these high-ﬁdelity signals.” Synchron’s catheter approach Synchron uses catheters to feed the Stentrode device to a blood vessel on top of the brain, rather than the openbrain surgeries used by other neurotech

Medical Design & Outsourcing

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developers like Elon Musk’s Neuralink. Once inside the vessel, Synchron’s mesh-like device expands to line the vessel wall so its 16 electrodes can capture and relay movement signals from the brain’s motor cortex to another device in the chest that translates the signals into laptop computer commands. “The novel approach of the catheter delivery increases the number of physicians who can deliver our devices compared to a very specialized type of surgery, “ Yoo said. “The techniques that we use are standard angiography procedures and other neurointerventional techniques performed by stroke doctors. We’re hoping that it’ll help with the proliferation of the technology and access to the technology, that it can be cheaper and more available for the patients who are in need.” The devices remained in place throughout the ﬁrst year of the study, and the blood vessel remained open, Synchron said ahead of a presentation at April’s American Academy of Neurology conference. While Synchron is studying the safety proﬁle of removing the device, the implant is designed to be permanent because the stent’s incorporation into the brain is helpful in a few areas, Yoo said.

www.medicaldesignandoutsourcing.com

TUBING TALKS

“[It] improves the isolation of the electrodes, so it doesn’t come in contact with the blood and other things that are conductive,” he said. “The electrodes inside the blood vessel secure the device in position and improve our ability to record the signal, so that increases stability and fidelity.” Breaking new ground Synchron said it is the only company with FDA approval to conduct clinical trials of a permanently implanted BCI. The company achieved the first human implantation in 2019, was granted breakthrough device designation by the FDA in 2020 and an investigational device exemption (IDE) in 2021. “These results are a huge advancement for the field of BCI,” Synchron co-founder and CEO Dr. Thomas Oxley said in a news release. “We’ve shown that our endovascular BCI approach is safe, and allows patients to accomplish daily online tasks without invasive brain

Synchron Director of Neuroscience Peter Yoo surgery. Years of research and technological development culminated in this moment, and as we continue to develop our technology, it has the potential to change the lives of millions of patients globally who suffer from paralysis and other debilitating neurological and brain-related diseases.”

Synchron cofounder and CEO Dr. Thomas Oxley Synchron’s team overcame several challenges along the way, Yoo said. “Mounting electronics onto stents that are going to be permanently implanted didn’t exist prior to us,” he said. “We started off manually making them; now we’re printing them. All of those

processes and methods had to be created from scratch, leaning on a lot of other manufacturing practices and know-how.” Once they had the recording heads, the question was how to connect those sensors into the blood vessels and relay the signals out of the patient. “The tortuosity of the blood vessels means that the device had to be flexible, yet firm enough so that you can push the device into the brain through those tortuosities,” Yoo said. “Getting those sweet spots right was definitely a challenge.” The main challenge was a lack of chronic data concerning a permanent device inside a blood vessel, but they looked to a routine treatment for intracranial idiopathic hypertension, where intracranial pressure builds up. “People have been putting a stent into the transverse sinus — which is the sinus that runs along back of the head sideways — permanently placing stents there with less than a 2% major complication rate,” Yoo said.

In December 2021, ALS patient Philip O’Keefe was the first person to post a message on social media directly through thought using an implantable brain computer interface, Synchron said. Photo by Paul Burston/University of Melbourne

TUBING TALKS

The Synchron Stentrode brain implant expands inside a blood vessel, placing its electrodes against the vessel wall to sense brain signals. Image courtesy of Synchron

“But that’s the only chronic-stentinginside-the-brain data that’s available. So we had to do a lot of work in the background, benchtop testing and some large-animal testing to make sure that leaving a permanent device with the lead inside the blood vessel doesn’t cause thrombosis or any other health risks.” What’s next The company conducted the safety study with support from the U.S. Defense

MEDICAL MOLDED CABLE ASSEMBLIES

Advanced Research Projects Agency (DARPA), the Ofﬁce of Naval Research, the National Health and Medical Research Council of Australia, the Australian Federal Government Foundation and the Motor Neurone Disease Research Institute of Australia. The study will continue in the U.S. and Australia as it opens to more patients. Meanwhile, Synchron will continue ongoing R&D in miniaturization and improved access to other blood vessels in the brain. Yoo described a future where Synchron’s technology might be able to diagnose conditions like epilepsy or perform deep brain stimulation without a craniotomy. “Reaching those areas through the blood vessels and stimulating from within the [vessels] means that we don’t need to come in contact with the brain directly, which has its own set of advantages in terms of immune responses,” Yoo said. “It’s nice to just leave the brain alone and … speak to it from a distance.”

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HOW THE SYNCHRON STENTRODE BCI IMPLANT U S E S C AT H E T E R S A N D L E A D S TO TRANSMIT BRAIN SIGNALS

Yoo explained how the catheter-delivered device makes its way to the brain and sends signals back. The following has been lightly edited for space and clarity. “We do a direct internal jugular vein (IJV) puncture — we don’t do a cut-down — to access the blood vessel. For most individuals, there is a pathway through the IJV that goes off the sigmoid, which is this coily, roundy bit, into the transverse sinus and then into our target vessel, which is the superior sagittal sinus at the top of the brain. Once you’ve delivered the device through a series of catheters and unsheath all the catheters, you have the lead of the device sticking out from the IJV. From that point, we do a standard tunneling procedure —often done in the cardiac EP space for implantable pulse generators — to tunnel the lead under the skin into a small chest pocket and place the telemetry unit inside the chest pocket. Everything’s completely inside the body. That’s obviously very good for infection control. "With our Some of the other devices device, we have transcutaneous connections, which means really made that it’s not fully implanted. careful designs With our device, we really made careful designs to make to make sure that the sure that the implantables are fully implanted and the data implantables transmission is wireless, are fully because we’re getting to the brain and we’re very implanted proactive about controlling and the data infection. Our current iteration of the device is transmission is transmitting raw data from wireless." the implantable through an RF link. Because it’s a custom communication protocol, it goes into a little intermediary box so we can sample the signal, and then that goes straight into a commercial laptop running our algorithms so we can translate the incoming signals into digital outputs so the patient can use generic, consumer-grade software and hardware at home.” Read more from the interview at https://wtwh.me/bNy

5 • 2022

Medical Design & Outsourcing

ORTHOPEDICS

Ariste Medical co-founder sees great potential for drug-coated orthopedics The drug-device developer says the patents and proprietary formulations behind its FDA-cleared antibiotic-embedded hernia mesh could prevent infection, inflammation or clotting associated with implants.

t’s been more than a decade since Lisa Jennings launched not one but two companies in the Great Recession. In 2020, she sold CirQuest Labs to MLM Medical Labs, where Jennings serves as chief scientific officer and managing director of U.S. operations. More recently, in March, her pre-commercial medtech development startup Ariste Medical won FDA 510(k) clearance for its antibiotic-coated hernia mesh. You can expect more to come from that technology, Jennings told Medical Design & Outsourcing in an interview covering future applications, the drug-device development process and what she’s learned through it all. “We hope this encourages thinking about more ways of mitigating complications with implantable devices,” Jennings said. “There are so many possibilities out there, new drugs being developed all the time. It’s really exciting to think that with various coatings out there and the types of devices, the applications for this technology can even be extended as we learn more about the disease process, and we learn more about new drug targets and develop new drugs that can mitigate some of these complications.”

Ariste Medical’s polypropylene hernia mesh Image courtesy of Ariste Medical

Jim Hammerand | Managing Editor |

Ariste Medical co-founder and Chief Scientific Officer Lisa Jennings 44

Medical Design & Outsourcing

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MDO: Is there anybody else doing the kind of work you’re doing? Jennings: This is the first product that we’re aware of that combines the benefit of the polypropylene mesh in addition to a coating that allows the residence of antibiotics to mitigate bacterial colonization for surgical repair of soft tissue. There have been some products where devices have been coated with antibiotics. We developed a proprietary coating that is biocompatible and allowed us to incorporate antibiotics into the coating, such that there was a drug residence or a drug-embedded technology, and this can broadly be used not only for other implantable devices but also for nonimplantable devices.

www.medicaldesignandoutsourcing.com

ORTHOPEDICS

The beauty of this technology is that it is a game-changer for polypropylene mesh used for open ventral hernia repair, but we also have done proofof-concept testing and demonstrated that our technology can be applicable for a variety of materials such as polyurethane and ePTFE (expanded polytetrafluoroethylene, also known as Gore-Tex). ePTFE is known to be one of the slippery surfaces, but we could also use our coating technology on ePTFE surgical implants such as vascular grafts. And we also have proof of concept that this can be used on metals, so there’s a lot of potential in the orthopedic space. This scanning electron micrograph of uncoated and coated grafts after 24 hours in an S. epidermidis broth in vitro shows colonization of bacteria on the uncoated graft (left) with minimal colonization on the antibiotic eluting graft (right), Artiste Medical said.

MDO: What are the common implantables and nonimplantables made from these kinds of materials that you’re eyeing as potential applications? Jennings: We have proof of concept in vascular grafts that would be used for peripheral bypass — the same material is often used for dialysis access — central venous catheters, and urinary catheters. We’ve done some work in that area already and in some of the orthopedic metals. This could go into several different directions as far as looking at market opportunity: perhaps sutures, shunts, maybe even small-diameter grafts, tissue patches, things of that nature. We think there’s an opportunity that can be extended to other products that target complications due to bacterial or other microbial infections or that can target other areas. We have some proof of concept in terms of reducing scar tissue formation with other drugs where these vascular grafts are used. We have very preliminary R&D type data, and we’re confident that this particular technology is a platform technology that can be extended to other products.

"The beauty of this technology is that it is a game-changer for polypropylene mesh used for open ventral hernia repair."

Medical Design & Outsourcing

5 • 2022

www.medicaldesignandoutsourcing.com

MDO: It sounds like if you can coat it, you can drug it? Jennings: We haven’t done an extensive survey of a lot of drugs, but the ones that we have used, we’re seeing the expected effect of the drug, the activity of the drug. I’m a vascular biologist by training, and my area of expertise is in the area of thrombosis. I could see many applications for clotting, for acute thrombosis that may occur when grafts or other catheters are used in patients, and it’s possible that we could mitigate clotting and reduce the extent or the generation of a thrombus during that acute period. We’re definitely interested in the orthopedic space because there’s a fairly significant incidence of infection in some of the implantable devices in orthopedics. … The platform could be pretty impressive in terms of where we could use our coating, our way of incorporating drugs and preserving their activity. Plus, we took it a step further and developed a methodology for coating devices that basically ensures that the desirable device properties are not compromised, but that we do have a consistent coating for each of the product lines. We’re very excited about our automated coating device that we can program for the appropriate coating cycles that are needed for a particular device. MDO: Does it spray? Does it dip? How does it apply that coating? Jennings: It’s more of a controlled motion. We have basically a drive system that allows us to coat the product, and then depending upon the polymer itself, how that polymerization is integrated into the coating process. It’s a controlled coating process that allows for a consistent polymer application to the device. And that’s pretty much all I can say. MDO: How soon might we see FDA approval for some of those other applications? Jennings: There’s certainly a plan. We’re a small company. We really focused on this one product, and we have over recent years developed that proof-ofconcept data to be able to move forward in some other product lines. But we’re just in the process of moving forward on strategies of that nature. Our thinking was we would continue to do R&D, but being a small company, our focus was to get this first product through the FDA.

MDO: If you could go back and give yourself a message when you were starting all of this, what would you tell yourself? Jennings: The R&D path served us well. Engaging a regulatory consultant sooner for navigating through the submission may have expedited that or shortened the timeline. We did utilize a regulatory consultant, but probably earlier than later is a good idea because they’re certainly helpful and have gone through that process with the FDA and can certainly advise a company in terms of focus and how the FDA will view the data and how much data would be necessary to gain that approval. Having someone with that regulatory expertise would be extremely helpful for companies to engage sooner than they may think they need to. Read more at https://wtwh.me/bON

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Leaders in medtech and cloud computing discuss payoffs and potential in device connectivity, product development and crossindustry partnerships.

J I M HAMMERAN D MAN AGI N G EDI TOR

f knowledge is power, that power comes from a steady stream of information, and we know there’s no shortage of that in healthcare. The challenge has long been how to capture that information, store it, analyze it and deploy it to improve medical product design, manufacturing and the health of patients. Then came the cloud, and with it a host of acronyms: software as a service (SaaS), platform as a service (PaaS), infrastructure as a service (IaaS), and — following the same convention — software as a medical device (SaMD). Over the past few months, Medical Design & Outsourcing connected with leaders in medtech and cloud computing, including the three largest providers of cloud computing services: Amazon, Microsoft and Google. They offered examples of success stories in the cloud, ways the cloud can lift medicine to new heights, and some advice for medtech insiders looking to harness the power of cloud computing. The following excerpts have been edited for space and clarity. Go to medicaldesignandoutsourcing.com for longer interviews and more on cloud computing, artiﬁcial intelligence and machine learning.

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MDO: What are some surprising and inspirational examples of what cloud computing enables with regard to medical device design, manufacturing and capabilities/performance?

Google Cloud Global Lead for Medtech Strategy and Solutions Alissa Hsu Lynch

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Alissa Hsu Lynch, Google Cloud global lead for medtech strategy and solutions: Researchers at Emory University used Google Cloud to create an algorithm that uses 71 factors to predict the onset of sepsis in patients within four to six hours with 85% accuracy, improving the time to diagnosis. [On another front], DeepMind’s AlphaFold machine learning system recently helped solve the protein structure problem, which has been a grand challenge in biology for 50 years. Research organizations can now leverage AlphaFold to better understand complex diseases and accelerate the development of new treatments, such as life-saving cures that disproportionately affect poorer parts of the world. >>

5 • 2022

Medical Design & Outsourcing

THE CLOUD IS TRANSFORMING MEDTECH

Microsoft Global Chief Medical Officer and VP of Healthcare Dr. David Rhew

Amazon Web Services Chief Medical Officer and Director of Machine Learning Dr. Taha Kass-Hout

Dr. David Rhew, Microsoft global chief medical officer and VP of healthcare: Sensoria makes a boot for diabetics to track pressure and movement and a variety of things, allowing us to pull all that data into the cloud and apply advanced analytics and AI to potentially predict pressure ulcers. We can think of putting sensors of any type on any device you wear or implant in your body. From there, the question is what do you do with the data? And that’s where artificial intelligence and machine learning can come in. Dr. Taha Kass-Hout, Amazon Web Services chief medical officer and director of machine learning: Ambra Health used AWS to expand its software as a service medical imaging data platform to five new countries in order to meet strict data security requirements. Butterfly Network is an innovator with Butterfly iQ, one of the first handheld whole-body ultrasound systems that uses AWS for making medical imaging universally accessible and affordable, providing a personalized experience for healthcare providers at drastically lower cost. Roshy Francis, GE Healthcare life care solutions chief technology officer: The pandemic overwhelmed hospital systems, and patient complexity has increased with multiple comorbidities. These dynamics require multi-specialty care teams to collaborate to make timely and accurate decisions in acute care settings. Clinical care teams can now virtually come together around a patient, with a complete picture of the patient from various systems, without having to be physically present at the bedside. We have deployed solutions on the cloud that help ensure care protocol compliance in the ICU and Labor & Delivery for timely interventions that lead to improved patient outcomes. We are now deploying solutions that allow complex procedures like anesthesia delivery to be monitored and guided by experienced anesthesiologists remotely.

GE Healthcare Life Care Solutions Chief Technology Officer Roshy Francis 50

Medical Design & Outsourcing

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www.medicaldesignandoutsourcing.com

MDO: What are some previously unthinkable advances that now seem increasingly likely to become reality? Larry Jones, Johnson & Johnson group CIO and global vice president of medical devices: Can you simulate a surgery? Can you create a digital twin of a hospital? Can you create a more personalized experience for surgery or any point of care? … If there’s an accident on the roadway and there’s trauma, shouldn’t the ambulance be the ﬁrst data collection? Leveraging the cloud, leveraging IoT (the Internet of Things) that by the time that patient gets to the hospital, the oncoming care team is already aware of everything about that patient, has the right equipment and makes sure that patient goes to the most appropriate hospital. … Healthcare should be a lot cheaper, and a lot of folks should have access to it. And I think technology can really, really help that. The art of the possible is extraordinary in a sector, quite frankly, that’s fraught with inefﬁciency. (continued on page 52)

Johnson & Johnson Group CIO and Global Vice President of Medical Devices Larry Jones

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THE CLOUD IS TRANSFORMING MEDTECH

Philips Virtual Care Solutions Business Category Leader Christine Storm

Christine Storm, Philips virtual care solutions business category leader: In healthcare, there are many data sources holding personal, operational and clinical data such as EMR, Laboratory, ECG, PACS or other data lakes. At the same time, many patients and caregivers are trying to access the information using applications or solutions along the care pathways but are struggling to access this data due to a very fragmented IT infrastructure. Digital platforms, such as Philips’ HealthSuite, provide the capabilities to unlock and integrate the data from various sources, and allow caregivers and patients to interact seamlessly with this data, and gain actionable insights from it. Rhew (Microsoft): We know the duration of a surgery has a direct impact on surgical outcomes. We now can get more granular. And that’s what’s

exciting because we’re starting to gather patient-specific information but can start also thinking about different devices and different procedures being done within, say, the surgical unit. We can then start pulling all that together and analyzing across the board, comparing hospitals to hospitals and providers to providers. There is so much variation in care, and a lot of times it’s unwarranted, and there are often best practices that can be gleaned. If we can understand what the benchmarks are and strive toward those, we can lead to better quality improvements. And that can only be done when you have data that’s accessible at the granular level, roll it up into different areas, benchmark it and allow for AI to be applied on top of it to provide real-time guidance and support and improve patient outcomes. (continued on page 54)

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THE CLOUD IS TRANSFORMING MEDTECH

D E S I G N I N G A L I F E - S AV I N G D E V I C E O N T H E C L O U D In its quest to build a better blood and vaccine cooler, Delta Development designed its Autonomous Portable Refrigeration Unit (APRU) over the cloud. The APRU refrigerates fresh blood and vaccines with a battery that lasts for days on a single charge. The cooler constantly monitors temperature and can withstand outdoor elements and extreme temperatures. Chief Technology Ofﬁcer Robert Futch shared his team’s experience using cloud tools to design, manufacture and sell the device.

“Cloud-based design had a bunch of benefits for my team. No. 1 on the list is that it didn’t slow down our development when everybody went to work from home at the beginning of the pandemic,” he said. “Onshape was a big part of this, but a few other tools like Greenlight, Dozuki, Github and good old Google Docs were also important.” Other benefits included version control, the ability to quickly scale with remote contractors, faster software bug fixes and manufacturing procedure updates, faster

collaborative reports leaving more time to design and build, and “super easy” customer support and phone call management. Cloud collaboration ultimately made employees happier, Futch said. “They have ﬂexibility and also had more time to go back to school,” he said. “It is easier to keep track of productivity as well. There’s no tribal knowledge and less supervision required. Everyone is aware of what they have to do and where to ﬁnd the right information.”

THE CLOUD IS TRANSFORMING MEDTECH

Rekha Ranganathan, GE Healthcare SVP and imaging solutions GM: Interventionalists can collaborate with each other with videos streaming realtime from cath labs or operating theaters,

especially for complex procedures, to bring the best patient care possible. With healthcare organizations moving toward value-based care models, collaboration is essential between doctors, departments, and even institutions. Medical providers can transfer data between each other through a cloud computing server, boosting cooperation, discussing dashboards and treatment options for increasing patient care and making it more personalized for better treatment. MDO: What sort of big, futuristic dreams do these or other advances inspire?

GE Healthcare SVP and Imaging Solutions GM Rekha Ranganathan

Johnson & Johnson MedTech Office of Digital Innovation Leader Peter Schulam

Medical Design & Outsourcing

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Lynch (Google): With the exponential growth of data in healthcare, the future of medtech will be about connected care. And in the future of connected care, technology will be a gateway to healthcare. I think it’s important to say that while AI has the potential to expand access to better care, we need to find ways to ensure equity, access and improved outcomes for everyone. AI technologies should work for the common good. I truly believe that big data and AI can help transform healthcare from reactive care to predictive, personalized and proactive care. But it will take all of us working together across the ecosystem — medtech and Big Tech, governments, health plans, health systems, research institutions and other stakeholders — to make this vision a reality. Peter Schulam, Johnson & Johnson MedTech office of digital innovation leader: There’s a lot of friction in healthcare, and we have to remove that friction. We’re focused on being smarter, less invasive, more personalized, but our overarching thing is we need to decrease patient outcome variability and improve operational efficiency. When we look at outcomes, we think there’s two main contributors: caregiver skill and provider judgment. And I think we have the ability through our assets that we’re innovating around to actually have impact on that. And if we do that, then we really believe that patient outcome will be improved. The standard of care will be improved. I tell everyone the variability that we see — if we narrow that variability and shift that whole curve to the right — that’s a good vision. www.medicaldesignandoutsourcing.com

Kass-Hout (AWS): Equity in care. How are we able to take all this information to provide more equitable care? Healthcare is a $7.5 trillion business globally, yet more than 4 billion people don’t have access to care — forget about highquality care, just access to care in general. I believe AI and technology have to be part of a solution to creating that more equitable access. The future of healthcare is so vibrant and dynamic right now. It’s so dependent on big data, on AI and on cloud computing. Promising innovations like precision medicine, conversational chatbots, intelligent scribes, and APIs for data and interoperability may make healthcare better and more efﬁcient and more equitable in the future. MDO: What does cloud computing mean for how medical device designers and engineers should be thinking? Schulam (Johnson & Johnson): When you’re looking at a medical device in the conventional manner, you spend a long time developing, you launch, and then you never iterate. Guess what? In the software world and the agile world, it’s exactly the opposite: a minimal viable product and multiple iterations. We have to create this hybrid innovation cycle. Jones (Johnson & Johnson): It means designing connectivity in your solution. Design with security in mind as part of the product offering. Be very proactive in what sensors you’re using, what are you designing, even to the point of what preventive maintenance looks like. Learning from Microsoft, as we’re designing products, don’t try to solve problems that’ve already been solved. There’s a lot of leverage across the board, and that’s why we’re we believe this audacious task is gonna take partnerships to do that. I remember when we had constraints on any product design. Storage was expensive. Computing was expensive. Battery life was challenging. Things like connectivity and speed, with 5G, 6G forthcoming with the cloud and being able to amass unlimited storage at a fraction of a cost, those constraints in your design aren’t as plentiful as they were in the past. I’m not a mechanical engineer, but I do believe that you’re now building without constraint.

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Medical Design & Outsourcing

5 • 2022

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Video games, software and apps are new tools for treating and managing medical conditions.

DeepWell co-founders Mike Wilson (left) and Ryan Douglas Photo courtesy of DeepWell

magine playing a video game where you are a wizard fighting for good in a magical realm. You must master control of your mind and body to increase your powers and abilities, creating a forcefield shielding you from enemies and strengthening your counterattack. In these moments of high anxiety, more control makes you more powerful, and you learn to make better choices under pressure. More than just a game, it's a futuristic component of mental health therapy as envisioned by DeepWell Digital Therapeutics, a new entry in the growing field of treating and managing medical conditions with software. "Through a lot of things we’ve seen in neurology, you can lead yourself to a place of entrainment and, over time, these are going to be preferential ways that you manage yourself," DeepWell cofounder Ryan Douglas said in an interview. His Seattle-based company launched in March with the goal of creating best-in-class gameplay that can entertain while simultaneously delivering, enhancing and accelerating treatment for an array of globally pervasive health conditions. If they do their job well, patients playing the games will be so immersed in the roleplay that they won't even think about the therapeutic side. Enjoying the roleplay makes the players more capable of learning skills and reaping the health benefits. Different applications and approaches for digital therapeutics DeepWell represents just one of many companies aiming to make waves through digital therapeutics. Each is doing things differently. "We are seeing tremendous momentum for the DTx industry, with more and more products coming to market and gaining commercial coverage and recent signals from the White House and Congress demonstrating their interest and recognition of DTx products as an important way to expand access to quality treatments for populations with public coverage, especially underserved communities,” Digital Therapeutics Alliance CEO Andy Molnar told Medical Design & Outsourcing. >>

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DIGITAL THERAPEUTICS

“While we are riding a massive swell, the wave hasn't even begun to crest. The community is expanding and convening this broad coalition of stakeholders is critical to really scale the industry and drive DTx adoption and integration to truly transform healthcare." Pear Therapeutics has been at the forefront of the effort with its three FDA-authorized prescription digital therapeutics (PDTs) for treating substance-use disorder, opioid use disorder and chronic insomnia. The Boston-based company went public through a special purpose acquisition company (SPAC) merger at the end of 2021, shortly after its fourth PDT platform received FDA breakthrough device designation for alcohol-use disorder. Pear has continued to push forward, garnering new Medicare coding for its PDTs, expanding to Japan and other new geographies, and launching a platform to offer PDTs through telehealth platforms, among other steps. Another PDT developer is Better Therapeutics, with offerings designed to deliver a novel form of cognitive-behavioral therapy for treating cardiometabolic diseases. The San Francisco-based company completed enrollment in a trial for its type 2 diabetes-treating PDT at the end of last year. Like Pear, Better Therapeutics also went public through a SPAC merger. In April 2022, the company reported positive outcomes for three studies. The research included the first study of nutritional cognitive behavioral therapy (nCBT) as a potential treatment for nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH). Yet another firm, DarioHealth, made big moves in March when it announced a $30 million partnership with pharmaceutical giant Sanofi. The companies said the deal will accelerate the commercial adoption of New York-based Dario's suite of digital therapeutics and expand digital health solutions on the Dario platform. Dario said its AI-powered digital therapeutic platform "provides adaptive, personalized experiences that drive behavior change through evidence-based 58

Medical Design & Outsourcing

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interventions, intuitive, clinically proven digital tools, high-quality software, and coaching to help individuals improve health and sustain meaningful outcomes." DarioHealth and Sanofi said they will collaborate on new or enhanced solutions to be offered through the Dario platform. "Our collaboration with Dario is another step towards accelerating Sanofi's mission of reversing the course of chronic diseases through the integration of healthcare and technology in a way that gives people the tools to improve their health," Sanofi Head of U.S. General Medicines Gustavo Pesquin said in a news release. "We are excited to help payers realize the potential digital health can bring to the patient experience, and we look forward to continuing to innovate with Dario on the next generation of chronic condition therapies."

DeepWell's plan: Make it fun DeepWell's founders were set to retire before they connected for their digital therapeutics venture. Douglas is a veteran in the ﬁelds of mental health, AI and surgical robotics, while co-founder Mike Wilson is a proliﬁc executive producer in the video game industry. (continued on page 60) www.medicaldesignandoutsourcing.com

"While we are riding a massive swell, the wave hasn't even begun to crest."

Pear Therapeutics' Somryst delivers cognitive behavioral therapy for insomnia, training the body to sleep. Image courtesy of Pear Therapeutics

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DIGITAL THERAPEUTICS

Douglas said he found hundreds of well-rounded studies showing how effective video games were at helping people, even as many of those studies had set out to prove the opposite. In March, they unveiled DeepWell Digital Therapeutics to bring therapeutic value out of video games to help ﬁght the mental health crisis most recently exacerbated by the COVID-19 pandemic. "It was only through digital therapeutics that you could get the reach to do the kind of thing that needs to happen to support therapists, psychologists and psychiatrists who are giving everything to a system that does not have a hope of winning the battle unless there are new interventions," Douglas said. "We’ve got to ﬁgure something out, so now is the time to do it." Douglas highlighted the expansive potential of video games and the array of potential indications for use as a result.

Pear Therapeutics designed the reSET prescription digital therapeutic for the treatment of substance abuse disorder. Image courtesy of Pear Therapeutics

He said the power to engage provides a great but underutilized method for therapy delivery. Could it be difﬁcult, though, to convince the masses that video games can be that therapeutic vehicle? After all, stigmas have surrounded the games for years, while Douglas even pointed out many studies he observed were aiming to expose ﬂaws. Wilson said he has long dealt with the negative perception surrounding video games in his 25 years in the industry. He blamed the corner of the industry that has been designed to take as much time from people as possible, likening it to casinos built on gambling addiction.

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DIGITAL THERAPEUTICS

But in his experience, Wilson has found the vast majority of games are not designed with that intent. While stigmas may exist, DeepWell is designing games to treat users, not consume them, he said. "People are concerned when they see people just ignoring everything else in their lives in favor of this one experience, this one addiction," Wilson said. "That’s just not what we’re going after. That’s not the intention behind these treatments." When Douglas came to Wilson with his research on the games and their appeal to different people with different perspectives, he saw the opportunity to offer new ways of thinking that so far seem only possible in gaming. In that space, having fun remains key to creating a good product, and that

opens up a new way of looking at things for DeepWell. "Most efforts in this general direction have not resulted in the most compelling games," Wilson said. "And it's literally just a perspective. It's putting the people who make the magic — the game developers — in charge. The science is in service of them, not the other way around."

"We've got to figure something out, so now is the time to do it." As far as bringing these games to market, Douglas said the regulatory environment is "pretty ﬂuid," with the FDA offering guidance and feedback. DeepWell aims to bring its games to

users over the counter as an adjunct therapy, catching people in a mild-tomoderate place. Therapists could use the games to identify when people are heading toward suicidal ideation and need speciﬁc interventions beyond DeepWell’s scope. The company hopes to launch its ﬁrst products in 2023. Development plans include DeepWell publishing its own games and working with other publishers to design their games with the intent to treat users. "We’re going to work on tools and a platform for a greater level of delivery for these games over time," Douglas said. "We’re hoping to take many that are already therapeutic and many more that are in development and bring them together for the greatest level of accessibility to people who are having these problems."

WATCH

DeviceTalks Tuesdays is a weekly virtual event that brings the insights and energy of our in-person events to your desktop. Each DeviceTalks Tuesday will kick off with a quick brieﬁng from the editors of MassDevice and Medical Design and Outsourcing. These presentations will give attendees insights on what trends will be moving medtech in the days to come

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Get ready for a great Minnesota get-together Few cities support the medtech industry like Minneapolis; here comes your chance to bring some of that energy back home with you.

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 |

Medical Design & Outsourcing

s a Boston guy, it pains me to admit another region is possibly superior to my hometown in any way. But I must admit that I’ve always envied the attention Minnesota gives to its medical device industry. It’s sad to say, but the medtech industry doesn’t carry the same star power in Boston as it does in Minneapolis. We hear about biotech companies (OK, so they did create some pretty useful vaccines recently), tech companies (Google? Amazon? C’mon) and online furniture stores (Wayfair? C’mon). 5 • 2022

But the medical device industry hums along in relative obscurity save a prominent sign on the outfield wall at Fenway for Boston Scientific. So, as a wise person once said, “If you can’t beat them, JOIN THEM!” I’m excited we’ll be plugging back into Minnesota’s medtech vibe on June 6-7 at DeviceTalks Minnesota. I’ve organized Minnesota medtech meetings in the past, and they’re always packed with energy and enthusiasm, good vibes that I bring back with me on the flight home. So we

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TIM HERBERT

PAUL IAIZZO

KEVIN LOBO

MICHAEL MCALPINE

TOM POLEN

SALLY SABA

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at DeviceTalks are looking to send you home — wherever it may be — with that same level of excitement, hope and enthusiasm for our industry. DeviceTalks Minnesota will be an event for the region’s expansive medical device community, from executives to entrepreneurs and OEMs to contract manufacturers. The two days will feature keynotes, panels and an exhibit space featuring the companies that are making the medical device industry go. You can ﬁnd the full agenda at DeviceTalks.com. But here’s a sampler: Keynotes • Tim Herbert, CEO of Inspire Medical Systems, will take us through Inspire’s successful build-out of its device to treat sleep apnea and explain where its neuro tech might take it in the future. • Paul Iaizzo, professor at Visible Heart Laboratories, will lead a panel of other medtech innovators from the University of Minnesota to demonstrate how advances in mixed reality are providing cardio device creators a better understanding of how their devices interact with the heart. • Kevin Lobo, chair and CEO of Stryker, will walk us through that company’s future as it digests medical device companies like Wright and tech companies like Vocera. • Michael McAlpine, the Kuhrmeyer Family chair professor at the University of Minnesota’s Department of Mechanical Engineering, will give a startling presentation about his work in 3D printing for chips and electronic devices. • Tom Polen, chair, CEO and president of Becton Dickinson, will discuss three irreversible forces that are changing healthcare. • Sally Saba, chief inclusion and diversity ofﬁcer at Medtronic, will sit on a panel exploring the industry’s recent efforts to improve diversity, equality and inclusion in its workforce. • Brett Wall, EVP and president of Medtronic’s neuroscience portfolio, will present the company’s view on the future of that sizzling specialty.

The sessions will include: • An Abbott presentation centered around the development of its Amplatzer Piccolo Occluder, the first medical device that can be implanted in babies weighing as little as 2 pounds. Santosh Prabhu, divisional VP of product development at Abbott Structural Heart, will lead that discussion. • Becton Dickinson leaders Dave Hickey, EVP and president, Life Sciences, and Brooke Story, worldwide president of Integrated Diagnostic Solutions, will share how the shifting role of diagnostics coincides with the transition to new care settings and acceleration of smart connected care, including artiﬁcial intelligence, informatics and robotics. In this discussion, leaders from BD Life Sciences will detail what these trends and advancements mean for healthcare providers and patients. • Inspire Medical’s Martin Abrams, VP of marketing and customer experiences, will detail how the neuromod company built its sleep apnea business through direct-to-consumer campaigns. DTC marketing is a growing force in medical device sales. Again, this is just a taste, but it’s going to be an exciting two days at the Hyatt Regency Hotel in Minneapolis. Keep checking DeviceTalks.com for agenda updates and don’t forget to register. It’ll be great to get together in Minneapolis again.

In addition to keynote presentations, we’ve also invited executives and engineers from industry leaders including Abbott, Becton Dickinson, Inspire Medical Systems, Medtronic, Philips and others to present their successful strategies and outcomes. www.medicaldesignandoutsourcing.com

5 • 2022

Medical Design & Outsourcing

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