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Medtech Trends to Watch in 2020

What were the biggest medical device trends for 2019, and what will be trending in 2020? Are there any unmet healthcare needs that medtech companies should begin to address in 2020?

  • Image by Gordon Johnson from Pixabay

    MD+DI checked in with a few medical device technology experts for our annual review of 2019 and a look ahead to 2020. Read on for their perspectives, and please feel free to offer your own in the comments. We’ve also thrown in a bonus page on unmet healthcare needs to focus on in 2020 and beyond.

    Here’s to a productive to 2020!

    Image by Gordon Johnson from Pixabay
  • Image by Gordon Johnson from Pixabay

    Digital Health

    “2019 was really the year of connected care/digital health—and there’s so much more to come,” says Ralph Hugeneck, senior director of technology at Nypro, a Jabil Company. “In recent months, we’ve seen big changes in reimbursement strategies that will influence this trend. For example, physicians are now reimbursed for working with connected care platforms. There is a huge demand in getting data from patients, whether regarding clinical trials or the everyday life of the patient, which requires a significant amount of integration—sensors that capture data, additional components in constrained space, movement in the diagnostics space to microfluidics for DNA sampling and processing.”

    Hugeneck says that while “digital strategy development has in general been getting better, faster, following the continued drive for more economical, value-based healthcare,” the trend has been “developing more slowly than expected, as many healthcare device makers evaluate their digital strategy options to acquire patient data and with validation of its use to improve patient outcomes.”

    Another trend developing is voice recognition, Hugeneck says. “The capabilities of consumer devices such as those enhanced by Amazon’s Alexa are seen in the healthcare space as potentially valuable for a range of uses, including controlling devices and in recording physician-patient conversations,” he says. “Also, in consumer device-inspired trends is auto-replenishment, a la Amazon Dash; we’ve seen customer interest in adding this functionality into the back end of ‘smart’ packaging to enable replenishment of consumables such as contact lenses and cleaning fluids via the patient’s smart phone.”

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    5G

    “Digital health is king and 5G is its crown,” says Maria Shepherd, president and CEO, Medi-Vantage. “Right now, greater than 46 million Americans, or 15% of the U.S. population, live in rural areas, according to the CDC and as defined by the U.S. Census Bureau. Rural care is the next frontier for large healthcare systems to provide care in remote areas through telehealth,” she says. “The quality and speed of a 5G network are imperative for positive outcomes. For example, 5G can support large healthcare systems through real-time transmission of large imaging files. Specialists will be able to review and advise on patient care and augment a local doctor's ability to deliver care that provide the best outcomes through remote and reliable monitoring of patients.”

    In 2020, Ralph Hugeneck of Nypro, a Jabil Company, expects “that the maturation of 5G will enable increased data flow without latency, including the video and audio capabilities vital to remote healthcare, thereby accelerating connected care strategy development.”

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    Wearables

    Wearable technologies could help address some of our greatest healthcare unmet needs, says Maria Shepherd of Medi-Vantage. While “wearable medical technology is in its infancy,” she says “a survey found that more than 58% of people are willing to wear wearable tech, making wearable technology for healthcare the source of advanced care for patients. Wearables will help patients get health support proactively and improve patient outcomes.”

    When it comes to fighting cardiovascular disease, Scott Thielman, founder and CTO of Product Creation Studio, sees the benefits wearables could provide. “Invasive procedures do save lives, but also look to influence better lifestyle choices. Apple, Samsung, and Google/Fitbit are already providing ubiquitous wearable platforms for monitoring activity and some parameters; there is an opportunity for the digital health industry to influence and enhance this trend with medical-grade monitoring that informs both care providers and patients in a reimbursable interaction. Real-time feedback helps nudge patients toward healthier choices, but an engaged relationship between the cardiologist can be a life saver.”

    And while “connected, digital solutions have been seen as risky for many years due to concerns about privacy,” says Stephanie Whalen, product development manager at NewDealDesign as well as a mechanical engineering consultant, “due to the large body of work that’s been undergoing in these areas, we’re going to see droves of companies use Bluetooth and other wireless technologies to enter the medical wearable market, for both staff and patient use.”

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    Data

    “It’s all about the data,” said Mark Wehde, MS, MBA, interim chair, Mayo Clinic Division of Engineering. “The hot tickets on the street are artificial intelligence and machine learning. And while we will see steady advances over the next year leveraging these technologies, it will likely be well into the next decade before we see them making a significant impact outside of niche markets like radiology.”

    Wehde says the big story in 2020 will be cloud migration and patient access to data. “In 2019, the Centers for Medicaid & Medicare Services proposed policy changes supporting interoperability of patient data with an aim of making it transferable through secure and standardized formats with a goal of empowering patients to better use their own personal data. Moving patient data to the cloud is a small and achievable step already being pursued by the major healthcare systems and supported by major EMR vendors such as EPIC and Cerner. Couple that with the intrusion of tech companies like Google, Apple, Amazon, and Microsoft, and we could see some significant changes to how we manage our data over the next couple of years.”

    Adds Tom Dudnyk, president of VIVO Agency: “Google has finally made their strategy known. They’ve gained access to Ascension and Mayo’s data. Many other health systems will be next. We know what happens when Google gains access to ALL the data. Disruption happens on an enterprise scale.” And “Amazon has made their strategy known. It’s not nibbling around the edges with PillPack. It’s with Cerner. They now have access to Cerner’s data. Now, they can create truly transformational disruption like they have everywhere else.” In 2020, Dudnyk predicts that “Amazon buys Cerner and turns Alexa into a virtual physician assistant that overcomes the substantial limitations of the EMR and makes recommendations on care. Doctors begin spending less time with the EMR, more time with patients, with less burnout. Alexa becomes a home-based virtual assistant and gains access to consumer healthcare data, furthering their machine learning and AI-based capabilities.”

    Alexei Wagner, MD, clinical assistant professor, emergency medicine at Stanford, sees “a shift in medtech companies moving focus and diversifying into data analytics, data collection, and digital health offerings that complement their medtech offerings.” Like Wehde, Wagner sees “a big shift to use AI and machine learning as part of their software offering.” He also sees “data analysis and AI-powered engines helping build new clinical risk scores and build on clinical decision support tools,” and expects “FDA will also clarify in more detail which types of apps require regulation” and “will take a more formal stand on whether to regulate clinical decision support tools.”

    Stuart Karten, president, Karten Design, expects more data-driven design in 2020. “Device companies have traditionally identified themselves as hardware companies, but they are transforming into data-driven hardware-software hybrids,” he says. “Data converted to the right information can drive value, especially if it's delivered where and when clinicians/patients need it.”

    Al Mashal, PhD, principal engineer, Medical Technology Division, Cambridge Consultants, believes AI advancements are helping to drive precision medicine. "Until recently, precision medicine has been associated mainly with pharmaceuticals; however, technological improvements in imaging and sensing mean that medical devices can now also be used to deliver more tailored therapies," he says. "An element of this is being driven by advancements in AI, which allow us to visualize more precisely. Another element is less expensive, higher quality imaging, which greatly increases our portable imaging capacities. Butterfly Network, with their new generation of ultrasound probe technology, is pushing the field of point-of-care ultrasound. Open Water and Hyperfine are two other ambitious companies that are aiming to make significant strides in this area. Our improved ability to collect real-time data means we can better predict the in vivo behavior of devices, bringing us closer to a virtual representation of the patient, a ‘digital twin.’ The more we can focus on the individual person, the more desirable the outcomes will be.”

    And thanks to all the digital health connectivity, Ralph Hugeneck of Nypro, a Jabil Company, says that “as systems are becoming more open, there’s more interoperability between devices, software systems, and platforms.” There are challenges, however. “The data collected by the device, for example a blood glucose meter, needs to be transferred to the cloud and then to the care provider’s EMR system. At this time, there are so many devices, disparate systems across the OEMs, and so many pieces and sources of data, that it is particularly challenging to aggregate and analyze that data to make decisions at the disease state level,” he says. “Providers, OEMs and hospital systems are all seeking standards in order to get a system in place wherein providers can upload data from devices to multiple systems.”

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    Robotics

    David C. Brooks, MD, director of minimally invasive surgery and program director of the advanced minimally invasive fellowship at Brigham and Women’s Hospital (BWH), thinks “the dispersion of robotics into numerous different abdominal surgeries, despite my disbelief, has been one of the biggest trends. This is significant because it validates what Intuitive has been saying for the last decade.”

    Scott Thielman of Product Creation Studio says that “Intuitive Surgical’s success over the last two decades convinced the medtech world that robots will be taken seriously by surgeons. Now with startups like Virtual Incision and acquisitive-crazed strategics like J&J and Medtronic all poised to enter the market in 2020, things are going to heat up fast. Expect the next robotic surgery wave starting in 2020.”

    “The field of robotics is on fire,” adds Bryce G. Rutter, Ph.D., Founder & CEO, Metaphase Design Group Inc. “All the major players now have a stake in this game with a wide variety of technical strategies. Over the next two years we will see how this active market space evolves and how players like Medtronic, Stryker, Intuitive Surgical, Verb, Transenterix, Titan, and others carveout unique areas of specialization.” Rutter says that in 2020 Metaphase will be deeply involved in the research and design of advanced robotic surgical systems, smart instruments, and next generation wearable drug delivery devices and remote monitoring systems that interlace digital solutions (app’s, websites, services, etc.) with physical products.

    Tom Dudnyk of VIVO Agency predicts that in 2020, orthopedic implants will “get standardized on a single robotics system.”

    And Mark Wehde of Mayo Clinic Division of Engineering expects another healthcare role for robots. “Robots have becoming more and more common in our larger healthcare systems. The high-tech robots like the daVinci system and the Mazor get a lot of press,” he says. “And they should—they are amazing machines and over the next decade are going to help our surgeons be more exacting and precise in their operations and they will allow us to provide high-quality care through assisted surgeries performed over long distances. However, it is another class of robot that is poised to dramatically change not only healthcare, but society—the rise of the smart robot. Japan has been leading the way in the development of personal care robotics, driven in a large part by their rapidly aging society. Now, leveraging the promise of AI and deep learning, these more-general-purpose robotics are poised to take over a myriad of tasks in a healthcare organization including housekeeping services, patient transport, and drug dispensing. These applications are not quite as splash worthy, but they will have significant impacts on cost.”

    Lance M. Black, MD, MBID, associate director, TMCx, TMC Innovation, tells MD+DI that "ABB robotics just moved into our campus with the sole purpose of exploring the healthcare industry with their robotic platform, an area this company has not been in historically. They are canvasing hospital labs, pharmacies, and other non-treatment areas that would benefit from automation using a technology that mimics a pair of highly-articulated robotic arms." 

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    Personalized Medicine Thanks to Additive Manufacturing

    “Additive manufacturing has made its way into our healthcare system,” says Mark Wehde of Mayo Clinic Division of Engineering. “These 3D printers are now being used for both anatomic models and cutting guides to help surgeons prepare for extremely exacting surgeries. More and more they are finding application in the creation of simulation models used in augmented reality applications, allowing surgeons can practice a surgery before they go to the patient. More recently, with the advancing quality of metal printers, the holy grail of patient-specific implants at the point of care is upon us. Hospitals are already implanting 3D-printed models using both PEEK (a thermoplast) and titanium. There are several manufacturers who provide these custom-printed implants. Within the next year or two we will start to see some hospital systems printing some of their own implants, and we will start to see studies aimed at evaluating the outcomes when we provide patient-specific replacement parts closely modeled to the patient’s own anatomy.”

    Stephanie Whalen, product development manager at NewDealDesign as well as a mechanical engineering consultant, says that “accessibility and process development in 3D printing has opened the way for both more-advanced device construction as well as more custom treatment solutions. I expect to see more of this in 2020.”

    Ralph Hugeneck of Nypro, a Jabil Company, says that 2019 saw significant developments within additive manufacturing such as “a dramatic increase in the range of available materials, while costs have decreased. I expect both of these trends to continue in 2020. More specifically, there will be an increase in medical and healthcare devices made with complex polymers produced by AM vs. injection molding, while in metals, the orthopedics space—knee and shoulder joints, spinal components—will continue to embrace AM’s ability to produce complex parts faster and at a lower cost.”

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    IVDs

    Personalized medicine is also advancing thanks to advances in in vitro diagnostics technology. “Personalized medicine will continue to make inroads with point-of-care assays and devices to support various new therapies,” said Scott Phillips, CEO and founder, StarFish Medical.

    For instance, the in vitro diagnostics market is “booming,” says Stacie Depner, engineering program director of Symbient Product Development. “In the not-so-distant past, having the DNA genome sequenced as well as a trend toward more-personalized healthcare and an increasing prevalence of infectious diseases have led this market to be booming in 2019,” she says. “We’re in an era of time in healthcare where people want more answers, more information, and with the trend of machine learning, it’s only going to keep soaring while more and more correlations prove to be causations.” Depner says the in vitro diagnostics market has been the largest and fastest growing within Symbient’s focus. The firm specializes in disposable medical products. "This diagnostics market makes up 70% of our revenue and 'the global in-vitro diagnostics market [that] was valued at USD 61.22 Billion in 2018 is predicted to reach USD 87.11 Billion by 2026, exhibiting a CAGR of 4.5%.' "

    A trend Depner would like to see “align into 2020 and beyond is the integration of more sophisticated diagnostics into wearables. The wearable market is projected to continue an accelerated growth,” she says, pointing to a global market for wearable medical devices expected to grow from $8.9 billion in 2018 to $29.9 billion by 2023 at a compound annual growth rate (CAGR) of 27.5% for the period of 2018-2023. “However, the majority of that market to date has been made up of me-too wrist-worn devices that track basic vitals and performance information. I’m looking forward with the hope that more devices such as Eccrine Systems’s Sweatronics that 'will enable prescribers to optimize pharmacotherapy—helping to solve a $500B/year problem for U.S. healthcare' continue to hit the market. Further integrating hot trends in the diagnostic and wearables markets along with gaining insights through machine learning will revolutionize healthcare.”

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    Less-Invasive Medicine

    Another trend is the advancement of less-invasive devices, observes Al Mashal of Cambridge Consultants. “Neuromodulation technologies continue to be a great example of this trend. There are many startups developing devices that either deliver therapy transcutaneously or have implants that can be placed with only a few small incisions,” he says.

    Scott Thielman of Product Creation Studio says there are a growing number of therapies available based on monitoring and stimulating electrical signals within selected nerve circuits. “In 2019, these represent a significant market in the device space. Spinal cord stimulation (SCS) — a large portion of neuromodulation devices — represented $2.5bn as recently as 2017. In a society suffering with opioid addiction, non-pharmacological solutions began to get serious attention in 2019,” he explains. “At Product Creation Studio, we have seen an uptick in inquiries for invasive and non-invasive therapies that stimulate a response in the body using electricity or electro-magnetic fields. Peruse the listof treated conditions on the International Neuromodulation Society’s website, and you might be ‘shocked’ at the potential range of device applications. 2020 will see a broader range of targeted neuromodulation therapies hit the market."

    And “from a surgical intervention point of view, recently acquired companies like Auris and startups such as Vicarious Surgical are leading the way with smaller, more dexterous robots that can maneuver to difficult-to-access regions of the body,” says Mashal.

    Perry Parendo, owner of Perry’s Solutions, says that “miniaturization continues to be important for the medical device industry. Small sensors and electronics allow capabilities that expand configuration options.”

    In 2020, medtech must continue to invest in interventional cardiology, says Thielman. “In the U.S., cardiovascular disease (CVD) continues to be the largest killer. Meanwhile, other industrialized nations have seen CVD fall to the number two killer behind cancer suggesting that we have work to do to improve circulatory care. For those of us involved in the development of interventional cardiac tools, 2019 brought further headwinds when data from the ISCHEMIA study suggested that stents and bypass are no more effective at preventing death than drug and lifestyle changes for stable heart disease. (Interventions were more effective at reducing chest pain, however.)”

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    Care outside the Hospital (aka Home Care)

    Remote monitoring, testing, and treatment were trends in 2019, observes Lance Black of TMCx, TMC Innovation. “From diagnostics capable of being completed at home to transitioning care from hospital to another setting only feasible through wearable monitoring tools, this trend is becoming more refined, in that a number of these technologies and supportive companies are realizing specific cases that demonstrate a clear value proposition,” he says. “An example is a company called Patch’d, monitoring blood pressure and heart rate to predict sepsis in those high-risk patients being discharged. The capability of this company to demonstrate real financial return to the hospitals all the while allowing those institutions to extend their reach into the home of the patient is a great example of this trend.”

    And this “wave of pushing healthcare out of the hospitals/clinics and to the home is just beginning,” he adds. In 2020, “we will definitely see more technology supporting telehealth, remote monitoring, and at-home care,” he says.

    Stephen B. Wilcox, PhD, FIDSA, principal of Design Science, saw “two strong, intertwined trends” in 2019: “an acceleration of one that’s been going on for some time—the movement of devices from the hospital to the home—and the impact of the internet of things, which is transforming devices into interconnected and adaptive systems,” he says. Wilcox offers the examples of “home dialysis systems that send data to the cloud, where it can be used by physicians, researchers, and biomeds responsible for servicing the equipment,” as well as “all sorts of home drug-delivery devices that send data to physicians and the patients themselves, and, of course, increasing sophistication with interconnected diabetes-care systems and cardiac implants.”

    Wilcox expects these trends to accelerate even more next year as the internet of things matures. “We’re thinking that 2020 is the year for two big things to happen—the final arrival on the market of closed-loop ‘artificial organs,’ probably starting with systems that connect continuous glucose monitors with insulin pumps, and the arrival of a whole new generation of interconnected large volume pumps that really take advantage of the internet of things, allowing remote programming and data transmission,” he says. “The latter were set back by the serious problems a few years back that led to recalls and a new FDA guidance on the subject. The delay means, I think, that we’re going to see a quantum leap in the nature of LVPs.”

    Telehealth could be even bigger in 2020 than it was in 2019, predicts Scott Thielman of Product Creation Studio. “We are finally using telehealth! 22% of physicians report having used the technology in 2019 vs. just 5% in 2015. We know it wasn’t the tech gating this one, so why has it taken so long to get people in front of providers without getting on the road to the clinic?

    “We have an aging population of tech-savvy patients (even Boomers own smartphones now) who want more instant information and want to spend less time traveling to and from clinics. On the flip side, burned-out clinicians are ready to embrace digital augmentation to speed their clinical workflows,” Thielman adds. “Remember, physicians are a segment that has been glued to their pagers and phones for decades already; the addition of video consultation doesn’t seem like a quantum leap here. We’ve also given the solution providers time to create some robust interfaces ready for adoption. Perhaps most critically, the reimbursement situation continues to improve with expanded coverage in 2020 for Medicare Advantage plans. So, by the end of 2020, I predict that most of us will have used telehealth services to ask our healthcare professional if we should be concerned about this mole, or this cough, or this fever.”

    The aging population and the shifting points of care are leading to new medtech solutions, observes Stuart Karten of Karten Design. “Because of the greying of our population, and the resulting disruption in healthcare, we’re seeing a rapidly shifting ecosystem, in which a new type of medical device is emerging,” he says. “For example, with Axonics, we transformed an innovative technology into a complete ecosystem of physical and digital products that improve the experience of people suffering from incontinence. With Axonics, and many of our other clients, we’re seeing a shifting ecosystem in which the point of care has moved from traditional settings. Based on our medtech clients’ success in the marketplace, we're seeing evidence of a pent-up demand for new types of patient-centric innovation.”

    Finally, “the hospital of the future will be reserved for those who are truly sick, requiring constant care, attention, and a host of expensive equipment,” believes Mark Wehde of Mayo Clinic Division of Engineering. “For the rest of our care? We can expect to see a return of the house call—that antiquated model of the traveling physician will be once again in vogue. But for this to happen, we need to create the virtual hospital of the future. Mercy Virtual Care Center is the world’s first hospital without beds, but it won’t be the last. The advances in home healthcare and telehealth are allowing physicians to visit their patients virtually in many cases, and when an in-person visit in needed, it’s the physician that goes to the patient. For many, many conditions we don’t need to stay in the hospital. In fact, often our mental health and recovery will be better in a familiar environment. Couple this with the incredible advances in connectivity, including the about to be released 5G network communication protocol, and we are likely to see more and more hospitals avoiding major and expensive growth and remodeling by simply sending many of their less-critical patients home. Organizations have been leveraging network connectivity and medical devices for telemedicine and home health monitoring for over a decade (decades really if you include some of the early ECG monitors that sent data from the patients home to the clinic over a phone line as early as the 1980s). But the intersection of cloud data storage, almost university connectivity, and the ubiquity of wearable consumer devices, and suddenly it seems that home monitoring is not only possible, but inevitable. This will lead not only to the home hospital, but also an associated concept of home healthcare. Patients will routinely be sent home with long-term monitoring devices to track their health and leveraging AI to report to their caregivers at some point in the future when the patient’s healthcare status changes.”

    Tom Dudnyk of VIVO Agency sums it up this way: “2020 is the year of delivering patient care to the home.”

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    User-Centric Approach

    Stuart Karten of Karten Design sees trends toward what he calls “Prosumer Medtech,” saying that “more and more devices are being put into the hands of patients. They expect consumer-level experiences. There is a growing demand and investment in making medical devices easier and more empowering for all. In 2020, I expect this shift to take hold with the value of design taking on a higher importance as consumer products companies flex into the healthcare space.”

    In 2019, “many product development efforts [were] fully embracing usability and human factors more than ever before,” observes Stephanie Whalen of NewDealDesign. “FDA guidelines for human factors studies, although released a few years ago, have produced an attitude shift for med device product development. There’s a renewed focus on ease of use during procedures and for patients.”

    Wilcox of Design Science believes that the rise of home care and the maturing of the internet of things will “make it even more imperative that devices be easy to use.”

    Adds Bryce Rutter of Metaphase Design Group Inc.: “Biologics and drug-delivery devices are in a transformational period. Devices in the market today are mechanical design platforms in search of delivering Pharma's next wonder drug, with little to no consideration of the end-user. User-centered design will transform this market sector by spinning out designs that are driven by usability and intuitiveness while preserving the dignity of the user.”

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    Sterilization Challenges

    EtO sterilization has come under new scrutiny this past year, presenting challenges for users. “If the issue [of] insufficient cleaning, disinfection, or sterilization of medical devices leading to hospital-borne infections wasn’t enough, now we are losing capacity in one of our major sterilization modalities—ethylene oxide sterilization," says Mark Wehde of Mayo Clinic Division of Engineering. "The challenge is that while there are other, safer sterilization modalities such as hydrogen peroxide and ozone are available, they are not widely disseminated nor have most of the existing surgical instruments been tested with those sterilization processes. This will continue to present a significant challenge to healthcare systems in 2020."

    There were also challenges surrounding reusable duodenoscopes. But Wehde points to recent progress: "On a positive note, Boston Scientific recently released a single-use duodenoscope, which is a significant advance in the prevention of hospital-caused illnesses. Devices like duodenoscopes are notoriously difficult to effectively clean and disinfect and have been implicated in several outbreak at hospital systems over the last decade, and it is nice to see a good solution for this problem.”

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    Startup Challenges

    “As the consolidation of large ‘strategic’ companies continues, startups will get squeezed. In order to attract capital, there will be more need for startup medtech companies to carefully consider the market dynamics of their field and ensure there are multiple exit partners,” said Scott Phillips of StarFish Medical.

    Perry Parendo remains optimistic for 2020: “Small and startup companies are showing high confidence, and [they] will be an important technology source and a significant contributor for job growth. This will make our ability to manage pure technology projects an important skill set to understand and improve.”

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    Healthcare Economics

    There appear to be several changes in the economics of healthcare.

    For instance, “the slow rise of episode-of-care payments and managed care will result in new opportunities for medical technology startups. New value propositions will emerge that enable device buyers to benefit from savings in other areas of the care continuum,” said Scott Phillips of StarFish Medical.

    Tom Dudnyk of VIVO Agency says that care reached a tipping point in 2019. “Health systems stop overfunding inpatient and begin allocating strategic resources to outpatient,” he observes. In 2020, he predicts several shifts that could impact the economics behind healthcare:

    • “Hospital price transparency makes clear how health systems are dictating prices, not payors.
    • “Bundled reimbursement moves from knee replacements to cardiovascular procedures.
    • “Vendor standardization gets serious as health systems make massive sole source decisions and partner with vendors in a more integrated fashion than ever before
    • “PCPs start losing patients to real time apps that provide immediate service, refills, etc.
    • “After years of vertical integration, companies will focus on horizontally integrated solutions that close gaps and deliver seamless care. This means acquisitions will be taking place that unify software, devices, and consulting services in a single company.”

    Stephanie Whalen of NewDealDesign would like to see the trend of lowering procedural and financial barriers continue. “From enabling outpatient procedures to at-home care, companies that pave the way for more procedures to be carried out in comfort and with ease will increase user compliance and drastically reduce healthcare costs,” she says.

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    Global Regulatory Changes

    Referring to a "global regulatory see-saw," Scott Thielman of Product Creation Studio says that “in 2019, the reality of MDR finally began to sink in. In 2020, it becomes the law of the land in the European Union. It is already changing the way that medtech startups look at the world. Formerly, a Europe-first approach was common-place as firms would seek the CE mark prior to making an FDA submission. MDR significantly throttles the predicate pathway making EU approvals far more challenging for many device companies. Meanwhile, under the guidance of Jeff Schuren, our own FDA has increasingly embraced experimentation and innovation over the last decade. For medtech entrepreneurs, a U.S.-first approach will be the norm in 2020.”

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    Unmet Clinical Needs

    Despite the progress highlighted in this feature, there are still plenty of unmet healthcare needs begging for medtech solutions.

    For instance, “the always-present sepsis, hospital-acquired infections, and non-opioid options for pain control continue to be largely unaddressed,” says Lance Black of TMCx, TMC Innovation. He points to some progress in sepsis treatment and monitoring: “We have seen a lot of recent interest around combating sepsis from startups, governmental agencies, and other hospitals. In 2019, we have supported companies responsible for predicting sepsis (Luminare), monitoring for sepsis (Patch’d), and treating sepsis (PATHEX).” However, sepsis remains “a large healthcare burden that is ripe for technology to have a significant role in.”

    Scott Thielman of Product Creation Studio says that “the high prevalence of fatty liver disease, 20%-30% in the U.S. population, is underappreciated. The more serious form, steato-hepatitis (NASH), may make up 5% of the population. With mild initial symptoms, this disease often progresses to liver fibrosis, cirrhosis or cancer before the patient seeks treatment. There is a need for more prevalent, lower-cost diagnostic tools and interventional or pharmacological therapies.”

    Thielman also believes that medtech could play a role in addressing the increase in suicide observed since increased since the turn of the century for the United States. “Deaths of despair are avoidable if support networks can be alerted and appropriate interventions and therapy provided,” he says. “But, the varied causes make the problem of identification very complex. There is a need for better and more broadly applicable suicide diagnostics, perhaps involving AI techniques. Often counseling and treatment with pharmaceuticals is part of the therapy, but there are many places where medtech companies can help. Adherence to therapy is critical, an aspect that digital health is particularly suited for. And, expect a growing role for neuromodulation techniques.”

    Stuart Karten of Karten Design describes a changing healthcare ecosystem and encourages medtech companies to address the needs of an aging population as well as the needs of unpaid caregivers. “The proportion of older people in the general population is steadily increasing worldwide, with the most rapid growth in low- and middle-income countries. An aging population has important implications for health systems, labor markets, public policy, and family dynamics,” he explains. “Medical device companies need to respond to the changes by understanding that we are in an era of transition, and leverage digital technology and design to address the chronic conditions--kidney disease, diabetes, heart disease, dementia, and others--resulting from our greying demographics. Today’s devices must fit into the new healthcare paradigm, and fully understand every voice in the ecosystem.”

    Ralph Hugeneck of Nypro, a Jabil Company, points out a few other unmet needs. One, “especially for pharma, is for the ability to produce a continual, real-time assessment of patient data,” he says. “An example is the call for a wristband to be worn by epileptics, that measures 20 different health parameters and by so doing, can predict when seizures will occur. This will alert the provider, who can then analyze the data and immediately make a recommendation to the patient on what actions to take—medication, not to drive, etc. This hasn’t yet been created, but there is demonstrable demand.

    “Lastly, the use of patient monitoring in the context of clinical trials is currently an unmet need, but one that I anticipate will be met in 2020,” Hugeneck continues. “Currently, data gathering in clinical trials is done manually, requiring considerable time and effort. The use of digital wearables by client participants to secure life data such as heart rate, temperature and other health indicators, would be a true game changer for clinical trials. Much more life data would be gathered with much more ease and with many more patients, ultimately cutting down lead times for clinical trials and enabling ease of more educated decisions.”

    There’s also another area “open” for innovation, says Stephanie Whalen, product development manager at NewDealDesign as well as a mechanical engineering consultant: “Managing hospital soundscapes/approaching medical design with sound management in mind—hospital background noise and competing alerts that are hard to localize are costing countless lives and money, not to mention the needless anxiety it causes patients and visitors. There’s a lot of opportunity to make this a better experience for everyone in a hospital environment,” she says.

    Image by Hebi B. from Pixabay

Daphne Allen

Daphne Allen is editor-in-chief of MD+DI. Daphne has covered medical device design, manufacturing, packaging, labeling, and regulatory issues as well as pharmaceutical packaging and labeling for more than 20 years. She previously served as executive editor of Pharmaceutical & Medical Packaging News and also served as an editor for Packaging Digest. Follow her on Twitter at @daphneallen.

 

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