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What Will 2019 Bring for Medtech?

  • Healthcare is definitely changing, evident from several developments in 2018. While payers and providers have been working for some time to improve healthcare quality while reducing costs, this year we saw medtech respond with new solutions for improving care, expediting it, even bringing it to the home. New medical devices and diagnostics—particularly digital health technologies—are enabling patients to participate more in their own care. And providers are starting to put disrupters such as artificial intelligence and robotics into action in hopes of improving efficiency and outcomes.

    Such healthcare shifts are occurring at a time of regulatory change, given the European Union’s Medical Device Regulations (MDR) and FDA’s potential revamp of the 510(k) process.

    To predict how 2019 could unfold, MD+DI looked back over 2018’s progress. We also checked in with a few healthcare and medtech experts for their perspectives. We’d love to hear your predictions, too, so please comment below or email [email protected]

    For a live discussion on what medtech can expect this year, please join MD+DI News Editor Amanda Pedersen as she moderates the panel, “What’s in Store for Medtech in 2019?” at MD&M West on February 5.  The panel will include Mike Devereaux, partner and director of manufacturing, distribution, and plastics industry services, Mueller Prost; Bryan O'Byrne, chief of international affairs and trade policy, U.S. Small Business Administration; Yarmela Pavlovic, partner, Hogan Lovells; and Vicki Barbur, senior director, IP and technology commercialization, commercial business, Battelle.

  • Digital Health and Connected Devices

    There’s no question that 2018 has been the year of digital health, and 2019 could be even bigger. The year 2018 kicked off with a number of digital health ideas highlighted at CES 2018, including products like Diabeloop using Bluetooth to help managing Type 1 diabetes, which has since received the CE Mark in Europe; and the BoneTag for tracking and identifying orthopedic implants.

    Medical Design Excellence Awards 2018 winners offered connected solutions for monitoring, such as MoMe Kardia and the Podimetrics Remote Temperature Monitoring System. Digital health was also popular among MD+DI’s audience—Beta Bionics was chosen as the Readers’ Choice Medtech Company of the Year given its own artificial pancreas iLet, currently authorized as an investigational device.

    The “Medical Internet of Things” was selected by attendees to one of our 2018 Webinars as one of the top healthcare technologies that offer the biggest disruptive potential to business over the next three years. Attendees of MD+DI’s Webcast, “Top Trends to Watch in Medtech” with Arda Ural Ernst & Young LLP, selected medical IoT as the top trend (33.9%), just ahead of artificial intelligence (30.5%) and genetic technologies (18.6%).

    And digital health funding continues to be impressive. According to venture fund Rock Health, 2018 investments in the digital health sector hit $3.4 billion by June.

    Vicki Anastasi, ICON’s VP and global head, medical device and diagnostics research, expects the adoption of digital health technologies will “likely be broad and rapid,” given that “healthcare systems are realizing the cost savings and impact on patient care that digital health technologies can bring.” In 2019 she expects that “we will see the use of real-world evidence for regulatory decision-making, either in addition to or as a replacement for traditional randomized clinical trials. We also expect an increase in the use of digital health technologies to influence patient-centric clinical trial design. Additionally, advanced computing has the potential to optimize dosing models and better predict cell and drug interactions.”

    Anastasi also believes that in 2019, “mHealth devices will go beyond supporting other therapies to being full-fledged Digital Health treatment devices. FDA is encouraging the development of Prescription Digital Therapeutic (PDT) devices – freestanding apps that help patients manage chronic diseases and behavioural disorders. Newer devices will use algorithms, AI, and machine learning to develop and guide customized patient self-care, and data will be streamed to a one-touch point, cloud-based database. Also, the potential of digital health technologies to improve treatment efficacy and transform healthcare delivery makes them attractive development targets, as part of device or drug programs or as free-standing products. As the healthcare industry moves toward value-based purchasing environments, their data-driven nature will give them an advantage in demonstrating efficacy.”

    Ralph Hugeneck, senior director of technology at Nypro Healthcare, predicts that the launch of 5G will have a big impact for high-performance communication. The Internet of Medical Things will be a hot medical technology in 2019, he says, adding that “technologies supporting low-bandwidth, low-power, and low-cost communication technologies will mature.”

    FDA also encouraged digital health innovation, expressed in a September 2018 statement that also mentioned the Apple Watch. Speaking about the Apple Watch announcement regarding ECG measurement, Hugeneck of Nypro said “the most significant thing was not the announcement of the functionality, but the speed at which Apple was able to get FDA certification,” he told MD+DI.

    And while we expect to see even more new ideas in digital health devices for patient use, we also may see an increase in connectivity for more traditional medical technologies used by clinicians.

    For instance, MDEA silver winner StealthStation, S8 Medtronic’s surgical navigation system for cranial, spine, and ear-nose-throat procedures, offers wireless connectivity to hospital and medical devices, while the MDEA bronze winner IntelliGuard Linked Visibility Inventory Station tracks medication in hospitals.So for 2019 and beyond, expect to see more connected sensors as well as a connected approach to the convergence of medical devices and pharmaceuticals for drug delivery.

    Frost & Sullivan’s Sowmya Rajagopalan, industry principal, told attendees at The MedTech Conference 2018 that the smartphone will be the new medical device accessory for clinicians. “Smartphone apps for diseases that impact the quality of life are a welcome change,” she said, mentioning efforts toward solutions for respiratory diseases, mental health, cardiology, and diabetes.

  • Data Management

    With all this connectivity, expect an explosion in data that need to be analyzed quickly, remotely, and securely. Some of this data will be collected and shared with patients and clinicians as needed; some of it will be acted upon automatically through algorithms and artificial intelligence. All data will need some sort of storage and analysis, and it will need to be protected in some capacity.

    Hugeneck of Nypro Healthcare expects to see in 2019 the “surfacing of meaningful functionality and business models for IoT, artificial intelligence and data analytics.”

    David Niewolny, director, market development, healthcare, at Real-Time Innovations (RTI), told MD+DI earlier in 2018 that by 2025, most hospitals will have the ability to network connect more than 90% of their devices. Medtech companies will need to help such users address the challenges with implementing such connected devices, such as reliability, security, interoperability, and scalability.

    Cybersecurity concerns have also prompted regulatory action, and for good reason. Mark Vilicich of CentrexIT, a managed IT services provider, commented to MD+DI author Mike Ford that “The medical/healthcare industry last year accounted for more than 23 percent of total breaches in 2017, resulting in the exposure of more than five million patient records,” as reported by Merlin International and the Ponemon Institute with a survey of more 600 executives.

    Vicki Anastasi of ICON says that “as the number of connected medical devices increases, so does the threat that a hacker could disrupt or disable products, putting patients at risk. This means device manufacturers will need to implement a coordinated cybersecurity vulnerability strategy to promote patient safety.”

    She points to several new FDA guidances released in 2018 for addressing cybersecurity provisions in medical device premarket applications, while also addressing post-market cybersecurity issues. “In July, FDA released a Medical Device Safety Action Plan. In October, FDA and Homeland Security announced a new framework to coordinate medical device cybersecurity efforts. Also, in the same month, FDA published a cybersecurity playbook with Mitre Corp. In addition, the EU General Data Protection Regulation came into force in May 2018, which means manufacturers will have to comply with new personal data collection, consent, and privacy regulations,” she explains.

  • Greater Comfort with Artificial Intelligence

    Could AI help further in 2019? In 2018, AI demonstrated that it can analyze healthcare imaging data efficiently. For instance, MDEA 2018 finalist PowerLook Tomo Detection uses AI “to optimize breast tomosynthesis reading efficiency, streamline workflow, and support cancer detection without compromising reading performance or increasing recalls.” A recent study demonstrated iCAD’s solution cut radiologists’ reading time by more than half.

    Another AI-based algorithmic tool, InferRead CT Chest scan, can detect and characterize pulmonary nodules from chest CT scans as well as pulmonary artery calcification, bone fracture, and chronic obstructive pulmonary disease. And MaxQ AI has developed FDA-cleared Accipio Ix for detecting intracranial hemorrhage (ICH) when used with noncontrast computed tomography (CT). 

    We’ve also seen AI put to use for analyzing data associated with other conditions. As mentioned earlier, the iLet Bionic Pancreas from Readers’ Choice Company of the Year Beta Bionics uses AI to analyze data from a continuous glucose monitor to control blood glucose levels. And Bay Labs’ EchoMD is being integrated into Edwards CardioCare platform for investigational use to retrospectively analyze echocardiograms.

    Significant change could be in store for healthcare. Tom Dudnyk, president, VIVO Agency, believes that “Panic is good. Google and Amazon are hovering overhead, and AI is ready to upend existing care models and medical disciplines. The panicked and highly motivated provider community is finally embracing self-disruption or reinvention from within. New behaviors like cross-departmental teamwork and horizontal disease-state management are being adopted, which will ultimately provide better outcomes.”

    In 2019 we anticipate that clinicians and patients could become more comfortable with AI assistance, which could encourage other medtech innovators to step forward with potential new uses.

  • Advancement of 3D Printing

    MD+DI Medtech Company of the Year 2018 Finalist Conformis has shown how 3D printing can help deliver patient-centered solutions. The company uses CT scans to capture a patient’s precise bone measurements and then its iFit Image-to-Implant technology to produce customized implants. Single-use instruments tailored to those patient-specific implants are then 3D printed. Study data shared in 2018 showed better patient outcomes in terms of fit and alignment as well as a reduced need for revision surgery.

    Another study, that of Stryker's 3D-printed Tritanium cages used in spinal fusion, showed that the products "exhibited significantly greater bone in-growth and biological fixation capabilities compared to traditional PEEK cages, and plasma-sprayed titanium-coated PEEK cages in sheep," MD+DI reported.

    At MD&M Minneapolis, keynote speaker Michael McAlpine, Benjamin Mayhugh Associate Professor of Mechanical Engineering at the University of Minnesota, shared his team’s research in 3D printing neural regeneration devices for peripheral and central nerve repair. Studies involved 3D printing a silicone nerve guide conduit that matched the original structure of the branching bifurcating nerve injury. His team also collaborated with another researcher to convert skin cells into stem cells and then 3D print scaffolds incorporating cells with up to 75% viability.

    And Biolife4D shared news that it had developed a cardiac patch using a highly specialized 3D printer designed to protect living cells during the printing process. 

    For 2019, Perry Parendo of Perry's Solutions LLC says that “with the expansion of 3D printing equipment capabilities and a much wider variety of material options, the potential opportunities for patients are at record levels. However, FDA guidance regarding additive manufacturing is an indication that this area has also been like the Wild West. The opportunists who are looking for short cuts will be separated from the true entrepreneurs who are doing the right things for the long term.” Parendo spoke at MD&M Minneapolis 2018 in the session, “Getting Your Product Performance to the Next Level." 

    And Hugeneck believes that for additive manufacturing in 2019, the “availability of more materials and reduction of material costs will boost the feasibility to replace injection molding with this technology.”

  • Demand for Faster, Better, More Economical Healthcare

    Increasing procedure efficiency and safety while reducing hospital stays aren’t new trends by any stretch, but in 2018 we saw medtech solutions lending a helping hand.

    MDEA 2018 winners VersaOne Fascial Closure System, Minne Ties Agile MMF, and CleanCision Wound Retraction and Protection System each offer their own ways for making procedures safer or more efficient. VersaOne Fascial Closure System is designed to deliver consistent port-site closure, added procedural efficiency, and ease of use, Medtronic reported. Minne Ties presents an efficient alternative to wiring a jaw shut with less patient impact, while CleanCision offers a new solution for irrigating abdominal incisions to fight surgical site infections. MD+DI’s audience selected CleanCision as the Readers’ Choice MDEA winner.

    And while robots aren’t ready to take over in surgery, they are definitely lining up to help doctors. One expert MD+DI talked with in 2018 reported nearly 60 robotic platforms under development or in use. And at the 2018 Transcatheter Cardiovascular Therapeutics 2018 (TCT) conference, Corindus Vascular Robotics's new CorPath GRX System was used to perform the first live transmission of a hybrid chronic total occlusion PCI using both manual and robotic techniques to successfully treat a patient suffering from a complete coronary artery blockage.

    Miniaturization is also enabling novel treatments while lessening their procedural impact. Axonics’s miniaturized neuromodulation device to urinary dysfunction and fecal dysfunction entered studies this past year, while implantable bioelectronics employing electrical impulses to regulate the brain and/or nervous system are emerging to treat chronic inflammatory diseases such as rheumatoid arthritis and Crohn's Disease.

    Diagnostics are also helping determine treatment much faster at the point of care, which could help prevent the unnecessary use of antibiotics. For instance, Abbott’s ID NOW boasts the fastest-ever time to influenza A and B test results. Another technology evaluates distinct light-scattering signatures in samples to discern Ebola from other diseases.

    Self care is also becoming easier for patients. MDEA winner Taltz from Eli Lilly and Co. for severe plaque psoriasis and psoriatic arthritis is provided in both autoinjector and prefilled-syringe form to suit different users. Wearables (often employing digital health) are allowing patients to monitor and care for themselves. Apple Watch 4 grabbed headlines for bringing mobile ECG to Apple users, and AliveCor demonstrated that its mobile ECG technology could help rapid diagnosis and treatment of heart attacks, according to a study presented at the 2018 American Heart Association’s Scientific Sessions in Chicago. Pear Therapeutics launched reSET-O, an app used to help those with opioid use disorder stay in recovery programs.

    For 2019, Perry Parendo believes that “in the near term it will be less about specific therapies, but instead about systems to streamline health care operations and increase effectiveness and compliance of treatments,” he told MD+DI. “I would like to see broader systems of collaborative standardization between insurance companies and providers developed, but that likely will not be during 2019.”

    Hugeneck of Nypro Healthcare expects to see a continued drive for value-based care.

    And Dudnyk of VIVO believes telemonitoring and telemedicine will be key in 2019. “The home setting is much more cost-effective than the acute setting so expect more treatment strategies to bring hospital-based therapies into the home. Telemonitoring will be used to manage these patients by identifying those who are not responding to therapy and enabling a cost-effective intervention prior to a costly exacerbation,” he predicts.

    And regarding telemedicine: “Consumers are driving the trend for easier and more immediate access to care. The investment community has taken notice by funding companies like 98point6, whose app provides video access to a human doctor, and Babylon Health, whose app provides virtual access to an AI-driven doctor. Expect virtual care services like these to catch on as their superior experiences prove incomparable to office-based care,” Dudnyk says.

  • Regulatory Change

    Perhaps one of the biggest lessons from 2018 is that work still remains for complying with the European Union’s MDRs. Paul Brooks, executive director at the Regulatory Affairs Professionals Society (RAPS), wrote in November 2018 that "more progress is needed to help companies prepare for the new regulations within the limited transition period."

    Anastasi of ICON tells MD+DI that “one of the biggest takeaways from 2018 is ensuring that organizations understand the importance of acting early to comply with the EU MDR and IVDR regulations. 2020 and 2022 are coming faster than you think, and launching a major transition effort is critical to getting a competitive edge. Manufacturers should be planning for the transition, assessing financial viability of pipelines and locking in notified body resources. In addition, they should assume they will not get extra time or extensions.”

    Added Parendo: “The progress and implementation of the EU Medical Device Regulation is interesting to watch unfold. How will this influence FDA practices? How will it impact healthcare in Europe? I predict some unintended consequences that will need to be dealt with quickly to reduce potential negative consequences. Equally, quick action to expand on areas that are creating surprising benefits.”

    FDA itself revealed plans to modernize the 510(k) clearance pathway and the de novo pathway, which is for new low to moderate risk devices without a predicate as a class I or class II device.

     

  • Business Takeaways for 2019

    In 2019 Dudnyk of VIVO expects a more discerning healthcare consumer. “Internet reviews, pricing transparency, and high-deductible health plans will empower consumers to shop for the best care at the best price. To win this business, providers will have to drop their prices and compete on value.”

    To help hospitals avoid readmission penalties, he believes that “the big, vertically integrated medtechs will need to horizontally integrate products, services, IT, and consulting across an entire disease state like lung cancer or COPD or diabetes. Many of these companies will have to tear down their portfolios and rebuild them to do so. A flurry of M&A activity will ensue.”

    Parendo predicts that “startup medical device companies are going to continue to accelerate in formation and growth. After several years of more mature organizations being acquired, those with the startup mentality will find a new opportunity to explore after a brief period of time to decompress. Several people are in the wings right now looking for the right thing for them.”

    And larger economic trends could impact medical device companies. Hugeneck of Nypro says that one of the biggest takeaways from 2018 is that “trade wars can have a significant impact on the healthcare industry as well. There is no escape.”

Daphne Allen

Daphne Allen is editor-in-chief of MD+DI. She previously served as executive editor of Pharmaceutical & Medical Packaging News, which serves as the pharmaceutical and medical device channel of Packaging Digest. Daphne has covered medical device manufacturing, packaging, labeling, and regulatory issues as well as pharmaceutical packaging and labeling for more than 20 years. She is also a member of the Institute of Packaging Professionals's Medical Device Packaging Technical Committee. Follow her on Twitter at @daphneallen.

 

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