Outlook 2023: The Regulatory Path Ahead
Executive Summary
What regulatory challenges will 2023 bring? Our international panel of top experts has a few guesses.
Cybersecurity and digital health, patent challenges and the Medical Device Regulations (MDRs) in Europe are among the continuing issues our experts predict will be top of mind in 2023.
2023 will be the year of ...
Elisabetta Biasin
Doctoral researcher in law at Belgium's Centre for IT & IP Law (CiTiP), KU Leuven
... policy debates in health data sharing, healthcare AI and cybersecurity. The European Health Data Space and the Cyber Resilience Act proposals will be at the policymakers’ table, and the AI Act is at an advanced stage of the legislative procedure. Keep ready to follow the discussions!
Read more about responses to the proposed Cyber Resilience Act.
Phil Brown
Director, regulatory and compliance, Association of British HealthTech Industries (ABH)
… an exciting time for UK regulatory matters. As the CA mark requirements take shape through enactment of new Statutory Instruments and the guidance outputs from MHRA-led focus groups, industry stakeholders will have the once-in-a-lifetime opportunity to input into our collective regulatory future. The increasingly difficult implementation of the MDR and IVDR has the potential for our sovereign regulator to consider divergent regulatory processes that are technically consistent with CE-marking, but based on greater global alignment, ensuring competitiveness for research and product introductions.
Read more about expected updates to the UK's device regulatory system.
Vera Elson
Partner, Wilson, Sonsini, Goodrich & Rosati
… the trend of medical device companies enforcing patents against competitors continue. Particularly after 2017, when the Supreme Court imposed restrictions on where a patent suit can be brought, one court that has seen a dramatic increase in competitor cases is the District of Delaware. Chief Judge Connolly was recently quoted as saying that the number of competitor cases in Delaware has “gone through the roof[.]” In 2021, each Delaware authorized judge handled on average over 220 patent cases alone. However, despite their caseload—or perhaps because of it—the judges generally do what they can to facilitate a resolution short of trial.
Read Elson’s commentary on one major patent case, Minerva Surgical v. Hologic.
Marcus Kuhlmann
Head of Medtech, Spectaris
... Medical Device Regulation continuing to be the greatest challenge for the medtech industry. We must succeed in clearing the huge certification backlog, so that we do not run into serious supply problems with medical devices. In addition, the industry will have to face the challenge of increased costs in all of the supply chain. 2023 will also be the year in which we will hopefully finally take a major step forward in terms of digitization in Germany. The hospital sector in particular, which is facing massive reforms due to rising costs, must finally come into the 21st century in terms of digitization. There is great potential to make processes in hospitals more efficient, and most importantly, to improve health care for the patients.
Read the what the head of the German medtech industry association had to say at the recent Medica Tech Forum in Düsseldorf.
Reid Rector
Partner, Gibson, Dunn & Crutcher
… new and evolving liability for manufacturers continuing to develop under the False Claims Act. The Supreme Court is poised to rule in one – and maybe two – False Claims Act cases in the coming year. Those cases affect how much control the government can exercise over private whistleblowers, and whether a company’s good faith, objectively reasonable interpretation of complicated regulations is a defense to liability. The Supreme Court’s resolution of these issues could significantly change the False Claims Act landscape for manufacturers.
Read about the cases that made 2021 the biggest year for FCA settlements ever.
Jeff Senger
Food and Drug Group partner, Sidley Austin
… the epicenter of growth and innovation being in the digital health space. Artificial intelligence and machine learning are developing their potential to transform medical care, and hopefully will not slowed by FDA's newly constrictive and confusing Clinical Decision Support Guidance. Wearables will multiply the ability to track and trend medical data on a never-before-possible scale. The Internet of Medical Things and electronic health records will improve coordination of patient care. Countering these positive technological developments, cybersecurity will pose an increasing problem as improved connectivity also creates more vulnerabilities. I look to FDA to continue its important contributions in these areas and seek legislative authority when needed to update outmoded authorities, as with their recently concluded software precertification program.
Read about the clinical decision support draft guidance document.
Steve Silverman
President, The Silverman Group
… the FDA strengthening its digital oversight. This prediction earns me gold in the Obvious Olympics. Still, 2023 will see important changes. First, FDA will counter headwinds in digital oversight, including staffing. FDA’s Digital Health Center of Excellence needs more people and a permanent director, both of which will happen next year. FDA also will grapple with its limited authority. This hamstrung the software precertification pilot because FDA couldn’t create new market pathways for digital devices. In 2023, FDA will leverage its current authority and seek new authority to oversee digital products.
Read an interview with Digital Health Center of Excellence acting chief Brendan O'Leary.
Bradley Merrill Thompson
Partner, Epstein Becker & Green
… strong health care industry growth for artificial intelligence. If you've heard that before and therefore are skeptical, you admittedly have good reason to be. There has been a lot of hype. While, according to an AMA survey, the clinical market seems more open now to using AI to help physicians improve the care they provide, perhaps the biggest driver in 2023 is that FDA will move forward with clarifying the regulatory pathway. After many years, FDA has finally set aside the precert program as unfeasible under the current statute. Now, hopefully the FDA will change its focus to working on such initiatives as the predetermined change control guidance to allow AI to morph within parameters without requiring additional agency approval, a huge step forward to making these products commercially feasible.
Read about the regulatory challenges faced by the FDA in considering artificial intelligence.
Kim Trautman
Managing Director and VP, MEDIcept, Inc.
… the trend of bringing medical devices to the US first with FDA’s predictable and stable market entry applications and review processes continuing to increase. The uncertainty of obtaining the CE Mark in Europe with the new EU MDR and IVDR requirements, which many are still very vague and being enforced very differently across designated Notified Bodies, is not likely to improve quickly even with the new EU proposed extension to the implementation plan going out to 2027/2028. Second, the rapid expansion of digital health and SaMD devices in the MedTech sector.
Read about FDA device center director Jeff Shuren’s efforts to keep innovation in the US.
Søren Underbjerg
Team Lead for Clinical Development and Market Access, QMed Consulting
… MDR Clinical Data Challenges. The MDR requirement for clinical data will impact all health care institutions that are or will be performing countless post-market studies in 2023. Public payers or insurance companies will either directly or indirectly be forced to pay a higher price for the devices as manufacturers will forward the cost.
I propose one cost-efficient solution that all parties can benefit from: Increase device reporting in investigator-initiated clinical studies. This does not need to be on separate objectives for the study, but at least mention the device used. This is common practice in the pharma industry, so why should it not be equal for devices, as all parties are interested in getting clinical insight into device safety and performance?
Read more about Underbjerg’s concerns about the EU’s Notified Body clinical evidence expectations.
Dan Vukelich
President and CEO, Association of Medical Device Reprocessors
… hyper focus on supply chain sustainability and efficiency for health delivery and medtech. Because 60% to 80% of greenhouse gas emissions from hospitals come from the supply chain, “low-hanging fruit” solutions such as programs to reprocess medical devices labeled for single-use will continue to grow substantially. Supply chain shortages, particularly for single-use devices with computer chips, will further drive the growth of reprocessing programs. FDA regulated processes and products with research that shows emission reductions, cost savings, and supply chain resilience will grow as hospitals see more single-use devices as assets rather than waste.
Read about FDA incentives that work against against device reprocessing.
Martin Walger
VDGH (German Diagnostics Industry Association)
…decision for the IVD industry sector. May will mark the first anniversary of the application of the IVDR, which will be an appropriate opportunity for a ‘stock check’ that will show us exactly where we stand with it. Manufacturers have done their preparations for transposing the regulation, but important IVDR implementation steps are still yet to be taken on the part of the EU legislators. First and foremost, the number of notified bodies must be increased. If that doesn’t happen, action should be taken to avoid long-term damage to ‘Standort Deutschland’ [the German medtech ecosystem] and the innovative drive of manufacturers, and, not least, to patient care.
Read about manufacturers’ experience with the IVDR.
Scott Whitaker
President and CEO, AdvaMed
Over the last year, the medtech industry faced down a number of daunting challenges and came out stronger than ever. The work AdvaMed and our members have done to secure a MDUFA V agreement, avert a semiconductor shortage that could have been a true crisis for patients, and protect grants for our small medtech companies has set us up for a promising 2023. By creating an environment that fosters innovation and growth in medtech, we are going to see better patient outcomes across the board in the coming year, especially in underserved communities. I am optimistic about the work we can do in the coming year on behalf of the patients and health care providers we serve.
Read about Advamed’s 2022-23 legislative priorities.
Kyle Zebley
Senior Vice President, Public Policy, American Telemedicine Association and Executive Director, ATA Action
… continued consolidation for the telehealth community. There is positive momentum at the state level, and telehealth advocates will continue to break down interstate barriers to care through the adoption of licensure compacts and licensure flexibilities, as well as policies leveling the playing field for telehealth access through technology and service neutral policies that further empower patients receiving virtual care services. In Washington, D.C., the new Congress and the Biden administration will work together to chart a permanent path for telehealth flexibilities after the expected end of the COVID-10 Public Health Emergency (PHE).
Read about ATA’s efforts to improve telehealth patient advocacy.