Outlook 2023: The Regulatory Path Ahead

… 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.

... 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.

… 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.

… 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.

… 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?

…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.

… 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).