What sets the FDA apart on medtech innovation? An expert weighs in

This past month, UCLA Biodesign and Boston Consulting Group took an in-depth look at the medical technology industry when it surveyed more than 100 senior executives about the medical device registration process.  

They found that the vast majority agree that the U.S. Food and Drug Administration is responding effectively to advancements in medical technology – suggesting a potentially exciting future.  

Healthcare IT News caught up with UCLA Biodesign executive director Dr. Jennifer McCaney to discuss the research project, the role of regulatory bodies in patient safety and what’s around the corner for medtech.  

Q. Could you tell me a bit about the research project UCLA Biodesign collaborated on with BCG?   

A. The last time a study was conducted that examined the impact of the global regulatory landscape on medtech innovation was over 10 years ago. The global regulatory landscape for innovative medical technologies has changed drastically over the last decade with the digital transformation of healthcare, changing tides in global regulatory policy in the United States and Europe, increased capital investment in digital health, and the introduction of innovative program policies and programs by regulatory agencies to support transformational medical devices and products. 

What has been the impact of these topics on medtech regulation? How are regulatory agencies responding to the advancements in medical innovation? As an early stage advisor in the medtech sector, I am acutely aware of the challenges innovators face in bringing new technology to market. BCG is a global thought leader in healthcare and was a logical partner in the preparation and publication of our research.   

Q. What did the project seek to investigate and what were some of the findings?   

A. The purpose of the research was to examine the impact of regulation on the advancement of medical innovation in the United States, Europe, and other key regions. We interviewed more than 100 CEOs and regulatory executives to understand their experiences developing and bringing innovative medical devices to market, with a specific lens on their experience with regulatory bodies.  

From these interviews, we discovered that medtech innovators are prioritizing the U.S. as their first go-to-market most notably because the FDA has responded more favorably to advancements in medical and digital innovation over the last decade than its global counterparts, medical device regulation is creating uncertainty and complicating patient access to innovative devices by raising requirements for CE Marking in Europe, and the U.S. now offers a more innovation-centric and digitally friendly ecosystem for regulation, capital investment and market potential.   

In this study, we also establish new benchmarks for time and cost required to develop a device and obtain regulatory approval in the United States.   

Further, we share peer-to-peer best practices for achieving regulatory approval with the FDA, and provide the FDA and the Centers for Medicare and Medicaid Services with recommendations from participants on how to advance regulation and reimbursement in the U.S.  

Q. What role do regulatory bodies play in patient safety?   

A. Patients need innovative solutions that address unmet needs related to the diagnosis and treatment of debilitating chronic and acute diseases, improving access to and affordability of healthcare, and promoting health equity for underserved populations, among other grand challenges.  

Innovators boldly set out to tackle these challenges for the benefit of patients with the aim to improve clinical, economic or social equitable health outcomes for patients, providers and healthcare systems, yet may find that their innovation does more harm than good to patients if not developed, tested or studied effectively.   

The FDA and its global counterparts serve as human health agencies with a mission to protect the health of patients by overseeing market approval of novel medical products and establishing pathways, programs and policies that promote the highest standard for safety and efficacy of medical technologies, devices and products seeking market approval.   

Safety and efficacy are at the forefront of [the] mission of regulatory bodies. As medical devices evolve and the underlying technology approaches new frontiers of complexity, regulatory bodies globally are challenged to keep pace with the exponential surge of new products.   

Q. So what sets the FDA apart from its international peers when it comes to medtech innovation?   

A. Seventy-nine percent of executives in our study believe the FDA has responded more effectively to the evolving needs of medical innovation [when] compared to its global counterparts, having invested in developing special programs, pathways and policies that promote patient access to innovative medical technologies, while upholding the highest standard for safety and efficacy of novel devices for patients.   

Examples of specific instruments that the FDA has implemented to promote innovation include the introduction of the breakthrough device designation to accelerate patient access to technologies that address significant unmet needs, the creation of the De Novo granting, the provision of regulatory guidance for software, and the establishment of the FDA’s Digital Health Center of Excellence.   

Q. Tell me more about the breakthrough device designation. How do you see it as driving innovation?   

A. An overwhelming majority of executives (75%) in our study believe that [the] breakthrough device designation provides an innovation fast lane to help accelerate patient access to novel technologies that serve significant unmet needs across detection, diagnosis and treatment.   

Also, 88% of respondents believe that guidance for the program is clear, and a majority believe that the program enables more flexible study design. Further benefits of the program are more frequent and informal communication with the FDA throughout the pre-submission, submission and review process.   

Q. We hear a lot about the dangers of bias being embedded in medical devices that rely on artificial intelligence and machine learning. How can product designers ensure their devices don’t replicate bias?   

A. In order to mitigate bias for AI/ML medical devices, it is important that product designers develop, train and test AI/ML based on diverse reference datasets and standards that are tailored to the intended use and desired outcomes of the medical device, whether based on patient, provider or healthcare system data.   

Product designers should focus on the equity, transparency and reliability of the data. The FDA, Health Canada and MHRA expand on this concept in 10 Guiding Principles, issued in 2021, for Good Machine Learning Practice for Medical Device Development. These principles further [the] point that datasets used for developing, training and testing AI/ML are independent of one another, therefore not replicating data inputs and results. 

Q. What excites you about the future of medtech and biodesign?   

A. The digitization of medtech and the rising tide of AI/ML enables advancements in personalized medicine, affordable and accessible and equitable healthcare, and the like. We expect to see great advancements in the next five years as private venture capital investment into digital health has grown exponentially in the last five years, exceeding total capital investment in medical devices by five times.  

When it comes to biodesign, the digitization of biodesign unlocks a wealth of opportunities for innovation with big data, IoT, AI/ML and software as a medical device. Biodesign 2.0 incorporates data science, in addition to traditional engineering and design-thinking approaches.  

In addition, the innovators of today must help shape the innovation landscape of tomorrow by grasping the fundamentals of health policy (regulation and reimbursement and quality standards) and designing innovations that align with existing policies or learning to partner with stakeholders to establish new policies that advance patient care.

And finally, globally conscious biodesign: Biodesign is no longer a domestic concept. Global companies incorporate biodesign thinking and processes into their internal discovery and R&D. Addressing issues in healthcare access and equity requires that we think globally and act locally to develop and commercialize innovations that truly address unmet needs for patient populations worldwide.  

This interview has been lightly edited for clarity.

Kat Jercich is senior editor of Healthcare IT News.
Twitter: @kjercich
Email: kjercich@himss.org
Healthcare IT News is a HIMSS Media publication.