UCLA And BCG Examine Global Medical Device Registration Landscape

UCLA Biodesign and Boston Consulting Group (BCG) recently took an in-depth look at the global medical technology industry, surveying more than 100 senior executives about their experiences with the medical device registration process. Overall, the vast majority of executives agreed that the U.S. Food and Drug Administration (FDA) is responding effectively to new innovations in medical technology, hinting at a potentially bright future for the medical devices industry.

The study examines the global regulatory landscape for innovative medical devices, which has changed drastically since the last time a study was conducted more than 10 years ago. The ongoing digital transformation of the healthcare industry, changes in global regulatory policy, increased capital investment in digital health, and the introduction of policies and programs focused on supporting transformational devices and products, have all created an environment more favorable to medical device innovation.

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The research team focused on the impact of regulation on the advancement of innovative products, interviewing more than 100 CEOs and regulatory executives to understand more about their experiences with regulatory bodies when developing and bringing innovative medical devices to market. The study found that the U.S. was a top go-to-market due to the FDA’s favorable response to medical and digital innovation relative to its global counterparts.

“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,” said Dr. Jennifer McCaney, UCLA Biodesign Executive Director in an interview with Healthcare IT News.

The study also offered best practices for product designers integrating artificial intelligence (AI) and machine learning (ML) into their devices, recommending a focus on equity, transparency, and reliability of data to prevent the introduction or replication of bias into datasets.

Overall, the results of the study suggest an exciting future for the medtech industry: rapid digitization and increased use of AI/ML is enabling rapid advancements in personalized, affordable, and accessible and equitable healthcare, and the marriage of biodesign and data science is unleashing new opportunities for big data, Internet of Things, and software as a medical device. Combined with regulatory bodies that offer clear guidance and support for innovative devices, the possibilities seem practically endless.