Innovation Grand Rounds: Regulatory Strategy 101: Approach for Innovative Clinicians & Researchers

On Wednesday, December 7, 2022, Erin McKenna, operating partner for Amplify and program director for Brigham Ignite, and John Hamilton, associate director of IP at Mass General Brigham Innovation, gave an Innovation Grand Rounds lecture titled “Regulatory Strategy 101: Approach for Innovative Clinicians & Researchers.”

In this Grand Rounds, McKenna and Hamilton offered practical advice for clinicians and researchers, who are creating new concepts and products that may be subject to regulatory approval.

Hamilton began with an overview of the U.S. Food and Drug Administration, the 100-year-old federal agency responsible for the protection of public health. The FDA uses a variety of tools to verify the integrity of manufacturing practices and data collection, ensuring the safety, efficacy, and quality of medical devices.

Hamilton provided an overview of these tools along with key questions the agency will ask when regulating products and designating the class of a medical device. He encouraged innovators who want to start engaging with the FDA to seek out necessary legal and regulatory expertise and not try to go it alone. “It can be a tricky field,” said Hamilton, “And you want to get on the right path as early as possible.”

McKenna discussed the FDA pre-submission process for getting feedback before an intended pre-market submission. This mechanism, known as a Q-Submission, gives inventors the opportunity to approach the FDA and ask specific questions about their product development plan. She went on to review the various regulatory pathways that can be used to bring a medical device to market and the key criteria used to determine which is right for your device.

Mass General Brigham Innovation Grand Rounds is a monthly live series from Mass General Brigham Innovation that features educational and experiential talks by innovators and executives from across the health care system. The catalogue of past Mass General Brigham Innovation Grand Rounds is viewable on the Innovation MESH Network, the official healthcare innovator development and learning platform of Mass General Brigham.