What is Regulatory Innovation?

With my recent change of employment status (from employed to self-employed), people have asked me, "What do you do?" I sometimes answer "I help medtech leaders get innovations to market better, faster, cheaper, and with more delight along the way." That often meets blank stares, with an unspoken question: "Yes, but what do you really DO?" When I answer that I do* "regulatory innovation," I get even more blank stares.

What's regulatory innovation? Here's the short version: If medtech innovation is inventing new medical technologies and new ways to develop them, regulatory innovation is inventing new regulatory technologies and new ways to make regulatory decisions.

Note: Regulatory innovation is sometimes comingled with regulatory science, a term that was coined by the FDA. I think it's worth distinguishing them, as science implies the generation of knowledge whereas evidence whereas innovation implies novel development and impact (ideally positive). The two often go hand in hand but are not synonymous.

Regulators innovate every time they do something new, novel, or different. Here are a few of my favorite examples from FDA:

• FDA and industry worked together to achieve the first-ever approval of an algorithm that enables interoperability between insulin pumps and continuous glucose monitors...a crucial step in reducing the burden of Type 1 diabetes care.

• As of October 1, FDA will refuse to accept medical device submissions that do not include a Software Bill of Materials (SBOM), which is an "ingredient" list of the software included. This has far-reaching implications.

• Every MDUFA commitment is a commitment to improvement, so whatever FDA does to achieve the commitment is an innovation.

Regulatory innovation is as normal as technology innovation. In fact, out of seven CDRH top-level offices, Office of Strategic Partnerships and Technology Innovation is one of the largest by budget.

How do you "do" regulatory innovation from outside the regulator's walls? For a number of years, I carried an FDA badge and worked together with regulators to change processes, implement IT, evaluate outcomes, and test new ideas. That was direct regulatory innovation "from the inside."

That said, regulatory innovation can't occur without strong participation - or even leadership - from industry. Regulatory decisions can only be made with what is presented in a submission, under the current law. Regulatory innovation comes from industry-regulator interactions.

How can one get involved? Here are several fora where regulatory innovation occurs (Note: I'm putting myself in danger of major criticism by writing a short list; obviously there are many more fora):

• Every medtech product R&D team doing something a little different can engage in regulatory innovation

• Medtech quality and regulatory teams are a hotspot for regulatory innovation projects

• The Medical Device Innovation Consortium and its events (FDA-focused)

• The Health Sector Coordinating Council (U.S. healthcare cybersecurity focused)

• MDUFA negotiations

• IMDRF for international harmonization and collaboration

• The Federal Register, via responses to policy proposals

The above are just a few that I have personally contributed to. The point is that regulatory innovation happens whenever significant medtech innovation happens.

~Shannon, the Optimistic Optimizer

*Note: I don't like answering what I "do" because my background, skills, and methods vary so much. The simplest answer is that I focus on achieving results. I do what is needed to achieve the results of a given engagement.