I’m a Regulatory Affairs professional who has spent the last 15+ years building an internal library of experiences, observations, and ideas from across domains. This library is a source of guidance and inspiration in the freelance consulting projects I take on, most of which involve Class III (high-risk) implantable medical devices at both the pre- and post-market stages. What I’ve learned so far has showed me the way to many timely approvals, some early enough to break records at the companies I’ve served. (These approvals, in turn, have translated into patients receiving safe and effective devices at an earlier point in their lives, the most meaningful outcome of all.)

I came to Class III medical devices with an outsider’s point of view, after I’d worked in the legal field and studied the law, literature, and music. Exploring medtech and regulation as a fascinated newcomer, I asked questions (even the naive ones) and set about identifying patterns. From there, a scaffolding quickly emerged from the real-world, hands-on experience I acquired in cleanrooms, conference rooms, and R&D labs. I’ve been building on it ever since.

Now, having worked in-house at Medtronic and W. L. Gore & Associates, and having served companies such as Johnson & Johnson, Abbott, Olympus, and Boston Scientific via consulting projects, I continue to guide clients through innovation and advancement of their medical technologies with clear thinking and effective communication. I’m also looking to what’s next: Research is accelerating; medical science may be entering a new golden age. As new discoveries bring potential rewards and risks at speeds and scales beyond human experience, my goal is to uphold — and advance — the highest professional standards in a way that helps unlock the future’s best promises.

Lastly, I’ve got skin in the game: I’m the recipient myself of implantable medical devices and know firsthand what it is for a patient to come face-to-face with existential uncertainty while being rolled into the OR. And I know what it is to recover (gratefully and joyfully) under the guidance of a team of specialists.

I can’t wait for what’s next.

Current interests (feel free to reach out to Andrea@BranchingPaths.LLC if you’d like to talk more about these or other topics):

• The concepts of citizenship and apprenticeship as applied to Regulatory Affairs — are there new and better ways for regulatory professionals to engage with one other as mentors and mentees?

• Supply chains

• Lessons in leadership to be found in biographies of all eras

A list of experience, including regulatory submission types, is available upon email request. Please reach out to Info@BranchingPaths.LLC.