SENIOR REGULATORY ADVISORY FOR SURGICAL DEVICES
There is no playbook for novel surgical devices.
I advise leadership teams on consequential decisions about novel surgical devices, bringing executive judgment, surgical expertise, and regulatory experience to questions of strategy, clinical evidence, and product risk. A board-certified general surgeon, I served at FDA from 2000 to 2025, most recently leading the office responsible for surgical and infection control devices. I help teams determine whether their regulatory strategy and evidence support the decisions ahead.
Binita S. Ashar, MD, MBA, FACS, MAMSE
Former Office Director, Surgical & Infection Control Devices
U.S. Food and Drug Administration
Regulatory Venture Partner, Puma Venture Capital
Regulatory Judgment Grounded in Surgery
I trained and practiced as a general surgeon, and stayed in clinical practice on a limited basis through much of my time at FDA. Regulatory decisions look different when you have been in the operating room. That shapes the judgment I bring to companies now. I also led FDA’s response to breast implant-associated lymphoma, an emerging signal that required decisions before the science was settled. That work earned the FDA Frances O. Kelsey Award for Excellence and Courage in Promoting the Public Health.
What Clarity Provides
Clarity provides independent senior judgment at the moments when regulatory strategy, clinical evidence, labeling, product risk, postmarket signals, and real-world use have to hold together.
Clarity is not a submission-writing firm, CRO, or replacement for an internal regulatory team. The work is strategic. I help teams identify risk, pressure-test assumptions, prepare for FDA interactions, and understand the decision in front of them.
Where Clarity is Most Useful
Choosing the Path
No clean predicate. Your device doesn’t fit cleanly into an existing predicate, and the submission strategy reflects that uncertainty.
Another path. You are about to take the standard regulatory path and want to know whether another regulatory path is supportable.
Building the Evidence
Trial design. You’re designing a clinical trial and need to know whether your proposed trial will likely address FDA’s key questions.
Labeling and risk. Your labeling, indications, or risk mitigations need to hold up under scrutiny you haven’t fully mapped.
AI and automation. Your device incorporates AI or automation, and you need to know how its decisions will be evidenced and defended after deployment.
Responding Under Scrutiny
Unexpected questions. FDA has asked questions your team didn’t anticipate, and the path forward isn’t clear.
Advisory committee. You’re preparing for an advisory committee and want to understand how your device will be assessed and how to communicate your results.
Postmarket signals. A postmarket safety signal has emerged, and you need to understand how FDA is likely to interpret it.
How I Work
I work with teams through focused advisory calls, on site working sessions, and preparation for FDA interactions.
My work often starts by helping a team see the decision in front of them more clearly. I review the materials they plan to put in front of FDA, including submissions, briefing documents, slide decks, and presentations. I look for regulatory and evidence opportunities they may not have recognized, especially in data they already have, FDA policy they may not have considered, or strategic options that have not yet been tested.
A large part of my work is coaching. I help teams frame the question, explain the clinical context, present the evidence, and anticipate the concerns FDA is likely to raise. The goal is not just to prepare better slides. It is to help the team walk into the FDA interaction clearer, more aligned, and better prepared.
Read my Perspectives on surgical device evidence, regulatory precedent, and clinical use.
Who Clarity Serves
Clarity works with companies developing surgical, robotic, AI-enabled, aesthetic, reconstructive, and infection-control technologies. I advise teams facing consequential decisions about indications, clinical evidence, product risk, and FDA interactions including when the regulatory path is already established. I work with private and public companies across the product lifecycle, from early clinical evidence to commercial-scale postmarket issues.