Expert Consultant, Regulatory Sciences
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and highlight how our colleagues work together on our higher purpose to improve patient health and safety throughout the complete product lifecycle.
I am a Regulatory Expert Consultant. I support clients with medical product regulatory, strategy, and policy challenges, applying my experience as a leader at the U.S. Food and Drug Administration (FDA) and my consulting work with medical product companies. These companies face unique risks, which I help clients understand and manage.
At the FDA, I directed the Center for Devices and Radiological Health (CDRH) Office of Compliance, where I led device quality initiatives and engaged industry and other stakeholders. I also led FDA drug compliance initiatives, serving as Assistant Director of the Center for Drug Evaluation and Research (CDER) Office of Compliance. I was an Associate Chief Counsel, leading drug and medical device enforcement actions.
I have also served the medical product industry. After leaving FDA, I joined McKinsey & Co., where I counseled pharmaceutical, medical device, and other clients on regulatory strategy, compliance and quality, and stakeholder communication. I later worked as a Vice President with AdvaMed, the leading medical device trade association, where I focused on product quality and compliance, pre-market approval, and device advertising and promotion.
There is no skill more important than listening. When people need help with tough problems, first and foremost, they want to be heard. This means letting clients tell their stories uninterrupted and without editing or redirection. As important, it means telling the stories back to confirm key facts, events, and client objectives.
This back-and-forth communication is key to effective client service. Of course, good client support requires more than just listening. But without listening as the first principle, client support suffers.
The biggest challenge is effective regulator engagement. Firms must know which regulators handle the problems that they face. Firms also must know how the regulators operate, the scope of their authority, and where there's regulatory "give" (room to go beyond standard practice).
Imagine, for example, a firm with a digital product that detects cancer. The product uses algorithms the FDA hasn't seen before, and standard FDA review and compliance practices are a bad fit. This means that the firm must judge where the FDA will and won't regulate and whether the FDA will accept new ways to show compliance. The firm must then use these insights to navigate product reviews and skillfully engage the FDA.
Getting these questions wrong means slower speed to market and greater regulatory risk.
A key FDA regulatory trend is creating and using digital products, both conventional ones with digital parts and purely digital products. Examples include heart pacemakers that "talk" to databases to improve treatment and digital diagnostics for medical conditions.
This is the next wave in FDA medical product regulation, and it combines innovation with traditional agency oversight. For instance, the FDA acknowledges that some standard quality requirements don't fit digital products, which are developed and change more often and quickly than conventional products. So, standard regulations must be redesigned to permit agile approaches.
Savvy firms will help the FDA map this new territory. This means knowing the key questions, where the FDA is open to input and new approaches, and which regulatory requirements must remain.
ProPharma's Regulatory Science experts offer insights and industry knowledge unavailable from generalist consultants. I see this gap often when working with large consultancies. The "firepower" these consultancies bring is helpful, but even more important is experts who know the landscape where they work. This means understanding regulatory practice and the factors affecting that practice.
As an expert, I use my FDA knowledge to find solutions that meet regulatory requirements and promote client needs. These solutions are powered by real-world insights that generalist consultants too often lack.
September 14, 2023
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