Bringing healing and hope through medical innovations

The Team

Chief Executive Officer

David Pudwill

Visionary Leader and Entrepreneur
A seasoned leader with over two decades of experience in regulatory affairs, biomedical engineering, and project management, uniquely positioning him to transform Prather Biomedical into a high-growth enterprise and ultimately take it public. With a proven track record of working with billion-dollar companies and overseeing complex, high-value projects, David’s expertise spans industries including medical devices, biotechnology, and food production.

A Career Defined by Excellence and Impact

David’s professional journey is marked by notable achievements, including leading regulatory and quality initiatives for globally recognized companies:

FDA (2008–2017)

Washington D.C. Metro Area
As a Branch Chief, Lead Medical Device Reviewer and Biomedical Engineer, David spearheaded cross-disciplinary teams of up to 15 experts, reviewing submissions worth $10s of billions in combined approvals. His role involved mentoring teams, serving as an acting branch chief, and ensuring the successful evaluation of PMAs, IDEs, 510(k)s, and more, including medical devices and combination products using animal-derived materials.

Redding, California, United States
As Senior Director of Regulatory Affairs and Quality Assurance, David managed a global team of more than 100 regulatory, quality and clinical specialists in the US, Canada, UK, and other countries, primarily supporting the ostomy business and wound care business, with combined revenues of over $1.1 billion, and responsible for successful regulatory filings worth more than $400 million in annual revenues for products with gross margins over 90%. He led critical interactions with the FDA and Health Canada, ensuring compliance and market success across multiple business units, including collagen-based medical devices.

Redding, California, United States
As Sr. Vice President of Regulatory Affairs, and as a Regulatory Consultant, David oversaw engagement with FDA for collagen-based products and provided strategic guidance on the regulatory path to grow from an initial $10 million valuation to what will be over a $1 billion valuation upon successful execution of a series of clinical studies and pre-market submissions to FDA.

Palo Alto, California, United States
As Principal Consultant, David has guided his clients in securing regulatory approvals for products exceeding $100 million in combined present value, including companies that have gone public, with the potential for future valuation well over $1 billion. The combined valuation of the companies he has advised in early stage development is currently more than $10 billion. His expertise encompasses training resources, regulatory strategy, and quality support for industry leaders.