E. James Hutchens
Chief Executive Officer
Jim Hutchens is a proven entrepreneur with over 30 years of experience in general and marketing management in the medical technology industry. Mr. Hutchens served as a Managing Partner in Origin Partners, a $55 million early stage, venture capital fund and was the founder and CEO of both Microsurge Inc., a venture-backed, minimally invasive surgery company, and Choice Therapeutics, an advanced wound-care company. Both companies were acquired by larger healthcare enterprises. Mr. Hutchens also served in senior executive positions at Microvasive Endoscopy, a division of Boston Scientific and Smith & Nephew. He is a former member of the Board of Directors of the Brigham and Women’s and Faulkner hospitals and holds a B.S. in Business Administration from Boston University.
Michael G. Vergano
Director of Operations
Mike Vergano has been president of The Harvest Group Inc. since 1998, where he has provided consulting services for start-ups and major corporations in all phases of project management, including product development, packaging, quality systems, operations, manufacturing engineering, and system/process design and validation. During his more than 30 years in the medical device industry, Mr. Vergano also held management positions at Apple Medical, Inc., Ciba Corning Diagnostics, Microsurge, Inc. and Boston Scientific Corporation. He is the holder of 11 medical device patents. Mr. Vergano holds a Bachelor of Science in Mechanical Engineering from Tufts University.
Pam Papineau
Director of Regulatory Affairs
Pam Papineau has over 30 years’ experience in quality and regulatory affairs with Baxter, Boston Scientific and Cogentix (Vision-Sciences), and has served as a consultant on a wide variety of devices that includes endoscopy, imaging, GI/GU, orthopedic and cardiovascular. Pam has successfully prepared dozens of FDA pre-market submissions and European Union (EU) technical files to support CE marking of a broad spectrum of medical devices, and has overseen numerous clinical studies entailing protocol development, reporting and management of Clinical Research Organization (CRO) services. Pam is an ASQ Certified Quality Engineer (CQE), a Certified Quality Auditor (CQA), a Certified Biomedical Auditor (CBA), an ISO 13485:2016 Lead Auditor, and holds Regulatory Affairs Professional Society (RAPS) certifications for the US, EU, CAN. Pam will work with Hogan & Lovells, the Company’s legal Counsel, to prepare for a pre-submission meeting with the FDA and follow-on activities through the regulatory approval process.
