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.
Chief Financial Officer
John Vacha has 20 years’ experience in the healthcare industry, most recently serving as President, CEO and Board Member of Intact Medical Corporation for 7 years before it was acquired by Medtronic in 2017. Previously, John served as Vice President, CFO and Treasurer of the company. John also served as Senior Consultant at Deloitte & Touche, LLP, where his clients included closely held high-tech manufacturing start-up companies, as well as large retail and manufacturing corporations. John is a licensed CPA in Massachusetts, holds a MBA and an MS in Accounting from Northeastern University in Boston, Massachusetts. He also serves as a member of the Board of Directors at the South Boston Health Center and holds two patents in electrosurgical instrumentation.
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.
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.