IME has a killer team, 3 members from BSX....a 38 Billion dollar company ! Who will most likely buy IME out shortly after Human Trial results
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 which was sold to Alliqua Biomedical a NASDAQ list company. Mr. Hutchens also served in senior executive positions at Microvasive Endoscopy, a division of Boston Scientific, Smith & Nephew, and Millipore. He is a former member of the Board of Directors of the Brigham and Womens/ Faulkner Hospital and holds a BS in Business Administration from Boston University.
Michael G. Vergano, Director of Operations
Michael 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.
Imagin Medical Inc. has hired Pam Papineau as the director of regulatory affairs.
Ms. Papineau has over 30 years of 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. Ms. Papineau has successfully prepared dozens of Food and Drug Administration premarket 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. Ms. Papineau is an ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) and Certified Biomedical Auditor (CBA), an ISO 13485:2016 lead auditor, and holds Regulatory Affairs Professional Society (RAPS) certifications for the United States, EU and Canada. Ms. Papineau will work with Hogan Lovells, the company's legal counsel, preparing for a presubmission meeting with the FDA and follow-on activities through the regulatory approval process.
