Gary Socola
Founder and President of HIGHPOWER LabsGary has been employed in the medical device industry since 1985 acting as a technical lead, quality, regulatory, or subject matter expert in the development of class II medical devices. Along with device development and validation, he has written patents, portions of American National Standards, and many successful 510k device submissions throughout his years of service.
He has extensive knowledge within the FDA QSR Part 820, GMP’s, ISO 13485 and ISO 17025 quality systems. He is a participant in the FDA’s Medical Device Advisory Committee for General Hospital and Personal Use Devices.
Gary is now involved in an advisory capacity at HIGHPOWER assisting when needed with medical device and sterilizer validation along with managing specialty projects.
In his spare time, Gary enjoys hunting and spending time with his five grandchildren.
Mariann Hughes
Vice President of HIGHPOWER LabsMariann spent over 15+ years working for a number of medical device manufacturers, prior to joining the HP team in 2017. As a member of the HIGHPOWER executive team, she focused on sales/marketing and streamlining organizational efficiency to position HP for future growth. With a MBA from Rochester Institute of Technology, Mariann has been influential in shaping the business culture and setting short, medium, and long term goals for HP. Promoted in 2021 to Vice President, Mariann now focuses primarily on business strategy and long-term planning for fiscal growth.
You will catch Mariann outside tending to her garden and spending time with her three boys whenever she can.
David Adams
General Manager of HIGHPOWER Labs Dave has joined the HIGHPOWER executive team in 2022, coming on board as General Manager. Dave has spent the past 10+ years working within ISO 13485:2016 single-use medical device manufacturing and contract organizations prior to his move to HP. During those years, Dave has served in numerous management roles, including Quality, Manufacturing, and Site Management. He has extensive experience in bulk manufacturing of biological and chemical indicators. Dave also holds an ASQ certification as a Quality Process Analyst. At HIGHPOWER, Dave oversees all day-to-day operations and his focus is on operating efficiency. Dave is an outdoor enthusiast who enjoys spending time his family in his spare time.
Donald Tumminelli
Sr. Technical Manager, Client Services at HIGHPOWER LabsDon has been a HIGHPOWER employee for 15+ years and has moved from a laboratory roll into client services oriented roll over the last five years. Don is often the face you will see at industry events and will often be the guy clients work with directly to kick off their project. Don has over 20 years’ experience in the medical device industry developing and validating medical devices, with an emphasis on reusable devices.
Don is a corporate member of AORN, ASTM, and AAMI and actively sits on committees which help shape the regulatory environment of medical devices. In addition, Don has been interviewed multiple times for articles and conferences as a speaker and industry expert.
In his spare time, Don is a part owner of a successful Restaurant in Rochester, NY. He enjoys traveling and spending time with his two daughters.
Michael Nolan
Technical Manager, Client Services at HIGHPOWER Labs Mike joined the HIGHPOWER Team in 2020 as an addition to the client services staff. He will often be the first point of contact and works closely with our clients to help guide them and build a quote for their appropriate testing needs. Mike brought to HIGHPOWER a wealth of knowledge with 20 years of experience in the industry having worked for multiple Class II device manufacturers specializing in biological/chemical indicators and sterilization. He is a longstanding member of AAMI and has joined several working groups on behalf of HIGHPOWER. Mike enjoys spending time with his family, is a member of the National Ski Patrol, coaches youth lacrosse and enjoys anything fitness related especially CrossFit.
Aaron Barton
Aaron has been an integral part of the HIGHPOWER Team since its inception in 2012. Initially starting in the facilities and equipment department, Aaron quickly proved himself to be the “go-to guy” at HIGHPOWER. He is now the Operations Manager who focuses on project management and process improvement, overseeing everything that comes into the lab and the warehouse. In his spare time, Aaron enjoys hunting and spending time with his family.
Emily Barton
Business Manager at HIGHPOWER LabsEmily has worked for HIGHPOWER in the Business Department for nearly 10 years. As a member of the HIGHPOWER executive management team, Emily’s primary focus has been overseeing all business operations at the front and back end. She works directly with client services and HIGHPOWER clientele to establish payment terms and handle all administrative aspects of project implementation ensuring we have the required resources so that everything runs seamlessly from start to finish.
Emily holds an MBA from Rochester Institute of Technology. She enjoys being active, playing soccer, and spending time with her daughter in her free time.