APDC’s Manufacturing Core consists of a number of companies that provide device design, development, and testing capabilities for medical devices. APDC project mentors and advisors can help make connections and recommendations for manufacturing partners and a sampling of those companies are shown below. Jack Griffis serves as the Director of our Manufacturing Core in addition to being part of our Technical and Product Core.
Device designers need to be aware of the unique requirements placed on medical device manufacturing. The manufacturing organization used to develop a working prototype may not necessarily be the same one that would be recommended to make a larger run of 100 required for verification and validation testing. Some firms do both, early stage prototyping as well as full scale production. However, in many cases it may more cost effective to do non-GMP design rapid prototyping before Design Freeze, while remaining aware of the need for ultimate design controls and record keeping that will be required for larger production runs and full scale GMP manufacturing.
Jack Griffis, M.S. Jack Griffis serves as director of the APDC Manufacturing Core and is part of the Technical and Product Core. In recognition for his achievements as a Principle Investigator on numerous NIH and NSF funded grants, Griffis received the 2011 Tibbett’s Award from the Small Business Administration. Over the course of his 23 years in the medical device industry, Griffis has been the recipient of 5 national design excellence awards for medical device engineering and has developed and cleared through the US FDA over 50 different commercial products in a variety of medical specialties. He is listed as an inventor on 36 issued US patents with an additional 16 pending and was recently inducted into the National Academy of Inventors. Griffis holds both a bachelors and masters degree in engineering from the Georgia Institute of Technology. He currently serves as Vice President, R&D, for MedShape, Inc.; a medical device start-up founded by Professor Ken Gall of Georgia Tech.