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.
APDC’s Manufacturing Core has partnered with a number of companies to provide device design, development and testing capabilities for pediatric devices. Jack Griffis serves as the Director of our Manufacturing Core in addition to being part of our Technical and Product Core. APDC project mentors and advisors can help make connections and recommendations for manufacturing partners and the following lists represents a few of those companies.