Provide Multi-Year Funding to Support Creation and Operation of Regional Centers for Medical Device Innovation:
Goal: Accelerate product development of new medical device products based on University technologies as well as technology originating in the entrepreneurial community by bringing together in one location the key infrastructure needed to rapidly move new medical devices and new medical technologies to market.
Provide one-stop facility with expertise and equipment capable of taking a technology for a new medical device into a GMP prototype useable in human clinical trials. The facility, by brining toegher in one location the key infrastructure needed to rapidly move new medical devices and new medical technologies to market, will accelerate the development of new medical device products
Major supporting activities include: Design, Iterative Prototype Development, and Testing of new medical devices, Pairing of clinicians with engineers and scientists to accelerate translation of medical technologies, Aggregation and management of intellectual property for clinical partners, and supporting activities (eg regulatory affairs, IDE compilation and filing, SBIR application support, etc.).
Model: Global Center for Medical Innovation [GCMI] at Georgia Institute of Technology. This is a recently formed not-for-profit public private partnership which provides facilities and expertise for design and development of innovative medical devices including cGMP manufacturing of prototypes for use in FDA regulated human clinical trials. GCMI is established as a partnership between academic institutions and clinical centers in a manner which is designed to accelerate the translation of innovation from the labs into human testing. GCMI is being developed to serve the SE region of the USA. GCMI (www.devices.net) represents an extension of concepts proven over the last 30 years at Georgia Tech's ATDC - Advanced Technology Development Center (www.atdc.org) to help entrepreneurs build successful technology companies. ATDC was recognized by Forbes.com in 2010 as one of the top ten incubators changing the world.