FDA Strategic Roadmap for 2018 and Beyond
Commissioner, Dr. Scott Gottlieb, released the FDA Strategic Roadmap for 2018 and Beyond. The Roadmap includes a vision for Computer Modeling including to develop and advance the use of in silico tools and models to evaluate device performance and patient outcomes as part of the Medical Device Innovation Consortium.
Real-World Evidence Test-Cases
NESTcc is seeking recommendations from industry for Real-World Evidence test-cases that could be implemented with early data network partners. If you are a medical device manufacturer interested in responding to this Call for Concepts, be aware that the deadline for submissions has been extended to January 31, 2018. Submissions are due at 5p.m. EST. A […]
Computational Modeling and Simulation Expanding in Orthopaedic Device Life Cycles
Read MDIC Computational Modeling a Simulation Working Group Chair Marc Horner’s article on how CM&S can accelerate orthopedic medical device product lifecycles.
NESTcc announces three new opportunities for engagement and launches the new www.nestcc.org
NESTcc News: NESTcc announces three new opportunities for engagement and launches the new www.nestcc.org. There are two open Requests for Proposals (RFPs) for contractor support and an open Call for Concepts from medical device manufacturers. All final deadlines are January 17, 2018 with interim deadlines in December.
Jeff Shuren on the MDIC Case for Quality
Jeff Shuren on the MDIC Case for Quality: “Ultimately what we’re looking for is value to patients – that we have better product out on the market, and we’re rewarding those companies that have that greater focus on quality.” View slides from the November 15 Forum here and read more from MedTech Insight.
Can partnering with patients help advance focused ultrasound?
Can partnering with patients help advance focused ultrasound? Jessica L. Foley, PhD, Chief Scientific Officer of the Focused Ultrasound Foundation discusses this and MDIC’s work in her blog.
CDRH Director’s Special Citation Recognized at 2017 Annual Public Forum
The Medical Device Innovation Consortium Virtual Patient Mock Submission Team received the CDRH Director’s Special Citation on August 7, 2017. Dr. Jeffrey Shuren, Director, Center for Devices and Radiological Health, CDRH, FDA presented the award to Dr. Kyle Myers, Director, Division of Imaging, Diagnostics, and Software Reliability, CDRH, FDA, Dr. Dawn Bardot, Vice President, Technology […]
MDIC Fellows Honored at 2017 Annual Public Forum
Susan Alpert, M.D., Ph.D, and Gregory Molnar, Ph.D were recognized as MDIC Fellows during the Annual Public Forum on October 3, 2017. MDIC Fellows have an honorary affiliation with MDIC in recognition of the regulatory science thought leadership provided on behalf of MDIC. MDIC Fellows have an ongoing commitment to serve MDIC’s mission externally and provide periodic […]
NESTcc News: Initial Demonstration Projects Address Key Use Cases for the NESTcc
NESTcc News: Initial Demonstration Projects Address Key Use Cases for the NESTcc
