Transformation/Innovation Opportunities for the NRC to Explore Federal Perspective Murray Sheldon, MD Center for Devices and Radiological Health U.S. Food and Drug Administration Nuclear Regulatory Commission Discussion of Medical Uses of Radioactive Materials (public meeting) Rockville, MD January 28, 2020
CDRH Mission and Vision 2 1/22/2020
Long-term Decline in Start-up Density Since 1988 * Stark decline in Medtech since 2006 to ~600 in 2012 *from: A Future At Risk: Economic Performance, Entrepreneurship, and Venture Capital in the U.S. Medical Technology Sector. Written by Innovation Counsellors LLC with support from AdvaMed Accell October, 2016 https://www.advamed.org/sites/default/files/resource/a_future_at_risk_advamed_october_2016.pdf 3 www.fda.gov
Makower Report (2010): FDA Impact on US Medical Technology Innovation $10M $8M $40M $13M United States FDA Apply for Safety study Pivotal study FDA approval IDE submission Initial reimbur- sement Same starting point: Clinical 0 7 14 21 28 35 42 49 56 63 70 (months) Development Initial reimbursement CE mark approval Safety study CE mark submission $8M Europe $1M ~ 4 years longer to regulatory approval in US versus Europe 4 Adapted from: Josh Makower white paper, “FDA Impact on US Medical Technology Innovation”, November 2010
Entrepreneurs-in-Residence Program One (Oct 2011 – May 2012) Overview: Th The En Entrepreneurs-in-Res esidence ce ( (EIR) p ) prog ogram a at t CDRH i is a ti time-limited r recruitment o of world- cl class en entr trep epreneu eurs and innovators t to o joi oin h highly-qualifi ified ed i inter ernal g gover ernmen ent e t employee ees i in th the e devel elopment o t of sol oluti tion ons i in area eas th that t impact i ct innovati tion Goal: The e EIR g goa oal is to o del eliver tr transformati tional ch change by c y combining the b best internal an and e external tal alent ap applyi ying ng t the he principles o s of lean an engineering i in rap apidly t testing, val alidating an and sc scal aling new ap approaches Focus: To better understan and t the drivers f s for t the CD CDRH v visi sion n an and d to develop a p a ne new expedited p d pathway y to improve p pati tien ent t acces ccess to o innovati tive m med edical d devi vices ces – ESRD Innovation Challenge (2013 – 2016) – Breakthrough Devices Program (2018) 5 Source: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHInnovation/InnovationPathway/ucm286138.htm
US Medical Device Industry: Innovation Challenges Fact ctors c s cited a ed as ha havi ving t the hi he highes est i t impa pact ct o on n dec decisions t s to move e medi edical de device i e inves estmen ent o t out utsi side e of U.S. S.* Regulatory Challenges – 38% Reimbursement Concerns – 18% Clinical Trial Time and Costs – 14% * from National Venture Capital Association/Medical Innovation & Competitiveness Coalition survey of 259 NVCA member firms investing in the healthcare sectors; 60% (156 firms responding) October, 2011 6
Entrepreneurs-in-Residence Program Two (Oct 2012 – May 2013) Focus: The The EIR t tea eams s confronted ed the t e three ee cha hallen enging a areas i s iden dentified b by NVCA CA that ha t have e the po e poten enti tial to be better er s sup upport a t a more e robust en environmen ent f t for medi edical al de device i e inno nnovati tion: – Streamlining clinical trials – Streamlining FDA approval to reimbursement – Striking the right balance between pre- and post-market requirements 7 Source: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHInnovation/InnovationPathway/ucm286138.htm
FDA Responds to the Challenge • Clinical Trials Prog ogram i in ODE E based on on recom ommendation ons f from om the he Ei EiR Pro rogra ram Early feasibility program: 17 approvals in FY 2013; 51 in FY 2019 Adaptive and Bayesian design Patient-Centric Benefit/Risk; Patient perspectives • Payor or Com Communicati tion Tas ask F k Force to o St Streamline t the path th f from FDA A A Approval al to P Payer Coverag age ( (from om Ei EiR) • Balan anci cing g Pre a and P Post-mar arket E t Evidenti tiary R y Requirements NEST – the use of Real-World Evidence Coordinated Registry Networks (CRNs) 8 www.fda.gov
Continuous Innovation Internal Innovation • Training vi visits to i o innovative i incu cubator ors/acce ccelerators • Training vi visits t to o payor ors Public Private Partnerships • KHI – American Society of Nephrology and FDA (2012) • KidneyX – American Society of Nephrology and HHS (2018): Uses prize competitions to accelerate the development of innovative solution that can prevent, diagnose and/or treat kidney diseases 9 1/22/2020
Thank You 10
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