Federal Perspective Murray Sheldon, MD Center for Devices and - - PowerPoint PPT Presentation

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Federal Perspective Murray Sheldon, MD Center for Devices and - - PowerPoint PPT Presentation

Jun 22, 2023 222 likes •333 views

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

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Murray Sheldon, MD Center for Devices and Radiological Health U.S. Food and Drug Administration

Transformation/Innovation Opportunities for the NRC to Explore

Nuclear Regulatory Commission Discussion of Medical Uses of Radioactive Materials (public meeting)

Rockville, MD January 28, 2020

Federal Perspective

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CDRH Mission and Vision

1/22/2020

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Long-term Decline in Start-up Density Since 1988

www.fda.gov *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

*

Stark decline in Medtech since 2006 to ~600 in 2012

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Makower Report (2010): FDA Impact on US Medical Technology Innovation

United States FDA submission FDA approval CE mark submission CE mark approval Europe Apply for IDE Safety study Pivotal study Initial reimbur- sement Safety study Initial reimbursement ~ 4 years longer to regulatory approval in US versus Europe

Adapted from: Josh Makower white paper, “FDA Impact on US Medical Technology Innovation”, November 2010

$10M $8M $40M $13M $8M $1M Same starting point: Clinical Development 14 21 28 35 42 49 56 63 70 (months) 7

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Entrepreneurs-in-Residence

Program One (Oct 2011 – May 2012)

Overview: Th The En Entrepreneurs-in-Res esidence ce ( (EIR) p ) prog

  • gram a

at t CDRH i is a ti time-limited r recruitment o

  • f world-

cl class en entr trep epreneu eurs and innovators t to

  • joi
  • in 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

  • luti

tion

  • ns i

in area eas th that t impact i ct innovati tion Goal: The e EIR g goa

  • al is to
  • 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

  • innovati

tive m med edical d devi vices ces

– ESRD Innovation Challenge (2013 – 2016) – Breakthrough Devices Program (2018)

Source: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHInnovation/InnovationPathway/ucm286138.htm

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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

  • n

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

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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

Source: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHInnovation/InnovationPathway/ucm286138.htm

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FDA Responds to the Challenge

  • Clinical Trials Prog
  • gram i

in ODE E based on

  • n recom
  • mmendation
  • ns f

from

  • m

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

www.fda.gov

  • Payor
  • r Com

Communicati tion Tas ask F k Force to

  • St

Streamline t the path th f from FDA A A Approval al to P Payer Coverag age ( (from

  • m 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)
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Continuous Innovation

  • Training vi

visits to i

  • innovative i

incu cubator

  • rs/acce

ccelerators

  • Training vi

visits t to

  • payor
  • rs

1/22/2020

Internal Innovation 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

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Thank You