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#P4C2014 Medical Device Innovation Consortium (MDIC) Innovator Presentation Stephanie Christopher, Medical Device Innovation Consortium Kathryn O’Callaghan, FDA Center for Devices and Radiological Health

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#P4C2014

Medical Device Innovation

Consortium (MDIC)

Innovator Presentation

Stephanie Christopher, Medical Device Innovation Consortium

Kathryn O’Callaghan, FDA Center for Devices and Radiological Health

#P4C2014

Tweet With Us

: @MDIConline

: @FDAcdrhIndustry

#P4C2014

Partnership OverviewThe Medical Device Innovation Consortium (MDIC) is a 501(c)3 Public-Private Partnership collaborating on Regulatory Science to make patient access to new medical device technologies faster, safer and more cost-effective.

Precompetitive space: Standards, data and processes that are common across an industry

Competitive space: Data, processes, and know-how specific to a product

FDA

Industry

Regulatory science develops tools and methods to aid in this step

Reduce time and cost of device development and review

#P4C2014

The need for this partnershipIndustry: Improve predictability in time and resources required to get a new therapy to patients

Regulatory: Promoting safety and efficacy of medical products in the face of rapidly changing technology

Patients: Having a voice in product development and access to safe and effective medical device innovation

#P4C2014

Value of the partnership

• Bring together leading experts from industry, patient groups and government to advance regulatory science of significant public health importance

• New tools including a patient preference assessment methodology catalog and framework

• Infrastructure to accomplish key strategic initiatives

#P4C2014

FDA 2014-15 Strategic Priorities for Regulatory Science

MDIC: Integral part of FDA Strategic Priorities

The Center for Devices and Radiological Health’s (CDRH) 2014-2015 Strategic Priorities describe the most important areas that they will focus on: • Strengthen the clinical trials enterprise;*• Strike the right balance between premarket and

postmarket data collection; and• Provide excellent customer service.

*MDIC collaboration through our Clinical Trial Innovation and Reform Project identified as a key aspect to strengthening the clinical trial enterprise strategic priority.

#P4C2014

Strategy

#P4C2014

Opportunities: Improving assessment

and access

Clinical Trial Innovation and

Reform

Patient-Centered Benefit-Risk Assessment

Computer Modeling & Simulation

Clinical Diagnostics

Tools, Methods and Approaches

#P4C2014

Future Plans

Publication of tools and methods– Patient-Centered Benefit-Risk Assessment

Methods Catalog and Framework– Blueprint for Early Feasibility Study Success– Modeling and Simulation in Clinical Trials

#P4C2014

Financing

Grants, contracts, restricted donations

Project seed

funding

Project Initiatives

MDIC member

dues

MDIC Infrastructure

#P4C2014

Our members1. Abbott Vascular

2. Abiomed, Inc

3. AdvaMed

4. ANSYS

5. Aptiv Solutions

6. B. Braun Medical

7. BD

8. Biomet, Inc

9. Boston Scientific

10. Cardiovascular Research Foundation, Skirball Center

11. CD-adapco

12. CMS

13. Cook Group, Inc

14. Covidien

15. Creganna-Tactx Medical

16. CVRx

17. Cyberonics

18. Edwards Lifesciences

19. FasterCures

20. FDA

21. Focused Ultrasound Foundation

22. Global Center for Device Innovation

23. HeartFlow, Inc

24. Holaira

25. IT’IS-USA

26. Immucor, Inc

27. Johnson & Johnson

28. LifeScience Alley

29. MDMA

30. Medtronic, Inc

31. NIH

32. NORD

33. NVCA

34. NAMSA

35. NxThera, Inc

36. PCORI

37. The Pew Charitable Trusts

38. SIMULIA

39. St Jude Medical

40. Sysmex Americas, Inc

41. Terumo BCT

42. Vital Images, Inc

43. W.L. Gore & Associates

15

13

12

3

Organization type

Small Company

Large Company

Patient and Non-Profit

Government

#P4C2014

MDIC Board of DirectorsAllan Coukell, The Pew Charitable Trusts Bryan Olin, PhD, Cyberonics, Inc.

William A. Hawkins III, Immucor, Inc. David Perez, Terumo BCT

Kathy Hudson, PhD, NIH Michael Rousseau, St Jude Medical

Ross Jaffe, MD, National Venture Capital Association, Versant Ventures

Peter Saltonstall, NORD

Richard E. Kuntz, MD, MSc, Medtronic, Inc Randall Schiestl, Boston Scientific Corporation

Bryan Luce, PhD, PCORI Jeffrey Shuren, MD, JD, CDRH, FDA

Aran Maree, MD, Johnson & Johnson Tamara Syrek Jensen, JD, CMS

Michael R. Minogue, Abiomed, Inc. Michael Tarnoff, MD, Covidien

William V. Murray, MDIC Nadim Yared, CVRx

Richard Naples, BD Dale Wahlstrom, LifeScience Alley

Commitment from Senior Leadership:

#P4C2014

FDA Leadership Commitment"This consortium is truly ground-breaking. It creates a safe space to collaborate on early-stage regulatory science efforts that will eventually benefit the entire industry: the advancement of innovation and ultimately, and most importantly, patients.”

FDA Commissioner Margaret Hamburg, MDMPRNews, December 3, 2012

"What we've lacked is a structure like the Medical Device Innovation Consortium that allows for a larger number of parties to come together to develop these projects on an ongoing basis - a significantly more effective way to do research.”

CDRH Center Director Jeffrey Shuren, MD, JDMedPage Today, December 4, 2012

#P4C2014

Summary

MDIC is a safe place for industry, government and non-profits to work together to build tools and methods to accelerate medical device access for patients

Ask us how to get involved.

#P4C2014

Questions

Check out our web site at www.mdic.org• Sign up to receive our

newsletter• Learn more about becoming

a memberOn Twitter @MDIConline