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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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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
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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
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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
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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.
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Opportunities: Improving assessment
and access
Clinical Trial Innovation and
Reform
Patient-Centered Benefit-Risk Assessment
Computer Modeling & Simulation
Clinical Diagnostics
Tools, Methods and Approaches
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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
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Financing
Grants, contracts, restricted donations
Project seed
funding
Project Initiatives
MDIC member
dues
MDIC Infrastructure
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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
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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:
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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
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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.