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Annual Meeting, 2014

Twitter: @MDIConline#MDIC2014

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Jeffery Shuren, MD, JDDirector, Center for Devices and Radiologic Health

US FDA

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Bill Murray, President & CEOMDIC Annual Meeting

June 2014

A Public-Private Partnership collaborating on Regulatory Science to make patient access to new medical device technologies faster, safer and more cost-effective

38 Members5 Members

2012 2013 Q1 2013 Q2 2013 Q3 2013 Q4 2014 Q1 2014 Q2

CM&S Executives & Fellows Meeting

Nationwide Rollout

Articles of IncorporationBy-laws; Business Plan

Key Accomplishments

1st Board Meeting

15 Members 24 Members 33 Members 35 Members

Computer Modeling & Simulation Patient Centered Benefit-Risk Clinical Trial Innovation & Reform

MDIC conducted two brainstorming sessions

with ODE and OSEL

• 30+ participants identified 50+ ideas

Executives and Fellows meeting at FDA including

70 members from industry, nonprofits, NIH, and

FDA

• Pre-meeting survey

Six working groups initiated

• Clinical trials powered by simulation & bench

• Library of models and data

• Orthopedics

• MR heating

• Blood damage

• Leads and human heart

Three priority deliverables established:

• Catalog of methods to assess patient preferences

• Framework for incorporating patient preferences

to benefit/risk assessments of new technology

• Agenda for future research regarding the

incorporation of patient preference information

into medical device regulatory approvals

Applied for and received $500K FDA contract

to conduct patient-centered benefit-risk assessment

methodology research

Catalog and Framework working groups established,

bringing together member organizations and

academic experts to collaborate on project goals.

• Held inaugural MDIC Chief Medical

Officer workshop at FDA to discuss

medical device clinical trials and

opportunities for innovation

• Conducted landscape analysis prior to

Chief Medical Officer workshop to

understand member organization

priorities for innovation in the medical

device clinical trial enterprise

• Formed project working groups to

collaborate on innovations in Clinical Trial

Design and Early Feasibility / First-in-

Human studies

3 Initial Projects:

Organizational Highlights

• 501(c)(3) status granted in 2014

• 43 Member Organizations to date

• $500K PCBR BAA Award

• Project teams: staffed and plans developed

Project Framework in place

Fully Staffed

3 Initial Projects Approved

MDIC.org launched

Full-time CEO onboard

43 Members

Pre-revenue

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Large

Company

10

Government &

Non-profit

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Small

Company

15

June 2014

43 Members

CTIR / CMO survey

$500K BAA Award

501(c)(3)granted

Umbrella Cooperative Research Agreements

(CRADA) w/ FDA1st Annual Meeting

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What is regulatory science, why is it important and what role does MDIC play?

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What is Regulatory Science?

The science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products

• Benefits patients by speeding the rate of important technologies reaching market

• Reduces time and resources needed for device development, assessment, and review. For example:

� Can lead to quicker, more efficient device approvals

� Can decrease the size and duration of pre-market clinical trials

Faster, Safer, More Cost-effectiveFDA Strategic Plan, August 2011Advancing Regulatory Science at FDA

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Why is it Important?

Increasing rate of innovations, diversity of applications & complexity of innovations have challenged traditional development and assessment systems

• More rigorous clinical trial proof is not only a regulatory expectation, it is a societal expectation

• Evidence of value will become part of premarket clinical trial considerations

• Informed patient preferences incorporated into benefit-risk decision framework; push for earlier access to potentially life saving technologies

• Balance of premarket and post market data collection through a Total Product Lifecycle framework is necessary

• Incorporation of state-of-the-art regulatory grade modeling and simulation tools to increase confidence and quality of product assessment is essential to support the pace of innovation

• Stakeholder collaboration is the most effective way to advance regulatory science

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The MDIC is uniquely

focused on the medical device

industry

• Preferentially focused on medical devices and

regulatory science• Industry led• Close partnership with FDA• National in scope

There are other public private partnerships focused on regulatory science

• Center of Excellence in Regulatory Science and Innovation (CERSI)-Georgetown

• CERSI-University of Maryland

There are many public-

private partnerships in the healthcare

space

• Medical Device Innovation, Safety and Security Consortium

• Biomarkers Consortium• Critical Path Institute• National Bone Health

Alliance• Observational Medical

Outcome Partnership• International Consortium

for Innovation and Quality in Pharmaceutical Development

Public Private Partnerships Have Worked Before:The MDIC is Uniquely Medical Device

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Optimizing Medical Device Development thru Regulatory Science

Total Product Life Cycle

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MDIC Scope and Activities

NIH CMS

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“Faster, Safer, More Cost-effective”MDIC Vision

Align

Achieve Accelerate

Bring together the expertise and resources of industry, government and non-profit

organizations

Invest in regulatory science to keep pace with technology

advances

Increase the throughput of medical device innovation

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FDA 2014-15 Strategic Prioritiesfor Regulatory Science

Center for Devices and Radiologic Health Strategic Priorities 2014-15

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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MDIC: FDA:Board Champion | TBD Acting Primary Contact |Michelle McMurry-Heath, MD, PhD |Acting Program Manager | Steve Binion, PhD | Associate Director for Science | Office of the Center Director | Director, Reg Affairs/Clinical Development | BD Center for Devices and Radiologic Health (CDRH)

Project Initiatives

Clinical DiagnosticsGoal: Identify one or more opportunities to improve Diagnostic trials approach/

infrastructure that will be of value to both the regulated industry and government

stakeholders, and is consistent with MDIC’s mission and project structure.

MDIC: FDA:Board Champion| Rick Kuntz, MD Primary Investigator | Bram Zuckerman, MD | Supervisory MedicalSenior VP & Chief Scientific, Clinical & Regulatory Officer | Office of Device Evaluation (ODE)Officer| Medtronic Primary Investigator | Kathryn O’Callaghan | Health Scientist|

Program Manager | Stephanie Christopher | MDIC Office of the Center Director | Center for Devices and Radiologic Health (CDRH)

Clinical Trial Innovation & ReformGoal: Streamline the clinical trial process, increasing efficiency and safety over the

total product lifecycle of medical devices

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Project Initiatives

MDIC: FDA:Board Champion | Ross Jaffe, MD Primary Investigator | Randall Brockman, MD | Chief Medical Officer | Director | Versant Ventures, and Office of Device Evaluation (ODE)Managing Director | National Venture Capital Association Primary Investigator | Robert Becker, MD | Medical Officer | OfficeProgram Manager | Stephanie Christopher | MDIC of In Vitro Diagnostics & Radiological Health (OVD)

Patient Centered Benefit-Risk AssessmentGoal: Develop a framework for including patient views on benefit/risk in device

development and regulatory assessment

Computer Modeling & SimulationGoal: Increase confidence in device safety and efficacy, reduce clinical trial size,

and accelerate device review through regulatory-grade models and simulations

MDIC: FDA: Board Champion| Randy Schiestl Primary Investigator | Kyle J. Myers, PhD | Director, Division of Imaging

VP, Global Operations & Technology | Boston Scientific & Applied Mathematics | Office of Science & Engineering Laboratories Program Manager | Dawn Bardot, PhD | MDIC (OSEL)

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Team Structure Framework

Project Manager

Steering Committee

Workgroup 1

Sub-team leadTeam members

Task Team ChairTeam Members

Grant Review Task Team

Workgroup 2

Sub-team leadTeam members

Workgroup 3

Sub-team leadTeam members

Project manager works with Steering Committee, MDIC staff, and sub-team leads to develop project scope and manage project resources, timelines,

and deliverables

Board Champion & CEOplus representatives from Membership Organizations:

Industry, Government,Non-profit, Patient groups

MDIC Staff

President & CEOProgram AdministrationEducation & Project Support

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Board of DirectorsExecutive Committee

Full Board

Allan Coukell | The Pew Charitable TrustsDirector of Drugs and Medical DevicesMDIC Vice-Chair

Vincent Forlenza | BDPresident, CEO and Chairman

William A. Hawkins III | Immucor, Inc. President and CEO MDIC Board Chair

Michael R. Minogue |Abiomed, Inc.President, CEO and ChairmanMDIC Secretary; Membership Committee Chair

William V. Murray | MDICPresident & CEOMedical Device Innovation Consortium CEO

David Perez |Terumo BCT President and CEOChairman, Blood Management Business Division, Terumo CorporationMDIC Finance Committee Chair

Jeffrey Shuren, MD, JD | CDRH, FDADirector, Center for Devices and Radiological HealthFood and Drug AdministrationMDIC Membership Committee Vice-Chair

Glenn L. Criser | Biomet, Inc.Senior VP, Quality/Regulatory/Clinical Affairs

Kathy Hudson, PhD | NIHDeputy Director for Science, Outreach, & Policy

Ross Jaffe, MD | NVCA, Director and Versant Ventures, Managing Director

Richard E. Kuntz, MD, MSc | Medtronic, Inc.Sr. VP and Chief Scientific, Clinical & Regulatory Officer

Bryan Luce, PhD | PCORIChief Science Officer

Aran Maree, MD |Johnson & JohnsonChief Medical Officer, Medical Devices & Diagnostics

Bryan Olin, PhD| Cyberonics, Inc.VP, Clinical, Quality & Regulatory

Michael Rousseau |St Jude Medical Group President

Peter Saltonstall | NORDPresident & CEO

Randall Schiestl | Boston Scientific CorporationVP, Global Operations and Technology

Tamara Syrek Jensen, J.D. |CMSDeputy Director, Coverage and Analysis Group

Michael Tarnoff, MD | CovidienChief Medical Officer

Dale Wahlstrom |LifeScience Alley and The BioBusiness Alliance of MNPresident & CEO MDIC Finance Committee Vice-Chair

Nadim Yared |CVRxPresident & CEO

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MDIC Membership Roster

1. 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, SkirballCenter

11. CD-adapco

12. CMS

13. Cook Group, Inc

14. Covidien

15. Creganna-Tactx Medical

16. CVRx

17. Cyberonics

18. DesignWise Medical

19. Edwards Lifesciences

20. FasterCures

21. FDA

22. HeartFlow, Inc

23. Holaira

24. IT’IS-USA

25. Immucor, Inc

26. Johnson & Johnson

27. LifeScience Alley

28. MDMA

29. Medtronic, Inc

30. NIH

31. NORD

32. NVCA

33. NAMSA

34. Novartis Pharmaceutics

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

Updated 6/6/2014

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Membership

Membership and participation in the MDIC is open to representatives of organizations that are substantially involved in medical and/or medical device research, development, treatment, or education; the promotion of public health; or who have expertise in regulatory science.

• Membership is offered at several levels based on organization type and, if applicable, annual revenue

• Membership has not been offered to academic groups

• Membership has not been offered to individuals

Contact: Bill Murray, CEObmurray@mdic.org952-314-1255www.MDIC.org

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Tamara Syrek Jensen, JDActing Director, Center for Coverage and Analysis

CMS

Role of Regulatory Science/ MDIC in Molecular Diagnostics: A CMS Perspective

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Michelle McMurry-Heath, MD PhDAssociate Director of Science

Center for Diagnostic & Radiologic Health, US FDA

Bill MurrayPresident & CEO

Medical Device Innovation Consortium

MDIC First-Year Perspective