MDIC Modeling and Simulation Summit

Transcription

1 1 Our Members Abbott Vascular, Abiomed, AdvaMed, ANSYS, AptivSolutions, B. Braun Medical, BD Becton, Dickinson & Co., Biomet, Inc., Boston Scientific, Cardiovascul`ar Research Foundation Skirball Center, CD-adapco, Centers for Medicare & Medicaid Services (CMS), Cook Group, Inc., Covidien, Creganna-Tactx Medical, CVRx, Cyberonics, DesignWise Medical, Edwards Lifesciences, FasterCures, U.S. Food & Drug Administration (FDA), HeartFlow, Inc., Holaira, Immucor, Inc., IT'IS USA, Johnson & Johnson, LifeScience Alley, Medical Device Manufacturers Association (MDMA), Medtronic, Inc., North American Science Associates, Inc. (NAMSA), National Institutes of Health (NIH), National Organization for Rare Disorders (NORD), Novartis Pharmaceuticals, National Venture Capital Association (NVCA), NxThera, Inc., Patient-Centered Outcomes Research Institute (PCORI), The Pew Charitable Trusts, SIMULIA / Dassault Systemes, St. Jude Medical, Sysmex America, Inc., Terumo BCT, Vital Images, Inc., W.L. Gore & Associates MDIC Modeling and Simulation Summit Opening Remarks, June 26th Dawn Bardot, Program Manager, MDIC

2 Vision Quick and Predictable access for Patients to Innovative technologies enabled by Computation Modeling and Simulation Evidence of safety and performance 2 The Future of Evidence

3 3 TPLC Use of CM&S Evidence VIRTUAL PROTOTYPING DESIGN IDEATION Total Product Life Cycle DESIGN OPTIMIZATION PREDICT SUCCESS? REDESIGNS PREDICT FAILURES? ROOT CAUSE Source: Regulatory Science in FDA's Center for Devices and Radiological Health: A Vital Framework for Protecting and Promoting Public Health

4 4 TPLC Use of CM&S Evidence Reimbursement Point of care

5 Basic Research Roadmap: Increasing the use of CM&S evidence Nonclinical Clinical Virtual Patient and Virtual Device Future Research to describe disease states 10+ years Who: Academia informed by Industry and OSEL/OSB Replace existing bench with simulation Now Research into physiologic properties 1-2 years Leap-frog technology safety evidence by simulation 5 years Autonomous control embedded systems Accredited models libraries Computer Modeling and Simulation Roadmap Mock Submissions Benchmarks Pilot Methods, Tools, Approaches, and Process 5 5 Now Model Credibility Data Archival Interoperability?? Who: Industry and OSEL/OSB informed by ODE Standards & MDDT

6 6 CM&S Team Structure Computer Modeling & Simulation Team MDIC Staff Executive Director: Bill Murray Program Administrator: Cynthia McKee Dawn Bardot, Ph.D. Program Manager Program Manager works with CM&S Steering Committee, MDIC staff, and project leads to develop scope and manage project resources, timelines, and deliverables Steering Committee Board Champion: Randy Schiestl Program Manager: Dawn Bardot FDA PI: Kyle J. Myers, Ph.D. Members Expert Panel Grant Review Academia and Individuals Working Groups Team Chair Team Members Clinical trials informed by simulation and bench Chair: Tarek Haddad Medtronic Library of models and data Chair: Dave Flynn Boston Scientific Orthopedics MR heating Blood damage Chair: Payman Afshari Depuy-Synthes Chair: Victor Krauthamer FDA Chair: Marc Horner ANSYS 6 Human heart and vasculature Chair: Wei Gan Medtronic

7 CM&S Steering Committee 7 Randy Schiestl, Vice President, Global Technology, Boston Scientific Corporation, MDIC Board Champion Dawn Bardot, Senior Program Manager, Modeling and Simulation, MDIC Kyle Myers, Director, Division of Imaging and Applied Mathematics, OSEL, FDA PI to MDIC Medical Device Manufacturers Matt Waninger, President, Cook MED Institute David Flynn, R&D Manager, Virtual Engineering, Team Boston Scientific Corporation MorrisMilton, Vice President, R&D, Cyberonics Dave Anderson, Sr. Vice President, R&D, St. Jude Medical Anita, Bestelmeyer, Director of Corporate Computer-Aided Engineering, BD Rich Thomas, Vice President, R&D, Endovascular Therapies, Medtronic FDA Tina Morrison, Advisor of Computational Models, Office of Device Evaluation Donna Lochner, Assistant Director, Office of Science and Engineering Laboratories Aldo Badano, Imaging Physics, Division of Imaging and Applied Mathematic, OSEL Gerry Gray, Deputy Director, Division of Biostatistics, OSB Matthew Myers, Computational Modeling, Division of Solid and Fluid Mechanics, OSEL Pras Pathmanathan, Computational Biology, Division of Physics, OSEL Non Profits and CM&S Expert Organizations Cheryl Liu, Life Sciences Engagement Manager, SIMULIA Marc Horner, Lead Healthcare Specialist, ANSYS Kristian Debus, Director for Life Sciences, CD-adapco Grace Peng, Program Director, Division Of Discovery Science & Technology, NIBIB/NIH Niels Kuster, Founding Director, Foundation for Research, IT IS

8 8 Attendees by geographic location

9 9 Attendees by geographic location

10 10 Demographics of the 134 attendees SECTOR GOV'T 2% MCID MEMBERSHIP FDA 31% Industry 51% Nonmember 39% Member 61% Academic 16%

11 11 We are here today to create a community of practice Focus modeling and simulation as regulatory grade evidence Communicate in common terms Find areas for early success Remove barriers of engagement Identify validation needs to demonstrate model credibility

12 12 Summit Logistics We appreciate your help keeping us on schedule Talk timing 14 minute podium and 5 minute 3-in-5 podium Lunch is boxed, we will eat in the room during the 3-in-5 presentations The MDIC Library Working Group will meet in this room, Thursdaytoday, at 5pm Folks wanting to go to dinner together tonight, sign-up sheets are in the back of the room arranged by working-group topic. Meet up at the end of today s session. Please use the sharpies and post-its to comment on the Roadmap posters WiFi, SSID: pewguest User Name: guest Password: LQuintana1960 We will be using Polly Everywhere to engage audience participation! PollEv.com/MSsummit