11/17/15 MDICx: Advancing U.S. Early Feasibility Studies – CDRH and MDIC Initiatives
10/26/15 MDIC CEO Bill Murray will speak at RAPS on New Regulatory Business Models: Consortiums and Public-Private Partnerships. This session will explore collaborative frameworks and their role in facing translational challenges in biomedical innovation.
10/8/2015 Case for Quality Open Forum in San Diego, CA
10/5-7/2015 AdvaMed 2015 in San Diego, CA
9/25/2015 MDIC Annual Public Forum in Washington, D.C.
9/15/2015 MDIC Program Manager Stephanie Christopher and MDIC PCBR Steering Committee members Marc Boutin, Brett Hauber and Kim McCleary are presenting at the EveryLife Foundation – 7th Annual Rare Disease Scientific Workshop: Incorporation the Patient Perspective in Rare Disease Drug Development, in Washington, DC
8/12/2015 MDICx Series: Advancing the Use of Central IRBs presented by Clinical Trials Transformation Initiative (CTTI)
7/30/2015 MDICx Series: Patient Preference Framework & CDRH Guidance
7/26-30/2015 US National Congress on Computational Mechanics in San Diego, CA
7/13/2015 Public Meeting-Reauthorization of Medical Device User Fee Program in Washington, DC
6/23-24/2015 Clinical Operations and Outsourcing in Medical Device Trials in Minneapolis, MN
6/23-24/2015 DARPA Biology is Technology– Solving Problems that Matter in New York, NY
5/28-29/2015 Medtech Partnering Forum in Tokyo, Japan
5/18-20/2015 BMES Frontiers in Medical Devices Conference in Washington, D.C.
5/13/2015 Patient Centered Benefit-Risk Framework Report Release in Washington, D.C.
5/6/2015 Medtech Investor Conference in Minneapolis, MN
4/29-5/1/2015 MDMA Annual Conference in Washington, D.C.
4/29/2015 CTIR Workshop in Washington, D.C.
4/27/2015 2015 ORSI Science Symposium in Silver Spring, MD
4/25-28/2015 ACRP 2015 Global Conference in Salt Lake City, UT
4/20-21/2015 2015 FDLI Annual Conference in Washington, D.C.
4/16-18/2015 Design of Medical Devices Conference in Minneapolis, MN
3/31-4/1/2015 SEMDA Conference 2015 in Atlanta, GA
3/24/2015 Case for Quality Stakeholder Forum in Washington, D.C.
3/15-17/2015 AIMBE 2015 Annual Event in Washington, D.C.
2/23/2015 Brookings Institution- The Future of Medical Device Safety and Innovation in Washington, D.C.
1/12/2015 CMTP Obesity Workshop in Baltimore, MD
12/16/2014 DARPA ElectRx Proposer’s Day in Arlington, VA
12/9-10/2014 Innovations in the Science and Practice of Clinical Trials in Rockville, MD
12/8-9/2014 Medical Device Clinical Trials Conference in Chicago, IL
12/4/2014 MDICx Series – NEW teleconference series of workshops featuring emerging trends in med tech regulatory science, MDIC projects and subject matter experts sharing perspective, progress and opportunities.
11/19/2014 LifeScience Alley Conference (LSA2014) in Minneapolis, MN
11/16-18/2014 Partnering for Cures Conference in New York, NY
9/13-17/2014 Transcatheter Cardiovascular Therapeutics (TCT 2014) in Washington, D.C.
9/10/2014 ANSYS Medical Device Innovation Summit in Minneapolis, MN
8/17-20/2014 ASME Advanced Design & Manufacturing Impact Forum in Buffalo, NY
7/9/2014 Congressional hearing on 21st Century Cures: Modernizing Clinical Trials in Washington, DC
7/9-10/2014 Clinical Operations and Outsourcing in Medical Device Trials in Minneapolis, MN
6/26-27/2014 MDIC Modeling & Simulation Summit in Washington, DC
6/25/2014 MDIC 2014 Annual Meeting in Washington, DC
5/22/2014 OCTANe’s Technology Investor Forum in Orange County, CA
5/21/2014 MedTech Investing Conference in Minneapolis, MN
5/19/2014 Additive Manufacturing: Medical & Healthcare Conference in Boston, MA
5/7-9/2014: ASME 2014 Verification and Validation Symposium in Las Vegas, NV
4/7-10/2014 Design of Medical Devices Conference featuring Bill Murray, CEO, and Dawn Bardot, PhD, Senior Program Manager, CM&S, in a regulatory science symposium
10/1/2013 RAPS: The Regulatory Convergence
9/19/2013 The Patient Preference Initiative: Incorporating Patient Preference Information into the Medical Device Regulatory Processes in Silver Spring, MD
7/9/2013 The FDA and Regulatory Science in Minnetonka, MN
6/18/2013 MD&M East Conference in Philadelphia, PA
Please contact us to schedule an event in your community.
11/09/2015 Videos published online from MDIC 2015 Annual Public Forum featuring a keynote presentation from FDA Deputy Commissioner of Medical Products and Tobacco, Dr. Robert Califf
11/03/2015 An interview with MDIC’s Dawn Bardot: Model of Success
10/2/15 The MDIC Patient Preference Framework was highlighted recently in the FDA Voice blog: Why partnerships are key to the science of patient input
09/22/15 MDIC highlighted as a successful example of collaboration with FDA in the September 2015 report to the FDA Science Board titled Mission Possible: How FDA Can Move at the Speed of Science
9/02/15 Press Release: MDIC program updates to be delivered at Annual Public Forum on September 25
8/25/2015 Press Release: MDIC Case for Quality Open Forum in San Diego on October 8
8/19/2015 Press Release: Announcing keynote speakers for the MDIC Annual Public Forum
8/18/2015 An interview: Computational Modeling and Regulatory Decision Making for Medical Devices
8/13/2015 MDIC identified as a key partner in FDA’s Role in Ensuring American Patients Have Access to Safe and Effective Medical Device Technology
7/31/2015 MDIC Newsletter, July 31: Message from the CEO, Project Updates, Annual Public Forum & Member Spotlight
7/13/2015 MDIC President and CEO, Bill Murray will be on a stakeholder panel at FDA’s upcoming public meeting on the Reauthorization of the Medical Device User Fee Program
6/29/2015 CDRH released a new draft guidance: Assessment of Radiofrequency- Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices.
6/15/2015 MDIC’s Early Feasibility Study was mentioned in MDDI’s blog.
6/3/2015 MDIC conducted a Early Feasibility/First-In-Human Studies and results are in. See results of study.
6/3/2015 NIH’s National Institute of Neurological Disorders and Stroke hosted the Brain Initiative Workshop: Industry partnerships to facilitate early access to neuromodulation and recording devices for human clinical studies featuring a presentation by MDIC’s Dawn Bardot.
6/2/2015 MDIC’s PCBR project is seeking proposals to complete a systematic review of the literature regarding communicating benefits and risk of medical interventions to patients and to physicians as part of a project on best practices in risk-benefit communication in regulated medical devices. See RFP here.
5/14/2015 The Gray Sheet published an article on collaboration between device companies and FDA on the use of virtual patients. See article here.
5/11-15/2015 MDIC’s Computer Modeling & Simulation Blood Damage working group participated in a verification challenge problem at the ASME Verification & Validation Symposium.
5/13/2015 MDIC releases first-of-its-kind Patient Preference Framework Report. MDIC Framework Press Release
4/22/2015 MDIC is excited to announce that FDA Deputy Commissioner of Medical Products and Tobacco, Dr. Robert Califf, will be provide opening remarks at the CTIR Workshop in Washington, D.C. on April 29th.
4/1/2015 Cover story in ASME’s Mechanical Engineering Magazine features MDIC Senior Program Manager, Dawn Bardot. Read article here.
3/2015 CEO Bill Murray and Senior Program Manager, Dawn Bardot, wrote a guest spotlight for MDIC member ANSYS’ magazine, ANSYS Advantage. Focusing on computer modeling and simulation, the article describes a brief history, the current role of simulation as evidence and looking toward an increased use in the future development and regulation of medical devices.
3/16/2015 MDIC’s PCBR project is mentioned in March 16th Edition of BioCentury of the 21st Century Cures Legislation
3/10/2015 FDA Commissioner, Dr. Margaret Hamburg, spoke about MDIC at the Senate Committee Hearing
2/23/2015 MDIC President & CEO, Bill Murray, will be presenting at Brookings Institution’s The Future of Medical Device Safety & Innovation Event
1/30/2015 FDA Voice: Listening to Patients’ Views on New Treatments for Obesity CDRH’s Jeff Shuren & Katie O’Callaghan discuss the FDA’s Patient Preferences Initiative and how it is trying to gather patient views through a variety of forums to identify and develop methods for assessing patient preferences. In addition, the post mentions the FDA’s work with MDIC on the PCBR project.
1/16/2015 MDIC E-Blast, January 2015: MDICx Series & Upcoming Events
1/15/2015 MDIC was mentioned in PricewaterhouseCoopers’ State of the Industry report: The FDA and industry: A recipe for collaborating in the New Health Economy. See report here.
1/12/2015 Bill Murray presented at CMTP‘s first workshop on the comparative effectiveness and value of weight loss treatments that builds upon the benefit-risk framework developed by the FDA.
12/17/2014 MDIC Newsletter, December 2014 A year in review, project updates and upcoming events
12/8/2014 MDIC Member, Ray Goodrich presented the State of the Industry Address at the Medical Device Clinical Trials Conference and mentioned MDIC in his presentation at the conference in Chicago, IL on December 8, 2014. See his State of the Industry Address.
11/21/2014 MDIC E-Blast, November 2014: Case for Quality Program Manager Introduction, MDICx Series, Partnering for Cures presentation.
11/3/2014 MDIC Update, November 2014 MDIC founder, Dale Wahlstrom, explains how medical device industry and FDA leaders joined forces to create the consortium.
9/11/2014 MDIC Newsletter, September 2014
8/27/2014 MDIC is gauging member interest in a possible initiative to explore global harmonization of clinical trial standards. If you are a member of the medical device community, please help us learn more about this issue by taking this short survey.
8/27/2014 Q&A with Bennett Levitan. In a conversation with MDIC, an expert on benefit-risk assessment explains the importance of patient preferences in the development and regulatory review of drugs and medical devices.
8/15/2014 FDA announces pilot program for qualification of medical device development tools
7/16/2014 The Gray Sheet: Device consortium addresses barriers to early U.S. feasibility studies, MDIC’s Murray tells Congress
7/9/2014 MDIC gives Congressional testimony at a 21st Century Cures hearing on modernizing clinical trials. Watch the hearing here (MDIC president Bill Murray’s testimony begins at 29:10). Read Murray’s written testimony here.
7/1/2014 MDIC Newsletter, July 2014
6/26/2014 View presentations given at MDIC’s 2014 Annual Meeting.
6/12/2014 Q&A with Marc Horner. In a conversation with MDIC, the technical lead for health care at ANSYS reflects on current and future applications for modeling and simulation, from hip replacements to cerebral aneurysms.
5/22/2014 MDIC update
5/9/2014 MDIC update
4/21/2014 MDIC update
3/19/2014 Bloomberg BNA: MDIC “off to a very good start,” FDA’s Hamburg says
3/14/2014 MDIC Newsletter, March 2014
3/10/2014 Compass Magazine: SIMULATING HUMANS: 3D modeling opens new research pathways in medicine
2/3/2014 The Gray Sheet: Device innovation consortium plans to finish patient-centered project this year
12/19/2013 MDIC Newsletter, December 2013
8/13/2013 MDIC Newsletter, August 2013
5/28/2013 MDIC holds second Board of Directors meeting
Focused on the Medical Device Ecosystem
MDIC is the only public-private partnership (PPP) focused exclusively on the strategic needs of the medical device ecosystem. MDIC is designed to create a collaborative environment where the industry, nonprofit organizations, and government can work together to advance pre-competitive medical device research so that the medical device community can keep pace with the needs of patients in the United States in a more timely manner.
Focused on Regulatory Science
Regulatory science refers to the development and evaluation of new tools, methods, standards, and applied science that support a better understanding and improved evaluation of product safety, quality, effectiveness, and manufacturing throughout the product life cycle.
Focused on Improving Health
MDIC has been formed to add value at the intersecting needs of the medical device industry, the FDA, and the related organizations that are together responsible for a vibrant medical device industry that serves the public health needs of the United States.