Events

7/26-30/15 US National Congress on Computational Mechanics in San Diego, CA

7/30/15 MDICx Series: Patient Preference Framework & CDRH Guidance

8/12/15 MDICx Series: Advancing the Use of Central IRBs presented by Clinical Trials Transformation Initiative (CTTI)

9/25/15 MDIC Annual Public Forum in Washington, D.C.

10/5-7/15 AdvaMed 2015 in San Diego, CA

10/8/15 Case for Quality Open Forum in San Diego, CA

Past Events in 2015

7/13/15 Public Meeting-Reauthorization of Medical Device User Fee Program in Washington, DC

6/23-24/15 Clinical Operations and Outsourcing in Medical Device Trials in Minneapolis, MN

6/23-24/15 DARPA Biology is Technology– Solving Problems that Matter in New York, NY

6/24/15 Case for Quality Open Forum MDICx Webinar

5/28-29/15 Medtech Partnering Forum in Tokyo, Japan

5/18-20/15 BMES Frontiers in Medical Devices Conference in Washington, D.C.

5/13/15 Patient Centered Benefit-Risk Framework Report Release in Washington, D.C.

5/6/15 Medtech Investor Conference in Minneapolis, MN

4/29-5/1/15 MDMA Annual Conference in Washington, D.C.

4/29/15 CTIR Workshop in Washington, D.C.

4/27/15 2015 ORSI Science Symposium in Silver Spring, MD

4/25-28/15 ACRP 2015 Global Conference in Salt Lake City, UT

4/20-21/15 2015 FDLI Annual Conference in Washington, D.C.

4/16-18/15 Design of Medical Devices Conference in Minneapolis, MN

3/31-4/1/15 SEMDA Conference 2015 in Atlanta, GA

3/24/15 Case for Quality Stakeholder Forum in Washington, D.C.

3/15-17/15 AIMBE 2015 Annual Event in Washington, D.C.

2/23/15 Brookings Institution- The Future of Medical Device Safety and Innovation in Washington, D.C.

1/22/15 MDICx Series- Patient Centered Benefit-Risk Assessment: Framework & Feedback

1/12/15 CMTP Obesity Workshop in Baltimore, MD

Events in 2014

12/16/14 DARPA ElectRx Proposer’s Day in Arlington, VA

12/9-10/14 Innovations in the Science and Practice of Clinical Trials in Rockville, MD

12/8-9/14 Medical Device Clinical Trials Conference in Chicago, IL

12/4/14 MDICx SeriesNEW teleconference series of workshops featuring emerging trends in med tech regulatory science, MDIC projects and subject matter experts sharing perspective, progress and opportunities.

11/19/14 LifeScience Alley Conference (LSA2014) in Minneapolis, MN

11/16-18/14 Partnering for Cures Conference in New York, NY

9/13-17/14 Transcatheter Cardiovascular Therapeutics (TCT 2014) in Washington, D.C.

9/10/14 ANSYS Medical Device Innovation Summit in Minneapolis, MN

8/17-20/14 ASME Advanced Design & Manufacturing Impact Forum in Buffalo, NY

7/9/14 Congressional hearing on 21st Century Cures: Modernizing Clinical Trials in Washington, DC

7/9-10/14 Clinical Operations and Outsourcing in Medical Device Trials in Minneapolis, MN

6/26-27/14 MDIC Modeling & Simulation Summit in Washington, DC

6/25/14 MDIC 2014 Annual Meeting in Washington, DC

5/22/14 OCTANe’s Technology Investor Forum in Orange County, CA

5/21/14 MedTech Investing Conference in Minneapolis, MN

5/19/14 Additive Manufacturing: Medical & Healthcare Conference in Boston, MA

5/7-9/14: ASME 2014 Verification and Validation Symposium in Las Vegas, NV

4/7-10/14 Design of Medical Devices Conference featuring Bill Murray, CEO, and Dawn Bardot, PhD, Senior Program Manager, CM&S, in a regulatory science symposium

3/5/14 The Brookings Institution: Biomedical Innovation: Identifying Challenges and Prioritizing Needs in Medical Device Research and Development

1/15/14 UMN Technological Leadership Institute: Leading Trends Impacting Our Medical Device Innovation Ecosystem

Events in 2013

10/1/13 RAPS: The Regulatory Convergence

9/19/13 The Patient Preference Initiative: Incorporating Patient Preference Information into the Medical Device Regulatory Processes in Silver Spring, MD

7/9/13 The FDA and Regulatory Science in Minnetonka, MN

6/18/13 MD&M East Conference in Philadelphia, PA

Please contact us to schedule an event in your community. 

 Latest News

7/1/15 MDIC President and CEO, Bill Murray will be on a stakeholder panel at FDA’s upcoming public meeting on 7/13: 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. The purpose of this guidance is to provide an assessment paradigm for radiofrequency (RF)-induced heating on, or near, multi-component, or multi-configuration, passive medical devices in the magnetic resonance environment.

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.

6/2/15 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.

News in Early 2015

5/14/15 The Gray Sheet published an article on collaboration between device companies and FDA on the use of virtual patients. See article here.

5/13/15 MDIC releases first-of-its-kind Patient Preference Framework Report. MDIC Framework Press Release

4/22/15 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.

4/1/15 Cover story in ASME’s Mechanical Engineering Magazine features MDIC Senior Program Manager, Dawn Bardot. Read article here.

3/15 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.

3/16/15 MDIC’s PCBR project is mentioned in March 16th Edition of BioCentury of the 21st Century Cures Legislation

3/10/15 FDA Commissioner, Dr. Margaret Hamburg, spoke about MDIC at the Senate Committee Hearing

2/23/15 MDIC President & CEO, Bill Murray, will be presenting at Brookings Institution’s The Future of Medical Device Safety & Innovation Event

1/30/15 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.

1/16/15 MDIC E-Blast, January 2015: MDICx Series & Upcoming Events

1/15/15 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.

1/12/15 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.

News in 2014

12/17/14 MDIC Newsletter, December 2014 A year in review, project updates and upcoming events

12/8/14 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.

11/21/14 MDIC E-Blast, November 2014: Case for Quality Program Manager Introduction, MDICx Series, Partnering for Cures presentation.

11/13/14 MDIC is mentioned in Medical Product Magazine for its collaboration with FDA and industry.

11/3/14 MDIC Update, November 2014 MDIC founder, Dale Wahlstrom, explains how medical device industry and FDA leaders joined forces to create the consortium.

9/11/14 MDIC Newsletter, September 2014

8/27/14 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.

8/27/14 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.

8/15/14 FDA announces pilot program for qualification of medical device development tools

8/13/14 MDIC takes part in White House-FDA roundtable on patient data donation

7/30/14 MDIC update: Study underway on data used in clinical trials

7/16/14 The Gray Sheet: Device consortium addresses barriers to early U.S. feasibility studies, MDIC’s Murray tells Congress

7/9/14 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.

7/1/14 MDIC Newsletter, July 2014

6/26/14 View presentations given at MDIC’s 2014 Annual Meeting.

6/12/14 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.

5/22/14 MDIC update

5/9/14 MDIC update

4/28/14 MDIC awarded funding for research on patient-centered device development

4/21/14 MDIC update

3/19/14 Bloomberg BNA: MDIC “off to a very good start,” FDA’s Hamburg says

3/14/14 MDIC Newsletter, March 2014

3/10/14 Compass Magazine: SIMULATING HUMANS: 3D modeling opens new research pathways in medicine

2/3/14 The Gray Sheet: Device innovation consortium plans to finish patient-centered project this year

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.