5/18/18 – MDIC to Reveal Patient-Generated P-Values from Parkinson’s Patient Preference Study at May 18 Workshop in Arlington, VA. Click here for details
5/17/18 – MDIC Program Directors Stephanie Christopher and Dan Schwartz will a webinar for the Clinical Trials Transformation Initiative (CTTI) titled MDIC and CTTI: Synergies in Clinical Trials Efforts. The webinar is May 17 at 12 p.m. Eastern and open to the public. Click here for details and registration information.
5/15/18 Save the Date – ASME V&V 40 Industry Day. The ASME V&V40 Standard on Assessing Credibility of Computational Modeling and Simulation Results through Verification and Validation: Application to Medical Devices is tentatively slated for final publication in June 2018. The V&V40 Subcommittee is organizing an industry day on May 15, 2018 to facilitate industry awareness and adoption by both engineers and regulatory. MDIC’s Dan Schwartz will be a panelist on the Regulatory Affairs Perspective for Advancing Opportunities in Modeling and Simulation. Click here for more details and registration information.
4/9/18 – 4/13/18 Join MDIC at the annual Design of Medical Devices Conference at the University of Minnesota April 9-12. MDIC working group members will lead panel discussions on the use of computer modeling and simulation in medical device development. Details at http://www.dmd.umn.edu/
Immediately following the DMD conference, join MDIC fellow Dr. Greg Molnar at the UMN Neuromodulation Conference April 12-13. Representatives from the MDIC PCOR project will take part in a “Voice of the Patient” panel discussion on April 12. Details at http://neuromodulation.umn.edu/
2/6/18 Join Stephanie Christopher, Program Director of MDIC on Feb 6 at the MD&M West for a panel discussion on the CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program
11/8/17 Join Stephanie Christopher, Program Director of MDIC on Nov 8 at the MD&M Minneapolis event. Examine Patient Preference Studies with topics covering how to design and conduct patient preference studies and using patient preference studies to speed approval.
10/10/17 Webinar – Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. From 1:00-2:30 PM EST, the FDA will host a webinar for industry interested in learning more about the final guidance document “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.” Registration is not necessary.
10/3/17 Join MDIC at its Annual Public Forum Tuesday, October 3 from 8:30 AM – 4:30 PM at the Kaiser Center for Total Health in Washington, DC.
9/25-9/27/2017 Join MDIC at the The MedTech Conference . Come hear three great panels: Building a Healthy NEST Egg: Exploring the Opportunities and Benefits of the National Evaluation System for Health Technology; Case for Quality: CDRH-Industry Update; and Success with Surrogates: A New Framework and Best Practices for Surrogate Samples to Support Diagnostic Innovators. And be sure to join us in the Exhibit Hall at booth 434, and at the Exhibit Hall Patient Pavilion for a panel on Partnering with Patients to Improve Innovation.
9/22/2017 Join Rachael Fleurence, PhD, Executive Director of NEST Coordinating Center, September 22 from 1:00 pm – 2:00 pm for Grand Rounds: Improving Evidence Generation for Medical Devices: The New National Evaluation System for Health Technology (NEST) webinar. Register here http://bit.ly/2wWlmUV
8/17/17 Join Jing Xie, VP Clinical Affairs of MDIC on Aug 17 at the NextGeneration Dx Summit. Examine Commercialization of Next Generation Diagnostic Testing and major opportunities and challenges for taking the next generation diagnostic testing to the market, regulatory, and reimbursement.
7/12/17 The 2017 MedTech + Digital Health Summit is a content rich, high quality, half-day program designed specifically for senior leaders, regulatory and quality experts, entrepreneurs, and business development executives from MedTech + Digital Health organizations. Life Sciences PA has partnered with leading industry and regulatory experts to bring timely content, relevant insights, and educated opinions on issues that matter most to the MedTech + Digital Health community.
6/16/17 – Preliminary results from MDIC’s Early Feasibility Study (EFS) project were presented on June 16th 2017, at the Transcatheter Valve Therapies (TVT) conference by Chip Hance, Board of Directors Member of MDIC. Slides from the presentation can be found here: Early Feasibility Studies (EFS) in the U.S. with a Focus on Valvular Heart Disease: Updates, Impact and Future Directions.
MDIC’s EFS project is intended to establish a baseline of EFS performance metrics and subsequently develop tools and best practices to improve the efficiency in EFS initiation and conduct. The success of EFS project will support the broad adoption of FDA CDRH EFS program which is envisioned to bring EFS back in the U.S. and provide U.S. patients’ timely access to safe and effective medical device technologies of public health importance first in the world.
Preliminary results identified several improvement opportunities during EFS initiation. In coming months MDIC’s EFS working group will focus on (1) increasing the performance metrics database robustness, and (2) developing tools and best practices to improve EFS efficiency in specific areas.
5/11/17 – MDIC CEO Bill Murray will take part in a panel discussion at a dinner symposium during Heart Rhythm 2017 titled “How Innovation and Cybersecurity Impacts Physicians and the Patients We Treat. Balancing the Risks & Patient Benefits with Medical Technology Advancements.” Details available here.
5/4 – 5/5/17 – MDIC will take part in the NIH workshop of Optimizing the Investment in Medical Devices for Rehabilitation. This workshop is sponsored by National Center for Medical Rehabilitation Research (NCMRR), National Institute of Child Health and Human Development (NICHD) and National Institute of Neurological Disorders and Stroke (NINDS). MDIC VP of Clinical Affairs Jing Xie will moderate the session “Industry Perspective of Commercialization of Rehabilitation Technology”
5/4-5/5/17 – MDIC at the IDEAL Conference in NYC May 4-5 MDIC CEO Bill Murray and Vice President, Technology Innovation, Dawn Bardot and other MDIC collaborators will present an introduction to the MDIC NEST Coordinating Center at this conference focused on the latest developments in the scientific methodology for investigating new surgeries and medical devices. Click for more details
5/2/17 – Join MDIC May 2 at the MDIC Case for Quality Metrics workshop, a pre-conference workshop in advance of the FDA/Xavier MedCon Conference. Leaders from the MDIC Case for Quality will demonstrate how to implement metrics in your organization in a meaningful way.
4/11-4/12/17 – MDIC will take part in two sessions at the AdvaMed Innovation Summit. MDIC Program Manager Dan Schwartz will moderate the session “Innovation in Clinical Evidence Generation, Synthesis and Appraisal to Advance Regulatory Science for the Total Product Life Cycle;” MDIC VP of Clinical Affairs Jing Xie will be one of the panelists. MDIC Program Director Stephanie Christopher will moderate the session “The Art and Science of Regulatory Patient Preference Assessment;” MDIC CEO Bill Murray will be a panelist
4/10-4/13/17 – MDIC will take part in a number of panels and presentations at the University of Minnesota Design of Medical Devices Conference. CDRH Director Jeff Shuren will give a keynote address on the NEST Coordinating Center.
4/2/17 – MDIC CEO Bill Murray will provide an overview of the NEST Coordinating Center at The American Heart Association’s Quality of Care and Outcomes Research Scientific Sessions April 2 in Washington, DC. Additional details on the Association’s web site.
3/2/17 MDIC Program Manager Stephanie Christopher will be a panelist at the Patients as Partners 2017 conference on the panel “Partnering with Patient Organizations for Advancing Cures.” Stephanie will be on the panel with Lauren McLaughlin from The Michael J. Fox Foundation for Parkinson’s Research, one of MDIC’s partners on our project “A novel method for incorporation of PCOR in clinical trial design.”
2/20/17 Dr. Dawn Bardot, MDIC VP Technology & Innovation, along with stakeholders from FDA and DCRI (Duke Clinical Research Institute), will present on MDIC’s Virtual Patients model during the CRT 2017 conference at a session titled, “Leveraging Existing Information for Future Studies: The Case for Bayesian Methods.”
1/10-1/11/17 MDIC CEO Bill Murray is among the speakers at Medtech Showcase, a two-day event serves as the medtech community’s dedicated home during the healthcare industry’s biggest week of the year. The event will serve as the premier networking forum for innovative medtech companies to share their technologies with an audience of potential investors and commercial partners.
10/17 – 10/19/16 Join MDIC at the AdvaMed 2016 conference. MDIC will host two great panels on patient engagement and innovation in clinical trial design.
9/21/16 MDIC Annual Public Forum: Wednesday, September 21, 2016 at the Ronald Reagan Building and International Trade Center, 1300 Pennsylvania Avenue, Washington DC 20004. >Check out the agenda here.
6/28/16 The Case for Quality Open Forum invites metrics experts from industry and academia to a day-long exploration of product and design quality metrics with the CfQ Metrics Workgroup, other colleagues and the FDA. We will address available metrics, how they may inform FDA decision-making, and potential pilot programs
6/1/16 The Medtech Conference, formerly known as the Medtech Investing Conference, will bring together investors, executives, and entrepreneurs here in Minneapolis to discuss critical issues facing start-ups including valuations, financing, business models, reimbursement, and exit opportunities.
5/10/16 The Case for Quality Open Forum welcomes industry, government, provider, payers and patients to hear how our Case for Quality Workgroups are working to shift medical device design and manufacturing to go beyond compliance to focus on the drivers of product quality and patient safety.
4/13/16 Join MDIC on April 13, 2016 at the 2016 University of Minnesota Design of Medical Devices Conference for two dynamic sessions focused on improving medical device development: Virtual Patients in Clinical Trials and Advancing US Early Feasibility Studies for Innovative Medical Technology .
4/11/16 The 5.10k Road Race & Fun Run hosted by the University of Minnesota’s Medical Devices Center Innovation Fellowship Program will kick off the 15th Annual Design of Medical Devices Conference. All ages and skill levels welcome. Family/pet friendly. Registration is open now!
01/12/16 Medtech Showcase Innovation Overview, San Francisco, CA. This program will feature plenary session and investor session. Discover new technologies in 30+ innovative medtech company presentations
12/9/15 MDIC CEO Bill Murray to present an MDIC overview at MassMEDIC regulatory update meeting
12/02-12/03/15 MDIC Clinical Trial Innovation and Reform working group members among the speakers at AdvaMed meeting “Medical Device Clinical Trials: Operations Challenges and Opportunities”
12/02/15 at 5pm, the University of Minnesota hosts Start-up Seminar: Faculty Experience in a Start Up, introducing the topic and participating in the panel will be Bill Murray, president and CEO of the Medical Device Innovation Consortium and board member of UMN start-up MesoFlow
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.
10/8/15 Case for Quality Open Forum in San Diego, CA
10/5-7/15 AdvaMed 2015 in San Diego, CA
9/25/15 MDIC Annual Public Forum in Washington, D.C.
9/15/15 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.
6/6/2018 – The National Evaluation System for health Technology Coordinating Center (NESTcc) has established a Data Quality Subcommittee and a Methods Subcommittee to support its efforts to conduct efficient, timely, and high-quality real-world evidence studies for medical devices. These subcommittees will develop data quality and methodological standards for NESTcc Network Collaborators – the organizations partnering with NESTcc to generate and analyze real-world data (RWD). Subcommittees will also be charged with designing processes for demonstrating conformance to the standards and will make recommendations for their implementation. Standards will build upon existing bodies of work and will leverage subcommittee members’ knowledge and experience from similar initiatives, including PCORnet, Sentinel, and MDEpiNet.
The subcommittees are comprised of members with a diverse set of stakeholder perspectives, including FDA, academia, industry, and society registries, who bring expertise from other national data initiatives and device-specific partnerships.
5/7/18 MDIC’s involvement in the Case for Quality highlighted in MedTech Insight article: Chasing Quality Isn’t Easy. But An FDA Pilot Aims To Boost Quality By Appraising The Capability Of Manufacturing Sites
5/1/2018 Join MDIC at the 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) from May 19 – 23 in Baltimore, Maryland. MDIC initiatives will be featured throughout the conference, including a patient-focused workshop, What Is Patient-Centered and Fit-For-Purpose Patient Preference Information? on May 22 from 3:45-4:45p.m. EST. MDIC Program Director Stephanie Christopher, MA, along with Anindita Saha, BSE (CDRH), Brett Hauber, PhD (RTI Health Solutions), and Margaret Sheehan, JD (Michael J. Fox Foundation Patient Council) will present a case study from a recently completed project using patient preference information to inform the statistical design of clinical trials to treat Parkinson’s disease.
The second MDIC initiative featured throughout the conference will be the National Evaluation System for health Technology Coordinating Center (NESTcc). A NESTcc panel, moderated by NESTcc Executive Director Rachael Fleurence, PhD (co-chair of the 2018 ISPOR Conference), will feature Owen Faris, PhD (CDRH, FDA), Naomi Aronson, PhD (Blue Cross & Blue Shield Association), and Kathleen Blake, MD, MPH (American Medical Association) on The Changing Landscape of Health Care Decision-Making. Dr. Fleurence will moderate the discussion on May 21 from 5:00-6:00p.m EST that will focus on how the rise of digital and health technologies is changing the landscape of decision-making in the health care system and the role NESTcc can play in enhancing RWE generation to improve decision-making. For a full list of NESTcc related activities at ISPOR and other events, please see https://nestcc.org/events/.
3/20/18 NESTcc Launches a Call for Experts to its Data Quality and Methods Subcommittees – The National Evaluation System for health Technology Coordinating Center (NESTcc) is seeking experts to participate in its Data Quality and Methods subcommittees. If you are an expert in the medical device space or if you have participated in the PCORI Methodology Committee, PCORnet, MDEpiNet, Sentinel, the International Medical Device Regulators Forum (IMDRF), the Clinical Trials Transformation Initiative (CTTI), or similar groups, you are highly encouraged to apply. Please visit nestcc.org/opportunities to read the formal Call for Experts and to download the application. The deadline to apply or to nominate a qualified applicant is 5p.m. EST on April 18, 2018.
2/7/18 What if FDA and Medtech Worked Together on Quality? An FDA initiative, now in its pilot phase, is helping the agency and medical device manufacturers see quality assurance in a new light.
2/2/18 The National Evaluation System for health Technology Coordinating Center (NESTcc) has selected 11 demonstration projects for their potential to provide proof of concept for innovative and scalable approaches to Real-World Evidence (RWE) generation across the medical device total product life cycle (TPLC).
Executive Director of NESTcc Rachael L. Fleurence, PhD explains, “the lessons from the NESTcc demonstration projects will be critical in informing the Coordinating Center’s strategy as it establishes the NESTcc Data Network focused on medical devices, an activity which is already underway and expected to make significant headway throughout 2018.”
Read more about these demonstration projects in NESTcc’s most recent press release.
1/11/18 FDA Commissioner, Dr. Scott Gottlieb, released the FDA Strategic Roadmap for 2018 and Beyond. The Roadmap includes a vision for Computer Modeling including to develop and advance the use of in silico tools and models to evaluate device performance and patient outcomes as part of the Medical Device Innovation Consortium.
1/10/18 NESTcc is seeking recommendations from industry for Real-World Evidence test-cases that could be implemented with early data network partners. If you are a medical device manufacturer interested in responding to this Call for Concepts, be aware that the deadline for submissions has been extended to January 31, 2018. Submissions are due at 5p.m. EST.
*Please note that this update extends only to the NESTcc Call for Concepts and is NOT applicable for anyone wishing to submit a response to separate NESTcc opportunities.
12/7/17 Read MDIC Computational Modeling a Simulation Working Group Chair Marc Horner’s article on how CM&S can accelerate orthopedic medical device product lifecycles.
12/4/17 NESTcc News: NESTcc announces three new opportunities for engagement and launches the new www.nestcc.org. There are two open Requests for Proposals (RFPs) for contractor support and an open Call for Concepts from medical device manufacturers. All final deadlines are January 17, 2018 with interim deadlines in December.
11/17/17 Jeff Shuren on the MDIC Case for Quality: “Ultimately what we’re looking for is value to patients – that we have better product out on the market, and we’re rewarding those companies that have that greater focus on quality.” View slides from the November 15 Forum here and read more from MedTech Insight.
11/16/17 Can partnering with patients help advance focused ultrasound? Jessica L. Foley, PhD, Chief Scientific Officer of the Focused Ultrasound Foundation discusses this and MDIC’s work in her blog.
10/3/17 MDIC Fellows Honored at 2017 Annual Public Forum
Susan Alpert, M.D., Ph.D, and Gregory Molnar, Ph.D were recognized as MDIC Fellows during the Annual Public Forum on October 3, 2017. MDIC Fellows have an honorary affiliation with MDIC in recognition of the regulatory science thought leadership provided on behalf of MDIC. MDIC Fellows have an ongoing commitment to serve MDIC’s mission externally and provide periodic strategic guidance to MDIC projects.
10/3/17 CDRH Director’s Special Citation Recognized at 2017 Annual Public Forum
The Medical Device Innovation Consortium Virtual Patient Mock Submission Team received the CDRH Director’s Special Citation on August 7, 2017. Dr. Jeffrey Shuren, Director, Center for Devices and Radiological Health, CDRH, FDA presented the award to Dr. Kyle Myers, Director, Division of Imaging, Diagnostics, and Software Reliability, CDRH, FDA, Dr. Dawn Bardot, Vice President, Technology Innovation, MDIC and MDIC Board Member Randy Schiestl on behalf of The MDIC Virtual Patient Mock Submission Team.
10/2/17 NESTcc News: Initial Demonstration Projects Address Key Use Cases for the NESTcc
8/1/17 Press Release: FDA Commissioner Scott Gottlieb to Deliver Keynote at MDIC 2017 Annual Public Forum
7/27/17 Today Dr. Scott Gottlieb, FDA Commissioner, blogged: FDA Announces New Steps to Empower Consumers and Advance Digital Healthcare
7/27/17 – MDIC CEO Bill Murray quoted in MedTech Insight regarding the formation of the CDRH Patient Engagement Advisory committee. “Patient input in clinical trials is critical and we are pleased that CDRH has encouraged this committee to explore how patients might be able to help medical device companies think about how they can better solicit and integrate patient input into the design of their clinical trials.” Access the article here.
7/14/17 NESTcc seeks input on innovative data and analytics solutions for medical device evidence generation. NESTcc is seeking to identify companies, organizations, collaborations and strategically coordinated registries from the private and non-profit sector that can offer third-party solutions that can address the real world evidence challenges in the medical device ecosystem. NESTcc is interested in identifying a range of collaborators from the academic, non-profit and private sectors with access to high quality data that can integrate such areas as cloud services, data aggregation, data storage, and data analytics to provide high quality, near real-time and cost-effective solutions to the NESTcc to support the needs of the medical device industry, the FDA and other key stakeholders. To learn more and complete the Request for Information click here.
7/12/17 The NEST Coordinating Center (NESTcc) will begin identifying Demonstration Projects in the Summer of 2017. NESTcc hopes to collaborate closely with projects that are developing, verifying and operationalizing methods of evidence generation and data use, demonstrating scalability across healthcare systems, device types and manufacturers, and that will help inform NESTcc’s strategy as it builds out critical functions and processes for a future sustainable organization. NESTcc will give designation for mature projects currently underway that have existing sources of funding for core activities. A short submission form to request the designation is available. Click here to read more and apply.
6/29/17 Medical Device Industry Looks to Take the Lead on Cybersecurity Standards There has been a distinct shift in the way medical device manufacturers view cybersecurity, according to William V. Murray, president and CEO of the Medical Device Innovation Consortium. The growing sentiment among companies is that a vulnerability shouldn’t be viewed as a competitive advantage, especially since research shows those vulnerabilities are often industry-wide problems.
5/31/17 Dr. Gottlieb’s Remarks to the 2017 FDA Science Forum feature the MDIC Virtual Patient work: “… CDRH, in collaboration with members of academia and the device industry, are developing novel methods to create models of virtual patient outcomes. Leveraging prior clinical data, these models can be used to augment and, thereby, reduce the time and cost of future clinical trials. It can also improve efficiency. FDA, through CDRH, is now using this approach in a mock premarket submission review.
5/23/17 Rachael Fleurence took the helm last month as the executive director for the NEST Coordinating Center. In a podcast interview with Medtech Insight, Fleurence talks about her qualifications and what she hopes the project will accomplish within the next year and beyond.
5/6/17 Patients with Parkinson’s Get Their Say on Device Trial Design The first-of-its-kind research collaboration between the Medical Device Innovation Consortium, The Michael J. Fox Foundation, FDA, and others is one step closer to designing trials with significance levels that dial in patient preferences.
5/3/17 An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials, The New England Journal of Medicine
3/28/2017 Following the receipt of $3 million in FDA seed funding, MDIC has begun operationalizing the Coordinating Center for the Medical Device National Evaluation System for health Technology (NEST). The Coordinating Center will strategically promote responsible sharing and efficient analysis of real-world evidence to inform and empower patients, accelerate medical device innovation, and improve health care outcomes. Learn more about the NEST Coordinating Center.
3/10/17 MDIC Virtual Patient Statistical Framework publication published: “Incorporation of stochastic engineering models as prior information in Bayesian medical device trials” Congratulations to the MDIC Computer Modeling and Simulation team in developing this work and the Clinical Trial Science team for operationalizing it!
11/15/16 MD+DI article explains how MDIC’s new collaborative project to integrate patient preferences into clinical trials may change how clinical trials are designed.
10/23/16 Medtech Insight article on MDIC’s new initiative to move clinical trials from generic p-values to therapy-specific patient values features interviews with our key collaborators. Also check out this blog post on the initative from The Michael J Fox Foundation.
10/21/16 Medtech Insight interviews MDIC CEO Bill Murray at the 2016 AdvaMed conference about MDIC’s new initiative to move clinical trials from generic p-values to therapy-specific patient values. See the video here.
10/18/16 MDIC announces new collaboration to move clinical trials from generic p-values of 0.05 to therapy-specific patient-values. Read announcement here.
10/11/16 MDIC Case for Quality issues first report on comparative analysis of medical device quality. Read announcement here.
9/26/16 Just released! The full report from the Case for Quality working group on Product Quality Outcomes Analytics is now available in the CfQ Resource Center for Sustained Quality. “Feasibility and Effectiveness of Analytics for Medical Device Product Quality Outcomes” summarizes the team’s work, observations and recommendations as they explored the use of medical device quality data to guide provider value analysis committee purchasing decisions toward better outcomes and cost management.
9/19/16 The National Evaluation System for health Technology (NEST) Planning Board released their recommendations for a NEST Coordinating Center in its third planning board report. Recommendations included “parameters for operational leadership, bylaws, and the creation of a representative governing board, as well as several demonstration projects meant to build the foundation of NEST and demonstrate how to more efficiently meet the public’s needs.” MDIC is honored to have been named the NEST Coordinating Center. Learn more about the National Evaluation System for health Technology here.
8/19/16 MDIC Clinical Trial Innovation and Reform report on excessive data collection in clinical trials highlighted in the Gray Sheet. Download the MDIC report and view our recent MDICx webinar on Clinical Trial Quality by Design, which highlighted some results from the report.
7/15/16 Recommendations from the MDIC Case for Quality Working Group on Medical Device Quality Metrics made headline news in the latest FDANews/International Devices & Diagnostics Monitor (Courtesy of International Devices and Diagnostics Monitor, FDAnews) and the Gray Sheet. Read how the CfQ Metrics pilot project landed on three metrics that span the product lifecycle.
7/11/16 FDA Commissioner Robert Califf and CDRH Center Director Jeff Shuren speak to the need for a National Evaluation System for Health Technology in a July 11 JAMA Editorial. Learn more about this important topic at MDIC’s Annual Public Forum September 21 in Washington, DC.
6/30/16 MDIC’s Contrived / Surrogate Samples (CSS) Use Survey is open. Currently, the speed at which innovative and improved diagnostics are developed can be hampered by the difficulty in obtaining clinical specimens. The use of contrived / surrogate samples can foster innovation when clinical specimens are difficult to obtain. This survey will take approximately 15 minutes to complete.
5/26/16 – MDIC releases draft Blueprint for Early Feasibility Study Success. As shared in a recent article, MDIC members are already realizing the strategic value of US-based EFS.
5/19/2016 Gray Sheet article (paid content) on FDA’s potential pilot program to delay inspections based on a manufacturer maturity model. As a part of Case for Quality, FDA may allow device manufacturers to put off inspection for a few years if independent verification of robust quality metrics are in place.
4/14/2016 MD+DI article highlights MDIC’s release of a draft Blueprint for US Early Feasibility Study Success. Article features an interview with MDIC EFS working group chair Karim Benali.
1/15/2016 Gray Sheet article on CDRH’s 2016-17 strategic priorities cites CDRH’s involvement with the MDIC PCBR Framework as part of CDRH’s commitment to integrating patient perspectives into regulatory decision making
1/11/2016 U.S. FDA commissioner nominee Robert Califf, MD, in written comments to the Senate, cites MDIC as an example of a public-private partnership that has been highly successful in promoting multi-sector dialogue
12/2015 The December Journal of Healthcare Contracting introduces supply chain leaders to the Case for Quality and the collaborative’s transformative potential. “If, as a medical technology community, we can agree on defined quality metrics that feed information back into the design and manufacturing process, we will reduce problems, reduce costs, and pass on the benefits to the consumer,” says CfQ Program Manager Dwight Abouhalkah
12/18/15 RAPS Regulatory Focus features an article by MDIC Board member Ross Jaffe, MDIC President & CEO Bill Murray, MDIC program manager Stephanie Christopher and CDRH staff Katie O’Callaghan and Annie Saha that highlights the MDIC Patient Centered Benefit-Risk Framework as a model of the regulatory science research possible in public-private partnerships
11/20/2015 Fierce Heath IT highlighted the recent JAMA editorial by FDA Deputy Commissioner Dr. Rob Califf which highlights FDA’s collaboration with MDIC on the development of the patient preference Framework and Catalog
11/20/2015 The latest Case for Quality Open Forum Presentations are available here
11/19/2015 JAMA editorial on patient engagement across the spectrum of medical device development by FDA authors including Deputy Commissioner Dr. Rob Califf highlights FDA’s collaboration with MDIC on the patient preference Framework and Catalog
11/18/15 CDRH is accepting applications for its Experiential Learning Program, due Dec. 16
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
10/02/2015 The MDIC Patient Preference Framework was highlighted recently in the FDA Voice blog: Why partnerships are key to the science of patient input
9/22/2015 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
9/02/2015 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.
4/01/2015 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.