November 8, 2018
- Barb Peterson | President & CEO, Emerson Consultants
- Liz Spurgin | Vice President, Health Economics & Patient Access, MDIC
Registeration and more information available, here.
November 14, 2018
AdvaMed hopes that you will join a complimentary webinar that highlights the role of industry representatives to medical device advisory committees. The webinar is scheduled for November 14th from 1:00-3:00 p.m., ET, and registration information is included in the attached brochure.
The webinar will feature an AdvaMed training document for industry representatives and cover topics that include:
- Essential elements of advisory committees: regulatory authorization, makeup, and conflict-of-interest review;
- What happens at advisory committee meetings and which topics are on and off the table;
- The IR’s role and best practices before and during committee meetings; and
- How consumer and patient representatives participate in committee meetings.
For more information, view AdvaMed’s brochure.
[toggle style=”default” title=”Past Events”]
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
[toggle style=”default” title=”Archived Events”]
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.