December 17, 2020
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Patients, patient advocates, and scientific experts have developed a discussion guide to help patients ensure they have the information they need to make decisions about medical procedures during the COVID-19 pandemic. Patients can use the guide when speaking with their health care providers. The tool is available, along with other resources, on MDIC's Patient Resources during COVID-19 webpage.
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MDIC continues to improve industry's ability to include patient perspectives in the development, pre-market approval, and post-market evaluation of medical devices. The Science of Patient Input initiative aims to provide a venue for continued collaboration to advance the art and science of patient engagement in regulatory science, including advances in methodologies and tactical considerations for integrating the patient's perspective and preferences in the design, clinical development and regulatory review of innovative medical technologies. If you're interested in providing feedback or contributing to some of our upcoming projects, please fill out this form.
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Clinical Science
MDIC's Virtual Patient Engagement Forum on November 18 provided opportunities for patients, patient groups, medical device industry professionals, investigators, health care providers, payers, and regulators to discuss challenges and best practices for communicating the uncertainty, benefit, and risk of medical devices. Two interactive activities allowed attendees to discuss the current challenges and brainstorm possible solutions based on lessons learned throughout the forum. Watch the session recordings.
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EFS is one of the most important regulatory developments in the last 20 years. MDIC has produced a series of videos, in collaboration with the Mullins Group, that highlight how the EFS program is enabling sponsors to accelerate time to market for devices. Two industry veterans and MDIC board members, Chip Hance, BS, MBA, and Rick Geffrion, MBA, are featured in the videos, which cover the history of the EFS program, the impact of the program on funding and pivotal clinical trial design, how MDIC has helped streamline EFS, and more. Watch the Accelerating Time to Market with Early Feasibility Studies videos.
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In 2020, the MDIC EFS Program was able to continue its work and advance the program despite the COVID-19 pandemic. The MDIC EFS Program began work to streamline sponsor-site budget negotiations, developed a tool kit comprised of all EFS tools and resources, highlighted sponsors and sites that are improving the conduct of EFS, and began expanding into new therapeutic areas. The latest edition of the EFS Express provides greater detail about these accomplishments. Learn more.
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Data Science and Technology
MDIC's new working group on 5G-enabled health care technologies is bringing together key stakeholders from different sectors to improve the process for developing and assessing innovative 5G-enabled medical devices while ensuring patient safety. The working group "is uniquely positioned to identify the knowledge gaps, particularly in the regulatory science areas, and facilitate the integration of 5G technology in medical devices," said MDIC President and CEO Pamela Goldberg. Learn more.
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The MDIC virtual Case for Quality Forum, which took place December 7-8, provided updates on the CfQ Collaborative Community and covered a culture of quality, advanced manufacturing, computer software assurance, and other topics. Watch the recordings.
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MDIC is in the process of drafting a revised 5-year strategic roadmap for its Computational Modeling and Simulation (CM&S) Program, which is built on a foundation of validation requirements demonstrating regulatory grade simulation results. This roadmap will chart the course of milestones to realize the MDIC CM&S vision of quick and predictable access for patients to innovative, yet, safe and effective technologies enabled by CM&S evidence. If you would like to provide input on the revised CM&S strategic roadmap, please fill out our survey.
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NEST Coordinating Center
At the NEST Forum on September 22, key opinion leaders from across the medical device ecosystem gathered to share the latest advancements and practical uses of real-world evidence through the 21 NESTcc Test-Cases underway, with deep-dive presentations on several completed studies. Watch the recordings and read the blog posts. The blog posts have key takeaways and perspectives from NESTcc's expert panelists on five of the Test-Case projects:
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At a NEST Collaborative Community virtual event on October 15, stakeholders including regulators, patients, payers, and industry discussed emerging issues related to unique device identifiers (UDIs). UDIs were selected as the initial focus of the Collaborative Community due to their broad relevance across the medical device ecosystem, the importance of related policy decisions to multiple stakeholders, and the urgent need for cooperative engagement. Read the blog post with insights from the event's presenters.
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On December 10, NESTcc announced the addition of two new members to its Governing Committee: David Feygin, PhD, MBA, chief digital health officer and vice president of IT digital health at Boston Scientific, and David Rhew, MD, chief medical officer and vice president of healthcare at Worldwide Commercial Business at Microsoft. Read the announcement.
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Jobs at MDIC
MDIC is hiring for multiple positions on our growing team. Learn more about open positions.
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About MDIC:
The Medical Device Innovation Consortium (MDIC) is a public-private partnership collaborating on regulatory, scientific, and patient value challenges within the medical device and diagnostic industry. Through its partnership with government, non-profit, and industry stakeholders, MDIC works to shape the future of healthcare by developing tools and resources aimed to advance approaches that accelerate patient access to safe and more cost-effective medical technologies.
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