MDIC names new VP of health economics and patient value | FDA's CDRH joins MDIC collaborative community | SPI whitepaper webinar recording, slides now available
October 22, 2020
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As MDIC's new Vice President of Health Economics and Patient Value, Jo Carol Hiatt, MD, MBA, will facilitate the organization's efforts to help medical device makers support CMS reviews, reduce costs, and expand patient access. Hiatt will work with the CMS, private payers, device makers and patient advocacy groups to ensure device makers understand what evidence they need to support coverage reviews. Learn more.
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The FDA's Center for Devices and Radiological Health has joined MDIC's Case for Quality Collaborative Community initiative (CfQcc). The CfQcc brings together manufacturers, health care providers, patients, payers, and regulators, along with MDIC members, in open, productive collaboration to enhance device quality and patient safety. Learn more.
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Clinical Science
The Science of Patient Input Communication Working Group Chair provided an overview of the report Best Practices for Communicating Benefit, Risk, and Uncertainty for Medical Devices, and the report's lead writer presented key findings, in a recent webinar. A heart patient and patient advocate also shared her experience with these types of communications. View the webinar recording and the slides.
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Patients, patient advocates, and scientific experts have developed a discussion guide to help patients ensure they get the information they need to make decisions about medical procedures during the COVID-19 pandemic. The tool is available along with other resources on MDIC's Patient Resources during COVID-19 webpage.
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MDIC recently released its framework for Real-World Clinical Evidence Generation: Advancing Regulatory Science and Patient Access for In Vitro Diagnostics. That framework, along with the Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD) project, are bringing together IVD makers, the FDA, and hospitals to use IVD RWE in regulatory systems. Learn more.
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Nine of the 13 early feasibility studies (EFS) for heart valve devices at Baylor Scott & White Research Institute since 2014 were conducted in the past two years. Program leaders say collaboration with MDIC is a primary factor in the growth of the EFS program. The research institute hosted the MDIC EFS working groups on contracts and institutional review boards that developed the EFS contract resource and informed consent templates. Learn more in the latest EFS Express newsletter.
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Data Science and Technology
MDIC is seeking proposals for assistance collecting, synthesizing, and reporting on health care industry maturity data and learnings from companies that use the MedTech Joint Security Plan. MDIC aims to develop a common method and framework for measuring cybersecurity maturity and drive industry-wide improvements that reduce overall cybersecurity risk. Watch the webinar, which covers questions about the RFP and the project.
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MDIC is establishing a workgroup focused on the development of 5G-enabled medical devices while protecting patient safety. The workgroup will identify regulatory research questions and knowledge gaps that should be addressed to accelerate 5G-enabled medical devices. Learn more.
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NEST Coordinating Center
On September 22, NESTcc hosted the NEST Forum to share the progress of its real-world evidence initiatives and 21 Test-Cases, with deep-dive presentations on five of the research projects. Read a few key takeaways on the NESTcc blog.
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On October 15, the NEST Collaborative Community hosted a virtual event with leaders from across the medical device ecosystem, including FDA, industry, payers, and patients, to discuss emerging issues related to unique device identifiers. View a recording of the event.
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The NEST Collaborative Community seeks nominations for a working group to provide perspectives and feedback on the UDI Adoption & Application study, and to help shape the response to its findings. Nominations are due Thursday, October 29. Learn more.
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Upcoming Events
This week, Accelerate Sustainable Capability pilot study stakeholders will describe the intent of the study and the collaboration among stakeholders to support and help manufacturers improve both performance and compliance. The pilot study builds on lessons learned from the existing Case for Quality Voluntary Improvement Program Pilot and is intended for sites struggling to meet regulatory compliance. Learn more and register.
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MDIC's Virtual Patient Engagement Forum on November 18 will provide opportunities to engage with patients, patient groups, medical device industry professionals, investigators, health care providers, payers, and regulators to discuss challenges and best practices for communicating uncertainty, benefit, and risk of medical devices. Two interactive activities will allow attendees to discuss the current challenges and brainstorm possible solutions based on lessons learned throughout the forum. Learn more and register.
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Join industry leaders and experts at the Veeva Medical Device & Diagnostics Virtual Summit, October 28-29, to learn how organizations are shortening the product development lifecycle and keeping pace with evolving regulations such as MDR. Learn more.
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The FDA is holding a virtual public meeting on November 17 to discuss the development, content, and format of its safety communications about medical devices. The agency will share current practices and solicit feedback from stakeholders on ways to improve safety communications. Learn more.
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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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