Articles from Medical Device Innovation Consortium

The National Evaluation System for health Technology (NEST), an initiative of the Medical Device Innovation Consortium (MDIC), is pleased to welcome Hologic, a leading global medical device and diagnostic company, to its Governance Committee. This appointment reflects Hologic’s commitment to advancing the use of real-world data (RWD) to support medical device evaluation and drive innovation in women’s health.

The Medical Device Innovation Consortium (MDIC), the first public-private partnership created with the sole objective of advancing medical device regulatory science, congratulates Dr. Michelle Tarver on her appointment as permanent director of the FDA’s Center for Devices and Radiological Health (CDRH).

The NEST Mark initiative which is being developed by the National Evaluation System for health Technology (NEST) has succeeded in empowering yet another efficient and streamlined path to FDA clearance for Intuitive labeling modification for its previously cleared robotic-assisted surgical devices (RASD) da Vinci Xi and X Surgical Systems.

Chip Hance assumed the position of Chair of the Board of Directors of the Medical Device Innovation Consortium (MDIC) at the organization’s most recent Board meeting. Hance, a longtime leader in the medical device field, reflected on the opportunities ahead for MDIC as he assumed Board leadership from the outgoing chair, Dr. Jijo James, Chief Medical Officer, MedTech and External Innovation at Johnson and Johnson.

The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), announced today it released a Request for Proposal as part of an ongoing collaboration between the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) that focuses on the Central Data Operations Hub as part of its Active Surveillance Program for medical devices:

The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), is soliciting the interest of organizations to partner in generating high-quality solutions and expertise with real-world data (RWD) to support improved evidence for medical devices. Expertise is sought in five strategic areas to realize the vision of the NESTcc real-world evidence (RWE) Marketplace for the medical device ecosystem:

A Medical Device Innovation Consortium (MDIC) program today released a new framework that provides U.S. medical device companies a systematic approach for patient-focused clinical trial design to better meet patient needs and priorities. The Science of Patient Input (SPI), with representatives from the U.S. Food and Drug Administration (FDA), patient advocacy groups, and the medical device industry, developed the approach so that the studies used to evaluate medical devices can better align with patients’ interests.

The Medical Device Innovation Consortium (MDIC) today released the first benchmark report of the medical device industry’s cybersecurity maturity in partnership with Booz Allen Hamilton. The online tool MDIC developed for surveying the medical device industry on cybersecurity practices as well as the baseline findings in this report aim to enable medical device manufacturers (MDMs), Health Delivery Organizations (HDOs), and other stakeholders to more effectively establish long-term strategic plans to increase their cybersecurity maturity and efficiently track their progress.

The Medical Device Innovation Consortium (MDIC) has partnered with PerkinElmer's Horizon Discovery to develop and manufacture somatic reference samples (SRSs) to simplify and support validation of next generation sequencing (NGS)-based cancer diagnostics. The SRSs are expected to be commercially available by early 2024, following a rigorous characterization and validation process in collaboration with the National Institute for Standards and Technology (NIST).

The Medical Device Innovation Consortium (MDIC) formally launched its Somatic Reference Samples (SRS) Initiative with a pilot project to improve the validation and regulatory review process for cancer diagnostics based on next generation sequencing (NGS).

The Medical Device Innovation Consortium (MDIC), today announced the publication of the MDIC External Evidence Methods (EEM) Framework. This framework, developed by subject matter experts from industry, academia, and the U.S. Food and Drug Administration (FDA), is a document intended to help stakeholders navigate their way through the process of leveraging external data by harnessing the power of statistics. The 21st Century Cures Act, as well as the learnings from the COVID-19 public health emergency, underscored the need to expand the role of relevant external data in the total product lifecycle of medical devices.

MITRE and the Medical Device Innovation Consortium (MDIC) announced the release of their co-authored “Playbook for Threat Modeling Medical Devices,” providing insights to organizations developing or evolving an approach to creating threat models in a systematic and consistent way. The playbook is available for download from MDIC and MITRE.

The Medical Device Innovation Consortium (MDIC) joins manufacturers and organizations across the country in celebrating Manufacturing Day 2021. MDIC and its members recognize that manufacturing innovation is a critical part of the total product life cycle for medical devices and directly impacts patient access to innovative, safe, and effective medical technologies.

The Medical Device Innovation Consortium (MDIC) announced today the launch of its Digital Health initiative. The scope of digital health-related efforts crosses over several existing programs at MDIC, including Data Science and Technology, Clinical Science, Health Economics and Patient Value, and NESTcc. This launch of the new Digital Health initiative recognizes the convergence of connectivity, information, and software of these active programs and provides an opportunity to focus additional efforts in Software as a Medical Device, Software in a Medical Device, Mobile Medical Application, Interoperability, Wireless Medical Devices, Patient-Generated Health Data, and In-silico validation/modeling.

The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), today announced the addition of two new members to its Governing Committee: Mohamed Salama, M.D., professor of pathology at Mayo Clinic and chief medical officer for Mayo Clinic Laboratories; and Eleanor Perfetto, Ph.D., MS, executive vice president of strategic initiatives at the National Health Council.

The Medical Device Innovation Consortium (MDIC) today announced a partnership with Booz Allen Hamilton to establish a benchmark of the medical device industry’s cybersecurity maturity and create resources to measure maturity over time. The benchmark will serve as a critical source of information and further enable the industry to continue to improve product security.