Initiatives

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.

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.

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.

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.