Editorial: The Ball is in Your Court: Agenda for Research to Advance the Science of Patient Preferences in the Regulatory Review of Medical Devices in the United States

Editorial: The Ball is in Your Court: Agenda for Research to Advance the Science of Patient Preferences in the Regulatory Review of Medical Devices in the United States

Press Release: FDA Commissioner Scott Gottlieb to Deliver Keynote at MDIC 2017 Annual Public Forum

Press Release: FDA Commissioner Scott Gottlieb to Deliver Keynote at MDIC 2017 Annual Public Forum

US FDA’s Device-Focused Patient Engagement AdComm Tackles Trial Challenges

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 […]

FDA Announces New Steps to Empower Consumers and Advance Digital Healthcare

Today Dr. Scott Gottlieb, FDA Commissioner, blogged: FDA Announces New Steps to Empower Consumers and Advance Digital Healthcare

NESTcc seeks input on innovative data and analytics solutions for medical device evidence generation

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 […]

The NEST Coordinating Center (NESTcc) will begin identifying Demonstration Projects in the Summer of 2017

The NEST Coordinating Center (NESTcc) will begin identifying Demonstration Projects in the Summer of 2017. NESTcc hopes to collaborate closely with projects that are developing, verifying and operationalizing methods of evidence generation and data use, demonstrating scalability across healthcare systems, device types and manufacturers, and that will help inform NESTcc’s strategy as it builds out critical […]

Medical Device Industry Looks to Take the Lead on Cybersecurity Standards

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 […]

Dr. Gottlieb’s Remarks to the 2017 FDA Science Forum 

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 […]