WASHINGTON – The 2019 annual forum hosted by the Medical Device Innovation Consortium (MDIC) takes place as the National Evaluation System for health Technology (NEST) approaches full operability. Acquiring the data needed to employ NEST as a source of real-world evidence (RWE) is still an issue. Harlan Krumholz, a cardiologist and health care researcher at Yale University and Yale-New Haven Hospital, said that disruption of the business models of the "data oligopolies" is critical for use of RWE for devices in both the pre- and postmarket settings.

Telehealth and telemedicine have been slow to catch on for a number of reasons, but the U.S. Federal Communications Commission (FCC) has proposed a pilot program to increase the use of telemedicine for low-income Americans and military veterans. While access to broadband services is still an issue for many, the so-called Connected Care Pilot drew support from a range of stakeholders, who argued that telehealth is critical to managing public health crises, such as diabetes and the opioid epidemic.

The U.S. FDA has granted breakthrough device designation to Laboratory for Advanced Medicine Inc. (LAM) for its liquid biopsy blood test for the detection of liver cancer. The test, which analyzes the DNA methylation pattern of cell-free DNA (cfDNA), is designed to detect the presence of hepatocellular cancer as early as stage 1, with both high specificity and sensitivity.

The FDA's September 2018 draft guidance for considerations of benefit-risk determinations for several device types, including PMAs, said that the agency "intends" to hold an advisory committee hearing if the FDA has any questions about the post-market data generated by the accompanying post-approval study. The final guidance pulls back on that language, but only slightly, stating that the agency "generally expects" to hold an advisory hearing in this circumstance, a difference in language that may or may not translate to a difference in function.

While regulatory science can lag behind technology advances, the FDA has for the past few years been exploring ways to harness the potential of artificial intelligence (AI) to streamline drug development and the approval process. A nexus for its efforts is the Information Exchange and Data Transformation (INFORMED) initiative anchored in the agency's Oncology Center of Excellence (OCE). At its inception in 2016, INFORMED was designed to tap into the power of big data and advanced analytics to improve disease outcomes.