Jeff Dunkel of Titan Spine Joins MDEpiNet

Jeff Dunkel, V.P. of Strategic Partnering at Titan Spine, is joining the Executive Operations Committee of the Medical Device Epidemiology Network Initiative (MDEpiNet). According to the March 17, 2016 news release, “MDEpiNet is responsible for developing datasets and creating new methods of conducting robust analytic studies, including new ways to study medical devices that improve our understanding of their innovation, safety applications, and effectiveness throughout their life cycle. By providing complete and accurate information on device use and performance, MDEpiNet will help the FDA, the medical device industry, medical professionals, and the American public make better, more informed health care decisions.”

“MDEpiNet aims to synthesize evidence from pre-market clinical trials, post-approval observational studies, domestic and international registries, medical claims data, and published literature on utilization of medical devices throughout their life cycle. Its goals include development of a conceptual framework for comparative examination of relationships between and among medical treatments, patient outcomes, medical devices, resulting in the development of novel study designs and analytical strategies, and application of these scientific advancements to CDRH regulatory decision making. Furthermore, the committee intends to advance development and testing of new approaches to medical device studies.”

Asked about the best ways to advance innovation, Dunkel told OTW, “It takes improved patient outcomes, clinical data, and education drive innovation. Over the years, the medical community has debated the innovative impact of medical technologies based on historic practice results and clinical studies. The new national trend is for our health community to look to big data and evidence-based medicine to decipher and advance innovation. The introduction of Meaningful Use patient characteristics, Unique Device Identifiers, and ICD-10 procedure codes increases the opportunity to differentiate patient care effectiveness on many levels. If we assess the treatment of any individual disease state, we can evaluate such things as patient characteristics, physician/surgeon skill sets, procedure used, devices, pharmaceuticals, and post-care education to look for patterns where we see improvement in patient outcomes compared to other treatment options. Through these channels, the ability to influence patient outcomes confirms or rejects innovation claims and, along with education efforts, helps to determine the speed of national adoption. Many forward-thinking health systems, insurance companies, and government agencies are already heavily invested in predictive registries.”

“This Executive Operations Board is an extraordinary group of medical community experts from across the country. They are already leading the charge within the FDA-sponsored Medical Device Epidemiology Network Initiative. My first step is to acclimate and add value without disrupting progress. We have already identified areas where my skill set best contributes towards the collective goals of this group and of evidence-based medicine efforts in general. This includes the application of new business measures for some of the partners we expect to incorporate in the near future, as well as an increase of awareness in the national medical community on of the capabilities of MDEpiNet. Outside of the collaborative efforts of the group, I have incorporated a significant amount of future planning information into national and regional speaking events, and noted a tremendous increase in interest on where evidence-based medicine is headed.”