Titan Spine executive appointed to FDA-sponsored medical device network


Jeff Dunkel, Titan Spine vice president for Strategic Partnering, has been appointed to the Executive Operations Committee of the Medical Device Epidemiology Network Initiative (MDEpiNet).

The initiative is a collaborative program of the US Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) through which CDRH and external partners share information and resources to enhance understanding of the safety and effectiveness of medical devices after they are marketed. The Executive Operations Committee has been implemented to advise and drive forward this form of evidence-based medicine.

As part of his role, Dunkel will work throughout the USA to educate health systems on the impact of data, registries, and the Affordable Care Act (ACA) for their facilities, practitioners and patients.

Peter Ullrich, chief executive officer of Titan Spine, comments, “We are proud that Jeff has been selected for the FDA’s MDEpiNet Executive Operations Committee. This group is comprised of key opinion leaders from industry, academia, and government.”

Jeff Dunkel adds, “It is an honour to be appointed to the FDA’s MDEpiNet Executive Operations Committee. We are working diligently to expand the partnership between the private and public sectors, while continuing to help guide the building of a national medical device evaluation system to improve and integrate a comprehensive infrastructure for real-world data, methodologies, and studies. Our goal is provide the guidance and vision necessary to ensure we are improving the safety and effectiveness of medical devices in the USA for patients and clinicians.”

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 should help the FDA, the medical device industry, medical professionals, and the American public make better, more informed healthcare decisions.

MDEpiNet aims to synthesise evidence from pre-market clinical trials, post-approval observational studies, domestic and international registries, medical claims data, and published literature on utilisation 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.

According to Titan Spine, Dunkel joined Titan Spine in 2014, bringing 15 years of experience in the healthcare industry, with particular focus on software, pharmaceuticals, medical devices, and diagnostics. Prior to joining Titan Spine, Dunkel led in the creation of a new strategic position that focused on the administration within health systems, ACOs, and Group Purchasing Organisations. He has been recognised for his knowledge on the economic impact of the Affordable Care Act on Hospitals and Health Systems, and he lectures for state and national organisations for that topic. Dunkel is currently responsible for strategy involving market access that incorporates policy, lobbying, training, product launch, contracting, negotiation, and management. He works closely in coordination with marketing, sales, and operations. Dunkel continues to be active within health care policy, holding regular meetings with government agencies including FDA, CMS, NIH, and the White House.