Titan Spine Exec Appointed to MDEpiNet

Titan Spine LLC has announced the appointment of Jeff Dunkel, vice president of Strategic Partnering, to the Executive Operations Committee of the Medical Device Epidemiology Network Initiative (MDEpiNet). The initiative is a collaborative program of the U.S. Food and Drug Administration’s (FDA) 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 a member of MDEpiNet’s Executive Operations Committee, Dunkel will continue his efforts of advancing innovation in medicine through policy and action. As part of his role, Dunkel will work throughout the United States to educate health systems on the impact of data, registries, and the Affordable Care Act (ACA) for their facilities, practitioners and patients.

“We are proud that Jeff has been selected for the FDA’s MDEpiNet Executive Operations Committee,” said Peter Ullrich, CEO of Titan Spine. “This group is comprised of key opinion leaders from industry, academia, and government. Jeff’s expertise and vast experience in healthcare systems and policy make him a true asset to the committee. Furthermore, his appointment is a major achievement for Titan Spine and validates our capabilities in our pursuit of advancing innovation. This reflects our company’s continued focus on supporting evidence-based medicine, innovation, and collaboration with our government agencies in the best interest of patient health in the U.S. population.”

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.

“It is an honor to be appointed to the FDA’s MDEpiNet Executive Operations Committee,” Dunkel said. “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 U.S. for patients and clinicians.”

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.

Dunkel joined Titan Spine in 2014, brining 15 years of expertise 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 organizations. He has been recognized for his knowledge on the economic impact of the Affordable Care Act on Hospitals and Health Systems, and he lectures for state and national organizations 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. He continues to be active with healthcare policy, holding regular meetings with government agencies including FDA, the Center for Medicare and Medicaid Services, the National Institutes of Health, and the White House. Dunkel is a graduate of Indiana University, where he obtained his Bachelor of Science degree.

Titan Spine offers a full line of Endoskeleton devices featuring the company’s proprietary implant surface technology, consisting of a unique combination of roughened topographies at the macro, micro, and nano levels (MMN). This combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting the upregulation of osteogenic and angiogenic factors necessary for bone growth, encouraging natural production of bone morphogenetic proteins (BMPs), downregulating inflammatory factors, and creating the potential for a faster and more robust fusion.^1,2,3

Titan Spine is a surface technology company focused on the design and manufacture of spinal interbody fusion devices. The company is located in Mequon, Wis., and Laichingen, Germany.

References:

1. Olivares-Navarrete, R., Hyzy, S.L., Slosar, P.J., Schneider, J.M., Schwartz, Z., and Boyan, B.D. (2015). Implant materials generate different peri-implant inflammatory factors: PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors. Spine, Volume 40, Issue 6, 399–404.
2. Olivares-Navarrete, R., Gittens, R.A., Schneider, J.M., Hyzy, S.L., Haithcock, D.A., Ullrich, P.F., Schwartz, Z., Boyan, B.D. (2012). Osteoblasts exhibit a more differentiated phenotype and increased bone morphogenetic production on titanium alloy substrates than poly-ether-ether-ketone. The Spine Journal, 12, 265-272.
3. Olivares-Navarrete, R., Hyzy, S.L., Gittens, R.A., Schneider, J.M., Haithcock, D.A., Ullrich, P.F., Slosar, P. J., Schwartz, Z., Boyan, B.D. (2013). Rough titanium alloys regulate osteoblast production of angiogenic factors. The Spine Journal, 13, 1563-1570.