Interactive Live Session with Carilion Clinic Innovation & Human Factors – Life Cycle of a Medical Device

From concept to commercialization, the journey of a medical device is complex, collaborative, and filled with critical decision points. In this interactive session, Carilion’s Pete Larkin will lead a dynamic discussion with Nate Jones, Aileen Helsel, and Robert Trestman as they walk through the full life cycle of a medical device. Together, they will explore the early stages of ideation and design, the role of human factors in shaping usability and safety, the rigorous clinical trial process, and the challenges of bringing a product to market.

Attendees will gain first-hand insights into how multidisciplinary teams navigate this process, learn about key considerations at each stage, and better understand the path from innovative idea to real-world impact in patient care.

Pete Larkin is a Senior Consultant on Carilion Clinic’s Corporate Communications team, part of the healthcare system’s Communications, Marketing and Planning Department. He’s held the post since April 29, 2019. In his role, Pete helps develop, maintain and expand Carilion’s relationships with community leaders, government officials and other decision-makers related to Carilion’s work in the areas of government relations, internal and external communications, issues management, corporate and social responsibility, strategic communications and planning and the Virginia Tech Carilion Strategic Partnership. He is the lead consultant for Carilion Clinic Innovation. 

Pete is a member of the Roanoke Regional Chamber of Commerce Board of Directors. He is in his sixth year as a Virginia Tech Carilion School of Medicine Multiple Mini-Interviewer. Pete served two terms on the Virginia Tech Alumni Association Board of Directors and is a former member of the Virginia Tech College of Liberal Arts and Human Sciences (CLAHS) Alumni Advisory Board. He was a longtime member of the Board of Directors of Visit Virginia’s Blue Ridge, the Roanoke region’s destination marketing organization. Pete served for over nine years as a volunteer and coach for Cave Spring National Little League; spent four years as a team parent for the Cave Spring High School baseball team; and was part of a four-person committee that helped establish Roanoke’s Blue Ridge Marathon, “America’s toughest road marathon.” Pete has volunteered for the West End Center, Ronald McDonald House Charities of Southwest Virginia and Junior Achievement and is an American Red Cross and The Blood Connection donor. In 2004, he served with United States Forest Service staff on the all-volunteer committee responsible for coordinating the selection and transport of the ’04 United States Capitol Christmas tree, which was relocated from its native Highland County, Virginia to the grounds of the U.S. Capitol in Washington, D.C.

Pete and his wife of 35 years, Susan, have lived in Roanoke County since 1995. Their son, Justin, and daughter-in-law, Rachel, live in Mableton, Georgia.

Prior to joining Carilion, Pete served as Chief of Staff for Virginia Sixth District Congressman Bob Goodlatte from January 2013 until the Congressman’s retirement on January 3, 2019. Pete began work as District Representative in the Congressman’s Staunton Office in 1993 before moving to Roanoke to begin service as District Director for the Congressman from 1995 to 2012. As Chief of Staff, Pete worked with the Washington office staff responsible for the Congressman’s legislative work and the District staff in offices in Roanoke, Lynchburg, Staunton, and Harrisonburg responsible for constituent service. Pete was the lone remaining member of the original Goodlatte staff upon the Congressman’s retirement from the House of Representatives.

A native of Mechanicsville, Virginia, Pete received a Bachelor of Arts in Communication from Virginia Tech in 1985. He worked for two-a-half years for the student-run radio station, WUVT, as a Sports Reporter, Sports Director, and play-by-play announcer for the Hokies’ baseball team. He began his professional broadcasting career at the Virginia News Network in Richmond in 1985. In 1986, he was hired to be a news reporter and anchor for WKDW-AM/WSGM-FM in Staunton. He was promoted to News Director in 1991 and helped the stations receive the 1992 Virginia Associated Press Broadcasters Awards for Outstanding News Operation, Best Spot News, Best Feature Story, Best Sports, and Best Documentary/In-Depth Story. He also helped the stations earn the Frank H. Fuller Memorial Award for News seven years in a row by contributing over 1,000 stories to the Virginia Associated Press.

In her role as Director at Carilion Clinic Innovation, Dr. Aileen Helsel leads the health system’s efforts to develop and commercialize Carilion inventions and grow the region’s entrepreneurial ecosystem.  Dr. Helsel has a strong background in biomedical research. After spending years at the bench, she switched gears and took a position successfully licensing and commercializing life science innovations for Washington State University.  She made the decision to move across the country to join the Carilion Clinic Innovation team in 2021 as the Licensing Manger and accepted the Director position in 2022. At Carilion Clinic, Dr. Helsel uses her ability to find creative solutions to break through the barriers that stand between innovative ideas, implementation and bringing them to market.  Dr. Helsel also serves as a board member for the Roanoke Blacksburg Innovation Alliance, Chorda Pharma, and ArchiveCore.  She received her Ph.D. in molecular bioscience from Washington State University, focusing on reproductive biology and stem cell biology, her B.S. in molecular biology and biochemistry from the University of Idaho and is currently pursuing an executive MBA at the University of Virginia Darden School of Business.  

Robert Lee Trestman, Ph.D., M.D., joined Carilion in April 2017 as Chair of Psychiatry. Dr. Trestman is a nationally recognized expert in psychiatry and population health and has an extensive background in education and research.

Dr. Trestman previously was a tenured professor of Medicine and Psychiatry at the University of Connecticut School of Medicine, with a joint appointment as professor of Nursing. He served as executive director of Correctional Managed Health Care (CHMC), a division of the University of Connecticut Health Center. In this role, he led a health system that provided global health care to all inmates within the Connecticut Department of Correction. Prior to that, he served in numerous academic and leadership roles at the University of Connecticut, Mount Sinai Medical Center, and the Bronx Veterans Affairs Medical Center.

Robert Lee Trestman PhD MD joined Carilion Clinic and the Virginia Tech Carilion School of Medicine in April 2017 as Professor and Chair of Psychiatry and Behavioral Medicine. Dr. Trestman has lectured and consulted nationally and internationally, authored or coauthored over 180 peer reviewed articles, book chapters, and commentaries.

Dr. Trestman is the Chair of the American Psychiatric Association’s Council on Healthcare Systems and Financing, is a Board member of the American Hospital Association, serves as the Liaison between the American Hospital Association and the APA and is Councilor to the American Association of Chairs of Departments of Psychiatry. He chaired the 2023 APA Workgroup on the Future of Psychiatry. He serves on the Board of the Bradley Free Clinic in Roanoke VA and is Chair of its Behavioral Health Committee. Dr. Trestman sits on the Western Virginia Division of the US District Drug Court as Expert Medical Consultant.

Dr. Trestman enjoys cycling and competes nationally as a saber fencer. His wife, Dr. Bonnie Hennig-Trestman, competes internationally as a foil fencer and has twice represented the United States at the Veterans World Fencing Championship. Between the two, they have five children.

Nate Jones joined the team at CSRPS in 2021, after 6 years of working for Carilion’s Accountable Care Organization as an analytics consultant and project manager. He has an undergraduate degree from Virginia Tech, a Masters in healthcare administration from Jefferson College of Health Sciences (now Radford University Carilion) and is a certified project management professional.

Nate’s role at Carilion’s Center for Simulation Research and Patient Safety is to identify and facilitate collaboration opportunities both internally to Carilion and with the local professional community as well as collaborating with researchers at Virginia Tech Carilion School of Medicine.

As part of the Vital grant, Nate and his team are standing up the Carilion Usability Works, where med tech device companies and startups can get formative and summative user-centered design consultation in preparation for FDA approval and user adoption.