Dr. Vetter’s previous medical device industry experience includes 12 years of research and senior-level management at Medtronic plc., a publicly listed NASDAQ company. Following completion of a PhD program, Dr. Vetter began her career as a Senior Scientist at Medtronic leading a research program with the primary goal of evaluating the potential of device-based mechanisms to treat heart failure at the cellular level. As part of this program, Dr. Vetter led collaborations between international physician consultants and Medtronic’s biomedical engineers to develop pioneering medical device therapies for patients with congestive heart failure. Dr. Vetter also led internal preclinical research to evaluate the new device designs and collaborated with external cardiologists to design and conduct human preclinical trials using the prototype devices. Following final design verification of the new device models, Dr. Vetter led the design and completion of the first clinical trial (INSYNC OUS) to validate the fully developed cardiac resynchronization therapy (CRT) system, which became the basis of the largest revenue source for Medtronic. Dr. Vetter subsequently developed and conducted CRT training for Medtronic’s sales managers and field clinical engineers in the U.S., Canada, The Netherlands, England, Australia, and Japan. She also stepped in as a field clinical engineer to support CRT implants and heart function optimization via echocardiography in hospitals throughout Australia during commercial product launch of the CRT system in that continent. Dr. Vetter then transitioned to leading clinical research for validation of multiple new product and therapy indication inititatives at Medtronic, including pilot and preclinical human research studies as well as IDE, post-approval, and post-market clinical trials. Dr. Vetter’s responsibilities progressed to leading high-level teams of scientists, engineers, regulatory affairs personnel, and clinical research personnel in parallel product development and global regulatory strategy development for Medtronic’s next generation cardiac rhythm management products. She assumed clinical and regulatory leadership responsibility for two of the largest product platform launches at Medtronic, leading global clinical research teams and working in collaboration with executive leadership across all functional areas of product development. Together with Dr. Vetter’s previous cross-functional experience, this provided an extensive, in-depth knowledge of the entire product development process, as follows:
- Initial technology concept research and development, including design and conduct of collaborative industry/academic human preclinical research;
- Interface with clinicians in private practice as well as academic hospitals, including evaluation of external research proposals and collaboration in the development and publication of multiple manuscripts and over 30 abstracts;
- Intellectual property development and protection;
- Product development lifecycle from proof-of-concept through final working prototype and product validation, market release, and post-market medical device performance evaluation and reporting;
- Quality systems, including cGMP as well as cGCP for clinical trial design, conduct, database development, data analysis, and publications;
- Commercial manufacturing requirements and processes;
- Development of global regulatory strategies and submissions;
- Development and integration of U.S. reimbursement strategies and global marketing strategies;
- Internal product release processes;
- Development of training and marketing materials, and direct, hands-on sales force training for commercial product launch.
Most recently, Dr. Vetter led a strategic cross-Business Unit initiative to launch a drug-device combination therapy for Medtronic, which was only the second such initiative for the company. Dr. Vetter led development of a successful Phase II IND submission and supervised the design and initial conduct of the clinical trial for validation of the new therapy, with added responsibility for organizing and supervising a large supporting cross-functional team of external consultants that included Duke University Clinical Research Institute. Prior to obtaining her PhD degree, Dr. Vetter worked as a veterinarian in private practice for six years. Dr. Vetter’s clinical experience as well as her extensive background in basic and applied medical research, biomedical engineering, and corporate medical device design and development have contributed to significant medical technology advancements. Dr. Vetter is Co-Inventor of multiple medical technologies granted U.S. and international patents. Dr. Vetter received a Doctor of Philosophy degree in Cell and Molecular Physiology, a Doctor of Veterinary Medicine degree (with honors), and a Bachelor of Science degree (magna cum laude) in Microbiology, all from the University of Minnesota Minneapolis/St. Paul campus.