KENNETH SUMNER

Guides medical device companies in planning their strategies toward expediting clinical studies, developing optimal regulatory pathways to commercialization and preparing for constructive interactions with FDA. Representative clinical areas currently having assignments include cardiovascular, aesthetics, wound closure, bariatric and neonatal health. Other contributions include participating as a lecturer on regulatory/clinical topics in the Stanford University Biodesign Program, as well as being an evaluator in the Venture Capital Investment Competition held annually on the campus of the University of North Carolina. "Building Regulatory Value for the Small Company" You can contact me at: kensumner@ksumnerconsulting.com

Led pre-clinical research, clinical research, regulatory affairs and medical affairs for this $5 Billion global supplier of products for minimally-invasive laparoscopic surgical procedures. Developed program of early invovlement with R&D and marketing to understand new product claims to prepare appropriate regulatory and clinical programs. Championed an end-to-end process for developing clinical and economic evidence from data generation through publication planning.

Responsible for the regulatory and quality programs for this start-up company developing a device-based therapy for Alzheimer's Disease. Prepared regulatory filings and presentations to FDA.

Developed a medical device practice focusing on regulatory issues for this international consulting firm. Published journal articles and gave podium presentations on a variety of regulatory topics at major trade association conferences (e.g. RAPS, AdvaMed and MDMA).

Responsible for the clinical, regulatory and reimbursement programs for this start-up company developing a therapy for prostate cancer. Oversaw clinical programs in South America, Europe and the U.S. Obtained CE Mark for first product. Regulatory and early clinical results led to securing Series B funding.

Corporate policy-level responsibility for regulatory/clinical and quality assurance operations worldwide for this $800MM manufacturere of pulse oximeters and ventilators. Provided leadership, management and technical guidance to 15 facilities. Initiated and obtained regulatory approvals for 30 new products in 24 months. Reduced average regulatory time from 250 days to 135 days.

Planned and organized new clinical trial leading to PMA approval and then a successful IPO raising over $40MM for this developer of a liquid cervical cancer screening instrument/reagent system. Company subsequently acquired by Hologic, Inc.

Helped this manufacturer of interventional cardiology products return to the market with balloon angioplasty products through new clinical studies and regulatory submissions. Revised quality assurance system through the formulation and implementation of new systems for data collection, analysis and documentation.

Organized clinical department of this maker of orthopedic implantable joint prosthesis to meet the IDE regulations for conducting controlled clinical studies. Succeessfully completed the first clinical study and PMA for a fiber metal hip implant system.