RCRI

STEPHAN W. NORSTED, PhD, MPH

Founder of RCRI, Inc., President and a Senior Principal Advisor in worldwide regulatory and clinical affairs.

Steve holds a PhD and an MPH in Epidemiology and has been responsible for the design, conduct and analysis of preclinical and clinical studies since 1980. He joined the medical device industry in 1988 and has held senior-level positions in Regulatory Affairs/Clinical Studies. Dr. Norsted served as an Epidemiologist for the Washington State Health Department, and has served as an instructor on preclinical and clinical studies for the graduate schools of three universities.

Steve is a member of Regulatory Affairs Professional Society (RAPS) and has twice served as Co-Chairperson of the Clinical Studies Committee for Life Science Alley. He lectures on clinical research methods and regulatory affairs at regional and national conferences.

TIERNEY L. NORSTED, PhD, MPH

Founder of RCRI, Inc., Executive Vice President and a Senior Principal Advisor in worldwide regulatory and clinical affairs.

Dr. Norsted holds a PhD and an MPH in Epidemiology and has been responsible for the design, conduct and analysis of clinical trials since 1981. Terry has held clinical and regulatory management positions for medical device companies since 1987 where she has been responsible for numerous successful domestic and international regulatory strategies, regulatory product submissions (Pre-IDEs, IDEs, 510(k)s, PMAs, HUDs/HDEs, reclassification petitions), as well as the design, implementation, and analysis of clinical trials of medical devices.

Dr. Norsted has significant regulatory and clinical expertise in the area of wound healing indications and tissue adhesive medical devices and recently successfully authored a reclassification petition to down classify topical tissue adhesive medical devices from Class III to Class II.

JENNIFER M. MARRONE, MBA

Founder of RCRI, Inc., Executive Vice President and a Senior Principal Advisor in worldwide regulatory and clinical affairs.

Jennifer has 25 years experience in the medical device industry, including preparing regulatory submissions (PMAs, IDEs, HUDs/HDEs, 510(k)s,
dossiers, technical files, etc.) as well as in negotiating with governmental authorities, interacting with clinicians, as well as successfully organizing and managing professional staff in regulatory, clinical and quality system/compliance departments for several medical device manufacturers (of varying employee size). Her experience in executive management, staff development and management, along with her hands-on expertise in regulatory, quality and clinical affairs, both US and internationally, enable her to provide innovative service to the medical device industry.

Jennifer holds a Master's Degree in Business Administration. She is actively networked throughout the medical product industry and welcomes opportunities to present on regulatory affairs, clinical study and quality/compliance topics at industry and trade association meetings.

LISA GRIFFIN VINCENT, PhD, MA

Chief Operating Officer and a Sr. Principal Advisor

Dr. Vincent holds a bachelor's of science in Nursing, Master's in Kinesiology, and PhD in Health Services Research & Policy, all from the University of Minnesota. She joined the medical research community in 1988 and has held multiple senior scientific and executive management positions in Clinical Research, Health Economics and Policy, and Medical Affairs for Fortune 500 companies and consulting firms. Her experience crosses the device, pharmaceutical, biotechnology, and healthcare payer industries and includes all phases of research with an expertise in late stage and post-market programs designed for effectiveness, long-term safety and surveillance, and risk management. Dr. Vincent has unique experience in working with companies to address complex industry compliance issues including Corporate Integrity Agreements, and establishing infrastructure and processes to prevent such issues in a rapidly changing environment.

Dr. Vincent has been very active in broader industry leadership including serving multiple years as chair of the AdvaMed Clinical Trials Workgroup influencing policy and regulations such as FDAAA Title VIII, Clinical Trials Registry and Results Databank, and was one of the contributing authors to the handbook funded by AHRQ and HHS' CMS, Registries for Evaluating Patient Outcomes: A User's Guide.

Management Team

CHRIS LYLE, MS

Vice President Health Informatics and Senior Principal Advisor

Chris is a biostatistician, holds a Master's Degree in Statistics and consults widely in health economics. He has 15 years' experience in the pharmaceutical and medical device industries, including extensive experience with orthopedic, spinal, wound healing, infection control and IVD devices.

Mr. Lyle has advised numerous clients in the design, analysis, and interpretation of clinical, preclinical, and health economics studies and routinely negotiates study designs with the FDA on behalf of clients.

DALE KLOUS

Vice President of Clinical Operations and a Senior Principal Advisor

Dale oversees the Clinical Affairs Department. He selects and trains staff, oversees RCRI's quality initiatives, and provides leadership in project and study management. He provides strategic, regulatory and clinical guidance to clients and RCRI staff through all stages of clinical trials and regulatory requirements.

Mr. Klous has over 21 years' experience in research and an additional 12 years in direct clinical practice as a respiratory therapist. As a clinical research professional, Dale managed the full spectrum of clinical-trial-related activities for drugs, devices, and biologics.

He has held senior management positions for numerous firms from entrepreneurial start-ups to Fortune 100 companies.

MARY FAUTSCH, RN, MBA

Vice President of Reimbursement and Health Economics and Sr. Principal Advisor

Mary has substantial experience developing and implementing reimbursement strategies for new and established products and therapies. She has worked with start-ups as well as established market leaders and has experience with hospitals, ambulatory surgery centers, and physician offices. She has worked with CMS and numerous private payers at the local and national level, has forged relationships with professional societies to obtain CPT codes, trained sales and marketing teams, developed innovative tools and services, and created high-performing reimbursement teams.

Ms. Fautsch has over 17 years' experience in the medical device industry and 13 years in nursing and hospital/clinic business operations. Her clinical background, executive management experience, and hands-on reimbursement expertise enables her to effectively navigate the dynamic healthcare environment. She holds a Bachelor of Science Degree in Nursing and a Master's Degree in Business Administration.

ZENGRI WANG, PhD

Director of Biostatistics

Zengri leads the biostatistics team providing fully integrated statistical services for clinical studies in various therapeutic areas. He has over 10 years in pharmaceutical and medical device industries and 5 years of college teaching experience. He brings significant experience in Bayesian and adaptive clinical trial design and analysis. Zengri joined RCRI from a Fortune 500 device and biologics company where he served as Statistics Manager. Dr. Wang holds a PhD in Biostatistics, MS in Computational Math from University of Minnesota, and B.S. in Statistics & Probability from Peking University. He is former President of American Statistical Association Twin Cities Chapter and a regular presenter at statistical conferences and workshops. He has also taught statistics at the college level, and has published numerous peer-reviewed statistical and scientific papers.