Melissa Martinson, MS PhD, is a founder and President of Technomics Research, LLC. The company, located in the Twin Cities, provides statistical and health economics evaluations of medical technologies and services to the medical device, pharmaceutical, biologics, and managed-care industries in support market approval by FDA and coverage by public and commercial healthcare payers.
Dr. Martinson holds a B.A. in Biology from Swarthmore College, an M.S. in Statistics and a Ph.D. in Health Services Research from the University of Minnesota. She is on the adjunct faculty at the University of Minnesota and St. Cloud State University, where she teaches graduate-level statistics and economic modeling.
Teresa Nelson, MS is a biostatistician with over 1510 years experience in the medical device industry in the areas of statistics and health economics. She has extensive experience in study design strategy - analysis of data, interpretation of results and writing of reports for government regulatory bodies and commercial insurers. She has worked on projects in all phases of research from feasibility or pre-market to those supporting market approval and and post-market and outcomes studies. She has FDA panel experience and successfully negotiated many FDA IDE approvals including some recent success with adaptive study designs.
Her experience in health economics includes outcomes studies and cost-effectiveness analyses using healthcare claims analysis and economic modeling. Ms. Nelson has utilized both Bayesian and Frequentist methods in clinical and health economics studies, including Bayesian cost-effectiveness analyses, meta-analysis and evidence synthesis. She has helped many clients determine which methodology is most advantageous for their project, especially from the perspective of the required sample size.
Manya Harsch, MS is a biostatistician at Technomics Research, LLC with over 10 years of experience in the medical device industry. She has worked at major medical device companies with emphasis on cardiac and urological devices. She is an enthusiastic, experienced critical thinker with strong statistical background and solid biological training and understanding of clinical trials. She has extensive experience with pre-IDE, IDE and PMA submissions, Condition of Approval studies, 510K submissions, Japan PMDA submissions and supporting PMDA GCP audits.
