Medical device companies have specialized Quality Assurance and Regulatory Affairs needs. These needs require specialized resources and expertise, especially when fast market access is also critical to company success. Let our medical device industry experts assist you with your company’s market access!
President and Principal Consultant
Thomas Kroenke has more than 30 years experience in the medical device and defense industries. He has held research, manufacturing, quality and regulatory positions at a variety of companies. In 2001, Thomas founded Speed To Market, Inc. (STM) to assist medical device companies quickly obtain and maintain market access for their products. He has assisted companies producing products ranging from invasive catheter accessories to radiological diagnostic and therapy systems.He is trained and certified as an ISO lead auditor and an MDSAP auditor.
Thomas has a bachelor’s degree in electrical engineering from the University of Nebraska – Lincoln, and a master’s degree in engineering management from the University of Colorado – Boulder.
Thomas and his family reside in the foothills near Boulder, CO.
|Karen Copeland, Ph.D.
Senior Project Statistician
Karen Copeland, Ph.D., has over 25 years of experience in clinical and healthcare statistics. Her experience includes working with all facets of medical device and diagnostic companies including R&D, quality, manufacturing, marketing, regulatory, and clinical trials. In addition, she has experience working with clients from the pharmaceutical manufacturing, chemicals, marketing, environmental, consumer products, food products, and web analytics industries. Core Competencies: General Data Analysis, Data Visualization, Statistical Design of Experiments, Statistical Process Control, Sample Size Estimation, Statistical Support of FDA Submissions, JMP Software, Technical Writing.
Karen earned a Ph.D. in mathematical sciences from Clemson University and a bachelor’s degree from St. Olaf College. She is a co-author of “Analysis of Means: A Graphical Method for Comparing Means, Rates, and Proportions” (ASA-SIAM Series 2005) and “Introductory Statistics for Engineering Experimentation” (Academic Press 2003) as well as an author of peer-reviewed papers.
Dr. Copeland currently resides in Steamboat Springs, CO with her family.
STM Advisory Board
Advisory Board Member
Raymond Riddle, Chief Regulatory Officer and Co-founder of Standard Imaging, Inc., has more than 25 years experience in various regulatory affairs and quality assurance positions with medical device companies such as Datex-Ohmeda, Nicolet Instrument Corporation and Ohio Medical Products, Inc. Mr. Riddle has written, or contributed to, more than 200 FDA submissions during his distinguished career, and has been a contributing member of the STM Advisory Board since 2001. Mr. Riddle has a bachelor’s degree in Biomedical Engineering, a master’s degree in Business Management, and graduate work in Medical Physics. He is a licensed Professional Engineer in the state of Wisconsin, and Regulatory Affairs Certified (RAC). Mr. Riddle is currently an American Society of Therapeutic Radiation and Oncology (ASTRO) Corporate Advisory Council member, a Medical College of Wisconsin Healthcare Technology Management Program Advisory Committee member, as well as an active board member with several small firms and civic organizations.
Mr. Riddle currently resides in Middleton, WI, with his wife and son.