Speed To Market, Inc.® Speed To Market, Inc.®
Speed To Market, Inc.®

Our People

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!

Founder

Thomas Kroenke
President and Principal Consultant

Thomas Kroenke

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 ISO13485 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.

STM Associates

Lori Carr
Senior FDA Project Consultant

Lori Carr

Lori Carr has more than 16 years experience in the medical device industry. She was a Medical Device Specialist FDA Investigator in the Cincinnati and Denver District Offices. She conducted international and domestic inspections of medical device facilities, and trained FDA investigators in conducting medical device inspections.

As a medical device specialist for FDA, she conducted numerous domestic and international inspections to ensure compliance with applicable FDA regulations including routine GMP, Pre-market (PMA), 510(k), and directed inspections from the FDA Center of Devices and Radiological Health (CDRH).

Lori has a bachelor’s degree in chemistry from Xavier University, and was a 2006 graduate of the federal government’s Office of Personnel Management Leadership Development Class. She is a certified quality auditor (CQA - ASQ), and regulatory affairs certified (RAC, US),

Lori resides in Aurora, CO with her husband, son, and daughter.


Karen Copeland, Ph.D.
Senior Project Statistician

Karen Copeland, Ph.D.

Karen Copeland, Ph.D., has more than 16 years of experience applying statistical methods to enhance the use of data. She has worked with clients in the medical device, medical diagnostics, biotech and pharmaceutical industries.

In the area of study design, Karen practices design of experiments and survey, sample size determination, and data collection optimization.

Dr. Copeland earned a master’s and doctorate degree 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 Boulder, CO with her family.

STM Advisory Board

Raymond Riddle
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.

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