Speed To Market, Inc.

CONSULTANTS, ADVISORS AND AFFILIATES

Speed to Market has assembled a staff of expert consultants and advisors to assist you with your quality and regulatory needs.

CONSULTANTS

THOMAS KROENKE - PRESIDENT and Principal Consultant

Thomas Kroenke has more than 18 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, Mr. Kroenke founded Speed To Market to assist medical device companies quickly obtain market access for their products, and maintain that market access through compliant products and systems. He has assisted companies producing products ranging from invasive catheter accessories to radiological diagnostic and therapy systems.

Mr. Kroenke earned a BSEE from the University of Nebraska - Lincoln, and an MSEM from the University of Colorado - Boulder. He is a Certified Quality Engineer, Regulatory Affairs Certified and trained as an ISO 9000 Lead Auditor.

KAREN COPELAND - PROJECT STATISTICIAN

Karen Copeland, Ph.D., has more than 10 years of experience applying statistical methods in a variety of industries including chemical, environmental, medical device, IVD, pharmaceutical, consumer, and food products. She has held academic and industrial positions before becoming an independent consultant.

Dr. Copeland earned her M.S. and Ph.D. in mathematical sciences from Clemson University and her B.A. from St. Olaf College. She is a co-author of Introductory Statistics for Engineering Experimentation (Academic Press 2003) as well as an author of peer-reviewed papers. She is a Certified Quality Engineer. Dr. Copeland currently resides in Boulder, CO.

KEVIN MORNINGSTAR - REGULATORY AFFAIRS PROJECT CONSULTANT

Kevin Morningstar has more than 21 years experience in the medical device industry. He has held operations, quality and regulatory positions at a variety of companies. Mr. Morningstar has experience with many types of medical devices including hemodialysis equipment, patient monitoring devices, diagnostic digital ultrasound image analysis systems and surgical instruments.

Mr. Morningstar earned a bachelor's degree in electrical engineering from the Michigan State University. He is Regulatory Affairs Certified, trained as an ISO 9000 Lead Auditor and registered as a Professional Engineer in the state of Colorado. Mr. Morningstar currently resides in Evergreen, CO.

ADVISORS

Raymond Riddle - Member, Advisory Board

Raymond Riddle, Vice President, Regulatory Affairs and co-founder of Standard Imaging, Inc, has more than 20 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 for the last three years.

Mr. Riddle has a B.S. degree in Biomedical Engineering, an M.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 by the U.S. Regulatory Affairs Professional Society (RAPS). Mr. Riddle currently resides in Middleton, WI.

AFFILIATES

MACKIE DEBELLIS ASSOCIATES, LLC

Mackie DeBellis Associates (MDA) is a consulting firm focused on translating technically complex ideas into innovative products and marketing messaging. Our core competencies are in Market Research & Strategy, Product Design & Development, Intellectual Property & Licensing, and Business Planning & Strategy. Much of MDA's experience is in the Medical, Consumer Goods and Education arenas in both the for-profit and non-profit sectors. MDA has designed, developed and marketed numerous products exceeding $35 million in sales revenue collectively. Our passion at MDA is American innovation. MDA uses a strategic market- and customer-driven approach to product and process development. We offer a cross-functional approach by evaluating the impact of different functional areas on a product launch or a marketing campaign. We use Design for Manufacture and Assembly (DFMA), a holistic process approach to product design, as a design tool. We team with other alliance partners to provide a customized and cost-effective solution to the project.

Contact Pamela DeBellis with MDA by phone at 303 775 1453 or via email at pameladebellis@hotmail.com.

CLASS 5 INC. (www.class5.net)

Class 5 Inc. specializes in sales and marketing solutions for the life science industry, including medical manufacturers, healthcare providers and distributors. We offer concrete solutions to established global medical companies, as well as emerging growth companies and start-ups. Class 5 has worked with domestic companies seeking to expand their market share, US companies seeking to distribute internationally, and international companies launching products in the US. From development to global launch, we have the skills to help your company optimize its competitive advantage and enhance its bottom line. Class 5 Inc. focuses on delivering medical marketing solutions in the following areas: market research, business planning, product marketing, distribution system development, marketing and technical communications and telesales. Our professional staff is comprised of senior medical sales and marketing professionals, financial analysts, clinical specialists, and marketing communications experts. We bring together a unique set of skills and experience to assist your company in attaining financial, marketshare, and operational goals in a cost-effective manner while solving problems in innovative ways.

Contact Scott Vierke with Class5 by phone at (970) 870-0576 or via email at scott@class5.net.

BEAR CREEK FREELANCE (www.bearcreekfreelance.com)

Bear Creek Freelance provides copywriting and editing services to the medical device industry, including production and/or editing of quality manuals, instructions, manufacturing, quality, and regulatory procedures. BCF also offers employee training in general business writing skills.

We offer over fifteen years experience in providing regulatory, quality and production documentation to a variety of medical device companies such as Medtronic, Inc. and Gambro Renal Products. Contact Bear Creek by phone at (303) 693-8455 or via email at info@bearcreekfreelance.com.