STILLWATER MEDTECH CONSULTING - Key Persons

Job Titles:

• Consultant
• Chairman of the Minnesota State Bar Association Food

Amy is a submissions expert. Amy has spent the last 26 years getting medical devices and pharmaceuticals to market. She counsels clients on regulatory strategies and prepares Pre-Submission, 510(k), De Novo, IDE, IND, DMF, and NDA submissions. She also helps device clients with CE marking and Canadian licenses. She has worked extensively on projects involving software devices, dental products, wound dressings, apps and combination products. Amy also is an expert on UDI issues. She can help you prepare and meet with FDA, whether it is a Pre-Submission, appeal or other critical issue. Amy previously worked at 3M, Dentsply, Ecolab, and RCRI. Amy is Chair of the Minnesota State Bar Association Food, Drug, and Device Section and co-teaches "Legal Basis of Regulatory Affairs" and 510(k) courses for the St. Cloud State University. She earned her Bachelor of Chemistry from the University of Minnesota and her Juris Doctor from Mitchell-Hamline School of Law. In her free time, Amy enjoys horseback riding, traveling, the arts and attending concerts, and spending time with her family. Amy is a decorated rider and has won various equestrian competitions. Amy is a submissions expert. Amy has spent the last 26 years getting medical devices and pharmaceuticals to market. She counsels clients on regulatory strategies and prepares Pre-Submission, 510(k), De Novo, IDE, IND, DMF, and NDA submissions. Amy also is an expert on U.S. and E.U. UDI issues. She can help you prepare and meet with FDA, whether it is a Pre-Submission, appeal or other critical issue. Amy previously worked at 3M, Dentsply, Ecolab, and RCRI.

Job Titles:

• Consultant

Dave is a regulatory expert. He has a thirty-five year career specializing in FDA regulatory affairs. He focuses on regulatory strategies, preparing domestic submissions, and creating and implementing quality management systems for compliance with FDA's QSR and international regulations and standards. Dave started his career as an investigator biomedical engineer in the FDA's Los Angeles and Minneapolis District Offices where he conducted approximately 300 quality assurance audits of medical device manufacturers in the United States and internationally including manufacturers of cardiac pacemakers, mechanical heart valves, angioplasty catheters, dialysis, anesthesia and respiratory care equipment, and intraocular lenses. He then worked for private industry in management roles at various medical device companies including SciMed (Boston Scientific) and Endocardial Solutions. Dave taught for the graduate level Regulatory Affairs and Services program at St. Cloud State University as an adjunct assistant professor. Dave earned his Bachelor of Science in Biology with a minor in Chemistry from San Diego State University, his Master of Science Biomedical Engineering from the University of Southern California, and his Juris Doctor from Mitchell Hamline School of Law. In his free time, Dave enjoys attending car shows, racing cars competitively, and spending time at is cabin.

Job Titles:

• Consultant

Dr. Erickson is a pharmaceutical expert. Ed provides strategic advice on the viability of new pharmaceuticals, and how to bring them to the U.S. market. He offers decades of R&D, business and regulatory experience. After receiving his Ph.D. in Organic Chemistry with an emphasis on Rational Drug Design, Ed began his healthcare career as a medicinal chemist with Riker Laboratories. After Riker's acquisition by 3M, Ed progressed through a series of R&D and general management positions - ending his 3M career as Vice President, Drug Delivery Systems. Following retirement, Ed has been active as a consultant and board member with a variety of pharmaceutical start-ups. Highlights from Ed's 3M career include managing the drug discovery team which first identified Imiquimod (AldaraÔ) - a novel immune modulator - then as head of global R&D, managing its development and regulatory approval. During this time, he was also responsible for the R&D effort to replace CFC propellants with HFCs in 3M's pharmaceutical inhalers. Ed then became R&D executive director for 3M's Life Science Sector, which included managing the hearing health and veterinarian businesses. Next, he became Vice President, Medical-Surgical Division, where he focused on developing infection control products. Later, Ed finished his 3M career with a divisional restructuring effort, separating its drug delivery activities from its ethical pharmaceutical business. Ed earned his Bachelor of Science in Chemistry, Masters in Chemistry and PhD in Chemistry, from the University of California, Santa Barbara. In his free time, Ed enjoys traveling, gardening, cooking, studying history, and spending time with his grandchildren.

Job Titles:

• Vice President, Operations
• Operations Expert

Jim is an operations expert. He assists companies with manufacturing operations; supply chain management, project management, and quality management systems. Jim has filled leadership roles at St. Jude Medical, superDimension, and 7 other medtech startups. Jim has led major product development programs, formulated operational and quality system strategies, managed manufacturing operations for devices and drugs, managed supply chains and contract manufacturing, developed and implemented quality management systems, and contributed to numerous IDE, PMA, IND, and NDA submissions. Jim earned his Associate of Science in Electronic Technology from St. Paul Technical College, his Bachelor of Science in Mechanical Engineering from the University of Minnesota, College of Science and Engineering, and his Master of Science in Management of Technology from the University of Minnesota Technological Leadership Institute. He also is as an Adjunct Professor of Design and Manufacturing of Medical Devices at the University of St. Thomas School of Engineering. In his free time, Jim enjoys competitive alpine ski racing, watersports, and coaching high school mountain bike racers, Jim is also an Instructor for the Performance Driving School at Brainerd International Raceway.

Job Titles:

• Co - Founder
• President
• Adjunct Professor at Mitchell Hamline School of Law
• Compliance and Regulatory Expert

Mark is a compliance and regulatory expert. He assists companies with: sales and marketing compliance under the AdvaMed and PhRMA codes, advertising and promotional review, federal and state sunshine reporting, answering regulatory questions, and making regulatory submissions. He has worked in the medical technology industry for almost two decades. Nearly half of that time has been spent practicing regulatory law.* Mark worked in commercial roles at ev3 (Covidien-Medtronic), Celleration (Alliqua), and MedTox Laboratories (LabCorp). Mark is an Adjunct Professor at Mitchell Hamline School of Law where he teaches Drug and Device Law He also sits on the Law Advisory Board for the school's Health Law Institute. He is on the Section Council for the Minnesota State Bar Association Food, Drug, and Device Law Section (former Section Chair). Mark is former Chair of Medical Alley Regulatory Special Interest Group. Mark earned his Bachelor of Science in Finance and Economics (double major) from the University of Wisconsin-La Crosse, his Master of Business Administration in Venture Management from the University of Saint Thomas, Opus College of Business, and his Juris Doctor from Mitchell Hamline School of Law. In his free time, Mark enjoys competitive alpine ski racing, traveling, golfing, biking, investing, and spending time outdoors with his family. A life goal of Mark's is to ski on every continent. He was three down and four to go.

Job Titles:

• Chief Executive Officer
• Co - Founder

Tom is a Quality and Regulatory expert. He has been a leading provider of quality and regulatory consulting services to medical technology companies around the world for the last 25 years. During this time, Tom has led the design and implementation of quality management systems at numerous companies, achieving registration to ISO 9001 and ISO 13485 and compliance with numerous other related standards. Tom has also guided remediation efforts at multiple companies to successfully resolve FDA 483s, Warning Letters, and Consent Decrees. Prior to co-founding Stillwater MedTech Consulting, Tom led St. Paul Consulting, a quality and regulatory consulting firm based in the Twin Cities. He has also founded and led two other startup companies. Most recently, Tom held leadership roles within Danish medical device manufacturer, GN Otometrics. He started as the Director of Global Regulatory Affairs/Quality Assurance and later became the General Manager of the company's Canadian Operations. Tom was responsible for all aspects of the business in Canada, including product development, sales and marketing, quality, regulatory, operations, finance, and manufacturing. Tom earned his Bachelor of Science in Business Administration from the University of Wisconsin-La Crosse. In his free time, Tom enjoys competitive alpine ski racing, spending time at his cabin with his family, golfing, and coaching his children in various sports. Tom played football in college and is a former professional football player.