Stephen A. Leeflang, BS, MBA

Steve is co-founder and principal at AUST. He initially came to the San Francisco Bay Area to work for a medical device start-up, Medtronic AneuRx, as an R&D engineer. At AneuRx Steve designed self-expanding nitinol stents for the AneuRx AAAdvantage Stent Graft System and helped establish large-scale production facilities in Tijuana Mexico. Following his tenure at AneuRx, Steve led product development at Bacchus Vascular as the company’s first engineer. At Bacchus Steve led development of a wide range of catheter-based devices including thrombectomy, distal protection, access site closure, drug delivery, and atherectomy products. He opened clinical sites in the US, Europe, and South America. Subsequently, Steve co-founded Acumen Medical where as VP of R&D he brought to market the Insight Endocardial Visualization System and multiple cardiac lead delivery catheters. Steve has over 50 issued US and international patents. He has extensive experience with quality systems and regulatory affairs, having directly contributed to 17 successful 510(k) submissions and multiple CE marked products. Steve earned a BS in Physics from the University of Utah and his MBA from UC Berkeley’s Haas School of Business with a certificate in Management of Technology.

Christian S. Eversull, BS, MA, MD

Chris is co-founder and principal at AUST. Chris has developed medical devices for the past 15 years, working in roles from design engineering to executive management. He is also a licensed physician trained in internal medicine with a research focus in cardiovascular electrophysiology. Chris began his career in engineering at Medtronic AneuRx developing AAA stent grafts. He then joined Bacchus Vascular to lead initial development of the Trellis Isolated Thrombolysis Catheter. In 2002, Chris co-founded Acumen Medical, a company focused on cardiac lead delivery, where he served as Chief Medical Officer until 2007. At Acumen, he led development of marketing and design specifications, translating clinical needs into product concepts. He also led regulatory and intellectual property strategy development as well as clinical product evaluation. Chris left Acumen to complete a residency in internal medicine at Stanford University Medical Center. He was awarded the Biodesign Innovation Fellowship and has published several peer reviewed articles relating to cardiac anatomy, imaging, and ablation. In addition to the foregoing, Chris received a BS with distinction from Stanford University's Program in Science, Technology, and Society with a technical concentration in chemistry. Chris also received an MA in Russian and East European Studies from Stanford. He has authored over 30 US patents and numerous pending applications.
Marybeth Gamber

Marybeth Gamber, BA

Marybeth is the Vice President of Regulatory, Compliance, and Quality at AuST. She started her career working for medical device start-up companies in the San Francisco Bay Area crafting and executing regulatory strategies, and creating and maintaining quality systems that were in compliance with US and OUS requirements. She moved to the Boston area where she continued her regulatory, quality, and clinical consulting as an independent consultant for several years before working at Boston Scientific Corporation. Most recently she’s worked at Boston Biomedical Associates developing preclinical, clinical, and strategic regulatory programs for clients.

In the more than 18 years Marybeth has been in the industry, she has provided regulatory and clinical strategic support for a wide range of therapeutic areas, including cardiovascular, neurovascular, peripheral vascular, pulmonary vascular, orthopedics, trauma, gastroenterology, renal, diabetes, obesity, and wound management. She has worked with an extensive range of device types, from intravascular catheters to permanent implants, and has experience in medical device product development process as well as post market surveillance activities. In addition, she has clinical experience including development of study protocols and other study related documents and performing BIMO audits at sponsors and clinical sites in preparation for FDA audits.

Ms. Gamber holds a Bachelor of Arts from Juniata College in English and is a member of the Regulatory Affairs Professional Society.

Mark Ritchie

Mark D. Ritchie BS, MBA

Mark is the Director of Finance and Administration situated in the Salt Lake City office. Mark spent over two decades as the Director Operations, VP Operations and Chief Operating Officer at Black Diamond Equipment, a publicly traded manufacturer of rock-climbing and back-country ski products designed and developed for the outdoor recreation industry. At Black Diamond Mark drove the development of the ISO 9001 compliant Quality System, developed global sourcing and supply chain strategies and capabilities while also overseeing IT, development and manufacturing functions. As COO he was responsible for all supply and quality related issues for multiple outdoor related consumer products brands (Black Diamond, Gregory Mountain Products, POC and Pieps). Mark earned a BS in economics from California State University, Los Angeles and an MBA from the Pepperdine University Graziadio School of Business and Management.