Who We Are
Our mission is to provide strategic and operational expertise in clinical market development, resulting in successful pre-clinical development, first-in-man, CE mark and post-market studies. At each stage, our goal is to achieve continued increase in the valuation of an emerging medical company. Working with clients’ senior management, we develop programs and manage projects that shorten time to market, expedite product adoption and accelerate market penetration of new medical treatments.
MAXIS LLC is based in San Jose, California, with day-to-day operations also managed out of our European Headquarters, MAXIS GmbH, in Frankfurt am Main, Germany. Field support staff are located in various geographies.
MAXIS has an experienced team of start-up experts, with comprehensive, multidisciplinary backgrounds and proven track records. We cover a vast array of interventional technology platforms, ranging from cardiology and structural heart to sleep apnea, neurology and orthopedics. With experience in preclinical engineering, design validation & verification, regulatory affairs, clinical research and trial management, MAXIS provides unmatched strategic and operational expertise that drives results, leading to improved commercialization and increased valuation. The MAXIS method creates credible funding milestones that engineer the market for successful commercialization.
PRESIDENT AND MANAGING DIRECTOR
Kathleen A. Marshall
Ms. Marshall created MAXIS, LLC, in 2002 after nearly twenty years as a significant strategic contributor to the overall success of multiple medical device start-up companies. She holds a BA from Amherst College and a MS in Regulatory Affairs from Northeastern University. She is an experienced senior executive, skilled in clinical research, market development and commercialization of new medical technology. During her career in medical device start-ups, she has established a proven track record in conducting international clinical studies, building global markets, branding emerging technologies and leading start-up ventures. She has successfully established and managed teams that have created lasting clinical value and financial returns. She holds dual citizenship in the USA and Ireland.
CHIEF MEDICAL OFFICER
James C. Leiter, M.D.
Prof. Leiter has led a distinguished career as a Professor of Medicine at Dartmouth Medical School. He holds BA and Medical Degrees from Dartmouth College and is a well-known clinical and academic physician. He has been widely published in a variety of medical specialties, including neurology, cardiology and pulmonology. He has provided scientific and clinical support to multiple medical device companies working with MAXIS and is highly respected for his strategic insights into emerging medical technologies. Prof. Leiter has published more than 140 papers on a wide range of topics in basic and applied physiology, neurobiology and medicine.
EXECUTIVE VICE PRESIDENT
SUJI J. SHETTY, M.B.B.S.
Dr. Suji Shetty joined MAXIS after more than 15 years working in clinical research and regulatory at several small companies. Prior to that, Suji worked as a research fellow at USC Keck school of medicine in Cardiology and Pulmonary and Critical Care. Since moving to Industry, he has participated in the development of novel technologies in cardiology, pulmonary, and neurology and has provided significant strategic, scientific, and clinical leadership in these fields. He has led multiple clinical research teams in pre-market and pivotal clinical trials. Working with the FDA on many projects, Suji has gained extensive experience in the breakthrough programs the FDA has offered over the past 10 years and has worked on projects through the EFS program, EAP process, Payor Communication Task Force, and multiple IDE projects. Suji holds a M.B.B.S from KempeGowda Institute of Medical Science in Bangalore, India.
VICE PRESIDENT R&D / ENGINEERING
RICHARD S. LILLY
Mr. Lilly joined MAXIS in 2015, after more than 25 years of design engineering, project leadership and development experience with surgical, disposable, reusable and implantable device companies. He has provided product design services and quality management for companies ranging from small start-up organizations to large multinational firms in a variety of med tech areas, including ophthalmology, cardiac surgery, structural heart, general surgery, women’s health and peripheral vascular disease. He has worked with quality and regulatory personnel in both Europe and the U.S. including the generation of preclinical data, test report writing, technical files for regulatory submission documents and he has been an integral contributor to several USA clinical trials. Rick has been instrumental in creating and implementing quality management systems for emerging technology companies. Rick’s intuitive and analytical research skills, coupled with his solid design engineering expertise—including modeling, design analysis, prototype generation, product performance testing, manufacturing process improvement—have been invaluable to early-stage companies. He is proficient in the use of CAD, FEA, and CFD with strategic product, team and company focus with proven ability to support other functional areas such as quality, regulatory, and pre-clinical requirements. Rick is named on 19 patents and has an B.S. in Mechanical Engineering from California Polytechnic State University in San Luis Obispo, California.
DIRECTOR OF REGULATORY AFFAIRS
Mr. Hirschmann joined Maxis, LLC in 2005 as Director of Regulatory and Clinical Affairs in Europe. He holds a BS in physiology and has many certificates in quality and regulatory affairs. He brings a wide variety of experience to the company, including medical training as an emergency medical technician, health and wellness consulting and medical writing. He is a certified Regulatory Affairs professional in MPG (German medical device law) and a certified Clinical Study Monitor. He has been responsible for clinical trials in cardiology, cardiac surgery, neurology, pulmonology and sleep disorders. Mr. Hirschmann has been a personal trainer for over ten years and was the National trainer and Coach for the German Women’s Volleyball team for disabled people. He is a German citizen and is fluent in German and English.
CHIEF OPERATING OFFICER
Dirk first joined MAXIS in 2009 as a summer intern. Since then, he worked as a finance executive in highly regulated markets and got his Masters’ degree in International Business in San Francisco as a Fulbright Scholar at HULT International Business School. Thereafter, he joined Amazon to, among other data driven projects, plan and launch Amazon Alexa and Amazon Echo in Germany, Austria and the U.K. After his time at Amazon, Dirk co-founded a high-tech data startup where he closed two fund raising rounds. Dirk brings vast experience in general management, strategic planning, finance controlling, and project management and has has joined the Management Team at MAXIS since 2020.