Management Team
James E. Muller, M.D.
Founder and CEO
Dr. James E. Muller serves as CEO and Chief Medical Officer of InfraReDx, Inc as the Company begins its commercialization of the FDA cleared LipiScan device, and conducts the clinical trials needed to document the full extent of clinical benefits the NIR system can provide. Dr. Muller formerly served as a Professor of Medicine at the Harvard Medical School where he conducted research for over 25 years on the causes of heart attacks. In 1989, he introduced the term "vulnerable plaque" to describe those plaques likely to disrupt and cause disease onset. He co-founded InfraReDx in 1998 after a detailed search to find the optimal technology to identify lipid-core containing coronary artery plaques that are suspected to be vulnerable plaques. He is the author of a multiple articles related to technical approaches that are under study for the identification of vulnerable plaque, the leading cause of death in developed countries.
Dr. Muller was one of three American Co-founders of the International Physicians for the Prevention of Nuclear War (IPPNW) the organization awarded the 1985 Nobel Peace Prize. He has extensive management experience from this work, and his prior leadership of cardiovascular organizations and clinical trials.
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Steven L. Nakashige
President and Chief Operating Officer
Steve has over 25 years of experience in the medical device and equipment industry. Prior to InfraReDx, Steve served as the President and CEO of Z-Tech Medical, an early stage breast cancer detection device company. From 2002 to 2004, Steve was the CEO of Agfa’s Healthcare Informatics Business Group, a $300m healthcare business consisting of both acquired and internally developed products and services. From 1994 to 2002, Steve served as the President and as a Director of Hologic, Inc., a public company that he grew from $20m to over $250m in annual revenues. During his time at Hologic, he successfully developed a bone densitometry product into a major global women’s healthcare business. As a result, the company was recognized by Fortune magazine and Medical Imaging magazine as one of the fastest growing and best companies of 1996 and 1997. In 2000, Steve also acquired Lorad, a premier film based mammography company which added to Hologic’s digital plate technology. This program created a market leading digital mammography system, which achieved FDA PMA approval in late 2001. Prior to Hologic, Steve was an executive with GE Medical’s Ultrasound business. Steve has also held executive operating and P&L positions with several other medical equipment companies, including Biosound, Inc. and Picker International.
Steve Chartier
Vice President of Clinical and Regulatory Affairs
Mr. Chartier brings over 12 years of industry experience in Regulatory Affairs and Clinical Operations to InfraReDx. Prior to joining, Mr. Chartier was the Director of Preclinical Development and Regulatory Affairs at NUCRSYT Pharmaceuticals, Inc., an innovative device company specializing in wound care and infection control. While at NUCRYST, his responsibilities included overseeing Clinical and Regulatory Affairs, formulation development, and documentation systems, where he was instrumental in the clearance and approval of multiple Class II and Class III medical device products in the US, Canada, Europe, and Rest of World. Prior to this, he held positions of increasing responsibility at Biogen Idec and the Dana Farber Cancer Institute. Mr. Chartier is Regulatory Affairs Certified as a member of the Regulatory Affairs Professional Society. He holds a Bachelor of Arts from Saint Anselm College.
Jeffrey Mazur, CPA
Corporate Controller
Mr. Mazur joined InfraReDx in October 2005, and brings with him over 10 years of experience in the medical device and high tech fields. Mr. Mazur has significant experience in financial reporting, internal controls and budgeting systems. Prior to joining InfraReDx, Mr. Mazur was most recently the Divisional Controller at NetSilicon, Inc, a subsidiary of Digi International. Prior to that, Mr. Mazur worked for seven years at Thermo Fisher Scientific, Inc. in various capacities, with primary responsibilities including SEC reporting, financial planning and analysis, and business unit controllership. Mr. Mazur earned his CPA while working for PriceWaterhouseCoopers. Mr. Mazur holds a BS in Business Administration from Boston University.
Jim Dillon
Vice President of Sales & Marketing
Mr. Dillon has over twenty years experience in the medical device industry originating from strong consultative Sales & Marketing, to Business Development in a wide array of surgical specialties. He has been involved with four highly successful medical device start-ups, VNUS Medical Technologies, Perclose, Heart Technologies and Devices for Vascular Intervention. He has served in various roles of business development and sales management within these startups during his career. He has continually earned recognition as a prominent Sales, Marketing and Business Development Leader in the medical device industry.
Mr. Dillon provided leadership for another Cardiology business in the high growth market of Acute Heart Failure. At Abiomed, Inc he had responsibility for the financial and strategic development of the US and Canadian business. Most recently, he has been consulting for another startup, TherOx, who is developing a breakthrough therapy to treat AMI and reduce infarct. He has been throughout his career intimately involved with the initial product development of new proprietary technologies and their commercial launch often involving execution of capital equipment acquisition strategies. Mr. Dillon also has been directly involved with establishing the initial sales/marketing forces and implementing the training programs which become the model for success within these global sales organizations. He has served as the primary interface between physician advisors and engineering teams for the clinical development and trials of these emerging technologies and their iterative development.
Robert C. Silva
Vice President of Product Development
Mr. Silva brings over 25 years of engineering experience to InfraReDx, including 17 years of experience in the design and development of medical devices. Before joining InfraReDx, Mr. Silva served in management as the Director of Software Development at Haemonetics Corporation and Transfusion Technologies Corporation, both suppliers of automated blood collection and separation devices. At these companies he directed the corporations’ software development efforts and was responsible for the program management of several projects, resulting in the market release of the OrthoPAT and Cymbal systems, two innovative automated separation devices responsible for the collection of red blood cells. Prior to that, Mr. Silva was a founder and the Vice President of Product Development at Symbiotics, Inc, where he was responsible for designing and developing innovative object oriented communications technologies that resulted in a family of products under the family name Networks!. These products were eventually incorporated by IBM and incorporated into their technology offerings and operating systems. Mr. Silva earned a B.S. and an M.S. in computer science from Northeastern University.
Deborah Thurston
Director of Quality
Deborah Thurston joined InfraReDx in October 2006, and brings with her experience in quality systems and design quality engineering. Prior to joining InfraReDx, Ms. Thurston was most recently the Manager of Quality Systems at ConMed Endoscopic Technologies (formerly Bard Endoscopic Technologies), a medical device company dedicated to providing better outcomes for the GI and Pulmonary patient. Among her accomplishments at ConMed was the successful quality system upgrade to the current ISO 13485:2003 quality management systems standard. Prior to this, she held multiple engineering positions at Raytheon Systems where she was trained as a six sigma specialist.
Ms. Thurston holds a BS and MS in Mechanical Engineering from Worcester Polytechnic Institute. She is a senior member of the American Society for Quality and is an ASQ Certified Quality Engineer.
Mark A. Wilder
Vice President of Advanced Development
Mr. Wilder joined InfraReDx in April 2005 and brings to the company more than 20 years of diverse engineering and technical management experience from a number of industries, including medical equipment, semiconductor equipment, optical data storage and aerospace. In addition to lead technical roles, he has held key management positions and participated at various stages of a number of startup companies.
Prior to joining InfraReDx, Mr. Wilder was most recently the lead Optical Engineer at MediSpectra, Inc., a medical equipment startup developing a system for early detection of cervical cancer. Previous to MediSpectra, Mr. Wilder was Director of Engineering at Intelligent Automation Systems, responsible for the development of a 3-D optical measurement system.
Mr. Wilder holds a BS in Optical Engineering from the University of Rochester and an MS in Electrooptics from Tufts University.