Team
Steve Axelrod, PhD, President and CEO
Steve received his Ph.D. from Yale in Elementary Particle Physics and did his post-doc in the same field at Stanford. He worked at Measurex-Honeywell for 15 years where he was Director of Measurement System and Hardware Engineering. In 2003 he entered the medical device field, and helped develop and commercialize the Xoft Axxent microTube and radiation therapy delivery system. Steve has led teams delivering numerous best in class systems and devices in both medical devices and industrial automation. Some examples are nuclear basis weight, X-ray and infrared absorption sensors, Large scanning frames, fast high channel count data acquisition systems, skin and vaginal applicators for radiation therapy, high precision measurement systems for characterizing and testing system and device performance. Steve has been CEO of G-Tech since November 2011. This project combines his experience leading high performance R&D teams, his passion for medical devices and his expertise in creating sophisticated measurement systems.
Anand Navalgund, PhD, Director of Clinical Science
Anand received his Phd in Biomedical Engineering from The Ohio State University and his Bachelors in Mechanical Engineering from the National Institute of Technology Kartnakata, India. Anand’s doctoral and postdoctoral work in neuromuscular and musculoskeletal biomechanics has given him a critical understanding of human physiology. Anand has been awarded the 2015 James W Freston scientific achievement travel award by the American Gastroenterological Association at its conference for understanding the management of Irritable Bowel Syndrome. He has also been the recipient of the Young Investigator Scientific poster award at the 2016 Digestive Disease Week. He has authored over 9 peer reviewed journal articles and over 30 conference publications. Anand also has previously served as a ScientificReviewer with the Patient Centered Outcomes Research Institute (PCORI).
Lindsay Axelrod, MTM , Senior Research Associate
Lindsay received her Masters in Translational Medicine degree from UC Berkeley/UCSF and has a bachelors in biochemistry from UC Davis. Lindsay is deeply interested in identifying solutions for improving patient care through novel technologies that can be used to diagnose, monitor and treat patients in an accelerated, cost effective manner. Lindsay is a former Lefteroff Intern at the Fogarty Institute for Innovation where she gained first hand biomedical startup experience working with Materna Medical, aiding them in business development, marketing and prototype development. At G-Tech Medical, Lindsay manages on-going clinical studies, participates in data processing and analysis. Lindsay has also co-authored scientific publications and has been first author on poster presentations.
Rob Kirby, BSME, MBA, Vice President of Strategy and Business Development
Rob has worked for over 20 years in medical device startup companies. His breadth of experience includes cross-functional program leadership, strategic planning, marketing and business development. Early in his career Rob led the product development and commercial launch of an innovative proton radiation treatment planning system. He later played key roles at Xoft in developing and launching a system that treats a wide range of cancers. In addition to driving US business development for this company, Rob also created the international distribution channel, quickly expanding the company’s reach to Europe, Asia, Russia and other markets and driving revenue growth. More recently he was the second employee hired by TAE Life Sciences, which just completed installation of its first device in China. Rob holds a BS degree in Mechanical Engineering from UC Davis and an MBA with a strategic planning emphasis from UC Riverside.
Michael Powell, PhD, Software Consultant
Michael is a software developer and programmer with over four decades of experience starting as an employee of Measurex Corporation working in process measurement and control products. Measurex Corporation was acquired by Honeywell International at the beginning of 1997 where he worked until 2003. Michael subsequently went on to work in the field of medical devices at Xoft, Inc., Solta Medical and now G-Tech Medical. Michael has worked in development languages that include 8086 Assembly, PDP 11 Assembly C, LabVIEW, Objective C and now Swift. At G-Tech Medical, Michael works on the iOS application that communicates with the G-Tech Patches.
Stu Brogadir, MD, MBA, Director of Medical Affairs
Stu is a triple boarded MD, MBA with decades of clinical practice and healthcare consulting experience. He began his career in academics at Penn and then moved to Manchester, NH, received his MBA at UNH, and began consulting with Ernst and Young while in full-time practice. His expertise with Ernst and Young was in strategic planning, technology review, physician-hospital relationships, alternative delivery systems/ambulatory strategy, and creative reimbursement strategies. Stu was a founder of the first PHO, the first ASC for endoscopic services, first high deductible HSA based healthcare plan, and the first bundled payment plan for endoscopic services in New Hampshire. Stu has been a senior medical director in pharma and a consultant to the GI Solutions Group at Medtronic Covidien. Most recently he was a regional medical director of the largest CIN in New Jersey. He also practices GI and has an academic medical school appointment. Stu was an undergraduate at Yale and received his medical degree at Cornell University Medical College. He was an intern and junior resident at Boston City Hospital and did his fellowship training at Penn and Jefferson in Philadelphia.
Jessica Holmes, MJ, Regency Market Access Consulting
Jessica Holmes is the Founder and Principal of Regency Market Access Consulting. Jessica has more than 25 years of experience in market access and reimbursement strategy, tactical planning and execution. Her expertise is in analyzing challenges and opportunities for novel technology and legacy products, and in developing intelligent, actionable solutions for success in the traditional reimbursement environment (e.g., Medicare/Medicaid and commercial health plans) and the emerging value-based/pay-for-
Lana Widman, MS, Quality Assurance Consultant
Lana Widman has extensive experience working with medical device manufacturing firms from startup to full scale manufacturing. Lana has held key positions in Quality Assurance and Regulatory Affairs focused on helping organizations take the fear out of quality and implementing Smarter Quality Management Systems that add value to the business. Lana has strong knowledge of FDA, European, and California Health & Safety Code regulations. She is certified as an ISO 13485 Lead Auditor and ISO 17025 Auditor.
Hoy & Associates, Regulatory Consulting Services
Hoy & Associates is a full-service medical device consulting company founded by Connie Hoy. Connie has worked in industry for 33 years and has a wealth of experience in developing and executing U.S. and international regulatory strategies. Connie’s team helps develop regulatory submissions and provides detailed audits to help companies prepare for scrutiny from regulatory agencies.
Eminence Clinical Research, Regulatory, and Quality Consulting Services
Eminence Clinical Research, Inc. provides a range of consulting services including comprehensive clinical trials consulting. Founded by Kelly W. Elliott, RN MS, President and CEO, Eminence designs and executes clinical strategies for all study phases and has significant experience in ensuring compliance so that the data meets requirements to support regulatory submissions. Kelly has held executive level positions at multiple medical device companies, successfully designing and executing clinical trial strategies resulting in new device approvals and new indications and dozens of publications in peer-reviewed medical journals.
Board of Directors
David J Kim, MD
David brings a unique set of professional and academic credentials as a Board member at G-Tech Medical and as Managing Director of DigiTx. David has deep experience across the healthcare, technology and investment fields – first as a clinician at a major HMO network, followed by a successful stint as COO at a growth stage company. In addition, David has two decades of experience in the investment sector, including as Principal at MPM Capital and as Partner at Pinnacle Ventures. David has been a director or a board observer of multiple medical device and biotech companies. Moreover, David is working with multiple academic accelerators and translational medicine programs including the Catalyst Program within the UCSF Clinical & Translational Science Institute and U. of Michigan MTRAC program. In addition to serving as Board Member at G-Tech Medical, David serves as a board member of Embr Labs, NeoSensory, Siris Medical, Tissue Analytics, and WellDoc. David completed his internal medicine residency at Harbor-UCLA Medical Center and later served as Director of Urgent Care and Assistant Chief of Internal Medicine at Kaiser South San Francisco.
David is a graduate of the Johns Hopkins University School of Medicine (M.D), Stanford Graduate School of Business (M.B.A.), and Pomona College (B.A., Biology).
Steve Axelrod, PhD
Steve received his Ph.D. from Yale in Elementary Particle Physics and did his post-doc in the same field at Stanford. He worked at Measurex-Honeywell for 15 years where he was Director of Measurement System and Hardware Engineering. In 2003 he entered the medical device field, and helped develop and commercialize the Xoft Axxent microTube and radiation therapy delivery system. Steve has led teams delivering numerous best in class systems and devices in both medical devices and industrial automation. Some examples are nuclear basis weight, X-ray and infrared absorption sensors, Large scanning frames, fast high channel count data acquisition systems, skin and vaginal applicators for radiation therapy, high precision measurement systems for characterizing and testing system and device performance.
Steve has been CEO of G-Tech since November 2011. This project combines his experience leading high performance R&D teams, his passion for medical devices and his expertise in creating sophisticated measurement systems.
Advisors
Uday N. Kumar, MD
Dr. Uday N. Kumar is a successful entrepreneur and Board Member in the healthcare industry, having played a leading role in founding and developing several successful medical device business, including Biomedical Modeling, iRhythm Technologies and Sympara Medical. He is the Founder and CEO of Element Science, and is a Board Member of Qurious.io. Uday is a cardiologist and cardiac electrophysiologist (EP) by training. His core medical device business expertise is in the areas of imaging applications, cardiac rhythm monitoring and other innovative cardiology technologies. He was Entrepreneur-in-Residence at Third Rock Ventures, where he focused on leading the development of new medical devices and technologies. Uday served for eight years as the Fellowship Director of Stanford’s Global Biodesign Programs (India and Singapore), and currently serves as a Consulting Associate Professor of Bioengineering at Stanford University and Director of Strategy for the Stanford Biodesign Program. Uday received his M.D. and B.A. in Biochemistry and Molecular Biology from Harvard University. He was a Biodesign fellow at Stanford, a cardiac EP and cardiology fellow at UC San Francisco, and internal medicine resident at Columbia.
Thomas J. Fogarty, MD
As an internationally recognized cardiovascular surgeon, inventor, entrepreneur and vintner, Dr. Fogarty has dedicated his entire career to improving patient care and is named on over 200 medical device patents, including the “industry standard” Fogarty balloon catheter. The motto, “There has to be a better way,” inspired Dr. Fogarty to found more than 45 medical device companies and create numerous devices, including the widely used Aneurx Stent Graft that replaced the traditional surgical repair. This less invasive approach has resulted in a significant reduction in mortality and morbidity in the management of the aneurysmal disease. A strong believer in the power of mentoring, he founded Fogarty Innovation on the campus of El Camino Hospital in 2007 to spur medical device innovation, improve patient care and lower healthcare costs. While he loved helping people as a surgeon, he believes in the multiplier effect that is created through widely adopted technology. Dr. Fogarty has been recognized by countless organizations for his contributions to medical science, including receiving the prestigious Presidential Medal of Technology and Innovation.
Product Development Partners
Sector One, Product Development Consulting Services
SECTOR ONE DESIGN provides product development consulting services with expertise in mechanical design of Medical Devices, Automotive Systems, and Sports Equipment. We provide full spectrum Mechanical Engineering services including: CAD surfacing and solid modeling, Rendering, FEA (structural analysis), R&D, prototype testing, fabrication, documentation, DFM, and supplier management.
Promenade Software, Development and Regulatory Software Services
Promenade Software provides expert development and regulatory software services for medical device manufacturers. They are ISO 13485 certified, and all work is done under IEC 62304 lifecycle controls. Their offerings include a full suite of DHF software documentation templates including Cybersecurity design controls and risk management.
Voler Systems, Product Design Services
Voler is one of the leading companies in new product design, embedded system design, medical device design, wearable device design, and IoT design. We are focused on electronics, firmware, and software. We have close partners who are equally capable at industrial design, mechanical design, optical design, transfer to manufacturing, manufacturing, and logistics. With these partners we can provide a complete product design from end-to-end.