Dwight D. Back, Ph.D., has worked in a high-level technical capacity across the spectrum of high tech industries from medical devices to NASA. He has worked with new Class I, Class II and Class III medical devices from gaining FDA approval through ongoing manufacturing support. This includes Class III implantable cardiology devices and combination devices. Dr. Dwight Back has developed processes for coating drug-eluting stents. His experience in silicone implantable devices for plastic surgery is unmatched. As a data expert, he solves R&D and manufacturing problems for small and large companies, and has worked closely with doctors, universities and the top research labs. Dr. Back has a BChE from the University of Dayton, and Master’s and PhD from the University of Notre Dame, all in Chemical Engineering.
Dwight Back, PhD
Srin assists medical device companies with mechanical and corrosion assessments of implants for regulatory approval. He spent a decade at the U.S. FDA as a researcher and regulatory scientist, contributing to numerous guidance documents and publishing approximately 50 scientific articles and 60 conference presentations on medical device performance. Srin holds a BS from the University of Michigan, as well as an MS and PhD from Georgia Tech, all in mechanical engineering. He serves as vice president of the SMST board and is an adjunct professor at Catholic University of America.
Ms. Tzur works with CardioMed as an affiliate consultant, bringing over 20 years of experience in regulatory affairs and quality assurance in the medical device industry. She specializes in developing and executing regulatory strategies, guiding small and mid-sized medical device startups and companies through regulatory compliance and quality assurance challenges. Her expertise includes pre-clinical verification and validation activities, ethylene oxide (EO) sterilization validation, as well as sterile barrier system validation. Additionally, she is skilled in quality system implementation, risk management, and biological safety. She is highly experienced in compiling, writing, and assembling regulatory submissions, as well as drafting technical documentation to support global regulatory approvals.
Ms. Tzur earned her Bachelor of Science in Chemical Engineering from the Technion – Israel Institute of Technology and is a ASQ Certified Quality Engineer.
Gary Binyamin, PhD
Dr. Binyamin works with CardioMed Device Consultants as an affiliate consultant. He has over two decades of experience successfully bringing therapeutic products to market, including medical devices, combination products, small molecule pharmaceuticals, and wearable diagnostics. Dr. Binyamin provides strategic and operational support spanning product development (bench and preclinical), project management, chemistry manufacturing controls (CMC), biocompatibility & toxicology, quality engineering, manufacturing, regulatory path evaluation & generation of submissions, and clinical trials.
He has contributed to numerous products worldwide, with both small start-ups and large multi-national companies, reaching millions of patients. Dr. Binyamin is an author of over 20 publications and he led the ASTM workgroup resulting in the first drug-coated balloon standard (F3320-18). Dr. Binyamin was trained as a chemical engineer, holding a Bachelor of Science from the University of Illinois at Urbana-Champaign, a PhD from the University of Texas at Austin, and completed the BioDesign Innovation Fellowship at Stanford University.
Diana Williamson
joined CardioMed Device Consultants in April 2023. Prior to joining CardioMed, Mrs. Williamson was Vice President of Research and Development at Svelte Medical Systems, a cardiovascular device startup bringing to market a new approach to coronary stenting. Mrs. Williamson led Svelte product development from inception to commercialization. She championed complex, multi-engineering testing of Class III medical devices for US, Japan, and Europe; won approval from regulators for commercialization, IDE clinical trials, and FDA PMA approval, SLENDER IDS® and DIRECT RX®. Directed and continuously optimized complex design control process to deliver product development in compliance with quality systems, FDA 21 CFR Part 820 and ISO 13485, and Regulation (EU) 2017/745 MDR. Before that, a project Lead Engineer at Cordis, then a Johnson & Johnson Company, where her work focused on neurovascular, coronary and peripheral product development. She also served as a Lead Engineer at Concentric Medical (now Stryker) working with delivery and ischemic stroke products. Mrs. Williamson began her career as an R&D Engineer in the product development group at Guidant Corporation, division of Vascular Interventions (now Abbott Vascular).
An inventor of 7 US issued patents and several patents pending, Mrs. Williamson holds a BS in Mechanical Engineering from the Massachusetts Institute of Technology.
Dr. Kainz
received his PhD Degree in Technical Science from the Technical University of Vienna, Austria in 2000. After working for the Austrian Research Center Seibersdorf, he joined the Foundation for Research on Information Technologies in Society (IT’IS) in Zurich, Switzerland, as Associate Director. At IT’IS, Dr. Kainz developed in-vivo and in-vitro exposure setups for bio-experiments. From Feb. 2002 to Feb. 2022, he was Senior Research Biomedical Engineer at the U.S. Food and Drug Administration (FDA) in the Center for Devices and Radiological Health (CDRH). In Feb. 2022 Dr. Kainz founded High Performance Computing (HPC) for MRI Safety and is currently CEO and President.
At FDA Dr. Kainz reviewed more than 1000 medical device submissions, has published over 200 peer-reviewed articles and book chapters, and has co-authored many FDA guidances. He has extensive regulatory experience related to 510k, PMA, and IDE submissions and was CDRH’s Senior Subject Matter Expert (SME) on Magnetic Resonance Imaging (MRI) safety. He is currently Senior Member of the Administrative Committee of the IEEE International Committee on Electromagnetic Safety and Member of many International Standards Committees.
His experience is focused on the safety and effectiveness of medical devices and the safety of humans in electromagnetic fields. This includes novel computational life science methods for safety and effectiveness evaluations using functionalized anatomical models of the human anatomy; MRI safety; performance and safety of wireless technology used in medical devices; electromagnetic compatibility (EMC) of medical devices; dosimetric exposure assessments from DC to light; and novel methods to computationally assess the safety and effectiveness of new neuroprosthetics, e.g., electroceuticals, and therapeutic stimulation methods.
In 2004 Dr. Kainz initiated the Virtual Family Project in co-operation with IT’IS and Prof. Ji Chen from the University of Houston. In 2010, he received the prestigious FDA Award of Merit for exceptional leadership in performance in addressing issues of compatibility of medical devices during MRI by applying transparently scientific research to device regulation. In 2016 Dr. Kainz initiated o2S2PARC (Open Online Simulations for Stimulating Peripheral Activity to Relieve Conditions, https://osparc.io/) in co-operation with IT’IS. o2S2PARC is one of the three integrative cores of NIH’s SPARC (Stimulating Peripheral Activity to Relieve Conditions) program’s Data Resource Center. The aim of o2S2PARC is to establish a comprehensive, freely accessible, intuitive, and interactive online platform for simulating peripheral nerve system neuromodulation and its impact on organ physiology in a precise and predictive manner. o2S2PARC’s goal is to make high-end biomedical simulation tools freely available in a user-friendly environment.
Dr. David Lin
Dr. David Lin works with CardioMed Device Consultants as an affiliate consultant. He has over 27 years of pharmaceutical regulatory experience in the technical, quality and regulatory requirements for chemical (synthetic molecule), botanical and biopharmaceutical (biotechnological and biological) product development. He currently provides regulatory and technical assistance to biotech and pharmaceutical companies that is planning to conduct clinical studies and to obtain approval for the marketing of prescription products (drugs and biologics) in the United States. Dr. Lin received his Ph.D. in organic chemistry in the area of protein chemistry in 1989 and a M.B.A. in 2002. His regulatory product development expertise was developed at Biologics Consulting Group as a senior consultant and at FDA while working as a CMC reviewer, CMC Team Leader, acting Deputy Division Director, and acting Division Director in the Office of New Drug Chemistry in the Center for Drug Evaluation and Research (CDER). He has review experience in numerous therapeutic areas. In addition to his review and management duties, Dr. Lin was involved in the development of FDA guidances and good review practices.
Jennifer Asleson
Ms. Asleson works with CardioMed Device Consultants as an affiliate consultant focusing on sterilization, microbiology and sterile barrier systems. She has over 25 years of experience in the regulated medical device and pharmaceutical industries in both the quality systems and technical arenas. Jennifer has extensive experience with the validation and routine processing for several modes of sterilization as well as the supporting sterility assurance program activities.
As an active member of the American Association of Medical Instrumentation (AAMI) Technical Committee 198 she is able to share the most current information on both technical and quality system requirements for sterilization and the supporting microbiology processes. Her recent time as a microbiology technical expert for BSI Americas provides insights from the Notified Body perspective for all classes of medical devices.
Jennifer earned her Bachelors Degree in Biological Sciences at the University of California, Davis along with a Minor in Musical Performance. She is an active member of AAMI, IEST and IoPP and holds American Society of Quality (ASQ) Certified Biomedical Auditor (CBA) and Certified Pharmaceutical Good Manufacturing Professional Certifications (CPGP) and is a Senior Member of ASQ.
Lisa Bellincampi, PhD
Dr. Bellincampi is an affiliated consultant with CardioMed Device Consultants, with almost 20 years of experience in R&D and Clinical Research in the medical device industry.
Dr. Bellincampi received her Ph.D. in Biomedical Engineering from Rutgers University / University of Medicine and Dentistry of New Jersey in 1999, where her research focused on tissue engineered implants utilizing cell culture and resorbable biomaterials in orthopaedic applications. She joined Orthovita, a biomaterials company, where she directed R&D programs and preclinical testing to support the company’s regulatory submissions and educational programs. While at Orthovita, she gained expertise in clinical research, developing and managing post-market clinical studies in spine fusion. Later, as Vice President of Clinical Research, Dr. Bellincampi oversaw post-market and IDE clinical study programs for applications in bone fusion, vertebroplasty, kyphoplasty, and bone screw fixation. She continued to develop her clinical research skills at Spine Wave, Inc., overseeing IDE and post-market clinical programs for the company’s injectable disc nucleus platform and other spine applications. During this time, she developed skills in managing global clinical trials, with projects in Europe and Australia. Her experience also includes regulatory submissions, regulatory and clinical compliance, FDA audits, and good clinical practices.
With a strong base in clinical research, biomaterials, and the medical device industry, Dr. Bellincampi brings expertise and support with regard to planning, development, and execution of clinical trials, development of clinical reports and other documentation for regulatory submissions, development of clinical evaluation reports for CE Mark products, and other medical writing such as abstracts, manuscripts, and materials for scientific or educational presentations. She has worked with both medical devices and combination products.
Steven Opolski
Steven Opolski works with CardioMed Device Consultants as an affiliate consultant and brings almost 30 years of industry experience. He is well recognized consultant specializing in design and computer modeling of a wide range of medical devices including stents, heart valves, AAA devices, vena cava filters and structural heart repair devices.
Steve graduated with a BS in Mechanical Engineering design from Worcester Polytechnic Institute and an MS in Mechanical Engineering design from Rutgers University. Steve has also worked for a variety of small and large medical device companies as an individual contributor specializing in finite element analysis (FEA) to being an engineering manager of an implant group responsible for all pre-clinical testing of implantable stents.
Since founding Atlantic Engineering (AE) in 2003, he has worked with a wide range of device companies world-wide in the early design stage through full engineering evaluations for regulatory submissions. While structural FEA is a specialty, AE also performs testing of wire and tubing in air or solution to determine the fatigue limit for various materials. This testing capability tends to compliment the modeling work. Steve also is available for design purposes and currently holds 17 US patents. Lastly, Steve works as an expert witness in patent infringement, product liability and medical malpractice cases.
Steve is a member of the American Society of Mechanical Engineers (ASME) and active with ASTM International Endovascular Devices Test Methods Task Group.