Meet the Speakers

Dr. Beck received her Ph.D. in Biomedical Science from the University of California San Diego, and her B.S. in Chemical Engineering from the University of Texas at Austin. She also received her Master of Public Health (MPH) in Epidemiology from University of Maryland Baltimore. Dr. Beck worked at FDA for over ten years, spending time as a scientific and regulatory reviewer, a chief of the Diabetes Diagnostic Devices Branch, and Deputy Office Director of Personalized Medicine and Molecular Genetics. In her branch office, which is under the direction of the FDA´s Center for Devices and Radiological Health, Stayce oversaw scientific and medical matters involved in assuring that new and existing diabetes devices manufactured by companies and made available to the public meet the FDA´s strict standards for safety and quality. Following her departure from FDA, Dr. Beck became the Vice President of Clinical and Strategic Partnerships at Dexcom, where she still works presently.

Ron Brown is a board-certified toxicologist with 35 years of experience in regulatory toxicology and risk assessment. He recently retired from the US FDA after 25 years of service and currently directs a small company, Risk Science Consortium, LLC, that provides consultation and training in toxicological risk assessment and computational toxicology. At the FDA, Ron was the senior toxicologist responsible for developing and reviewing toxicological risk assessments of extractable and leachable (E&L) compounds from medical devices. While at the FDA, he served in a number of leadership roles in standards development organizations. At the international level, he served for many years as convener of ISO TC194 WG11 which is responsible for the development and revision of the ISO 10993-17 standard, Biological evaluation of medical devices-Part 17: Establishment of allowable limits for leachable substances. At the national level, he represented the United States as an expert on ISO TC194 WG11 and served as co-chair of the AAMI Biological Evaluation Committee. Prior to his position at the US FDA, Ron served as a Senior Associate at the ILSI Risk Science Institute. He is founding member and former President of the Medical Device and Combination Products Specialty Section of the Society of Toxicology and former President of the Dose-Response Specialty Section of the Society for Risk Analysis.

Seth Carmody, PhD is the Vice President of Regulatory Strategy at MedCrypt and founder of DRX Labs. Before MedCrypt and DRX Labs, Dr. Carmody worked as the cybersecurity program manager at the U.S. FDA's Center for Devices. Dr. Carmody brings eight years of experience in guiding medical device technology policy.

Ms. Chan received her B.S. in Biomedical Engineering from Johns Hopkins University in 2002, and her M.S.E. in Bioengineering from the University of Maryland in 2010. Directly following her undergraduate degree, Dulciana began her FDA career as a research associate in the Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL). A year later, she became a Biomedical Engineer at FDA, and for 14 years operated in various branches of the administration, including as a scientific reviewer and policy analyst in the Office of Device Evaluation (ODE), and as an OSEL principle investigator. Dulciana has extensive experience in the areas of electromagnetic compatibility (EMC) testing and electrical safety, and is an asset to Acknowledge Regulatory Strategies, where she is now a Senior Regulatory Specialist.

Mr. Dedania began working for FDA after achieving his B.S. in Biomedical Engineering at University of Tennessee followed by an M.S. in the same field at the New Jersey Institute of Technology. For six years, Jemin worked as a Biomedical Engineer at FDA, reviewing technical data and research protocols for orthopedic device submissions, and conducting tests on submitted devices to determine performance safety. While at FDA, Jemin became a Senior Biomedical Engineering Lead Reviewer, which he maintained for nearly two years before leaving the agency. He currently works as a Staff Regulatory Affairs Specialist at Stryker. He will receive his MBA from The Johns Hopkins University Carey Business School this year.

Laura received a Bachelor's Degree in bioengineering from the University of Pittsburgh and a Master's Degree in Biomedical Engineering from University of Tennessee before working in R&D for such companies as Smith & Nephew, Medtronic, and Abbott Vascular. She started at FDA in 2012 where she was a lead reviewer of premarket applications for orthopedic devices, and was one of the founding members of the Additive Manufacturing Working group. Since then, she has supported medical device manufacturers implementing additive manufacturing into their business as Global Medical Business Development Manager at EOS. Currently Laura is working with the Veterans Health Administration's Advanced Manufacturing group to develop 3D printed point of care solutions at VA Hospitals across the US.

Kevin Go received his Master of Business Administration from The Johns Hopkins University Carey Business School and his Bachelors in Biomedical Engineering from Northwestern University. Kevin has experience working in both the public and private sector, as well as various-sized organizations ranging from small start-ups to multi-national corporations. In his time at FDA, he served as a Lead Reviewer and as an MRI specialist for the Division of Orthopedic Devices, where he reviewed numerous pre- and post-market submissions. Additionally, he also served as an Advisor to the CDRH Innovation group and Payor Communication Task Force, where he provided early regulatory and reimbursement assistance to small businesses. After working at the FDA for over 5 years, he now consults at RQM+ as a Project Engineer. In his current role, he assists clients navigate through FDA and EU MDR regulations. Kevin is a Certified Quality Auditor (CQA) from the American Society for Quality (ASQ).

Nada initiated her career at Biomat Sciences as a R&D engineer supporting dental products. She joined CDRH’s Office of Device Evaluation (ODE) in 2004 and led FDA review teams for original (and sometimes controversial) devices, including a silicone gel-filled breast implant PMA, a drug-eluting neurovascular stent IDE and two novel neurological stent HDEs for the treatment of atherosclerotic disease. As a Senior Science Health Advisor at CDRH, Nada led cross-Center and Agency programs for the advancement of FDA’s mission, including the Health of Women (HoW) program, the Network of Experts program and the Patient Preference Initiative. She collaborated with the Center for Tobacco and the National Institutes of Health (NIH) to improve regulatory efficiency and to strengthen data collection and she was the CDRH Liaison and Subject Matter Expert to FDA’s Office of Women’s Health (OWH) and the Office of Minority Health (OMH). After 12+ years at FDA, Nada joined Experien Group in 2017 as Chief Strategy Officer, where she helps medical device and combination product manufacturers generate regulatory and clinical roadmaps for successful commercialization.

Nada holds an M.S. in Biomaterials and a B.E. in Biomedical Materials Science & Engineering from Queen Mary College, University of London. She earned her M.P.H. from Johns Hopkins Bloomberg School of Public Health. Nada is a Certified Quality Improvement Associate (CQIA) and a Certified Quality Auditor (CQA) from the American Society for Quality (ASQ).

Alexia obtained her BS and MS degrees in Biomedical Engineering from Johns Hopkins University. She spent 3.5 years at FDA as a premarket reviewer of spinal devices, focusing on anterior spine/intracolumnar devices. She joined the Regulatory Affairs team at Stryker’s Spine division in 2017 and is currently a Senior Staff Regulatory Affairs Specialist providing global regulatory strategies for new product development, supporting global compliance initiatives, and aiding in sustaining production and marketing efforts.

Dr. Katzenmeyer-Pleuss is a former FDA medical device reviewer with over 10 years of experience in the regulated medical device industry and 18 years in the broader biomaterials field. She has extensive expertise in international medical device regulatory requirements and device biocompatibility and reprocessing (cleaning/disinfection/sterilization). Dr. Katzenmeyer-Pleuss holds a PhD in Bioengineering from the University of Washington and a Bachelor of Science in Chemical Engineering from the University of Wisconsin-Madison. She currently operates KP Medical Device Consulting LLC, which offers customized regulatory solutions for clients ranging from small start-ups to large, multinational medical device and pharmaceutical companies.

Prior to starting KP Medical Device Consulting LLC, Dr. Katzenmeyer-Pleuss worked as a Senior Regulatory and Biological Safety Consultant at NAMSA, a leading global Medical Research Organization (MRO), in both the United States and in Europe. At NAMSA, she led and drafted regulatory submissions, led meetings with FDA, and developed regulatory assessments and strategy for international markets. She also served as a biological safety expert, drafting Biological Risk Assessments, advising on biocompatibility testing plans, and consulting with clients on the resolution of regulatory agency deficiencies and mitigation of unexpected test results. While at FDA, Dr. Katzenmeyer-Pleuss worked as both a lead and senior reviewer for pre-market submissions as well as a subject matter expert in biocompatibility, sterilization, and reprocessing (reusable and reprocessed single-use devices).

Dr. James Kleinedler received his B.S. in Chemical Engineering from Iowa State University, and then his Ph.D. in Toxicology from LSU Health Science Center, where he focused on cardiovascular combination products. Immediately after completing his graduate work, Dr. Kleinedler joined the FDA as a Biomedical Engineer in the Interventional Cardiology Devices Branch. During his tenure at FDA, James managed the review of Class II and Class III premarket device applications, product development protocols, investigational device exemptions (IDEs), and premarket notifications. Since 2014, Dr. Kleinedler has worked at Boston Scientific Corporation where he works as a Fellow in Regulatory Affairs and leads the company’s Emerging Therapy Team. In this role, he develops strategies for commercialization of devices in new therapeutic areas that recognize shared needs across regulatory, clinical and reimbursement.

Allison Kumar has over 15 years of regulatory experience, and is currently the CEO and Principle Consultant at Arina Consulting, LLC. Prior to founding Arina Consulting, Allison spent over ten years at FDA, working as a biomedical engineer, and later as a Senior Program Manager in the Emergency Preparedness and Medical Countermeasures (EMCM) Program. In her role as a Senior Lead Reviewer, Allison reviewed research protocols, as well as scientific and technical data related to peripheral vascular devices and novel combination products submitted in support of 510(k)s, IDEs, and PMAs. As Senior Program Manager in the EMCM Program, Allison worked to advance innovation and enhance the regulatory approval process for novel medical technologies that address unmet public health and patient needs.

Allison continues to provide specialized and strategic direction to academia, industry, and government partners, and is a key opinion leader on scientific and regulatory policy issues in areas such as combination products, cardiovascular devices, general hospital and advanced surgical devices, medical mobile apps, critical care medicine, traumatic brain injury, healthcare-associated infections, and medical countermeasures.

Ms. Leismer received her Bachelors in Biomedical Engineering from Johns Hopkins University. She is currently a Principal Regulatory Affairs Specialist at Medtronic supporting the Pain Therapies Neuromodulation business. Prior to joining Medtronic, Sarah worked as a Biomedical Engineer at the FDA for five years, leading the review of premarket submissions as a lead scientific reviewer of orthopedic spine devices. She also participated in a collaborative reviewer program acting as both an ODE reviewer and OSB MAUDE analyst and received the FDA Outstanding Service Award for this work. After leaving FDA, she joined the regulatory and clinical affairs team at Greatbatch Medical and later QiG Group supporting a variety of device types in different stages of the total product lifecycle. She joined Medtronic in 2016 and has previously supported the coronary and structural heart transcatheter heart valve therapies team. Sarah's interests include regulatory strategy and planning during the early stages of product development, and the interpretation and adaptation required in the rapidly evolving regulatory landscape of the US and EU markets.

Dr Joshua Levin is a regulatory affairs professional with over eight years of FDA experience. Dr Levin spent his undergraduate education at Brandeis University where he earned his B.A. in Chemistry, before continuing his education at Harvard to earn his Ph.D. in Biochemistry and Molecular Biology. During the first 15 years of his career, Dr. Levin worked in product and process development for a variety of diagnostic and research products companies. Dr. Levin spent his time at FDA as a Scientific Reviewer and as the Postmarket Team Lead at the Office of In Vitro Diagnostics and Radiological Health. After leaving FDA, Dr Levin has been working in Quality Assurance and Regulatory Affairs in the In Vitro Diagnostics industry. Dr. Levin is currently the Director or Quality Assurance and Regulatory Affairs for ASELL, LLC in Maryland where he supports the company’s own product development efforts as well as providing regulatory and quality support for ASELL’s commercial clients.

Michael has 10 years of experience in the medical device industry, including direct experience with FDA device review processes and intricacies. Michael has extensive experience with clinical trial development for medical devices, quality system regulations, and all manner of FDA interactions. Prior to starting Nilo Medical Consulting Group, Michael worked first as a lead reviewer in both the Interventional Cardiovascular Devices Branch and the Dental Devices Branch before working as a Senior Regulatory Affairs Specialist at Biotronik, Inc., where he worked with international teams to develop regulatory and testing plans to meet FDA requirements. While at FDA, he examined pre-market submissions for cardiac medical devices and reviewed dental devices such as implants, abutments, bone-grafting materials, bone plates, and trans-mandibular joint implants.

Michael graduated Summa cum Laude from University of Pittsburgh with a degree in Bioengineering before receiving his Masters of Science in Biomedical Engineering from University of Alabama at Birmingham.

David Pudwill received his B.S. in Biomedical Engineering from Case Western Reserve University in Cleveland, Ohio, which he utilized to get a position as a field engineer at St. Jude Medical before beginning his 9 years at FDA. While at FDA, David was a Biomedical Engineer, Chief of the Implantable Electrophysiology Devices Branch, and Congressional Affairs Specialist. Until recently, David worked at ConvaTec, where he worked as the Senior Director of Ostomy Franchise Regulatory Affairs & Quality Assurance and later the Senior Director of Regulatory Affairs. In April, David founded Mr. Regulatory. Mr. Regulatory is a California based corporation specializing in medical device regulatory education and consulting services, mainly for small and medium sized medical device startups.

Dr. Rhim received her doctorate degree in Biomedical Engineering from Duke University, and her Bachelor and Master of Science degrees in Materials Science and Engineering from M.I.T. Prior to joining NSF International, Caroline served as an FDA Branch Chief for the Anterior Spine Devices Branch at the Center for Devices and Radiological Health (CDRH). Caroline also led the review of premarket submissions as a lead scientific reviewer in both the Division of Orthopedic Devices and Division of Cardiovascular Devices. During her tenure at FDA, she was involved in streamlining the premarket and postmarket review process, as well as the classification efforts for posterior cervical screw systems.

Dr. Stephen Weber received his B.S. from the University of Michigan, and his M.D. from the University of Michigan Medical School. After completing residency at the University of California, Davis, as well an international fracture fellowship and an arthroscopy fellowship, Dr. Weber went into orthopedic practice at Sacramento Knee and Sports Medicine. After over 35 years as an orthopedic surgeon, specializing in sports medicine and conditions related to upper extremities, Dr. Weber joined the Center for Devices & Radiological Health (CDRH) as a Medical Officer in the Office of Health Technology (OHT) 6. While primarily reviewing upper extremity devices, he was also involved in complex reviews of spine, hip, knee and ankle devices. Furthermore, Dr. Weber provided his shoulder expertise to several inter center Combination Product reviews, as well as reviews in the Division of Surgical Devices. After leaving FDA in late-2019, Dr. Weber joined M Squared Associates as a Senior Medical Advisor, and also holds a position at The Johns Hopkins School of Medicine as an Assistant Professor in the Department of Orthopedics.

Eriko achieved her doctorate in biomedical engineering from the University of Arizona with a focus in medical imaging and radiology. In her post-doctoral positions, she combined her technical and project management skills to help transition preclinical research into clinical studies. Upon completing her academic positions, Eriko continued on to a position as a biomedical engineer and medical device reviewer at the Center for Devices and Radiological Health (CDRH) at FDA.

She leveraged her background in medical imaging at her position in the CDRH and contributed to the agency not only as lead and consulting reviewer, but also by her involvement in FDA internal working groups and as a representative to technical standard organizations. Her involvement with FDA submissions across multiple centers, offices, and divisions, as well as her experience with a wide range of FDA submission types within CDRH, brings valuable insight into how to address and navigate regulatory challenges.

Dr. Komiyama received her Ph.D. in Neuroscience from Stanford University and her B.A. in Molecular and Cell Biology from University of California, Berkeley. She received her Regulatory Affairs Certification (US) in 2014. While working at FDA as a biologist and reviewer in the Office of Device Evaluation, she acted as a lead reviewer and consult on 510(k) Premarket Notifications, Investigational Device Exemption (IDE) applications and Premarket approval (PMA) submissions. Her specialty was in biocompatibility requirements for implanted devices. She also researched neurotoxicity and systemic toxicity of medical devices in the Office of Science and Engineering Labs in support of FDA recognized ISO and ASTM standards. She started AcKnowledge Regulatory Strategies in order to serve clients who manufacture implantable and other patient-contacting medical devices.