2020 Virtual RegAF Speakers
Dr. Eriko Yoshimaru
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. Allison Komiyama
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.
Mr. Kevin Go
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 recently joined R&Q Solutions as a Senior 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).
Mr. David Pudwill
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. David currently works at ConvaTec as the Senior Director of Ostomy Franchise Regulatory Affairs and Quality Assurance.
Mr. Michael Nilo
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.
Dr. Stayce Beck
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.
Dr. Caroline Rhim
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. Robert Allen
Dr. Allen received his Bachelor’s and Doctorate degrees in Bioengineering from the University of Pittsburgh, Swanson School of Engineering. As a Ph.D. candidate, his research focus was in cellular and medical product engineering. In 2015, he began work at FDA as an American Institute for Medical and Biological Engineering (AIMBE) Scholar. After completing his tenure as an AIMBE fellow, Dr. Allen joined the FDA’s Center for Devices and Radiological Health (CDRH) as a biomedical engineer and staff fellow. Robert acted as a lead reviewer in the former Division of Cardiovascular Devices, coordinating the review of pre-market regulatory submissions such as 510(k)s, pre-submissions, and various supplements for Investigational Device Exemption (IDE) and Pre-Market Application (PMA) submissions. He also worked as a biocompatibility consulting reviewer, evaluating the potential biological response patients could have to a medical device.
Ms. Sarah Leismer
Ms. Leismer received her Bachelors in Biomedical Engineering from Johns Hopkins University. She is currently a Principal Regulatory Affairs Specialist at Medtronic supporting the coronary and structural heart transcatheter heart valve therapies team. 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 initially supporting the pain therapies group in the Neuromodulation business. 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.
Ms. Allison Kumar
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.
Dr. Seth Carmody
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. Carmody brings eight years of experience in guiding medical device technology policy.
Mr. Ron Brown
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 organization. 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 the founded 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.