About the team
Piet Lesage | Principal Consultant
Piet started his career marketing and selling imaging solutions for the medical ultrasound OEM market a little over 30 years ago. Ever since he has been actively expanding the international presence of businesses. He has assisted European and US companies grow their presence outside their borders finding partners, opening subsidiaries and acquiring and integrating companies, and has developed, and negotiated many complex million-dollar business deals in Asia, Europe, and the Middle East. He has often dealt with highly regulated industries and has been exposed to very sensitive situations. At one time having to self-declare a non-conformity to the US government. At another when a major customer violated the Foreign Corrupt Practices Act. Nowadays, he helps US MedTech companies expand overseas, and vice versa, foreign companies enter the US market. He is particularly focused on the intersection of regulatory, reimbursement and commercial strategies.
Molly Schmid | Senior Consultant, SBDC @ UCI Beall Applied Innovation
Molly Schmid, Ph.D. currently serves as an SBDC consultant focusing on providing customized solutions for life science businesses facing growth challenges. Dr. Schmid brings more than 20 years of experience in the life science and small business technology industries and has held a variety of impressive leadership roles in bioinformatics, pharmaceuticals and health technologies, as well as the entrepreneurial space. She has also published several patents and publications. She was Vice President of Life and Health Technologies at ieCrowd, a global community of innovators where she coached Olfactor Laboratories, Inc. staff to transform novel vector control products into commercially viable technologies. She was also Senior Vice President of Preclinical Programs at Affinium Pharmaceuticals, Inc. in Toronto, Canada, where she managed several multi-million dollar technical projects, including a three-year $15 million discovery-stage collaboration with Pfizer. In addition to Applied Innovation’s successful SBDC program, Dr. Schmid currently serves as an Entrepreneur-in-Residence for Alfred Mann Institute of Bioengineering at USC. She also has been an adjunct professor for USC Marshall School of Business’s Lloyd Greif Center for Entrepreneurial Studies, and UCLA’s Anderson School of Management. Dr. Schmid earned her Ph.D. in Biology at the University of Utah and worked as a research fellow at the University of Oregon.
Kwame Ulmer | Principal, Ulmer Ventures
Kwame Ulmer brings nearly twenty years of experience evaluating medical technologies in the government and serving in senior operating roles at medical device companies. This experience allows him to help companies at all stages efficiently navigate global regulatory agencies. Kwame has particular expertise in all aspects of the USFDA, from premarket applications to postmarket compliance. Mr. Ulmer previously served as Vice President, Regulatory Affairs and Quality Assurance at Implant Direct, a Danaher Corporation (Fortune 150) operating company. He led efforts to shorten global registration timelines, improved product quality by process optimization and achieve best-in-class department engagement scores. Kwame has in-depth knowledge of the cross-functional activities needed to take a medical device from concept to product launch in markets including North America, EU, EMEA, China, and LATAM. Kwame has served in progressive leadership roles at the US Food and Drug Administration (FDA) and personally evaluated over 1,000 medical technologies. He has successfully overseen products through all FDA application types (IDE, 510(k), PMA, 513(g)) and advised over 100 early-stage MedTech companies on a regulatory path. Mr. Ulmer is a member of the Executive Committee of Tech Coast Angels (LA), the world’s largest angel investing network and a Venture Partner at Wavemaker Three-Sixty Health - the leading Southern-California based, early-stage venture capital firm (Seed and Series A) focused on the healthcare industry. Kwame earned his B.S. in Physics from Lincoln University (Pennsylvania) and both an M.S. in Materials Engineering and M.B.A. from the University of Virginia.
Dr. Frances J Richmond | Professor/Chair Dept. of Regulatory and Quality Sciences, USC School of Pharmacy
Frances Richmond, Ph.D. is the Chairman of and a Professor in the Department of Regulatory and Quality Sciences in the School of Pharmacy. She comes to USC from Queen’s University, where she was Professor and Director of the Medical Research Council in Sensory-Motor Neuroscience. Dr. Richmond’s research interests have included both basic and applied studies of movement systems. She is conducting animal and clinical trials of implantable devices and consults on regulatory aspects of medical product development. She is currently directing Program of Certificate, Master’s and Doctorate programs in Regulatory Science at the University of Southern California. Her current interests are focused on the regulatory and clinical management of new product development in biomedical areas.
Eri Hirumi | Manager, Global Regulatory Affairs
Eri has a bachelor's degree and classwork in Biochemistry and Molecular Biology from Purdue and California State University at Long Beach. Eri started her career as a Development Chemist for a very small electrophoresis product line that provided training on a broad spectrum of skills on the complete product life cycle. This training highlighted the key importance of managing documentation. The growing labeling knowledge sparked her interest in other parts of regulatory. Working on the labeling requirements led to an opportunity to lead the Technical publications group in Brea. This, in turn, developed a detailed knowledge of world-wide IVD labeling requirements and the interplay with different standards. Eri shifted her career to into Regulatory Affairs. She continues to expand her knowledge on global regulatory requirements. Different requirements such as chemical hazard communication, global registrations, import/export requirements, biological origin permitting and country of origin marking requirement were all interwoven into supporting a complete product life-cycle. Being an auditor for TÜV SÜD provided an excellent platform for building a solid foundation of Quality Management Systems as defined by EN ISO 13485 and the European regulatory processes and documentation requirements. Eri is constantly expanding her knowledge base and now working with a Neurovascular Implant company as the regulatory landscape shifts to accommodate the MDSAP and the new EU MDR/IVDR.
Debra Topham | President, Knowledge Bank
Debra K.W. Topham’s consulting business, knowledge bank, provides “health checkups” for food and supplement labels to comply with FDA, USDA, and FTC regulations. Debra is a 30-year industry veteran having reviewed over 4,000 labels including the launch of Tesco’s Fresh&Easy Neighborhood Market private-label brands and a nutrition scientist with Nutrilite (a division of Amway). Ms. Topham is both a Certified Nutrition Specialist (CNS) and a Certified Food Scientist (CFS). She also lectures at multiple universities and provides workshops on labeling for retail and foodservice markets.
Dr. Thomas Lee, M.D., M.B.A. | Chairman of the Medical and Life Sciences Committee for the Orange County Chapter of Tech Coast Angels
Dr. Lee is the Chair of the Medical and Life Sciences Committee for the Orange County chapter of Tech Coast Angels (TCA). He has been the deal lead for several of Tech Coast Angels’ medical and life sciences companies and also heads the medical/life sciences prescreen process for TCA-OC. Dr. Lee is a practicing anesthesiologist in Orange County, California with interests in neurosurgical and trauma anesthesia. He has recently taken a keen interest in the burgeoning field of aesthetic and rejuvenation medicine and will soon be opening the Jade Phoenix Medical Spa to put into practice what he has learned. Moreover, Dr. Lee has published works in the medicinal natural products research space and is heavily involved with the medical, pharmaceutical, and medical device startup community in Orange County.
Dennis Rubenacker | Senior Partner, Noblitt & Rueland
Dennis L. Rubenacker is co-founder and Senior Partner of the consulting a firm of Noblitt & Rueland specializing in software quality management, software verification & validation, software development, design control, risk management, quality systems, and electronic recordkeeping for FDA regulated industries. He has extensive experience dealing with product development, software development, and software quality assurance for medical device instrumentation. Mr. Rubenacker has held system & design engineering, software engineering, software quality assurance, electronics engineering, project management, and management consulting positions in the research and development of medical devices, aerospace systems, and consumer electronics for over 35 years. His medical product line experience includes monitoring, diagnostic, and therapeutic critical-care devices. His experience includes clinical chemistry analyzers, immunoassay analyzers, microbiology analyzers, implantable & external defibrillators, glucose monitors, pacemakers, cardiac output computers, ejection fraction computers, oxygen saturation computers, retroperfusion pumps, cardiac imagers, EKG monitors, infusion pumps, catheter-sensor interfaces, and home healthcare monitoring devices. Additionally, he has experience with manufacturing process instrumentation and electronic recordkeeping including ERP systems as related to FDA regulated industries. He has been involved with the FDA, Los Angeles district, grass roots partnering subcommittee on electronic recordkeeping and has lectured on FDA electronic recordkeeping with several organizations including the Food and Drug Law Institute (FDLI). Mr. Rubenacker has assisted both domestic and international companies including companies ranging in size from less than $1,000,000 in sales to Fortune 100 companies. Mr. Rubenacker received his B.S. in Electrical Engineering with highest honors from the University of Illinois and is a member of the Institute for Electrical and Electronic Engineers (IEEE), RAPS and ASQ.
Sigi Caron, RAC | President, Caron and Associates
Ms. Caron has over twenty-five years of progressive experience in basic research, regulatory affairs, clinical research and new business development in both the academic setting and in the medical device and pharmaceutical industry. Ms. Caron has successfully submitted multiple 510(k)’s, IDE’s, INDs, PMA’s, obtained Orphan Designations for biologics and several medical devices and has successfully submitted several fast track, breakthrough, and RMAT designations. She has over 15 years of experience in biologics submissions, including an embryonic stem cell therapy, and multiple autologous stem cell therapies and allogeneic therapeutics for cardiovascular diseases. Over the past five years of practice, she has successfully submitted 12 INDs for gene therapies in clinical areas such as critical limb ischemia, heart failure, diabetic neuropathy and ALS, 1 IND for an embryonic stem cell product, and several eINDs. Over the last 5 years, Ms. Caron has also successfully negotiated and obtained approval for 15 IDEs spanning therapeutic areas such as stroke, cardiac arrhythmia treatment, cardiac implants, in vitro diagnostics, stroke devices, and critical care devices. Ms. Caron’s clients include both Fortune 500 companies and startups in the fundraising stages. Prior to consulting, Ms. Caron was Vice President of Regulatory Affairs and Quality Assurance at TheraCardia, a venture-backed startup company developing a paradigm shift emergency cardiac assist system for treating patients in cardiac arrest. Ms. Caron negotiated a reduction of clinical trial requirements (endpoint & enrollment requirements) for the device by two thirds and helped shape the FDA’s policy for CPR devices. Ms. Caron also negotiated an agreement for Medicare Coverage with the medical device coverage group at CMS (formerly HCFA). Prior to joining TheraCardia, Inc., Ms. Caron held several management positions at medical device companies including Biosense Webster, a Johnson & Johnson Company, Smith & Nephew’s Endoscopy Division, Codman, a Johnson & Johnson company and Johnson & Johnson Orthopedics. Before working in the medical device and pharmaceutical industry, Ms. Caron worked as a basic researcher at the Woods Hole Oceanographic Institution where she obtained grants from government agencies o fund original research, managed and administering them, designed and built novel chemical analyzers, and published four papers in peer review journals (two-first author papers). Ms. Caron holds a BS from UCLA in Biology (emphasis in mathematics) and an MBA from Northeastern University’s High Technology MBA program (emphasis in biotechnology management).
Grant Bennett | CEO, BrandwoodCKC
Grant Bennett has a deep and practical experience of regulatory affairs gained through medical devices industry roles across the Asia Pacific. His prior experience includes roles as Regional Regulatory Affairs Manager Asia Pacific and Australia/New Zealand Quality Assurance Manager with a US-headquartered, multinational supplier of professional Medical Devices. An internationally respected industry leader, Grant chairs both the Regulatory Affairs Expert Panel and National Advisory Council for Australian industry peak body AusMedtech. He is an adviser to the Asian Harmonization Working Party (AHWP), supporting regulatory guidance development in pre-market assessments, labeling and UDI implementation. Grant has specialist expertise in distribution and logistics and requirements for Universal Device Identifiers (UDI) and national implementations including the Australian National Product Catalogue (NPC) controlled by the Australian National E-Health Transition Authority and the corresponding DHB National Catalogue for Healthcare in New Zealand. Before joining the Medtech industry, Grant had extensive prior experience in accountancy, commercial software and project management. Earlier roles included support of existing clients with the implementation of their MRP systems, as well as developing process flows, detailed financial analysis, and reporting, allowing clients to better understand their business.
Robert Stringer | Principal Consultant, BrandwoodCKC
Robert Stringer has more than 25 years of experience in the Australian and New Zealand pharmaceutical industry. Prior to establishing Capital K Consulting, Robert was a member of the leadership team at AstraZeneca Australia, having managed the Regulatory Affairs, Clinical Research and Strategic Planning & Business Development teams. His career also includes the green fields market entry into Australia of Sandoz (the generic arm of Novartis), ultimately holding the role of Research and Development Manager. In this role, his responsibilities included leading the regulatory, product development, and quality assurance functions, along with joint leadership of the product sourcing and partnering arrangements. At Sandoz, Robert achieved the world-first market approval of a biosimilar. Robert is an active supporter of the industry. His deep engagement with professional associations includes the provision of pharmaceutical training programs to the Australian Association of Regulatory and Clinical Scientists and participation in the Regulatory Affairs Professionals Association (RAPS).
Terrance (TJ) Theil | Principal Consultant, BrandwoodCKC
TJ Thiel has worked in quality and regulatory affairs in the Australian, US, and European medical device and diagnostics industries for more than 20 years. From major multinationals to small start-ups, TJ has deep experience with global regulatory approvals and registration, providing clients with planning and strategy suitable for both local and world-wide product launches. TJ has prepared, submitted and achieved significant approvals for medical devices – including active implantables (AIMDs), implantables and Software as Medical Device (SaMD) – and in vitro diagnostics including point-of-care, self-testing and laboratory devices. TJ holds Regulatory Affairs Certification (RAC) and has delivered regulatory approvals including FDA 510(k), PMA and De Novo; CE-marking; Health Canada; TGA; PMDA and NMPA. He has provided due diligence activities for company acquisitions regarding the target’s business viability, quality system status and regulatory position. TJ’s expertise also supports businesses to create, revise and execute quality systems that are efficient and understood by all employees to provide compliance in a consistent and concise manner.
Allison Komiyama | Founder and Principal Consultant, AcKnowledge Regulatory Strategies, LLC
Allison Komiyama, Ph.D., RAC, is a consultant who works on regulatory strategies and submissions for medical device and IVD manufacturers. Her work has focused mainly on US regulations, with a specialty in pre-submissions, 510(k) notifications, de novo applications, IDEs, and 513(g) submissions. After her education in molecular biology and neuroscience, Allison moved to DC to work at FDA as a reviewer in the Office of Device Evaluation (ODE). She acted as a lead reviewer for premarket submissions and was a consult for files evaluating the biocompatibility of patient-contacting devices. After her time at FDA, she worked as a project manager and regulatory affairs manager at an IVD company in Poway, CA, and then as a senior regulatory specialist at a consulting company in Del Mar. She started AcKnowledge Regulatory Strategies, LLC in 2014 in order to serve medical device manufacturers who need FDA approval. She was certified by RAPS in 2014 and works with a team of 7 people in Old Town, San Diego.
Matthew Grumbling | Partner, Nguyen & Tarbet
Matt is a chemist (M.A., Johns Hopkins University) and a registered Patent Attorney. His practice is focused on patent strategy in chemistry, pharmaceuticals, biologics, and natural products. Prior to joining Nguyen & Tarbet, Matt was a Lead Patent Counsel in Wilson Sonsini’s San Diego office, where he worked for over ten years. Before that, he was in-house counsel in a pharmaceutical research and discovery company, where he focused on large-scale manufacture (Kg quantities) of DNA and DNA derivatives. He also worked in McDermott, Will & Emery’s San Diego and Washington, D.C. offices, as a patent agent and patent counsel, respectively. Prior to becoming an attorney, he worked as a patent examiner in the USPTO, where he was a Primary Examiner in Tech Center 1600. In addition to being a member of the USPTO patent bar, he is admitted in AZ, CA, and MD.
Paul Kramsky | Regulatory Consultant
Paul S. Kramsky is an independent regulatory consultant specializing in the support of small medical device firms. Prior to this, he was President of Rockin’ Regulatory, Inc., a regulatory and quality consulting firm and was Vice President, Global Regulatory Affairs, for Bausch + Lomb. Previously, Mr. Kramsky was Director of Regulatory Affairs for the surgical division of Bausch & Lomb. Prior to Chiron, he was employed by Allergan Medical Optics. Mr. Kramsky has more than 35 years of Regulatory Affairs and Quality Assurance experience in the medical device industry and more than 25 years of leadership experience in Regulatory Affairs. Mr. Kramsky has been an active member of the Board of Orange County Regulatory Affairs Discussion Group (OCRA) where he served as President and Chair of the Program Committee. He was president of the Western Section of the Regulatory Affairs Professional Society (RAPs) prior to its reorganization. He has a Bachelor’s and Master’s degree in Biological Sciences from California State University Fullerton.
Concept to Commercialization 2.0