Critical Innovations is currently developing multiple medical devices toward regulatory clearance. The company focuses on task-shifting evidence-based interventions to earlier echelons of care and more general specialty levels, to simplify management and allow for rapid provision in emergency and combat environments. To date, the company has worked under more than 20 different Department of Defense awards from all three military branches charged with medical technology development (i.e. U.S. Army, Air Force, and Navy), including such agencies as the Air Force Medical Support Agency; Army Medical Research and Development Command; Defense Health Agency; and, Office of Naval Research. Contract types have included Small Business Innovation Research (SBIR), Joint Warfighter, and Other Transactional Authority. As a prime contractor, Critical Innovations currently has a 100% transition rate from Phase I to Phase II, as well as Phase II to Phase III, for all eligible SBIR programs.
Ross I. Donaldson, MD, MPH, CTropMed, FACEP
President & CEO
Dr. Donaldson is President & CEO of Critical Innovations LLC, as well as an Associate Professor of emergency medicine and epidemiology respectively in the UCLA Schools of Medicine and Public Health. Triple-boarded in emergency medicine, emergency medical services (EMS), and clinical informatics, Dr. Donaldson has been principal investigator on over $50 million dollars’ worth of funding, with research focusing on emergency, critical, and trauma care. He is also the creator of WikEM, the world’s largest and most popular emergency medicine open-access reference resource, and the inventor of numerous patented medical technologies. He has been featured as an expert on CNN, BBC, NPR, and other media outlets, and an invited speaker at over 100 national and international conferences, including at Medical Design & Manufacturing, Department of Defense, and various think tanks. He has worked around the globe, frequently in areas of conflict and recent disaster, and been the lead architect of national emergency care plans in several countries. For five years in Iraq alone, he led the instruction of over ten-thousand surgeons, physicians, EMTs, nurses, and community members, while spearheading the development of pre-hospital and hospital-based emergency and trauma systems for the country, for which he received the Humanitarian Award from the California chapter of American College of Emergency Physicians. Dr. Donaldson has worked for close to two decades at the Harbor-UCLA Medical Center, one of Los Angeles’ main Level I trauma centers, serving previously as the Director of the Emergency Medicine Global Health Program and Global Health Fellowship. He is also the critically acclaimed author of The Lassa Ward, a memoir about international humanitarian work. Among other honors, he has been named Los Angeles' Top Emergency and Trauma Doctor from the Los Angeles Business Journal and the inaugural recipient of the FOAMed Excellence in Education Award from the Society for Academic Emergency Medicine.
Timothy Fisher, M.B. Ch.B.
Vice President of Research
Dr. Fisher received his medical degree from Leeds University in the United Kingdom in 1983, where he first worked clinically. He then came to the United States and spent 20 years in academia at the USC Keck School of Medicine in Los Angeles, achieving the rank of Associate Professor of Research. He then transitioned to industry and has been the co-founder or owner of several medical companies. As Chief Scientific Officer for Ceremed he led the company in obtaining ISO 13485 certification, CE mark, and FDA 510(k) approval for their first medical device, Ostene. This hemostatic product went from concept through all stages of design control (including product development and testing; manufacturing process design and validation; packaging and sterilization; and regulatory approval in both the U.S. and Europe) within the company’s first 18 months. Dr. Fisher spearheaded marketing the device, including establishing an international distribution network with a dedicated in-house sales team. Within a few years, annual sales surpassed $5 million. Additional products were developed for major medical companies, which saw the company’s core technology utilized in more products approved for use in the orthopedic and spine markets of the U.S. and Europe. This gave Dr. Fisher a unique opportunity to develop partnerships with major companies in developing a variety of medical devices. The success of the product lines led to Ceremed being acquired by Baxter Healthcare. In early 2014, Dr. Fisher founded NeoMatRx, as a research and development company leveraging his expertise of working through the full product design lifecycle. He worked with customers to develop their products all the way from initial concept, through manufacture and regulatory approval, to market, with multiple products focused on the military trauma market. With expertise in the fields of medicine, device development, chemistry, and life sciences, Dr. Fisher then transitioned to Vice President of Research for Critical Innovations, where he plays a pivotal role in all aspects of medical product research, development, and commercialization.
Jonathan Armstrong, PhD, CSci, CChem FRSC
Director of Quality Assurance & Regulatory Affairs
Dr. Armstrong has over 25-years of experience in both academia and industry. He obtained his PhD in Physical Chemistry from the University of Greenwich, London, UK, focusing on the fundamental properties of alkylene oxide copolymers (AOC) and their application in medicine. He then proceeded to work for 15-years in various research capacities, including as an Assistant Professor of Research, in the Department of Physiology and Biophysics at the Keck School of Medicine, USC. Dr. Armstrong subsequently transitioned to industry and was co-founder of several medical technology companies, including StealthCells, Ceremed, and NeoMatRx. At Ceremed, he was a co-inventor of the company’s lead product, Ostene®, a bone hemostasis material that proceeded to significant commercialization sales. Dr. Armstrong has developed medical devices and products for multiple companies from concept through product launch. He specializes in quality and regulatory compliance, and has built and run quality management systems for multiple entities. As Quality Manager for Ceremed, Dr. Armstrong facilitated ISO 13485:2003 certification and obtaining the CE Mark, including training and providing quality support to Ceremed’s contract-manufacturers. Dr. Armstrong is a Fellow of the Royal Society of Chemistry and has 45 peer-reviewed publications, 3 book chapters, 8 issued patents and over 80 presentations at national and international conferences. He currently directs the management and implementation Critical Innovations’ quality system, certified to ISO 13485:2016 and in compliance with the FDA’s 21 CFR§820 Quality System Regulations.
Oliver Buchanan, BSc (Hons)
Director of Development & Engineering
Mr. Buchanan has worked for over a decade in the medical device field, since initially graduating from the University of Sussex with an honors degree in Physics. He started in product development, working closely with surgeons for Ceremed, Inc. in the Research & Development (R&D) department as an R&D Associate. With a focus on medical device R&D and engineering, Mr. Buchanan quickly became a lead project manager and R&D engineer, acquiring a variety of skills essential for those tasks. He then transitioned from Ceremed, Inc. to NeoMatRx, a medical device R&D consultancy agency, where he oversaw new product development and engineering as the Director of Projects. There, he worked to design and develop medical devices, with a focus area in emergency combat care. Mr. Buchanan subsequently transitioned to Critical Innovations LLC as Director of Development & Engineering. With expertise in ISO 13485 Design Control, Mr. Buchanan ensures there is a smooth transition for product development from concept through to commercialization, including meticulous adherence to the quality system at all levels of development to provide a complete and necessary Design History File (DHF). These actions are aided by full involvement in concept development, 3D CAD drawing, and early prototyping, as well as design verification, process development, pilot manufacturing, and full-scale manufacturing transfer. The ability to view the development process from start to finish during the initial phases of the project allows Mr. Buchanan to have early oversight of all design and engineering actions. He has extensive experience in the development of medical devices and is an expert in engineering and prototype design, including 3D modelling in industry-leading software, hands-on prototyping in both the laboratory, and experimental design execution.
John Cambridge, PhD
Director of Special Projects
Dr. Cambridge has worked in both academia and industry for the past 20 years, focusing on medical product applications and production. He obtained his PhD in Polymer Chemistry from the University of Manchester, Manchester, UK, before spending 7 years as a Postdoctoral Research Associate at the USC School of Medicine. There, he synthesized and modified numerous polymers to provide novel drug delivery and other medical application benefits. He then proceeded to industry and was a co-founder of Ceremed Inc., and co-developer of Ceremed’s lead product, Ostene®, a bone hemostasis material. As Production Manager for Ceremed, Dr. Cambridge was responsible for developing and overseeing large-scale medical device production. He set up production lines, trained staff, and supervised manufacturing. He was also a key member of the technology transfer team responsible for transitioning production to partner companies, such as Baxter and Biomed Technologies Inc. Dr. Cambridge also co-developed the AOC family of products and took several projects from concept through to product launch. After successful commercialization of Ceremed, Dr. Cambridge became a co-founder of NeoMatRx, a medical device research and development consultancy agency, where he led manufacturing transition and subcontractor oversight for multiple medical products. He currently serves as the Director of Special Projects for Critical Innovations, where his unique skill set and background allow him to focus efforts on a wide range of projects.
Perry Lew, MS, MBA
Director of Operations
Mr. Lew is a skilled industrial and systems engineer with over 20 years of experience in medical manufacturing and operations. During that time, he has worked for a series of medical companies and gained comprehensive skills in those areas. He began his career in the manufacturing of petrochemical analyzer systems, commodity products, and circuit board materials, where he served in various roles including as design, quality, and manufacturing engineer, as well as production supervisor. Mr. Lew later transitioned to Baxter Healthcare, where he served as a principal engineer and project leader for various process improvement projects aimed to increase throughput, reduce defects, and improve yields across the entire plant. He subsequently moved to higher management at Ceremed, Inc., where he worked as a project engineering manager, and subsequently at Danaher Corp., where he worked in the areas of value analysis / value engineering. Mr. Lew has received a Bachelor of Science in chemical engineering from Cal Poly Pomona, a Master of Science in industrial and systems engineering from University of Southern California, and an Master of Business Administration from the University of California at Los Angeles (UCLA). He is a Certified Six Sigma Black Belt and ASQ Quality Engineer, with extensive experience with the regulatory and quality requirements for the production and oversight of medical products. Mr. Lew is currently Director of Operations for Critical Innovations, where he ensures that projects successfully transition from early product development to large-scale manufacturing and full-scale production.
Subject Matter Experts
Captain David Tanen, MD, FAAEM, FACMT (USN, Ret.)
Dr. Tanen is a retired U.S. Navy Captain and an expert in emergency medicine. During his 22 years in the Navy, CAPT Tanen completed multiple combat deployments including a tour in Somalia, two tours in Iraq and two tours on the Navy’s hospital ships completing humanitarian missions around the world. While serving as senior academic faculty at Naval Medical Center San Diego, he held the positions of Research Director and Residency Program Director. He is currently Associate Director of Residency Training and a Professor of Clinical Medicine at the UCLA-Harbor emergency medicine residency program. Dr. Tanen is a graduate of Harvard University, UCLA School of Medicine, and the Howard Hughes Medical Institute Research Fellowship Program where he studied psychopharmacology at the National Institutes of Health. He completed his Emergency Medicine residency training at Naval Medical Center San Diego and a Medical Toxicology fellowship at Good Samaritan Regional Medical Center in Phoenix, AZ. He is board-certified in both Emergency Medicine and Medical Toxicology.
Denise Whitfield, MD, MBA, FACEP (Former Commander, USN)
Dr. Whitfield is a former Commander in the U.S. Navy and expert in emergency medicine and emergency medical services (EMS). She has extensive experience in field medical care in diverse environments. She spent 12 years on active duty in the Navy with combat deployments to both Iraq and Afghanistan. As a Naval Flight Surgeon, she completed operational assignments with the Marine Corps. Following residency training, she was assigned to Naval Hospital Guam and was an active participant in the Critical Care Committee, advising on the optimization of critical patient care on the island. While in Guam, she also served as the Emergency Medical Services medical director for Joint Region Marianas Federal Fire. In 2013, she was selected to serve as a White House Physician for the Obama administration. During this tour, she successfully oversaw operational medical planning for all Presidential, Vice-Presidential and First Lady travel as the Chief of Protective Medicine, was selected to serve as Physician to the First Lady, and was the Medical Director for Camp David Emergency Medical Services. Prior to active duty service, Dr. Whitfield graduated from Stanford University with a Bachelor of Science in Biological Sciences and earned her medical degree from UCLA. She currently is Director of Education & Innovation at the Los Angeles County EMS Agency, as well as faculty in Harbor-UCLA Medical Center's Department of Emergency Medicine and a Health Sciences Assistant Clinical Professor at UCLA. Dr. Whitfield is a board-certified diplomate of the American Board of Emergency Medicine and a fellow of the American College of Emergency Physicians.