Dr. Ollerenshaw works with CardioMed Device Consultants and brings more than 25 years of leadership experience in medical device and biomedical product development. He has expertise in the strategic development and execution of preclinical studies supporting exploratory work, through to regulatory submissions and post market product collateral.
Most recently, Dr. Ollerenshaw led the preclinical capability at a surgical robotics company in Northern California, and previously has led preclinical strategic support for innovative neuromodulation and tissue regeneration technologies at a large medical device company in the Atlanta area. Dr. Ollerenshaw has worked as GLP Study Director of a number of cardiovascular studies at CROs and he has expertise in model development, essential histopathology and biocompatibility study strategy in implantable device evaluation. Dr. Ollerenshaw has performed efficacy studies for cardiovascular pharmaceuticals and medical devices including coronary and aortic stents, hydrogels, tissue adhesives and sealants, vascular grafts, tissue matrices and stem cell seeding strategies. He has also managed ISO-10993 biocompatibility panel studies and has been a subject matter expert for successful 510(k) vascular device submissions.
After gaining his PhD in vascular biology from the University of Leicester in the UK in 1989 and completing his academic career at Emory University in Atlanta as Instructor in Medicine in the cardiovascular research division, he moved into industry to continue focused research in cardiovascular disease models. He has published extensively in the medical and scientific literature in research articles and book chapters. Within the medical device industry, Dr. Ollerenshaw has worked for more than 25 years in development of significant advances in biological vascular graft materials and cardiovascular products. This has included the design and development to regulatory approval of the first non-crosslinked xenograft vascular conduit. His expertise is in developing and executing strategic preclinical studies to support a variety of medical devices and therapeutics. He is highly skilled in technical writing in both preclinical and clinical materials including study protocols, final reports, clinical evaluation reports, white papers and other supporting regulatory submission documentation for medical devices.