Mr. Kirwan is an exceptional leader with over twenty five years’ experience in the medical device industry. He has a proven record of product launches across several medical disciplines including spine, laparoscopic surgery, cardiovascular, biomaterials and biologics. He has extensive knowledge of all phases of R&D and product development from concept through clinical trials and field use. He is experienced in manufacturing, operations, quality systems, business development and assessment of new technologies.
Mr. Kirwan’s background in biomedical engineering began as a graduate of Worcester Polytechnic Institute where he received a BS in Mechanical Engineering with Biomedical Interest with Honors and an MS in Materials Science and Engineering. He also served as the Norton Fellow during his graduate studies at WPI.
Mr. Kirwan started his career at Brimfield Precision, a premier medical contract manufacturer, where he learned the various aspects of medical device manufacturing. Prior to graduation from WPI with his BS, Mr. Kirwan developed and patented a novel drive mechanism for laparoscopic instrumentation which formed the basis for a new business unit.
A few years after graduating with his Master’s degree, Mr. Kirwan was hired by the Vascular Systems Division of C.R. Bard to help develop a novel AAA device. Additionally, he established a comprehensive verification and validation program for the device.
Mr. Kirwan then spent time at Focal Incorporated developing delivery systems for surgical sealant biomaterials. He continued work for the company after it was acquired by Genzyme Biosurgery. In addition to product development, he also helped to run three clinical trial sites in Europe in support of one of the company’s neurosurgery products.
Mr. Kirwan then gained experience in the spinal implant market with Blackstone Medical where he served as the Vice President of Product Development for the Biologics Division. There Mr. Kirwan and his team were responsible for launching over ten new products in three years creating an entirely new product segment for the company. As part of his business development responsibilities, Mr. Kirwan was involved with bringing the first commercially available stem cell product to the market. In 2006 Blackstone Medical was bought by Orthofix International. When Mr. Kirwan left Orthofix in 2008, the Biologics division had grown to 25% of the total company sales.
Most recently, Mr. Kirwan served as the President of a small medical device development firm, Incite Innovation. Incite was originally started as a self-funded venture firm with engineering capabilities. In order to select appropriate investment targets, Mr. Kirwan created a quantitative process for project evaluation and selection which included the assessment of technology, intellectual property, regulatory and marketing. Based on this work, Incite patented two fixation technologies specific to spinal implants. One of the technologies is currently being marketed as a cervical interbody device in the US market.