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Expert is a medical device consultant and executive with more than 20 years experience in the medical device industry. His expertise spans all aspects of medical device commercialization, from medical device product development to medical device manufacturing and quality control; from Food and Drug Administration medical device regulation and submissions such as 510(k)s documents to medical device clinical research; from medical device product introduction to technical support, including medical device evaluation, hazard analysis and product recall management. Expert's activities have included medical device development for Fortune 50 companies such as General Electric (e.g. GE Medical Systems, Johnson and Johnson), numerous early stage companies (e.g. Ventracor) and growth companies (e.g. Cardiac Science)

Expert is currently an independent consultant as founder of his own consulting firm. In this capacity, he has led due diligence and consulting projects with medical device companies and their investors in the areas of regulatory strategy, medical device evaluation, medical device product development, medical device manufacturing and medical device field corrective actions and recalls. In addition, he has served as project manager for large new product development projects for companies such as General Electric and Johnson and Johnson.

As COO of Ventracor, Expert was responsible for the company's product development, global manufacturing, quality assurance, regulatory affairs, and clinical research. In this capacity, he interacted closely with the US Food and Drug Administration and obtained unconditional approval for the company's clinical trials under Investigational Device Exemption (IDE). Under his leadership, the company fully enrolled the trial in approximately one year, establishing the foundation for a Pre-Market Approval (PMA) from the US Food and Drug Administration.

While Senior Vice President of Operations at Cardiac Science, Expert led the company's rapid growth from a start-up to a $180 M/year company in the areas of global manufacturing and quality assurance, regulatory affairs, technical support, and clinical research functions. He served as the company's main interface with the US Food and Drug Administration for product recalls and audits, improving the company's quality control system and re-establishing the company's credibility with the US Food and Drug Administration in the areas of quality system regulation, 510(k) product submission and product recalls. His activities in global manufacturing led to a 50% reduction of the company's defibrillators cost of goods, while simultaneously improving product quality, receiving a supplier quality score from General Electric in the top 10 percentile and improving the products' first-pass manufacturing yield to over 99%.

Prior to Cardiac Science, Expert was Manager of X-Ray Imaging Engineering at GE Medical Systems (now GE Healthcare), where he was responsible for the development and manufacturing transfer of new X-Ray imaging products. In that capacity, he introduced numerous new X-Ray Imaging products to manufacturing under GE's new "Design for Six Sigma" process. He also worked with a large number of GE medical Systems' smaller technology providers to help them improve quality systems and product development processes.

Expert is an excellent team builder and communicator. He is fluent in 3 languages (English, Dutch and French) and was the recipient of a Fullbright Scholarship. He was elected member of the honor societies of Phi Kappa Phi, Sigma Xi and Eta Kappa Nu and has a Ph.D. in Acoustics engineering from Pennsylvania State University.

Client company, a medical device company in a rapid growth phase, had received a warning letter from FDA after an audit. FDA ruled it had not received satisfactory response from Company and was preparing more serious action. After investigating specific product issues that lead to warning letter, he restored client's credibility with the FDA by (1) implementing continuous improvement plan for the client's quality system that addressed FDA's findings (2) helping client develop and implement a product recall plan and (3) executing a clear communication strategy with the FDA. As a result, the client passed the FDA's follow-on audit.Client class II and class III medical device company was about to invest significant capital (>$50M) in the production of a new product and wanted an external evaluation of the product before giving a go-ahead. After evaluating the product development process, he uncovered significant gaps in the verification and validation of the design. He also highlighted serious issues with the client's product development process, which could have exposed the company to detrimental action by regulators. He helped the company correct these issues and avoid a large investment mistake as well as exposure to regulatory action by FDA.Client class III medical device company was interested in acquiring a competitor. During the due diligence phase, he uncovered that the company to be acquired had significant issues in its quality system, and that a new product soon to be released posed a significant risk. As a result, the client company decided not to proceed with the acquisition, avoiding significant product problems and ultimately legal issues, as the competitor struggled with a large-scale recall.Large Venture Capital firm needed in-depth analysis of a new technology with ophthalmology applications in light of a possible investment. He evaluated the technology and uncovered significant unmitigated risk. As a result, the client avoided a poor investment decision.