Implementation of risk management in medical device companies: A survey analysis of current practices.

摘要

This survey analysis examined current practices related to the implementation of risk management in medical device companies. Twenty-six of the Top 30 (by global market revenues) and twenty-seven other medical device companies with direct product sales in the U.S. market participated in the study. Through a literature analysis, the researcher developed a systematic framework, the "Behavior+Capability" model, to explore risk management attitudes and practices of a medical device company according to six dimensions. This framework was used to construct a forty-question survey instrument for the study. Most respondents to the survey classified their companies as relatively risk averse. Most viewed their risk management systems as satisfactory but some elements, such as risk communication, independence of risk managers, breadth of risk tools and methods to capture lessons learned, were not well-developed. Respondents in most companies and particularly the largest companies judged their risk management systems as relatively immune to the current economic climate. Most systems appeared to be highly driven by regulatory requirements rather than business imperatives.;Results suggested that initiatives to achieve best practices in risk management might be improved by incorporating more advanced approaches and applications of risk management tools and techniques. More research on specific aspects of weakness identified for some medical device companies might elucidate root causes for the challenges. Risk management systems might be enhanced further in medical device companies by expansion of training for typical in-house activities to include outside certification or graduate programs, or by introducing risk management as part of curricula in engineering or regulatory science programs.