Date of Conferral
Doctor of Business Administration (D.B.A.)
Supply chain management (SCM) practitioners who ship temperature-sensitive diagnostic medical devices (DMDs) to clinicians must use effective cold chain management (CCM) strategies to avoid temperature excursions that contribute to medical device errors. Such errors have caused patient harm and death, which costs the U.S. health care system billions of dollars per year. The purpose of this qualitative multiple case study was to explore strategies for selecting and managing cold chain shipping solutions (CCSSs) requiring SCM executives to trade cost for regulatory compliance and predictability when mitigating temperature variations that occur during shipping. The conceptual framework for the study was the 6-change approaches, and its underpinnings that framed the exploration into the strategies some medical device executives use for shipping temperature-sensitive DMD tests and controls. Data were collected from in-depth interviews, field notes, and existing literature. The target population was 3 SCM executives working in California, New Jersey, and Ireland with at least 5 years of CCM experience in the medical device industry. A purposive sampling procedure guided the selection of participants for in-depth interviews. The data analysis included pattern matching techniques, central analysis, and collapse analysis. The results of this study indicated 3 successful strategies: validation of CCSSs, compliant shipping of DMDs, and CCM best practices. The study was socially significant because the findings may prevent medical device failures that have caused U.S. Food and Drug Administration recalls and patient harm.