Facing the Inevitable: Being Prepared for Regulatory Requirements for Laboratory Developed Tests.

OBJECTIVES: We introduce regulatory terms, definitions, and the Quality System Regulation as proposed by the US Food and Drug Administration in the 2014 draft guidance entitled Framework for Regulatory Oversight of Laboratory Developed Tests and explore medical device requirements applicable to a laboratory environment to design, develop, and validate laboratory developed tests (LDTs). METHODS: We performed nine interviews with laboratory professionals to explore concerns and challenges regarding the draft, translated the results into operational factors, and surveyed professionals to test the factors that would comprise a regulatory quality management system framework. RESULTS: Nine interviewees and 35 survey respondents shared concerns of risk classification, process validation, patient safety, and general ambiguity regarding the proposed requirements for development of LDTs. CONCLUSIONS: Respondents agree that a regulatory quality management system is needed in laboratories that develop LDTs, but the translation and method for design control to a clinical laboratory do not exist. As a result, laboratories are taking the wait-and-see approach.

Shared vision between fathers and daughters in family businesses: the determining factor that transforms daughters into successors.

Family businesses are critical to the United States economy, employing 63% of the workforce and generating 57% of GDP (University of Vermont, 2014). Family business continuity, however, remains elusive as approximately 70% of family businesses do not survive the second generation (Poza, 2013). In order to augment our understanding of how next generation leaders are chosen in family businesses, we examine daughter succession. Using a sample of pairs of family business fathers and daughters and drawing on an earlier study of the dearth of successor daughters in family businesses (Overbeke et al., 2013), we reveal that shared vision between fathers and daughters is central to daughter succession. Self-efficacy and gender norms influence shared vision and when fathers and daughters share a vision for the future of the company, daughters are likely to be transformed into successors.