The influence of design and development practices on outcomes [electronic resource] : a case-based analysis of medical device design

Through an inductive, multi-case analysis, this dissertation examines how design and development practices, involving physicians and medical device developers, influence the clinical and financial outcomes of early stage medical device companies. This research was motivated by an interest in understanding the role of physicians in the device development process, specifically in terms of how physician interaction influences the acceptance or rejection of new medical products. An analytic framework for case-based research was first developed based on exploratory interviews with leaders in the medical device field. Retrospective case studies were then conducted on eight entrepreneurial firms (four rival pairs) in the areas of pulse oximetry, robotic surgery, cardiac bypass surgery, and minimally invasive spine surgery. Primary data sources included interviews with engineers, physicians, and business executives from each company; product development data including device prototypes, regulatory clearance data, and intellectual property (IP); and clinical and financial outcomes data. Following the period of data collection, within-case and across-case analyses were performed. The interview data for each case was coded for design and development practices involving physician-developer interaction, using NVivo qualitative analysis software (QSR International, Version 8). Development practices were analyzed using logic models to examine causal relationships between practices, and product and company outcomes. Design and development practices were further examined and supported using a combination of qualitative and quantitative evidence. Based on the multi-case analysis, this dissertation provides an overview of physician-developer interaction characteristics throughout each phase of the medical device development process. This includes a description of the roles and responsibilities of physicians engaged in development efforts, and their corresponding team affiliations. The research also illustrates four key factors that contributed to medical device adoption for the cases studied. First, the data highlight that designing products under variable use conditions (i.e. with variable patient populations and physicians of varying skill levels), enabled firms to optimize products for widespread clinical use and to increase the predictability of product outcomes. Second, the study shows that product adoption relied on maximizing benefits for multiple product stakeholders, while minimizing required changes in physician behavior. The data further illustrate that total benefit to product stakeholders was influenced to the greatest degree by benefits afforded to hospitals and physicians, assuming patient benefit was greater than or equal to the standard of care. Third, the study highlights that managing perceptions toward product use through performance data positively influenced product adoption to a greater degree than did market demand or regulatory clearance. Fourth, rival explanations for outcomes, involving limited physician interaction, indicate that competitive advantages were achieved through maintaining dominant financial and intellectual property positions. From these findings, the Insight-Value-Perception (iVP) Model for user-centered medical device design was constructed. The model links design and development practices to outcomes, from a combination of consumer-oriented, technical, and financial perspectives. This research provides theoretical contributions to product development and user-centered design literature, and provides practical contributions for developers in the medical device field. A contribution to product development literature is made through documenting the combined benefits of maximizing product value for stakeholders while managing data-driven perceptions toward product use. For the field of user-centered design, this research captures the benefits of designing medical technology with and for a broad consortium of product end-users, as opposed to industry leaders alone. The research also documents the importance of identifying the often-conflicting needs of product stakeholders, and then optimizing devices to satisfy the needs of those with the greatest influence over product use and adoption. For medical device practitioners, this dissertation provides design, regulatory, and product-testing strategies shown to increase technology adoption across the eight cases studied. From this thesis, the author proposes future studies to inform policies and strategies for device manufacturers and the FDA, and to advance knowledge in the fields of user-centered design and product development.

Keywords: Mechanical Engineering
Advisor: Leifer Larry J. primary advisor. Thesis advisor
Linehan John H. (John Henry)
Steinert Ralf advisor. Thesis advisor
Sutton Robert advisor. Thesis advisor