Collaborative Medical Device Design (cMDD)

The medical device industry requires multi-disciplinary collaboration between researchers and physicians (Freudenthal et al. 2011). In responding to the challenges associated with medical device development, Ogrodnick (2013) proposed a collaborative model in which design teams have a/synchronous access to a repository of information regarding the progress of the development of a medical device.  This research investigates the nature of interactions between manufacturers and physicians throughout the process of medical device development to facilitate more effective practice. A literature review explored the history of medical devices; design and development processes; overall approaches to design and case studies involving healthcare practitioners coupled with collaborative processes. From this detailed review, three gaps in knowledge were identified: industrial design practice in medical device development is not well described; the models and frameworks of user involvement were unverified; user involvement was based on formal agency requirements. Empirical studies were undertaken to identify the state of the art in medical device development and opinions of physician users. These studies were conducted to identify the practices, opinions and influences for collaborative medical device design. The industry study consisted of a multiple case study research design and was used to elicit the practices of 18 major medical device manufacturers. Industry participants were selected on the basis of meeting specific criteria in location, size, type of device manufactured and use of industrial design. Interviews with practicing physicians were conducted to gain insights.  The responses from the participants were analyzed using NVivo software, card sorting and data visualization to identify routes to more effective engagement in collaboration during medical device design. The findings indicated that there were seven issues ideas priorities for collaborative practice. These included: user integration throughout the development process; the negotiation/ownership of intellectual property; the knowledge of impact to device design; consistent communication between device developers and physician users; timeliness and efficiencies of interactions; the identification/connection of partners; and meeting legal requirements of healthcare laws. These issues were translated into design requirements and six potential tools for cMDD. Using a Pugh matrix, each concept was evaluated against the developed requirements. As a result, the comprehensive computer application concept, which addressed the maximum number of issues, was selected and further developed for the purposes of validation. The navigation and graphic design was completed and a video, which justified the purpose and explained the software, was produced. To evaluate the concept, seven reviewers consisting of both industry representatives and physicians, whom had no previous knowledge of the research project, evaluated the video with positive responses, further potential uses for the software and suggested improvements. This research concludes that within the current regulated process of development there was flexibility in the application of design control during the conceptual phase and that the majority of developers followed a user driven approach to design. Industrial design was responsible for aesthetic design but limited in impact due to a lack of training in clinical science. Physician users are involved however lack knowledge of development process requirements and their impact. Further that there are barriers to collaboration that prevent consistent and valued interactions. Finally, the research resulted in a confirmed app-based tool that would support the promotion of cMDD.