Designing Industrial Design in the Highly Regulated Medical Device Development Process. Defining our valuable contribution towards usability

Abstract

The role of industrial design in medical device development is scantily described in literature. Yet, based on design practice in industry and as evident by design competitions, clearly industrial design is active in the practice of developing medical devices. Only one article provides a description of industrial design activities and contribution to the practice of medical device design and includes the following areas: aesthetic design, form giving, human factors application and testing, along with contextual inquiry/ethnography methods (Petrie & Copeland, 2011). Further, in instances where team disciplines or members are defined, such as the study by Martin, Clark et al whereby team members included: engineering, nursing, medical physics, and clinical physiology, design or industrial design is missing (Martin, Clark et al. 2012, Grocott, Weir et al. 2007). This paper aims at describing the role of industrial designers within the agency mandated processes using a multiple case study methodology to identify contemporary approaches in device development. Case study methodology is commonly used to assess user engagement as well as design and development practices (Elf, Putilova, Koch, Öhrn, et al., 2007; Patricia Grocott, Weir, & Ram, 2007; Medina, Kremer, & Wysk, 2012; Taylor, Furniss, & Blandford, 2007; Yin, 2013). A total of 18 cases were developed with participants from both the EU and US. For this study industry participants were selected by type: medical device manufacturer (large/medium/small) and design firms that have primary focus in designing for medical device development. Participants include the major manufacturers of laparoscopic surgical devices, orthopaedic implants, assistive surgical technologies, endovascular devices, neurovascular devices, critical care devices, cardiac assistive technologies, neurologic diagnostic devices, and general hospital equipment. Results indicate ID leadership was found within large and small organization but are challenged on implant focused device companies; the influence of ID included the application of human factors principles, aesthetic form and branding; ID influence was limited by the lack of clinical training in regards to science and medicine; and the value of industrial design was not well incorporated within agency promoted design control processes. This paper defines ID practice in medical device development and concludes with a proposed graphic of the regulatory mandated design process highlighting ID involvement.