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 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 S2190 MARYBETH PRIVITERA 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.

Systematic methods for descriptive analysis of physician hand movements during surgical or catheter based interventions have not been previously reported. Although such data would provide critical guidance in the design of surgical instruments, there is currently little to no information about the chronological and spatial integration of operator movements and user conditions during catheter based interventions. The essential function of the hand is to provide physical coupling between the cognitive process and the environment, translating intention to action. The ideal surgical instrument is a contiguous extension of the haptic unit (the hand) that enables an expanded range of effector actions and environmental effects. In reality, however, there is an interface between the hand and the surgical instrument creating a barrier that can introduce variable levels of interference and impedance between the cognitive process and the intended task. The objective of this project is to analyze surgical effector outputs as a function of operator psychomotor inputs using synchronized multimodal image data recorded during clinical cases of transcatheter neurological intervention. Research methodology consisted of observations and digital recording (video and/or still photography) of 24 diagnostic cerebral angiograms. These were analyzed to synchronously document physician hand movement, surgical effector output (as represented by the fluoroscopic image monitor), spatial orientation feedback (as represented by rotational movements of the fluoroscopic imaging plane with respect to patient anatomical axes), and to identify user specific conditions. The results are presented in a defined procedure map and user behaviors based upon physician experience (e.g., fellow/trainee versus attending physician). As stated in the Association for the Advancement of Medical Instrumentation HE 75 human factors standards for medical device design, there is a clear need to develop human factors standards for endovascular devices. This research will serve as a guide to this effort. The models and multimodal image database generated by this project will also be used in the development of interactive educational tools to train physicians to perform these advanced applications.