ABSTRACT The medical device industry creates life changing innovation and advances the practice of medicine, the health of consumers and provides employment. (AdvaMed 2014) The device industry, along with the medical practice is highly collaborative and heavily regulated. As such, designers need to know as much about the individual (patient) end use as they do about all end-users(Ogrodnik 2013) In the context of a complex and challenging product development environment, this paper reports on a study to address the following research questions: what are the theoretical approaches to design in the medical device industry; what are the defining aspects of the relationship between device development teams and their respective users; and what is the role of industrial design in this process? The methodology employed a literature review of current device development processes, including the significance and definition of a medical device; the history of medical device development; governmental and regulatory influences; and collaborative design processes. Findings indicate that by suggesting contextual inquiry and formal usability assessments, regulating agencies have only encouraged user involvement but not provided a framework within their mandated process beyond testing after the device design is finalized. In essence, users are passive participants, typically tapped as a resource to meet agency requirements. Additionally, there is a lack of commensurate work on the practicalities of user engagement, such as gaining access. Practices exist promoting user involvement in consumer product design that may be applicable to medical devices. Lastly, the role of industrial design is not recorded, yet it is evident the methods are utilised. Further, in instances where team disciplines or members are defined, such as the study by Martin, Clark et al (2012) whereby team members included: engineering, nursing, medical physics, and clinical physiology, design and/or industrial design is missing. (Martin et al. 2012) Keywords: Medical Device Design, Co-design, Participatory Design, Industrial Design, Regulatory Influences INTRODUCTION 1 The purpose of this paper is to provide an overview of collaborative medical device design processes with an emphasis on the role of users and industrial design. Through literature the following areas are explored: the significance and definition of medical device, the medical device development (MDD) process, governmental and regulatory influences, collaborative design processes, the role of industrial design, and the role of users. COLLABORATIVE DESIGN PROCESSES IN MEDICAL DEVICE DEVELOPMENT Mary Beth Privitera, MDes University of Cincinnati privitmb@uc.edu Darren Southee, PhD Loughborough University D.J.Southee@lboro.ac.uk Mark Evans, PhD Loughborough University M.A.Evans@lboro.ac.uk