title: Value driven innovation in medical device design: a process for balancing stakeholder voices.
abstract: The innovation process has often been represented as a linear process which funnels customer needs through various business and process filters. This method may be appropriate for some consumer products, but in the medical device industry there are some inherent limitations to the traditional innovation funnel approach. In the medical device industry, there are a number of stakeholders who need to have their voices heard throughout the innovation process. Each stakeholder has diverse and unique needs relating to the medical device, the needs of one may highly affect the needs of another, and the relationships between stakeholders may be tenuous. This paper describes the application of a spiral innovation process to the development of a medical device which considers three distinct stakeholder voices: the Voice of the Customer, the Voice of the Business and the Voice of the Technology. The process is presented as a case study focusing on the front-end redesign of a class III medical device for an orthopedics company. Starting from project initiation and scope alignment, the process describes four phases, Discover, Envision, Create, and Refine, and concludes with value assessment of the final design features.
authors.affiliation: Bioventus LLC, 4721 Emperor Blvd, Suite 100, Durham, NC 27703, USA. javier.deana@bioventusglobal.com
authors.forename: F J
authors.initials: FJ
authors.lastname: de Ana
authors.forename: K A
authors.initials: KA
authors.lastname: Umstead
authors.forename: G J
authors.initials: GJ
authors.lastname: Phillips
authors.forename: C P
authors.initials: CP
authors.lastname: Conner
mesh_terms: D001698:Biomedical Engineering / Q000379:methods / Q000458:organization & administration / Q000639:trends; D004867:Equipment Design / Q000379:methods / Q000639:trends; D006801:Humans