Understanding clinical needs and the clinical use case during early medical device innovation using early health technology assessment

Medical device innovation (MDI) processes, such as needs determination and developing the clinical use case (CUC), are highly complex. Inadequately defined CUCs are responsible for several of the most significant challenges that medical technology innovators face. Despite this, there are few resources that provide guidance to innovators during these early stages of MDI. Using the action research methodology, this thesis proposes a guide and MDI framework for helping innovators determine unmet needs and develop the CUC. These resources were applied to three real-world case studies. The resulting insights were shown to improve each ventures' strategies, translating to improved venture outcomes.