Concept generation aims to translate a clinical idea into a device concept. We may conduct background research to define the clinical problem and engage in brainstorming exercises to generate concepts. We will gather as much information as possible through this work and generate a guidance document that summarizes the concept and identifies its key features. 

Once we have completed the work to generate sufficient device concepts, they are typically described in a memo with sufficient detail to serve as an invention disclosure. Intellectual Property may be captured as an invention disclosure or patent application. A freedom-to-operate analysis is sometimes performed to help determine limits on concepts. The concepts will be ranked and then down-selected with client input. 

Once we have completed concept generation and evaluation, we will create a detailed project plan and estimates for further work. We will leverage our experience to create a customized plan defining clear and relevant milestones for each client’s project. The plan will outline further development work on the device and provide a roadmap for commercialization.