Refining product concepts for design and development
Research and Feasibility studies focus on developing the draft intended purpose statement to define the medical device’s user needs and design specifications. If several versions of the intended purpose were developed during ideation and conception, this phase would narrow the options for innovators to consider in Design and Development.
The research stage involves deep investigation to define the potential product’s intended purpose, features and functionality. Early-stage research activities involve desk research, bench studies and prototyping.
Research and Feasibility involve deep research to define the potential product’s intended purpose, features, and functionality. By the end of the phase, innovators should have sufficient technical, clinical, market, IP, regulatory, and economic information to determine the feasibility of the intended purpose statements generated during the conception phase.
The outputs of the Research and Feasibility phase are:
- Determination of the feasibility of the product from a technical, clinical and financial perspective.
- User requirements for Design and Development.
- Design Inputs (or specifications) outlining the device’s technical and functional requirements, including performance criteria, dimensions, materials, and safety features.
After feasibility studies, a review should be performed to decide whether the medical device concept should proceed to Design and Development. At this point, the product concept enters a formal process, and Design Controls, including documented Design & Development Planning, apply. If several product concepts show merit, it is helpful to prioritise based on company resources and create a technology roadmap for future development projects.