The heart of medical device innovation
The design and development (D&D) phase, a pivotal and multi-layered process, is at the heart of the medical device innovation lifecycle. It typically consumes over half of the development timeline and resources, underscoring its crucial role.
The early ideation, conception and research phases lay the foundation for the subsequent D&D process. One or more product concepts are researched to gather evidence supporting their technical, clinical, market and financial feasibility. Early-stage research is characterised by creativity and a degree of freedom in designing and implementing research processes.
The design and development (D&D) phase marks a significant transition to processes subject to regulatory oversight. It is a formal, documented process. Quality Management System (QMS) standards, such as those specified in ISO 13485:2016, require process documentation for D&D activities. US Food and Drug Administration (FDA) regulations require a formal, documented design control process. Design controls begin with D&D planning and are characterised by period design reviews, occurring at strategic time points in development.
The medical device proceeds through a series of design controls, starting with user requirements and ending with design transfer (to manufacturing). D&D is the phase where the user requirements and design inputs drafted in the research and feasibility phase are finalised and formalised. Investing resources in the early-stage research phases helps ensure a smooth transition into the D&D phase. However, multiple iterations may still be necessary to optimise the design. Once the design inputs have been finalised, a design freeze is implemented, after which no further design changes should occur (at least, in theory). From this point, the development process shifts to generating design outputs, which are tested through verification and validation.
Concurrently, the D&D phase translates the medical device design into a manufacturable product (design transfer). This includes selecting appropriate materials, developing manufacturing processes, and establishing quality control measures. Once a device successfully navigates the regulatory approval process, it enters the manufacturing and commercialisation phase.