Fundamental to the effective development of a new medical device is having a clear definition of the clinical need it must meet. The clinical need may be related to improving patient outcomes, or reducing procedure times or costs. Once that need has been established, it’s the responsibility of the medical device development team to generate a product concept that will deliver the intended benefits. This is the objective of the first phase of the medical device development process: The Concept or Feasibility phase.

After the clinical need is identified, the team translates it into user requirements, which define the device requirements from the perspective of the people who will use it, which could be physicians, nurses, patients, or others, depending on the device. The user requirements enable the team to then define specifications, which are measurable attributes related to the device’s performance. For example, how much load must the device apply? To what angle must the distal end of the device articulate? What is the maximum temperature the device should reach? These specifications are critical in subsequent development phases, particularly the Design and Development and Verification and Validation phases, because they serve as the foundation for the testing that will be defined and performed to establish that the device design (or Design Outputs) satisfies the specifications (or Design Inputs).

Teams employ a variety of ideation methodologies to generate design concepts, but brainstorming is common. Brainstorming is a well-established process used by a group of people to generate a large volume of ideas. For it to be most effective, preparation is an important factor, as is skilled facilitation of the group during brainstorming sessions. It’s also helpful to include participants with a range of experience levels and expertise to obtain a breadth and depth of design concepts.

Once the team generates a number of design ideas, they evaluate and down-select them, often using a rating and ranking matrix: Design ideas are evaluated for criteria, for example, development challenge, clinical utility, or product cost. The matrix then ranks the ideas to indicate which show the most promise, and the team selects one or more design ideas for prototyping.

Prototyping is the next step in the Concept or Feasibility phase. The team transforms the chosen design concepts into the prototype designs they will build for initial evaluation. The focus at this stage is on rapid iteration — designing components that can be fabricated via rapid prototyping processes, like 3D printing, and then evaluating the prototypes on the bench and/or in an animal. Teams may also use these prototypes to obtain clinician feedback on the device’s form and/or function.

Based on the evaluation results and clinician input, the team may revise the device design and build a new prototype for evaluation. They will repeat this iterative design-build-evaluate process until a prototype demonstrates that its design can satisfy the defined clinical need. At this point, a design architecture has been established, and the team can move to the next phase in the medical device development process: Design and Development. There is still a lot more work to be done before the design can be “frozen.” We’ll share more about that work in our next article. So, stay tuned!

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