Medical Device Development: How We Work

Our medical device development process is thorough and effective, and allows us to deliver consistent results. But innovation can’t be found in formula. So although we are guided by the process, it’s methods allow us the freedom to follow intuition, inspiration and to find the magic where it hides.

And although our process is consistent, we recognize that each medical device development project is unique, with its own set of challenges. So we tailor each engagement to the needs of each client.

Mapping the problem

Using a variety of techniques, we gather input from your team and develop a comprehensive view of the design problem for which we’ve been engaged to help you solve. The result of this activity is a clear understanding of the project goals and the specific circumstances (regulatory, competitive, etc.) within which your company operates. The team gains a broad knowledge of the project terrain and can begin to chart a course toward success.

Background research

Work here depends on the scope of the project. Background research could include any or all of the following: on-line competitive research; development of “mood boards”; review of applicable patents; study of competing products; etc.

User research, anthropometric and ergonomic studies might also take place in this stage, but most often would occur after concepts have been generated and the project direction is more defined.

Concept ideation

We explore a universe of product forms, manufacturing methods, mechanism concepts, component architectures and anything else that pertains to the project. The typical deliverable from this stage is a comprehensive book of sketches that communicate our ideas. Using the sketch book, the team can discuss pros and cons of each approach and begin to narrow in on an ultimate design.

If appropriate, we will also develop rudimentary sketch models so we can explore ideas immediately in three dimensions.

Iteration

Typically, several concepts are chosen to be pushed forward. We will develop those concepts in more detail, usually employing a variety of methods (hand sketching, quick modeling and part development in CAD).