Two More Lessons On Requirements

On the path to helping our clients achieve success with their medical device developments, here are two more lessons we have learned about requirements.

Lesson 3: Focus on what-not-how

Perhaps the biggest potential mistake in the design process is to focus prematurely on the "how" characteristics in the requirements document. The attention early on should be on what the product does, achieves or could be. Don't focus on how it will achieve it. The requirements should focus on the what-not-how of the product.

One way to support success in this area is to make sure requirements and specifications are "independent" measures and not dependent measures. For example, in a potential medical device, actuation rate would be an independent variable that would depend on the design of the mechanism and power source that powers the actuation. These how's should not control what your medical device could achieve.

Lesson 4: Release and track changes

Requirements change. The goal is to make sure that changes are clearly communicated to the design team in order to facilitate success. We quickly complete a requirements document and release it. Any changes that occur go through an approval process, and the act of changing and disseminating the revised requirements document is an effective communication tool. We make it easy for clients to design, communicate and reach their ultimate goals.

At PADT Medical we work closely with clients to help in every aspect of getting their idea to market, including developing medical device requirements that enable success.