Tailoring Medical Device Product Development

My medical device company has a single process for product development and design controls, regardless of the countries of launch, device classification, or risk.

Question:

How can the product development process be customized for each project without compromising design control?

Answer:

First, it is important that an organization have a single process for all its medical device products. This enables the company to standardize expectations across the organization, plus it is much easier to maintain.

Second, the process can be tailored to the particulars of the device and project. The best place to capture the specifics for the project is in the Design & Development Plan (DDP). Two major approaches can be used to capture the specifics.

• Additive approach: A minimum set of requirements is specified for all projects. Additional requirements are added based on countries of launch, device classification, or risk.
• Subtractive approach: All requirements are specified. Individual requirements are removed from the list based on countries of launch, device classification, or risk.

Using a decision tree is a useful way to help the project team ascertain and document which activities will be included in the project. As with all projects, if the assumptions change during the project, the decisions need to be revisited and updated as appropriate.

DDPs take many different forms, from prose to checklists to the project schedule to decision trees. Use the approach that makes the most sense for the organization.

Third, regardless of the approach taken for tailoring, the process must be reflected in the company’s procedures related to design controls.

Bottom line, these three elements will assist your organization in customizing its product development process based on countries of launch, device classification, and risk.