Planning & Layout

Basics of Design Planning

The purpose of design planning is to identify what needs to be done in your project, who needs to do it, and when it needs to be done. Your design plan should be treated as an ongoing activity that is monitored closely over time as your medical device progresses through the various lifecycle stages.

The most effective way to execute on the plan you put together is to have a clear understanding of the clinical needs your product intends to solve; in other words, the user needs of your medical device. From here you can establish a solid design plan for your medical device.

Many medical device professionals believe “planning” is simply about following a timeline or Gantt Chart, an approach that has become more and more common in design and development planning for medical devices.

The issue that crops up with such an approach is that the Gantt chart is now so commonplace that many companies will ONLY produce a chart, then assume they’ve fulfilled the design planning regulatory requirements. However, this is not the case if you read through the guidelines, there is no mention of needing to produce a timeline or schedule at all.

What are the regulatory expectations for design planning?

The key regulatory requirements of medical device design and development planning can be found in section 7.3.2 of ISO 13485, the international quality management system standard for medical devices, and FDA 21 CFR Part 820.30 (b), the quality system regulation for medical devices.

A design plan must describe how Groups or activities will interface

A project has a lot of resources and you need to define your team. It’s widely accepted that you must define your core team and the different functional areas required (e.g. marketing, engineering). You need to describe how each of these core functions will interact with one another throughout the design and development of your medical device, as outlined in Part 820.30.

The good news is, while the wording in 21 CFR Part 820.30 (b) and ISO 13485 7.3.2 is not exactly the same, the intent behind the two of them is very much in-sync. Everything that one says is more or less defined in the other.