We’ve looked at the process that Ctrl group uses to plan a project; how we make sure that we’ve the necessary information, systems and processes to keep the project on track throughout development and delivery.

Key principles:

• Design should be part of the product development process from the start.
• At its core, design is a process of making design proposals and receiving feedback.
• A good design process is iterative.
• In software-as-medical-device projects, there may be no distinction between the process of designing something and producing it.
• An iterative design approach fits well with an agile approach to product delivery
• The design process should aim to answer a different question at each phase of the product development process: discovery, alpha, beta, live.
• Design controls are a regulatory requirement for documentation but should not dictate the process you follow.
• The different components of design controls should not be thought of as steps in a waterfall process but streams of parallel activity.
• New medical devices should aim to support personalised medicine. The design principles of “inclusive, engaging and adaptive” can provide a roadmap for achieving this.

We recommend taking the short multiple choice quizzes on the next pages to check that you’ve grasped the basic principles.

There are also three tasks associated with this module, these can be done individually or as a group.

In our next module we’ll be focusing on verification and validation in the design process, and factors to consider such as good clinical practice and adverse events and incidents.