Part 9: When to Invoke Design Controls in a Medical Device Project
Many medical device executives bemoan the burdens of Design Controls, claiming that they stifle creativity and drive up costs. That may be so, but we’re stuck with them. Given their unavoidability, we’re left to find ways to make these controls less burdensome and perform whatever work than can be done outside their strictures “off the books.”
The first part of this is making your QMS agile and easy to use so that compliance with design controls carries as little cost as possible. This means a less prescriptive approach, elimination of low-value process requirements like restrictive formats, and efficient approval routing. This style provides less hand-holding and can be problematic with inexperienced workers, but can be safely used by the experienced development professionals at DeviceLab.
The second part is embodied in what we call the Research Phase. At DeviceLab, we use the research phase to answer known questions and discover unknown unknowns prior to establishing the proof-of-concept design. Documentation is limited to research notebooks, which are not released to document control. In this mode, we’re free to change paths instantly, try multiple alternatives, and pursue ideas.
The research phase ends when a conceptual design has been formulated. A formal design plan is created, and the design requirements are accumulated. Information can flow from the Research phase into Proof-of-Concept (like design choices), but if there is an important research test result underpinning the design, you may want to go back and repeat it under controlled and documented conditions.
So, in our experience, most projects benefit from a little time in the unsupervised sandbox before moving to the pool with its long list of rules. When playtime’s over, we invoke Design Controls built for rapid evolution. In this way, we keep the burdens of Design Controls from vexing our clients.
That’s the last post in this series about the process of medical device design at DeviceLab. If you haven’t read the previous ones, please check them out!
DeviceLab, Inc. is a design firm specializing in medical devices. Operating for over 20 years in Irvine, Ca, DeviceLab provides design and engineering services to clients ranging from startups to Fortune 500 companies. Check out our website, www.devicelab.com to learn more about us.