A Critical Design Review (CDR) is an essential formal checkpoint in the product development process. Undertaking CDR’S ensure designs are fit for purpose, ready for production and checked before further financial investment is made.

An organised and robust CDR helps to identify mistakes and highlight risks/concerns as well as highlight where further design improvements could be made. A CDR ultimately saves time and shares responsibility across all stakeholders.

Designer’s Self-Checks (in preparation for a CDR meeting)

  • Thoroughly review your design solution against your Project Brief & Product Design Specification (PDS)
  • List any concerns, issues, concessions or problems – try to be self-critical
  • At this stage in the project, it is likely you’ll have a detailed 3D CAD model. Therefore, you should run in-built CAD system tests, such as; interference detection, hole alignment and draft analysis etc
  • Ensure your project risk log is fully up to date
  • Prepare a component interaction map and ensure all parts are listed, so you can systematically cross-check all interactions and their inter-related features

Once you have covered the above points, the next stage is to request a formal in-house CDR. You should invite the design team, design manager, and all key stakeholders such as manufacturing representatives and the client. Use BS.7000:2 to help you identify who should be in the meeting for your business.

Critical Design Review Meeting

The goal of any CDR meeting is to make sure designs meet the requirements of all stakeholders. Remind those attending the CDR of their responsibility in it too. It’s a shared responsibility and not just the designers to make the project a success!

The project’s lead designer should be prepared to cover the following agenda:

  • Explain the overall purpose of your design and how it meets the Product Design Specification (PDS)

Following the meeting, minutes should be complied and distributed to those involved.

Once approved, the design team can work on the agreed changes. Once the changes are deemed complete, you should organise a ‘back mod’ review meeting with your design management team to ensure changes were understood and have been complete. If so, the Design Manager should then formally approve the designs for prototype manufacture.

By keeping to a formal method of review, you can limit your exposure to unnecessary risk, which could hinder your project in terms of its delivery schedule, development costs and ultimately the return on investment. Hopefully, these guidelines are useful and help you develop your own formal review system. Please get in touch to learn more and discuss how HD can help you.

 

Mark Heynes - Medical Device Design Director at Haughton Design Mark Heynes 5 February 2023

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Get in Touch with Mark Heynes

Design Director

Mark ensures that projects are delivered on time and are suitably resourced to guarantee quality of output. Mark is heavily involved in our design services, having a wealth of experience in healthcare devices, trainer devices, IVD’s, and inhalation. ​

Mark holds a Bachelor’s Degree in Product Design along with 20 years’ experience working on a wide range of design projects. 

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