details about design transfer

  • 6 January 2023
  • 1 reply
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H

Hi everyone,

I am Himang having 6 years of experience in the medical device industry with 3+ years of experience in medical device development and manufacturing environment. 

I have worked as Quality engineer in one company while as R&D Engineer in another but was not able to connect the dots between the two experience. I mean, how Design transfer occurs? What needs to be considered while transferring the prototype designed in the R&D into a commercial product ready for production? What are the documentation do we consider, and prepare to have a successful design transfer?

The post is open for discussion, and their personal experience are highly appreciated.

 

Thank you

1 reply

Etienne
Userlevel 5
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Hey @him0609 ! 

It’s a good question, and one that engineers should ask because understanding the full product lifecycle will make you a better engineer in the long run, and could also open up doors of opportunity for leadership within your company. 

The first things that come to mind is to understand the organizational differences…

R&D is typically interested in developing a prototype to prove the feasibility of the technology. Different people would argue that Design Controls doesn’t necessarily start in R&D, but at the very least, you should have a pretty good understanding of the problem you’re trying to solve. And if you understand the problem that you’re trying to solve, then you should have a pretty good grasp of the User Needs. 

Which gets us into Product Development (PD), which is the department that typically takes the tech that R&D has come up with, and begins the Design Controls & Risk Management activities and documentation, as well as the design for manufacturability (DFM). Just like there is an overlap of PD with R&D at the end of the R&D phase, there should be an overlap of PD & Manufacturing during the progression through the Design Controls development process.

As PD develops the medical device, they should have a cross-functional team of Manufacturing Engineers to ensure the manufacturing processes are as efficient as possible (or that the manufacturing is just possible in general), and Regulatory Affairs to ensure the Design Verification & Design Validation activities are adequate for whatever regulatory agencies the device will be submitted to. 

So, that may be more generic than you were looking for, but that is a high level overview of the hand off.. The Design Transfer is just like it sounds - the transfer of a completed design of a medical device to the manufacturing group which takes over ownership of the production process (while bringing in PD from time to time to evaluate potential changes to achieve faster manufacturing throughput, or updates to the design due to post market surveillance and feedback from the field).

Let me know if you have any specific follow-up questions! Also, if anyone else has additional thoughts, I’d love to hear what I might be missing!

All the best,
Etienne Nichols

Stay hungry. Stay foolish.

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