Building Your Design Controls (and Pitfalls to Avoid)

March 29, 2023


What do engineers need to understand about manufacturing? How can you apply that knowledge to design controls? On today’s episode, our guest Tom Rish covers the topic of Design Controls. Tom is the Director of Guru Services at Greenlight Guru and a Product Development Engineer in Orthopedics.

Listen as we talk about the differences between user needs and design inputs and the pitfalls companies get into when building design controls. Tom also shares what he thinks people should understand about cross-functionality, why it sometimes makes sense to start from scratch, and using the design control process strategically.

Listen now:

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Some of the highlights of this episode include:

  • Thinking in terms of manufacturing

  • Things everyone ought to know about working cross-functionally

  • Why starting from scratch may be better

  • Who needs to be looking at design controls and when they should be looking

  • The difference between a design review and a stage review

  • What Tom got to see that helped him understand how things worked

  • What to look for on the manufacturing floor

  • Using the design control process strategically


Tom Rish LinkedIn

Etienne Nichols LinkedIn

MedTech Excellence Community

Greenlight Guru Academy

Greenlight Guru

Memorable quotes from Tom Rish:

“If you can get a tool in a certain spot you can do it, but if you can’t, you can’t.”

“We like to say at Greenlight Guru: the outputs are the recipe.”

“I think that a lot of times people use design reviews and stage reviews interchangeably.”

“I can’t even put into words how valuable it was to go down to the manufacturing floor as an engineer.”

About the Global Medical Device Podcast:


The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or Spotify.

Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...

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