# Building Your Design Controls (and Pitfalls to Avoid)

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-03-29
- Length: 35m
- Episode: 312
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-29-building-your-design-controls-and-pitfalls-to-avoid
- Listen: https://podcast.greenlight.guru/episode/building-your-design-controls-and-pitfalls-to-avoid

## Summary

Tom Rish, Director of Guru Services at Greenlight Guru, explains how to build effective design controls for medical devices by distinguishing between vague user needs and measurable design inputs. He argues that engineers should start from a clean slate rather than copy-pasting from previous Design History Files, as this prevents the solidification of tribal knowledge and leads to better designs. Rish emphasizes involving manufacturing, regulatory, and clinical teams early in the process to ensure the final product solves the actual clinical problem rather than just meeting arbitrary specifications.

## Chapters

- [2:10](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-29-building-your-design-controls-and-pitfalls-to-avoid#t=130) Introduction: Tom Rish and Greenlight Guru
- [2:51](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-29-building-your-design-controls-and-pitfalls-to-avoid#t=171) Tom Rish's Background in Orthopedics and Manufacturing
- [7:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-29-building-your-design-controls-and-pitfalls-to-avoid#t=451) Defining User Needs vs. Design Inputs and Outputs
- [11:56](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-29-building-your-design-controls-and-pitfalls-to-avoid#t=716) The Pitfall of Copy-Pasting Design History Files
- [15:16](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-29-building-your-design-controls-and-pitfalls-to-avoid#t=916) Common Challenges: Vague Inputs and Siloed Testing
- [18:03](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-29-building-your-design-controls-and-pitfalls-to-avoid#t=1083) Agile Methodology and Frequent Design Reviews
- [23:33](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-29-building-your-design-controls-and-pitfalls-to-avoid#t=1413) Learning from Surgeons and Manufacturing Floors
- [32:05](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-29-building-your-design-controls-and-pitfalls-to-avoid#t=1925) Using Design Controls Strategically as an Engineering Tool

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- Tom Rish (other)
- Etienne Nichols (other)
- ISO 13485 (other)
- FDA 21 CFR Part 820 (other)
- SolidWorks (tool)

## Related episodes from other shows

- [157 - Design Inputs that Don't Suck, Risk Control Measures and Problems with Verification with Chuck Ventura](https://hardwarepodcasts.com/podcast/lets-combinate/2024-10-09-157-design-inputs-that-dont-suck-risk-control-measures-and-problems-with-verific) (Let's Combinate)
- [S1E17 Precise Speech, Customer Success, & General Engineering Love | Jesseca Lyons](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-26-s1e17-precise-speech-customer-success-general-engineering-love-jesseca-lyons) (Being an Engineer)
- [176 - The Fastest Way to Ruin Drug/Device Development (And How to Avoid It!) with Eric Sugalski](https://hardwarepodcasts.com/podcast/lets-combinate/2025-02-19-176-the-fastest-way-to-ruin-drug-device-development-and-how-to-avoid-it-with-eri) (Let's Combinate)
- [A Look Inside Medical Device Manufacturing with Philips’ Natalia Mendez](https://hardwarepodcasts.com/podcast/manufacturing-happy-hour/2022-09-27-a-look-inside-medical-device-manufacturing-with-philips-natalia-mendez) (Manufacturing Happy Hour)
- [Dakota Welker | User Needs, Design Inputs, Verification & Validation](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-09-25-dakota-welker-user-needs-design-inputs-verification-validation) (Being an Engineer)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-29-building-your-design-controls-and-pitfalls-to-avoid. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.