# Design Assurance: The Unsung Heroes of R&D

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-10-13
- Length: 48m
- Episode: 284
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-13-design-assurance-the-unsung-heroes-of-r-d
- Listen: https://podcast.greenlight.guru/episode/design-assurance-the-unsung-heroes-of-rd

## Summary

Orla Connaughton, founder of Aztek Medical, explains that Design Assurance (DA) is the quality engineering function of the R&D process, ensuring products meet regulatory requirements through controlled documentation rather than just technical prototypes. She argues that DA professionals must bridge engineering and regulatory needs, managing 'horizontal' standards like ISO 14971 risk management and 'vertical' device-specific standards to create a cohesive story for regulators. Connaughton highlights a current shortage of DA talent, noting that under the EU MDR, companies face hundreds of documentation-related questions per submission, often requiring expensive remediation because initial development lacked proper design controls. She emphasizes that DA 'packs the parachute' for product development, protecting companies from post-market failures and ensuring efficient clearance times.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-13-design-assurance-the-unsung-heroes-of-r-d#t=0) Introduction: Orla Connaughton and Aztek Medical
- [2:54](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-13-design-assurance-the-unsung-heroes-of-r-d#t=174) Defining Design Assurance and the Working Prototype Trap
- [6:56](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-13-design-assurance-the-unsung-heroes-of-r-d#t=416) When to Implement Design Controls and Traceability
- [12:40](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-13-design-assurance-the-unsung-heroes-of-r-d#t=760) Horizontal vs. Vertical Standards and the Lion King Analogy
- [19:26](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-13-design-assurance-the-unsung-heroes-of-r-d#t=1166) Qualifications, Creativity, and the Mindset of a DA Professional
- [26:05](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-13-design-assurance-the-unsung-heroes-of-r-d#t=1565) Design Assurance as the Quality Engineer of R&D
- [31:26](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-13-design-assurance-the-unsung-heroes-of-r-d#t=1886) The Parachute Story and Post-Market Protection
- [36:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-13-design-assurance-the-unsung-heroes-of-r-d#t=2160) EU MDR Review Times, Documentation Gaps, and Talent Shortage

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- Aztek Medical (company)
- Green Light Guru (company)
- ISO 14971 (other)
- ISO 14155 (other)
- ISO 10993 (other)
- ISO 11607 (other)
- ISO 13485 (other)
- 21 CFR 820 (other)
- EU MDR (other)

## Related episodes from other shows

- [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)
- [031 - "The Five Stages Of Regulatory Grief" with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott) (Let's Combinate)
- [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)
- [How Design-First Thinking Supercharges Manufacturing Performance with Clarity Design Founder Tom Lupfer](https://hardwarepodcasts.com/podcast/ems-c-level/2026-03-11-how-design-first-thinking-supercharges-manufacturing-performance-with-clarity-de) (EMS@C-LEVEL)
- [217 - 5 Fixable Problems Holding Back Drug–Device Programs](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-10-217-5-fixable-problems-holding-back-drug-device-programs) (Let's Combinate)

## 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/2022-10-13-design-assurance-the-unsung-heroes-of-r-d. 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.