# Dakota Welker | User Needs, Design Inputs, Verification & Validation

- Show: [Being an Engineer](https://hardwarepodcasts.com/podcast/being-an-engineer)
- Published: 2026-09-25
- Length: 43m
- Episode: 40
- Page: https://hardwarepodcasts.com/podcast/being-an-engineer/2026-09-25-dakota-welker-user-needs-design-inputs-verification-validation

## Summary

Dakota Welker, founder of Think MedTek, explains his four-phase product development methodology for medical device startups, emphasizing user needs, design inputs, verification, and validation. He details how he rescues stalled projects by clarifying scope and documentation, and describes a specific case where bringing manufacturing in-house and negotiating with multiple vendors reduced costs by 50%. Welker also discusses his transition from automotive and pneumatics to medical devices, his focus on CFD tools like Simscale, and the importance of balancing engineering rigor with client communication.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-09-25-dakota-welker-user-needs-design-inputs-verification-validation#t=0) Introduction: Dakota Welker and Think MedTek
- [1:33](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-09-25-dakota-welker-user-needs-design-inputs-verification-validation#t=93) Welker's Background: Physics, Entrepreneurship, and Career Path
- [7:59](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-09-25-dakota-welker-user-needs-design-inputs-verification-validation#t=479) The Four-Phase Development Process: Documentation to Prototype
- [14:14](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-09-25-dakota-welker-user-needs-design-inputs-verification-validation#t=854) The Value of Documentation and Managing Client Expectations
- [19:45](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-09-25-dakota-welker-user-needs-design-inputs-verification-validation#t=1185) Case Study: 50% Cost Reduction via In-House Manufacturing
- [21:53](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-09-25-dakota-welker-user-needs-design-inputs-verification-validation#t=1313) Verification vs. Validation in Medical Device Development
- [25:52](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-09-25-dakota-welker-user-needs-design-inputs-verification-validation#t=1552) Rescuing Stalled Projects and Scope Misunderstandings
- [34:13](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-09-25-dakota-welker-user-needs-design-inputs-verification-validation#t=2053) Daily Routine, Work-Life Balance, and Future Goals

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)
- [Pricing, margins & unit economics](https://hardwarepodcasts.com/topic/pricing-and-unit-economics)

## Most relevant to

founders before launch

## Mentioned

- Think MedTek (company)
- Purdue University (other)
- Lean Startup (other)
- Upwork (other)
- FDA (other)
- SimScale (tool)
- Ansys (tool)

## Related episodes from other shows

- [#392: Verification and Validation in MedTech: A Practical Guide with Devon Campbell](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-11-22-392-verification-and-validation-in-medtech-a-practical-guide-with-devon-campbell) (Global Medical Device Podcast)
- [#470: The Real Cost of MedTech Innovation: From Idea to Pre-Production with Lisa Voronkova](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-09-22-470-the-real-cost-of-medtech-innovation-from-idea-to-pre-production-with-lisa-vo) (Global Medical Device Podcast)
- [#471: From AI Visuals to FDA Approval: Fixing MedTech’s Design-to-Market Gap](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-09-21-471-from-ai-visuals-to-fda-approval-fixing-medtechs-design-to-market-gap) (Global Medical Device Podcast)
- [Best Practices for Clinical Evidence Management](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-22-best-practices-for-clinical-evidence-management) (Global Medical Device Podcast)
- [#461: Why Manufacturing is Part of Product Development with Mike Dolphin](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-06-22-461-why-manufacturing-is-part-of-product-development-with-mike-dolphin) (Global Medical Device Podcast)

## Citing this page

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