# Lean and Agile at a Product Development Consultancy

- Show: [The Pragmatic Embedded Podcast](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast)
- Published: 2021-06-28
- Length: 33m
- Page: https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-06-28-lean-and-agile-at-a-product-development-consultancy
- Listen: https://agileembeddedpodcast.com/episodes/lean-and-agile-at-a-product-development-consultancy-YAY9ISN8

## Summary

Jose Borquez, CEO of Bold Type, a product development consultancy specializing in connected wireless medical devices, explains how his firm integrates Lean and Agile methodologies into hardware and regulatory-heavy workflows. He details the use of formative usability studies, iterative sprints that include documentation updates, and the strategic advantage of over-the-air firmware updates for post-launch improvements. Borquez also discusses the challenges of managing client bureaucracy and the importance of rapid, transparent communication to maintain trust and speed.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-06-28-lean-and-agile-at-a-product-development-consultancy#t=0) Introduction: Jose Borquez and Bold Type
- [1:45](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-06-28-lean-and-agile-at-a-product-development-consultancy#t=105) Applying Lean and Agile to Medical Devices
- [6:58](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-06-28-lean-and-agile-at-a-product-development-consultancy#t=418) Iterating Design Controls and Requirements
- [9:25](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-06-28-lean-and-agile-at-a-product-development-consultancy#t=565) Hardware Phases vs. Software Iteration
- [13:17](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-06-28-lean-and-agile-at-a-product-development-consultancy#t=797) Managing Client Bureaucracy and Speed
- [18:28](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-06-28-lean-and-agile-at-a-product-development-consultancy#t=1108) Building Trust and Handling Bad News
- [26:39](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-06-28-lean-and-agile-at-a-product-development-consultancy#t=1599) Formative Usability Studies and KOLs

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Embedded firmware](https://hardwarepodcasts.com/topic/embedded-firmware)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)

## Most relevant to

early-stage companies

## Mentioned

- Bold Type (company)
- FDA (other)
- ISO 13485 (other)

## Related episodes from other shows

- [Waterfall vs. Agile: Battle of the Product Development Methodologies](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-28-waterfall-vs-agile-battle-of-the-product-development-methodologies) (Global Medical Device Podcast)
- [16: Democracy Is the Worst Form of Government](https://hardwarepodcasts.com/podcast/embedded-fm/2013-08-28-16-democracy-is-the-worst-form-of-government) (Embedded.fm)
- [#335: Accelerating SaMD Development in a Compliant Agile way](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-09-08-335-accelerating-samd-development-in-a-compliant-agile-way) (Global Medical Device Podcast)
- [#066 - How to apply lean startup principles to hardware, with Ash Maurya of Leanstack, USA](https://hardwarepodcasts.com/podcast/the-hardware-entrepreneur/2019-01-16-066-how-to-apply-lean-startup-principles-to-hardware-with-ash-maurya-of-leanstac) (The Hardware Entrepreneur)
- [5 Actionable Lessons Learned from the RADx Initiative by NIH](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-27-5-actionable-lessons-learned-from-the-radx-initiative-by-nih) (Global Medical Device Podcast)

## Citing this page

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