"Do not do ego-design." A professor told Bart Verleije that in school, and it shaped how he has built medical devices ever since.

Bart is Commercial Director at Voxdale, a Belgian design and engineering firm, with more than 1,400 projects over 19 years. He explains how a napkin sketch becomes a certified, manufacturable device, and where most MedTech projects go wrong before they reach a patient.

In this episode:

- His BURST framework: Business, User, Regulatory, Sustainability, Technology

- Why design for manufacturability has to start on day one

- How to stop feature creep and trade off conflicting requirements

- The Ergotrics story: an inflatable system for turning and proning patients

If you develop devices, this one will change how you scope your next project.

Connect with Bart: https://www.linkedin.com/in/bartverleije/

Voxdale: https://www.voxdale.be

00:00 From a napkin sketch to a certified device

00:56 Meet Bart Verleije: 1,400+ projects, 19 years at Voxdale

01:45 Commit to your product before you build it

05:05 "Do not do ego-design"

06:42 Why every stakeholder needs at least a neutral stance

09:56 The BURST framework: Business, User, Regulatory, Sustainability, Technology

15:46 Design for manufacturability from day one

20:30 The operational cost teams overlook

23:20 A healthy take on AI in documentation

28:29 Database-first documentation and regulation as code

30:13 The conservation of misery: trading off requirements

34:04 Only five value drivers make the board

37:28 "How do you know this?" Breaking false requirements

40:11 Over-requirement is the biggest cost driver

41:33 From a highway traffic jam to proning patients

45:10 The toothpaste factory and the 20-dollar fan

48:17 Bart's advice: commit, talk to experts, stay in your lane

55:28 Closing

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