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„It works!“ – and why that is not sufficient.
Reading duration: 2 Minuten
Summary
Many start-ups in the MedTech sector find themselves facing unexpected regulatory, structural, and economic hurdles after building a successful prototype.
This article explains how a simple “It’s working!” becomes an approved medical device – and how teams can bridge the gap to reality through QMS, project structure, and cultural transformation.
This article explains how a simple “It’s working!” becomes an approved medical device – and how teams can bridge the gap to reality through QMS, project structure, and cultural transformation.
From Prototype to Product: Facing Reality in MedTech Development
Many medical device teams experience the same shock: the prototype works, everyone is motivated – and then the project crashes into the reality of regulatory requirements, economic feasibility, and structured product development.
In my new article, I explain why this isn’t failure – but the beginning of a crucial cultural shift:
- From tinkering to true development.
- From prototype to product reality.
- From research mindset to responsibility.
What it takes for teams to navigate this transformation – and why a functioning QMS is an enabler for real progress.
![[Bild Christoph Taegert-Kilger]](https://www.ctk-medical.com/wp-content/uploads/2025/02/portrait_ctk_600px-1.png)
Author of article
Christoph Taegert-Kilger
As an experienced project manager, system/software architect and quality manager, I support startups and established companies with best practices of system and software engineering, from idea and prototype to approved medical device.