---
title: The Detectivio Journey, from Idea to MedTech Product
description: This is a story about how the Medtech company Detectivio successfully navigated through the field of medical device development to go from idea to their first clinical investigation.
---

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# [The Detectivio Journey, from Idea to MedTech Product](https://www.aurevia.com/news/the-detectivio-journey-from-idea-to-medtech-product)

 Written by [Aurevia](https://www.aurevia.com/news/author/aurevia) | 19 Jan 2021

The beginning of a journey – The winding road from idea to product for a high-tech medical device company! This is a story about how the Medtech company Detectivio successfully navigated through the field of medical device development to go from idea to their first clinical investigation.

**Stefan Malmberg, MD and VD at Detectivio**

**During my 12 years of clinical experience,** ranging from emergency departments to rural primary care, doctors like me have been looking for better ways of rapidly assessing the severity of diseases. I kept searching, but to my surprise, I didn’t find any relevant solutions.

Focusing on this challenge, I co-founded a Medtech company that we decided to call **Detectivio.**

At Detectivio, we are creating a device that will help nurses and doctors save lives by doing automatic contactless triage – **a bit like the medical tricorder in Star Trek!** The method replaces the old-fashioned multi-device vital sign measuring procedure with a 30-second scan of the face.

**In the beginning**, we enthusiastically focused on developing our technology. Meanwhile, we realized that we had to learn a new vocabulary specifically associated with medical device development. The processes related to clinical validation and regulatory compliance were also mostly unexplored territories for us.

Is it a medical device? How is it classified? “**Regulatory body” – is that a compliment or an insult?** MDD or MDR? Practice rigorous risk assessment while juggling the FDA, CE, ISO, IEC, and QMS? And what about the monitor?

**The list of questions seemed endless**, and the sources that well-intentioned individuals pointed us to for guidance (manuals, recommendations, and standards) were overwhelming! Additionally, we learned that not all experts and consultancies understand the reality and needs of a start-up.

Finding individuals and organizations, who recognize (and anticipate) our difficulties and enthusiastically provide support and advice by sharing knowledge and experience, has been instrumental for Detectivio’s progress. **Scandinavian CRO**, represented by Jeanette Demorney at the Gothenburg office, can provide the support we need, whether it involves reviewing a clinical investigation plan or discussing the regulatory strategy.

We are well past the list of questions that initially seemed endless. But for Detectivio, with **exciting upcoming clinical investigations**, implementation of a quality management system, and a process for software lifecycle management, and more, there are always new questions to ask!

[View full post](https://www.aurevia.com/news/the-detectivio-journey-from-idea-to-medtech-product)

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