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.
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!
Find out how Scandinavian CRO can support you with your medical device journey.