A fundamental mistake in MedTech is to treat AI as another software project. It is not. An AI-enabled medical product can involve product safety, clinical performance, quality management, data protection, cybersecurity and AI regulation at the same time.
That creates a particular challenge for MedTech organisations: the issues are connected, but the teams dealing with them often are not.
- Product develops the functionality.
- Regulatory manages MDR or IVDR.
- Quality owns the QMS.
- Legal assesses AI, data protection and contracts.
- Cybersecurity manages security risks.
Each team may do an excellent job. But who connects the pieces?
Where the risks overlap
The difficulty is that one product decision can trigger questions across several areas at the same time. For example:
