Licensing an ECG algorithm: what remains with the manufacturer

Editorial draft · Sample article for design review

Define the product relationship

An algorithm license is one part of a device development program. The manufacturer and software supplier need a shared understanding of the intended use, technical interface, and respective responsibilities.

Make the responsibilities visible

Supported inputs, updates, data handling, and performance documentation deserve explicit discussion. Distinguish the scope of the licensed technology from the claims proposed for the finished product.

Capture the open questions

Which decisions remain with your organization, and which evidence can the supplier provide? Resolve those questions before the commercial agreement becomes the development plan.