Medical Device Link.

Originally Published MX September/October 2005

BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT

Start-up medtech companies can be extraordinarily innovative, but that doesn't mean that they don't encounter obstacles on their way to growth and success.

One of the biggest issues small medtech companies face is how to get their products commercialized quickly. Achieving FDA market approval or the CE mark that permits companies to launch their products onto the European market may require specific expertise that a small company may not have internally.

The ThermoSense cardiovascular diagnostic system by Thermocore Medical Systems NV (Ghent, Belgium).

Medtech start-up Thermocore Medical Systems NV (Ghent, Belgium) developed a cardiovascular catheter to diagnose potential heart disease, which affects millions around the world. In collaboration with Cambridge Consultants, Thermocore developed an innovative thermography catheter with a functional probe containing four tiny sensors that perform up to 25 measurements of the artery wall each second, to detect unstable or vulnerable plaque that signals incipient heart disease.

To speed the delivery of this product onto the market, Thermocore established a larger virtual company by adding a team at a contract design and development house to which Thermocore outsourced product development for the catheter. As a result, the company was awarded the CE mark and was able to get its catheter into clinics more quickly than if it had developed the project in-house.

Copyright ©2005 MX