“How to Design Safe Medical Products”, an article appearing in the July issue of the American industry magazine “Machine Design”, is worth reading. It gives an overview of how to deal with the risks associated with designing medical products. It was written by Dr. Peter Havel, Senior Vice President of TÜV SÜD Product Service and responsible for medical products worldwide.
Optimal risk management
In his article, Havel emphasizes that designing equipment to medical industry standards is not enough to cover all potential risks associated with a medical product. He describes how developers using a combination of different analytical methods including standards, that provide guidance on safety, are able to identify, evaluate, and minimize risk. Using specific examples, Havel explains different types of failures and errors and suggests possible strategies to minimize risk. He also deals with the issue of the reliability level of built-in safety systems.
Strategies for software and ergonomics
Havel dedicates a longer section of his article to the specific challenges presented by the development of medical software. He presents the V-model as a commonly used procedure to control typical software risks. Up to now, safe ergonomic concepts have been insufficiently standardized. Havel describes practical approaches which manufacturers can use.
This article was published in English with an American audience in mind. However, since it describes basic working procedures and addresses international standards, it is worthwhile reading for all those working in medical product design.