Het IDEAL-framework

• Medical devices have to be tested for safety before they can be brought onto the market; effectiveness does not have to be demonstrated.
• The ‘IDEAL model’ is in place for the development and evaluation of new surgical interventions and procedures; ‘IDEAL’ stands for the 5 phases of the model: Idea, Development, Exploration, Assessment and Long-term study. The model is based on the assumption that innovation and evaluation should be interwoven from concept through to the, preferably randomised, clinical trial phase.
• Prospective registration of new interventions from the pre-clinical development phase onwards can prevent waste of money and effort, as unsuccessful ‘new’ registered interventions will not have to be developed again in the same manner.
• The IDEAL model, with a few adaptations, also seems to be a practically useful and suitable model for new medical devices. It will allow patients efficient access to new interventions and medical devices for which the safety and effectiveness has been sufficiently clinically established.

Conflict of interest and financial support: ICMJE forms provided by the authors are available online along with the full text of this article.