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Companies are going to have to adapt themselves to the concept of "Utilization assessment" of new developments in medical engineering. This applies not only to the products, but also to investigation and treatment methods. G-BA defines utilization here as a "more than a minor positive effect of a medical treatment on patients, when you consider the risk involved“.

Meaningful data about utilization, economy and medical requirements are gaining in importance. Health insurance would also like to have an evaluation of treatment methods after the market launch. Moreover, the manufacturers will have to increasingly provide comparative studies in the field of medical engineering, publish all the investigation results and fulfill demands for substantiation, if randomized study is not feasible.

Comment:  Actually, it is obvious what Joachim M. Schmitt, Managing Director, BVMed, postulates: "Innovative medical technologies are only going to be useful if they offer a greater benefit compared to the existing methods and if it can be achieved at the same or lower costs, or if higher expenditure brings in even greater benefits". But even then, that is not going to guarantee a successful market entry, especially if the expenditure and expenses on research and development rise during its course. The questions that are open here, are: in which field can we expect innovations, what are the trends in medical engineering and which ones will prevail? A new development should also get the benefit of a reimbursement strategy at an early stage.

[ilink url=““]Link to the source (BVMED)[/ilink]