BVMED annual report 2011/2012
The report of the german Medical Technology Association 2011/2012 showed that the medical device market again rises after a difficult business period in the last year. The money is earned with innovative products not older than three years. In the medical device industry nearly every tenth euro is reinvested in research and development. The export share and the amount of sales is still rising while the increasing cost pressure cut the profit margin.
The benefit evaluation of the market-relevant innovative products and medical care processes will be one of this years most important topics. Reflecting the well-proved approval procedures for medical devices the promoted trend of politics and regulatory authorities to perform clinical studies for a wider range of medical devices is incomprehensible. Criminal wheelings and dealings as in the PIP breast implant scandal will not be prevented by raising requirements of the approval conditions.
Instead it´s more important to analyze the quality of CE-marked higher risk medical devices systematically (e.g. Arthroplasty Register).
To improve the post-market approval performance and safety of medical devices the commitment of manufacturers, hospitals and, last but not least, patients will be needed.
Category: Medical Devices