German
Proving a medical benefit faster
03.11.2011
The cost of medical products and devices only becomes classed as eligible for reimbursement if the health system as a whole profits from the innovation and this benefit is also documented. Medtech companies often find it difficult to prove such a benefit because any evaluation of it depends on drugs and accordingly is very closely linked to a direct benefit to the patient. [more...]
What is going wrong with endoprosthetics?
28.09.2011
Almost 400,000 hip and knee joints are replaced by prosthetic implants in Germany each year. However, the number of corrective operations is also high with just under 35,000 joint implants being substituted. Outside of normal replacements, such corrective intervention may become necessary prematurely if, for instance, dislocation or aseptic prosthetic loosening occurs. The new voluntary endoprosthesis register should ensure transparency for products and users.
The fact that completely problem-free products exist is documented in Sweden where a mandatory prosthetic implant register has been kept for over 30 years. At total of 97% of some prosthetic hip replacements still work 20 years after being inserted. So what are the reasons when things go wrong? [more...]
Ergonomics as a source of errors
27.08.2011
Two thirds of adverse events with medical products derive from errors of usage and only one third from product errors. The number of errors of usage could be reduced by making products more usable and ergonomical in design. [more...]
The problematic case of medical software?
18.07.2011
The sector software manufacturers had in fact been expecting a clarifying word from the Medical Devices Expert Group (MDEG) of the European Commission this spring. The committee had wanted to comment on the placement of medical software into the various risk classes. [more...]
Medical Device Authorisation: Clear or Cloudy?
17.05.2011
According to a comparison study conducted by the Boston Consulting Group, the market authorisation of medical innovations proceeds at a more rapid pace in the EU than in the US. In spite of this, the comparison did not show an increase in recalls. Summary: The faster market access did not come at the cost of patient safety. Does this mean that all is well in the world of medical device authorisations in the EU? meditec writer Ramona Riesterer portrays the thoroughly mixed opinions in the medical technology industry. [more...]
Finding the way out of the licensing labyrinth
09.03.2011
Undeniably, FDA licensing and CE certification present the greatest obstacles to putting successful medical products on the market. For young companies in particular, getting a grip on the diverse requirements is a significant risk which not infrequently puts an end to promising, innovative ideas and projects. The example of a start-up in the field of ophthalmology shows how a practically oriented, adaptable sample process can provide a reliable compass by which to keep on track for success. [more...]
“A cold sweat when the inspector calls“
09.03.2011
Since the EU requires the state of the art to be followed when developing medical products, the latest products are always on the market here. However, the system has its weaknesses because adherence to regulatory requirements is monitored by notified bodies subject to private law. Martin Rümke, Head of VDI Medical Technology Working Group and consultant with Chemgineering Business Design GmbH advocates adopting a more critical attitude towards notified bodies. [more...]
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