Abstract

New and emerging medical technologies will offer patients improved and personalised treatments, better prognosis and reduced recovery times. Consequently, new risks will also emerge. Issues related to risk management and regulation including requirements for training and education should be discussed with all stakeholders at a European level. Advances in imaging technology, biosensors and lab-on-a-chip devices will enable more precise diagnosis, at an earlier disease stage and at the point of care. Minimally invasive surgery techniques combined with sophisticated implant systems, constructed from innovative materials and possibly using state-of-the-art software and telemetry, provide continuously improving therapy options. New generations of medical technology products are more and more resulting from so-called "converging technologies", i.e. the combination of different technologies which leads to the crossing of borders between traditional categories of medical products such as medical devices, pharmaceutical products or human tissues. Furthermore, the trend can be observed that a growing number of diseases and disorders can be treated with technological solutions instead of medicines. Next to product specific risks, general aspects like unknown properties of new material classes, the combination of different technologies and increasing computerisation should be managed. Further risk management is needed because clinicians are facing a technology gap and need specific training to work with new technologies. On the other hand, innovation should not be hampered unnecessarily and that the availability of innovative technologies to patients should be pursued.