Challenges in the translation of innovative products and technologies into the clinical practice

In times of increasing technicization and digitalization, the importance of translational medicine has increased. A successful translation from basic research to the clinical application is a costly and time-consuming process that depends on many factors. Negative examples from the past (thalidomide, metal-on-metal bearings in hip arthroplasty) show that translation also entails risks for the patient. In recent years, stricter requirements for the manufacture and approval of medical devices have been introduced to ensure patient safety. Autologous chondrocyte transplantation (ACT) is an example of successful translation. Preclinical experimental animal studies were followed by clinical patient studies with market approval and implementation in the routine clinical practice. The effectiveness of a product is not the only decisive factor in whether a product is approved for the market. Between the basic science and the willingness of the market to invest in the further development and commercialization of a product is a significant hurdle, which is also called the Valley of Death. The product will ultimately be approved for the market and used clinically only if this hurdle is overcome. The minced cartilage procedure for the treatment of focal cartilage defects recently passed this hurdle and completed the translation process. Only short-term results are currently available and early users are already using this technique although randomized studies and medium-term results are not yet available. Further studies will show whether a clinical benefit emerges and the product stays on the market.     «

In times of increasing technicization and digitalization, the importance of translational medicine has increased. A successful translation from basic research to the clinical application is a costly and time-consuming process that depends on many factors. Negative examples from the past (thalidomide, metal-on-metal bearings in hip arthroplasty) show that translation also entails risks for the patient. In recent years, stricter requirements for the manufacture and approval of medical devices have...     »