The clinical development of new medical devices

The current requirements for clinical studies to demonstrate the effectiveness of a new medical device (MD) are still insufficient. It is no longer acceptable to go in our hospitals MD without clinical study where the only requirement is CE making.The clinical development of a new MD includes two stages: feasibility studies and studies to demonstrate clinical benefit. Feasibility studies are offered immediately following the pre-clinical phase. They allow the development of the technique and to determine the judgment criteria. The demonstration of clinical benefit based on the achievement of a randomized controlled trial with the help of the results of feasibility studies. Eligible patients must correspond to those for whom this is new for MD in practice. The choice of control group is the best treatment the literature. One primary endpoint will be provided in accordance with the main objective must be clinically relevant and validated. Measurement endpoint should be as objective as possible. The multicenter trial will be preferred to facilitate the recruitment of patients and make it easier to extrapolate the results of the study.A well-conducted clinical development enhances all new MD in the interest of the patient. This involves improving the support of project promoting reconciliation between industry, clinicians and academic research structures.