OBJECTIVES

: To analyze the role of real world evidence in Value Based Health Care of medical devices.

METHODS

: A literature search (research string released on 2^nd April, 2018) was performed on PubMed including the following as main keywords: medical devices, real-world data and value-based healthcare. No restrictions on language, year of publications, and type of reference were imputed.

RESULTS

: Fifty-eight papers were identified and scrutinized. 2 additional references were identified through other sources. 27 were included. The records were published between 2004 and 2018. Once plotted against the year of publication, an upward trend was visible starting from 1 (4%) publications in 2004 up to 4 (15%) in 2016 and 5 (19%) in 2018. 81% of the records reported evidence in cardiology and cardiac surgery area; 7% in neurology. Most data came from registries (63%) and administrative databases (33%). The sponsors were healthcare industry (4%), academia (93%), health authorities (4%).

CONCLUSIONS

: Value based healthcare has become a hot topic both for policy makers and for the medical devices industry. The constantly increasing production of real world evidence and analyses based on observational data, registry and administrative databases confirms the increasing interest in this research area. The clinical practice may substantially differ from controlled trials; the use of real world data not only completes the body of evidence on a specific therapy, but also may drive the updates of clinical guidelines. Both the technological progress and the production of real world evidence have become so fast that an adequate way to timely develop guidelines should be sought. Alongside, the use of real world evidence may play a relevant role when policy makers need to measure the value of a medical technology.