The Growing Need for Real-World Evidence in Medical Devices

Mar 12, 2020

Posted by Evidera, Inc.

Medical devices are part of everyday life and essential throughout all areas of healthcare, including prevention, diagnosis, and treatment. They include any device intended for medical purposes, such as instruments, implants, machines, materials, software, etc., and range from tongue depressors and blood pressure cuffs, to cardiac stents and joint replacements, to surgical robots and software. Innovation of medical devices is often an iterative development process based on recognized need rather than transformational improvement to address a unique, unmet clinical need. As a result of the iterative nature of medical device development, little, if any, clinical evidence showing improvement in outcomes is available to support the product launch. Hospitals, ambulatory surgical centers, and physician offices are the primary buyers of medical devices and frequently view them as commodities. Most hospitals have implemented cross-functional value analysis teams to evaluate the clinical and economic impact of adopting new technologies, including medical devices. The result is a crisis where medical device manufacturers are facing extreme pricing pressure on both new and existing products and are being asked by hospitals to provide evidence to support product claims and value propositions – evidence the manufacturers often do not have. In this environment, there is a significant need for manufacturers to invest in evidence generation to change the discussion with hospitals from price to value.

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