Comparative Effectiveness Research: Through the Lens of Medical Innovation

The Top headline of FDA News Device Daily today read, “Comparative Effectiveness Research has Benefits, Risks Experts Say?. Why would Device Daily consider comparative effectiveness to be risky? Many obvious concerns come to mind. There are distinct risks that the process imposed on the device industry may stifle growth. Worries abound related to the direction policy makers may employ such as when studies will be required (e.g., at the early stages of development, or later in the cycle of real-world experience), how studies will be conducted (e.g., by the government or a public/private entity), who will determine the type, scope, design and rationale for conducting such studies, what the studies will be used for (e.g., to restrict coverage, to control access).
The medical device industry has legitimate reason to worry from the increasing banter of politicians and inexperienced policy makers suggesting that comparative effectiveness controlled by a new government agency will be the silver bullet to manage unbridled utilization of medical interventions. Those experienced in device trial design and commercialization strategies for devices know that the struggle to move new innovation to the patient already takes years driven by inconsistent and irregular evaluative processes imposed by technology assessment authorities in some 3000 private payer health plans, individual hospital technology assessment groups, state Medicaid coverage entities, and Medicare local and national cov...

Source: Disruptive Women in Health Care - September 25, 2018 Category: Consumer Health News Authors: dw at disruptivewomen.net Tags: Uncategorized Source Type: blogs