Factoring Economic Criteria into Medical Device Trials

Medical Device

Diagnostic and Interventional Cardiology published interesting, thought-provoking article on the inclusion of economic costs into product evaluations—presently the FDA approval process precludes such criteria.

The authors, medical scholars and investigators from Canadian and one American university, suggest that the FDA might consider costs as well as outcomes into the regulatory process. In fact, they refer to a recent study driven by the University of Alberta and Innovative Health, Scottsdale, that showed economic considerations have much to add in the medical device policy area.   The authors provide the reader a brief tour of the FDA regulatory review process and the rapidly growing number of clinical trials.  Thereafter, they posit that adding a medical device cost analysis might be a befit to medicine.

They use the catheter ablation of atrial fibrillation (AF), which is used to restore and maintain sinus rhythm in patients with symptomatic, non-permanent AF. A second-line treatment, presently the FDA focuses on health outcomes (curative and palliative) as indictors of acceptability. 

For a complete comprehensive picture of a device, costs need to be examined in relation to outcomes produced by the resources deployed in the procedure to demonstrate cost-effectiveness.  See the link below to read this article in its’ entirety for an interesting perspective with a relevant real-world catheter ablation of AF example.