Using Medical Device Approval Data to Illustrate Some Challenges in Regulating Repair Aftermarkets

Abstract

Manufacturers of complex, hospital-based medical devices can exercise significant control over access to device parts and repair information, which can lead to excess costs and negative patient outcomes. As a result, there have been increasing calls to improve repair supply access for hospital biomedical staff and independent service companies. This study uses medical device approval data to demonstrate Australia’s reliance on United States manufacturers for its most complex, expensive and high-risk medical equipment. It then discusses the economic and political challenges this poses for Australian regulators seeking to improve competition in the repair aftermarket. However, while regulators may face difficulty moving against the interests of US manufacturers, Australian hospitals and independent repairers stand to benefit incidentally from changes made in larger markets such as the EU and US, where the repair campaign is strongest.