Medical device global recall

The adage that all politics is local has never been more applicable than in a medical device recall which spans the globe – having the right team on the ground with local knowledge and local contacts is critical.

H/Advisors APA worked with an international team of in-house and country-based consultancy firms, to provide the Australian and NZ perspectives for the recall of a medical device.

Our efforts were focused on proactively addressing the regulator, health departments and customer concerns across the two countries – noting a different response from regulators in terms of process in each market.

The company had no local public affairs or communications presence, and the recall posed a major disruption to clinical services until alternative solutions could be found - no easy feat during the COVID-19 disruption to international supply chains and a product manufactured overseas.

H/Advisors APA provided resourcing, a crisis communication operating framework, supporting templates and guides to first prepare for the recall announcement and communications obligations.  We then guided the client through the initial phases of the recall when regulator and customer scrutiny was at its highest.

The healthcare company managed to navigate the recall without any major negative media coverage in Australia, and was able to both build new and deepen existing relationships with key regulators and health departments because of its open, consultative and collaborative approach.