By Deborah Bell, executive director of business development in Australia, Avania Whether to control costs or to recruit a larger population, medical device manufacturers are looking beyond the U.S., the EU, and Asia to conduct clinical trials. When planning global studies and early commercialization, Australia is a strongly considered market. The access to innovative medical […]

By Jennifer Varela, Senior Manager, Reimbursement at Avania Mack Rubley, Executive Director, Business Development (US) at Avania Admittedly, requesting reimbursement for investigational device exemption (IDE) clinical trials in the United States is a complex, daunting process frequently overlooked by medical device manufacturers. However, if payers — most notably the U.S. Centers for Medicare and Medicaid […]

Alwin van den Broek, Project Manager and Data Protection Officer Anne Leijsen, Director, Medical Writing Long before the pandemic, medical device companies were scrambling to meet the European Union’s new Medical Device Regulations (MDR), slated for adoption on May 26, 2020. As COVID-19 began to take hold of the world in March 2020, the Trade […]