Regulatory Roadshow: Regulation and reimbursement when entering the US


Two new seminars have been announced as part of the AusBiotech Regulatory Roadshow, which has been designed to help SMEs, early-stage companies, and clinicians understand the medical device evidential requirements of both regulators and payers in the US healthcare market.

AusBiotech is partnering with Syneos, the Australian Research Council Training Centre for Medical Implant Technologies (ARC CMIT), and the University of Melbourne for the Victorian seminar; and Syneos and Wrays for the West Australian seminar.

The seminars include case studies of companies that got it wrong, resulting in market access delays and greater development costs, as well as those who succeeded first time around. Considerations for bringing new products to market in Europe, and how a US strategy should be fully integrated into CE marking strategy, will also be explored.

Adam Steadman, Syneos Health US, will present at both seminars and holds extensive knowledge of the medical device and diagnostics clinical trial arena in the US, Europe and Asia Pacific. Adam has more than 14 years' experience in a clinical research organisation (CRO) in a number of financial, operational and business development roles. As VP of Clinical Development, he is now responsible for the global operations of the Medical Device & Diagnostics Business Unit. Adam has been instrumental in the development of the SyneosOne service offering in medical devices - which combines both clinical and commercial services to provide a unique end-to-end delivery from first-in-human through to full global commercialisation.

The lunchtime seminars are part AusBiotech’s work in supporting start-ups and SMEs in Australian life sciences.

The conversation of regulating medical devices will continue at Australia’s premier medical technology conference, AusMedtech 2020, where an engaging line up of keynote speakers and knowledgeable panellists will share their expertise and insights to further advance the sector nationally and globally.

The Regulatory Roadshow is free for AusBiotech members and $75 for non-members.