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Bio Technology : July 2009
AusBioEVENTS Another success: AusMedtech 2009 Philip Merryweather, MD of Vericap Finance addresses delegates at the conference dinner. Hamish Hawthorn, CEO of ATP Innovations, facilitating the hypothetical. AusBiotech CEO welcomes the Minister for Science and Medical Research, the Hon Jodi McKay MP, to officially launch the event on behalf of major sponsor, the NSW Department of State and Regional Development. AusBiotech’s AusMedtech 2009 saw more than 200 medtech professionals gather in Sydney for two days of workshops, speeches and networking to learn from one another about the fast-growing and exciting sector. The largest concentration of Australian medtech companies are located in New South Wales, making it the epicentre of medtech and a very fitting place to meet. The event, with the NSW Department of State and Regional Development as the major sponsor, was officially launched by the Hon Jodi McKay MP. In her speech, the Minister for Science and Medical Research said NSW was delighted to be hosting the conference. NSW is home to 45% of Australia’s medical device companies, including global success stories like Cochlear and ResMed, and with over 70% of Australia’s medical exports coming from within the state, Sydney is a fitting location for discussion about growing and supporting the medical technology sector. The stimulating program of workshops and presentations was of excellent quality and included a workshop with international guest, Mike Heyl, an attorney at law from Hogan and Hartson, based in Washington DC. While his firm specialises in regulatory issues more generally for more than 600 clients, Mike specialises in the registration of medical devices with the US Food and Drug Authority (FDA). 50 Australasian BioTechnology Volume 19 • Number 2 • July 2009 To get a medical device to market in the US requires the clearance of a 510(k) submission or the approval of a Premarket Approval Application (PMA) by the FDA. Mike walked the audience through the process’s requirements, based on US law, FDA guidance documents and the experiences he and his colleagues have had with the many submissions Hogan and Hartson have made to date. Mike spoke about how the FDA classifies medical devices and which types of devices qualify for the submission of a 510(k). The session included how the 510(k) process varies from the PMA approval process and what is required to be provided in a submission. Mike says we may be seeing some changes within the FDA: “It appears to be in a trend of requiring more data.” This may extend review times with more requests for clinical data and make the process more challenging. Mike says that seeking professional advice can help fast track the process, especially when a company is making its first submission. The keynote speaker was Donal O’Dwyer, Chairman of Atcor Medical Holdings and Director of Cochlear, Sunshine Heart Inc and Mesoblast, who spoke about the global economic environment for medical technology. Donal said the ageing population and growing wealth in