It is often surprising at how much thought is given to registering a device in Australia and how little is given to who would be the potential payers once the device or technology reached the market.
Access to reimbursement or payment is critical to commercial success. No matter how clever, innovative, or clinically effective a technology is, it will fail in the market place if no one will pay for it. Before venturing too far down the commercialization path you should consider whether you can answer ‘yes’ to any of the following questions:
• Will a doctor be paid by the Australian Medicare system for using your device or technology?
• Is the device eligible for inclusion on the Commonwealth Prostheses List?
• Is there a Australian Refined – Diagnostically Related Group (AR-DRG) that covers the procedure in which the device is used so that it will be simple to access the public hospital sector under Activity Based Funding (ABF)?
• Is the device or technology able to be supplied at a price that will make it economically viable to sell in Australia’s public or private hospital systems?
• Is there a defined funding pathway for devices and technologies that are used outside the hospital system
• Will private health insurers cover the device or technology?
If you don’t know the answers or you don’t understand the questions then it will certainly be worthwhile to find out more. Some products will simply face too many reimbursement hurdles to be commercially viable. It is better to be well informed earlier rather than later as there are substantial risks that can be avoided with the right information.
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