Australia is a great place to do business for suppliers of medical devices. However the system is complex and can be hard to navigate for the uninitiated
Registration with the Therapeutic Goods Administration (www.tga.gov.au) is always the first step and a legal requirement. However access to reimbursement or direct payment is critical for commercial success.
No matter how clever, innovative, or clinically effective your product is, it will fail in the important Australian marketplace if no one will pay for it.
Innovators should consider the following questions:
- Will a doctor be paid by the Australian Medicare System for using your device or technology? mbsonline.gov.au
- Is the device eligible for inclusion on the Australian Government’s Prostheses List? http://www.health.gov.au/internet/main/publishing.nsf/Content/health-privatehealth-prostheseslist.htm
- Is there an 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)? ihpa.gov.au
- Is the device or technology able to be supplied at a price that will make it economically viable to sell in the public or private 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?
- Do you have reliable intelligence on the emerging political and economic issues in Australia that will have implications for medical technology reimbursement?
If you don’t know the answers or you don’t understand the questions, it would certainly be worthwhile to find out more before you launch your product. It is better to be well informed earlier rather than later so that commercial risk can be accurately assessed.
For more information see www.medtechnique.com.au