Increasingly medical technology innovators are developing devices that are inexpensive alternatives to implantable devices.  These devices can be a fraction of the cost of implantable devices yet there are hurdles to accessing the Australian market despite the cost advantages.

The simplest pathway to private reimbursement for medical devices is the Department of Health’s Prostheses List.  It is important to be aware of the criteria for listing.  In simple terms some of the key criteria are:

  1. The device must be registered with the TGA
  2. The patient must be admitted into a hospital to have the device implanted
  3. The device must be implanted during a procedure which has a Medical Benefits Schedule Item number.
  4. The patient must leave the hospital with the device implanted in their body

If your device doesn’t meet all these criteria then you will need to look at alternative funding pathways.  These may include accessing private health insurer ancillary benefit payments, patient pay models, workers compensation insurance or possibly accessing new technology funds in some states.  Alternatively the economic benefits of your device can be demonstrated to a variety of payers using economically based marketing tools.

I have recently come across several companies that have spent significant amounts of money on applications that have had no chance of success. It is essential that companies are well informed of all the options and the likelihood of success of each option before committing precious resources.  Please see: for more information.