Without a doubt, you are aware of the TGA’s announcement regarding customised orthotics falling under the new category of patient-matched devices. Despite being a biomedical engineer and not a podiatrist, I am still fortunate enough to be included in numerous podiatry Facebook groups where I have seen the reaction to this announcement unfold.
With a medical device commercialisation background, I have been asked to help distil what this announcement means for you and how this can benefit you, your clinic and the overall podiatry profession.
What we know
Orthotics are medical devices. Suppose you get a chance to review the Therapeutic Goods Act 1989. You would find that the definition of medical devices includes products intending to treat or alleviate injury or modify the body’s anatomical or physiological functions. Fortunately, orthotics don’t have a measuring function, are not provided sterile, don’t connect to an energy source and are non-invasive. This means that they generally fall under a ‘class 1 medical device’. The TGA has an excellent tool for you to use, which you can access here.
Who is the manufacturer?
But, who is the manufacturer? This question was the most common one I saw in those Facebook groups. If you are involved in the design, production, packaging or labelling of the device, you will find you are a manufacturer. It seems to me, the confusion behind this statement surrounds whether or not you are involved in the ‘design’ or ‘production’.
Firstly, ask yourself, ‘do you believe you are designing the orthotic or sizing up the patient?’ Suppose you’re working with an orthotic laboratory that has provided you with a framework to measure a patient, or you are assembling or adapting the device for an individual patient without affecting the intended purpose. In that case, you are not designing the device. You are likely not a manufacturer. If you are following your processes, not operating with a framework supplied to you by the laboratory, and/or you are defining the orthotic’s intended use, you may inadvertently be designing the orthotic! Similarly, if you are producing the orthotics entirely in-house, you are quite clearly the manufacturer.
Change can be scary, but in this case, there are plenty of potential benefits. While the TGA will now expect a higher version of quality control to be placed on orthotics, this means you will be able to communicate higher-quality goods to your patients. Because you will have to verify that you are sourcing safe materials through documentation, you can now ensure your suppliers are providing safe materials for your clinic. Have you ever seen proof of that?
A word for clinic owners
And lastly, for the owners of clinics. If you have multiple podiatrists manufacturing orthotics on-site, you should develop and document procedures for assessing patients, designing the orthotic, and verifying the patient’s orthotics. This will allow you to ensure graduate and junior podiatrists are prescribing within your established framework and have the design decisions made by a previous podiatrist who might have since left the clinic.