Starting a health startup is an exciting journey, but navigating the regulatory process can be a bit of a daunting task. In Australia, the Therapeutic Goods Administration (TGA) is the authority responsible for regulating medical devices, medicines, and other therapeutic products. If you’re planning to introduce a new health product to the Australian market, understanding the TGA approval process is crucial. In this 2 min Q&A you’ll hear from one of our LuminaX alumni talk about their experience in obtaining regulatory approval for their medical device.
MEET THE FOUNDER
Prof. Nick Ralph is the Founder and CEO of Thermal Armour, a manufacturer of wearable medical devices that eliminate hypothermia – the world’s most common serious adverse event in surgery.
Navigating the TGA Landscape: Insights from Prof. Nick Ralph
Q: How did you determine whether you needed, or didn’t need TGA?
A: Navigating the world of medical device regulation requires a clear understanding of your product and its intended medical outcomes. This was my first step in discerning whether engagement with the Therapeutic Goods Administration (TGA) was necessary. Utilising the TGA’s online tools were really helpful as their guidelines clearly delineate what constitutes a medical device. However, I quickly learned that engaging directly with TGA staff was super helpful. My advice is to build a relationship after you’ve built an understanding around your device (don’t waste their time and come prepared!). Their guidance is instrumental, especially in areas where the regulations were open to interpretation.
Unforeseen Realisations in the TGA Domain
Q: What was something you didn’t realise about the TGA process?
A: Reflecting on our progress, one thing I hadn’t realised was the possibility of obtaining approvals overseas as a means of hastening approval here from regulatory bodies. Securing approvals in larger economies can sometimes fast-track the process in Australia. I think my other piece of advice is “be wary of consultants”. I’ve been very lucky with Dr Lee Walsh from Platypus MedTech but not before making the mistake of employing other consultants first. I learned the hard way that not all are as knowledgeable as they claim. Always do your homework and seek out credible references before engaging anyone.
The Honest Truth on Consultants
Q: What is something you could have done differently?
A: I would encourage founders to educate themselves on regulatory standards and to leverage the experiences of industry peers. You need to understand your business, your runway, your device, your manufacturing processes… everything to do device regulation well. And I think nothing beats learning from those who’ve already walked this path. I would also, in retrospect, approach consultants with more scepticism. Once, a consultant made grand promises with an unrealistic timeline and a hefty fee. I was lucky I baulked at it but it was a red flag that taught me the value of due diligence.
Take the time to understand the process, gather the necessary documentation, and be patient throughout the evaluation period.
Prof. Nick Ralph is the Founder and CEO of Thermal Armour, and a 2023 LuminaX Accelerator graduate.
Through the LuminaX Accelerator, the LX Health team delivers a range of 1.1 mentoring opportunities, including workshops and coaching for founders who are seeking TGA approval, FDA approval, and building an MVP in the healthcare space.
If you are a healthtech startup that needs this support, learn more about our program and program dates here.