I'm fresh off the back of a capital raising workshop by a rising star in radiotherapeutics and had wondered how they are navigating the sticky, messy spiders web of un-harmonised regulatory frameworks across the EU, US, UK and AU markets. All of which are serious compliance mapping exercises confronting a HealthTech or LifeSciences startup. Also a great spot to burn seed or Series A funding, fast. Naturally, it took me, first of all, to the Therapeutic Goods of Australia website, where I skimmed briefly through their Lifecycle approach to Regulation, published in 2011. Not a mention of digital platforms like Apps, or their more pervasive and complex AI cousins. Similarly scant mention in the MTAA Strategic Plan, but at least some placeholders of intent, by my interpretation (Australia, we've got some catching up to do). The FDA are, at least, wrestling with the definitional and regulatory questions of where to apply the right level of scrutiny. But it's a messy space to navigate.
One of my sideline interests is the work being done by TheHealthHorizon team in Canberra, Australia as they map the inbound HealthTech innovations that will influence the way we seek, receive and integrate healthcare in our lives. Another cap I wear is as a HealthTech Hackathon host and advocate, nurturing new ideas and building connectivity in our local regional digital talent pool, seeing clinicians grapple with real world problems and trying to bridge it quickly in a fast prototyping event. For some of them, they may go onto more formal incubation or acceleration pathways, but it's one filled with plenty of compliance hurdles if they cross over into the curious hell of Software as a Medical Device. Honestly, I can see why ventures take the simpler path and go for lowest risk profile "health coaching" apps. It's low hanging fruit, but has a trade-off of shallow IP moats, easily knocked off and forked into a variant.
Locally, there are signs of early seeds and saplings, but lots of soil needs tilling. The Health Informatics Society of Australias new Certified Health Informatician credentialformalises a certain kind of Lion Tamer pathway. However, we're facing Hydras here, with complex solution architectures and plenty of recursive feedback loops as we try and get our heads around how we deliver, track and iterate on behavioural change interventions, delivered in the form of a pleasing conversational interface. Naturally, I'm following the Human Behaviour Change Project with a high level of interest, but you can pretty quickly see why it's hard for clinicians to integrate a fast moving technology.
So, I remain curious. If you're a Hydra wrestler, or designing a personalised support system that's aiming for global traction, yet fits into the Software as a Medical Device morass, I'm wondering how you balance your speed to MVP + market investor imperatives against building in the checks and balances your customers expect. It's an open question for a complex innovation space. Our early career innovators are going to need some pretty good Hansel and Gretel breadcrumbs to navigate the space though.