With All This Said, Where Are We Seeing A Real Novel Difference Being Made?

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In Conversation with Bronwyn Le Grice

By Mansi Gandhi
Monday, 04 July, 2022

A passionate digital health commercialisation advocate with more than 20 years’ experience under her belt, Bronwyn Le Grice needs no introduction.

Her name is synonymous with digital health commercialisation, and under her leadership, ANDHealth has worked with over 550 emerging digital health companies to drive commercialisation of their technologies. Bronwyn has worked across the health technology sector spanning commercialisation, venture capital, capital raising and industry advocacy.

She founded ANDHealth — Australia’s only digital health commercialisation organisation — with a specific focus on digital medicine and digital therapeutics, in 2017, in collaboration with a consortium of industry partners. ANDHealth’s unique cooperative commercialisation model has led to significant growth within Australia’s nascent digital health sector and continues to be a driving force for the development of sovereign capability in evidence-based, regulated digital health technologies.

In 2021, Bronwyn was named the recipient of the Victorian Pearcey Entrepreneur of the Year Award for contributions to Australia’s technology sector, and the 2020 BioMelbourne Network’s Most Valuable Women in Leadership Award. Here she reflects on innovation commercialisation, exciting developments in digital health and challenges ahead.

Hospital + Healthcare (HH): Bronwyn, could you please summarise the focus of your current work?

Bronwyn Le Grice (BLG): ANDHealth’s purpose as an organisation is to accelerate the commercialisation of Australian digital health technologies. We support digital health innovators and entrepreneurs to take their technologies from idea to scale-up and international market entry. We do this through a series of programs that are funded by both government and industry which allow us to support Australian innovators in the space. All of our programs are tailored to the specific challenges that digital health companies — versus medical devices or biopharmaceuticals technologies — face as they commercialise.

In the past four and a half years that ANDHealth has been running, we have supported over 550 Australian digital health companies to drive the commercialisation of their technologies. It is encouraging to see both the number of new technologies and the maturity of those technologies is consistently increasing with ANDHealth’s support.

HH: What are the major hurdles facing healthcare commercialisations?

BLG: Within the digital health sector, we are seeing that policy structures, as in many sectors, lag the types of technologies that are trying to reach the market. We see really interesting digital health interventions which have shown that they can significantly improve patient outcomes in clinical trials but lack any clear framework to secure reimbursement to drive commercial-scale uptake. This means that, once these companies have secured regulatory approval, they really are dependent on their ability to find a paying customer that sits outside of a traditional reimbursement pathway in order to get to become a sustainable business.

In the past couple of years, we have seen significant improvement in the Australian landscape, including the Therapeutic Goods Administration’s guidance of Software as a Medical Device (SaMD) in 2021, which established a clear regulatory path for digital health solutions and the rapid adoption of telehealth and telemedicine technologies during the COVID pandemic. As we return to normal, we need to ensure that key policy frameworks don’t return to pre-COVID settings. Rather, we need to continue to incentivise the use of technologies that continue to support the delivery of care and improvement of patient outcomes outside the physical clinical setting.

Australia now has a strong regulatory environment for digital therapeutics and digital medicines that provides health professionals and consumers with access to safe, evidence-based digital health products that improve patient outcomes. Importantly, it also supports digital health innovators and entrepreneurs to build an internationally competitive digital health sector.

The other major challenge that digital health companies we work with report is access to funding — both grant funding and private capital — and specifically funding that is geared towards digital health.

Although the technology base of digital health solutions may be more aligned with IT investment, the market that digital health companies operate in is very much health care, which can involve long sales pipelines, complex procurement pathways and global enterprise-scale customers. Attracting ‘smart capital’ and appropriate grant funding streams for digital health companies is a key focus for ANDHealth.

HH: What’s your advice for health professionals turned entrepreneurs or for aspiring startup founders?

BLG: My first piece of advice for digital health innovators is to make sure they can verify and validate that there is a market and a clear paying customer for their health intervention, and that they can deliver a strong value proposition that will incentivise the prospective customer to pay. Whilst solving a clinical need is clearly key, there are many clinical needs that can be solved but which don’t provide a market that can sustain and grow a globally competitive company.

It is common for innovators to highlight how much their technology can save the healthcare system, but unfortunately, overall system savings don’t always result in a purchasing decision. That’s why it’s important to validate that there is a paying customer early on when developing a product, especially if it is a Software as a Medical Device (SaMD), or another intervention that has a clinical efficacy requirement and which might spend significant time in clinical trials before achieving a clearance to market the product in key markets.

One of the most common areas of company failure in the digital health sector occurs when companies solely focus on their clinical need, clinical trials and product design for end users, and fail to verify at scale that their proposed paying customer is able or willing to pay for the product. Internationally, there are a number of case studies where companies have been forced to shut down because the company’s target customers are simply unwilling or unable to pay.

Whether your target customer is a hospital system that’s under extreme budget pressures, a clinician who may see your technology as a nice to have and not a must have, or a patient that doesn’t want to pay out of pocket for health care, digital health companies must verify the commercial pathway as well as the clinical need for their product early, in order to efficiently capitalise on their early-stage investment.

HH: What are some of the most exciting projects you are currently involved in?

BLG: In September 2021 we hit a major milestone of receiving $19.75 million from the Medical Research Future Fund (MRFF), which is the largest ever federal government investment specifically into commercialisation of digital health technologies.

Using this MRFF funding, the ANDHealth Digital Health Accelerator Fund and the ANDHealth+ program offer the most substantial funding and support opportunity for digital health companies focused on preventing, diagnosing, treating, mitigating or managing disease.

The support offered by ANDHealth involves national and international industry leaders and advisors, providing specialised help that is not available anywhere else in Australia. Seeing this support translate into successful companies and technologies which have impacted over 500,000 patients so far is by far the most rewarding aspect of our organisation.

HH: Any specific areas within the health industry where you’d like to see more startup activity, and why?

BLG: Throughout the pandemic and to this day we are seeing a significant increase in funding in global markets for digital therapeutics and mental health interventions. This is promising because when you start to see increasing investment, it is often related to market dynamics improving in those key areas.

Our goal at ANDHealth is to support as many evidence-based digital and digitally enabled health technologies as possible to enter the Australian healthcare system. The Australian Government’s Modern Manufacturing Initiative established a strong focus on medical technologies as a driver of post-pandemic growth, but we cannot overlook the critical role of software in the modern medical technology industry. Very few medical devices do not require some level of connectivity in today’s market, and the value add of a medical technology that’s impact is augmented by sophisticated software cannot be underestimated.

Here is the link:

https://www.hospitalhealth.com.au/content/technology/article/in-conversation-with-bronwyn-le-grice-671442119

 I found this article very in interesting and have to say I was utterly amazed to read that ANDHealth had “supported over 550 Australian digital health companies to drive the commercialisation of their technologies.”

In the past 30 or years there has been adoption of only a few digital health innovations – EHRs in large and small organisations, secure messaging of clinical and diagnostic information, laboratory and RIS systems, telehealth (which is really hardly innovative)  and e-prescribing would seem to just about exhaust the list! Additionally there are some more specialised systems but after those not much.

Each of these systems have been largely evolutionary rather than revolutionary and it really is hard to imagine what is coming down the pike that will stimulate or foster major change, except maybe with more remote care and monitoring.

My point is that we are seeing a lot of activity but very little real fundamental change, as such, over the last decade or two. We also seem to see – except for the blindingly obvious, very little evidence of clinical benefit etc. I wonder just what all the researchers are actually doing that is working and making a difference.

Have I got this wrong and there is really great onward progress and improvement, or not, and how can we be more efficient in getting there? Is anyone else seeing a real impact for all this activity, and is the ADHA helping or hindering?

Digital Health seems, to me, to be dotting I’s and crossing t’s rather than making substantive and consequential progress!

What do you think and do you agree with the profitability focus of the article?

David.