Speaking of Science: The Artificial Heart Frontiers Program: engineering the next generation of artificial hearts with Professor Shaun Gregory

For National Science Week, we hosted Co-Director of The Artificial Heart Frontiers Program, Professor Gregory. Watch and listen as he discusses how this program is engineering the next generation of mechanical circuitry support devices and in doing so, building a cardiovascular device ecosystem in Australia.

Recorded on Tuesday 12 August 2025 from 10:00 am – 11:00 am AEST.

Video transcript

0:07 Prue Torrance
OK, well welcome everyone.

Before we formally begin, I'd like to start by acknowledging the Ngunnawal people, the traditional custodians of the land on which I'm standing today. I acknowledge and respect their continuing culture and contributions that connect and enrich our country.

I pay my respects to their elders, past, present and emerging and extend that respect to anyone joining us online today.

My name is Prue Torrence, and I am the Acting Chief Executive Officer of the National Health and Medical Research Council and welcome to another instalment of NHMRC's Speaking of Science series, where we host some of Australia's leading and most respected health and medical professionals to discuss their research breakthroughs, innovations and other insights.

Just a little bit of housekeeping before we get into more introductions. I will shortly introduce our speaker and there will be opportunities for Q&A towards the end and you can use the chat function to put your questions in at any time.

We are also recording this session that will be uploaded to our website to view and you can of course view past Speaking of Science webinars on NHMRC’s website.

This Speaking of Science seminar is coming to you in National Science Week. National Science Week is an annual celebration of science and technology and it provides an opportunity to acknowledge the contributions of Australian scientists to the world of knowledge.

It's a week long celebration and we're right in the middle of it, and it promotes and encourages interest in science, engineering, mathematics, technology and innovation and aims to communicate the relevance of these topics in our everyday lives.

At NHMRC, we continue to be astounded by the knowledge and skills that make up the health and medical research workforce and the real impact that their projects have on everyday lives through the research and its translation into practise.

That brings me to introducing our guest speaker for Speaking of Science, Professor Shaun Gregory, who is revolutionising the next generation of implantable heart devices.

Holding both NHMRC and Heart Foundation fellowships, Professor Gregory's research applies a translational approach to cardiovascular engineering, with a particular focus on devices used to support or replace the heart.

Professor Gregory is the Director of the Queensland University of Technology Centre for Biomedical Technologies, Founder and Director of the Heart Hackathon Student team competition, Director of the Cardiorespiratory Engineering and Technology Laboratory, and President of the International Society for Mechanical Circulatory Support.

And that's not all. Professor Gregory is also the Co-Director of the Artificial Heart Frontiers Program, a multidisciplinary consortium applying cutting edge technologies to transform the healthcare of people with heart failure.

Did you know over 30,000 Australians are diagnosed with heart failure each year, over 60,000 Australians are hospitalised each year for heart failure and around 64 million people worldwide are affected by heart failure?

The Artificial Heart Frontiers Program is committed to revolutionising implantable heart devices to save countless lives both now and in the future.

Please join me in welcoming Professor Shaun Gregory to speak on the Artificial Heart Frontiers Program and how it's engineering the next generation of artificial hearts.

Thank you.

3:40 Professor Shaun Gregory
Thanks, Prue.

I'll just share my screen. Hopefully you can see that.

3:49 Prue Torrance
Perfect.

3:50 Professor Shaun Gregory
OK, thanks Prue very much for the introduction.

I'll be talking about the Artificial Heart Frontiers Program and how we're engineering the next generation of artificial hearts. Even though it's just my name on the screen there, there's a lot of people involved in this program.

We'll go through some of those a little bit later, but I just want to acknowledge everyone who's involved in this program, whether they're chief investigators, some of our research scientists, our professional staff involved, and all of the support staff as well.

I'd also like to acknowledge the Turrbal and Yuggera as the First Nation owners of the lands where I stand. I pay respect to the Elders, laws, customs and creation spirits and extend this to the lands where you all join from today as well.

I recognise that these lands have always been places of teaching, research and learning and I acknowledge the important role Aboriginal and Torres Strait Islander people play within the community.

Cardiovascular disease and heart failure, as Prue alluded to, it's a huge global problem. Many of you are probably aware that cardiovascular disease is the leading cause of death globally, making up about a third of all global deaths. The estimated global prevalence is in the range of around 500 million. It's hard to get really detailed statistics on that, but that's a pretty close estimate.

Then if we think about the subset of those patients that have heart failure, that's around 64 million people. Now heart failure is really an inability of the heart to pump enough blood to supply the body with what it needs. It can kind of be broken up into 2 distinct categories with about 50% of the population in each category.

We have half ref, which is heart value with reduced ejection fraction on the left of that image there and this is where the heart typically gets a little bit bigger.

The ventricle of the blood pumping chamber, let me just use a laser pointer, gets quite large and thin walls and it has an inability to pump. It has a systolic sort of heart failure.

Then we have the H PEF patients. This is heart failure with preserved ejection fraction and these patients are typically a little bit more older and a little bit more frail and their ventricles are typically a lot smaller, and they have very thick walls usually. These ventricles have trouble filling and if they have trouble filling, then they also can't eject enough to supply enough blood to the body.

They're the 2 main types of heart failure and the gold standard treatment for these patients with heart failure is a heart transplant. This is of course the end stage of that therapy. There are medical management to happen before that, but a heart transplant is really the gold standard end stage therapy.

It's only about 8,500 heart transplants performed worldwide per year and only about 120 in Australia per year. There's clearly a discrepancy between the supply and demand of these donor organs and that's where we need something to either keep the patient alive while they're waiting for a transplant because it can take a while to match a donor with a recipient and receive a transplant or even as a permanent long term therapy.

This is where we have something called mechanical circulatory support or MCS. MCS predominantly comes in 2 different types. We have on the left you see a total artificial heart and on the right you see a ventricular assist device. To briefly go through the differences in these, a total artificial heart, essentially what they do is they open the chest, and they cut out the entire heart. They completely remove the heart or the pumping chambers of the heart and then they replace that with a mechanical device that pumps blood around in place of that heart.

These devices are then powered through usually pneumatics or electronics which supply power and basically pump pressure to the device and then a ventricular assist device or a VAD.

On the other hand. This keeps the heart in place, but it pumps blood in parallel to the native heart so that while the native heart pumps some blood from the left ventricle to the aorta, the ventricular assist device has a parallel circuit where it takes blood out of the ventricle through the pump and then back into your aorta.

This pumping function can take over as little or as much of the heart's pumping ability as it needs to essentially with a ventricular assist device.

If we have a look at the technology of these devices over time, we'll start off with ventricular assist devices. If we look at where we started, we had these very large devices that you'll see on the left.

Anyone who is a clinician a couple of decades ago might remember seeing these devices where essentially the patient is in the bed up here, and then the blood would flow from their chest out through these tubes and then into this series of chambers, which takes over the atrium and the ventricle of the heart on one side.

Then in this case, this patient has support of both sides of the heart, so one for the left and one for the right side. There are valves in these devices just like what you have valves in your normal heart and these pumping chambers are essentially made up of balloons inside a rigid chamber where the balloons are then compressed using pulses of compressed air through a driver like what you see on the right here, which is about size of a small washing machine.

That blood isn't pumped through that device and back into the patient to provide their circulatory support, but you can imagine a essentially a balloon inside a chamber that is having to beat just like your normal heart is beating.

Your heart beats around 40 million times per year, so you can imagine how quickly one of these balloons is going to wear out. Typically, these days can last maybe one or 2 years, sometimes a little bit longer. They're very large devices and so on. While they have saved many lives, they are certainly room for improvement with these devices.

Where we are now is we have these completely implantable devices that are just small mechanical pumps and if we think about as an engineer about the way the heart works, the heart is really just a pump and so we don't really need a pulse necessarily to keep these patients alive. We just need to keep blood flow moving around the body and there's better ways of doing that.

Just like the pump that you can see on your screen there, which is a small pump basically attached to the inflow to the ventricle and the outflow to the aorta of the patient. Here it's powered via a cable that comes out through the skin which attaches to a controller as you can see here and that controller receives power from usually either 2 sets of batteries or you can plug into your mains power supply as well.

A little bit more detail of how these pumps work. You can see on this slide here, you can see it has a spinning impeller. This has an impeller in the middle, which is basically a spinning disc that has blades on it that generates pressure and flow for the device.

Blood comes in from the left ventricle, gets spun around just like your fish tank pump at home or your car radiator pump, and then spun out into your aorta. The disc is spinning quite fast, usually around say 5,000 revolutions per minute and that would usually create quite a lot of mechanical wear in the device as well. You would have wear particles going everywhere and really short device lifetimes.

But what we can do is we can use magnetic systems to levitate that spinning impeller and spin that impeller. So essentially it is levitated and sitting floating in free space in this blood cavity without touching anything and spinning at the same time, again without touching anything with blood surrounding it and so that means that we have 0 mechanical wear. There's nothing touching anything.

It has essentially very long durability and large blood gaps and you can even see if I have a device that's been moved from a patient previously, if you look on my camera, you can see the inside of the device.

This is what the device looks like. The bug goes in here, goes into the device into an impeller there, which spins around and that impeller is magnetically levitated and rotated. That's how the devices work.

The most modern devices for ventricular assist devices, the total artificial heart, still haven't evolved the same way as a ventricular assist device has. Total artificial hearts are the commercially available devices at least, and we'll go over a much more advanced device soon that's not quite commercially available yet. But the commercially available devices consist of 2 large pumping chambers that sit within the chest.

You can see that the heart has been removed, and these devices have replaced the heart again. They have these balloons inside these kinds of rigid chambers where they use compressed air from a driver through this tube to squeeze the balloons within that chamber and these are essentially 2 devices that are basically velcroed together to support the heart. You can see a sort of similar device on my screen there. This is about how big they are compared to my hand.

This is one side of the device, and these drivers typically weigh around 10 or 11 kilograms, so they're quite heavy. They are sort of made to be carried a little bit more rather than that large sort of washing machine style versions where the patients were really confined to the ICU.

Now the great thing about these devices is that they've dramatically improved survival for these patients. If we have a look, there was a pivotal study done in 2001 or published in 2001 called the REMATCH trial and if we have a look at the survival of these patients on what was optimal medical management at the time, after one year there was only around 25% one year survival on optimal medical management. Whereas when we put in the device, the one that I just showed before on my screen, that device roughly doubled the survival to about 52% at one year.

That was a really great finding and really good for our field that we showed that we could support the heart, we could do better than optimal medical management, despite the fact there were many complications with these patients, but survival was a little bit better.

If you have a look at where we are now though, these devices like the one I showed before with the spinning disc in it, we're now seeing one year survival of 87. In some, 90-92% one year survival and when you think about how sick these patients are, that's really quite incredible and the fact that heart transplant has an approximately 92% one year survival. We've almost met the survival of heart transplant at one year.

We still have some way to go to meet the longer term survival of heart transplant. But the technology is definitely getting there and thankfully these patients can now go home and they can live a reasonable quality of life on these devices, albeit with several complications. But the technology is certainly getting there to support the patients the way we need to.

If we have a look at the implant numbers, I think when everyone who's in this field, when they saw the invention of these new more modern fancy devices, they pretty much thought, OK, we're going to see the implant numbers exponentially increase because we're having so much success with the devices.

But we haven't really seen that if this is data from the what's called the Intermacs database, which is a registry of almost all of the implants that happened in the USA, which makes up roughly 50% of the global implants and we can see over the last 10 years that implant numbers have been pretty much stagnant around the 2,600 mark. Now I drew that red line in the graph, is from Intermacs, but I drew that red line to show that it's been relatively stagnant.

Then we need to start thinking about why that is. Why are we not getting these devices into more patients? And one of the reasons is certainly where these devices are implanted.
They're difficult to implant. They require a complete program of work to use these devices, and it takes a lot to set that up. They're also very expensive and you can probably see on the map the countries that are able to afford this.

You see that if we look at a map of all of the centres in the world, pretty much there's this great website called MyLVAD where you can look up where all of the places are, where you can get one of these devices, or if you have trouble with your device, where you can go in and get support and we see that it's predominantly North America, Europe, a few centres around Asia and Australia.

There's clearly a very big gap in regions like Africa, most of South America, a lot of Southeast Asia. Even though there are some areas in Asia that have recently implemented centres since I made this slide, there's still very big gaps in where you can get these devices. Some of that is to do with the cost of the device, which one VAD might cost in the range of $130,000 Australia.

If we think about the limitations of these existing technologies with VADs there's still fairly large devices that require quite invasive surgery. The surgery usually requires that the patient's chest to be opened, the heart exposed, the patient be put on cardiopulmonary bypass and then the device implanted through a fairly lengthy process. Smaller devices will of course work a bit better.

The cost of the device and the program, as I showed on the last slide is a really big obstacle for rolling out these devices to more places. Also, the lack of training in getting these devices rolled out as well. They also don't have a physiologic responsiveness, they don't respond the way that the normal heart does, and I'll go through that a little bit later.

They have at the moment fairly poorly designed wearable systems, which makes them quite difficult to use for some people. They don't really have suitable remote monitoring, which means that a lot of the time the patients have to stay either in the clinic or close to the clinic.

There are a few cases and places where you can be further away, but a lot of places around the world require that the patients must have a caregiver, for instance, and things like this. They have that cable that comes out through the skin as well called the drive line and you can imagine having a cable that's coming out of the skin for what might be a month, it might be a year, it might be 10 years that you have this device. You can gather, you can get a lot of infections at that point and so we need to figure out why that is and how we can make that better.

There's also currently no solution for patients with HEPF as 50% of the heart family population has no option with these devices. If we think about why that is, well, the HEPF patients that can get these devices, they have these large ventricular cavities where we can put a device into there and when it sucks that blood out to pump it around to your aorta, you still have that reservoir of blood in there, so it doesn't collapse the chamber.

Whereas for a HEFT patient, if you would have put that device into this very small ventricular cavity, as soon as you turn the device on, it's going to suck all of that blood out and completely collapse that chamber. There's got to be a better option for those healthcare patients who are also a little bit more older, typically a little bit more frail and may not be able to withstand the complicated surgery.

Meanwhile, if we look at the limitations with total artificial hearts, there's really no long term durable device available, plus all of the above complications as well, so that’s really where the Artificial Heart Frontiers Program comes in.

This was, or is, a $50 million initiative from the Medical Research Future Fund and we need to say our sincere thanks to the MRFF for their support of this program and for working with us in this program as well. The way the program works is kind of explained on the screen there.

I still remember this was kind of the first back end drawing, I call it of how we're going to make this program work.

My Co-Director, Professor David Kay from the Alfred Hospital in Melbourne and I sort of came up with this design of what are the inputs to the program and what are the outputs? How does it really work? The inputs here are leveraged Australian technology through our existing research and development that's happened in our universities and also within our industry partners.

We have a very strong multidisciplinary experts with all of the expertise you could possibly need to develop one of these devices sitting within Australia all at the same time, which is really quite a unique time for us in the cardiology, cardiac surgery, intensive care, all of the engineering disciplines, the industrial designers, human factors engineers, the manufacturers, the clinical evaluation and so on.

We have a team with a very strong commercialisation track record that's been there and done that before. They know how to get a concept to clinic. Those are the inputs, and the outputs are essentially 3 commercialised devices that I'll go through in a moment.

But then also quite significant benefits to Australia in that way, creating Australian jobs and an ecosystem of cardiovascular innovation and the next generation of medtech development and manufacturing. Also, in building an international reputation and improving outcomes to patients on a global scale.
Let's have a look at the 3 devices that we're working on within this program.

They are a new total artificial heart, something very different to what exists at the moment, an improved ventricular assist device for patients with HFrEF and a mini pump or a very small device that we can implant in those patients with HFrEF.

Looking at the total artificial heart first. The idea of this device is that it's not going to be one of those short term balloons with compressed air sort of devices. This is a long term durable total artificial heart, and this is being developed by a good friends at BiVACOR and they deserve all of the credit for the development of this device.

The Artificial Heart Frontiers Program’s role here is to help them and assist them with their Australian clinical trials, support their clinical control development and support their pretest development preparation, which I'll explain a little bit later on.

Now BiVACOR were invented in Australia.They started here. They also have a base in the USA which obviously helps them to build their patient population and investment. But as I said, it was essentially designed here at the start by a guy called Daniel Timms and his amazing team.

The way that the device works is it is similar to those rotary pumps I explained before, like the one that I showed up on my screen with the spinning impeller. It has that spinning in colour or spinning disc essentially in the middle of the device and these spinning discs would usually have blades on one side of the device to support one side of the heart.This device does that by having blades on both sides of that spinning disc.

On the left of the device, we can see a wider set of blades. These support the high pressure circulation of the left side of the heart and systemic circulation and on the right, we have a thinner, a taller set of blades that support the lower pressure pulmonary circulation, replacing the right side of the heart and so with one spinning disc, they can support both sides of the heart.

What that means is they only need one motor drive system and one magnetic levitation system to make this device work within a casing that has two inlets and two outlets, just like your normal heart does.

It's this beautiful magnetically levitated device, no mechanical wear at all. Has a whole bunch of incredible technology and it has the ability to adapt to the native blood flow that your body needs as it works.

It's powerful enough for an adult, it's small enough for a child, it's lightweight, it's blood friendly and it has a lot of really big advantages over any existing device or any device even emerging on the market, and the great thing is BiVACOR were able to put that device into a patient in July 2024 with clinical studies ongoing now with excellent results.

Some of you may have even seen in the news about, I think it was probably about 6 months ago, it came out in the news that an Australian man actually survived for 100 days with the titanium heart, which is a world first. Trials in the US went so well that they could be shorter term because they were very fit and ready for a transplant. In this case, the patient took a little while longer to get a transplant that did very well on the device and survived for more than 100 days, which was an incredible achievement by their team.

Then moving on to the next device within the program is the Horizon Ventricular Assist Device. Now this is to support those patients with HFrEF. Some existing technologies have many limitations and so the idea of this device is to potentially leverage some of the technology from that total artificial heart, such as the physiological responsiveness of that device, the magnetic levitation systems and motor systems and turn that into a device that supports one side of the heart.

Because you need devices that support all different patients that have heart failure, some patients need a ventricular assist device, some patients need a total artificial heart and so the idea is to have a suite of devices for all patients.

This device is still in early stage development. But again, being able to leverage that technology from the total artificial heart and the know how that comes from that team and from our contributors in the universities in our program, it promises a much faster development of this device.

Then comes our mini pump. Now it doesn't actually look like the pump that's on the screen there at the moment. We put that in as sort of almost like a placeholder image because we have to protect what our device currently looks like. But this is really a first to world solution for patients with HFrEF or diastolic heart failure. The idea is it will be a substantially less invasive implant for these patients.

We've even had to flip the development curve here and, and instead of focusing just on the pump to start with and the surgical procedure a little bit later, we've actually focused on the surgical procedure first to identify the constraints that we need to build into our pump.

We've come up with a really nice, less invasive implant through our colleague David McGiffin, who's part of our program.Then we're using that to develop the device which we're aiming for 5 to 10 year lifetime at least for that device. It'll have that physiological adaptation, so the ability to adapt to blood flow and it really is designed specifically for that population of patients with HFPEF that currently have no other therapy.

All of our devices will also include our supporting technology which, even though we're developing the pumps, the supporting technology is just as important.

I'll go through the. I've picked 3 of these as slightly more detailed examples to go through. A little bit more detail on the subsequent slides and that is that the user informed designs the infection prevention strategies and the control systems.

But just briefly on the other things, we're developing much better surgical tools to implant these devices, particularly looking at ways of implanting them without needing cardiopulmonary bypass which leads to more complications for these patients. We're developing remote monitoring systems for these patients, so then we can keep track of how they're going, how the device is performing and make sure that we're supporting them quite well if they're not able to get to the clinic.

Improve verification and validation technologies, so that way we can really accelerate the development of our devices through that pipeline and get them into patients quicker.

Then developing better education and training tools so that we can roll out our devices into more centres and get our clinicians skilled up and how to use these devices much quicker and ultimately get better results for these patients.

To go through the other supporting technology. First of all, I want to talk about user informed designs and it's really important that we're thinking about all of the users in our product life cycle. From the moment it's packaged, and it's sent out in the distributors, and the cardiac surgeon opens it and implants the device.

Then you know, you've got the nurses in the cardiac surgery unit as well, you might go out, be discharged into the intensive care unit, you've got everyone in the ICU, you've got then the cardiologist that looks after the patient long term, you've got the board nurses, you've got the MCS coordinators, you've got the patient of course, and you've also got the caregivers of that patient as well.

For us, it's really important to understand what everybody needs and so we have a team of human factors engineers led by Cara Wrigley at UQ, who's doing some amazing work mapping out that journey for these patients and the caregivers and all of the users.

This is an example that you can see on the screen where the patient is generally, well, they're feeling unwell.They've been diagnosed with heart failure. They're now listed for a transplant. Maybe they get their device that their VAD put in, they’re discharged from the hospital. They're going through the routines, they're starting to get into their rehabilitation, they get their donor heart. Maybe and then they can get back to a normal sort of quality of life and we're identifying what they need along each stage of that as well.

The same thing with again, all of the users It's a tremendous amount of work, but it's really helping us with all of our decisions.

The next thing in our supporting technology that I briefly wanted to touch on is our infection prevention strategies.I mentioned before that these devices have this cable that comes out through the skin. The device is implanted in the patient, but it needs power, and it also needs signals, and it needs to send and receive those signals. It has a cable that comes out through the skin that attaches to the controller and the batteries and then you can see the dressings that are put on the patient to try and prevent infection and also try and hold that driveline quite steady.

Because as you can imagine, a cable that's coming out through your skin, if it's a little bit too loose and it gets caught on the car door or on something else, it can kind of pull on it quite hard and cause quite a bit of damage. Cable management is incredibly important for these patients. A lot of patients get infection. It's one of the leading causes of death and leading complications early in life for these patients and it's imperative that we look at ways of reducing that complication.

Now, some things that we can do is apply a coating to that driveline to make sure that it better integrates into the body, to make sure that when it is integrated into the body, it prevents the formation and the translation of that infection or that biofilm into the body, which causes really serious problems and so we are working on coatings.

I've sort of just put a black box there because I can't really show exactly what we're working on. But we've got a few ideas that we're looking at as far as different material coatings, different surface structures.

We can think about different meshes where the skin can integrate a little bit better off seeding that with different things to prevent infections and to prevent them from migrating into the body as well, so that's one option.

We think that it's really important that we do look down that option because a lot of patients are still going to need that cable coming out of them for various reasons. Some patients may not be able to survive without a cable and so we might be thinking, OK, how do we get power and signal to the device without a cable? But we can do that without bones.

You know, if you take your phone and it's low on battery, you can put that on a mat and it can charge without actually having to plug it in ad this is through technology essentially called transcutaneous energy transfer, which means wireless power transfer between devices.

If we put a coil or a pad inside the patient that can receive that power and connect that to a battery so that when they're plugged in or not, they don't have anything sending with the power. They can still rely on their implanted battery to keep the device running.

Then we have something on the outside like a vest that sends that power into the body. Then we can do all of this power and data transfer without having to have a cable across the skin, which sounds great, and it can work. There's a lot of work happening in that, including in our program.

But there's also a big risk if your phone doesn't charge when you put it on that wireless power transfer, you can plug it in, and you might not be able to text someone for a little while. But the risk with this is that if that battery runs out for that device that's supporting your life, then you may pass away before you can get to the hospital. We really need to think about those risks when we're designing these solutions.

The last sort of supporting technology I wanted to touch on is our control system development. If you think about the way that your heart works. If you wake up and you want to go for a jog, your heart will be constantly changing its rate and its force of contraction to meet the oxygen supply that you need, that your body needs. It will increase its rate and force, it will decrease it and that will change throughout the day as you're sleeping, exercising, at work, and so on.

These devices don't do that at the moment, so the way that they work is the clinician puts the device that the surgeon puts the device in, the cardiologist sets the speed of the device, and then the patient is usually discharged home and then comes in every so often for a checkup. The speed of that device remains constant throughout that, which means that the blood flow from that device remains relatively constant as well.

It's not adapting as your body needs it, but there are ways that we can fix that. If we were to put a sensor in the device or in the patient that tells us what the patient is doing and how much blood they need, then we can use that sensor and a control system that automatically updates the speed of the pump to continuously supply your body with what you need. If you go to sleep, it might sort of reduce its speed a little bit so that way then it doesn't deliver too much blood flow.If you want to exercise, it rapidly increases its speed. As you stand up, sit down, lay down, all of these constant changes that your body does throughout the day, it will be able to cope with that. It would sense that and be able to change its performance again.

There's a risk. What happens if something goes wrong? What happens if the sensor fails? What happens if the device goes too fast? Things like this and when you're thinking about the regulatory and the legal aspects of that, it can get a little bit complicated.But these sorts of systems do exist in some other medical devices such as insulin pumps, ventilators, and so on.

So, moving on from the technology, I just briefly wanted to touch on the development pipeline. I remember when I was a postdoc and I was sort of developing, or starting to do research into medical devices, and you think that all you have to do is resolve the technical problems and design a nice prototype device and then it'll be pretty easy to get to clinic.

Then later on you realise how really wrong that was and that the main technical parts really happened in this sort of proof of concept phase, whereas the real work happens after that. It's a huge amount of work to then actually develop tests and go through all of the regulatory approval for these devices.

The way I kind of like to look at it is the development of that prototype device where you get something that works pretty well is almost like you've gotten to base camp at Everest. That was probably the easy part, now you have to climb the mountain and that's what we're trying to do at the moment. That's where the $50 million is going to. It's really helping us climb that mountain and get these devices out into the patients.

We also have a staged development of the devices in our program so that then we're not necessarily focusing on doing everything all at once. It's really about leveraging a lot of the technology that exists between all of our partners. Speaking of those partners, you can see them on the screen there. The lead organisation for this is Monash University. Obviously very substantial contributions coming from QT, BiVACORE, UQ, The Alfred Hospital, The Baker Heart and Diabetes Institute, Griffith University, Saint Vincent's Hospital in Sydney and UNSW in Sydney. Tremendous partners to work with and we have an incredible team on this program.

As I said before, co-led by Professor David Kay at The Alfred and myself, but with some really incredible people in our program. These are the chief investigators in the program and these are the ones that are leading the individual projects that are helping form our program to get our devices out.But I really also want to acknowledge all of the people that are involved in this program whose faces aren't on the screen at the moment.There's approximately 50 people either fully employed, or at least partly employed, within this program that are making this a success. I really want to acknowledge and thank them for all of that hard work that make this all makes this all happen.

Second last slide. Now a lot of people ask me what was involved in winning a $50 million grant. It was really not easy. We were very lucky to have been involved in the MRFF Frontiers back when they had the 2 stage process, where the first stage they awarded 10 grants of $1,000,000 for teams to essentially develop their $50 million program. So, we were lucky we were one of those 10.

We got the $1 million which helped us put all of the documents that you see on the screen together. This was an enormous amount of work that led to around 600 pages of content in our application and when I say content, I don't mean CVs and track records and publication lists. This was all real content there. Things like research and commercialisation plans, voice of customer, market research reports, health economics, regulatory reimbursement reports, IP arrangements, budgets, risk reports, clinical trial protocols, path to market plans, a massive business case where we worked out exactly who our market is and how big that is and so on.

All of our financial projections for many, many years, for the next 12 years, something like that. It was an enormous amount of work, and a lot of people are involved in that, we have to thank for it as well and not just the research team as well, a lot of professional services involved in that.

Wrapping up, very happy to answer any questions about the program. In summary, I suppose we're sort of developing the next generation of these mechanical circuitry support devices and in doing so, building a cardiovascular device ecosystem in Australia as well. It's a big program, lots of jobs and hopefully we have some really good successes at the end of this.

Thank you very much everyone for listening and again, more than happy to answer any questions.

39:05 Prue Torrance
Great, thanks a lot, Sean.

I might just see if the support team can turn my video back on, but in the meantime, you can hear me. That was fabulous. Thank you for that presentation, really fascinating. Really amazing to see how the technology has come from these very large external devices now to having quite small number of batteries and pumps attached external to the body and then even the BiVACORE item, which looked kind of too good to be true fully internal device for the future. Really fascinating to see.

I'm now going to open up for questions, so anyone listening who's got a question, feel free to put it in the chat or to raise your hand.

But I'm going to kick off with the first question.

We do find with our audiences for Speaking of Science that they're as interested in the technologies and the innovations as they are in your career journey, and you mentioned briefly your postdoc in medical devices.

I wondered if you could tell us a little bit more about your journey and how you ended up working particularly on these artificial hearts?

40:14 Professor Shaun Gregory
Oh, I think I actually had an extremely linear journey in my career.

I studied biomedical engineering because I had a passion for maths and science and human health back when I was very young and so I studied biomedical engineering and I did my capstone project, my final year project with Daniel Timms, who's the inventor of the BiVACORE, device and so I worked with him on that.

Then I did Masters virus research with him as well on ways of testing these devices and then my PhD with him and also my PSC and John Fraser, my two of my big mentors on these devices and then sort of started running a research laboratory directly out of my PhD in in cardiovascular engineering.

Did that postdoc at UQ for 3 years, went over to Griffith for 2 years because we want to be granted, so put that through there. Then went down to Monash University for about 6 years and built up a cardiovascular engineering program there.

I was lucky enough to be based out of the Victorian Hospital. If anyone in Melbourne has seen that beautiful building and even help design some of the engineering labs within that building as well during my time there and work with Steve Nichols and the team out there.

And the Alfred Hospital, of course. I was based in the Alfred for about 4 years during my time in Melbourne at the Baker Institute with David Kay and Vin Pellegrino and David McGiffin and then Savannah Marasco and all the amazing clinicians out there. I've kind of always had an engineering lab inside a hospital and I think that's been really one of the key parts of my entire career.

You know, I'm an engineer, right? I think about things in a technical way, but having my office and my lab in a hospital means that we can have the clinicians, the patients, all of these kind of people in the laboratory telling us, hey, the device that you're developing, the cable needs to go on the other side so I can implant it or that tube needs to be a bit longer so I can get that into the patient or whatever it is.

It's that real integration of engineering and medicine that I think has led to a lot of this success. That's kind of a quick summary.

42:24 Prue Torrance
Fabulous, thanks.

And yes, I have family who've experienced the new heart hospital. It's fabulous.

Alright, so we do have some questions coming through in the chat now and so the first question is really about whether or not the devices are kind of reusable.

Can the devices be used in another patient after the original recipient then gets a donor heart?

42:48 Professor Shaun Gregory
OK, so I'll kind of talk about that in in 2 ways.

First of all, if the questions about reusability, despite the fact that they might be $130,000 each device, no, they're not reusable. When we take them out, we have to cut the cable there and you don't really want to repair that and have a repaired device in you and there's also a lot of other issues with reusing the device.

But if the patient gets a donor heart and doesn't do well, they might be put on ECMO, which is a different type of mechanical circulatory support. This is sort of a temporary version that's a little bit less invasive, but you're stuck in the intensive care unit, and you might be put on a device like that typically if you have a donor heart.

But I mean, I haven't really heard about one of these devices being used in a patient that's had a transplant.But I don't see any reason necessarily why they couldn't be.It would really just depend on the clinician's decision at the time.

43:43 Prue Torrance
So you've already touched then just briefly on the cost and one of the other questions is how has the cost of these devices changed over time?

Are the new ones going to be a more affordable option or are they actually heading towards being more expensive?

43:56 Professor Shaun Gregory
That's a good question.

Look, the devices have maybe increased a little bit in their cost over time as they've gotten a little bit more complicated and more R&D goes into it. There are more regulatory hurdles to get through and you need to recoup that money for your cost of your device, things like that.

Our devices, we're aiming to be quite low cost, particularly the mini pump with the intention of being substantially lower cost than the existing devices.

There's ways that you can do that, sort of some in a way, engineering sacrifices you might even say, that you can make within the device to make it much cheaper to manufacture and also make it a little bit easier to get through the regulatory hurdles and things like this without really sacrificing the quality of the device.

That’s something that we're taking a really big focus on within our program is the final cost of the device, because unless we can make it cheaper, we're not going to be able to roll this out to more patients.

44:54 Prue Torrance
Yeah. OK.

The next question is around whether or not the devices are actually intended to be simply for that transition period waiting for a transplant, or are they intended to be a permanent solution and used indefinitely?

45:09 Professor Shaun Gregory
Originally, these devices were made as a bridge to transplant. This is where the patient needs a transplant. You can't get one yet, they're not available. You're sort of circling the drain. You need something to keep you alive, to keep that blood flowing and so these devices would be implanted strictly as a bridge to transplant originally.

Now those indications have really broadened, so it's actually now more than 50% of the implants are for what's called destination therapy. Destination therapy is where you put these devices in.You might be ineligible for a transplant, but you can put these devices in and then they are able to live for might be 10-15 years longer with one of these devices.

We're also starting to see some indications for bridge to recovery we call it, where we might be able to change slightly the way that we manage the device and manage the patient to give them the correct pharmaceuticals to allow their heart to actually recover.

Now this is a little bit rare. I think it only happens in around 3% of patients, something like that. But there are more indications that it might be possible with better medical management of these patients to get more recovery when you can actually take the device out and leave their native heart in place. There are a few different indications coming in for these devices.

46:25 Prue Torrance
Wow, that sounds exciting.

OK, so the next question is really around protecting the tissues around the heart.

You talked a lot about the driveline and managing infection risk there, but what about more internally with natural hearts being soft and the artificial hearts being quite hard? What do you do with the tissues around to protect them? Or is it not been shown to be a problem?

46:47 Professor Shaun Gregory
Look, it's really important that we make sure that the anatomical interactions between the device and the patient are optimised. If they're not, you can have bleeding. You know, I think the question definitely alludes to it. If you have something soft against something that's hard and they're not integrating fully, you can you have a pathway for blood to just come out of there, especially from a high pressure left ventricle.

The interaction between that chamber and the device has to be perfect and that's why we're really considering the surgical tools and those surgical connections early in our program. The way it's currently done is that you have essentially what's called an inflow cannula and an outflow graft. The inflow cannula, which is this bit on the device, it has a sewing ring placed around. It's not showing on this device because it's been taken off, but there's a ring that comes around the device and that ring has a hard component that attaches to the hard device, but it also has a soft flexible component that is sewn onto that soft tissue of the left ventricle.

It’s kind of like this mediation sort of device that connects that soft tissue with the hard part and you have a similar strategy with the total artificial hearts as well.They have a sewing ring or sewing attachment that you sew that soft part onto the device that connects the hard device onto it.

Same thing with the outflow graft is quite a flexible soft connection that you sew onto the patient, right.

48:13 Prue Torrance
Next question is about any signs of failure in the device. Are there any signals that the devices give off or any ways you can track and see that they're likely to fail before they do?

48:27 Professor Shaun Gregory
Yeah, another great question. Yes, is the answer to that.

We have to keep track of these devices quite closely. The devices, they essentially output quite a few signals that we can use to get an indication of how the device is performing. We don't necessarily put like sensors on them; they don't have pressure sensors.

One of the older devices did have a flow sensor on that, but it's not really implanted in patients. What we use is the motor current of the device. That motor that's spinning, that impeller, we can record the current that it uses and that current, we can then actually get a lot of information about what's happening to the device and what's happening to the patient.

If that current goes way up, we might suspect that there's a blood clot in the device that's drawing a lot more current to spin it at that speed and so that's when we can get an alarm. The device alarms, the patient might have to go into the clinic, get an assessment and may even need a replacement device so we do get quite a lot of information out of the device.

We can also look in some devices at the waveforms of those currents. We can estimate the flow rate that the device is outputting based on those waveforms. There's a whole bunch of things that we can do clever things that we can do with the data that comes straight from the device to detect what's happening inside the patient.

49:41 Prue Torrance
Is every severe heart failure patient eligible for the use of an artificial heart or device, or can there be some comorbidities that might rule them out?

Ignoring the access issues around cost, the health of the patient, how does that affect their eligibility?

49:58 Professor Shaun Gregory
Yeah. These are really assessed on a case by case basis. Not every single patient is going to be able to get one of these devices. It's going to come down to things like your age, your health, smoking, drinking, how your other organs are doing, all of that kind of stuff as well. It really is a case by case, yeah.

50:19 Prue Torrance
And possibly not the question for the engineer, right?

50:23 Professor Shaun Gregory
I'm not the one that has to make that decision.

50:24 Prue Torrance
Thank you. Alright, now we have a funding question.

You told us about getting the $50 million grant and the work that went into that. But the question is, what do you think would have been the impact of not having the initial $1 million funding for the planning of the project?

50:41 Professor Shaun Gregory
Another really good question.

I remember when we submitted the grant and we went through the interview, which the interview was crazy, by the way.I said afterwards, pretty much no matter what happens, I don't think I can ever go through that again.

That was the craziest few years of my life. It was utterly exhausting and then we got the grant and it's been craziest since. But I remember saying that I don't think I could do that again.

I don't think I would necessarily apply for one of these grants again because it was quite damaging too just me.But in the end, I actually got involved in another application after that in one of the rounds that didn't get the $1 million and so I saw what the impact was, and it was so much harder.

We were able to at least call on the support, employ people, project managers, partnership managers, legal people.We were able to get consultants involved in the bids that went in after hours that didn't have that support. They weren't able to get that support and I think that meant that in the end, the applications that were submitted were probably not as mature as what ours was.

We used that $1,000,000 really to assess, as I showed in that list of documents before, what our regulatory plan was, what our reimbursement plan was in multiple jurisdictions.

We assessed our business case. We assessed all of these kind of things, which meant that we had really high confidence that we could achieve what we wanted to achieve and a fairly low risk for the program, which I think is very important when the government's putting in $50 million.

On the other hand, without that 1,000,000 and if you're not able to develop that knowledge and reduce that risk, I think that there's a bit of a problem there.

I think that you'll have potentially programs that are maybe not as developed, maybe higher risk and maybe that's OK, but there's going to be potentially some issues down the track with that.

52:30 Prue Torrance
Great, thank you. I have one last question to close us off.

We've talked a lot about the changes in the technology over time and it was a really good series of images as well around that, over time.

Fast forward to 10 years in the future, what do you think artificial hearts look like both in a kind of engineering sense and in outcomes for patients living with severe heart failure sense?

What's the future?

53:00 Professor Shaun Gregory
I mean, luckily you picked 10 years because our path to market for these devices is approximately 10 years.

I'll refer back to that slide where I showed our 3 devices on that slide and I'll say that's what I think the future of these devices looks like because in 10 years, my hope is that all 3 of those are commercially available devices.

We have a suite of devices that is there to support all patients with heart failure and I think that they will have a lot of those supporting technologies in the control systems that automatically adapt the device to meet what the patient needs.

They'll have really wearable systems where the patients can actually use them and interact with their devices, have remote monitoring where they can live remotely and still the clinician gets feedback on it and they will hopefully be implanted in a lot more patients and saving a lot more lives. That's really our vision for our program.

53:52 Prue Torrance
Fabulous, thank you. That's a great vision and it's really been a pleasure to listen to you speak today. You're very passionate about your research and your projects and I'm sure everyone is feeling very inspired about the future.

Thank you in particular to being part of our celebrations for National Science Week and for now joining the ranks of our Speaking of Science alumni.

A reminder to everyone that they're recording will be made available and do please sign up and listen to future Speaking of Science series.

It is a great pleasure for all of us at NHMRC to recognise the contributions of Australian health and medical research and to see everyone's interest with the questions that are coming through.

I want to also recognise the contributions, particularly in a funding sense of the Medical Research Future Fund and I know that some of the program managers are actually have been listening to this seminar today.

That concludes today's Speaking of seminar. It's been a great pleasure to host you and all the best for the future.

54:54 Professor Shaun Gregory
Thank you so much for having me, it was a real pleasure. 

End of transcript.