Interview with our CEO

Rainer Schultheis is the CEO of Saphenus Medical Technology GmbH, an Austrian medical technology company founded in Krems in 2016 with the aim of using bionic principles to develop innovative product categories for amputees and diabetics that improve gait safety and reduce pain. Its aim is to use regenerative approaches to help people keep their limbs and improve their quality of life. The interview was conducted by Fritz Hinterberger.

Before becoming an entrepreneur, Rainer Schultheis gained twenty years of experience as a science journalist and author, including at the Austrian Broadcasting Corporation (ORF). Since 2005, he has been involved in several scientific projects on ecological and social sustainability (focussing on human and social capital) at the Sustainable Europe Research Institute (SERI). Together with Accent, he founded the MedTech Factory in Baden/Vienna to support young companies in this field. Rainer Schultheis studied at the University of Vienna (meteorology) and at the University of Economics and Business Administration (business administration) and is also a member of the Austrian Chapter of the Club of Rome. 

The interview focuses on the importance of sustainability for the success of start-ups, particularly with regard to the acquisition of funding and investors. Schultheis emphasises that a rethink of linear growth is necessary and that this applies not only to medical technology, but also to young companies in their growth phase. He believes that taking social impact and sustainability issues seriously is crucial to a company’s success.

Q: Let’s start with you and your company. You work in an area that most of us will hopefully never have anything to do with.

A: Yes, and at the same time it’s a surprisingly large group of people who are affected. In our part of the world, around 0.5% of the population are amputees. That means between 30 and 40,000 people in Austria, for example, and ten times that number in Germany and 2 to 2.5 million in Europe. Incidentally, most amputations in Germany are a consequence of diabetes. So-called traumatic amputations, for example as a result of a car or motorbike accident, are constantly decreasing, mainly because many can now be saved in intensive care medicine. And a little bon mot The ones who. Incidentally, the number of diabetes amputations in the USA is twice as high as in Europe. 

And on the other hand, the appalling events of recent years in the war zones, i.e. Israel, Palestine, Ukraine and Russia, have resulted in a terrible number of amputations, where amputation is unfortunately obviously part of a war strategy – with minefields the size of Austria, by the way. So every second wounded person in the war in Ukraine is one who has to be amputated. This means that a great many people there are affected by traumatic amputations. And then you generally have a lot of amputations in developing countries due to poor infrastructure. People get caught in electric circuits, for example, and we’re talking about 50 to 55 million amputees worldwide. That’s a market that can’t be served at all. It’s unbelievable. 

Q: How do you see the current situation beyond the bare figures?

More than half of these amputees – that’s around 30 million people – don’t have a prosthesis. At best, they sit at home, but often they don’t have anyone to take them from A to B and, if they are unlucky, they are also marginalised. That’s a very large number. And with amputations, compared to other disabilities or illnesses, it is clearly visible from the outside and therefore very emotional when someone is missing limbs. It’s something that immediately touches you. So the market is surprisingly large and many people are unfortunately unsupplied. 

Rainer: Today, many amputees do not receive adequate prosthetic care and the aim must therefore be to make prostheses available at a lower cost or even free of charge – neither in Austria and certainly not in the Global South. The company Saphenus is working on solutions to close this gap and make prostheses more affordable without compromising on quality and functionality.

Q: What orders of magnitude are we talking about financially?

A: In our part of the world, where labour costs are so high, they account for almost the entire cost of a prosthesis because the sockets have to be precisely adapted to the body. Together with the actual prosthesis, you end up with an order of magnitude of €70 to €80,000 for a lower leg prosthesis that is replaced every six years. And you can say that the price for someone who is also missing a knee, i.e. who has had a thigh amputated, doubles or triples again. 

Q: Are these costs covered by insurance?

A: More or less. Because there is a clear two-tier society here – between those who have an accident in their free time and those who have one at work or on the way to work. This means that in the event of an accident at work, the best possible care is guaranteed by law. And in the case of a thigh amputation, for example, this means that someone receives a micro-process-controlled prosthesis with a socket in the region of €80-100,000 from the state, which is rebuilt every six years. However, if the same accident with the same level of amputation and the same reason for the amputation happens during your free time, you are only entitled to a prosthesis that may cost a maximum of €10 to €15,000. That is unfair. 

And I think that if we look at the SDGs and the UN Convention on the Rights of Persons with Disabilities, everyone is actually entitled to the same level of social participation. It is incomprehensible to me that the legislator makes such big differences. Why should someone who has had a leisure accident have to stop every time they go down a flight of stairs? And someone who has had an accident at work is allowed to go down the stairs even though they have suffered the same amputation. 

Q: And your product can now be used for both. 

A: Our product can do both and can therefore potentially close this gap, because it means that patients can ‘feel’ the prosthesis in analogue mode without additional microprocessors. It was really amazing for us to hear that after a few weeks, patients have the feeling that their prosthesis is just as warm as their preserved leg. 

Research has shown us that this sense of touch has incredible regenerative power. The amputation of peripheral limbs is ultimately a ‘use case’ for which we can make an important contribution with this knowledge. 

It allows you to do a lot of things that were not possible before. I’m talking about climbing stairs, but walking in the dark, for example, is almost as impossible as walking backwards. This suddenly becomes much easier with our feedback system and is therefore a great way to significantly improve quality of life, even with simple prostheses. 

Q: And you are now taking this to countries such as Tunisia or Ukraine.

A: We started quite early on – even before the medical device was approved as such – through an extremely committed person from a family of entrepreneurs, Christian Bouda, to make it possible for people to stand on both feet again with the simplest of means in a country where 90% of amputees have no prosthesis, namely Tunisia. That was an incredibly great project. We now have ‘Second Leg’, an analogy to Second Hand, so to speak, because we started by collecting prostheses from the AUVA and then built prostheses using the materials that were available locally. 

And with a great deal of innovation and improvisation, we have now managed to provide many people with prostheses. But we have learnt even more from this. For us, that was the proof of concept for other regions? And then the war in Ukraine started. So now we are actually in the war region very early on for a company and are providing care for people there who have lost their legs due to trauma.

Q: What comes back to Austria from these experiences?

A: All these projects help us to better understand how we can make prostheses more affordable and at the same time support the bionic principles we have developed. That’s why we have also travelled to a completely different market in addition to Ukraine and Tunisia, namely Asia, to see whether there are manufacturers there who produce prostheses at low cost with our regulatory requirements and perhaps find proprietary solutions together with them. 

Q: What does this ultimately mean for Saphenus as a company? 

A: I would perhaps use the analogy of health insurance glasses. Prostheses are produced and distributed in a highly regulated and anything but free market. Our aim is to improve prosthetic care and thus do something for the common good by making things cheaper – for those affected and for the state. We even envisage that prostheses should no longer cost anything at all, but only the production of the sockets. And that the prostheses should be made available to amputees for the period of use – perhaps in return for a loan fee paid by the health insurance company. 

After all, the average life expectancy of an amputee is six years because many also have other illnesses. However, expensive prostheses generally last much longer and are not so high-tech that they only last six years.

This begs the question of whether €100,000 every six years really makes sense when €100,000 can be used to provide ten amputees with our system, with practically the same quality of life. 

If we spread this idea to the masses, then the costs of our system are de facto irrelevant. And our goal is then really only for the state or state-organised social insurance to essentially bear the costs of the adaptation. But the cost of the prosthesis itself should no longer be the argument in favour or against.