Using low-temperature re-moldable thermoplastic, the Amparo prosthetic socket is designed to fit on an amputee’s residual limb in a matter of hours, without the need for a trained prosthetist or any return visits to the clinic. Doris Retfalvi learns the story behind this international student collaboration
There are more than one million amputations happening around the world annually – that’s one every 30 seconds. In the developed world, this is most often caused by peripheral vascular disease (the blockage of blood flow to a limb) or diabetes, but in the developing world it is external risk factors like land mine injuries, factory accidents and poor sanitation that claim the limbs of those affected. According to the Journal of Orthopaedic Surgery and Research, patients in the developing world are more susceptible to amputations because they often seek medical attention when it is too late to salvage the limb and amputation is the only option.
Around 80 per cent of the world’s lower limb amputees don’t have access to modern prostheses, and those who do have to make frequent visits to the clinic to assure their prosthesis is always well adjusted. On top of this, materials used in the manufacture of prosthetics are usually exported from developed countries and may cost over six times the average income of a family living from a developing country, the American Academy of Orthotists and Prosthetists reveals.
Addressing this global issue was the topic assigned to Lucas Paes de Melo, Wesley Teerlink, Jessica Menold, Matthew Dion and Isabel Bahiana Wotzasek – a team of five students taking part in a 2014 multidisciplinary project of design-thinking, led by the Global Engineering Teams in Berlin. The aim of the project was to take students specialised in healthcare, engineering and design out of the academic environment and face them with the problems and demands of the real world. So the team decided to travel to South Africa and Brazil to speak with underprivileged amputees to learn about their struggles trying to obtain a prosthetic leg. Here they found out that after an amputation, the residual limb changes volume throughout the day and high temperatures can cause it to swell to the point it cannot fit into the prosthetic socket.
Matching their findings with the available solutions on the prosthetics market, the students decided to design a re-moldable prosthetic socket made from low temperature thermoplastic that could be fitted directly to an amputee’s residual limb, instead of using the casting method required by traditional sockets. The socket would not require the intervention of a trained prosthetist, thus reducing the time and number of visits the amputee would have to make to the rehabilitation clinic. They named it Amparo, which is Portuguese for support and protection.
But their solution had too much potential to be limited to a university project. So the students decided to turn their idea into a business. ‘We had an idea of how the prototype would be built but we had no money to research different materials or do fittings with amputees. We needed funding before we could actually build the product,’ says Lucas Paes de Melo, now CEO of Amparo. ‘So in 2015 we wrote the business plan, putting the whole product idea and development into a business concept to help us in our application for a government grant.’
Six months later, Amparo received the EXIST Business Start-Up Grant of €200,000 from the German Federal Ministry of Economic Affairs and Energy that helped them run clinical trials and develop the socket. In the summer of 2016 Amparo was officially launched as a Berlin-based startup.
‘Many clinics we had run trials with in Berlin believed our product could be applied in the interim phase of an amputation,’ says Paes de Melo. ‘Every time a person has an amputation there’s an initial six-month phase where they are still adapting to their life as an amputee. In this period the residual limb is really swollen so it changes quite a lot in volume.
‘So to have a product like ours which is re-moldable means you can reshape the socket as the amputee goes through the recovery process. Last year we went to India and Brazil and we realised there was a need in those markets. But being a very small and new company, to start to sell your products overseas would pose a lot of challenges. So we have readapted the business model to start serving amputees in Germany. We plan to expand to Europe by the end of this year, after which we would go to developing countries.’
To launch a prosthetic device in a highly regulated German market that’s already filled with established industry players isn’t easy. But Paes de Melo is optimistic. ‘We have just started the regulation process which should be finalised by the end of April this year. Our case is quite privileged because that product is really low-risk so you don’t have to go through so many tests to regulate it as it is non-invasive. If we get into the German market we can get into any market.
‘What is more challenging is the fact that healthcare is so consolidated with big firms that it makes it hard for a startup like ours to join the circle,’ Paes de Melo adds. ‘You have to be really, really impressive because not many people give credit to small firms. We’ve been quite successful in that sense because we’ve created a technology that is user-centred and did a lot of research before developing the product. So the end result was something that was really needed.’
Amparo will also be setting up partnerships with a number of orthopaedic clinics around Berlin, including Koch Orthopaedie run by prosthetist Daniel Koch, who has already assisted the team in their initial research. These partnerships will help Amparo run a few months of pilot projects before hitting the market by mid-2017.
The end-user response to the Amparo socket has been widely positive, with clinical trial participants even requesting to use it outside the clinical environment, says Paes de Melo. ‘We have done over 20 fittings so far but since we don’t have the product certification we don’t feel comfortable legally to let people even voluntarily take home the device. We’re actually starting to do pre-sales but we want to deliver the first devices after we finish the pilot projects.’
With three awards won already, including the ASME Innovation Showcase USA award in 2016, Amparo’s proudest moment was when they saw the first amputee walk with the help of their innovation. ‘Her name is Melissa and she liked our project from the beginning. She kept volunteering to come back and help us out with our trials. I think that for people from the developed world to know that there are others less privileged that go through the same problems but don’t have access to the same help, it really strikes a chord with them. Melissa was one of these people and I think this is why she kept coming back.’
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