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.
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.
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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.
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.
Doris has a Masters Degree in Magazine Journalism and has previously worked on the editorial desk of Good Housekeeping Magazine UK. She was also a data research associate at DrugDev, an online pharma clinical trials hub based in London.