Alivio Prosthetic and Mobile Clinic

There are at least 30 million lower limb amputees and 90% of them do not have access to modern prosthetics. If they are in fragile contexts, the chance of having access to a prosthetic clinic is close to zero. Alivio is solving the problem of access to prosthetic devices for lower limb amputees in fragile contexts specifically, and developing countries for vulnerable populations in general. User research video: https://shorturl.at/ceBNZ

A prosthetic limb is the current solution for people who undergo an amputation. A prosthetic socket is the interface between the residual limb and the mechanical leg itself. It's what keeps the leg attached to the body and is the most challenging piece. The socket must be individually customized by a highly trained prosthetic technician. This process may take between 8-20h of work, depending on the professional skill level and what equipment he has access to. It also requires an equipped prosthetic workshop with several tools, which can easily cost $50k. 

Above all, there needs to be many interactions between amputee and technician, at least two - the first one to take the mold of the stump, and the second one to deliver the leg. Nevertheless, its common that there are changes to the stump in between this time frame and there's a need to modify the socket. This can increase the number of interactions significantly (even 8 times, depending on the case) So its normal to say on average there must be at least 3 interactions between patient and technician. 

Also, after the surgery, the amputee's stump is very swollen and will shrink significantly in the first year, requiring the amputee to have between 3-5 sockets in this period. This process must be repeated every time. 

The lack of access to prosthetic clinics and multiple sockets affects the rehabilitation process of the amputee, delaying his recovery and drastically affecting his quality of life. In summary, there’s a lack of technologies that can be affordable and fit in fragile contexts, as well as no appropriate prosthetic clinics to service amputees in need.

Alivio has developed the Alivio Socket and Mobile Clinic. Two elements of our solution.

The Alivio Socket is a pre-mounted off-the-shelf prosthetic socket for lower limb amputees, the interface between the residual limb and the mechanical leg itself. It is made out of a low temperature thermoplastic material, therefore it can be molded directly to the amputee’s residual limb. The entire socket making process takes only one hour to be completed, significantly reducing the waiting times for amputees as well as the labor cost for prosthetic clinics. By fitting the socket in only one appointment, there are no chances of providing prosthetic sockets that won’t fit properly, because the amputee leaves that session already walking it their device. It comes in a conic shape format and can be used for both right or left leg, which reduces storage space requirements. 

The material used was developed by Alivio and it does not lose its properties during heating or cooling phases. This means it can be remolded multiple times, at least five times up to now. This means that whenever the amputee's limb changes its shape he can get a completely new socket format by a prosthetic technician for no additional material costs.

Here is a short clip of how the product works. It’s not a product demo, but it's the closest we have to it, for it has some images of an amputee being fitted in Kenya: https://f.io/dRKj9z88

The Alivio Mobile Clinic is an allusion to the fact that the product can be done anywhere. All the tools required for the Alivio Socket fitting process were also developed by Alivio and they can fit into a portable sports bag. All in all it means the technician can now provide prosthetic fitting services at the hospital, at the amputee's home or anywhere else just by having access to electricity - which could also be as simple as a small generator or even a car’s battery. With this technology the prosthetic clinic becomes mobile, and is now able to service amputees in remote or rural areas.

Here is another short clip that emphasizes the technology’s portability power. Again, this is not a product demo but rather statements from prosthetic technicians and lower limb amputees: https://f.io/E0TJR_bF

The first question a lower limb amputee asks after their surgery is: “will I be able to walk again?” For that they'll need a prosthesis. There is a lack of prosthetic clinics spread throughout fragile context areas, making prosthetics either not available, or available with extremely long waiting lines to receive a prosthetic leg. Above all, amputees must travel to the Prosthetic Clinic several times and stay away for extended periods of time, which is challenging due to the lack of means - resources or transportation.

In some places there are mobile clinics that rotate periodically only in urban centers. Amputees must still spend periods of time far away from home in order to receive a prosthetic leg. At the prosthetic clinic, technicians take a mold of the stump and will only deliver the prosthetic leg next time they go back to that area, which could happen months afterwards. In many cases the stump has already changed its shape and the prosthesis won't fit them any longer. What usually happens is that they either wait longer to receive an appropriate device, or they end up keeping a bag quality fit device, which could result in other health problems (gate issues, back pain, etc.). The Alivio Socket and Mobile Clinic solve this issue by providing a leg at the user’s location and in only one appointment.

If they make it to the prosthetic clinic - or the clinics come to them - the question then becomes: “how will I cover the costs of the device as well as multiple traveling expenditures?”. Prosthetic devices are usually not covered by governments or health insurances in developing countries, let alone in fragile contexts. Therefore they must be purchased privately. The average cost of a modern prosthetic leg in developing areas is around $700, which is hardly affordable in many places. Sometimes people receive donated prosthetics (free of charge) from local or international non-profit organizations, such as the ICRC or HI, but that's far from being the norm. The Alivio Socket solves this issue due to its cost-efficient remoldability, having many socket shapes in only one device.

The immediate and obvious consequence is that amputees won’t have access to prosthetic legs. They likely will be isolated in their communities and economical activities, either due to social stigma or for not being effective enough, fast enough, good enough. This means they will be constantly dependent on other people, most likely their family members, causing a burden to their micro-economy and reinforcing the cycle of poverty they are currently inserted in. If they do get a prosthesis they will be empowered to act more independently which is great already. Prosthetic legs are like having a car, it needs constant repair. In case the provider leaves their site, they are likely not to have a leg after a couple of years, putting them back in vulnerability. The Alivio Mobile Clinic solves this issue by drastically reducing the cost of prosthetic services, especially in remote areas.

Alivio’s team is currently composed of 5 team members.

Lucas, CEO, has 10 years of experience in the filed of prosthetics. Originally from Brazil he understands the conditions of emerging markets and is connected to several local organizations (i.e. INTO, AACD, IMREA, ABBR, etc). Alivio will start operations in Kenya as first market, so involvement with organizations operating locally is crucial:

- representatives of people with disabilities (i.e. NCPWD)

- government related organizations for policy and service provision (i.e. MoH of Orthopedic Technology, KNH)

- Service providers of prosthetics (PCEA; APDK)

- international organizations (i.e. ICRC, HI, AIC-Cure)

After many field trips, Lucas is moving to Nairobi next September - being on the ground is the best way to learn properly (user, provider, politics, society, culture, etc). Although has prioritized Assistive Products in its public health policy, it doesn’t have the resources for proper implementation at scale to its population. It does not yet provide devices free of charge to its population, which cannot be afforded by the majority of its population.

With  Lucas, Alivio is joining forces with Humanity & Inclusion (HI) in order to trial a project in Dadaab and Kakuma, two refugee camps in Kenya that could benefit from its mobile services and immediate fitting technologies. This will help in better understanding the situation of amputees in fragile contexts.

Richard Frost, Chief Strategy Officer, was one of the founders and CEO of Motivation (https://www.motivation.org.uk/) and has 30 years of experience with Assistive Technology in developing countries. Having lived in many different countries (India, Sri Lanka, Romania, Russia, etc.) for several years enabled him to understand the situation of people with disabilities and support the development of the “WHO Guidelines for wheelchairs” (https://www.who.int/publications/i/item/guidelines-on-the-provision-of-manual-wheelchairs-in-less-resourced-settings). He is directly involved in programs and consultancy involving WHO, ATscale and AT2030.

Stefan Constantinescu, CTO, comes from Romania and has worked in motivation for 30 years developing wheelchairs. He has lived in Tanzania and worked closely with TATCOT, Africa's most prominent P&O school, to better understand the technician’s perspective. This can be easily seen as he is one the people behind the “WHO Wheelchair training” programs (https://www.who.int/publications/i/item/9789241503471). As the technical brain behind Alivio he has taken on a new challenge to create the same impact in prosthetics as he has in wheelchairs.

Cally Moore, CFO, has also worked in Motivation for more than 15 years managing numbers, budget and finance plans for the cause of Assistive technology in developing countries. In paralel, she is also the CFO for WDC (https://uk.whales.org/) and has vast experience in managing stakeholders and deliverables for grant holders, private investors, loans and financial plans for social/environmental impact organizations.

Antonio Bösze, Product Developer, is a motivated hands-on Brazilian engineer who has made his initial career by developing prosthetic and orthotic products close to users in different organizations in Brazil. Self-taught in English, 3D printing and many different engineering fields, he has the empathy and motivation required to understand and develop appropriate solutions for people with disabilities.

We have already developed a manufacturable prototype, which is currently being produced in China. Molds for one size are already in place and making prototypes for different material tests. We envision that 3 sizes might be necessary to fit the majority of amputees, but this has not yet been defined.

At the moment we are doing material testing with Fraunhofer IAP organization (Germany) with our prototypes. This will enable us to understand specific properties of different material combinations for strength, stiffness, molding temperature, etc, which will largely define how the material might react to different environments. This process has started and we expect to receive testing results by May this year. 

In parallel, we are about to start clinical testing, which will be performed with 10 users (lower limb amputees) with our clinical partner (Certified Prosthetist & Orthotist - CPO) in Australia. This is fundamental in order to develop and define the fitting process of our technology (step-by-step Alivio Socket fitting guidelines to CPOs). This process is expected to be finalized by June this year.

Next in line we'll run our prototypes with the selected material through the ISO tests for CE conformity (ISO 10328 - structural testing for lower limb prosthesis; and ISO 13485 - quality management systems).The testing labs have already been reserved and we expect all structural tests to be finalized by July this year.

At the moment there are no users using our solution on a daily basis. The clinical testing mentioned above is only meant for the fitting method development, therefore users do not leave the prosthetic clinic with the solution - they only experience it for a couple of hours at a time.

Nevertheless, following the steps mentioned in the previous question, we have already signed MOUs with several organizations in Kenya (such as the Kenyatta National Hospital, AIC-CURE and private practices), as well as others that have demonstrated significant interest to trial our technology (such as the ICRC mission in Somalia, HI refugee camps in Kenya and APDK). 

Since our technology can be used with any other kind of prosthetic component adaptors, we could do trials with organizations that use regular modular components (technology largely used worldwide) as well as with the ICRC, which have their own prosthetic component adaptors.

Field trials are planned to start in October this year, after a technology training workshop planned to be held in September in Kenya. We currently have resources to trial the technology with 60 amputees in 4 locations, nevertheless the interest shown has been from around 10 different organizations. We are currently looking for research partners that could run data management for a research protocol we have already developed.

The way I have heard of MIT Solve is that it's really good at putting the most brilliant social/environmental impact entrepreneurs in the same room to think together in order to understand each other's challenges and help them solve these issues. There's no money in the world that could even pay for something like that. 

We don't see Solve as clearing our current financial needs, but rather connecting us to like-minded people that will help us throughout our way to bring our solutions to the world in a more successful way. I'm of the opinion that surrounding myself with the power of other heads thinking together can shake the world.

Also, being an entrepreneur is not an easy path to take, being an impact entrepreneur is even more difficult because you are constantly challenged by the society's status-quo that prioritizes profit over people, which is unfortunately still the norm nowadays. Although the impact community is growing, it's still not taken as seriously as it should, considering the world we are living in with all its current and future challenges.

As for some specific support:

Being part of a network with people that have similar goals is one of the most powerful things I have gained from different places (Accelerators, Competitions, Study Programs, etc). Because being part of something is bounding, that's what brings people together, and if that "something" is related to our passion, which is bringing solutions to vulnerable populations in developing contexts, this would be the most precious thing to take home.

We would love to have the top MIT departments to help and run our product research with the field trials we intend to do from October on. It would be beyond amazing to get such support from this competition.

Although we have people from a developing country in our team (Brazil and Romania for now), and with experience in many other developing countries, I feel that being able to implement our solution in different places will require a major cultural adaptation in every different setting, so support in those regards would be marvelous.

These are just a few examples of what we believe we would gain from such an experience.

Lately, a very common trend in the prosthetics industry solution space is to work with 3D printing technology, which brings an interesting perspective to the space  but still has many challenges. In some ways, 3D printing tech is very advanced, but it requires another level of skill development of the technician. In developed areas its more common to see prosthetic clinics slowly moving towards this direction, but it’s not as common in developing areas, even in emerging markets - for this is also not widely taught in school. The learning curve can be as long as 1 year until a technician can confidently make prosthetics sockets with lower margin of error in a software.

Thinking further of developing areas, it’s common to experience power shortages, which would require starting the process all over again from the start whenever this happens - which could be weekly or even daily. Supply of filament materials or broken parts is a challenge in remote areas. And if there’s a problem with the printer itself, it could be challenging to find an adequate professional to repair it. Not by accident , there are many 3D printers locked in dusty rooms in developing countries. In the same direction, the solution many companies have found is to centralize the socket design and manufacturing and ship the final product to the prosthetic clinics, which could take weeks to months depending on the distance. 

The traditional way of making prosthetic sockets in the industry is done indirectly - with a plaster mold of the amputee’s residual limb. The fact that Alivio is molding the socket directly to the residual limb reduces the margin of error of its final shape. 

1) This is possible because the technician is in direct contact with the residual limb and can feel the difference in its tissue composition (fleshy areas as opposed to bony areas) as they have different needs. For socket stability the fleshy areas must be controlled / pressured with a hard socket shell, which simultaneously avoid tissue gangrene, and bony areas must have space to allow movement and avoid friction. 

2) Prosthetic technicians are manual workers and a direct-socket-fit technology works much closer to the way they have learned their profession in school and are used to work in their daily activities. As seen in user research with this stakeholders group, this is a much more intuitive way of making prosthetic sockets and help them deliver prosthetic legs at a much faster pace - which can be extremely beneficial in locations with high demand.

Last but not least, another significant difference is the fact that the whole process requires only a few hand tools, simplifying the infra-structure required to provide prosthetic legs to a simple portable bag. This could potentially multiply the setup of new workshops to all areas where there’s a high number of amputees and a shortage of prosthetic clinics, which is practically the reality of every developing country and not only fragile areas.

Since the Alivio technology is still under development, our impact goals for the next year are still shy in comparison to what we want to achieve with our company. We see impact both inwards and outwards.

Outwards wise: since we plan to run field trials with our prosthetic socket in Q4 this year, we plan to qualify around 10-15 prosthetic technicians (capacity building). We can improve the service provision of 5-10 different prosthetic centers. In this time frame, and with this number of trained professionals, we believe we can fit around 250-350 amputees in the next year (Q2 2024) - between user-centric design research and quality of life academic research.

To achieve this we have a business development strategy for Kenya at the moment. We must engage with several prosthetic centers in the country, which is already under way, so we can introduce them to our technology. Prosthetic technicians are the gatekeepers (meaning they are the ones who have direct access to the amputees), so they must be involved in every part of the process. 

Product demonstrations are usually the first live contact people have with our technology. Training and skills improvement would be a second and deeper level of engagement with the prosthetic clinics. Officializing partnerships and/or acquiring customers would then be of a sequent involvement, which could continue the impact we are envisioning. 

Inwards wise: working internally on common goals and shared values is how we believe to be impacting on our team members. Since we focus specifically on developing countries' markets, this is a way to bring our brains together in order to potentially create a much greater impact. On Q4 this year we will start our operation in Kenya and will hire our first local team member, which we also see as a way of impacting local communities. Although we envision a large impact potential for our future, right now things might be small and we don’t see it as a problem, we have to start somewhere - one life impacted is larger than none.

In five years we envision to be servicing at least 2500-3500 amputees per year with 150+ prosthetic clinics amongst partners and customers from the private and NGO sectors.

Our longer term plans include:

1) Be operating in the whole East African region and potentially enter the West African market as well (still needs some business development work to identify market potential);

2) Have entered the BRICS market (Brazil, Russia, India, China and South Africa) and hopefully some neighboring countries as well - we have already started engagement with Brazil, for instance.

3) Install distribution and training centers in the areas we’ll be operating at to serve those markets as regional hubs - this will always include the setup of local teams.

4) work with local prosthetic schools in order to improve the profession through training and capacity building.

5) working with international organization to work with and setup standards for direct-fit technology for prosthetics and orthotics.

Alivio is a young startup and since we are still in our R&D process and not yet operating, our impact measurements and progress are still on the making. Still we really like the framework IMP provides (https://impactmanagementplatform.org/) for it englobes a much deeper perspective on the impact that is being created. We have already foreseen on how to navigate it in the future, as shown below:

1) WHAT is the intended positive impact (impact now vs. impact goal later)? As OUTPUT we will measure the number of prosthetic devices fitted to lower limb amputees. As OUTCOME we will measure the level of physical abilities that were restored.

2) WHO are we impacting? Underserved lower limb prosthetic users in Low and Middle Income Countries (LMICs). The OUTCOME BASELINE would be divided into a) those who can purchase prosthetic devices; and b) those who cannot purchase devices at all.

3) HOW MUCH are we impacting them? In terms of SCALE, how do we compare the baseline of underserved lower limb amputees as opposed to well served populations? In terms of DEPTH, a) what’s the marginal change in comparison to existing solutions for our improved products / longer product usage time ?; and b) what’s the deep change from 0 to 1? In terms of DURATION, we would like for them to use the device for at least 5 years, but “what’s the value in it?”.

4) As for CONTRIBUTION, there’s a DEPTH COUNTERFACTUAL such as a) comparison to better products available: what’s the function outcome difference?; and b) comparison to those who otherwise would not have gotten it. And a DURATION COUNTERFACTUAL such as a) how long do other products last?; and b) no comparison when there are no products available.

5) What are the RISKS involved in our activity? a) stakeholders risk: How to track evidence?; b) stakeholders participation risk: basic survey; c) drop-off risk: product failure; d) unexpected impact risk: unknown harmful effect of intervention; e) execution risk: product training success rate; f) external risk: regulation/landscape costs, importation impediments; g) alignment risk: mission drift, quality decreases with scale; h) efficient risk: smaller team may not be able to execute project; and i) endurance risk: people not following through the entire rehab process, technology breaks sooner than expected, project disappears before its sustainable.

There are two users we think of, the amputee and the prosthetic technician.

To be an amputee means that you have physical limitations that make you do certain activities in different ways - maybe not as fast, not as efficient. This means that you are dependent on other people, most likely your family members, in order to accomplish simple daily activities, or even economically dependent for they don’t have a job or any sort of income.  It is also limiting in social terms and how you interact with different members of your community. Even simple activities, like going to church for example, can be challenged when you have a noticeable disability. 

Therefore, for the amputee to receive a prosthetic leg has a direct impact in their lives, which is to improve mobility levels. As for medium term outcomes would be more social activities within the communities, which could involve engaging in economic activities. On the long term perspective, a significantly impactful outcome is that they will be empowered by becoming more independent and engaging in these activities and be reinserted as productive members of the society. This will not only have a powerful impact on their individual lives, as well as in their families and communities where they currently live.

From the technician’s perspective, educational levels for certified prosthetists and orthotists are not very high, meaning they usually get very basic skill improvements in their programs and are inserted in the job market. This means the products they provide to people with disabilities are not as high quality as they could be, and therefore could potentially harm the people they are trying to help. 

By providing them with continuous training with the Alivio technology, which potentially reduces the margin of error of prosthetic socket design, would improve both their skill level as well as the quality of life of people with disabilities in the short term. As for the long term, once this technology is adopted by more centers, we believe we could multiply the number of prosthetic clinics in all developing countries in need in order to provide better services and good fighting devices that positively impact the entire society that lives both near and further away due to the mobile clinic approach.

The way we see it, and how we have experienced it in our field, we believe that “low-tech” is much more impactful in order to create more access to those who need it the most, both for lower limb amputees as well as for prosthetic technicians.

With basic mechanical engineering knowledge we have developed a reinforced low-temperature thermoplastic material. It molds at 80-90 C degrees and is significantly resistant to the rough conditions of developing areas. The material mixture recipe was fully developed in house and cannot be reverse engineered.

As the direct-fit system (socket + tool set) is able to copy ergonomic 3D shapes through a mold making process with a vacuum. we will be able to mold other areas of the body as well. On a later stage we will be able to further develop other products in the field of disability, being upper limb prosthetic sockets the most obvious. Beyond that we will be able to make orthotics, wheelchair-seats, handles, splints, and much more.

The conic shape in which we apply the material is also of unique design, for it has gathered data from hundreds of amputees in order to define a sizing system that accommodates 95% of residual limb shapes.

As an interface between the prosthetic socket and the residual limb, it allow all different sorts of solutions available. This could range from silicone sleeves, which are considered more comfortable, or foam soft sockets, which are more affordable. 

On top of that, we want to work and collaborate with every single player in the industry, therefore we are working towards making interchangeable adaptors to every technology available in the market. This is made regardless of whether they are our  competitors or not, for we believe that collaboration is the real key to access and prosperity.

We'll run co-creation workshops within our field trials so the users can also be co-creators to solutions for themselves. This is a practice we'll be including in all the field trials that will start in Q4 this year. This is already something that is being executed with the current Accelerator Program we are taking part of at the moment until June 2023 (Innovate Now in Nairobi).

We see another way of incorporating diversity is to have team members from different cultural backgrounds. Right now we have people from Brazil, UK, Australia, Romania and China. Also following that logic, every time we open a new hub/location, we want our leaders to be from the local communities and therefore make the company also localized. 

Qe envision to create events and workshops where the whole team will meet in one location a few times a year in order to do team building, cultural exchange and mission/vision alignment.

Although this is not reflected at the moment, we envision to have gender equality as well as cultural equality, meaning we would like to have 50% of tem members to be women, and we are also open to having non-binary team members. This is desirable and we'll make an extra effort to make sure we find people who fit into the position's profile and enriches the diversity of the organization.

Another way that we believe to be fair is to have an ESOP program where every team member will also be an owner and fell they are working on their own project instead of working for other people.

For being very tangible, our business model is relatively simple for both revenue and impact, which could be seen as 2 sides of the same coin.

1) In terms of Revenue we consider the customers: we sell prosthetic components and tools to prosthetic clinics that provide legs to lower limb amputees. These clinics can be owned by either a private person/entity, an NGO or the Government.

The value we bring can be summarized as a time/cost saver as well as a service improvement described with a few different aspects:

a) We cut down on their costs in terms of labor time - from an average of 10 hours to only 1 hour - 90% less time to make the Alivio Socket;

b) Less margin of error with socket crafting, which ultimately boils down to less time and materials waste;

c) The clinic gains the ability to serve amputees remotely with our portable toolset, which is both a USP they may now offer to their clients as well as a travel time/cost saver, for they can provide that leg in only one appointment/trip;

d) With Alivio’s Mobile Clinic it is fairly cheap and easy to multiply the number of prosthetic clinics across a territory - this is fairly interesting for clinics that would be interested in opening branches in different regions, and especially to Governments from developing countries that would like to better serve their populations in both urban or remote areas.

2) In terms of Impact we consider the beneficiaries: lower limb amputees can walk again. Nevertheless, this can be broken down into a few different segments

a) Now people not only can become mobile, but they can walk on the very same day with a device that will for sure fit to their residual limbs correctly;

b) They won’t have to pay for extra sockets, due to the remoldability factor of our material they can have different shapes with the same product;

c) They won’t have to travel long distances with high costs in order to acquire a prosthetic leg or do maintenance work on their devices any longer;

To start our R&D work, which includes technology development up to the point of finalizing clinical trials in Kenya, we managed to get two sources of funding: a Grant and a Convertible Loan, which will fund us until Q1 2024. 

We will require extra funding to support our manufacturing setup as well as our market entry activities, which will start in Q2 or Q3 2024, depending on how early we can secure our next funding round. 

The primary goal is to sell products to existing prosthetic clinics, specially to large organizations such as ICRC and HI. The secondary goal is to make contracts with governments in order to set up new prosthetic clinics across their territory and improve public prosthetic services for their populations.

After then we’ll start making revenues, but the sales cycle in this industry is very slow and large amounts to large organizations take time to be achieved. Also, contracts with governments are never fast to be accomplished and executed, it will require to initially install a pilot project and only when successful we’ll be able to expand it. Therefore, we foresee  we’ll need at least two years of exponential growth in order to break even, so we'll need to fund ourselves for another 2-3 years (latest until 2027).

For these activities we envision to do the same financing combo as before: Grant + Convertible Loan (or equity investment).

If we manage to deliver our contractually agreed milestones, our Grant funder is interested in continuing to support us in the long term, and so far we’ve been delivering everything accordingly. 

For the investment round we’ll start looking for potential investors after our next Milestones, which will be to do product demos in Kenya next July. Financial plan and Pitch deck are already in the making. We still have a lot of equity in the company to be able to do some transactions and still be in control of the organization.

As mentioned in the previous questions, so far we have received both Grant money and a Convertible Loan from a business angel. 

The Grant was received from the Disability Impact Fund and the Convertible Loan business angel may unfortunately not be disclosed. 

Although I’m not able to share totals and percentages, so far we have received over 500k USD as a combination of both sources.