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Tomorrow’s mobility solutions, today

Periodic Reporting for period 1 - MotionTech (Tomorrow’s mobility solutions, today)

Reporting period: 2018-08-01 to 2018-11-30

Each year, over 1,000,000 people undergo a leg amputation worldwide. The number of people living with limb loss is expected double before 2050. We are all aware that this is a very traumatic and life-changing experience for anyone. But, one of the main issue in the 21st century remains: painful prostheses.
Due to the complexity related to producing tailored prosthetics, 90% of amputees use artificial limbs with a standardised shape, which have an imperfect fit. With today’s manual manufacturing methods, the production of fully personalised systems has various limitations, making personalised systems inaccessible for the wide majority of amputees. Most amputees thereby experience injuries that range from rashes to ulcers, and that can even lead to re-amputation in a number of cases.
What if amputees could be freed from using painful prostheses? What if fully personalized prostheses could be made affordable to everyone?

A liner is a silicone sock surrounding the residual limb of the amputee which aims at distributing the pressure imposed by the rigid socket in which the amputee puts his or her stump. A prosthetic leg can then be attached to the socket. Today, O&P centres have two options when choosing a liner for their patient:
- Standardised liners: come in standardised shapes and sizes (S, M, L) for an affordable price. Prosthetic parts suppliers often propose several models and several sizes to try to match each amputees’ situation as much as possible. They represent 90% of the liners currently in circulation.
- Tailored liners: are tailor-made to match the morphology of each amputee’s stump, but for a higher price (two to four times more expensive). Tailor-made liners offer a highly intimate fit and are therefore the most comfortable solution. However multiple limitations inherent to the way they are produced make them difficult to afford. This is why only 10% of amputees are equipped with this kind of liners.

We are bringing the vision of personalized prosthesis for everyone to reality by pushing the boundaries of 3D printing technologies. We have developed a series of novel technologies and propose a new service model to help orthotic & prosthetic (O&P) centres treat their patients as they would like and break free from the limitations of today's tailored liner manual manufacturing methods.
1. An iPad-based 3D Scanner, to seamlessly acquire the shape of the patients' residual limbs
2. Automated design software for 3D liner model creation, to enhance the efficiency of the production process. This tool is powered by AI-based image processing technologies.
3. A patent pending silicone 3D Printer to print customised liners

The objectives of the present project were the following:
1. Clinical study strategy development and partner search
2. Country-based service model assessment,
3. Internationalisation strategy development,
4. Patent strategy monitoring
The objectives were all met to various extends during the unfolding of the project.

The clinical study strategy development proved to be the trickiest point to tackle. Indeed, our device being a Class I / Custom made device, the framework for conducting clinical studies in that context is not so clear. A global clinical strategy was defined, including clinical evaluation and early market introduction of the product, and long term clinical follow up once on the market. This strategy is based on both EU regulatory framework evolution (introduction of new MDR), product and industry specific circumstances, and business imperatives.

The country-based service model assessment was executed and yielded positive results. Ten countries were originally targeted (Switzerland, France, Germany, United-Kingdom, Belgium, Italy, Spain, Portugal, Austria). A first overview was done for each country. The full assessment was completed only for the countries where the best business potential was identified. For the country-based service model assessment, the following points were of interest:
a) the number and size of O&P centres,
b) their current process for liner-fitting and production,
c) the current cost for liner fitting and production as well as
d) shipping possibilities and cost
A full analysis combining the 4 above points was executed for Switzerland, France, Belgium. If it remains to be deepened, an overview analysis was performed for Germany, the UK, Spain, Italy, Portugal and Austria.

From this, an internationalisation strategy was developed. This strategy includes not only target entry date for each country, but also export strategy, scheduled sales and manufacturing growth plan, human resources plan, and execution strategy.

Substantial efforts were also invested in the patent strategy monitoring. Most of these efforts went towards the building of a competitive patents landscaping system. Through this system, over 150 patents were reviewed and analysed, drawing crucial insights for the future technology developments of the company.
An important milestone was achieved with the market introduction of our first product. Shortly after, we conducted the first field trials with patients and prosthetic technicians. These first pivotal achievement contributed to proving the viability of the entire business case that we built around MotionTech. Indeed, the success of these tests brought, amongst others, key validation of the two following aspects:
1. Entire technology chain demonstration: if the building blocks of the technology enabling our service were all individually proven, the successful fitting of a first patient proved that not only our technology chain works, but that it yields products that patients and prosthetists are satisfied with.
2. Value proposition for O&P centres: the tests we conducted were based on the value proposition we intend to use for scaling. The fact that O&P centres which we conducted the tests with were enthusiastic is a live witness of the attractiveness of this value proposition..

At the end of the project, we therefore reached the point where tracks has been laid for our venture to start the scaling phase.