An e-Health expert system for diagnosis and treatment of diabetics to reduce the risk of skin breakdown and co-existing foot diseases

Project Information

DIAIoT

Grant agreement ID: 854036

DOI

10.3030/854036

Project closed

EC signature date 11 February 2019

Start date 1 March 2019

End date 31 August 2019

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

VOXELCARE SL
Spain

Periodic Reporting for period 1 - DIAIoT (An e-Health expert system for diagnosis and treatment of diabetics to reduce the risk of skin breakdown and co-existing foot diseases)

Reporting period: 2019-03-01 to 2019-08-31

Summary of the context and overall objectives of the project

Voxelcare wants to approximate his knowledge and technology to prevent and mitigate the foot damages created by diabetes. Diabetes causes a lack of sensitiveness in the foot
that may lead to ulcers and to amputation in the worst cases. As it can be seen in the feasibility study we have performed, the prevalence of diabetes in different regions of the world, will grow until be trippled in
2030 according the WHO (World Healt Organization). Most of the countries with a huge prevalence of diabetes are countries with a lack of knowledge and culture about insoles, orthotics and in general podiatry.
Some of these countries are for instance Egypt, Iran, Pakistan, Saudi Arabia, India, Indonesia....

The halt of the rise in diabetes and obesity, is one of the targets on Global Action Plan undertaken by the WHO, for the prevention and control of non-communicable diseases 2013-2020. In line with this objective, Voxelcare
wants to put his technology and knowledge in the hands of people, that even not having an educational degree in podiatry, could be able to design and manufacture the insoles (depending on the business model). This action
would help mitigating the damages on diabetic feet and improving the life quality of people affected by this disease.

Currently Voxelcare System is used by experts with several years of experience in the insoles design and prescribtion. Now we want to convert this system in a powerful e-health tool, with the needed knowledge and technology
to allow the care providers in the above mentioned countries to prescribe orthotics to the diabetic people.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

We have been working in the following points that were part of the scope of supply of this grant agreement:

1) Technical Road Map.

We have identified 3 main Workstreams:

- Diagnostic Tool online.
- Automated design of the insoles.
- Knowledge data base in the online system.

2) Viability of the product.

We have defined the possible business models and the minimum solution set that would allow us to address to diffetent markets.

Opt 1: Basic component sale, like an scanner and then Voxelcare would provide the insoles. There would be a minimum investment for the
scanner and then the customers would be charged for the insole production.

Opt 2: Customer produces insoles for end users/patients, e.g. clinic. The investment would mean the scanner, the Software license and the Milling Machine.

Opt 3: Franchise model: The investment would mean the same as option 2 but additionally a fee per pair produced would be charged to this type of customers,
that would produce insoles for many entities.

3) Technical cooperation

We have developed our system in an open way, so that we can integrate devices from other suppliers (3D and 2D scanners, pressure plates...) and additionally the manufacturing
files can be customized for different milling machines. This will facilitate the entry in the market by using existing technology or devices already available on site. One of the
goals of phase two is to assess and execute possible partner agreements in countries like India, China, Indonesia....

4) IP Protection

During the issuing of the feasibility study and business plan, we have also developed some legal documentation with the support of an expert lawyer. These documents are:

- Distributorship Agreement of Voxelcare.
- Software Licence and Technical Assistance agreement.
- Services agreement.

In these documents we include clauses protecting our software and hardware

Additionally we have included our Software as an asset in our accountancy, as the first step to register it for intellectual property purposes.


5) Market Attractiveness Model

We have developed a matrix with different criterias for market evaluation, including several criterias like:

- Adressable Market (disease prevalence)
- Cost and effort to setup distribution chanels
- Obtainable Prices
- Competition and other entry barriers
- Regulations
- Network Connectivity.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

At the end of the project, Voxelcare expects to have the most easy of use tool for insole design. Allowing countries with no culture of wearing insoles, to have access to this
product that will give benefits from the health and life quality point of view.

Voxelcare expects also to have a scientific clinical validation of insoles to demonstrate improved ouctome of Voxeclare insoles. As per some articles, e.g the one named
INSoles To Ease Pressure (INSTEP), published in the medical journal BMJ Open, it is estimated that 30% of people with diabetes have diabetick peripheral neuropathy, leading
to a risk of foot ulceration development, The prescription of for therapeutic insoles is largely based on expert opinion and clinical experience but there are no studies or
protocols to indicate the optimal features or efficiency fo the different devices designe to improve outcomes.

Improved design system automation

System with scanner control unit for foot data intake