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A Customizable Robot to Include Children with Autism Spectrum Disorder

Periodic Reporting for period 1 - HOOKIE (A Customizable Robot to Include Children with Autism Spectrum Disorder)

Reporting period: 2017-01-01 to 2017-05-31

Autism Spectrum Disorders (ASDs) are a group of developmental disabilities characterized by impairments in social interaction and communication; symptoms typically are apparent before the age of three. About 1 child out of 68 suffers from ASD, which implies that the number of cases in the EU-28 is in the ballpark of 10 million: this bears enormous financial and social costs to their families as well as to the EU national health systems, mostly related to the needs of special education. Recent studies have proved that robotics can play a key role in this domain leading to the claim that robots may act as co-therapist – especially for high-functioning autistic children – in order to help them to improve their social skills. In general, ASD children perceive robots as more predictable, less complicated and threatening than humans. Nevertheless, the few commercially available robots for ASD children are often very expensive, limited in scope, and not directly accessible to the families.

This is the framework in which we have introduced our Hookie – a customizable 3D-printed robot aimed at the inclusion of high-functioning ASD children by assisting them in educational and social tasks. Hookie is built with off-the-shelf components and has a price target of €500, which makes it accessible to both institutions and families. Its design and functionalities have been defined in collaboration with experts in ASD.

Our overall objective is to make of Hookie a global commercial success in order to have a real impact on the life of children with ASD and their families. At this stage, we needed to carry out a comprehensive feasibility study, which we have done within SME Instrument phase 1. We set four main objectives for our project:
Establish a pricing strategy and validate the business model by conducting a comprehensive analysis of the competitors and an extensive market segmentation/quantification;
Carry out a 'freedom to operate' analysis – both from the commercial and legal/regulatory viewpoint – and define the strategy to protect the intellectual property;
Secure pilot trials with at least six partners covering all the targeted EU countries for the tier 1;
Write a business plan addressing the requirements of the national markets, which will include a financial viability plan as well as an operational strategy.

The conclusions of the action have been very beneficial for the business and for the consortium partners. The financial help and coaching services provided via the SME Instrument phase 1 have definitely helped to advance further in the commercialization plans. The insight gained during the feasibility study has convinced us that the project should go ahead, trying to reach TRL9 within approximately two and half years from today. We have managed to study several EU markets in which we expect to commercialize Hookie and discovered risks and opportunities that we did not know before. We have also taken all necessary steps to ensure our freedom to operate and to secure the IP of the robot.
The work performed over the five months of the project has concerned three main topics.

First, the freedom to operate, both in terms of Intellectual Property and in terms of legal/regulatory/ethics issues. From the IP viewpoint, the existing prototype was meant to be a first design with the sole purpose of testing the functionalities with user and perform broad dissemination activities. Hence, its IP has not been protected so far. Nevertheless, a new design is currently being developed and that will be sufficiently different from the existing one to pass the novelty checks necessary for a patent. The algorithms are covered by a trade secret. The patent will be filed as a Dutch National application in order to gain priority for future PCT and European patent application, so that the new design will be disclosed and disseminated. The consortium has also set in place a technology watch protocol, which includes also the IP of potential competitors, established during the feasibility study has already been implemented: the corresponding reports will be produce at the end of every quarter from Q3 2017 onwards. From the legal/regulatory/ethics viewpoint, there are no major hurdles along this line. Hookie complies by design with the General Data Protection Regulation 679/2016, which is to be the legal framework in the EU at least for the next decade. Our feasibility study also confirmed one of our hypothesis: Hookie should not be directly used as a medical or therapeutic device, since in that case we would be obliged to comply with the medical device regulation reform (5 April 2017), which is very restrictive and extending largely the scope to prima facie non-medical devices. Additionally, our analysis has shown that Hookie will gain the CE marking without much of a trouble.

Second, the commercial and financial viewpoint. Our analysis has made evident barriers and opportunities in the different countries in which Hookie will be commercialized (at first, Spain, the Netherlands, Sweden, and the UK; then, Italy, France, and Germany). Our domestic markets (Spain and the Netherlands) have opposite characteristics, with the former being very fragmented (hence with slow revenues but with low risk of overall failure) and the latter being very centralize (hence potentially fast revenues but with high risk of overall failure). The UK has somehow ideal scenarios that deserve to be pursued and Sweden has turned out to be riskier than expected. France and Germany have exceeded expectation in terms of potential penetration, whereas Italy is extremely fragmented and difficult to achieve.
As a conclusion, we have decided to go ahead with our plans in Spain, the Netherlands, and the UK, while Sweden will be further tested via a pilot (already secured). France and Germany will follow, and Italy will be on hold but we establishing promising leads via informal channels. From the financial viewpoint, we have refined our pricing strategy, which is though depending on the final costs of the prototype. The Bill of Materials has been considerably reduced and there is room for a further reduction in the final version that will be taken to the market.

Third, the pilot trials in the countries of interest. We have secured four: in Spain, Sweden, USA, and Panama. In Italy and UK there are some leads that should eventually end up in pilot trials for 2018. In Q2 2017 we have also carried out an additional pilot in Spain with very positive results.

As for the dissemination actions, we have presented Hookie at two different events, one in Europe and one in the USA, gathering a lot of interests from potential partners and clients.

In conclusion, all the objectives of the project have been achieved: in some cases exceeding the expectations (such as on the IP exploration and on the technical side.
The impact of the project is directly proportional to the current huge socio-economic impact and costs of Autism in children. In the past few decades, the number of diagnosed cases of Autism Spectrum Disorder has skyrocketed: nowadays, about 1 in 68 children has been identified with ASD and there are about 75,000 newborns with ASD in the EU-28 every year. The related financial costs are enormous: ASD costs more than heart disease, cancer and stroke combined , mainly due to inclusion programmes – such as special education.
Hookie will favor the inclusion of thousands of European children helping them to bridge the educational and social gap, This project has been fundamental to take the next steps in the commercial exploitation of Hookie and make it a future European success.

A preliminary five-year projection assumes a conservative target market penetration in our initial EU markets. Our (confidential) estimates tell that at the end of year 5 the sales of the whole Hookie robot will contribute around €2.7M of revenue annually to the companies, and this is only one – though the largest – revenue stream. Additional activities related to the sales of the kit, the software licenses, and the training will account for an additional €600k, bringing the total turnover to about €3,3M at the end of year 5.
Hookie robot