1- Legal feasibility analysis:
A detailed regulatory analysis was performed by the LuxAI team, as well as by subcontracting a Contract Research Organization specialized in regulatory analysis of medical devices. This included a detailed study of the definition of autism as well as the positioning of QTrobot and its app store as a medical device. The conclusion was that, for the time being, to market the QTrobot as an assistive robot which does not fall into the definition of the medical device, and to conduct further experiments and clinical trials to declare the solution as a medical device in future, to show solid evidence for the value of the solution, to create barriers for the competition, as well as to be able to reimburse the solution by public health systems and insurances. To this end, a detailed pathway toward a medical CE and FDA approval was derived. In addition, a peer to peer review system is foreseen to ensure the quality of the content on the app store for the near future, and a plan to build a data-driven system to monitor and validate the effectiveness of the apps was developed for a longer term. This resulted in a technological roadmap which not only provides an automatic way of quality control, but also will enable us to offer evidence based personalized assessment and intervention with potential to revolutionize both the field of autism as well as socially assistive robotics for healthcare.
2- Practical feasibility analysis:
We developed a MVP of our solution for an autism app store for QTrobot. This included building a cloud server to backup and sync the apps created on a robot, including the app itself, the robot’s gestures and multi-media content such as videos, audios and images, and a software framework to easily share a selected set of apps from a user account to other accounts. The technical challenges also included, for instance, normalization of robot’s joints, in order to ensure a gesture recorded on one robot can be exactly replicated on other robots.
Two autism therapists were subcontracted to build 40 applications for QTrobot, targeting early stage development of children with autism. The therapists successfully developed the applications using our graphical interface, completely independent of the LuxAI technical team. These applications were then reviewed by two board certified therapists who provided feedback and confirmed their quality and usefulness. The applications were then shared with multiple educators and therapists who successfully used them for training of children with autism. The result of the tests in the living lab was a great success, leading to sales of robots. The achievements of the living lab was not limited to only validating the feasibility of the therapy store concept and the sales. It also supported us to create marketing materials in collaboration with the end users including several video testimonials from therapists and parents and several demonstration videos showing how the robot interacts and teaches new skills to children with autism and other mental disorders.
3- IPR management
A specialized firm was subcontracted to perform a landscape and whitespace analysis regarding the means and methods for providing support to children with autism. This included global market overview of therapeutic treatment technologies for supporting children with autism, and specially using robots, and identifying relevant patents and categorizing them according to the different technology parameters related to therapeutic treatment technologies. Total of 1149 publications were analyzed, out of which 247 were identified as relevant to the subject matter and classified according to the technology used, domain and method of application. This analysis provides a solid basis regarding the existing technologies and trends, main competitors and the most relevant patents and the whitespaces to develop a patent portfolio for formal IP protection. The next steps underway are to build on this solid base to make a through freedom to operate analysis, as well as to make a patentability search of two novel ideas of our project.
4- Business Plan
We developed detailed business and financial plans for the next 10 years. The business model and roadmap improved in several ways, including the addition of two revenue streams (B2C and app store) as well as the additional of value added services such as the premium support and analytics dashboard. A detailed financial plan, including a three years monthly cash flow, was developed considering various revenue streams of B2B, B2C and app store targeting the developed world using direct sales, distributors and online store, and including various costs such as sales and marketing, personnel, R&D, after sales support, and general and admin expenses. The therapy store was shown to be a very interesting new source of revenue for LuxAI, which has made the business model more attractive for the private investors by showing the high potential of LuxAI to make a scalable and profitable business from both hardware and software.
