About the project
1 in 4 people over 25 will go through a stroke, meaning that just over 12 million people every year have their first stroke worldwide. Seeing how the population is ageing (especially in developed countries), this is quite an alarming statistic. It's equally worrying that about 50% of stroke survivors end up having cognitive deficits – many of which will remain undetected and/or untreated. There's not much a patient can do at home to improve their condition. Or there wasn't – until now.
ABAStroke is a startup from Poland that aims to revolutionise the neurorehabilitation market. In 2021 they received funding from the Polish National Centre for Research and Development. Together with Revolve Healthcare, they're developing a digital health application (DTx / DiGA) for at-home digital rehabilitation of post-stroke cognitive deficits. The app is based on Applied Behavior Analysis (ABA) methodology and supported by AI algorithms that create an individualised therapeutic path for each user.
Combining ABA methodology, the subject-matter specialists' expertise, and machine learning, ABAStroke provides patients with unlimited virtual exercise combinations in an independent, personalised, and effective treatment.
And since the application will be classified as Software as a Medical Device (SaMD) in class IIa MDR, we must ensure all the relevant quality and security standards. In the end, the final product will be prescribed and reimbursed, just as a medication would be.
I couldn’t imagine a better software development partner for us than Revolve Healthcare. The fact that they are ISO 13485 certified and have expertise in medical device certification is crucial for us. We’re certain that the final product will not only be MDR-compliant, but also high quality, secure, and scalable.
The task and solution
When ABAStroke came to us, they had a clear idea of what they wanted to build. Having gone through an observational study with their prototype, they have proven that digitising ABA methodology in the neurorehabilitation of stroke survivors made sense.
However, they needed to turn a web-based prototype into a software product that could be used by as many people as possible – right on their mobile phones. This challenge required forming a team working on the app from start to finish – from "game" mechanics based on neurological expertise to developing a complete mobile app poised to go through clinical trials and become a SaMD.
ABAStroke chose us as their software development partner because they needed a certified medical software development services provider who's flexible, who understands a healthcare startup's needs, and who's prepared to guide them through their certification process. When the team was forming on the client's side, we discussed how Revolve Healthcare could be involved.
Currently, we're responsible for the entire software development and most of the technical documentation while working closely with ABAStroke's business, subject matter (neuropsychological and psychological), design, and machine learning teams. Our Head of Regulatory Affairs consults the MDR certification process with the client's representatives weekly, and we analyse the project's risks and ways of mitigating them together.
Building a digital health app that brings real value to specific end-users while ensuring regulatory compliance is not an easy task. Especially when you only have 12 months to complete it (because that's the initial project timeline). But working closely with the client – through ongoing, open communication and properly implemented processes – we're confident that this cooperation's result will be truly amazing. We can't wait for ABAStroke to help millions of people suffering from post-stroke cognitive deficits!
What was done
Below are the key things we've worked on in this managed project.
Multi-element patient motivation system
Documentation of the software design and development process
Our work doesn't start, and it doesn't end with software and documentation. We participate in making critical strategic decisions together with the ABAStroke team, especially when it comes to technical and regulatory matters.
We work together with different team "sections" and members every day to make sure everything from the conceptual work, to design, development, integrations, and regulatory matters is processed and delivered according to the roadmap, which we agreed on (and keep adjusting in an agile manner) with the startup's decision-makers.
Most of all, we feel like we're an essential part of ABAStroke's team. It's great to work with a client who's as open, responsive and flexible as we always try to be.