Unhindr are a startup formed at Imperial College London, who have designed the world’s first AI adjusted prosthetic device. Devised of a wearable robotic liner that uses Artificial Intelligence to learn the wearer’s comfort settings, the device then adapts to them automatically throughout the day. This is adjustable via a mobile app, giving the user complete control over their prosthesis, eliminating the requirement for clinic visits or socket replacements.
Unhindr have been recognised by numerous industry awards.
Unhindr had already developed a prototype, but they required help in determining a regulatory pathway & roadmap for their route to market. They approached us with the challenge of identifying potential issues within the software and formulating a development process to create a robust, safe and effective end product, within the required standards.
Our software engineering team provided an agile and integrated resource for Unhindr, responding quickly to their requirements. We started with a full prototype analysis, before kick-starting the regulatory process, by creating requirement specification documents and carrying out a full FMEA, gap analysis and code review. Our experience of working to harmonised standards (ISO 13485 / IEC 62304 / ISO 14971) and our team’s broad understanding of all of the new requirements ensured we not only offered a full audit of the product, but were also able to offer ongoing support as they build their product roadmap.
We were able to plug in to Unhindr’s existing team, working with numerous stakeholders and could also tailor our solution to fit with their budget.
Our expertise and thorough understanding of the product development process and applicable standards enabled our team to capture potential problems without the client having to explain them. We identified a number of elements within their code (as well as some within the hardware) which were potentially high risk, and suggested ways to mitigate these pitfalls in the code. We suggested changes in order to employ failsafe measures, further increasing the likelihood of regulatory approval.
We provided Unhindr with a set of documentation, which they can use as a roadmap to guide them through the remainder of the regulatory process, giving them a much clearer idea of their development pathway. Demonstrating knowledge of the end to end process and regulatory requirements will also stand Unhindr in good stead with regards to potential investors.