Case Studies

Kickstarting the development roadmap with standards

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Unhindr

BACKGROUND

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.

 

THE CHALLENGE

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.

 

Wearable robotic liner that uses AI to learn comfort settings |Adjustable via a mobile app giving the user complete control | Required help formulating a devoplment pathway within the required standards

 

Roliner

OUR APPROACH

Our software engineering team provided an agile and integrated resource for Unhindr, responding quickly to their requirements. We started with a full analysis of the protoype, 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.

 

Regular and open communications ensured the project remained flexible | Full prototype analysis, FMEA, gap analysis and code review carried out | Documentation provided to guide Unhindr through the remaining regulatory process |

 

RESULTS

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.

Roliner

 

"At eg, we regularly work with early stage start-ups who have an innovation and need help identifying the process by which they get their product successfully to market. Undhindr were a good example of this. Our team were able to use their knowledge & expertise to identify potential issues, provide a suggested mitigation and map out a development pathway to take their idea to a genuinely safe implementation" - Rouzet Agaiby, Head of Business Development | eg technology

 

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