Confidence and quality through safety and clinical studies
How can we prove to you that you’ll be 100% safe using Quin?
That’s the question I try to answer every day. Your safety is literally in my job title – Head of User Safety and Compliance.
It’s not an easy question. Everyone living with diabetes is different. You all experience diabetes differently. I have to account for every one of you. Fortunately, I work with a great team who understand this too. So, how can we prove to you that you’ll be 100% safe using Quin? The simple answer is we can’t. No one can. Your safety when managing diabetes depends on you as much as it does on the technology Quin, or anyone else, provides. But there are many ways we can try, when we work together, to get as close to 100% as possible.
Processes designed to reduce risk
First, we test every idea with our research programme users. People, like you, living with diabetes. Their feedback and thoughts identify potential risks early and drive the design and experience of Quin. Next, the product team and I break down the idea. Sat in a circle of chairs on the wooden floor of our office, we identify potential risks and control measures to reduce those risks. Every opinion is valid and debated over three or more hours. Changes are made to the design, the tech, the ideas themselves.
These can be exhausting sessions. Understanding risk doesn’t come easy. Once ideas are developed, our automated and manual testing is comprehensive. We run over a thousand tests of the code, interface and performance. We even walk around Finsbury Park to ensure the iPhone activity sensors are accurate.
After weeks of design, development and testing, our CEO, Lead Engineer and I assess Quin. What is the probability of risks occurring? Have we done enough to reduce those risks? Do we believe the benefits of Quin outweigh any residual risks? Meetings where the phones are off and laptops are closed. Another few hours of debate and deep thought.
Finally, we review Quin with our diabetes and endocrinology adviser, Professor Jeremy Turner. His final analysis determines our release state. If he’s not comfortable, we start again. So far, we’ve proven to him time and again that our users come first. The release goes out.
Unlike most digital health startups, we prioritised quality, safety and regulatory compliance from the beginning.
We have achieved:
- Class 1 CE Mark certified under the EU Medical Device Directive
- A quality management system under audit with a notified body, DQS Medizinprodukte, for ISO 13485:2016 certification
- Adherence to ISO 14971:2012 for risk management processes
- Adherence to IECs 62366 and 62304 for usability engineering and software lifecycle processes
And for 2020, we are taking our vigilance to the next level.
We have designed a four stage clinical study. This study will collect clinical data from a controlled group of beta users, expanding in number at each stage. The fourth stage will culminate in a clinical trial. We will involve clinical trial units to ensure we run a safe and effective trial. The results will be reviewed by clinical specialists in diabetes and published so we can be transparent with you about the safety and benefits of Quin.
” When the new EU Medical Device Regulation fully applies on May 26th 2020, we will be ready. “
We know the processes we need to enhance and have a plan to improve them. Our clinical data will not just be gathered once but monitored constantly. We will identify how Quin performs on a daily basis and where we can improve. We will do this while respecting your data and privacy. We will be completely transparent with what data we use and how we use it. Where we need your health data to ensure we keep you safe, we will be responsible, protect it securely and store it pseudonymously.
Quin vs digital health
Ultimately, we wouldn’t release Quin if we were not confident that it was safe and beneficial to people with diabetes. We don’t want to be one of the 85% of healthcare apps that don’t meet safety standards. How many of the existing diabetes apps put quality and safety first?
We go above and beyond to give you the confidence in Quin that we have in ourselves; the knowledge that your health is our main priority; the understanding that we’re here to solve a problem that should have been solved by now; the trust that we will be transparent and show you how this will be achieved.
We want to work with the best clinicians and nurses and researchers, with those who challenge us every day on our ideas and implementations, with teams that will look not just at blood glucose data but also quality of life, and with people like yourselves who care about improving diabetes self-management as partners, not patients.
In 2020, we will find more of these people and, together, move ever closer to our 100% safe goal.
Update as of July 2020: The Quin app is now live in the iOS App store! We were also certified for ISO 134845 in May 2020 which embodies our safety first mindset. This demonstrates that our Quality Management System is appropriate and effective for the design, development, manufacture and distribution of medical device software for the management of diabetes.