Customer love and regulated medical apps

April 28, 2017

Very early in our customer research, we knew we weren’t just making an app to record and review diabetes data.

Our customers have tried using a lot of different logbook-style apps over the years to help them develop insights for making the hundreds of decisions they make everyday. But the only app they can really see themselves using regularly is one that can actually make those decisions for them. Or at least significantly relieve the mental and emotional burden of making those decisions.

Decisions

From the moment we realised this, we knew we would have to be regulated as a medical device. Making — or helping people make — decisions opens the door to making potentially wrong decisions. We have to take extra steps to make sure that doesn’t happen. And that — we were informed by many — would make building our app a slow, expensive, tedious, and a possibly futile journey.

Added to this, as any app maker knows, making an app people love means making it with them. Asking what they think and regularly giving them features they love. And in our case, as a medical device, giving them features they love means clearing them with the regulatory bodies first.

How do you walk the line between these two very desirable goals: customer love and customer safety? It’s a question that has to be answered by every medical app maker. The interesting features — the ones that really help our customers — could also really hurt them. The stakes are high.

CE Mark

Last week we received our CE Mark as a class I medical device. For the uninitiated, this means we’ve taken the necessary steps to comply with the European Medical Device Directive (the US will come later), and make our device safe for our users. Right now, we’re in beta with only minimal functionality, so the potential for harm is minimal. But by the time we get to actually making the decisions for our users, we’ll have to go well beyond this level of certification.

Our strategy is to start small and gradually expand the scope — and therefore the risk — of what we do, and for whom. We’ll add a few features, evaluate the risks they introduce, add the necessary regulatory compliance measures, and re-certify with the regulatory bodies. And then do it all all over again. Every month. Eventually, we’ll get into features that need clinical trials. These will of course take longer, but we won’t have to “stop the line” while we develop them. We’ll carry on delivering other features that keep our customers happy, and release those that require trials as and when they’re approved by the regulatory bodies.

Since diabetes is so poorly understood, it will take many years to get to a level where it completely relieves our customer’s diabetes decision-making burden. And we will be happily walking the line between customer love and customer safety until then. I’ll share some of the lessons we’ve learned so far in my next post.

Love, Cyndi

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