The main connectivity objectives in the medical device world are data capture and use, device control and local information display. Underpinning these objectives is data transmission and the spectre looming ever larger is data security, as Tim Portass, technical director at Staffordshire-based app technology firm ARC Development explains.
Connectivity shouldn't be a problem, the IoT industry has standards for all this. All we have to do as device manufactures is to choose the appropriate standard. If only it were that easy. In the connectivity world it's true to say that the nice thing about standards is that there are so many to choose from. And if you don't like this year's standards, you can always wait for next year's.
So what's our strategy for turning the connectivity headache into competitive advantage and new revenue? Bolt-on solution? Develop in-house? Hybrid? The bolt-on solution ought to have the advantage of reducing time-to-market but gives no differentiating factor and a third-party dependence. The in-house development approach sacrifices time-to-market in favour of controlling and owning a bespoke end-product, with no third-party dependence but an expensive ongoing in-house maintenance effort in a domain which does not perhaps naturally fit well with in-house expertise.
The hybrid approach can offer the best of both worlds, working with a partner to use their experience and lower level connectivity components to go quickly to market and resulting in a bespoke solution that is flexible and adaptable.
So to turn our attention to the security question: as with all security, not just medical device connectivity security, it's an arms race. You need to ask yourself how you want to play that arms race. And it's the subject of a discussion outside the scope of this article.
Selection of not only connectivity technology but also high level connectivity data flow design will determine not only your solution today, but how well your device is future-proofed.
So this could mean high level design decisions such as placing a smart device into your connectivity solution rather than connectivity directly from your device to a router. This could mean lower level decisions like selecting Bluetooth and not wifi at your device, with the concomitant changes to software as the device provisioning changes and of course working practice changes for the user.
This exercise is looking to make your product not only competitive today but to provide longevity in the market without falling foul of new standards or new market trend. It also has a significant impact on the security question.
Connectivity project planning
Planning is key: And in the race to get products to market a good plan today is better than a perfect plan tomorrow. Plan towards your delivery objective: Test plans and specifications should be produced early as this defines the design and build objective for engineering.
If your safety has been designed-in from the start then you reduce your exposure to nasty surprises with notified bodies. The difference between having the right engineers available and less experienced engineers who are perhaps meeting these issues for the first time, can be a big cost and time-to-market difference.
The notified body you choose for CE marking needs to be a good fit to your own working practice. Different notified bodies have different approaches and different strengths. Medical device connectivity takes all players, including the MHRA and notified bodies, into new areas and new ground is being broken in terms of what is acceptable medical device operation. Additionally the MDD to MDR transition, has obliged the notified bodies to change their working practice and although largely sorted out now, there has been a little process uncertainty over the last year or so.
Outside the strictly regulated world of medical devices, connectivity solutions can look at delivering the MVP and then building upon it. That's not so easy with medical devices where CE marking issues with clinical trials mean we are looking to get a full solution right first time.
In the initial stages of your connectivity effort, choose a partner with experience specifically in end-to-end connectivity in medical devices and in bringing connected devices to market through the complex and ever-changing technical and regulatory maze.
