Medical technology companies have a lot to consider when developing new products: a successful device must address an unmet need, deliver value to users and the health system, meet regulatory standards, and so on.
But many companies are neglecting a key issue which is becoming increasingly essential – digital technologies and connected devices must be compatible with existing systems. For too long, interoperability was a secondary consideration. Sometimes it was not a consideration at all.
In future, this simply will not be a viable approach. I believe interoperability must become a core element of medtech product design. If your device does not connect seamlessly with other systems, you will be trying to sell a fax machine that doesn’t connect to the phone line.
For users – patients, health professionals and healthcare providers – the idea of digital and connected devices that cannot sync with others is becoming unthinkable. One-off solutions are off the menu. If it doesn’t connect, it cannot scale. If it cannot scale, it doesn’t work.
Avoiding duplication and errors
Think about it from a patient viewpoint. They want unified access to their own data, and EU legislation makes this a right. People expect to be able to collect data from multiple organisations and multiple devices, including apps and home monitoring tools.
From a health system perspective, interoperability is fast becoming a ‘no brainer’. Failure to combine data sources means missed opportunities to derive insights from artificial intelligence, for example.
Worse than that, it leads to inefficiency and leaves the door open to errors. If patients, health professionals or administrative staff have to manually re-enter data, we have needless duplication which implies avoidable costs. But it also risks human error: typing mistakes can have serious consequences and some data may not be transposed at all.
For European consumers, the idea of hospitals re-typing test results from a fax into a desktop computer makes no sense.
And they are correct. It’s time to get everybody to agree on one shared language or a shared way of integrating data.
This is doable: look at diagnostic medical imaging where there is acceptance of a universal standard (DICOM). To make this happen for all medtech, I firmly believe we need to agree on a single standard. Quite a few medtech companies do support interoperability, but they do so in a proprietary fashion. If it doesn’t support a standard interface, it cannot scale. If it cannot scale, it doesn’t work.
A shared language
My advice is for vendors to embrace the work of the Integrating the Healthcare Enterprise initiative (IHE). Whereas most standards create information models focused on the exchange of data, IHE’s starting point is to standardise workflows – including device-relevant workflows. From there, they pick the most relevant standard (for example, IEEE 11073 combined with HL7 version 2 and/or FHIR) to support the workflow. A sizable portion of medtech companies already support these standards.
After 20 years working in this area, I am optimistic that convergence is on the horizon. Not only do consumers expect it, health systems increasingly support only scalable technologies that are interoperable ‘out of the box’.
We may not crack this tomorrow, but the medium-term trend is clear: interoperability is expected. Companies who fail to embrace it will fall behind. Let’s embrace the IHE standard and build interoperability into all medical technologies.
