How to avoid making OTA retrofitting for ECG an expensive mistake
Networking is one of the central components of digitalization. In addition to the transmission of measurement data, the maintenance of devices is also an important aspect of networked devices. This allows software updates, security patches, and even functional enhancements to be installed without anyone having to be on site.
The digitalization of healthcare is contributing to the fact that devices that could previously only be operated locally are now increasingly being equipped with communication interfaces. However, a retrofit that enables wireless maintenance via over-the-air (OTA) updates, for example, is not only a technological challenge. At least as difficult is meeting the regulatory requirements that are designed to protect privacy and ensure effective cybersecurity, among other things.
In addition, a strategic decision on the scope of the functional enhancement is required before the technical development process can begin. This decision determines whether the enhanced product can be brought to market quickly and at a competitive price – or whether time-consuming and costly recertification is necessary. Errors in documentation, testing, and validation can also lead to a notified testing body tending toward a more complex process in unclear cases.
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