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Availability of rich IoT functionality brings a broad set of challenges for medical device builders. When implementing IoT feature sets in a medical device setting, there are a number of challenges to be investigated, implemented and supported including:
IoT Enabled solutions must provide a prime user experience both for the user as well as web/mobile application and IoT Platform. The experience transition from devices to web/mobile applications should be cohesive and seamless.
Security is a fundamental concern for medical device manufacturers to ensure they comply with laws like HIPAA when dealing with Protected Health Information (PHI).
Selection of a base platform that includes hardware, software, and connectivity options that work together and can fulfill specific needs.
Medical devices should be future-enabled to remotely handle firmware updates for bug fixes, enhancements or security patches. This remote update capability can also reduce cost of servicing devices.
Regulation and compliance requirements for medical devices keep evolving e.g. EU MDR/IVDR requirement mandates conformance to ISO 14971 to implement post-market electronic surveillance.
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