しかし、IoTの豊富な機能が原因で、医療機器メーカーはさまざまな課題に直面することになります。医療機器にIoTの機能セットを実装する場合、以下のような課題について検討する必要があります。
医療機器用のIoT/クラウド・ソフトウェア
医療機器用のIoT/クラウド・ソフトウェア
しかし、IoTの豊富な機能が原因で、医療機器メーカーはさまざまな課題に直面することになります。医療機器にIoTの機能セットを実装する場合、以下のような課題について検討する必要があります。
Delivering the Best User Experience
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.
Ensuring Patient Data Security
Security is a fundamental concern for medical device manufacturers to ensure they comply with laws like HIPAA when dealing with Protected Health Information (PHI).
Hardware/Software Connectivity
Selection of a base platform that includes hardware, software, and connectivity options that work together and can fulfill specific needs.
Maintenance over Product Lifespan
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 Conformance/Compliance
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.
