Remote Upgrade of Medical Equipment - Minimizing Unintended Risks and Maximizing Security
February | 2016
With the increasing complexity of software in medical equipment, it becomes an imperative to periodically upgrade the software of the install base across widespread geographies while ensuring device security and patient safety. And as Medical Device OEMs embark on their IoT journey, remote software upgrade capability along with remote troubleshooting are adopted as the first set of use cases given their clear ROI when it comes to diagnosing the need for software upgrades. There are reliable technology available from several vendors to manage install base and deliver software upgrades in a reliable manner leveraging cloud scalability. Requirements that aid in improved reliability of the business process to consistently deliver software upgrades with increased security and addressing regulatory concerns will determine continued success driving adoption by both internal stakeholders and customers. Following are certain key requirements for consideration.
Single Source of truth for software upgrade eligibility - Given that the install base may be spread across different countries with different regulatory needs, it is important to correctly configure whether a given update package is applicable to a given version (hardware, software, geos and others) of medical equipment. This information should be in the control of regulatory affairs of an organization and used directly while making a decision on whether an installed equipment is eligible for an upgrade given the need for specific regulatory process for different countries. Copying this information manually by remote services team into an IoT platform delivering remote upgrades to installed equipment could be prevalent but may lead to different unintended risks and hence best avoided.
Consistency of software updates -Despite best efforts, there will be significant population of devices that will be unconnected despite having the capability to connect. This is primarily due to the security and privacy protocols of healthcare provider organizations. This raises the following major concerns.
Security - While integrity of the software package delivered and the secure channel adopted to deliver the upgrade are basic requirements, following could be some important security considerations.
In addition to above considerations, other factors like scalability of the overall solution to handle large upgrade payloads could determine the success of a remote software upgrade project. Certain basic architectural patterns like Valet-Key pattern provide scalability while addressing security concerns should be considered as part of overall architecture and design.
With increasing concerns around device security and sensitivity around reliability of the software upgrade process by both internal and external stakeholders, it is important to evaluate above requirements as you continue the journey to deliver remote software upgrades in a timely manner to your critical medical devices that directly impact patient care and safety.
Satish Mahankali leads the Medical Devices IoT Practice at Wipro, brings in over 18 years of experience designing solutions for multiple industry verticals including Medical Devices, Healthcare Payor and Consumer Electronics. Satish brings in a cross industry experience in solution design, delivering large and complex business processes transformation projects across industry verticals. Changing the way healthcare is delivered is a primary focus area for Wipro, Service transformation through connected products leveraging IoT paradigm & technology is a key enabler and current focus area for Satish. He has also been a speaker in industry events on IoT and Field Service transformation.
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© 2021 Wipro Limited |
Pharmaceutical & Life Sciences