Conventional medical devices (a self-contained appliance worn by or implanted in a patient) are rapidly evolving into “medical device ecosystems.” Today, traditional medical devices are often integrated with some combination of a mobile application, base/charging/connection station, and a cloud-based repository. As patient and device data flows among these components, the risks from cyber threats, data loss and corruption, and software errors increase.
Representing the lea ding cloud connectivity solution designed specifically for medical devices, Galen Data’s Chris DuPont and Keith Drake share their insights on how to identify data risks for different types of medical devices and how to cost-effectively mitigate them. Rather than approaching data risk analysis and mitigation as a single step in the design process, DuPont and Drake present a concept that considers data risk mitigation throughout the product lifecycle: from design and development, through testing and investigational trials, to commercial launch and post-market surveillance.
Key presentation takeaways:
• How to identify the types of data risk for different medical devices
• Why the benefits of medical device cloud connectivity outweigh the risks
• Minimizing commercial risk through automated post-market surveillance
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