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BATTELLE

Safe, Secure & Easy to Use

Adding layers of device security often creates a concurrent reduction in usability and convenience for end users. If security requirements make use of the device too difficult or interfere with clinical workflow, patients or healthcare workers may develop workarounds that ultimately reduce data security and safety for the device.

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what’s inside

Threat Profiling

Threat profiling involves defining and ranking potential cybersecurity threats based on the physical and software attributes of the device.

Heuristic Evaluation

Heuristic evaluation involves comparing device requirements against industry best practices and guidelines and identifying areas of concern.

Cybersecurity Testing

Cybersecurity testing should be conducted at the prototype stage as well as prior to FDA submission.

Usability Research

Generative and contextual research help manufacturers understand the user characteristics, environment of use and clinical workflow.

Human Factors Testing

The FDA requires human factors testing prior to device approval. However, conducting testing at the design and prototype stages can uncover potential usability issues earlier in development.

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apply what you learn

The right balance of usability and cybersecurity will be unique to each device. Finding this balance will require an integrated approach to device development that includes both security and human factors considerations from the very earliest stages of development.

Just provide a bit of information on the right and you can learn more with our white paper: Safe, Secure and Easy to Use: Balancing Cybersecurity and Usability in Medical Devices.

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