White Paper

Safe, Secure and 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.
Get the white paper

Icon: Illustration of a question mark

What's Inside

Threat Profiling

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

Usability Research

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

Heuristic Evaluation

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

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.

Cybersecurity Testing

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