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Helping clarify how IEC 62366 standard affects front end innovation | By Paul Miklautsch

Every year, more than 250,000 people die because of medical mistakes due to human errors and system failures. Use errors caused by inadequate medical device usability have become an increasing cause for concern. The IEC 62366 standard provides the process for medical device manufacturers to follow and document their learnings. 

At Start Something Bold, we work with medical device manufacturers and pharmaceutical companies to deeply understand users and test their interactions with concepts. The IEC 62366 standard defines a process to analyze, specify, develop and evaluate the usability of a medical device as it relates to safety.

For a front end innovation project, a team may be focused on learning about users, their needs, and the scenarios in which they work. It may also involve understanding and testing user interactions of current or similar products within their work environment. This provides a strong foundation that can be documented in the usability engineering file at the early stages of a project, which can be built upon later as more concepts are developed and usability testing is conducted. 

To speed up the process, our team is credentialed to be in the hospital to conduct user research and contextual inquiries. This observational research allows us to see first hand the behaviors of users and their interactions with healthcare professionals and patients. In addition, 1:1 interviews allow us to have conversations with users to better understand their thoughts and perceptions as we define user requirements. 

Later in the process, as concepts are developed and refined additional research will test the user interface and user actions of concepts to understand their ability to perform tasks and associated risks with user error.

We believe there to be a competitive advantage for companies through increased usability, and benefits for patients to be cared for in a safe environment. 

By Paul Miklautsch - November 26, 2019

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