When it comes to medical devices, usability isn’t only about making things easier for the user but rather about preventing risks and increasing safety. At Innokas, we’ve helped various customers ensure that the usability related documentation of their device is top notch and ready for scrutiny and continuous process. An interview with Innokas usability expert Minna Eskola illuminates three most common areas where companies need usability support, and how proactive usability engineering can save time, money, and lives.
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Usability is a safety issue

At Innokas, we have worked with customers who initially underestimated the role of usability. They may not realize that a confusing user interface or unclear instructions can lead to hazardous situations. Additionally, they might not be aware that usability engineering isn’t just a nice-to-have, but a regulatory requirement to be applied in all medical device design.

Regardless of the complexity or classification of a device, a usability engineering file must be part of its technical documentation. The level of effort can be tailored and scaled, and usability-related activities and content integrated into other processes and documentation where appropriate.  

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Three common usability support needs

We typically support our customers in three key areas:

1. Early-stage assessment

We help define the user profiles and groups, use environments, and other content specific to use specification of the device. We also support the planning of usability activities and help align them with the device’s risk profile.

2. Design phase support

From initial planning to final summative evaluation, we guide and conduct usability activities throughout the design process. This ensures that usability is built into the product, not patched later, and supports risk management and safety-related decisions made during the design and development.

3. Post-development corrections

Sometimes usability is overlooked during development. In these cases, we help identify gaps and correct them, ensuring the device meets usability requirements before it enters the market.

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Proactive usability saves time and money

Usability issues discovered late in development – or worse, after launch – can be expensive and damaging. By addressing usability early and thoroughly, companies can avoid delays, reduce safety and project risks, and drastically improve user satisfaction.

At Innokas, we tailor our support to the needs of each customer, whether they’re new to usability engineering or already have experience. If you’re unsure whether usability engineering is correctly and adequately covered in your device, it’s never too early or late to ask for advice.

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Questions about usability?