Case Study essity

Medical staff shows a patient how to correctly apply a wrist orthosis in a formative usability test. A usability engineer takes notes.

essity Wrist Orthosis

Medical Usability Engineering
Formative Evaluation
Summative Evaluation
Usability Testing

Essity supports patients and healthcare professionals with products along the entire treatment pathway. The focus is on practical solutions for wound care, compression and orthopedics — always with the goal of improving care, whether in clinical settings or at home.

This time, the focus was on a new wrist orthosis. It should not only provide stability but also feel comfortable, be easy to put on, and perform well in everyday use. And because medical products are rightly subject to strict requirements, we kept all regulatory guidelines in mind in addition to user comfort.

Formative Evaluation

Based on the Use Specification and Use Scenarios provided by essity, our Medical Usability Engineers developed a test plan. The first project phase involved a formative evaluation. The focus was on everything essential for safe use: Is the orthosis applied correctly? Can it be used safely?

The evaluation was conducted under realistic conditions with participants who accurately reflected the actual user group. Thanks to our test participant pool, we were able to recruit precisely.

The goal was to identify additional use errors and use difficulties in order to address them before the summative evaluation. The insights were documented in a test report, enabling the project team to immediately derive meaningful actions.

Medical staff shows patient the wrist orthosis in a formative usability test. — Standardized instructions ensure reliable results

The evaluation was conducted under realistic conditions with participants who accurately reflected the actual user group. Thanks to our test participant pool, we were able to recruit precisely.

The goal was to identify additional use errors and use difficulties in order to address them before the summative evaluation. The insights were documented in a test report, enabling the project team to immediately derive meaningful actions.

Patient puts on wrist orthosis independently in usability test. A usability engineer takes notes. — Applying the orthosis independently under the supervision of usability engineers

Summative Evaluation

Following the formative findings, the summative evaluation took place. The objective was to verify whether the revised version could be used safely and effectively. All procedures and analyses were based on the EU MDR and DIN EN ISO 62366-1.

The results were clear: the issues identified in the formative test had been successfully addressed. For example, pictograms and product illustrations were revised according to our specific recommendations — making application significantly easier for non-medical users.

Usability Engineer takes notes after completing the test tasks. — Checking that the orthosis fits correctly in order to identify possible use errors

After the two-step approach, the project came to a successful conclusion. The results were compiled in a structured Usability Evaluation Report. This was integrated into the Usability Engineering File and served as the final usability assessment in accordance with the EU MDR.

It’s great when good usability can truly make an impact — or in this case, provide stability. 😉