Overview

A short story on how the Usability Engineer team at Philips Design (Blumenau Studio) has overcome a scaled formative and summative test for EHR solution

Basic facts

In 2017, I was part of the Usability Engineer team at Philips Design and, we had the challenge of evaluating Philips' EHR solution to receive CE Mark and FDA approval for Medical Devices.

The letters ‘CE’ appear on many products traded on the extended Single Market in the European Economic Area (EEA). They signify products sold in the EEA have assessed to meet high safety, health, and environmental protection requirements.

https://ec.europa.eu/growth/single-market/ce-marking_pt

The Challenge

As Philips' EHR system has over 700 functions (for different user journeys within hospital daily activities) we had to come with a smart strategy to test it without taking too long (it could take over 2 years to test the entire solution).

List of our major challenges:

• Philips' EHR solution has over 700 functions (user journeys)
• CE Mark and FDA needs to be focused on functionalities and tasks that have patient risk
• Not all functions had risk to the patient, some functionalities were for hospital financial users, for example.
• Tight agenda to launch the product on a new platform

Results

With the suggestion of our creative director, we started executing an usability engineering strategy on the Design System to test its safety against functions that have patient risk.

Steps followed to evaluate the EHR

1. List all solution functionalities and user journeys
2. Classify patient risk for each functionality
3. List all design system components
4. Classify patient risk for each component 
5. Create a matrix between components and functionalities that has a high risk for patients
6. Based on this matrix, list all necessary functions and components that needed to be evaluated
7. Evaluate with the internal medical team to find the first high priority usability issues
8. Fix all usability issues
9. Evaluate with the external medical team in a partner hospital
10. Fix all usability issues
11. Submit the evaluation process and results for the CE Mark Quality team