Kick off your Human Factors Engineering process with our 3-step package
As Human Factors Consultants, we help MedTech and Pharma companies develop and realise their groundbreaking ideas according to the IEC 62366 standard for the Application of Usability Engineering to Medical Devices. With our help, you will get off to a good start.
What is the HFE kick-off package?
Human Factors Engineering (HFE), also known as usability engineering, will support you to make easy-to-use products and document the safety of use (e.g., decreasing the amount of errors that users make).
We often help companies kick off the process of making their product safe and effective to use with our 3-step package that fast-tracks getting the prototype into the hands of users:
Step 1: Use Specification
In compliance with IEC 62366, our first step is to define important characteristics related to the context of use of your medical device. In this step, we help you specify the intended use, users and use environment and deliver it in a standardised format called a Use Specification. This step includes a step-by-step breakdown of the tasks users are intended to perform, called a Perception-Cognition-Action (PCA) Task Analysis.
Step 2: Provisional Instructions for Use
We make the layout, copywriting and pictures for a provisional Quick Reference Guide and/or Instructions for Use that will enable users to realistically interact with your device in a formative usability test. What we deliver can be the first step to the development of Instructions for Use. This step ensures a lean route to getting important insights for further development of both the instructions and product design.
Step 3: Formative Usability Test
The third step is to evaluate the safety and efficacy/effectiveness of the device design in an early (formative) usability test.
The test helps you identify unintended behaviour (difficulties and use errors) and to qualify the root causes hereof. You might even discover risks not previously thought of, which is essential to give you a good HFE process. We thoroughly analyse the insights from the test and provide actionable recommendations for design mitigations to increase safety and efficacy/effectiveness.
Cost and timeframe
This 3-step HFE package is often completed within a month and usually costs around 250.000 DKK VAT excluded.
The exact cost will vary depending on how far you are in the process (e.g. have you already collected some initial user insights for the use specification document, or do you need help collecting them?) and your needs (e.g. do you need help designing or prototyping the device interface?)
No matter where in the process you are, we can help you.
Outcome and Deliveries From the HFE Kick-Off Package
Outcomes From the Kick-Off
- Get a good start on the documentation you need to comply with the IEC 62366 standard, and get closer to an FDA or EMA approval
- Get an overview of the entire HFE process
- Make your medical device safer and more effective to use for your intended users
- Ensure that your medical device considers not only the users’ wants and needs, but also the capabilities and limitations we have as humans
- Get key insights about your intended users and use environment(s)
- Ensure that the instructions for Use (IFU) are easy to understand
The delivery format is a series of documents:
A Use Specification document, including a PCA task analysis. In combination with the formative test, this can lay the foundation for your Risk Management, as you will get an analysis of initial failure modes and observations of difficulties.
Provisional instructions for use
A detailed protocol and moderator guide for the formative usability test, which can be replicated or extended for later formative tests
A report with a thorough analysis of the observed behaviour and other insights from the usability test. With actionable recommendations for further design development (both device and instructional material).
We help with all parts of the HFE process
The standard HFE package described here includes a use specification document, a provisional IFU, and a formative usability test - but we also help with other parts of the HFE process. For instance:
User research and collecting user needs
Identifying known use-related problems, for instance by investigating knowledge from previous versions of your product or from similar products from competitors
Risk analysis, including identifying characteristics related to safety such as critical tasks and failure modes, use-related hazards and hazardous situations
Selecting use scenarios for formative testing and summative validation
Design review
Design control
uFMEA file
Together, we find the best possible HFE package for you.
