Am I able to sit in on the session?
Yes! We are also working on remote video access.
Can I combine my product and packaging usability sessions together?
Unfortunately, no. The Intended Users for a device are different than the Intended Users who open and dispense the product/device.
Can I provide my own users for my usability study?
Yes! Standard Usability Evaluations are excluded from being able to provide your own end users.
Can I use simulated product?
Yes, but the simulated product/device must be size and weight representative.
How are you conducting the study in leu of no specific standard?
An ASTM Guidance document will be balloted in 2024. In the meantime, we've used the following standards to author our usability plans:
- ISO 11607-01 Section 7
- FDA1757
- IEC 62366
- AMMI/ANSI HE75
How many samples do I need for a usability evaluation?
1 to 3 per user. Having a sample size on the higher end is preferred.
When do I perform usability?
Formative studies should be performed before a design freeze. Summative studies should be conducted after sealing validation.
Why are 15 users required?
The 15 users requirements are directly tied to requirements of IEC 62366 and AMMI/ANSI HE75.
Still have questions? Reach out through our Contact Us page and we'll help you get the information you need.