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.
Can PCL help with protocol authorship?
PCL can act as extra fire power for your existing team and author your protocols.
Does PCL have production minimums?
PCL does not have production minimums! We can accommodate annual volumes as low as one finished good annually.
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.
I need help purchasing a sealer. Can PCL help with this?
PCL partners with many medical device sealing manufacturers and would be happy to help procure a sealer for your sealer validation.
What is a Test Parameter Sheet (TPS)?
The TPS is our way of ensuring that your team and ours are accurately interpreting the details of your study. You review and agree or clarify before we begin your packaging testing.
When do I perform usability?
Formative studies should be performed before a design freeze. Summative studies should be conducted after sealing validation.
Who drafts the Test Parameter Sheet?
A PCL engineer will review the quoted test plan, protocols and other supporting information and draft the TPS. As soon as everything is aligned, you sign off and we get started.
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.