Science and labs
Human factors and packaging
We check that real people can use your product safely. We test whether they understand the label and the instructions. We also test whether a pack is hard for young children to open but still easy for adults.
What it is
In one sentence
Human factors work studies how people actually use a product, so we can find and fix the mistakes they are likely to make.
Who it is for
Teams that make medical devices, drug-device combination products, medicines, nutraceuticals, cosmetics and consumer health products. It helps both before the design is final and when you need evidence for a regulator.
Problems it solves
What goes wrong, and how we prevent it
Use errors found too late
A problem found after the design is fixed is costly to change. We run early, small studies while the design can still change. These are called formative studies.
Warnings that people miss
A label can be correct and still be misread. We watch whether people can find, understand and act on each warning, dose and step.
A pack that stops adults too
A child-resistant pack must also open easily for the adults who need it, including older people. We test it with a child panel and an adult panel.
What you get
Deliverables
- A human factors and usability study plan, built around your users and how they will use the product
- Formative usability studies (early studies that shape the design)
- Summative usability studies (a final study that shows the design is safe to use)
- A use-related risk analysis: what users could get wrong, and which tasks are critical to safety
- Recruitment of users who match the people who will really use the product
- Moderated sessions, where a trained person guides and watches each user
- Comprehension tests for labels and instructions for use
- Child-resistant packaging protocols, with child panel and adult panel testing
- Evidence to compare packs and improve a design
- Testing run and reported through an ISO/IEC 17025 accredited facility
- Study documents ready to include in a regulatory filing
How it works
How a study runs
Timing depends on the protocol, who we need to recruit, when the packs are ready, and whether the study is formative or summative. We confirm a schedule after a short feasibility review.
Understand the product and its users
We learn what the product does, who will use it, where, and how it could be misused.
Write the protocol
We turn this into a study plan. It sets the user groups, the tasks, the pass criteria and what we will measure.
Recruit and run the sessions
We recruit users who match the real users. We watch each session and record every use error and every point of confusion.
Analyse and report
We explain what went wrong and why. We suggest changes to the design, the label or the pack. You get a final study report.
Regulators and standards
Standards we test to
We confirm the standard and the accredited scope for each study before it starts.
- ISO/IEC 17025
- The international standard for testing labs. It shows a lab can produce reliable results. Our testing runs through an accredited facility.
- IEC 62366-1
- The international standard for usability engineering of medical devices. Our partner labs design studies to it.
- ISO 8317
- The international standard for child-resistant packs that can be opened and closed again. Our partner labs test to it.
- Terms explained
- A use error is when a user does something the designer did not intend, or misses a step. A critical task is a task that could cause harm if done wrong. A formative study shapes the design. A summative study shows the final design is safe to use. A child-resistant pack is hard for young children to open but not hard for adults.
Proof
Proof
Studies we run include child-resistance testing, human factors (usability) studies, transport validation and stability studies.
FAQs
Questions we are often asked
Which human factors studies do you run?
Formative and summative usability studies, use-related risk analysis, critical task reviews, label comprehension tests and simulated-use studies. Simulated use means people use the product in a realistic setting, but not on a real patient. We run them for medical devices, drug-device combination products and consumer health products.
What is child-resistant packaging testing?
It checks that a pack is hard for young children to open. It also checks that adults can still open it and close it again. We follow a set protocol with a panel of children and a panel of adults, and we record what each person does.
Is the testing done in an ISO/IEC 17025 facility?
Yes. Testing is planned and recorded through an ISO/IEC 17025 accredited facility. Before a project starts, we check that the facility's accredited scope covers your test.
Which products can you test?
Medicines, medical devices, combination products, nutraceuticals, cosmetics and some FMCG and consumer health products. We test both how people use the product and how they handle its pack.
Can you help us write the study protocol?
Yes. We start from the product, the people who will use it, the ways it could be misused and the route to approval. From these we write a protocol. It sets the user groups, the pass criteria and what we will measure.
Do you recruit users who match our real users?
Yes. We build each user profile from the people the product is meant for. We think about age, experience, reading level and physical ability, such as grip strength or eyesight.
Can human factors work start before the design is final?
Yes, and it is often the best time. Early formative studies find use errors and points of confusion while changes are still cheap to make.
Can you test our labels and instructions for use?
Yes. We check whether people can find, understand and act on the important parts. These include warnings, preparation steps, dose information and how to dispose of the product.
What documents do we get?
The protocol, records of each user and session, a log of anything that did not go to plan, the analysis, the use errors found, suggested changes to reduce risk, and a final study report.
How long does a study take?
It depends on the protocol, who we need to recruit, when the packs are ready, and whether the study is formative or summative. We give you a schedule after a short feasibility review.
These answers are general information, not advice for your product. Rules change. Check the latest guidance, or ask our team about your product.
Related services
Often used together
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Accredited labs
Use this when you need stability, packaging, transport or batch release testing.
Learn more about Accredited labs → -
Regulatory affairs
Use this when you need a product approved, a licence renewed, or an audit passed.
Learn more about Regulatory affairs → -
Clinical trials (CRO)
Use this when you need a study in people to prove your product is safe and works.
Learn more about Clinical trials (CRO) →
Start a conversation
Talk to our human factors team.
Tell us about your product, its users and its pack. We will suggest the studies you need and how to plan them.