For MedTech Engineers
A clinician can be trained on a device. A patient or caregiver at home usually can't, and no one is there to catch a mistake. That's why home-use devices require rigorous lay-person usability testing. Concise Engineering plans and runs usability programs built around IEC 62366-1, from usability engineering plans and risk assessments through summative testing and HFE reports, so your file shows the device is safe for the people who will use it.
Sound Familiar?
- Our device will be used at home, and we're not sure how much testing that adds.
- We've only gathered feedback from a few enthusiastic users, and I worry they don't represent everyone.
- I don't know which tasks FDA will treat as safety-critical for a lay user.
- Our usability documentation is scattered, and submission is getting closer.
Usability Testing Built for Lay Users
Home-use devices face a higher bar because the person using them has no clinical training and no one standing by. We prioritize safety-critical tasks, assess use-related risks, and write formative, pre-summative, and summative test protocols around the patients and caregivers who will use your device. Every step follows IEC 62366-1 requirements, and the documentation is built to support FDA guidelines and your clearance.
- Usability engineering plans and usability risk assessments
- Formative, pre-summative, and summative test protocols for lay users
- Usability test reports and HFE reports for your submission
- IEC 62366-1:2015 compliant usability process development
Why Concise Engineering
- Engineers talking to engineers. We fit usability work into your design process, so findings reach the team while changes are still practical.
- Risk first. We focus testing on safety-critical tasks, where a use error by a lay user could cause harm.
- Experience you can build on. We've authored usability documents for product approvals since 2008, well before the FDA guidances in 2011 and 2016.
How It Works
- Discovery call - your device, your users, and where usability work stands
- Usability engineering plan and use-related risk assessment
- Formative and pre-summative testing with representative lay users
- Summative testing, test reports, and HFE report
Frequently Asked Questions
Why do home-use medical devices need more usability testing?
Lay users have no clinical training, may be managing a health condition, and use the device without anyone watching. Use errors that a clinician would catch can go unnoticed at home. That's why home-use devices require rigorous lay-person testing, with tasks and participants that reflect how the device will be used day to day.
Who should take part in usability testing for a home-use device?
People who match your intended users, such as patients, caregivers, or family members, across the range of ages, abilities, and experience you expect. Relying on a few enthusiastic users can create an echo chamber. A broader group shows how the device performs for everyone who will use it.
What are safety-critical tasks?
Safety-critical tasks are the steps where a use error could lead to harm, such as setting a dose, connecting a component, or responding to an alarm. A usability risk assessment identifies them early, so testing focuses on the tasks that matter most for patient safety.
What documentation does a home-use device need for usability compliance?
Typically a usability engineering plan, usability risk assessments, formative test protocols, summative test protocols, usability test reports, and a human factors engineering (HFE) report. Together they show how use-related risks were identified, tested, and addressed. Pre-summative protocols help confirm the summative study is ready before it runs.
Can you handle the entire usability program?
Yes. We can provide any and all documentation and testing needed for usability compliance, from process development through the final HFE report. Some teams bring us in for a single protocol or report. Others hand us the full program so their engineers can stay focused on the design.
How long has Concise Engineering done usability work?
We've authored usability documents for medical device approvals since 2008, before FDA published its human factors guidances in 2011 and 2016. Our usability services include home-use devices and the lay-person testing they require.
Design for the person at the kitchen table. Let's plan usability testing for your home-use device.
Book a Discovery Call
Concise Engineering helps teams developing home-use medical devices plan and run lay-person usability testing under IEC 62366-1, including usability engineering plans, risk assessments, formative, pre-summative, and summative protocols, test reports, and HFE reports for FDA submission.