Procedure: Single Lay User Prototype UI/UX Testing
Country: Global Procedure
Version #: 01/05/2024
Author: Vlad Reznikov
Editor: Daria Kostiuchenko
ID: GP-MD-PTS-SR
Category: MD&IVD/Others
Validity: NA
Certified by: Vlad Reznikov
Copyright: Pattern of USA Inc.
SUMMARY
Single Lay User Prototype UI/UX Testing is integral to the success of a healthcare startup developing medical devices. It aligns the design with user needs, identifies potential challenges, ensures regulatory compliance, and contributes to the creation of a competitive product.
User-Centric Design: It ensures that the user interface (UI) and user experience (UX) are designed with the end user – often individuals without technical expertise – in mind. This approach promotes accessibility and usability, enhancing overall user satisfaction.
Identification of User Challenges: Testing with lay users helps uncover potential challenges or difficulties that may not be apparent to developers or industry experts. This information is invaluable for refining the design to address user needs effectively.
Enhanced Usability: By obtaining feedback from individuals who represent the target user demographic, the startup can make informed adjustments to the UI/UX, leading to a more intuitive and user-friendly medical device. This can contribute to increased adoption and compliance with device usage.
Risk Mitigation: Early prototype testing with lay users allows for the identification and mitigation of potential risks or safety concerns related to the UI/UX. This proactive approach aligns with regulatory requirements and ensures the development of safe and reliable medical devices.
Regulatory Compliance: Regulatory bodies often require evidence of user testing in the development process. Single Lay User Prototype UI/UX Testing provides documentation that demonstrates the startup’s commitment to meeting regulatory standards and ensuring the safety of the medical device.
Iterative Improvement: Feedback from lay users enables iterative improvement, allowing the startup to refine the prototype through successive testing phases. This iterative process ensures that the final product aligns closely with user expectations and needs.
Competitive Advantage: A user-friendly and well-tested UI/UX can provide a competitive edge in the healthcare market. Positive user experiences can contribute to positive reviews, recommendations, and increased market adoption.

Must-Have Requirements, Recognized Standards, and Certifications:
- IFU
- Prototype or 10 single-use disposable samples
- Specific queries
Nice-to-have:
- Structured UX check-list
- Guidelines
Typical Gaps and Deficiencies: Digital interface, connectivity or mobile app failure
Implementation Period: Immediately
Deliverables: Detailed and structured UI/UX report with recommendations for UX and regulatory compliance
PHASE | TASK | TASK | START | DURATION | Fee | KPI | ||
NUMBER | TITLE | OWNER | W/M/Q/Y | in weeks | 3rd Party | Service | State | |
0 | In-house Pre-Submission Activity | |||||||
0.1 | NDA signing or validation | Executor | week 1 | 1 | ||||
0.2 | Contract Closing | MAH | week 1 | 1 | ||||
0.3 | SOW is approved by MAH | MAH | week 1 | 1 | ||||
0.4 | Invoice is sent to MAH and paid | MAH | week 2 | 1 | POP | |||
I | UI/UX Prototype Testing | |||||||
I.1 | Prototype and IFU forwarding to Executor | MAH | week 3 | 1 | ||||
I.2 | Virtual pre-testing meeting for orientation | Executor | week 4 | 1 | ||||
I.3 | Regulatory compliance check for medical device prototype | Executor | week 4 | 1 | ||||
I.4 | IFU and/or Guidelines regulatory compliance check | Executor | week 4 | 1 | ||||
I.5 | Connectivity testing (if applicable) | Executor | week 5 | 1 | ||||
I.6 | User Interface (UI) testing | Executor | week 5 | 1 | ||||
I.7 | General design testing | Executor | week 5 | 1 | ||||
I.8 | Usability testing | Executor | week 5 | 1 | ||||
I.9 | Special features testing | Executor | week 5 | 1 | ||||
I.10 | User Experience (UX) evaluation | Executor | week 6 | 1 | ||||
I.11 | Comprehensive report with feedback | Executor | week 6 | 1 | Report | |||
I.12 | Virtual post-testing meeting for reporting | Executor | week 7 | 1 | ||||
F | Final Phase In-house Post-Authorization Activity | |||||||
F.1 | Service Acceptance Certificate Signing | MAH | week 8 | 1 | ||||
F.2 | Final Invoice | Executor | week 8 | 1 | ||||
F.3 | Final Payment | MAH | week 8 | 1 | ||||
F.4 | Contract Termination | Executor | week 9 | 1 | ||||
F.5 | Archiving and limiting access | Executor | week 10 | 1 | Archiving |
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