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.

Gp Md&ivd Others Single Lay User Prototype Ui Ux Testing Simplified Regulations Card Gantt Chart (1) Page 0001

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

 

Feel free to submit a Request for Proposal (RFP) for a specific country or territory to info@patternofusa.com