Best Medical Device Usability Testing & Formative Usability Testing Providers

Medical devices must be designed and validated to ensure they can be used safely and effectively by intended users^[1][2][3].

This requirement applies to:

• Devices with user interfaces — devices with displays, controls, or software interfaces require usability validation^[1][2]
• Devices used by lay users — devices intended for home use or use by non-professionals require extensive usability validation^[1][2]
• Devices for US market (FDA) — FDA requires human factors validation for many medical devices^[2], especially those with use-related risks
• Devices for EU market (MDR) — MDR requires usability engineering for medical devices^[3]
• Devices with use-related hazards — devices with potential for use errors require risk analysis and validation^[1][2]
• Devices with instructions for use — devices that rely on instructions require instructions evaluation^[1]
• Class II and Class III devices — higher-risk devices typically require more extensive usability validation^[2]

Note: The extent of usability testing required depends on device category, user type (lay vs. professional), use environment, and regulatory pathway. A usability engineering plan helps determine which studies are needed. Formative studies are typically conducted during development, while summative studies validate the final design.

Usability / human factors testing services typically include:

• Use-related risk analysis: Identification and analysis of use-related hazards and risks^[1][2] — required for usability engineering process
• Task analysis: Analysis of user tasks and workflows^[1] — helps identify use scenarios and critical tasks
• Formative usability studies: Studies conducted during device development to identify and fix usability issues^[3] — typically iterative, with multiple rounds of testing
• Summative usability studies: Studies conducted with final device designs to validate usability and demonstrate safety^[3] — required for regulatory submissions
• User interface evaluation: Evaluation of device displays, controls, and software interfaces^[1][2]
• Instructions for use (IFU) evaluation: Evaluation of user manuals, labels, and instructions^[1][2] — required if device relies on instructions
• Validation testing: Testing to demonstrate that use-related risks are acceptable^[1][2] — typically conducted as part of summative studies
• Participant recruitment: Recruitment of representative users (lay users, healthcare professionals, etc.) for usability studies
• Usability engineering file (UEF): Documentation of usability engineering process^[1] — required for regulatory submissions
• Test reports: Comprehensive test reports suitable for regulatory submissions

Additional services may include:

• Usability engineering plan development
• User needs analysis
• Design recommendations
• Regulatory strategy and pathway guidance

Pricing for usability / human factors testing varies based on several factors:

• Study type: Formative studies are typically less expensive ($15,000 - $40,000) than summative studies ($30,000 - $75,000+) due to scope and regulatory requirements^[1]
• Number of participants: More participants = higher cost — formative studies typically use 5-10 participants per iteration, while summative studies may use 15-30+ participants^[1]
• User type: Recruiting lay users may cost more than professional users due to recruitment difficulty and compensation requirements
• Study complexity: Complex devices or multiple use scenarios require more extensive testing, adding to cost
• Services included: Risk analysis, task analysis, user interface evaluation, instructions evaluation, and validation testing may be included or charged separately — full-service packages may cost more but provide comprehensive support
• Participant recruitment: In-house participant recruitment may be included or charged separately — recruitment costs vary by user type and geographic location
• Usability lab vs. remote: Lab-based testing may cost more than remote testing due to facility costs, but may provide better control and observation
• Number of iterations: Formative studies often require multiple iterations — more iterations = higher total cost
• Regulatory support: Additional regulatory consulting or usability engineering file (UEF) development may add $5,000 - $15,000
• Lead time: Rush services (studies within 4-8 weeks) typically cost 20-50% more than standard lead times (8-16 weeks)

Typical pricing ranges:

• Formative study (single iteration): $15,000 - $40,000
• Formative study (multiple iterations): $30,000 - $80,000+
• Summative study: $30,000 - $75,000+
• Full program (formative + summative): $60,000 - $150,000+
• With risk analysis and UEF: Add $10,000 - $25,000

Tip: Request quotes from multiple providers and compare not just price, but also study scope, participant recruitment, lab capabilities, regulatory experience, and lead times. Accredited providers with regulatory experience are essential for successful submissions.

When selecting a usability / human factors testing provider, consider these factors:

1. Study type support: Verify the provider offers both formative and summative studies^[1] — some providers specialize in one type, while others offer comprehensive programs
2. User type support: Verify the provider can recruit your intended user types (lay users, healthcare professionals, etc.) — recruitment capabilities vary by provider
3. Participant recruitment: Determine if you need in-house participant recruitment or can provide participants — in-house recruitment adds value but may increase cost
4. Usability lab capabilities: Verify the provider has appropriate facilities (dedicated lab, remote testing capability, etc.) for your study needs
5. Services offered: Verify the provider offers all services you need (risk analysis, task analysis, user interface evaluation, instructions evaluation, validation testing)^[2][3]
6. Standards experience: Confirm the provider is experienced with IEC 62366-1^[2], IEC 62366-2^[1], and FDA Human Factors Guidance^[3] — regulatory experience is essential
7. Regulatory acceptance: Confirm test reports and usability engineering files (UEF) are accepted by your target regulatory authorities (FDA, EU notified bodies, etc.) — providers with regulatory experience generally provide documentation suitable for submissions
8. Prior data evaluation: If you have prior usability data, confirm the provider can help evaluate its adequacy and determine if additional studies are needed
9. Lead time and availability: Compare lead times (standard vs. rush) and availability windows — usability studies typically take 8-16 weeks from start to final report
10. Sample requirements: Understand sample requirements and whether prototypes or final devices are needed — affects project timeline
11. Response time and communication: Check quote response SLAs and communication quality — fast, clear communication is essential for project success
12. Pricing transparency: Look for providers that provide detailed quotes with clear breakdowns of included services, participant recruitment, iterations, exclusions, and potential additional costs

Red flags: Providers that lack regulatory experience, cannot recruit your user types, lack appropriate facilities, or cannot provide examples of successful regulatory submissions.

Getting quotes through Cruxi is simple and fast:

1. Submit one request: Fill out a single form with your device details, user type, study needs, participant requirements, timeline, and budget
2. Routed to Pro providers: Your request is automatically sent to Pro usability testing providers that match your requirements (typically 3-5 providers)
3. Compare quotes: Receive detailed quotes directly from providers and compare pricing, lead times, study scope, participant recruitment, lab capabilities, regulatory experience, and included services

Benefits:

• Save time by avoiding individual provider outreach
• Compare multiple options side-by-side
• Pro providers respond fastest (typically within 24-48 hours)
• No obligation to accept any quote
• Access to providers with regulatory experience and proven track records

Alternative: You can also request quotes directly from individual providers via their profile pages.

Recommendation: For fastest response times and best quote comparison, prioritize Pro providers when requesting multiple quotes.

To get accurate quotes and start usability studies efficiently, providers typically request:

• Device information: Device name, category, class, intended use, and regulatory pathway
• User type: Lay user, professional healthcare, or both^[1] — affects study design and participant recruitment
• Use environment: Home healthcare, professional healthcare, or both^[1] — affects study design
• Study type: Formative (development) or summative (validation)^[2] — laboratories can help determine requirements
• Services needed: Risk analysis, task analysis, user interface evaluation, instructions evaluation, validation testing^[3][4]
• Target markets: Where you plan to market the device (US/FDA, EU/MDR, etc.)^[4][5]
• Prior data: Any existing usability data or studies — may reduce study scope
• Participant requirements: Estimated number of participants, user demographics, and whether you need participant recruitment
• Sample readiness: When samples/prototypes will be available and whether they are functional
• Timeline: Desired start date and any hard deadlines (e.g., regulatory submission deadline, market launch date)
• Attachments: Device specifications, user manuals, prior usability reports, or other relevant documentation

Tip: More complete information leads to more accurate quotes and faster project kickoff. If you're unsure about study requirements, use the "Help me scope" option in the RFQ form — providers can help develop a usability engineering plan.