The Cost of Overlooking Usability: Why Medical Device Companies Can’t Afford to Get Human Factors Wrong in 2026
From 2020 to 2024, the FDA oversaw recalls of nearly 4,000 medical devices.¹ According to IEEE Spectrum’s analysis of the FDA recall database, device design ranks as the top recall category among over 56,000 entries.² Behind every recall is a cascade of hidden costs: regulatory scrutiny, corrective action investigations, field safety notices, customer complaints, and damaged reputations. Yet despite FDA requirements and mounting evidence, many medical device companies still approach human factors engineering (HFE) and usability validation as an afterthought—treating it as a late-stage regulatory checkbox rather than a strategic imperative integrated throughout development.³
Here’s the truth: inadequate usability engineering doesn’t just increase regulatory risk—it multiplies your post-market costs, delays time-to-market, and can turn your breakthrough device into a compliance nightmare.
The Regulatory Reality: Usability Is No Longer Optional
As of February 2, 2026, the FDA’s new Quality Management System Regulation (QMSR) incorporates ISO 13485:2016 by reference, fundamentally harmonizing US requirements with global standards.´ This isn’t just a paperwork shuffle—it’s a seismic shift in how usability engineering integrates with risk management and design controls.
The regulations are clear. FDA 21 CFR 820 (now the QMSR) and ISO 13485 both require manufacturers to demonstrate that their devices can be used safely by intended users in their actual environments. IEC 62366-1:2015—the recognized international standard for usability engineering—provides the specific framework.⁵ This standard mandates both formative evaluations during development and summative validation testing before market release.
Yet compliance is just the floor. The real question is: Are you doing enough usability testing to avoid the financial penalties that come from getting it wrong?
The Real Cost: When Usability Failures Hit Your Bottom Line
Consider what happens when usability validation is inadequate:
• Post-Market Complaints Surge: Confusing interfaces, unclear labeling, and counterintuitive workflows generate complaints that must be investigated. Each complaint triggers regulatory documentation requirements under 21 CFR 820.35 and can escalate to Medical Device Reports (MDRs) if patient harm occurs.⁶
• CAPA Overload: Every systemic usability issue requires Corrective and Preventive Action (CAPA). The FDA issued over 700 inspectional observations related to CAPA deficiencies in recent years.⁷ Each CAPA investigation consumes engineering resources, quality team bandwidth, and senior management attention—diverting focus from innovation to firefighting.
• Product Recalls: Device design failures are a leading cause of recalls. A ClariMed analysis found that from 2010 to 2012, 36% of medical device recalls resulted from design-related failures.⁸ Recent data shows device failure was the number one cause of recalls in 2024, accounting for 11.1% of recall events.⁹ Recalls are expensive: field actions, customer notifications, device returns, redesign efforts, and reputational damage can cost millions.
• Regulatory Penalties & Warning Letters: Insufficient human factors validation can trigger FDA 483 observations and Warning Letters. Failing to address usability-related risks identified in your own testing—or worse, not conducting adequate testing at all—puts your entire quality system under regulatory scrutiny.
• Patient Safety & Liability: Use errors can lead to serious patient harm or death. The FDA’s guidance explicitly recognizes that poor human factors design is a root cause of thousands of patient deaths and injuries linked to medical device use error.¹⁰ Beyond the ethical imperative to prevent harm, the legal and financial exposure from adverse events can be catastrophic.
What Most Companies Miss: The Formative-Summative Disconnect
Here’s where many medical device companies stumble: they conduct a single summative usability validation study at the end of development and call it done. This approach is not only insufficient—it’s expensive.
Formative Usability Evaluations
Formative Usability Evaluations are iterative, qualitative assessments conducted throughout the design and development process. They’re exploratory sessions where real users—clinicians, patients, technicians—interact with prototypes to identify design strengths, weaknesses, and unanticipated use errors.¹¹ Think of formative testing as course corrections: catching problems early when fixes are cheap.
Summative Usability Evaluation
Summative Usability Evaluation is your final validation—conducted at the end of development with production-equivalent devices and representative users in realistic conditions. It provides objective evidence that the user interface is safe.¹² The FDA recommends at least 15 participants for summative studies. If critical use errors emerge during summative testing, your summative study effectively becomes formative—requiring design changes and retesting.
The Hidden Truth: Companies that skip or minimize formative testing pay for it exponentially later through failed summative studies, redesigns, delayed launches, and post-market complaints.
The Cross-Functional Imperative: Why Usability Can’t Be Siloed
Effective usability engineering requires genuine cross-functional collaboration—not just engineering, but representatives from clinical, quality/regulatory, manufacturing, service, and even marketing. Why? Because each stakeholder brings unique insights:
• Clinical users understand workflow, patient interactions, and real-world constraints
• Quality/regulatory teams ensure testing aligns with IEC 62366-1 and QMSR requirements
• Manufacturing identifies assembly and labeling challenges that affect usability
• Service engineers understand field failures and user complaints
Cross-functional usability teams catch issues that single-discipline reviews miss. They also ensure that usability testing directly feeds into your risk management (ISO 14971), requirements traceability, and design verification processes.
Requirements Management: The Backbone of Robust Usability
Here’s where most companies struggle: managing the traceability web between user needs, design inputs, industry standards (IEC 62366-1, IEC 60601-1, etc.), risk analyses (ISO 14971), and usability test results.
Without a robust requirements management system, you cannot:
• Trace each critical task back to design inputs and user requirements
• Link hazard-related use scenarios to risk mitigations
• Demonstrate that usability test results validate your design against requirements
• Prove compliance to auditors and regulators
Current digital requirements management and QMS software tools are essential for managing this complexity. The new QMSR requires manufacturers to demonstrate bidirectional traceability and comprehensive documentation of design controls.¹³ Without this infrastructure, you’re flying blind—and auditors will notice.
The Upside: Real User Feedback Makes Better Products
Here’s the best part: when done right, usability engineering isn’t just about compliance—it’s about building products people love to use. Engineers and designers often discover that hands-on sessions with real clinicians are among the most valuable parts of the development process. Watching a physician struggle with a control panel or seeing a nurse improvise a workaround provides insights no amount of bench testing can reveal.
Multiple rounds of formative testing aren’t a burden—they’re an investment in product excellence. Early user feedback identifies critical design flaws when they’re still easy to fix. It prevents embarrassing “oh no” moments during summative validation. And it builds confidence that your device will succeed in the real world, not just in the lab.
A Structured Approach: What Success Looks Like
Leading medical device companies follow a logical, structured usability engineering approach:
Phase What It Involves
Early User Research Define intended users, use environments, and preliminary use scenarios
before detailed design begins
Hazard Analysis Integration Identify use-related hazards and hazardous situations per ISO 14971;
classify tasks as critical or non-critical
Multiple Formative Rounds Conduct 3–5 formative evaluations during development with evolving
prototypes—testing UI concepts, workflows, labeling, and training
effectiveness
Requirements Traceability Maintain bidirectional traceability between user requirements, design
inputs, standards compliance, risk controls, and test results
Rigorous Summative Validation Conduct final summative evaluation with 15+ representative users,
production-equivalent devices, and realistic use scenarios—documenting
objective evidence of safety
Post-Market Surveillance Monitor complaints, MDRs, and field feedback to identify emerging usability
issues and feed learnings back into future designs
This structured approach doesn’t just ensure regulatory compliance—it dramatically reduces the risk of expensive post-market failures.
The Bottom Line: Usability Is a Strategic Investment, Not a Cost Center
As the medical device industry moves toward the February 2026 QMSR deadline, the message is clear: human factors engineering and usability validation are non-negotiable. But beyond compliance, robust usability engineering is a competitive advantage. It reduces post-market costs, accelerates time-to-market, prevents recalls, and most importantly—it saves lives.
The companies that thrive in 2026 and beyond will be those that invest proactively in usability—conducting multiple rounds of formative testing, maintaining rigorous requirements traceability, and building true cross-functional collaboration into their design processes.
The question isn’t whether you can afford to invest in usability engineering. It’s whether you can afford not to.
About Springboard Solutions
Springboard Solutions bridges the critical gap between technology and regulatory compliance in medical device development. Founded by Dan Raymond—who brings the rare combination of having served simultaneously as VP of Engineering and Acting Director of Quality/Regulatory for a complex proton radiation therapy system—we provide strategic, tactical, and regulatory consulting services. Our hands-on experience achieving FDA 510(k) clearance and implementing end-to-end regulatory processes per FDA 21 CFR 820/ISO 13485 brings real-world expertise to help medical device companies optimize their regulatory journey through compliant business systems integration, requirements management, risk analysis, and usability engineering validation.
Contact_us@springboardsolutionsllc.com
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References
¹ U.S. Government Accountability Office. (2025). Medical Device Recalls: HHS and FDA Should Address Limitations in Oversight of Recall Process. GAO-26-107619. https://www.gao.gov/products/gao-26-107619
² IEEE Spectrum. (2025). Medical Device Recalls Software Woes. https://spectrum.ieee.org/medical-device-recalls
³ Thrive Thinking. (2023). How to Circumvent Costly Design Blunders by Bringing Human Factors Engineering Forward in the Device Design Process. https://thrivethinking.com/2023/03/23/hfe-in-medical-device-design/
⁴ U.S. Food and Drug Administration. (2024). Medical Devices; Quality System Regulation Amendments. Federal Register 89 FR 6456. https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments
⁵ International Organization for Standardization. (2015). IEC 62366-1:2015 Medical devices—Part 1: Application of usability engineering to medical devices. https://www.iso.org/standard/63179.html
⁶ Qualityze. (2025). Medical Device Complaint Handling: A Complete Guide. https://www.qualityze.com/blogs/medical-device-complaints-fixes
⁷ Qualityze. (2025). CAPA for Medical Devices: Ensure Compliance and Quality. https://www.qualityze.com/blogs/capa-medical-devices-industry
⁸ ClariMed. (2025). HF ROI: Medical Device Recall Analysis. https://clarimed.com/resources/blog/human-factors-return-on-investment-through-the-lens-of-medical-device-recalls
⁹ XS Supply. (2025). Medical Device Recall Statistics: 2025 Data. https://xs-supply.com/blogs/metrices/medical-device-recall-statistics
¹⁰ U.S. Food and Drug Administration. (2016). Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices
¹¹ Johner Institute. (2025). Formative Evaluation: What the FDA and IEC 62366 Require. https://blog.johner-institute.com/iec-62366-usability/formative-evaluation/
¹² Medical Device HQ. (2021). IEC 62366-1: How to Perform Summative Evaluation for Medical Devices. https://medicaldevicehq.com/articles/summative-evaluation-medical-devices-iec62366-1/
¹³ Cognidox. (2025). Medical Device Design Controls for ISO 13485 and FDA 21 CFR 820. https://www.cognidox.com/blog/what-is-design-control-iso-13485-fda-21-cfr-820
