Medical Device Usability Testing: 38 Important Guidance Documents and Research Papers for Medical Device Development
For the benefit of clients and colleagues, we have curated a list of 38 important guidance documents and research papers focused on medical device testing, validation, and development processes.
In our view, these resources represent some of the most useful formal guidance/research in the field of medical device innovation. These resources are also among the most widely cited and downloaded works related to the development, safety, and efficacy testing of medical devices. We have referenced many of these resources in our own work at Mauro Usability Science to inform strategy, usability, and compliance in medical device projects.
The list begins with critical medical device testing/development guidance documents and follows with important peer-reviewed research papers.
As you will note in reviewing the following links and summaries, most of the resources we pulled together are free to access. However, some are located behind pay walls. In the end, good data is well worth the investment. We hope you find these resources informative and helpful.
Important Disclaimer: We do not receive any form of compensation for citing any of the following content.
Contributing Authors: Charles L. Mauro CHFP, Chris Morley MSc, Aanal Patel MSc
1. FDA’s 2016 Applying Human Factors and Usability Engineering to Medical Devices
Summary
The FDA’s 2016 guidance document remains the most current finalized guidance specifically addressing human factors engineering for standalone medical devices. It outlines the agency’s expectations for incorporating human factors into device design to ensure safe and effective use. Emphasizing a structured usability engineering process, including user research, task analysis, formative evaluations, and summative usability validation, the guidance aims to mitigate use-related risks. It aligns with international standards like ANSI/AAMI/IEC 62366-1:2015 but offers more specific regulatory context for FDA submissions. Its primary goal is to reduce critical use errors and improve patient safety by ensuring devices match user capabilities and limitations.
Summary
This FDA guidance discusses integrating human factors (HF) studies in the development of combination products, such as drug-device or biologic-device combinations. It emphasizes aligning clinical and HF testing to identify and mitigate user risks. Key elements include usability testing, risk analysis, and interface design optimization. While complementing the 2016 guidance on standalone medical devices, this document extends its principles to integrated products, helping ensure that drug-device interactions are safe, intuitive, and suitable for intended users.
3. ANSI/AAMI HE75: Human Factors Engineering – Design of Medical Devices
Summary
ANSI/AAMI HE75 is a comprehensive standard offering detailed guidance on implementing human factors engineering throughout the lifecycle of medical device development. The standard aims to reduce user error and enhance device usability by promoting user-centered design. It addresses interface design, labeling, packaging, training, and software/hardware integration. Widely adopted by manufacturers and recognized by the FDA, HE75 complements regulatory guidance and provides practical tools for designing intuitive and effective medical devices. Mauro Usability Science wrote a critical analysis of this guidance, which can be accessed at the link HERE.
4. ANSI/AAMI IEC 62366 Medical Devices – Application of Usability Engineering to Medical Devices
Summary
This international standard defines usability engineering processes for minimizing use-related risks in medical devices. ANSI/AAMI/IEC 62366-1:2015 offers a regulatory framework that integrates human factors engineering into design and development. It focuses on identifying safety-related usability problems and ensuring that medical devices can be used effectively and safely by their intended users. While HE75 serves as a practical design reference, 62366-1 provides the underlying engineering and regulatory structure for usability practices.
Summary
This FDA guidance outlines content and formatting recommendations for Instructions for Use (IFU) documents provided with prescription drugs and biologics. It emphasizes clarity, simplicity, and visual aids to promote correct and safe use by patients. The IFU should offer step-by-step instructions for handling, storage, dosing, and disposal. The document supports human-centered design principles and aims to improve patient comprehension and compliance. A related analysis by Mauro Usability Science further contextualizes its role in the evolving landscape of drug delivery systems.
6. ISO 14971:2019: Medical Devices — Application of Risk Management to Medical Devices
Summary
ISO 14971:2019 provides a globally accepted framework for risk management in medical device development. It guides manufacturers in identifying, evaluating, and controlling risks to patients, users, and others. Covering product lifecycle and context of use, this standard emphasizes documentation, stakeholder alignment, and iterative assessments to ensure that safety and performance risks are appropriately addressed.
7. FDA’s 2022 Content of Human Factors Information in Medical Device Marketing Submissions
Summary
This draft guidance clarifies the documentation of human factors (HF) activities required in medical device marketing submissions. It is intended to supplement the FDA’s 2016 guidance by providing updated and more specific recommendations for reporting usability engineering processes, user testing outcomes, and risk mitigation strategies. It also addresses labeling and IFU documentation, promoting the integration of clear, usable design and communication to improve safety and effectiveness.
Summary
This Q&A-style guidance complements previous FDA documents by providing clarity on the application of human factors engineering (HFE) in the development of combination products. It covers usability testing, interface evaluation, and documentation practices for integrated systems (e.g., drug-device products). The guidance underscores the importance of designing intuitive interfaces that reduce use-related risks and support safe and effective use by intended users.
9. FDA Good Manufacturing Practices (GMP) for Medical Devices
Summary
This document outlines FDA changes to GMP regulations aligning them more closely with ISO 9000 principles. It emphasizes the role of systems engineering, structured processes, and development discipline in ensuring safe and effective device manufacturing. The guidance explains the implications of new rules for system design and production, advocating defined design controls to enhance regulatory compliance and product safety.
10. Regulation (EU) 2017/745 on Medical Devices
Summary
This regulation harmonizes medical device rules in the EU to improve patient safety and market efficiency. It mandates high standards for clinical data, usability, and post-market surveillance. Emphasizing transparency and risk control, it aims to align medical device oversight across member states.
Summary
This literature review analyzes 30 studies on user experience (UX) testing in healthcare device design. It examines usability evaluation techniques such as scenario simulation, surveys, and task analysis. The review highlights challenges such as inconsistent testing protocols and the need for user-centered design approaches. It emphasizes the importance of rigorous usability assessments in creating safe and efficient devices for both patients and professionals.
12. Estimating the Number of Usability Problems Affecting Medical Devices: Modeling the Discovery Matrix
Summary
This study introduces a novel matrix-based method for estimating the number of usability problems in medical devices. Traditional margin-based models often underestimate issues due to unobserved data (i.e., undiscovered usability problems). The paper proposes a statistical framework that better estimates total problem counts using participant-problem matrices, improving the accuracy of usability risk assessments and test completeness.
13. Medical Device Usability: Literature Review, Current Status, and Challenges
Summary
This comprehensive review analyzes 144 scientific papers on usability in medical devices. It categorizes evaluation methods by hardware, software, and processes, and identifies target users across patient and professional groups. The study reveals that nearly half of the reviewed literature lacked context-specific facility data and emphasized the importance of task-based simulations. It advocates for improved alignment with technical standards and ethics in device development to enhance usability and reduce harm.
14. Conducting Effective Summative Usability Tests of Medical Devices
Summary
This article discusses how summative usability testing plays a critical role in ensuring that medical devices are safe and effective. Drawing from past regulatory, commercial, and standards-based motivations, the article underscores how testing identifies user interface flaws and verifies mitigations. With historical data showing thousands of annual deaths due to use errors, the piece reinforces usability testing as an essential validation step to safeguard against harm.
Summary
This research analyzes case studies from 18 medical device companies in the EU and USA, revealing challenges in applying international human factors standards. Issues include limited user access, weak user feedback influence, restrictive contracts, and uncooperative clinical users. The study concludes that greater collaboration between developers and users is necessary to fully integrate usability into device design under regulatory expectations.
16. Usability Testing Medical Devices: A Practical Guide to Minimizing Risk and Maximizing Success
Summary
This experience-driven paper offers an overview of U.S. regulatory requirements, sample methodological documents, and practical guidance for effectively planning and conducting usability studies for medical devices.
Summary
A review of the literature indicates that while current usability tests for Software as a Medical Device (SaMD) are generally designed in accordance with international standards, there is a notable lack of formalization in how these tests are implemented and administered. This guide provides practitioners with actionable insights on planning and executing usability tests in compliance with FDA and international standards. It includes real-world case examples and emphasizes how thorough usability engineering can reduce design risks and improve success in regulatory reviews.
Summary
This paper presents a model that integrates usability into early-stage device design. Applied to a robotic rehabilitation device (LEPRE), the model includes expert interviews and System Usability Scale (SUS) testing with therapists and patients. Results confirm that embedding usability into design reduces costs and improves development efficiency.
19. Organizational Ergonomics in Medical Device Design Standards
Summary
This article explores how organizational ergonomics—teamwork, workflow, and institutional processes—affect the implementation of medical device standards. It argues that design standards must account for real-world organizational settings to ensure usability and safety in healthcare environments.
20. Title: The What and How of Medical Device Design Validation: A Human Factors Methodology
Summary
This paper outlines a methodology for determining which medical device requirements need validation and how to execute effective usability tests. It provides frameworks for selecting metrics and user groups, aligning closely with FDA Quality System Regulation.
21. Good Design Practice for Medical Devices and Equipment, Part I: A Review of Current Literature
Summary
This literature review evaluates the relationship between product validation and design practices in the context of regulatory pressures. The authors argue for “design for validation” strategies to support efficient and effective development.
22. Medical Device Development: The Challenge for Ergonomics
Summary
This article emphasizes the under-explored role of ergonomics in capturing user needs and integrating them into medical device design. It highlights the need for methodical approaches to understanding use contexts and better ergonomic practices during device development.
23. The Essential Principles of Safety and Effectiveness for Medical Devices and the Role of Standards
Summary
This publication details the foundational principles medical devices must meet to be deemed safe and effective. It explains how voluntary and mandatory standards help manufacturers demonstrate compliance with these principles, particularly in performance, risk management, and material safety. It highlights the shared responsibility between regulatory authorities and manufacturers to ensure public health and product quality.
Summary
This study investigates the integration of usability early in the design of complex medical technologies to improve user acceptance and mitigate risk. Using an action research approach, the authors introduce “user proxies” in usability workshops to represent end users. Findings support usability inclusion in design stages to minimize errors and increase acceptance, while also noting challenges in translating feedback into technical design.
Summary
This scoping review analyzes 77 clinical investigation protocols including usability outcomes. It finds that most studies use questionnaires and interviews, while observational methods are less frequent. The review highlights the feasibility of combining clinical and usability evaluations and recommends tailoring methods to healthcare settings and user groups to improve patient-centered assessments.
26. Usability of Home Use Medical Technology: The Patient Perspective
Summary
This qualitative study captures usability experiences of 360 patients and caregivers using 503 home medical devices. Participants reported daily use, frequent training challenges, interface issues, and device costs. Despite regulatory guidance, usability problems persist. The study calls for better post-market surveillance and iterative design processes that respond directly to user-reported challenges.
27. Usability of Medical Devices
Summary
This book chapter outlines methods for designing medical devices per IEC standards, covering development, testing, and assessment phases. It discusses how usability, safety, and satisfaction intersect in user interface design. Examples and structured sections help readers understand compliance strategies for devices intended for diverse user groups.
Summary
Through in-depth interviews and surveys, this study identifies dimensions of usability and user experience (UX) specific to medical technologies. Findings show professional and lay users prioritize different aspects. The study introduces a category system of UX dimensions for medical devices and recommends differentiated testing based on user background.
Summary
This analytical literature review of 88 sources explores the intersection of UX and usability in healthcare. It compares design principles and methods, identifies strengths and limitations of common assessment tools, and stresses the need for UX methods tailored to medical contexts. Future directions call for refined regulatory and academic standards.
30. Usability Validation of Medical Devices: Issues in Identifying Potential Use Errors
Summary
This paper critiques the process of identifying use errors during usability validation. It discusses best practices such as triangulating incident data, literature, and user feedback. The authors describe obstacles in data sourcing and interpretation but affirm the value of multi-source evidence in revealing different error types and informing safe design.
Summary
This paper summarizes a panel discussion on how human factors principles must be applied to device labeling and instructions for use (IFU). It includes legal justifications, best practices for documentation, and audience questions around misuse. The panel emphasized that human-centered IFUs are both a legal requirement and a professional obligation.
Summary
This article proposes a structured approach for analyzing incident databases (like MAUDE) to identify usability risks in devices under development. It outlines a stepwise method for efficient data retrieval, categorization, and application to design improvements. This proactive risk identification aligns with FDA recommendations.
33. Human Factors and System Thinking for Medical Device
Summary
This chapter advocates for systems thinking in clinical engineering. It presents methods to evaluate device usability and resilience in evolving healthcare environments. Topics include device selection, process mapping, decision time, stakeholder involvement, and operational cost analysis, providing a toolkit for system-aware medical device evaluation.
Summary
This paper details a usability case study in a gynecological OR, leading to the creation of 21 context-based design guidelines. Through observations and interviews, researchers analyzed device use in real surgical settings, identifying factors like staff interactions and equipment layout. The guidelines aim to support safer, more intuitive OR technologies.
35. Designing Training and Instructional Programs for Older Adults
Summary
This book explores how to adapt learning programs for older adults engaging with health technologies. It covers cognitive aging theories, instructional methods, and usability considerations. The review emphasizes strategies to accommodate physical and mental changes in older users while promoting confidence in self-managed care.
36. New Database Tracks Faulty Medical Devices Across The Globe
Summary
The International Medical Devices Database by ICIJ compiles safety alerts and recalls across 11 countries. It empowers users to search 70,000+ records by manufacturer, device name, or region. The database exposes global gaps in device oversight and serves as a transparency tool for patients, providers, and regulators.
37. The Business Case for Medical Device Quality
Summary
This FDA report presents the economic rationale for prioritizing quality throughout device development and manufacturing. It details how poor quality increases cost and damages reputations, while proactive quality systems reduce recalls and improve outcomes. Case studies demonstrate measurable ROI for quality investments.
38. Digital Health: A Path to Validation
Summary
This article reviews the fragmented validation landscape for digital health technologies. It proposes a formal evaluation framework across technical, clinical, usability, and cost domains to build stakeholder confidence. The authors stress aligning digital health development with end-user needs and regulatory expectations.