Accessibility compliance in medical device software is more than a regulatory checkbox; it’s a strategic necessity that impacts user safety, market reach, and brand reputation. For decision makers such as Chief Product Officers, Heads of Engineering, and VPs of Technology, ensuring that software is accessible for people with disabilities is important for several reasons.
More than one in four adults in the U.S. live with some type of disability, according to the CDC. It’s critical to ensure that all aspects of a digital experience are designed with full accessibility and these users in mind.
Digital is an increasingly important resource in many aspects of life – from education and employment to commerce and health care – and it’s essential that it be accessible in order to provide equal access and opportunity to people with disabilities.
Building Trust and Reputation With Accessible Medical Devices
By demonstrating a commitment to accessibility, a company signals that it values all users and is dedicated to providing high-quality, safe, and effective products. This not only fulfills moral, ethical, and regulatory obligations but also opens up new market opportunities.
As remote patient monitoring and bespoke care gain traction in healthcare delivery, companies can reach a broader audience with accessible medical device software. Patients who rely on devices for at-home health management may experience permanent or temporary physical limitations – impaired vision, reduced mobility, etc. – that impact their experience with a device interface, mobile app, or website. To optimize care plan adherence, ease patients’ rehabilitation and health journeys, and build trust, it’s important to accommodate these needs.
A decade ago, ensuring the needs of people with disabilities wasn’t a priority. Now brands are competing for this outsized consumer segment of 1.85 billion people with $1.9 trillion in annual disposable income. Companies that prioritize accessibility are better positioned to compete in a market that increasingly values inclusivity and user-centric design.
LEARN MORE ABOUT: Equitable Access to Health Care
Enhancing User Safety and Reducing Hazards
The FDA emphasizes the importance of human-centered design and usability in medical device software, which inherently includes accessibility considerations like screen reader compatibility, keyboard navigation, and sufficient color contrast. This approach ensures that devices are usable for people with varying disabilities.
Accessibility considerations can impact several portions of the FDA submission process, including:
Software Documentation: The FDA requires detailed documentation of the software development process, including usability testing. This documentation helps the FDA evaluate the safety and effectiveness of the device by ensuring that all aspects of the software, including accessibility features, are thoroughly tested and documented.
Hazard Analysis: Hazard analysis, another critical component of the FDA submission process for medical device software, involves identifying and assessing all potential hazards associated with the device, including those related to accessibility. This analysis helps ensure that all risks are identified and mitigated, contributing to the overall safety and effectiveness of the device.
Human Factors Engineering: The FDA expects manufacturers to incorporate human factors engineering principles into the design and development of medical devices. This involves designing devices that are easy for all users to learn and use, thereby reducing the likelihood of user errors and enhancing overall device safety. Regular testing with accessibility tools and real users with disabilities is essential. This helps identify and fix any accessibility issues that might not be apparent during development.
Risk Management: A comprehensive risk management plan identifies and addresses all potential hazards, including those related to accessibility, to maintain the device’s safety and effectiveness.
By prioritizing accessibility, companies can significantly reduce the likelihood and severity of failure modes, thereby enhancing user safety.
SEE ALSO: Accessibility Testing in the Product Development Lifecycle
Important Factors for Accessibility in FDA Submissions
While the FDA does not explicitly mandate accessibility documentation, experts highly recommend it as part of the overall usability and human factors engineering documentation. Including accessibility documentation can demonstrate that developers designed the device to be safe and effective for all users, which can facilitate the approval process.
When preparing regulatory documentation for an FDA submission, consider the following key factors regarding accessibility:
User Needs Assessment: Conduct thorough assessments to understand the needs of users with disabilities.
Usability Testing: Include users with disabilities in usability testing to identify and address accessibility issues.
Compliance with Standards: Ensure compliance with relevant accessibility standards, such as the ADA, the Web Content Accessibility Guidelines (WCAG) and Section 508 of the Rehabilitation Act.
Risk Mitigation: Identify and mitigate risks associated with accessibility issues in the risk management plan.
Clear Documentation: Provide clear and comprehensive documentation of all accessibility considerations, testing, and outcomes.
EXPLORE NOW: The Future of UX is Digital Accessibility
An Expert Partner for Compliant Medical Device Software
Ensuring accessibility compliance in medical device software requires expertise in regulatory requirements, user needs, and technical standards. We leverage our deep industry and medical device knowledge, insights into patient and employee journeys, award-winning partnerships with leading technology platforms, and optimized global delivery teams to help our clients navigate these complexities.
Partner with us to ensure your medical device software meets the highest standards of accessibility and compliance. With our comprehensive understanding of the product lifecycle, regulatory landscape, and device ecosystem, we are a trusted ally in delivering innovative and compliant digital solutions. We invite you to discover why 14 of the 20 largest medical device firms have trusted us to innovate digital experiences and help drive better outcomes for internal business teams, patients, and their caregivers.
Contact us today to learn how we can support your medical device compliance journey.
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