Medical devices need to be accessible for all users, including people with disabilities and other impairments.
Advances in medical technology mustn’t leave anyone behind. However, medical devices risk creating barriers to healthcare if they aren’t user-friendly for people with different needs.
Modern tech innovations in medicine have enabled smart devices specially designed for users with disabilities. This includes:
- Prosthetics
- Hearing aids and visual aids
- Mobility tools
- Communication technologies
Even standard devices like blood pressure monitors, glucose meters, or infusion pumps must be tested for accessibility to ensure they’re inclusive, functional, and safe for everyone to use.
Making sure medical devices are accessible is a critical responsibility manufacturers can’t shirk. It helps
- Meet the needs of patients and health professionals
- Ensures no one is left out
- Keeps people safe
- Keeps medical device manufacturers on the right side of legal standards, such as FDA regulations and ADA requirements
To help ensure your medical devices are accessible, here are 10 testing best practices along with some do’s and don’ts to guide you.
Integrate accessibility testing early in the development process
Don’t make testing an afterthought. Start testing from the design phase. Early integration of accessibility testing can help you identify potential barriers before they become a part of – and a major problem in – your final product.
Early accessibility testing also helps ensure your device meets legal requirements and regulatory standards like WCAG – Web Content Accessibility Guidelines.
Do’s:
- Establish clear accessibility guidelines and objectives. Do this at the very beginning of the project.
- Involve accessibility testing experts during the design phase.
- Conduct regular accessibility reviews throughout the development process.
Don’ts:
- Wait until the end of the dev cycle to fix your accessibility issues.
- Assume that following general design principles alone is enough to make your medical device accessible.
- Forget the importance of training other team members on essential accessibility standards.
Use a combination of testing methods
Automated accessibility testing tools can identify common accessibility issues faster. But they shouldn’t be the sole method of testing. Tools like Axe-Core and Google Lighthouse help streamline the process. But again, manual testing is also essential. It will help you catch nuanced issues that automated tools may sometimes overlook.
Relying on automated testing tools alone will give you a false sense of security. Combine automated and manual testing methods for a full assessment.
Do’s:
- Use automated tools for initial scans to identify common issues.
- Complement automated testing with manual reviews and user testing.
- Document findings from both automated and manual testing for future reference.
Don’ts:
- Rely exclusively on automated tools to identify all accessibility issues.
- Ignore the insights provided by manual testing and user feedback.
- Skip the documentation of testing results.
Engage users with disabilities
Conduct manual testing with real users, especially individuals with disabilities in your testing process – and think about health professionals with special needs as well as patients. Their feedback is invaluable in understanding how well your medical device meets their needs.
This practice helps you identify usability issues with the device. It also makes your design approach more inclusive. The feedback from users with disabilities can be crucial as it provides insight into their unique needs and experiences.
Do’s:
- Get individuals with impairments to participate in your device’s usability testing.
- Create a comfortable environment that encourages open and honest feedback.
- Use diverse user groups to capture a wide range of experiences and needs.
Don’ts:
- Assume that the development team understands the needs of users with disabilities.
- Conduct testing without considering the specific disabilities of participants.
- Overlook the importance of user feedback in the design process.
Test with assistive technologies
You must ensure that your medical device is compatible with various assistive technologies, including:
- Screen readers
- Speech recognition software
- Alternative input devices
Testing with these technologies can reveal specific barriers that users may encounter. This will help you address these issues more effectively.
Testing your medical device with various assistive technologies is vital to ensure compatibility and usability.
Do’s:
- Identify the most commonly used assistive technologies among your target audience.
- Conduct tests with these technologies to uncover specific issues.
- Involve users who rely on assistive technologies in the testing process.
Don’ts:
- Assume that your device is compatible with all assistive technologies without testing.
- Overlook the importance of testing for different versions of assistive tools.
- Ignore feedback from users who use assistive technologies.
Run usability testing
Accessibility is about more than dodging legal infringements and ticking boxes. For elderly patients, a remote monitoring device can determine their quality of life and whether they can live independently.
Run usability testing with individuals who have disabilities to identify any navigational or informational challenges they may face.
Testing assesses how easily and effectively healthcare professionals and patients can interact with your medical device.
Do’s:
- Gather qualitative data by observing users when they interact with your medical device or app.
- Ask users to verbalize their thought processes during testing.
- Analyze the results to identify common usability challenges.
Don’ts:
- Conduct usability testing without involving users with disabilities.
- Ignore the qualitative feedback from users in favor of quantitative metrics alone.
- Dismiss usability issues as minor if they affect the user experience.
Evaluate compliance with accessibility standards
Regularly assessing your medical devices against established accessibility standards can help identify areas for improvement.
Do’s:
- Familiarize your testing team with WCAG and ADA guidelines.
- Run regular audits to ensure compliance with standards.
- Keep abreast of current accessibility regulations and standards.
Don’ts:
- Treat compliance as a checkbox item; it should be an ongoing process.
- Ignore updates to accessibility standards that may affect your device.
- Assume that meeting minimum standards is sufficient for user satisfaction.
Perform real-world scenario testing
Test your medical device in real-world environments. This will help you understand how users interact with it in their daily lives. Such testing can reveal context-specific issues that may not arise in controlled settings.
Do’s:
- Try to simulate real-world conditions during testing (e.g., varying lighting, noise, different device usage scenarios).
- Observe users in their natural environments to understand context-specific issues.
- Gather feedback on how the device performs in everyday scenarios.
Don’ts:
- Limit testing to controlled environments without considering real-world applications.
- Overlook the impact of environmental factors on device usability.
- Assume that results from controlled testing will directly translate to real-world use.
Implement ongoing testing and maintenance
Accessibility is an ongoing commitment. It requires regular reviews and updates. Make a point to update your accessibility testing protocols. After updates, protocols must be able to accommodate new features and changes in technology.
Establish a routine for testing and maintenance to ensure your medical device remains accessible over time.
Do’s:
- Establish a schedule for automated accessibility testing and reviews.
- Update accessibility features in response to user feedback and changing standards.
- Maintain an open line of communication with users to gather ongoing feedback.
Don’ts:
- Treat accessibility testing as a one-time event.
- Ignore accessibility issues that arise after the initial launch.
- Assume that previous testing is sufficient for ongoing compliance.
Document and report your findings after testing
A thorough documentation of accessibility testing efforts and their results is critical for transparency and accountability.
Do’s:
- Maintain detailed records of all testing results and issues identified.
- Share findings with stakeholders to prioritize necessary changes.
- Use documentation as a resource for future projects and improvements.
Don’ts:
- Overlook the importance of documenting both successes and challenges.
- Keep findings confined to a single team; share them across departments.
- Ignore the need for follow-up on previously identified issues.
Invest in accessibility training for your team
When getting started, your dev and testing teams may be a little unsure about how to do accessibility testing.
Training them in accessibility guidelines will give them the knowledge they need to identify and resolve accessibility issues effectively. If you want to enhance your team’s skills, consider working with accessibility experts or consultants.
Do’s:
- Offer regular training sessions on accessibility best practices and standards.
- Encourage team members to stay updated on the latest accessibility trends and technologies.
- Consider partnering with an accessibility testing company for specialized training.
Don’ts:
- Assume that all team members are familiar with accessibility issues.
- Limit training to a one-time event; make it an ongoing initiative.
- Neglect the importance of practical training that includes real-world scenarios.
Summing up
Follow these best practices and the do’s and don’ts, to create medical devices that are accessible and user-friendly for all.
Accessibility is more than just a legal requirement; it’s a commitment to inclusivity that can significantly enhance health outcomes. Devices that meet everyone’s needs:
- Improve user satisfaction
- Build trust in your brand
- Expand your market reach
Investing in accessibility testing helps cut the risk of regulatory violations and potential legal challenges while fostering a culture of continuous improvement within your organization.
As a quick reminder, prioritizing accessibility:
- Empowers both healthcare professionals and patients
- Enhances their experiences
- Contributes to better health outcomes
This commitment to inclusivity is both a social responsibility and a smart business strategy – a win-win for everyone.
