Usability testing on medical device labeling can help avoid these consequences and improve your return on the investment (ROI). Usability testing is a ’Best Practice’ method for assessing the efficacy of your labeling and enhancing its value to your users.
Imagine being able to anticipate how the FDA and users might react to your medical device labeling before launch. Usability testing helps you do this by providing an objective assessment of its effectiveness and usability. Based on recent reviews of device submissions, the FDA has expressed concern that most labeling is ineffective and unusable by the intended user; professional or lay, and may be a source of use errors leading to adverse events. As the same time, we know that most users don’t read the manual. Usability testing is a ’Best Practice’ method for assessing the efficacy of your labeling and enhancing its value to your users.
Medical device labeling includes paper-based user manuals and quick start guides or electronically delivered videos, DVDs or web-based tutorials and can consume 20% or more of the cost of a new product. Regardless of cost, ineffective labeling produces economic consequences that can: negatively impact clinical studies, hinder FDA approval, delay launch dates, spike costly Customer Support calls, and in worse cases, provoke liability claims. Usability testing on medical device labeling can help avoid these consequences and improve your return on the investment (ROI).
Imagine being able to anticipate how the FDA and users might react to your medical device labeling before launch. Usability testing helps you do this by providing an objective assessment of its effectiveness and usability. Based on recent reviews of device submissions, the FDA has expressed concern that most labeling is ineffective and unusable by the intended user; professional or lay, and may be a source of use errors leading to adverse events. As the same time, we know that most users don’t read the manual. Usability testing is a ’Best Practice’ method for assessing the efficacy of your labeling and enhancing its value to your users.
Medical device labeling includes paper-based user manuals and quick start guides or electronically delivered videos, DVDs or web-based tutorials and can consume 20% or more of the cost of a new product. Regardless of cost, ineffective labeling produces economic consequences that can: negatively impact clinical studies, hinder FDA approval, delay launch dates, spike costly Customer Support calls, and in worse cases, provoke liability claims. Usability testing on medical device labeling can help avoid these consequences and improve your return on the investment (ROI).
Areas Covered in the seminar:
- What are the key FDA standards and guidelines regarding medical device labeling.
- Recognize how labeling fits into your overall risk management plan.
- Explain use error risk and labeling as a mitigation strategy.
- What are the types of usability testing and when to use them.
- What are critical tasks in conducting a usability test on medical device labeling?
- What are the ’real’ costs of labeling.
Who Will Benefit:
This session will benefit those who develop, manage, or audit user labeling for medical devices. Depending on your organization, this could include professionals in:- Engineering
- Regulatory
- Quality Control
- Quality Assurance
- Packaging and Clinical Affairs
Course Provider
Patricia A Patterson,
