Beyond Usable to Valuable: Usability Testing on Medical Device Labeling

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

Instructor Profile:
Patricia A. Patterson, CPT is a Certified Performance Technologist and President of Agilis Consulting Group, LLC. For more than 25 years Pat has applied the systematic, research-based methodologies of Human Performance Technology (HPT) to improve how people learn to use information and technology to produce measurably superior results. Pat is an industry member of the FDA’s Home Healthcare Committee focused on reducing the number of adverse events in this growing segment of the medical device industry. She is also a contributing author to the user documentation/training change in HE 75: Human Factors Design for Medical Devices, currently being developed by the Association for the Advancement of Medical Instrumentation (AAMI) for eventual adoption by the FDA, expected later this year. Pat is also a frequent speaker and author on the subject of labeling and training has published several articles in Medical Device & Diagnostic Industry and the Regulatory Affairs Professional Society (RAPS) Focus magazinene.

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