Considerations for Human Factors Evaluations of Combination Products

Duration: 90 Minutes
The basic principles of human factors engineering can be applied universally to improve the safety and usability of any medical product. However, each product still has its own unique considerations. Combination products or medical devices that include a drug or biological components, can introduce concerns that do not necessarily apply to non-drug devices. To ensure that product design is optimized, it is important to take a product's specific needs into consideration. This course describes how to apply human factors principles to the design and development of combination products while also maximizing safety and meeting the expectations of the FDA.
Human Factors FDA
Instructor: Natalie Abts
Product ID: 502265
Objectives of the Presentation
  • Identify unique attributes of combination products
  • Describe the human factors regulatory requirements for combination products
  • Understand techniques for evaluating combination products early in development
  • Understand factors in risk assessment
  • Anticipate potential product use problems
  • Identify user population constraints
  • Describe the correct way to conduct product validation
  • Learn essential labeling requirements
Why Should you Attend
This session will describe factors that should be considered when developing, evaluating, and validating combination products. Topics will focus on human factors techniques to apply to the design and development process. FDA human factors regulations regarding combination products will also be discussed. Product developers, risk managers, and human factors engineers developing or evaluating combination products will benefit from this course.

Areas Covered
  • Types of combination products
  • Combination product examples
  • Effects of the user population on design
  • Differences between devices and combination products
  • Formative evaluation of combination products
  • The role of product labeling and instructional materials
  • Expected use errors for combination products
  • FDA requirements for combination products
  • Validating combination products
  • Considerations for specific product types (e.g. pre-filled syringes, implants, infusion pumps, etc.)
Who will Benefit
  • Pharmaceutical and drug companies
  • Usability/human factors engineers
  • Design and development engineers
  • Risk managers and regulatory personnel
  • Project managers for combination product development teams
Topic Background
Applying human factors and usability engineering to the development of medical devices and products is vital to ensuring they are safe and usable to the target populations. For combination products, special considerations need to be taken into account to ensure that optimal treatment is being delivered in a safe manner. When developing these products, we can learn from previously documented use problems of similar products and anticipate needs before a device design is finalized. This course will describe how to apply human factors principles and take unique product attributes into account to maximize safety and usability.
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Natalie is the Program Manager for the Usability Services division of the National Center for Human Factors in Healthcare. She oversees the technical and quality aspects of usability projects conducted both for the medical device industry and within MedStar Health. She is involved in all aspects of planning and executing usability tests, and also leads an initiative to incorporate usability testing in medical device procurement. She has a special interest in ensuring that safe and effective products are brought to market through successful FDA submission. Natalie holds a master's degree in industrial engineering, with a focus on human factors and ergonomics, from the University of Wisconsin, where she was mentored by Dr. Ben-Tzion Karsh. Some of her previous work involved research on primary care redesign for the aging population and implementation of process improvement efforts in the ambulatory care setting.
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