Kate Klaus to Speak at MedTech Intelligence Virtual Conference

September 30, 2020


Medmarc's Risk Management Attorney and FDA Specialist, Kate Klaus will be presenting at MedTech Intelligence's Virtual Conference. Kate will be speaking along with Senior Human Factors Consultant , Deb Bilings Broky, Ph.D. and Director, Instructional Design & Creative Services, Renee Bailey of Agilis Consulting. 

Designing Instructional Materials to Support Health Literacy for FDA Submissions

Regulatory authorities increasingly require that users with low health literacy be included in the human factors testing of devices or drug delivery products.  Users with low health literacy differ from others in the way that they interact with and interpret written materials such as instructions for use (IFU) or other printed materials that accompany medical devices or combination products.

Instructional materials designed without this important user group in mind can lead to unanticipated pre- or post-market issues that may be safety related or can derail a regulatory submission.  Some research indicates that more than 50% of post-market adverse events are related to user cognitive issues.  During product development, manufacturers have a prime opportunity to design materials for low health literacy users by combining best practices in instructional design and human factors testing.

Poorly written materials that do not adequately inform all users on the correct use and possible risks of devices can also lay manufacturers open to products liability suits if something goes wrong.  “Failure to inform” is a common grounds for legal action against companies.

In this webinar, you will learn how to address the needs of users with low health literacy to improve product use and mitigate potential pre- and post-market issues. You will also learn how to include users with low health literacy in your human factors testing to optimize instructional materials.


What you will learn:

  • What health literacy is and is NOT
  • Why health literacy is an important consideration in the design of instructional materials
  • Which instructional design elements are effective for users with low health literacy
  • What tools can be used to measure health literacy
  • How to include low health literacy users in human factors testing of instructional materials
  • Potential products liability consequence of inadequate instructional materials

Who should attend:

  • RA/QA professionals
  • Product developers
  • Instructional designers
  • Human factors professionals
  • Legal counsel