Designing Instructional Materials to Support Health Literacy for FDA Submissions Webinar
A Virtual Event
September 30, 2020

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


Wednesday, September 30
12:00 PM - 12:05 PM
12:00 PM - 12:05 PM
12:05 PM - 1:20 PM
12:05 PM - 1:20 PM
1:20 PM - 1:30 PM
1:20 PM - 1:30 PM
Risk Management Attorney/FDA Specialist
Senior Human Factors Consultant
Agilis Consulting
Director, Instructional Design & Creative Services
Agilis Consulting


What are the registration prices:

Medical Technology Organization:

  • Early bird registration is $95 - Available until Aug. 21, 2020
  • Regular Registration is $125 - Available between Aug. 21- Sept. 21, 2020
  • Late Registration is $150 - After Sept. 21, 2020

Group Registrations:

If you register a group of more than 2 registrations at the same time, each registration after the 1st receives a 50% discount. Remember, in order to receive this discount, registrations MUST BE MADE AT THE SAME TIME. There will be no retroactive refunds of registration fees. 

How do I log in to the event?

  • You will receive an email with a link to GotoWebinar with instructions how to log into the live event by Sept. 28, 2020.  Please note that this will be a live event.

Can I ask questions of the speakers?

  • Yes! You will be able to type your questions into a chat dialog box and the moderator will read it out loud to the speakers.

What happens if I miss the event:

  • There are no refunds or cancellations within 7 business days of the starting date of the event.

Cancellation and Refund Policy:

  • All cancellations must be made via email. Should you not be able to attend the virtual event, you may have someone else from your organization take your place or use your registration fee as credit towards a future MedTech event. If these options are not possible, you can receive a refund of the registration fee less a 20% processing fee up until 7 business days prior to the virtual event. There are no refunds for cancellations within the 7 day period prior to the virtual event or for "no-shows" to the virtual event.