Mark







FDA Sponsored Research









UserWise is excited to announce that the U.S. Food and Drug Administration officially accepted our grant application and our Training Decay project is now in full swing! 


We are continuing to assemble a consortium of leading experts in the field of human factors, medical device validation, and quality engineering for this project.

The full description of the consortium and project background can be found in the following presentation slides:

Background Information


The FDA invited Shannon Clark to present on her proposed training decay research at FDA headquarters in December 2017 to all of the FDA HF experts (e.g. Irene Chan, Shannon Hoste, Hannibey Wiyor, Xin Feng, Kimberly Konston, etc.). Earlier in 2017, Irene Chan encouraged UserWise to apply for a grant to further research training decay. The FDA then approved our White Paper, invited us to submit in the final stage of the grant proposal process, and formally accepted the grant application as a 2-year project.


The research project, "Training Decay Selection for Medical Product Usability Validation Testing," which started in 2018, builds upon Clark’s paper, literature review, and presentation about training decay from 2016.

As of early 2020 we have selected an insulin device to use in the evaluation. The study design has been finalized to include training decay periods varying between no delay through a 7-day delay between training and testing. We are gearing up to complete testing later in 2020. 

As part of the grant, we have formed a consortium of industry thought leaders to act as volunteer expert reviewers of the protocol and report and advise on the project. These leaders serve as a consortium of industry experts, and need to reflect the general population of companies and stakeholder. We are continuing to expand our consortium. If you are interested in joining the consortium either as an official member or observer, contact us with your job title, company affiliation, company size (if a manufacturer/sponsor), and educational background.


The involvement includes:
  • 2-hour review of study approach with optional attendance to a presentation on the study scheme
  • Potential participation in a 30-minute advisory session in 2019
  • 2-hour review of the report and/or attendance to a findings presentation in 2020
Sincerely,
The UserWise Team


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