Human Factors industry opinion survey: ​US submissions for drug delivery devices

13 April 2023
MediPhorum Drug Delivery
Human Factors industry opinion survey: ​US submissions for drug delivery devices
1.75 MB

MediPhorum Human Factors group, is gathering global insights towards harmonizing best practices in human factors study design and FDA submissions across industry, predominately related to biomanufacturers combination products. This group consists of subject experts and team leaders from global medtech / combination product companies.

When considering Human Factors (HF) studies leading up regulatory submissions, it is observed that there is a lack of clarity around implementation of some aspects of HF regulatory guidance and study design.

Perversely, trends in regulator feedback can conflict with industry understandings of good practice; examples include the appropriate use of IFU (instructions for use) in knowledge testing and ordering of root cause analysis debrief in relation to study activities. This has led to differing experiences and discrepancies in agency information requests.HF studies represent a significant part of the product design process and the lack of a harmonized understanding of regulation and corresponding regulated procedures can cause significant delay in time-to-market. Six-month delays are common, and further inconsistencies in the Agencies review process, including the FDA and Notified Bodies, adds risk to planning and timelines.

A survey was developed including both multiple choices and open-ended questions. The survey covered key topics where the majority of discrepancies in HF practice were noted with questions on HF strategy, definition of intended users, samples used and bridging submissions.

This poster was recently presented at the Human Factors and Ergonomics Symposium in Orlando USA on 26th March 2023. The team plan to publish a best practice guidance which will streamline information, help reduce noise and generate more confidence based on the survey results and further strengthened through a webinar and interviews. It is hoped that the guidance will inform a consistent HF approach across industries, and ultimately accelerate HF processes. We hope this report will support future work with regulators towards harmonizing practice across the industry.

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