How to Get Medical Device Video Right
Video showing medical devices, their use and their benefits, for clinicians or consumers.
Tomas Lindqvist
The key figures
- Intended use
- devices are cleared or approved for defined uses
- Promotion
- marketing material is treated as labeling
- Risk information
- benefit claims usually require balanced risk information
- Clinical footage
- requires patient authorization
Why this is worth getting right
Promotional video is part of device labeling, so it must stay within the cleared intended use.
Do this, not that
Do
- Base scripts on the cleared indications
- Include required risk information
- Show use exactly as the instructions describe
- Get regulatory review before publishing
- Keep videos updated with device changes
Don’t
- Uses beyond the cleared indications
- Benefit claims with no risk information
- Patient footage without authorization
- Outdated device versions in current video
When to bring in help
Our advice Bring in help before publishing device promotion.
Where this comes from
- U.S. Food and Drug Administration — Medical device advertising and promotion
- U.S. Department of Health and Human Services — HIPAA for professionals
The figures and practices above come from the sources listed.
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Where to go next
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