Medical devices, drugs, etc., require [“clean” environments](https://www.cleanroom-industries.com/media/tz_portfolio/article/cache/how-personnel-are-monitored-in-a-cleanroom-191_L.jpg), and also require FDA auditing / supervision. The personnel must be trained, the facility must be vetted by the FDA, the product must be approved by the FDA, etc. It takes at least a couple years.
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