Complete framework for analyzing healthcare market opportunities at the pre-seed stage. Navigate FDA pathways, validate clinical needs, and build investor-ready materials.
510(k) exempt, fastest pathway
510(k) required, 3-6 months
PMA required, 1-3 years
Timeline varies by device class: Class I devices may be exempt from FDA review, Class II devices typically require 3-6 months for 510(k) clearance, while Class III devices need 1-3 years for PMA approval. Software-as-Medical-Device may qualify for expedited pathways.
Healthcare pre-seed rounds typically range from $1.5M to $4M, higher than other sectors due to longer development timelines, regulatory costs, and clinical validation requirements. Digital health startups may raise on the lower end, while medical device companies often need more capital.