Table 1.

Characteristics of companies participating in the evaluation and validation of the Startup Maturity Index

Clinical focus	Device stage	Anticipated device class	Anticipated regulatory pathway	Number of team members	Fundraising stage
Orthopedics	Concept	Class I	510(k) exempt	Less than 3	n/a
General hospital devices	Manufacturing	Class I	510(k) exempt	Less than 3	Seed
Orthopedics	Commercial use	Class I	510(k) exempt	3 to 10	Seed
Ophthalmology	Marketing	Class I	510(k) exempt	Less than 3	Seed
Obstetrics and gynecology	Prototype	Class I/Class II	510(k) exempt	Less than 3	Grants only
Neonatology	Prototype	Class II	510(k)	3 to 10	Grants only
Urology	Concept	Class II	510(k)	Less than 3	Grants only
Emergency medicine	Advanced prototype	Class II	510(k)	3 to 10	Seed
Radiology	Advanced prototype	Class II	510(k)	3 to 10	Grants only
Microbiology diagnostics	Advanced prototype	Class II	510(k)	Less than 3	Seed
Neurology	Clinical testing	Class II	510(k)	3 to 10	Seed
Mental health	Clinical testing	Class II	510(k)	More than 10	Series A
Infection control	Concept	Class II	510(k)	Less than 3	n/a
General hospital devices	Manufacturing	Class II	510(k)	More than 10	Series B
Physical rehabilitation	Commercial use	Class II	510(k) exempt	3 to 10	Seed
Allergy & immunology	Advanced prototype	Combination product	TBD	3 to 10	Seed

n/a = Not applicable; TBD = to be determined.