HealthTech
Also known as: Medical Device, MedTech, Hardware Healthcare
Healthcare innovations whose primary regulated component is physical hardware — including medical devices, diagnostics, IVDs, and combination products subject to FDA device regulation. Software-only solutions, including SaMD, are classified as Digital Medicine.
Full Definition
HealthTech solutions are characterized by physical form factors, FDA 510(k) or PMA regulatory pathways, reimbursement through procedure or device codes, and capital equipment or disposable transaction models. The H-BMC addresses HealthTech and Digital Medicine separately where their commercial dynamics differ meaningfully — particularly in regulatory pathway, transaction model, and sales cycle. SaMD (Software as a Medical Device) is classified as Digital Medicine in the GAITS framework — even though FDA regulates it as a medical device — because its commercial model, cost structure, and market dynamics follow the software pathway rather than the hardware pathway.