Table 3.

Stages of the medical device total product life cycle (TPLC) when ISCT credibility evidence may be collected (indicated with dark gray).

ISCT submodel	Medical device TPLC stage
	Design ideation	Device prototyping	Design optimization	Non-clinical bench testing	Animal studies	Early feasibility clinical study	Traditional feasibility clinical study	Pivotal clinical study
Device model
Patient model
Coupled device-patient model
Virtual patient cohort model
Clinician model
Clinical outcome mapping model
Full ISCT