Developing a medical product — a device, a drug or a combination product — is a long, costly, high-regulatory-risk process. Early decisions (opportunity selection, user-needs definition, translation into engineering requirements, regulatory pathway, clinical-evidence plan) make the difference between a program that reaches the market on time and one that stalls, overruns or is recalled. The industry uses structured methodologies — the stage-gate process, FDA Design Controls under 21 CFR §820.30, and ICH Q8 Quality by Design — to manage this complexity with cross-functional discipline.

This instructor-led online course builds competence in the stage-gated medical-product development process. It covers innovation and discovery, R&D, prototype development, design controls, product testing, clinical evaluation, regulatory approval and commercial launch. Students apply structured product-development methodology (stage-gate models, design controls under 21 CFR §820.30, ICH Q8 quality-by-design) and examine cases of weak development practices that led to recalls or enforcement actions, integrating ISO 14971 and ICH Q9 risk management across the cycle.