Translation of New Tissue Engineering Materials to Clinical Application

The total product life cycle (TPLC) provides a framework by which medical device companies incorporate international regulatory guidelines and best practices to translate product concepts, including novel biomaterial therapeutics, into clinical and commercial reality. The TPLC emphasizes continuity between all phases of a medical product’s lifetime, including Concept/Feasibility, Design/Development, Validation, Commercialization/Production, Post-Market Surveillance/Support. This product development cadence evolves through definition of the unmet clinical need and market opportunity, application of design control methodologies, consideration of manufacturability and scalability, and execution of the evidence generation and regulatory strategies. Throughout each of these activities, design controls are leveraged to promote cross-functional engagement of sales and marketing, research and development, quality assurance, regulatory affairs, operations and finance to ensure the medical device will provide a safe and efficacious solution for patients and surgeons.