Glossary Term
Concept Design
Definition
Concept Design is the initial phase of the product development process where ideas for a medical device are generated, visualized, and refined. It focuses on identifying potential solutions to address specific clinical needs, incorporating user requirements, regulatory considerations, and technological feasibility.
Relevance to the MedTech Industry
Concept Design establishes the foundation for innovative medical device development by aligning early-stage ideas with clinical, technical, and market demands. It reduces development risks by providing a clear vision for subsequent phases, such as prototyping and detailed design.
Additional Information & Related Terms
Human Factors Engineering Ensures the concept design is user-friendly and aligns with clinician and patient needs.
Prototyping Often follows concept design, providing tangible models for testing and feedback.
Risk Management File Developed alongside concept design to address potential safety and compliance concerns.
Design Controls Regulatory requirements that guide concept development within the MedTech industry.