Glossary Term
Biodesign Process
Definition
The Biodesign Process is a structured methodology used for innovating medical devices and healthcare solutions. It emphasizes identifying unmet clinical needs, inventing solutions, and implementing them in the healthcare market. Originating from Stanford University’s Biodesign program, this process integrates engineering, clinical insights, and business strategies to develop impactful MedTech innovations.
Relevance to the MedTech Industry
The Biodesign Process fosters a systematic approach to medical device innovation by prioritizing clinical needs over technology-driven solutions. It ensures that new devices address real-world challenges, meet regulatory and market demands, and provide value to patients and stakeholders.
Additional Information & Related Terms
Human Factors Engineering Ensures that devices designed through the Biodesign Process are user-friendly and safe.
Needs Assessment The foundational step in the Biodesign Process to identify critical clinical challenges.
Rapid Prototyping A key activity in the invention phase to test and refine device concepts.
Market Access Strategy Guides the implementation phase to ensure successful commercialization of innovations.