Core Viewpoint - The article emphasizes the communication gap between doctors and engineers in the medical device innovation process, highlighting the need for a "translation mechanism" to convert clinical needs into quantifiable engineering requirements [1][22]. Group 1: Communication Challenges - Doctors express needs based on clinical issues and patient symptoms, which often lack the specific parameters engineers require for product development [3][5]. - The difference in cognitive paradigms between doctors and engineers leads to difficulties in communication, as engineers seek quantifiable inputs while doctors focus on clinical experiences and symptoms [7][8]. Group 2: Engineering Requirements - Engineers need to translate vague demands like "safety" or "efficiency" into measurable technical specifications, such as "maximum error margin" or "system response time" [9][10]. - The design control process in engineering requires clear documentation of design inputs and verification against those requirements to ensure compliance and quality [10][14]. Group 3: Case Studies and Examples - The concept of "clinician-innovator" highlights the importance of doctors learning engineering language to effectively communicate unmet needs [11]. - Cross-disciplinary collaboration, such as the Stanford Biodesign project, demonstrates the necessity for engineers to observe clinical procedures to identify pain points and translate them into design solutions [18][20]. Group 4: Establishing a Translation Mechanism - The proposed translation mechanism involves three stages: scenario-based understanding, parameterization of needs, and iterative feedback loops to refine product requirements [15][21]. - Successful examples from institutions like Stanford and Oxford show that structured communication and collaboration between clinicians and engineers can significantly enhance the efficiency of medical device development [25].