About

Specialization Molecular biology, signal transduction, microbial model building, protein purification, cancer pathology

Duty Guidance for teams focusing on IVD kits; drawing on her academic and professional expertise and understanding of applicable regulations to help academic or research teams commercialize their technologies and bring their products to market.

Responsible team Kit for Precise Diagnosis of Rheumatoid Arthritis Ultrasound Vortex Technology for Thrombolysis Clinical Device for Antimicrobial Susceptibility Testing of Sepsis Pathogens

Specialization Biomedical materials and biomolecular engineering, bio-membrane R&D, surface modification for medical devices, medical devices regulations and product launch applications: having been certified as a reserve seed consultant for medical devices regulations and for Creo Parametric/AutoCAD competence.

Duty Guidance for teams focusing on biomedical materials; drawing on her academic and professional expertise and understanding of applicable regulations to help academic or research teams commercialize their technologies and bring their products to market

Responsible team Gastrointestinal hemostatic powder and its delivery device system Minimally invasive intervertebral disc annulus fibrosus repair system Novel Wireless Wearable IAH Detector Biodegradable Duodenum Barrier Implant for Obesity and Glycemic Control Large Patient-Specific Mandible Prosthesis Cranial burr hole cover of 3D bioceramic bone graft substitute using the additive manufacturing method Negative Pressure-Guided Bone Cement Injection System Dressing and Augment Implant System for Rotator Cuff Repair Novel Absorption-Type Bladder Irrigation Solution

Specialization Molecular biology, oral immunology, murine model building, gene cloning.

Duty Guidance for teams focusing on IVD kits; drawing on her academic and professional expertise and understanding of applicable regulations to help academic or research teams commercialize their technologies and bring their products to market.

Responsible team HIGH PRECISION BLOOD TEST FOR DETECTION OF BREAST CANCER

Specialization Digital circuits, medical electronics, medical devices regulations evaluation, medical devices market assessment.

Duty Guidance for teams focusing on medical electronics; drawing on his academic and professional expertise and understanding of applicable regulations to help academic or research teams commercialize their technologies and bring their products to market.

Responsible team Mobile multi-channel ECG detection system for suspected coronary heart disease or acute coronary heart disease. Novel Ultrasound Lipolysis System Transcranial Ultrasound Stimulation for Alzheimer’s Therapy Passive All Optical Intraocular Pressure Measurement Device High-frequency ultrasonic anesthesia needle transducer High-Definition Neuromodulation System

Specialization Signal processing applications, electro-mechanical integration and testing, R&D and design controls for medical devices, medical devices regulatory and GMP certification consulting.

Duty Access to institutional resources, technical assistance for project preparation, and provision of testing, planning certification paths, and prototyping services in the run-up to preclinical trials and premarket notification.

Specialization Circuit design for medical electronics, medical care software design, structural design for minimally invasive surgical instruments and other medical machinery, development of medical care products and systems, design and introduction of safety accreditation for medical devices, introduction of ISO 13485 or GMP quality management, regulatory pathway and certification planning for medical devices, patent roadmap analysis, international product accreditation and registration, applications for access to government projects, and guidance for startups

Duty Tapping of institutional resources, assistance in project preparation, and provision of testing, verification planning, and prototyping services in the run-up to preclinical trials and premarket certification
Introduction of ISO 13485 or GMP quality management (IRCA-certified ISO 13485 and 9001 lead auditor), patent roadmap analysis

Specialization High-end implantable biomedical materials, nano cancer drug delivery, gene therapy, nano-photothermal therapy, regenerative medicine, cytoskeleton design, development of 3D cell culture systems, functional membrane surface modification, patent strategy.

Duty Guidance for medical devices startups, including in the preparation of plans for seeking government funding, capital matching, regulatory pathway for product launch, technological recommendations and heterogeneous matching, patent strategy, business plan, and matching of sales outlets.

Responsible team Duogenic StemCells Corporation Taipeibio Co., Ltd.

Specialization 數位電路、醫療電子、醫療器材法規評估，醫療器材市場評估。

Duty 主責醫療器材體外檢測試劑領域的團隊輔導，藉由過往學經歷的經驗與醫療器材法規的了解，協助學研團隊依循醫材法規朝向技術商品化，達產品上市。