New Product Development of Medical Devices

• The course integrates the training of important disciplines of product design (stage one), ranging from idea generation, concept formulation and prototyping, to quality management, with the implementing of the skills (stage two), where the learner practice the skills in the development journey of Lab-on-a-Chip (LOC) based molecular diagnostics (MDx) products. The learners will learn about fundamental design principles as well as engineering concepts that are applied to the actual design process. They will be taught how to use computer-aided design software and prototyping tools, and progress to medical diagnostics product innovation and development projects under the guidance of experts in this field.
• Microfluidics Lab-on-a-Chip (LOC) is an emerging technology which enables the miniaturization of medical diagnostic instrument and devices. It needs specific knowledge and skills regarding the microfluidics and Lab-on-a-Chip fundamentals, immune-sensing and optical detection, nuclei acid and cell analysis, and body blood treatment. This course is to bridge the gaps. The learners will learn the up-to-date knowledge about the how to transfer a laboratory protocol of body fluid analysis into a miniaturized MDx instrument and cartridge based on microfluidics Lab-on-a-Chip strategy.
• Trainees will understand the concepts and applications of MDx technology. With the guidance of the very experienced experts, the learners will be able to get hands-on experience in practicing the nuclei acid testing, and experience the new product development (NPD) process of medical diagnostic instrument including the establishment of quality management system for medical devices.

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