This course is delivered 2 evenings per week (online or in class, whichever you prefer) and 2 Saturdays per month.
A three-semester taught course in Medical Device Technology & Business (60 ETCS Credits) leading cumulatively to a Postgraduate Diploma in Science in Medical Device Technology & Business.
Module 1: Medical Device Technology
Medical device types and classification, connected health and mobile devices, human anatomy & Physiology, medical device design cycle, value engineering of medical devices, manufacturing, assembly, packaging & testing, combination products.
Module 2: Medical Device Quality Systems & Regulation
Medical device regulations - ISO 13485, DFA requirements - Class I, II and III devices, statutory frameworks medical device design, manufacturing, quality system elements, validation and change control, facility plant design, product process validation.
Module 3: Emerging trends in Medical Device
Challenges facing the MedTech sector, move towards value-based healthcare, growing regulatory pressures, resource constraints, product & process differentiating capabilities, growth initiatives, transforming cost structures and reorganising for sustainability,
connected and combined smart medical devices, software-based medical devices.
Module 4: Strategy, Leadership & the Culture of Innovation
Current challenges of MedTech industry, strategic thinking in the industry, leading change, the culture of innovation, corporate governance and business ethics.
Module 5: Operational Excellence & the Science of Innovation
Origins fo operational excellence, operational excellence implementation models, lean sigma implementation, design for six sigma, science of innovation, TRIZ concepts, key performance indicators (KPI), quality function deployment.
Module 6: Medical Measurement and Analysis
Medical data analysis, distributed databases, data collection systems & data architectures, data analysis software, data storage and data integrity, data management in product and process design, characteristics of data, data types and information,
functions of visualisations, tables & graphs, visualisation techniques and applications, software applications for data visualisation.