Course summary

The MPhil in Translating Medical Device & Advanced Therapy Research is aimed at individuals who are interested in the development and implementation of medical devices and/or advanced therapy interventions. The course would benefit individuals in clinical practice, academia or industry who require the knowledge to translate research in complex interventions through the clinical validation and implementation pathway. The taught course is delivered by experts in their field, including lectures, small group workshops and online learning. There is a particular focus on case studies of successful development and implementation of medical devices and/or cell and gene therapy research. The course will cover: Pre-clinical development and prototyping Innovation and team building Regulatory and ethical frameworks Conducting clinical trials in Medical Devices and Advanced Therapies Statistical analyses for clinical trials Critcal appraisal Scale up and implementation strategy Enterprise and commercialisation Conducting inclusive and patient/clinician-relevant research The course has the following aims: 1. For participants to acquire broad knowledge and expertise in medical devices and advanced therapeutics, with knowledge relevant to every stage of development from initial proof of concept work to commercialisation; 2. To establish participants abilities to map out the stages required to bring a new device or advanced therapy to market, and the knowledge to build a team with the skills to complete this; 3. For participants to acquire transferable knowledge and expertise in the design, analysis and critical appraisal of research as well as communication and team building in a research environment; 4. For participants to develop skills in planning, conducting and delivering a research project. Learning Outcomes On completing the course, participants will be able to: Knowledge and Understanding

• demonstrate advanced knowledge and understanding of the pre-clinical development of Medical Devices and Advanced Therapies research;

• demonstrate a broad understanding of the regulatory and ethical frameworks around Medical Devices and Advanced Therapies research, and the conduct of clinical trials;

• demonstrate a broad understanding of how Medical Devices and Advanced Therapies are scaled-up and implemented, including the theory behind this process, intellectual property, economics and interactions with industry;

• demonstrate knowledge and understanding of data analysis techniques including meta-analysis as well as an introduction to big data and machine learning;

• demonstrate advanced knowledge and understanding of the importance of inclusivity, sustainability and social responsibility, communication and team building in the design and delivery of Medical Devices and Advanced Therapies research;

• demonstrate originality in the application of knowledge, together with the practical understanding of how research and enquiry are used to create and interpret knowledge in the field;

• demonstrate in-depth knowledge of the background to their selected research project, including the research methods and methods of data analysis.