Through this module, the student will understand and apply Design Control and Risk Management principles to the design of Medical Devices.

The module content includes the full Design and Development process including the full product life cycle from product concept to product launch, encompassing the phases of Design and Development and the elements of Design Control as required to ensure regulatory compliance. This module will also give the students an understanding of Risk Management as it applies to the design and development process and to medical device design. The content will be delivered such that it addresses the practical needs of industry, and all company sizes within the sector from Start-up through to SME's and multi-national corporations.

1. Critically evaluate product design to ensure compliance with essential safety and performance requirements.

2. Explain the technical documentation required to demonstrate compliance to relevant regulatory requirements and quality standards.

3. Communicate and proceduralizethe relationship between Design Control and Risk Management principles.

4. Demonstrate the ability to identify,critically assess, and manage risk throughout the medical device life cycle.

Medical technology can be defined as the application of science and engineering to develop solutions to health problems or issues, including the design of smart devices for predictive and diagnostic healthcare. Medical technologies are used to lower the risk of a disease, minimise illness duration, enhance the quality and accuracy of care and widen access to care. Therefore, medical technology plays an important part in our society in improving quality of life and reducing the effect of debilitating illnesses.

The most significant trend in healthcare product innovation is to bring together different medical technologies to satisfy the needs of patients and medical professionals. Medical technologies are rapidly converging and having a major influence on the development of new medical devices to deliver more efficient products. Among others, these technologies include artificial intelligence, gene editing and therapy, organ and tissue printing.

This module aims to give students a deep understanding of the medical technology field, with a special focus on medical device design and engineering. The topics will be presented through case studies and will include a team project demonstrating the ability to develop a medical device concept incorporating several existing and emerging technologies, including software as medical device (SaMD).

1. Analyse several current and future medical technologies, including software as medical device, and how they are applied or planned to be applied in healthcare,

2. Discuss how future medical technologies could influence the nature of healthcare provision, as well as predictive and diagnostic healthcare,

3. Examinethe opportunities for the application of future medical technologies,

4. Determinethe development and commercial challenges within the medical device development process,

5. Apply the medical device development process, from clinical need through to regulatory approval and product introduction,

6. Develop a medical device concept usingthe medical device development process, including clinical need, user needs, patient feedbacks and stakeholder needs, using several technologies.

This module provides the student with the design of experiments concepts, tools and techniques for optimising products and processes. The student will learn to build empirical models of a process and assess their validity. The R statistical software or equivalent will be used extensively for data analysis and interpretation.

1. Demonstrate principles of statistical design, hypothesis testing and model diagnostics

2. Plan, conduct and analyse experiments using completely randomised design (CRD) and randomised block design

3. Design,analyse and interpret the results of the factorial, fractional factorial and repeated measures design

4. Analyse and interpret data from experiments involving latin square design, split plots and response surface design

5. Review concepts of statistical power and sample size and theirimplications for design and analysis of experiments

In supporting the development of skills to deliver state of the art medical technologies, it is imperative that regulatory obligations are understood and applied. The global legal framework to develop and commercialize medical devices is extremely complex and highly regulated. The ability to interpret and implement these expectations in the innovation process is critical to success. Key regulatory principles are a priority for inclusion at design and development stage and when incorporated competently and accurately will ensure the positive delivery of safe and effective technologies for human use.

1. Compare and contrast the globalregulatory requirements pertinent to commercialising high risk medical technologies.

2. Explainthe technical documentation and post market deliverables to continuously demonstrate safety and efficacy for medical technologies

3. Evaluate the regulatory and business risks at each stage of the innovation and design process.

4. Communicate and proceduralize the systematic regulatory deliverables and associated technical file inputs.

5. Demonstrate the ability tolead aproject toapproval stage by anticipating and engaging withregulatory experts and sourcing regulatory intelligence.

This module aims to provide learners with a detailed knowledge of the relevant information required in test protocols and complete test reports for pre-clinical performance evaluation and assessment of technologies in a premarket submission to regulatory bodies. The module will have a particular focus on non-clinical bench performance testing, biocompatibility evaluation, human factors and software verification in validation and will explain the guidance documentation in place by the various regulators for Medical Technologies.

1. Demonstrate a detailed knowledge and understanding of non-clinical premarket submission, types of tests required, and associated standards for medical technologies.

2. Source and interpret, regulations, standards and guidance to design and execute a relevant test (objectives and methods, pre-defined pass/fail criteria, results summary, discussion and conclusions).

3. Critically evaluate test data to inform design improvement of medical technologies.

4. Interpret key clinical terms and demonstrate an ability to prepare a clinical evaluation report on the perofmace of a medical technology.