This module is designed to introduce students to the Medical Device Evaluation process that is required prior to clinically trialing a medical device. It provides detail on the regulations that govern medical device evaluation, the preclinical models that can be used to evaluate a medical device prior to clinical evaluation, and how to statistically analyse and visualise the data generated by preclinical testing of medical devices.

The syllabus will cover: An introduction to medical device evaluation and the relevant regulations (including risk management, design controls and biological evaluation). 2D cell culture and in vitro testing (including aseptic technique, culturing of cells in vitro, and in vitro cell-based assays for medical device evaluation). Statistical analysis and data visualisation (including descriptive statistics, inferential statistics, and data visualisation). Ex vivo tissue testing and ex vivo tissue studies (including human tissue overview, human tissue testing, and ex vivo testing of medical devices). Animal models and in vivo studies (including an overview of animal models, in vivo studies for medical device evaluation, and histological assessment of explanted tissue). Alternatives to animal models (including 3D cell models, organoid models, and organ-on-a-chip models).

On successful completion of this module, students will be able to: 1. Describe the principles and purposes of preclinical medical device evaluation including the state of the art in preclinical model design and use. 2. Apply the principles of preclinical testing to evaluate a medical device. 3. Describe the principles of data analysis (including statistical analysis and data visualisation) and its role in the preclinical evaluation of medical devices. 4. Analyse data to evaluate a medical device.

On successful completion of this module, students will be able to: 5. Evaluate the ethical concerns and impact of gender on the acquisition and testing of in vivo animal testing and ex vivo human tissue testing.

On successful completion of this module, students will be able to: 6. Perform the laboratory techniques necessary to culture and analyse animal cells outside of the body for use in medical device evaluation.

Lecture based teaching: A series of lectures will be employed to present the main concepts/topics of the module, following the previously outlined syllabus. These lectures will be inter-linked and follow a logical rational flow. Graduate attributes will be developed through a learning process that will be based on the latest research studies, including the lectures own research in medical device preclinical evaluation. Students will report, discuss, and critically analyse these topics, which will be within the context of module. The latest technology enhanced learning tools such as Brightspace and Microsoft Forms will be used to deliver content in the form of tutorial videos and quizzes. Laboratory based teaching: The module will utilise a blended learning approach where the laboratories sessions will be flipped to ensure collaborative, proactive student engagement in a practical setting. The students will then spend time in a laboratory setting, learning skills that will allow them to utilise preclinical models to evaluate medical devices. Tutorial based learning: The module will utilise a blended learning approach where the tutorial sessions will be flipped to ensure effective delivery of the required content. Tutorial videos will provide students with example data and facilitate them in effectively processing the data, thereby receiving hands-on experience with descriptive and inferential statistical analysis.