Project Course: Biomedical Product Development

Aim

Knowledge and understandingOn completion of the course, the student shall be able to:

• Describe the principles and methods for developing a method of medical diagnostic testing
• Describe the foundations of the validation of biomedical methods
• Describe the principles of the production and quality monitoring of a method of medical diagnostic testing
• Describe regulatory issues in medical research and development
• Describe the demands placed on a method of diagnostic testing from a commercial perspective

Skills and abilitiesOn completion of the course, the student shall be able to:

• Develop and validate a method of medical diagnostic testing on commercial grounds
• Document and assess relevant biomedical laboratory data for subsequent quality control
• Use the project format to identify knowledge requirements, formulate a project plan, assign work and present the results in the form of a project report
• Present an informative and accurate description of a method of medical diagnostic testing orally and in writing to recipients who are not necessarily specialists in the techniques that are being applied
• Identify customer benefits and needs in the development of biomedical products
• Work in projects applying a project management method based on the three guiding parameters of quality, time and cost

Judgement ability and approachOn completion of the course, the student shall be able to:

• Acquire, critically appraise and evaluate knowledge within the field of medical product development from an academic, social and ethical perspective.
• Critically process a commercially viable diagnostic test from a social perspective and with economic awareness

Content

The course is an introduction to project management methodology in which the student learns to develop a method of medical diagnostic testing for healthcare, the “life science” industry or research. This includes basic knowledge of medical validation, regulatory issues within good laboratory practice (GLP), good manufacturing practice (GMP) and CE marking, as well as quality management in regard to documentation. The aim is to understand the requirements placed on the development of a medical diagnostic tests for research and healthcare. The course also aims to teach the student how to work in projects in accordance with the guiding parameters of time, economics and quality. The course also encompasses the fields medical validation, evidence-based healthcare, GLP, biomedical improvement studies, clinical biochemistry and laboratory medicine, which are integrated with project management methodology.