MEng Materials Science and Engineering with Metallurgy

Taking research ideas from the laboratory to the clinic for patients is complex but very aspect important in biomedical materials research. 

The unit aims to:

1. provide an insight into taking research ideas into the clinic, focussed on biomedical products (class I- III devices) and tissue engineering/regenerative scaffolds (including acellular, cell-containing and decellularised matrices).
    
2. describe how in vitro tests, bioreactors, in vivo tests, as well as clinical trials can be applied appropriately (and where necessary) in the lab-to-clinic journey.

A greater depth of the learning outcomes will be covered in the following sections:

• Knowledge and understanding
• Intellectual skills
• Transferable skills and personal qualities

Lectures (live and pre-recorded), including from invited external experts from selected regulatory consultants, biomedical device start-ups/spin-outs, SMEs/cell therapy businesses/catapults; coursework, recommended textbooks, web resources, and electronic supporting information (Blackboard).

• ILO 1: To classify biomedical devices (e.g. Class I, II/IIa/IIb/III)
   
• ILO 2: To describe the important stages involved in translating a biomedical device idea into the clinic, and the regulatory process (focussed on the UK/EU (CE marking) and USA markets), including post-market surveillance
   

• ILO 3: To apply intellectual property and regulatory aspects in lab- to-clinic translation strategy
   
• ILO 4: To select appropriate experimental and test methods that are product specific to meet regulatory requirements
   
• ILO 5: To build a lab-to-clinic road-map for an innovative biomedical device or combined advanced therapy medicinal product (cATMP)
   

• ILO 6: Develop skills to work as part of a team to analyze and solve problems in research and business across cultures
   
• ILO 7: Communicate and present orally and in writing
   

Feedback given (Written and verbal)

• Bioreactors for tissue engineering: Principles, design and operation, J. Chaudhuri and M. Al-Rubeai, eds., Springer, 2010.
• The business plan workbook: The definitive guide to researching writing up and presenting a winning plan, 7th edition, C. Barrow, P. Barrow and R. Brown, Kogan Page, 2012.
• Futurewise: The six faces of global change, 4th edition, P. Dixon, Profile Books, London, 2007.
• The tipping point: How little things can make a big difference, M. Gladwell, Abacus, 2002.
• When cultures collide: Leading across cultures, 3rd edition, R. D. Lewis, Nicholas Brealey Publishing, 2006.