MATS65502 15 Semester 2 Postgraduate Taught Level 7 Jonny Blaker Unit coordinator 1 FHEQ level (Framework for Higher Education Qualifications) ' Masters/Integrated Masters P4 ' European Credit Transfer & Accumulation System Rating : 7.5 <table border="0" cellpadding="0" cellspacing="0" cols="6" id="ACE_UM_CRSE_DERIVED_UM_GROUPBOX6$0" role="presentation" width="791"> <tbody> <tr> <td align="left" valign="top"> <table> <tbody> <tr> <td align="left"><p>Taking research ideas from the laboratory to the clinic for patients is complex but very aspect important in biomedical materials research. Biomedical scientists and engineers often have innovative ideas and the translation of the ideas into clinical practice is both challenging and exciting. This unit will cover all the aspects of getting a biomedical product/idea to the market and through regulatory bodies. This unit will be very beneficial to biomedical materials scientists, entrepreneurs and those interested in business opportunities in materials science and engineering and enter the medical device testing and regulatory sectors.<br /> <br /> Specifically the unit will cover: Nomenclature; FDA and MHRA device classifications; pathways to device development and the regulatory process; in vitro and in vivo testing (including pre-clinical models); patent/IP strategy; sterilization; good laboratory practice (GLP), good manufacturing practice (GMP) and good clinical practice (GCP). A range of products will be investigated (including case studies) concerning traditional biomedical devices (e.g. stents/current implants, electrical patient interfacing devices), natural and synthetic scaffolds for tissue engineering/regeneration, and more contemporary advanced therapy medicinal products (ATMPs), as well as patient bespoke 3D (bio)printed devices/scaffolds; clinical trials and planning from the materials perspective.</p></td> </tr> </tbody> </table> </td> </tr> </tbody></table> <p>Taking research ideas from the laboratory to the clinic for patients is complex but very aspect important in biomedical materials research. Biomedical scientists and engineers often have innovative ideas and the translation of the ideas into clinical practice is both challenging and exciting. This unit will cover all the aspects of getting a biomedical product/idea to the market and through regulatory bodies. This unit will be very beneficial to biomedical materials scientists, entrepreneurs and those interested in business opportunities in materials science and engineering and enter the medical device testing and regulatory sectors.<br /><br />Specifically the unit will cover: Nomenclature; FDA and MHRA device classifications; pathways to device development and the regulatory process; in vitro and in vivo testing (including pre-clinical models); patent/IP strategy; sterilization; good laboratory practice (GLP), good manufacturing practice (GMP) and good clinical practice (GCP). A range of products will be investigated (including case studies) concerning traditional biomedical devices (e.g. stents/current implants, electrical patient interfacing devices), natural and synthetic scaffolds for tissue engineering/regeneration, and more contemporary advanced therapy medicinal products (ATMPs), as well as patient bespoke 3D (bio)printed devices/scaffolds; clinical trials and planning from the materials perspective.<br />&nbsp;</p> <p>The unit aims to:</p><ul> <li>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).</li> <li>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.</li></ul> <p>A greater depth of the learning outcomes will be covered in the following sections:</p> <ul> <li> Knowledge and understanding</li> <li> Intellectual skills</li> <li> Transferable skills and personal qualities</li> </ul> <ul> <li>To classify biomedical devices (e.g. Class I, II/IIa/IIb/III)</li> <li>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</li></ul> <ul> <li>To apply intellectual property and regulatory aspects in lab- to-clinic translation strategy</li> <li>To select appropriate experimental and test methods that are product specific to meet regulatory requirements</li> <li>To build a lab-to-clinic road-map for an innovative biomedical device or combined advanced therapy medicinal product (cATMP)</li></ul> <ul> <li>Develop skills to work as part of a team to analyze and solve problems in research and business across cultures</li> <li>Communicate and present orally and in writing</li></ul> <p>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).</p> 2 Written assignment (inc essay) 100% <p>Feedback given (Written and verbal)</p> N <div style="margin-left: 3.3pt"><ul> <li style="margin-right:81px">Bioreactors for tissue engineering: Principles, design and operation, J. Chaudhuri and M. Al-Rubeai, eds., Springer, 2010.</li> <li>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.</li> <li>Futurewise: The six faces of global change, 4th edition, P. Dixon, Profile Books, London, 2007.</li> <li>The tipping point: How little things can make a big difference, M. Gladwell, Abacus, 2002.</li> <li>When cultures collide: Leading across cultures, 3rd edition, R. D. Lewis, Nicholas Brealey Publishing, 2006.</li></ul></div> Lectures 15 0 135