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GS523

*Graduate Studies Form for Modules attached to Structured PhD and/or Research Masters Programmes*
Title		BioInnovate II Core and project: Concept Development and Implementation
Credits (ECTS)		15
Module Places		Open to all MSc in BioInnovation candidates . Open to all PhD candidates affiliated to the Colleges of: Science Engineering & Informatics Medicine, Nursing & Health Sciences Business, Public Policy and Law
Module Code: Please indicate if generic (GS) or specialised		GS523
Prerequisites		BioInnovate I core and project: Needs finding to concept generation
Elective Places		28
Module Descriptor:
This module on medical device development will be delivered jointly by the faculty of NUI, Galway, University of Limerick, Royal College of Surgeons Ireland, Dublin City University and University College Cork and students will be mentored by expert practitioners from the medical device and investment companies. Students will also be mentored by the MSc BioInnovation Fellows on a weekly basis. The course focuses on concept selection, development of an intellectual property strategy, evaluation of regulatory & reimbursement strategy, financing, and operational planning. The project component is comprised of direct mentor sections with real medical device experts and coaching sessions run by the academic staff across the partner institutions. Textbook: Biodesign: The Process of Innovating Medical Technologies (Zenios, Makower & Yock) 2010 Learning Outcomes: On successful completion of this module, students should; demonstrate awareness of the process for innovating medical technologies; demonstrate awareness of how to develop a solution to a specified need taking advantage of the power of the creative group process and prototyping demonstrate appreciation of regulatory affairs and reimbursement strategy acquire significant experience of teamwork in a multi-disciplinary setting have utilised appropriate approaches to transform the idea into a prototype be able to reflect on the experience have completed a project report on the implementation plan Module Delivery This module will be delivered following a blended learning model which consists of three primary components: Online materials (in the Blackboard site for the module) and guided reading; Weekly workshops with associated activities and discussion; Individual and team research on the specific need. Attendance and class participation are essential components of this course. During the lectures, students will have the opportunity to ask questions about the lecture topics and to interact directly with academic staff. All reading assignments must be completed prior to attending class. The MSc BioInnovation fellows act as mentors for the course. The fellows are experienced physicians, engineers, and entrepreneurs who are spending a year completing a fellowship in bio-innovation for an MSc in BioInnovation award. As such, the needs for the course were generated through careful observation and research by the fellows. The following topics and will be covered and expanded with regard to a selected need: Research and Development strategy Exploration of prototyping facilities Exploration of medtech development Intellectual Property Strategy Financial Modelling Clinical Trial Design Reimbursement Strategy Funding sources; Venture, capital and angel funding Quality systems and assurance Licensing and alternate pathways All students will work in teams. Teams can be no larger than four people and no smaller than two people (no exceptions). Consultant assignments will aim to balance the team composition in terms of number and disciplines. An acceptable team is composed of students from different programs with different experiences (i.e. Business, Medical, Engineering, Design, etc.). Extensive library and online research as well as interaction with physicians, the BioInnovate fellows, and other faculty will be important in the students success. Class participation will be evaluated during each practical by the teaching faculty. There are also three scheduled coaching sessions in which the teams will be required to make a presentation of their project for discussion and review. These coaching sessions will be evaluated by the faculty. Lastly, evaluations by the innovation fellow working with the teams of students and members of the team will contribute to their final assessment. Assessment(s): The module will be assessed on a pass/fail basis. The students will be assessed on the quality of their input as an individual, to the project team and class participation. The final deliverables include: A detailed description of the clinical problem they are trying to solve A review of the broader market space and competition A complete description and rendering (on paper or via prototypes/models) of the medical technology solution. An explanation of the market, IP, reimbursement, regulatory strategies. The development considerations and clinical strategy. A full detailed operational plan including funding and financing models The final write-up should cover all the points in the various steps of the Biodesign Textbook Road Maps. The final project should not exceed 120 pages including drawings and references. At the end of the modulethe team will present their projects to a panel of experts consisting of venture capitalists, entrepreneurs, and business leaders in the medical device field. They will receive real-time feedback.
Workload: (specify or delete as appropriate)
Class Contact	30 class hours in lectures 10 contact hours with Fellows 3 coaching sessions with faculty
Workshop
Specified Assignment(s)	Poster and Oral presentations and final Project report
Assessment(s)	Final PowerPoint & Oral Presentation 35% Final Project Document 35% Class Attendance 10% Fellow & Team evaluation 10% Faculty evaluation 10%
Result Successful completion of assignments	Pass