Graduate Studies Form for Modules attached to Structured PhD and/or Research Masters Programmes

Title

BioInnovate II Core: Concept Development and Implementation

Credits  (ECTS)

10

Module Places

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

GS522

Elective Places

12

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 BioInnovation Fellows on a weekly basis. The course s focuses on concept selection, development of an intellectual property strategy, evaluation of regulatory & reimbursement strategy, financing, and operational planning.  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 you experience
  • have completed a consulting report on your 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 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. 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:

  1.  Research and Development strategy
  2. Exploration of prototyping facilities
  3. Exploration of medtech development
  4. Intellectual Property Strategy
  5. Financial Modelling
  6. Clinical Trial Design
  7. Reimbursement Strategy
  8. Funding sources; Venture, capital and angel funding
  9. Quality systems and assurance
  10. Licensing and alternate pathways

Assessment(s):

The module will be assessed on a pass/fail basis.  You will be assessed on the quality of your input to the team you are consulting and class participation. Consulting input to the team will take the form of a consulting report to your team. The nature of the consulting report will depend on your discipline and it will be as follows:

  • Engineering Students: Report should address the R&D strategy for the project. . The specific issues to address will be based on the needs of the team.
  • Medical Students/Residents: Report should address the clinical strategy for the project. The specific issues to address will be based on the needs of the team.
  • Management Students: If a standalone company is being pursued, the report should be a comprehensive financing and funding model. However, if another strategy such as licensing seems more appropriate, then the details of that plan should be presented.

 

Class participation will be evaluated during each lecture by the teaching faculty. You will be expected to attend all lectures and presentations for your team and the needs presentation.  In addition, we will require you to submit an evaluation form for each section of the textbook. Lastly, evaluations by the innovation fellow working with your team and members of your team will contribute to your final assessment. 

Workload: (specify or delete as appropriate)

Class Contact

30 class hours in lectures

10 contact hours with Fellows

Workshop

 

Specified Assignment(s)

  • Final Consulting report

Assessment(s)

Class Participation  20%                                                                20%

Team and Fellow Assessment  30%                                            30%

Consulting Report  50%                                                                 50%

Result Successful completion of

assignments

Pass