GS521

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

Title

BioInnovate I core and project: Needs finding to concept generation

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

GS521

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.  PhD candidates affiliated to the Colleges will also be mentored by the MSc BioInnovation Fellows on a weekly basis. The course encompasses the entire process from identifying clinical needs, validating needs, brainstorming, and concept creation for new medical devices.   Textbook: Biodesign: The Process of Innovating Medical Technologies (Zenios, Makower & Yock) 2010

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. As such, the needs for the course were generated through careful observation and research by the fellows. 

The following topics will be covered and expanded with regard to a selected medical need:

1.  Introduction to Innovation and Needs Finding including Needs presentation by Fellows
2. Disease State and Existing Treatments
3. Healthcare analysis and Stakeholders
4. Weighing factors and filtering Needs
5. Needs presentation by individual students and poster
6. Team formation on selected need
7. Needs Brainstorming and introduction to product design
8. Organizing and selecting concepts
9. Reimbursement basics
10. Regulatory affairs basics
11. Business Models
12. Presentation on concept development overview

On the first day of class, students will be presented with an array of possible need-areas to choose from. They will be asked to rank their top 7 needs (in order of priority) that they wish to pursue. A lottery will be performed and a single need will be assigned to each individual student. Students will be asked to individually present these needs to the class in a one-day poster session. Students will also be expected to create a “Need Specification” document. This document will not exceed 8 pages and should detail the ideal needs for the project. A template for the need specification document is provided in the textbook document on needs filtering  At this session, the students will be asked to assess whether to either pursue the need during the next phase of the class (GO) or abandon the need and join a team working on a different need (NO GO).

Team Formation: After the poster session, students will submit the following information to facilitate balanced team formation:

a)       Students wishing to form a team around the need they investigated should submit a list of 6 (or more) possible team members (including possible consultants). These possible team members should ideally be classmates they have already approached and who have expressed an interest to work with them.

b)       Students wishing to abandon their original need and join a team investigating a new need, should submit a list of other needs they would like to work on and possible classmates (6 or more) with common interests they would like to work with. The list of names should include classmates they have already approached and asked to work with.

Project teams will be announced. In order to form teams that are balanced in terms of composition and interests, the following guidelines, as well as student preference, will be use to determine the final team assignments :

• 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.).

The goal of the team is to take the need specification chosen and develop at least 5 viable concepts, which represent 5 new and different ways of solving the problem.

Extensive library and online research as well as interaction with physicians, the Biodesign innovation fellows, and other faculty will be important in their success.  Each team will need to be prepared to present three slides in PowerPoint format describing their need and specification for discussion in class in a group coaching session. The team will also need to present three additional slides describing their concepts for the group coaching session. A final review of the presentations will be made in the coaching session. In addition, they should have submitted to the Technolgoy Transfer Office at least one if not more invention disclosure forms (IDF’s) covering their inventions if recommended by the BioInnovate fellows or university faculty.

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. Their final deliverable, the mid-stage concept development overview should 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 their top 4 concepts.
• An explanation of the market, IP, reimbursement, regulatory and development considerations for each of the concepts proposed.
• This final deliverable includes a final PowerPoint presentation and written final project for each team. The final write-up should cover all the points in the various steps of the Textbook Road Maps. The final project should not exceed 15 pages including drawings and references

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)

Individual: 20%

Deliverable 1: Poster & Oral Presentation

Deliverable 2: Written need specification

Team:

Deliverable 3: Final PowerPoint & Oral Presentation  30%

Deliverable 4: Final Project Document 30%

Class Participation  20%

Result Successful completion of

assignments

Pass