1. Seeking and celebrating the finest in student biomedical innovations BME IDEA Competition

2. Sponsored by NCIIA, Medical Design Excellence Awards / Canon Communications, llc, Industrial Design Society of America (IDSA), in partnership with Biomedical Engineering Society and the Council of Chairs of Bioengineering and Biomedical Engineering Programs We are seeking additional corporate and foundation sponsors to support contest expenses and expansion.

3. 30 Institutional Participants as of October 4, 2004 BME IDEA Competition Arizona State University Boston University Carnegie Mellon University Case Western Reserve Duke University Florida International University Georgia Institute of Technology LeTourneau University Lousiana Tech University Marquette University Milwaukee School of Engineering North Carolina State University Rose-Hulman Rutgers, the State University of New Jersey Tulane University Stanford University University of California, Irvine University of Cinncinnati University of Miami University of Pittsburgh University of Rochester University of Southern California University of Texas, Austin University of Wisconsin Vanderbilt University Washington State University Washington University Washington University School of Medicine Wayne State University Wright State University

4. Contest Objectives To identify and recognize innovative, commercializable medical devices and technologies developed by entrepreneurial student teams. Winning entries will –solve a clinical problem; –meet technical, economic, legal, and regulatory requirements; –feature novel and practical designs; and –show potential for commercialization. BME-IDEA Competition

5. Structure Participation is by invitation with one contest entry per school. Interdisciplinary Teams Categories: surgery, therapeutic applications, diagnostic applications, rehabilitative and assistive technologies, and home healthcare. Participating teams receive a $500 stipend in the form of reimbursement for team expenses. All competition transactions take place online, using a tool located at www.nciia.org. BME- IDEA Competition

6. Schedule –December 1, 2004: Registration deadline –April 15, 2005: Competition materials submission deadline (online) –April 16-June 15, 2005: Judging of entries –June 2005: Finalists announced –October 2005: Winners announced at BMES Conference BME-IDEA Competition

7. Judging –Initial judging will take place in conjunction with the MDEA conference in June 2005 –Judges will be drawn from MDEA panels along with appropriate faculty from BME and Business BME-IDEA Competition

8. Criteria: Entries will be judged on –Technical feasibility –Clinical utility –Economic feasibility and market potential –Novelty and patentability –Potential for commercialization –Benefit to quality of life and care BME-IDEA Competition

9. Technical Feasibility Ability of design to meet customer needs and solve clinical problem Ability of design to meet technical and performance requirements –Applicable industry standards (ASTM, AAMI) –Compliance with regulatory requirements (FDA, ISO, EU)

10. Clinical Utility Design features that provide enhanced benefits to patients or end user –Comfort, fit, safety, serviceability, etc. –Overall improvement of healthcare Potential for design to –Impact quality of life, and quality of care –Reach underserved populations

11. Economic Feasibility and Market Potential Ability of design to meet cost constraints Potential to meet needs of market Ability to serve large share of potential market Potential for device/technology to obtain regulatory approvals

12. Novelty and Patentability Innovative use of materials or components New application of existing technologies in design of product Innovative manufacturing process or design changes that significantly reduce manufacturing costs Potential for patentability

13. Potential for Commercialization Assessment of potential market success –Market analysis Market need and size Estimated manufacturing cost, selling price Reimbursement status –Anticipated regulatory pathway –Assessment of patentability & prior art –Business plan

14. Awards and Recognition –Prizes will be awarded in a ceremony at the BMES conference in October 2005. –Prizes will include cash awards of $10,000 and product development and commercialization resources, including recognition in Canon llc publications. BME-IDEA Competition