1. www.medec.org ADVANCING HEALTHCARE THROUGH INNOVATIVE TECHNOLOGIES AND DEVICES ASSURER DE MEILLEURS SOINS DE SANTÉ GRÂCE À DES TECHNOLOGIES ET DES DISPOSITIFS INNOVATEURS Stephen Dibert, President & CEO May 27, 2008 Medical Device Compliance Canada

2. 2 Medical Device Compliance Congress May 26-27 2008 Who is MEDEC? National association created by and for the Canadian medical device industry Primary source for advocacy, information and education on the medical device industry Our focus is accelerating access to medical device technology

3. 3 Medical Device Compliance Congress May 26-27 2008 MEDEC Code of Conduct Came into effect in 2005 Was designed to ensure MEDEC’s members are guided by ethical business practices in their relationships with healthcare professionals Further promotes socially responsible industry conduct Was developed by the medical device industry in Canada and stakeholders Provides guiding principles for MEDEC’s members, staff and industry partners Describes and promotes ethical business practices and interactions

4. 4 Medical Device Compliance Congress May 26-27 2008 What’s Covered by the Code Member-sponsored product training and education Sponsorship of third-party educational conferences Sales and promotional meetings Arrangements with consultants Gifts to healthcare professionals Grants and other charitable donations

5. 5 Medical Device Compliance Congress May 26-27 2008 Enforcement and Compliance Issues Voluntary participation Few levers for enforcement Variability in Corporate priority –USA vs RoW –Disagreement on level of enforcement required Variability in practice amongst members – golf Value added clauses permitted in Canadian tendering Moving target as codes and compliance programs evolve Industry needs to understand – define yourself, or be defined

6. 6 Medical Device Compliance Congress May 26-27 2008 What’s Worked Awareness Presentations to members senior management teams and sales meetings Advertisements in MEDEC and professional journals Communications with key stakeholders Incentives (we lack viable disincentives) Diabetes Committee created an in depth implementation guide that included mandatory training in all companies –Goal is to enhance standards and reputation Trademark acquired for the symbol and members sign a “licensing agreement” to use the materials –Branding as an industry and company differentiator –Complaints process attached to trademark use

7. 7 Medical Device Compliance Congress May 26-27 2008 sdibert@medec.org www.medec.org www.medec.org/members/code_files/cofc.pdf sdibert@medec.org www.medec.org www.medec.org/members/code_files/cofc.pdf