KEYNOTE ADDRESS

The How and Why of Medical Devices Standards

Dr. Tofy Mussivand

Abstract:The utilization of medical devices includes prevention, diagnosis and treatment of disease. Despite themany benefits, devices also pose potential adverse effects. As a result, standards have beenimplemented as a precluding determinant to protect the public against adverse effects and supportapproval for clinical use.

Standards are formulated based on the following:

1. Safety, efficacy and protection of society2. Need for helping patients3. Scientific knowledge available at the time of device/drug approval4. Level of risk that is acceptable, reasonable and can be acceptable by all stakeholders

including patients, society, hospitals, healthcare providers and governments

Valid, scientific evidence is required for reasonable assurance of the safety of a particular medicaldevice. It is imperative that this evidence be measured using a dynamic set of standards formulated byall stakeholders.

Bio for Dr. Tofy MussivandDr. Tofy Mussivand received his undergraduate education and training in engineering andmanagement. Following many successful years in senior positions in government, crown corporations,and the private sector, Dr. Mussivand went on to receive his doctorate in Medical Engineering andMedical Sciences at the University of Akron and Northeastern Ohio Universities College ofMedicine. Thereafter, Dr. Mussivand joined the internationally acclaimed Cleveland Clinic Hospitaland Research Foundation where he gained invaluable knowledge and experience in the developmentof medical devices, artificial hearts, cardiac care and medicine. In 1989, Dr. Mussivand was invited toreturn to Canada to continue his pioneering work.

Dr. Mussivand has achieved both national and global recognition. His breakthroughs have resulted inthe establishment of scientific eminence for Canada in the fields of medical devices, artificial hearts,remote power transfer, in situ sterilization, DNA detection, heart failure treatment devices etc.Presently, he is Professor of Surgery and Engineering at the University of Ottawa and CarletonUniversity; Chair and Director, Cardiovascular Devices Division of the University of Ottawa HeartInstitute (OHI) and Chairman for Medical Devices Centre of the University of Ottawa and CarletonUniversity. Globally, he is Chairman of the component of ISO responsible for standards developmentfor mechanical circulatory devices and he is President of the World Society of Cardio-ThoracicSurgeons.

Combining his scientific, management and business expertise, Dr. Mussivand has been the Chairmanof several Boards, member of various Boards of Directors and the CEO of several successfulcorporations. His leadership has been responsible for the creation of over 1000 man years in theCanadian work force and have been the catalyst for an influx of more than $900 million, primarily fromoutside of Canada, during the last twelve years.

ix