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Topic

Many industries are already utilizing standards to incorporate environmentally preferable attributes. The Association for the Advancement of Medical Instrumentation (AAMI*) Sustainability Committee is developing a Technical Information Report (TIR) that will address sustainability across the total medical device product life cycle. This TIR is a multi-stakeholder effort involving representatives from industry, hospitals, and regulatory authorities. This panel will highlight how the various stakeholders have come together to work on and agree to the common elements to consider. Panelists will include Cliff Bernier, Director, Standards, AAMI, who will speak to the AAMI perspective, Suzanne Fiorino, Sr. Director, Johnson & Johnson MD&D Sustainability, who will address the industry perspective, and Ramé Hemstreet, Vice President, Operations, Kaiser Permanente, who will consider the customer perspective.

Learning Objectives 

  • Attendees will understand the standard elements of sustainability included across the total medical device product life cycle.
  • Attendees will come away with an understanding of the importance of more sustainable product development from various stakeholder perspectives.
  • Attendees will learn the process by which a AAMI Technical Information Report is initiated, developed, and approved.
  • Attendees will learn about how American National Standards and International Standards for medical devices are initiated, developed and approved.

Presenters


Suzanne Fiorino Sr. Director Sustainability and Q&C - Strategy & Analytics, Johnson & Johnson

Suzanne Fiorino is Senior Director, MD&D Sustainability and Quality Strategy. Her responsibilities include development and deployment of the sector’s Sustainability Strategy and leadership of the Quality and Regulatory Compliance Strategic Planning process for Johnson & Johnson’s Medical Devices & Diagnostics business.

Suzanne has previously held several leadership roles in both the Medical Devices & Diagnostics and Pharmaceuticals businesses at Johnson & Johnson in the areas of Health Care Compliance (HCC), International Regulatory, Quality, and Process Excellence. Prior to joining Johnson & Johnson, Ms. Fiorino was the owner of Amgis, Ltd., a Quality Improvement and Compliance consulting firm, and she also held positions at QualPro Inc. and Union Carbide Corporation.

Ms. Fiorino holds an MBA in New Ventures Management from the University of Tennessee at Knoxville, a B.S. in Chemistry from Canisius College, and has completed her coursework toward a doctorate in Industrial/Organizational Psychology. She is a Six Sigma Master Black Belt and a Senior Member of ASQ.


Clifford Bernier, Director of Standards at Association for the Advancement of Medical Instrumentation

Clifford Bernier, Director, Standards at the Association for the Advancement of Medical Instrumentation, serves as the Secretary of ISO/TC 150/SC 2, Cardiovascular implants and extracorporeal systems and administers the US Technical Advisory Group for this activity. He is responsible for the development of more than 130 International and American National standards and the administration of over 35 standards committees. Standards and technical reports under his jurisdiction include heart valves, ventricular assist devices, cardiovascular absorbable implants, vascular prostheses, blood/gas exchange devices, dialysis equipment, and vascular device-drug combination products, among others. He is the recipient of the 2012 ASTM Robert E. Fairer Award established to recognize the advantages of standards for the public good. He founded and staffs the AAMI Sustainability Committee.


Ramé Hemstreet, VP, Operations, Kaiser Permanente 

Ramé Hemstreet is the  VP of Operations at Kaiser Permanente. Mr. Hemstreet is responsible for integrating and coordinating all components of facilities services, including a multibillion dollar annual construction program and a $68 million real estate portfolio.

Drawing on 28 years of experience planning and executing facilities construction and management, Ramé haS wide-ranging experience planning, negotiating and implementing complicated and often controversial infrastructure and facilities projects in various cultures and circumstances. He is experienced in both international and domestic environments, having successfully managed large organizations and programs in Japan, Europe, Oceana, California, Washington, D.C. and the Midwest.

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