1. University of Minho School of Engineering Uma Escola a Reinventar o Futuro – Semana da Escola de Engenharia - 3 a 8 de Outubro de 2011 SHANTESH HEDE* Supervisors: Luis Alexandre Rocha, Paula Ferreira and Manuel Nunes * shanteshhede@gmail.com DEVELOPMENT OF SUSTAINABLE MEDICAL DEVICES I. INTRODUCTION Medical Devices consume significant non-renewable resources, throughout its Life Cycle. Thus affecting social, economic and environmental sustainability. Therefore, it necessitates the inclusion of Sustainability in the Design and Development Phase. II. AIM and MOTIVATION: To Devise a Multifaceted Product Development Framework: To illustrate the correlation between the Design & Development Phase and Sustainability throughout the Product Life Cycle. To present and apply a priority based decision model incorporating appropriate criteria for developing medical devices. Fig. 2: Medical Devices are a result of multiple interdependent processes and decisions. DSM (Source: DSMWeb.org) can illustrate the interdependencies (& conflicts) of the “Value” of each Process(s) from the Scale of 1 to 9, in order to accommodate the Dynamically changing Business and Regulatory scenarios. A. B. C. D. E. B) Design Structure Matrix (DSM) & Value Engineering Analysis Example: Dialysis Cartridge designed by Hanson and Hitchcock, 2009 INPUTS (COST) -Knowledge -Human Resources -Services & Resources IV. CONCLUSION T he Framework, accounts for the interdependencies between the various developmental processes, pertinent to the 3 “Value” Dimensions. The decision making tool, assists in conflict resolution between various product requirements, at every developmental stage, by focusing on the essential criteria and limitations of the accessible resources.. III. MULTIFACETED FRAMEWORK Parts A ABCDE B C D E x x x x x x Process Plan Sequence DC A BE Fig.1: Conflict resolution, during Product Development (Refer Section C) and inclusion of other 2 Tiers only in accordance with Tier 1 (Non Negotiable). A) PRIORITY BASED DECISION MAKING MODEL USING A NALYTICAL H IERARCHY P ROCESS Market Competitiveness, Profitability, Safety and Regulatory Compliance (Functionality and Sustainability) End-of Life Opportunities, Growth in Market Share and Employment Community Development and Corporate Expansion. TIER 1 (Mandatory and Non Negotiable). TIER 2 (Negotiable). TIER 3 (Negotiable). OUTPUT (VALUE) -Profit: Economic & Social Goals -Knowledge Growth. -Emissions and Waste. -Safety and Regulatory Compliance. -Product Functionality PROCESS Fig. 4: 1. Preliminary Design Review (PDR):Clinical Studies, Prototyping, Design Validation of Sub-systems. 2. Critical Design Review (CDR) of Production Tool Development, Integration, Assembly and Testing. Market and Portfolio Planning Idea Generation Concept Definition Proof of Principle & Product Layout C) Comprehensive Sustainable Product Development Framework-A Life Cycle Approach Extraction Resources Sales and DistributionUseMaintenance End-Of-Life Disposal Transportation Design Cancel Production Requirements Conceptual Design Specifications PDR Iterate using AHP CDR Fig. 3:Value Engineering Analysis (Source: SAVE International). The “Value” pertains to Business Performance, Regulatory Compliance and Sustainability. The said approach minimizes negative consequences at the downstream phase. End-Of Life Options: Recycling Remanufacturing V. ACKNOWLEDGEMENTS The author acknowledges the contribution of MIT Portugal Program, University of Minho and Foundation Of Science and Technology, Portugal.