SHANTESH HEDE* Supervisors: Luis Alexandre Rocha, Paula Ferreira and Manuel Nunes

1. DEVELOPMENT OF SUSTAINABLE MEDICAL DEVICES SHANTESH HEDE* Supervisors: Luis Alexandre Rocha, Paula Ferreira and Manuel Nunes * shanteshhede@gmail.com A. B. C. E. D. 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. Idea Generation Iterate using AHP Sales and Distribution Use Maintenance End-Of-Life Requirements A) PRIORITY BASED DECISION MAKING MODEL USING ANALYTICAL HIERARCHY PROCESS Transportation Market and Portfolio Planning Specifications III. MULTIFACETED FRAMEWORK Resources Disposal Extraction Concept Definition Conceptual Design TIER 1 (Mandatory and Non Negotiable). Market Competitiveness, Profitability, Safety and Regulatory Compliance (Functionality and Sustainability) • Fig.1: Conflict resolution, during Product Development (Refer Section C) and inclusion of other 2 Tiers only in accordance with Tier 1 (Non Negotiable). Proof of Principle & Product Layout Design PDR CDR End-of Life Opportunities, Growth in Market Share and Employment TIER 2 (Negotiable). Community Development and Corporate Expansion. TIER 3 (Negotiable). Cancel A B C D E A x x A Production x B x B E x C B) Design Structure Matrix (DSM) & Value Engineering Analysis C D D x E OUTPUT (VALUE) -Profit: Economic & Social Goals -Knowledge Growth. -Emissions and Waste. -Safety and Regulatory Compliance. -Product Functionality INPUTS (COST) -Knowledge -Human Resources -Services & Resources Parts • PROCESS Process Plan Sequence Example: Dialysis Cartridge designed by Hanson and Hitchcock, 2009 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. 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. • C) Comprehensive Sustainable Product Development Framework-A Life Cycle Approach • End-Of Life Options: • Recycling • Remanufacturing • 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. • V. ACKNOWLEDGEMENTS • The author acknowledges the contribution of MIT Portugal Program, University of Minho and Foundation Of Science and Technology, Portugal. IV. CONCLUSION • The 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 theaccessible resources. • .