University of Minho School of Engineering <Department of Production and Systems 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. INTRODUCTIONMedical 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. CONCLUSIONThe 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

Part

s

AA B C D E

BCDE

x xx x

x

x Process Plan SequenceDC

A

B E

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 ANALYTICAL HIERARCHY PROCESS

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

ExtractionResources

Sales and Distribution Use Maintenance End-Of-Life

Disposal

TransportationDesign

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. ACKNOWLEDGEMENTSThe author acknowledges the contribution of MIT Portugal Program, University of Minho and Foundation Of Science and Technology, Portugal.