DEVELOPMENT OF SUSTAINABLE MEDICAL DEVICES

SHANTESH HEDE* Supervisors: Luis Alexandre Rocha, Paula Ferreira and Manuel Nunes
* shanteshhede@gmail.com

University of Minho School of Engineering <Department of Production and Systems Engineering>

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.

III. MULTIFACETED FRAMEWORK

A) PRIORITY BASED DECISION MAKING MODEL USING ANALYTICAL HIERARCHY PROCESS

Market Competitiveness, Profitability, Safety and Regulatory Compliance (Functionality and Sustainability) TIER 1 (Mandatory and Non Negotiable).

Fig.1: Conflict resolution, during Product Development (Refer Section C) and inclusion of other 2 Tiers only in accordance with Tier 1 (Non Negotiable).

End-of Life Opportunities, Growth in Market Share and Employment Community Development and Corporate Expansion.

TIER 2 (Negotiable).

TIER 3 (Negotiable).

B) Design Structure Matrix (DSM) & Value Engineering Analysis

A. B. C.
Parts A B C D E A x x B x x C x D x E

A B E
INPUTS (COST) -Knowledge -Human Resources -Services & Resources PROCESS

E.

D.

C D Process Plan Sequence

Example: Dialysis Cartridge designed by Hanson and Hitchcock, 2009

OUTPUT (VALUE) -Profit: Economic & Social Goals -Knowledge Growth. -Emissions and Waste. -Safety and Regulatory Compliance. -Product Functionality

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

Idea Generation End-Of Life Options: Recycling Remanufacturing Market and Portfolio Planning Concept Definition Proof of Principle & Product Layout Iterate using AHP Requirements Specifications Conceptual Design PDR Design CDR Cancel Production Sales and Distribution Use Maintenance End-Of-Life

Transportation Resources Extraction Disposal

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.

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 the accessible resources. .

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

Uma Escola a Reinventar o Futuro Semana da Escola de Engenharia - 3 a 8 de Outubro de 2011