As a result of intense global competition, Medical Device manufacturers are finding they must boost innovation while facing some new and highly complex business challenges, including global product development, outsourcing of design and manufacturing, and the need to update product development technology. And, while dealing with these challenges, they must continue complying with strict regulatory requirements imposed by governing agencies around the globe.

The FDA's Medical Device Recall Report FY 2003 to FY 2012 shows that there has been a striking 97% increase in the number of recalls (FDA-Recalls). To reverse this trend, medical device companies should adopt new approaches that enable a greater focus on the quality of products; also, FDA's Medical Device Recall Report FY 2010 to 2012 states that recalls were due to design errors as well. Using a collaborative design system that can integrate quality, compliance and engineering teams from their silos and each team can view information more meaningfully for their role; also, this kind of system helps companies to shift from document-centric process to product-centric process.

In the collaborative design environment, there is an increasing demand for the exchange of information and sharing them to reduce lead time and to improve product quality. Software and communication technologies can be a proper approach in this context, for instance, PLM (Product Lifecycle Management) systems. Each product lifecycle development phase has lot of processes & technology and managing this learning can be placed in a closed-loop system. In this paper, we present a detailed overview of how PTC's product suite (Windchill) helps to achieve the Total Product Lifecycle (TPLC) model product development system considering the medical device manufacturing industry as our case.

Malek Dukaly

Affiliation

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Total Product Life Cycle For Medical Device Industry Using Windchill PLM Modules