Life sciences sector uses PLM to shorten “innovation-to-registration” cycle
By Jim Fulcher, contributing editor -- Manufacturing Business Technology, 9/1/2007 12:00:00 AM
Like so many other kinds of companies, medical device manufacturers are under pressure to innovate, says Todd Hein, senior director of life sciences for product life-cycle management (PLM) vendor Agile Software. What adds a level of complexity is that they also must document their processes for regulatory bodies around the world.
“Competition and globalization are cutting away at their profit margins, so medical device manufacturers need to automate PLM processes to cut costs,” says Hein. “Use of PLM also speeds innovation-to-registration cycles. These companies must register their devices with a country's regulating body—such as the FDA in the U.S.—before they can sell the device there. Consequently, time-to-registration—rather than time-to-market—becomes a key metric.”
A PLM system engineered for the medical devices market meets these requirements as it enables managing information from R&D, manufacturing engineering, production, and suppliers. Agile's solution, for example, allows users to add quality assurance to prove that the manufacturer followed design processes in accordance with FDA requirements.
HeartWare is a Framingham, Mass.-based device manufacturer with a portfolio of left-ventricular-assist devices used for long-term treatment of advanced heart failure. Its success hinges on the ability to rapidly innovate its product offerings while supporting rigorous compliance directives for electronic documentation.
With its parent company in Sydney, Australia, and facilities in the U.S., HeartWare normally conducts clinical trials throughout Europe and Australia. Its trade secrets, technology, and design history are among HeartWare's key assets. Product information was housed in a consortium of hard drives scattered throughout the organization, and access was limited. Manual documentation control systems also required time-consuming tracking and revision control.
To remedy the situation and enhance information security, HeartWare selected Agile's Advantage PLM solution for its flexible licensing options, deep domain expertise, configurable solutions, and extensive customer references. The result is a single application to view the product record, quality system compliance, and knowledge archives across its global enterprise.
“We deployed Agile Advantage because we didn't want to lose the flexibility and agility of a start-up company, but needed a world-class solution that would allow us to communicate and exchange information—based on a robust security model—with our global skilled partners in manufacturing, regulatory, research, and clinical advisory capacities,” says Jeff LaRose, chief science officer, HeartWare. “Agile Advantage frees us of the inherent burden of an inefficient documentation control process, manual quality management processes, disjointed historical knowledge, and unnecessarily complex supply chain communications. Now we have a system to effectively manage growth as we move from clinical trials to commercialization of our ventricular assist technologies worldwide.”
HeartWare is using Agile OnDemand—Agile's software-as-a-service (SaaS) version of Agile Advantage—to securely collaborate with key stakeholders throughout the company's product network. This type of delivery model offers the flexibility to migrate, as business needs dictate, from an SaaS model to an in-house solution without the expense and problems of reconfiguration.
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