CIMdata PLM Industry Summary Online Archive
10 April 2007
Implementation Investments
HeartWare Optimizes Collaboration and Quality Management Across the Product Network With Agile OnDemand
Agile Software Corporation announced that HeartWare Inc. implemented Agile Advantage 2006, a leading PLM solution suite for small and medium enterprises (SMEs), to streamline and provide visibility into its pre-revenue medical device business processes. As a mid-sized medical device manufacturer, developing a family of Left Ventricular Assist Devices (LVADs) for the treatment of advanced heart failure, HeartWare selected Agile Software for its flexible licensing options, deep domain expertise, out-of-the-box configurable solutions and extensive customer references. Like any medical device manufacturer, HeartWare's success depends on its ability to rapidly innovate its product offerings, while at the same time supporting rigorous compliance directives for electronic documentation as mandated by the FDA and other regulatory bodies.
"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 seamlessly communicate and exchange information, based on a robust security model, with our skilled partners in manufacturing, regulatory, research and clinical advisory capacities located across the globe," said 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 in place that supports our plan for success and ability to effectively manage growth as we move from clinical trials to commercialization of our ventricular assist technologies world wide."
With its parent company in Sydney, Australia, HeartWare has facilities in the United States, with clinical trials being conducted throughout Europe and Australia. As a growing, pre-revenue enterprise, HeartWare's developed trade secrets, technology and design history are among the company's key assets. Prior to implementing Agile Advantage, access to valuable product information was limited across the enterprise and housed in a consortium of hard drives scattered on various computers throughout the organization. In addition, manual documentation control systems required time-consuming tracking and revision control and provided limited security.
HeartWare implemented 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. With the Agile OnDemand licensing model, HeartWare has the flexibility to migrate, as their business needs dictate, from a SaaS model to an in-house solution without reconfiguration headaches and expense. Agile PLM provides HeartWare with a single application to view the product record, quality system compliance and knowledge archives across its global enterprise. Recognizing the different needs of SMEs to compete in a global economy, Agile Advantage 2006 delivers benefits crucial to small and medium size customers: ease of management, ease of implementation, quick time to benefit, low total cost of ownership, and flexible licensing options that take into account limited IT resources.
"Small to medium companies in the medical device industry are doubly challenged to meet stringent regulations as they compete with larger, global organizations," said Craig Livingston, vice president and general manager, SME solutions, Agile. "To level the playing field, SMEs like HeartWare are increasingly turning to Agile Advantage as a flexible, user-friendly solution which reduces operating and direct materials costs, the cost and risk of compliance issues, and time-to-market, allowing medical device manufacturers to focus on product innovation."
Become a member of the CIMdata PLM Community to receive your daily PLM news and much more.
Tell us what you think of the CIMdata Newsletter. Send your feedback.
CIMdata is committed to your privacy. Your personal information will never be sold or shared outside of CIMdata without your express permission.