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Custom Devices Benefit from Cross-Collaboration

It is more difficult today than ever before to be a successful medical device company. Patients are more educated and demanding about therapies, the global market is diverse and expanding, and regulatory and documentation requirements are stringent. It is for these reasons that companies need a strong IT program, according to Dan Staresinic, senior director of consumer products and life sciences at Siemens PLM Software.

And these days, it's not just about the "occasional special design but [instead is about] the trend towards mass customization of your therapies in the market at large," said Staresinic during yesterday's Siemens Webinar, "Transforming the Business of Patient-Specific Medical Products." Staresinic said that having a strong IT platform for innovation, which remains a gray area for some medical device companies, involves using product lifecycle management (PLM) software. PLM links plan, development, manufacturing, and support processes together for manufacturers. Although many companies use such software, a study by the firm AMR Research shed some light on software adoption and how this can affect patient-specific design processes. Only 31% of respondents claim to be using PLM at least partial basis. By the end of 2010, nearly 90% of respondents will have at least evaluated the impact that PLM could have on their business. So, the question remains--what is the rest of the industry doing? Alex Winber, director of OrthoRecon Knees at Wright Medical Technologies, said using PLM software as part of a product development process allowed Wright Medical to advance its Prophecy knee implant from inception to launch in less than one year. Wright Medical used Siemens' PLM Software to develop the interface for the product. However, despite this success story, AMR Research's study found that there's a lack of clarity surrounding the roles of R&D and operations at companies, especially within companies that are focusing on developing patient-specific devices. Custom products are being seen as a way to differentiate a product portfolio in an increasingly competitive marketplace, and a strong, cross-functional relationship between R&D and operations is essential.

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