Medical Device Link.

ENGINEERING INSIGHT

A company that develops motion-preserving spinal implants, Ranier Technology recently implemented a PLM system that automates regulatory compliance.

When it comes to business, growing pains generally are a good problem to have. That doesn’t mean they can be ignored, however. As Ranier Technology (Cambridge, UK) made the transition from being a developer of polymer-based motion-preserving spinal implants into a full-fledged manufacturing and sales organization, its homegrown data management system was struggling to keep up. It was time for a system upgrade. After extensive competitive benchmarking, the manufacturer chose Windchill from PTC (Needham, MA, USA) as the backbone of its product life-cycle management (PLM) system.

Ranier Technology’s Compliant Artificial spinal disc (CAdisc) is described as a next-generation total disc replacement device that achieves a new threshold in biomechanical properties and durability. The product is manufactured by means of a proprietary polyurethane process that imparts a high modulus to one region and a low modulus to a second area. The two distinct regions are connected by a third, where the modulus varies continuously from the soft to the hard area.

With the technology well under control, the company’s primary objective became achieving regulatory approval for its product within a planned time frame and on budget. The company’s homegrown system, which was built on a Microsoft platform and used file folders for data storage, could no longer provide the efficient management of product data, design history documentation, and certification processes that the company needed. “We wanted to automate regulatory compliance, improve communications, and simplify filing, tracking, and finding critical information,” says technical director Rob Snell. “We felt PLM would provide the necessary infrastructure to change the way people performed their jobs. The combination of PTC’s Windchill with the PTC Medical Device Template,” adds Snell, “was the best solution to help us comply with strict design controls, [maintain the] device history file, and [meet] regulatory requirements.”

Global Appeal

Ranier Technology started by putting Windchill through its paces. The goal of the implementation project was to show that Windchill could operate in compliance with European and US regulatory requirements, automate work flows, improve management visibility and oversight, and enhance collaboration with outside partners. Ultimately, Windchill will result in a 10 to 20% gain in employee productivity, according to Ranier Technology, and produce a complete audit trail for design development and documentation. The firm expects to demonstrate full compliance to regulatory bodies by this summer.

Windchill PDMLink stores fixed data, and ProjectLink handles data in the preapproval stages. All of the project activity that used to be filed within a Microsoft folder is now managed in ProjectLink. When specifications are finalized, the data are transferred to PDMLink, which is the control mechanism for the quality system and design history. The Medical Device Template in PDMLink supports US FDA security, traceability, and automation requirements including 21 CFR Part 11.

Although the project is still in the implementation stage, Ranier already has seen improvements in some of its processes and in the way the firm interacts with clients. Moreover, the Windchill infrastructure will accelerate the development of future projects.

It’s a safe bet that the company’s pipeline will be filled with products that have similar requirements for data management, work flow, and regulatory approval, says the firm. Consequently, the PLM system that has been put in place will allow common data to be shared among projects. Some manufacturing and test data are directly transferable, resulting in substantial time savings. “By virtue of this project-to-project synergy, overall productivity improvements and time savings of 20–30% should be the absolute minimum achievable,” says Snell.