Novare Surgical Systems adopts Arena PLM Software and eliminates bottlenecks in the medical device product development process
The right information to the right people at the right time
Minimally invasive surgery is one of the biggest trends in medicine, offering patients less trauma and pain, minimal scaring, shorter hospital stays and speedier recoveries. With its sophisticated instrumentation, Novare Surgical Systems is one of the companies at the forefront of the medical device industry, advancing this emerging field and helping make minimally invasive surgeries more widespread.
Novare Surgical is part of a continually transforming healthcare industry and medical device industry that requires companies to innovate quickly, speed product development, decrease costs and maximize efficiency — while meeting all regulatory compliance and quality requirements.
As a growing medical device company, Novare Surgical had always worked to optimize its resources, performing research and development in-house while outsourcing manufacturing. For outsourcing to be effective, the company needed to effectively manage supplier relationships while tightly controlling the information distributed to each partner. It had to be certain the right information was reaching the right people at the right time, while keeping its intellectual property secure.
Te be able to consistently hit product launch dates, Novare Surgical sought to more effectively manage the evolving definition of its products — and ensure that the latest information could be accessed by everyone who needed it. This was particularly true of data modified by engineering change orders (ECO’s), which could lead to costly errors if outdated versions were used. Because the company relied on a manual approach based on spreadsheets, email, and phone calls, Novare Surgical was experiencing unnecessary bottlenecks in its product development process.
PLM Software for a medical device innovator
Novare Surgical Systems selected Arena PLM software to improve control of its product development process, more easily comply with medical device industry standards and regulations, boost productivity, and enhance collaboration with suppliers.
Novare is employing Arena PLM software to electronically control engineering changes, track and store the vast quantities of data that enable the company to comply with medical standards and regulations, and share files for 24/7 access from anywhere in the world. The anytime, anywhere access is particularly significant for the company, which frequently saw approval cycles slowed by the heavy travel schedule of several key employees. Now those employees use the Internet to log into Arena PLM software anywhere, gain instant access to a single and accurate version of the product record, and keep the product development process moving effectively along.
“A typical change order may have many different documents, associated drawings and bills of materials. Each supplier needs different pieces of information, and up until now, I’ve had to manage everything manually”, said Donna Nelson, document control specialist at Novare Surgical Systems. “We had to go digital, we couldn’t throw any paper away for compliance reasons, and we were running out of space. A typical review of our device history meant 50 pounds of paper. Distributing documents to our vendors involves more than 400 drawings. If we miss just one it’s a problem — there’s just too much risk for human error when the process gets that large,” said Nelson.
To learn more, download the Novare Surgical Systems Case Study.
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