Swan Valley Medical (SVM) is a privately held medical device company founded in 2006 by a retired urologist and engineer/entrepreneur. SVM now has design and manufacturing operations in Denver with suppliers all over the country, including one overseas in Taiwan. With the expansion, Swan Valley Medical’s Chief Operating Officer Laurence Sampson began to realize that the company desperately needed a better way to manage product information to facilitate synchronization across a globally dispersed supply chain.
“It had become difficult to disseminate the information to both internal employees and suppliers,” explained Sampson. “When using a paper system to record quality process data, it is increasingly difficult, in a timely manner, to accurately recall the correction evidence in the context of an external audit,” said Sampson. “At some point in time it became necessary to get better structure and organization around the documentation.”
To meet FDA and other regulations, Sampson knew SVM needed a professional system to manage information to organize evidence of compliance and avoid costly penalties and brand damage. Unfortunately for Sampson, SVM was burdened with inefficient paper-based manual processes that exposed themselves to a potential compliance risk due to misplacing critical documentation.
In Part II of our interview with Sampson, we discuss how Arena PLM has helped medical device companies like his streamline efficiencies and avoid compliance pitfalls.
Arena: As a medical device company, what is most the important goal for you to achieve?
Sampson: My focus has really been to make the quality of QMS projects as good as possible. That’s very important to me. I don’t know how to put a number on it because it really comes down to this: mistakes or a lack of evidence are often much more expensive than the work that was originally done. Mistakes can appear three years down the road and evidence can be difficult to find after you don’t remember what was done…it can be difficult or impossible to re-create those logs.
Arena: How do product lifecycle management (PLM) and enterprise resource planning (ERP) work together at SVM?
Sampson: I’m trying to sort out where Arena PLM should stop and an ERP system start. And so one of the things I’ve been working on is receiving “inspection.” I’m trying to decide, especially given the fact that we don’t have an ERP system yet, should we put or receive an “inspection into the quality system as a quality process or is that something that is really better left to an ERP system? Arena provides a nice interface with ERP systems. It does a great job of maintaining the documents, the document numbers and the paper that is associated with that system. I struggle with software tools, (operational software tools in general) and where to draw that line between the mature systems that you are using.
Arena: Can you describe the innovative ways you’ve used Arena Projects?
Sampson: One of the ways we use Projects is with quality management. When we do our management review meeting, we track all of the action items coming out of those review meetings with Projects. One example is training; in the past, we have done our training for standard operating procedures (SOPs) as simply a read and acknowledge approach. We have now come to the conclusion that in many cases read and acknowledgement is not sufficient. We put together a Corrective and Preventive Action (CAPA) on the training program. We tested the program, compiled a list of all the SOPs we’re going to put in the program, and then trained the appropriate employees. There is not only a list of tasks associated with the project but there is also a prioritized list of SOPs.
It’s nice you can create a project — then in the quality process where you are trying to document evidence of completing the remediation of the CAPA — you just link it in. That way when you come back and you’re in the middle of a six-month project with an auditor who comes in and says, “What’s your status?” Well, the link to the project is right there. You can click and show them exactly where you’re at in the project to finish up that CAPA, in how much time you expect to be completed and which aspects of the system you’re touching upon. I think it's useful when you have quality processes tied in directly with the tasks associated with getting the process completed. It works great for us.
To learn more about how Arena PLM helps medical device companies, watch our webinar with Swan Valley Medical's COO Laurence Sampson: "Accelerate Medical Device Innovation By Removing the Risk of Quality Failure."