How Swan Valley Medical Overcame Compliance Pain
Swan Valley Medical (SVM) is a privately held medical device company founded in 2006 by a retired urologist and engineer/entrepreneur. The focus of the company is on development and commercialization of sophisticated urological surgical instruments incorporating new approaches and technologies to enhance and improve upon existing surgical devices and procedures.
“Swan Valley Medical has developed a line of unique, patented, single-use surgical instruments and accessories for application in the field of urology,” said Swan Valley Medical’s Chief Operating Officer, Laurence Sampson. “The company’s first urological instrument was an innovative, patented cystostomy device for placement of suprapubic catheters in adult patients. The product, which has received regulatory approvals in the United States, European Union and Canada, can be used as part of a regimen to manage the symptoms of urinary retention or incontinence.
Sampson recently spoke at an Arena webinar and was praised unanimously by attendees for his insights into the wide range of manufacturing and compliance challenges impacting medical device companies today. In this two-part interview, Sampson shares some truly uniquely important tips and advice on how medical device companies can innovate in an increasingly strict regulatory environment compounded by global competition.
Arena: As a medical device manufacturer, what are some of the greatest process manufacturing challenges you face and how has a product lifecycle management (PLM) system helped resolved those issues?
Sampson: The biggest challenge is not the documentation of the processes as it is the work required to “close them.” With Arena, I don’t worry about engineering change orders (ECO) being closed improperly from the standpoint of documentation of the approval, the sign offs and the activity date — all that is automatic. Someone can’t just go in, delete a file and remove some of the data like you could with a paper file or even with a typical repository system because it is really impossible to change from a workflow standpoint. So when we’re going into these quality systems now — with Arena — we’re using an unbreakable repository system for cross-linking all the evidence.
Arena: What is another common challenge medical device companies face?
Sampson: Finding the evidence needed in an audit is also difficult. When the only method available to track evidence is to create a document it can be very time consuming to find the applicable documents. Searching on the basis of a document name or attribute depends on the memory of the person doing the search. The cross linking in Arena makes this process much quicker.
Arena: In addition to finding a way to better meet compliance mandates, what other process improvements are needed?
Sampson: We would bring suppliers in to do typical mechanical design and interface with our medical advisory board. We were really running on paper, CAD systems and prototypes, so there came a point where we decided we had better improve our standard processes. Since implementing Arena, we’ve added a root cause analysis and non-conforming material processes so that each one of these different processes can initiate the others. Then, when you get an audit, you have an integrated, cross-linked evidence chain for whatever problem you’re dealing with. It’s been great.
Arena: What advice do you have for other medical device companies?
Sampson: Implementing a PLM system early in the development process was a tremendous savings in time. Not only are our records correct and complete, but the approval process is quick and painless over a very large geographical area. I would recommend starting the PLM process very early in the development process.
Stay tuned next week for Part II of our conversation with Larry Sampson in which he shares his thoughts on how PLM works with Swan Valley Medical’s enterprise resource planning (ERP) system to maximize the medical device company’s business results.