Growth, Compliance with PLM Software

Obtaining of the CE Mark means that marketing of the Vessix Vascular product can begin throughout the European Union.

Vessix Vascular is a privately held, venture-backed company developing novel radiofrequency balloon catheter technology directed towards a variety of clinical applications including the treatment of medication resistant hypertension via percutaneous renal denervation, and peripheral in-stent restenosis. This new technology has the potential to help the one in three adults in the world who suffer from hypertension – a condition that is more common than cancer, diabetes, and coronary artery disease combined.

Vessix Vascular offers a unique approach to treating uncontrolled hypertension that is faster, easier to use, and less painful for patients than any renal denervation system currently available in the market. Comprised of a group of individuals with previous experience at successful medical device companies, one of their first priorities was to formalize their product development processes to prepare for their market introduction, successfully meet regulatory guidelines, and implement best practices early on.

As a small group, Vessix could get by with their paper processes for managing engineering changes, product documentation, and Bill of Material (BOM) information, but knew this process would not be effective as they grew – particularly where they needed to track engineering change history with full audit trails to meet regulatory requirements.

“Even as a start-up, we faced multiple challenges using a paper-based system to manage product revisions,” states Rinda Sama, director of operations and quality, Vessix Vascular. “Documents would pile up on people’s desks which meant that items were not reviewed right away, causing delays, and many times by the time it was reviewed, the product was already in the next revision.”

The team at Vessix had previous experience with Product Lifecycle Management (PLM) software as a tool to automate product design and development processes. They wanted to implement PLM early on as a best practice for managing BOMs, engineering changes, product documentation, training records, and eventually corrective and preventive actions (CAPAs).

“Implementing a solution early on prevents the company from being bogged down by legacy data and processes when transitioning to an automated system in the future and also helps to eliminate resistance to change from employees entrenched in those practices,” Sama states. “Tools like Omnify that are affordable, already configured to meet the needs of medical device manufacturers and can adapt to a company’s processes make it easy to adopt PLM as a start-up and get off on the right foot.”

As they evaluated PLM vendors, they were looking for a solution that did not require huge backend support, which they could install on their existing servers. A colleague at another medical device company using the Omnify Empower PLM system recommended Omnify Software.

Vessix officials selected the Empower PLM solution because it met their needs as a small start-up, featuring an easy to use and configure system and also delivered the features for controlled product development processes to meet compliance requirements. The scalability of Empower PLM ensured Vessix that they would be able to continue to use the tool as the company grew.

Customer Success
Empower PLM has supplied Vessix Vascular with a proven scalable solution as they have already grown from 10 users to 25.

“Empower PLM is part of our day to day life at Vessix and the employees here love it,” Sama comments.

Empower PLM addressed Vessix Vascular’s manual revision management issues by providing team members with the ability to see all engineering change orders (ECOs) in real time. ECOs no longer pile up on people’s desks.

“All of our product design and development processes are streamlined and viewable in a single snapshot and the time to process an ECO is transparent,” Sama says.

“We converted the Vessix Approved Supplier List from a static Excel spreadsheet to a dynamic Omnify list,” states Joseluis Espinosa, project manager and omnify administrator, Vessix Vascular. “In this way, vendors are now able to be linked with individual parts and assemblies. Opening a vendor record displays every part acquired from them. Another advantage to dynamic vendor management is the simplicity with which secondary vendors are able to be qualified and linked to pre-existing parts.”

Omnify Empower Vendor Management provides an additional layer of information not available through the legacy paper system. Similarly, management of all tools and equipment are through the Omnify Empower Training Management Module in order to track calibration and preventive maintenance.

Prepared for Regulatory Compliance
Vessix Vascular is ISO 13485:2003 compliant which specifies requirements for a quality management system. The company has already been through two ISO 13485 Quality System audits using the Omnify Empower PLM system. Prior to Empower PLM, they would have to find and print documents to pull for an audit. Now, they can quickly search in Empower PLM to show the necessary documents along with change history, who approved the change, its release date, change justifications, and links to any other Omnify items relevant to that part.

The company recently received their CE Mark, which will allow Vessix to begin marketing the product throughout the European Union (EU).

“Omnify PLM offers some subtle yet powerful advantages to the CE Marking application and review process,” Espinosa states. “Design History Files and Phase completions were enhanced by citing project deliverables with dynamic links through the Omnify BOM structure, which increased the response speed when regulatory bodies inevitably requested more information. In addition, the web interface kept overseas employees in the loop with time-sensitive signoffs and item releases, and uploading legacy design documents en masse was a breeze, facilitating research into previous-generation projects to address regulatory concerns.”

Vessix Vascular
Laguna Hills, CA
www.vessixvascular.com
 

Omnify Software
Tewksbury, MA
www.omnifysoft.com