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Addressing Compliance Mandates with Product Lifecycle Management

How lifecycle management software can enhance product development.

Regulations from the FDA impact every step of the medical device lifecycle from properly classifying a device and developing a regulatory strategy, to preparing FDA submissions. So, just how are successful medical device manufacturers cost effectively achieving compliance while, at the same time, meeting their product delivery targets?

altDue to the fast pace of new technology, emerging market opportunities, and competition from start-ups, medical device executives find themselves in an environment where they must continually innovate with flawless execution to survive. Technology, such as Product Lifecycle Management (PLM) may very well be the most valuable investment a medical device manufacturer can make.

Mandates outlined in the FDA regulations related to medical device development protocol cover everything from device design and manufacturing, to training and installation, to processing inquiries and/or complaints. Meeting the requirements of regulations such as Part 11 of Title 21 of the Code of Federal Regulations (21 CFR Part 11) and 21 CFR Part 820 Quality System can determine the success or failure of a medical device manufacturing company. Part 11 regulations state that manufacturers who track their documentation electronically must meet the electronic records and electronic signature guidelines. Part 820 requires manufacturers to have a quality system for the design, manufacture, packaging, labeling, storage, installation, and servicing of finalized medical devices.

As a central system, PLM manages the numerous Bills of Materials (BOMs), engineering changes, parts, and associated documents created during the design process. Medical device manufacturers can easily maintain, access, and report on required information such as a Device Master Record (DMR), Design History Record (DHR) or Design History File (DHF). Additionally, in following CFR Part 11 guidelines for managing information electronically, PLM can support the required password protected signoffs, authorized electronic signatures, and history tracking for complete electronic audit trails. Security features to control accessibility to information, such as defined user roles, address security guidelines. Lastly, next generation PLM systems typically offer quality management and training records management capabilities, which support requirements for meeting Part 820 Quality System guidelines.

Case in Point: The Pathway to PLM
One such company, Pathway Medical Technologies, Kirkland, WA, an innovator of endovascular treatments for peripheral artery disease (PAD) and maker of a device that clears out blockages in clogged leg arteries used PLM technology and received FDA 510(k) clearance in 2009 to market its JETSTREAM G3™ peripheral atherectomy catheter for use in the treatment of PAD in the lower limbs.

Ken Perino, Senior Director of Quality Assurance & Regulatory Compliance at Pathway Medical, was the one to spearhead the company’s initiative to enhance its product development process with PLM. He implemented Omnify’s Empower PLM solution in order to streamline the entire engineering change process, implement better control with document vaulting, improve BOM management, and make product information (drawings, blueprints, revisions, and supporting materials) easily, yet securely, accessible to appropriate team members.

His guidance to other medical device companies is that they should look for PLM solutions that are easy to use, fast to deploy, and very affordable without skimping on essential PLM functionality. Too often, the biggest problem with many PLM tools on the market is that they have become more complicated without becoming more functional. It is very difficult to solve a complex problem with a complex tool and a much better solution is choosing a PLM approach that is straightforward.

According to Perino, “because our PLM completely automates our process, when you submit your engineering change for review, the system sends it out to everyone who is a signer or observer in parallel and the engineering team can view engineering changes in real time.” This level of automation makes Pathway Medical’s process more efficient and provides a better documentation trail for auditors and compliance purposes.

Bottom Line

Medical device manufacturers are required to have formal processes in place to manage data for all facets of design and development such as: change control, supplier management, corrective and preventive actions (CAPAs), inspection, and test procedures. In addition, evidence must be presented that formal processes are being adhered to. Not only can a system like PLM that provides traceability and clear tracking of procedures and sign offs facilitate this; it is an essential key to success in an industry that has become overwhelmingly competitive and regulated.

This article was written by Chuck Cimalore, CTO and President, Omnify Software, Tewksbury, MA. For more information, visit http://info.hotims.com/45605-164.