Product lifecycle management essential for compliance mandates

Rapid industry growth, competition, the regulatory environment and an inherent need to streamline operations are driving more and more medical device manufacturers to adopt technology solutions like PLM (product lifecycle management).  

The bottom line for medical device companies trying to compete in today’s high-tech world is that adopting new software technologies is no longer a luxury or superfluous to a company’s success—but, rather, an essential key to success in an industry that has become overwhelmingly competitive and regulated.

Based on industry statistics, it is obvious that intensified regulatory scrutiny has become a harsh reality for medical device manufacturers.  Over the last several years medical device companies have been hit with injunctions, undergone product recalls, or found t  hemselves operating under Food and Drug Administration (FDA) consent decree.  FDA regulations seem to impact every step of the medical device lifecycle from properly classifying a device and developing a regulatory strategy, to preparing FDA submissions.  

The Millennium Research Group, the global authority on medical technology market intelligence, anticipates that device manufacturing executives will rely on technology solutions to overcome some of these regulatory burdens and save costs in hopes of recuperating lost profits from the Patient Protection and Affordable Care Act of 2010’s recent addition of excise tax on medical devices.  

Medical device executives find themselves in an environment where they must continually innovate with flawless execution to survive by turning to their IT gurus and engineering architects for technology solutions and discovering that next generation PLM systems may very well be the most valuable investment a medical device manufacturer can make for their medical device development process. Identifying a clear methodology and an efficient and cost-effective path through the medical device development lifecycle can increase a manufacturer’s speed to market while ensuring compliance.

The mandates outlined in the FDA regulations related to medical device development protocol such as Part 11 of Title 21 of the Code of Federal Regulations (21 CFR Part 11) and 21 CFR Part 820 Quality System cover everything from device design and manufacturing to training and installation, to processing inquiries and/or complaints.  

Meeting the requirements of CFR Part 11 and Part 820 regulations can determine the success or failure of a medical device manufacturing company. To be compliant with the Part 11 regulations, manufacturers who track their documentation electronically must meet the electronic records and electronic signature guidelines set forth by the FDA.  Part 820 requires manufacturers to have a quality system for the design, manufacture, packaging, labeling, storage, installation and servicing of finalized medical devices.

One example

Pathway Medical Technologies, a Kirkland, WA-based innovator of endovascular treatments for Peripheral Arterial Disease (PAD) and maker of a device that clears out blockages in clogged leg arteries uses 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 (below the knee).

Ken Perino, Sr. Director of Quality Assurance & Regulatory Compliance at Pathway Medical Technologies was the one to spearhead Pathway’s initiative to automate their product development process.  At Pathway Medical, document control, engineering change, BOM and regulatory conformance processes are managed via the Omnify Empower PLM system. All departments that have governing procedures are using the system including: design engineering, quality, regulatory, manufacturing engineering, purchasing operations, and even facilities management.  Any changes made to any procedures are performed and managed within the PLM system.

The company is required to meet International Organization for Standardization certification (ISO 9001:2008 international standard). ISO auditors check to see how Pathway (or any company they are auditing) manages its product documentation, change orders/change management, and engineering processes.

Medical device manufacturers like Pathway can easily find required information for auditors, generate custom reports as needed and prove out their processes. PLM systems make all this required information available at a person’s fingertips to be easily presented to auditors.   

--Eric Marks is industry practice leader for PricewaterhouseCoopers.