Medical Device Manufacturers Address Compliance Mandates with PLM
Due to the fast pace of new technological developments, 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.
Judging by industry statistics, it's clear that intensified regulatory scrutiny has become a harsh reality for medical device manufacturers. Over the past several years many medical device companies have been hit with injunctions, undergone product recalls, or found themselves 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.
So, just how are successful medical device manufacturers cost-effectively achieving compliance while meeting their product delivery targets? They are turning to their IT gurus and engineering architects for technology solutions, and discovering that next-generation product lifecycle management (PLM) systems may be the most valuable investment a medical device manufacturer can make for their product development process.
Keeping the Pace: Technology Is Key
The Millennium Research Group, an authority on medical technology market intelligence, predicts that device manufacturing executives will rely on technology solutions to overcome some of these regulatory burdens. They will also turn to technology to save costs, in hopes of recuperating lost profits from the Patient Protection and Affordable Care Act of 2010's addition of excise tax on medical devices.
Identifying a clear methodology and an efficient, cost-effective path through the medical device development lifecycle can increase a manufacturer's speed to market while ensuring compliance. According to Saju John Mathew, an industry analyst with research and consulting firm Frost and Sullivan, "What is key is that the right steps are taken at the right times and are properly documented for FDA compliance and approval, avoiding the need to repeat phases — a misstep that can be extremely costly in both time and capital, and can throw a medical device manufacturer way off course."
PLM Aids Compliance Efforts
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 these 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. Clearly these regulations require exceptional information management techniques, and they can pose a daunting challenge to manufacturers, many of which have traditionally relied on manual or semi-automated solutions to manage product development. Attempting to manage and access this information in a paper-based fashion can prohibit medical device manufacturers from adequately complying with FDA regulations.
More and more medical device companies are adopting PLM technology in order to streamline business operations and properly design safe, effective, and compliant products. As a central database, 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 technology can support the required password-protected signoffs, authorized electronic signatures, and history tracking for complete electronic audit trails. Features that control accessibility to information, such as defined user roles, address security guidelines.
Next-generation PLM systems also typically offer quality management and training records management capabilities which support requirements for meeting Part 820 Quality System guidelines. The ability to manage the complete product record and address quality system requirements with PLM can save device manufacturers time and money by streamlining the entire product development process and eliminating the need to invest in separate systems.
Case in Point: The Pathway to PLM
One company that's adopted PLM for these purposes is Pathway Medical Technologies, which creates endovascular treatments for peripheral arterial disease (PAD) and makes a device that clears out blockages in clogged leg arteries. In 2009, Pathway Medical received FDA 510(k) clearance to market its JETSTREAM G3 peripheral atherectomy catheter for use in the treatment of PAD in the lower limbs (below the knee).
Ken Perino, Pathway Medical's senior director of quality assurance and regulatory compliance, spearheaded the company's initiative to automate its product development process. Having worked in previous medical device start-ups, Perino had become well versed in the benefits of a PLM system. He implemented the Empower PLM solution from Omnify Software 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 the appropriate team members.
Perino's advice for other medical device companies is to look for PLM solutions that are easy to use, fast to deploy, and affordable, without skimping on essential PLM functionality. Many PLM tools on the market have become more complicated without becoming more functional. It is very difficult to solve a complex problem with a complex tool; users are better served by a straightforward PLM approach.
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 procedures are performed and managed within PLM system.
"Gone are the days that a physical folder is being passed around and e-mails are flying around in regards to where the folder is in terms of going through the different teams for an engineering change," said Perino. "Because Omnify 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 not only makes Pathway Medical's process more efficient, it also provides a better documentation trail for auditors and compliance purposes.
Simplifying the Audit Process
Medical device manufacturers are legally required to have formal processes in place to manage data for all facets of design and development, including change control, supplier management, corrective and preventive actions (CAPAs), inspection, and test procedures. In addition, evidence must be presented that formal processes are being followed.
PLM technology delivers a controlled environment for managing and tracking product data through automated processes, which is critical to achieve compliance. The visibility into the complete product record and managing of all product information within one environment certainly helps to ease the audit process.
In the case of Pathway Medical, 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. Prior to automating with a PLM system, Pathway Medical would have to show and explain its manual process, walk an auditor through all of their documentation, and search for requested documents in folders and file cabinets — a cumbersome project.
Adopting a PLM system to centralize all product-related information and properly track data allows medical device manufacturers like Pathway to easily find required information for auditors, generate custom reports as needed, and prove out their processes. PLM systems put all this information at a user's fingertips, ready to be presented to auditors.
Medical device manufacturers need a better understanding of which strategies are being successfully used to ensure device quality in the face of regulatory uncertainty. Cambashi, a global industry analyst and market consulting firm, observes that while the global market and supply base for medical device manufacturers offer new opportunities for innovation and growth, they also bring new challenges for keeping costs and risks low — especially in such areas as R&D, sourcing, manufacturing, quality assurance, regulatory compliance, supply chain, and financial operations.
Compliance Dynamics, a services company that specializes in helping medical device companies with their business management system, operational, and regulatory compliance needs, knows this well and has been helping medical device companies navigate their way around these obstacles through the use of sophisticated systems and technology.
"It's no longer just about proving to the FDA that your company has effectively addressed the required [regulated] processes, but that you're a soundly run business as well," said Roger Martin, president of Compliance Dynamics. "This is where a solid PLM system implementation can shine. The FDA has made it clear that they want companies to fulfill the regulatory requirements while demonstrating they can be successful as a business. After all, having a medical device in the market and the manufacturer out of business is a loss for all parties involved."
The Bottom Line
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 such as PLM. For medical device companies trying to compete in today's high-tech world, adopting new software technologies is no longer a luxury, but is instead an essential key to success in an industry that has become overwhelmingly competitive and regulated.