Question: What solution is enabling more modern medical device companies to reduce risk and ensure quality? The answer? An all-in-one product development platform in which quality and key ALM components are embedded with next-generation design solution integrations—all woven into the product lifecycle management (PLM) design environment.
How does a product development platform help a medical device manufacturer? Allow me to explain.
Before we delve into tired buzz phrases, such as “holistic solutions,” “complete quality pictures” and “enterprise-wide visibility,” let’s investigate why PLM is the critical first step—outside of well-defined risk analysis and evaluation phases—in a medical device company’s plan to reduce risk and ensure quality in their design processes.
To start with, PLM was created to allow all product companies—not just medical device OEMs—to better manage documents to streamline their extended supply chain efficiencies, improve cross-functional collaboration and increase enterprise-wide visibility into the design process. By this very function alone—coupled with configurable routing and electronic signatures—companies can reduce costly risks and significantly improve compliance processes. And, by having quality information always tied out to the product record, the user is assured that all cross-functional parties—upstream and downstream—are aware of all the changes, all the time.
PLM specifically helps medical device OEMs by empowering them with greater management control over their quality documents. This expansive list of quality-related documents includes billa of materials (BOMs), change orders, design history files (DHF), device master records (DMR), validation and verification certifications, risk management reports and product records. And let’s not forget the need for a well-documented paper trail for 21 CFR Part 11, 21 CFR Part 820, and corrective action and preventive action (CAPA).
A modern PLM solution offers greater document control for medical device companies by consolidating all design information in one centralized system and tying it to the product record, thus enabling OEMs to easily share BOMs with globally dispersed suppliers. Because quality-related documents can be complicated (a DMR is an enormous compilation of records containing the procedures and specifications for a finished medical device), a PLM solution, especially one embedded in an all-in-one product development platform is needed to avoid misplacing documents and keeping a tight rein on version control.
Now when quality processes (CAPAs, supplier corrective action requests (SCARs), corrective action requests (CARs, NCMRs, 8D, etc.)) are integrated into the PLM system, supply chain teams have access to the quality product records, enabling them to be proactive rather than reactive in managing quality. And because this information is tracked and visible throughout the organization, auditors can quickly and easily verify compliance.
All of this leads us up to part two of this elucidation, which is the benefits of having a single product development platform. Now, once again, we’re not talking “an integration” of quality and PLM—we’re talking about a PLM solution that has quality and ALM built right into it.
Tune in next week to learn about the value of next-generation add on tools to your PLM solution to reduce a broader array of risks.
And to learn more how an all-in-one product development platform like Arena is enabling medical device companies to meet increasingly stringent regulations while enabling the ability to innovate quickly, read our blog post “Advantages of Embedding Quality with PLM.”