The fast pace of new technology, emerging market opportunities, and competition leave medical device executives, particularly those in the small to medium size (SMB) space, in an environment where they must continually innovate with flawless execution to survive. Addressing the challenges of continual new product introductions, shorter product lifecycles, and growing compliance mandates that focus on quality, make superior data management critical to this industry.
An inherent need to streamline business operations is driving more and more medical device companies to adopt Product Lifecycle Management (PLM) technology in order to properly design safe, effective, and compliant products. SMB medical device executives are discovering that next-generation PLM technology may very well be the most valuable investment they make due to its ability to support best-in-class engineering and quality processes.
PLM for Enterprise Quality Management
This article is based on data from a recent LNS Research report titled, “An Enterprise Approach to Quality for SMB Discrete Manufacturers,” with a particular focus on data from the medical device industry.
To support the research, LNS performed a Quality Management Survey and asked SMB executives a number of questions regarding strategic objectives as well as top challenges as each pertains to the quality management space. Based on the survey responses, executives in charge of quality for medical device companies ranked the ability to better manage operational risk and ensuring compliance as the top two quality management objectives. When asked about the challenges they face in trying to reach their objectives, the majority of executives cited "effectively measuring quality metrics" and "disparate quality systems and data sources."
It is evident from this survey that quality managers for SMB medical manufacturers need tools to automate quality processes and properly track and manage information in a centralized system in order to meet their objectives. PLM technology can provide a viable solution with the ability to automate paper-based processes, supply a single system to manage both product and quality information, simplify the aggregation of data for reporting and analysis, and support medical compliance requirements.
PLM was designed to manage product data throughout the product lifecycle. A PLM system is crucial during the design phase, where engineers need instant access to product data including specifications, engineering parameters, and documentation. PLM tracks and manages component data, Bill of Materials (BOMs), product documentation, engineering changes and revisions as well as compliance data, and centralizes all of this information for easy access by all team members. Extending PLM to encompass quality management allows manufacturers to link quality information to the product record all within a single environment. This provides a mechanism to automate quality processes, aggregate and report data across multiple product lines and business units, and enhance visibility into quality information across the organization.
According to LNS, many organizations are already using PLM to deliver quality management functionalities in the engineering and design stages. Examples may include the use of PLM to conduct risk management such as Failure Mode and Effects Analysis (FMEA), using simulation tools to help companies quickly and cost-effectively implement changes, employing Design for Reliability (DfR) to tie upfront quality (pre-build) to the back-end (post-build) and enhance the overall quality process and change management capabilities that allow organizations to effectively manage engineering and product data changes over time.
Leveraging PLM for quality management can help medical device manufacturers produce higher quality products, gain a significant competitive advantage, and meet their overall quality objectives with the ability to:
1. Reduce Independent Systems and Separate Silos of Data
PLM provides a central location to track and manage all product related information and reduces the number of manual/home-grown systems that are commonly used by SMB medical device manufacturers such as Excel spreadsheets, network files and folders, and paper process.
By using PLM as a platform for quality management, SMB medical manufacturers are able to develop a unified information management system for engineering and quality. This offers a single point of entry for all product and quality information and eliminates the duplication of data in various systems. Streamlining independent data sources delivers more accurate product information, improves knowledge sharing, supports better design processes, and provides improved visibility into quality information.
2. Provide a Holistic View to Measure Quality Metrics
PLM enables cross-functional collaboration on all product quality issues. This is instrumental in effectively measuring quality metrics at the enterprise level.
PLM systems provide the ability to raise quality issues (such as Corrective and Preventive Actions, Non-Conforming Materials Reports, Customer Complaints, etc.), assign and track key contributing factors (Defect Codes, Root Cause, Failure Modes, etc.), and define closed-loop and workflow processes for resolution and signoff. PLM enables companies to aggregate this data across the entire enterprise in order to effectively report and identify areas of concern and efficiency and track overall organizational improvements.
3. Facilitate Adherence to Growing Compliance Requirements and Industry Standards
Being in a highly regulated industry creates additional pressure for SMB medical device companies. These companies are faced with the challenge of how to handle their product design and development to meet existing and impending guidelines from regulatory bodies such as the Food and Drug Administration and International Organization for Standardization.
PLM ensures that medical device manufacturers have the proper processes in place to be in compliance, particularly with quality system requirements, and simplifies the audit process. PLM systems facilitate compliance management by storing all compliance data, automatically tracking all product changes, managing all quality items such as CAPAs, and providing the necessary audit reports including Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR). Automated and documented processes make proving compliance much easier, support a smoother audit process by having all information readily available, and lower the cost of compliance.
4. Help Improve Product Design to Gain a Competitive Advantage
Implementing a quality system at the product concept stage in PLM supplies all personnel involved in quality with early visibility into how products will be designed and built, which can help avoid potential product issues before the manufacturing and product launch stages. Having a system that connects quality issues and field feedback with the same product records used by engineering and design teams allows these teams to have direct access to the “voice of the customer.” This information helps engineers to make better design choices and ultimately design better, safer, and more effective products. PLM can help position SMB medical manufacturers to gain a competitive edge over larger competitors by helping to bring new, high-quality products with enhanced customer-driven features to market faster.
5. Lower the Cost of Quality
As reported by LNS, catching and resolving quality issues before they become a larger problem is vital to maintaining a low cost of quality. Identifying quality issues in the design phase can drastically improve the customer experience, new-product introduction cycles, the cost of quality, and long-term profitability.
In conclusion, PLM provides a holistic approach to managing data. This helps to better identify key problem areas/bottlenecks with the ability to aggregate quality data across multiple product lines and throughout the supply chain. With PLM, SMB medical device manufacturers are able to adopt continuous improvement practices that result in efficiencies such as higher-quality products from suppliers, fewer product returns, and shorter time-to-market, all of which contribute to a lower cost of quality.
Chuck Cimalore, the CTO and Co-founder of Omnify Software, is an expert in Web-based PLM solutions for small to mid-size businesses. Prior to founding Omnify Software, Cimalore held positions as application engineer, software engineer, engineering manager, and vice president of engineering since 1994.