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Overview
Hospitals, healthcare centers as well as consumers rely on reliable and high-precision medical equipment to deliver the highest quality of medical care. The production of electronic and electromechanical medical devices and equipment is largely handled by contract manufacturers (CM). These CMs specialize in specific areas such as device assembly, or provide full service capabilities including logistics and post-sales service. The strong emphasis on quality in medical device manufacturing imposes stringent demands on the design and validation cess, as well as the packaging and logistics aspects. Furthermore, this industry is strictly FDA-regulated, and regulatory certification and compliance monitoring are critical needs to establishing strong customer and market credibility.
Business Challenges
In their effort to successfully acquire new customer contracts and deliver quality products, medical device manufacturers face the following challenges.
- Complying with ISO 9001/9002 and EN 46001/46002 guidelines, cGMP and other federally mandated standards
- Developing a well-defined and adaptive product design process to optimize product cycles and provide collaboration capabilities with strong collaboration with OEMs on design changes
- Creating and maintaining detailed documentation on Tier I, Tier II and Tier III levels of ISO/EN with appropriate controls for review, approvals and distribution
- Providing leading sterilization procedures (STERRAD, EtO) and validation procedures that test the integrity of these processes and are compliant with FDA/ANSI/AAMI standards
- Providing leading packaging procedures compliant with ISO 11607 requirements for terminally sterilized medical devices, and subsequent testing services including Peel strength testing and
Bubble emission testing
- Quickly detecting design and manufacturing process flaws and launch the necessary recurrence prevention actions
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Establishing and revising training procedures for in-house staff on production instructions, sterilization, equipment certification and packaging
Solution Features
In order to address the various operational challenges that are characteristic of the industry, medical device manufacturers need to adopt a solution that is capable of effectively automating a vast majority of the regulatory monitoring procedures and functions. A high degree of efficiency can be derived through the adoption of a software platform that can seamlessly tie together transaction systems, inventory systems and shop-floor production systems to provide key performance metrics that reflect the latest status of inventory levels, unresolved production problems and operating costs.
The regulatory compliance challenges require structured processes for pre-production quality planning and subsequent deviation/error detection during the manufacturing phase. These can be better implemented through a robust document management system, training and calibration modules, and a system of alerts and notifications to track process deviations and trigger self-correcting procedures.
The MetricStream Value Proposition
MetricStream’s EPM platform and suite of applications are ideally suited to address and meet the stringent quality demands of the medical device industry. The platform is 100% web based and is built to industry standards including J2EE and XML, while the applications suite is strategically designed to comprehensively tackle each quality aspect including CAPA, NCM, Audits, Document Management, Supplier Quality, Inspection and Equipment management. MetricStream’s feature-rich solutions are designed to precisely meet the needs of medical device manufacturers and will strongly position them to achieve.
- Operational Visibility: Create custom alerts, notifications, escalation features and industry leading “dashboard” metrics to track process deviations and exception situations
- Document Control: Increase document tracking efficiency by adopting a sophisticated and secure document management system to create, maintain and retrieve documents relating to the design process (engineering drawings), production process (instruction manuals), and regulatory process (quality compliance documents)
- Tight Integration: Lower the cost of worker training through the training module which integrates with HR modules and includes skill set tracking, training schedules and certification rules
- High Internal Quality: Significantly improve the quality of finished goods through the CAPA module, enabling early error detection, timely containment actions and rapid resolution steps to minimize output variations
- Improved Supplier Management: Better manage supplier quality and performance through the Inspection and NCM modules and active participation in the Quality*Stream supplier portal
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