The medical devices industry has always been a challenging environment for manufacturers. External audits, stringent requirements, and rigorous rules and regulations necessitate a meticulously developed and comprehensive business strategy. With Industry 4.0 driving rapid changes across the whole medical sector, medical devices companies continuously face evolving regulations, increased market competition, and the need for improved patient outcomes.
In this transitional landscape, MedTech companies must embrace digital transformation to stay competitive and ensure the highest standards of quality and compliance. Yet, digital transformation is more than just a buzzword—it's a critical necessity that begins with achieving digital traceability and truly paperless manufacturing.
Imagine a scenario where a defect in a medical device is discovered, or the FDA requests detailed information about a specific product batch. How quickly do you think your company could respond and address the issue to avoid further complications? How accurately can you trace the defect's origin and assess its impact? In these high-stakes situations, it’s not about having just some system of record. Implementing a robust digital traceability system is non-negotiable for MedTech companies that want to maintain their market competitiveness.
Digital traceability enables you to:
Respond swiftly and accurately to defects: Immediate identification and containment of defects minimize the risk of harm to patients and protect your reputation.
Ensure compliance with regulations: Regulatory bodies like the FDA demand precise and rapid reporting. Digital traceability enables you to meet these requirements with confidence.
Make informed manufacturing adjustments: When defects are detected, you can quickly implement corrective actions, preventing future issues and improving overall product quality.
Achieving digital traceability in the medical devices industry is the foundation for any successful journey toward manufacturing excellence. Without it, you will most likely find it extremely difficult to effectively transition to more advanced digital processes or reap the full benefits of Industry 4.0 technologies.
A Manufacturing Execution System (MES) is the backbone of digital traceability and a crucial component of any digital transformation strategy. For MedTech companies, an MES like DELMIA Apriso offers a comprehensive solution that addresses the unique challenges of the industry. By implementing an MES suited to your specific production needs and manufacturing model, you can:
Enhance traceability: Track every step of the manufacturing process in real time, from raw materials to finished products, ensuring complete visibility and control.
Streamline operations: Digital solutions eliminate manual processes, reduce errors, and improve efficiency, all while ensuring compliance with industry regulations.
Enable paperless manufacturing: Transitioning to a paperless shop floor not only improves data integrity but also enhances transparency in reporting and auditing processes.
The benefits of MES implementation are not just theoretical. Real-life examples from companies like Straumann highlight the tangible impact of digital transformation. Since implementing MES in June 2016, Straumann has achieved remarkable results:
User adoption: Over 400 solution users in the Villeret (CH) facility, the largest manufacturing site for Straumann.
Role-specific functionality: 14 distinct user roles within the MES, including Scheduler, Raw Material Clerk, Operator, and Quality Controller, ensure that every aspect of production is managed efficiently.
Order management: The system handles approximately 18,000 orders annually, streamlining production processes.
By going paperless, Straumann has saved over 1,260,000 pages of paper annually, equivalent to saving 15 spruce trees. In addition to these quantitative benefits, Straumann’s MES implementation has led to:
Improved operational efficiency: Shop-floor operators report higher satisfaction and efficiency thanks to the streamlined processes.
Enhanced workflow management: Complex manufacturing processes are easier to manage and monitor with the MES's workflow-based approach.
Seamless SAP integration: The integration of DELMIA Apriso MES with SAP modules (Materials, Production Planning, Quality Management) has further enhanced operational coherence and data flow.
Another compelling example of how MES can revolutionize MedTech operations is the experience of CoorsTek, a US-based technical ceramics manufacturer. Renowned for developing advanced ceramic materials, which often outperform metals in mechanically demanding applications, CoorsTek faced significant operational complexities due to its rapid expansion and the high demands of its customers.
With over 6,000 employees across 27 manufacturing facilities and over 10,000 pieces of equipment, CoorsTek needed a solution that could streamline its operations and maintain high-quality standards. The company selected the Apriso suite on our partner’s Dassault Systèmes’ 3DEXPERIENCE platform to enhance its manufacturing efficiency, productivity, and quality. Further, CoorsTek partnered with Andea to replace the Tracker solution with DELMIA Apriso and improve its maintenance operations.
CoorsTek started working with Andea after they were highly recommended due to their extensive experience in both the Apriso platform and manufacturing software in general. It was clear very early on that this recommendation was warranted as Andea exceeded our expectations both in what they produced and how they did it. We, as a combined team, successfully completed our implementation under budget with over 300% of the planned scope. I’m very excited about our future partnership and I look forward to implementing our complete manufacturing solution globally.
By implementing DELMIA Apriso, CoorsTek has experienced a transformative change in its operations. The technical ceramics manufacturer’s significant operational complexities have turned into outstanding operational improvements that allow for:
DELMIA Apriso provides real-time data that enables CoorsTek to proactively address maintenance needs and avoid unplanned downtime. This visibility has been crucial in maintaining equipment uptime, which is critical for meeting the fast-paced production demands of the company’s customers.
The integration of inline inspection processes ensures that quality issues are identified before products are shipped. This has minimized quality escapes and reduced scrap, which is particularly important given the fragility of the ceramic-making process.
The user-friendly interface of DELMIA Apriso simplifies the daily tasks of shop-floor workers, making it easier for them to plan their day, find required tasks, and submit reports. This ease of use is especially beneficial for training new staff, ensuring consistency and repeatability across the organization.
CoorsTek has improved stakeholder engagement and decision-making through better document management. The US-based manufacturer can now ensure that the latest quality procedures and work instructions are always available, helping the company meet regulatory requirements.
CoorsTek’s implementation of the 3DEXPERIENCE platform, with DELMIA Apriso at its core, has laid a strong foundation for future growth. The company is now better equipped to handle the complexities of its operations, improve its responsiveness to customer demands, and continue its legacy of producing high-performance technical ceramics.
For MedTech companies, the path to digital transformation is paved with challenges, but the rewards are immense. Achieving digital traceability through MES implementation is not just a step forward—it's a leap toward a future where quality, compliance, and efficiency are optimized.
However, like every journey, digital transformation too has its difficulties. According to a BCG survey, only 30% of MedTech companies are currently in the "win zone" for digital transformation success, which is slightly below the cross-industry average of 32%. This reflects ongoing challenges within the sector, particularly in areas such as agile governance and the deployment of high-caliber talent. That’s why a trusted MES reseller and integrator is so important for medical devices companies thinking about or starting their digital journey.
MedTech companies in the “win zone"
The cross-industry average
Looking ahead, MedTech companies are shifting their focus from simply digitizing support functions to more innovative digital products and services. Key initiatives include digitizing the supply chain for improved demand forecasting and real-time tracking, developing a digitally enabled salesforce, and incorporating predictive and preventive maintenance for machinery within smart factories.
Supply chain management also happens to be one of the main areas where DELMIA Apriso’s features foster transparency and enhance coordination, enabling personnel to remain updated and actively engage in information exchange, tailored to the relevant level of authorization.
Environmental, Social, and Governance (ESG) considerations are also becoming central to MedTech's digital transformation strategies. BSG’s findings show that approximately 85% of MedTech companies plan to increase their investments in ESG initiatives, surpassing the cross-industry average. Social priorities, such as enhancing employee health and safety through wearable technology and improving governance through digital monitoring, are particularly prominent.
MedTech companies planing to increase investments in ESG initiatives
To overcome these challenges, MedTech companies are prioritizing investments in technological and human enablers. BSG’s study also shows that over 80% of companies plan to invest in infrastructure and cloud enablement, AI, big data, and modernizing their tech architecture. Furthermore, there is a strong emphasis on modernizing the technology organization and operating models, as well as continuous learning and new talent leadership models.
MedTech companies prioritizing investments in technological and human enablers
At Andea, we understand the unique needs of the medical devices industry and are committed to helping you achieve your digital transformation goals. We’ve been there to see how DELMIA Apriso has been a proven game-changer for your industry’s top performers like Straumann, Intuitive Surgical, and CoorsTek. They've all successfully:
Upgraded their legacy MES systems
Standardized processes for efficiency
Improved operational flexibility
Increased system security
Unified user interface design
Streamlined work across the enterprise
Our experts believe that we’ll see continued investment in advanced manufacturing technologies in the medical device and pharmaceutical industries. The future of MedTech lies in embracing MES solutions to drive innovation and manufacturing excellence.
Let us guide you on the journey to a paperless, digitally traceable, and fully optimized manufacturing process.