The Crucial Role of Production Planning in Medical Device Manufacturing

When it comes to medical device manufacturing, manufacturers need to meet strict standards and regulations to stay competitive. In such a highly regulated environment, the effectiveness of a medical device product plan is often ignored – not because of the lack of willingness, but rather, the nature of the sector’s specific demands.

Fortunately, with electronic quality management systems (eQMS) and modern production planning and control (PPC) solutions, manufacturers finally have the power to not only make sure their medical device product plans are transparent and efficient, but still traceable and compliant. The importance of production and operations management in a medical device product plan is nonnegligible, yet often ignored.

What Is the Modern Strategy of Medical Device Production Management?

Medical device production management is always subject to numerous restrictions and procedures imposed by governmental bodies. Sudden changes, such as regulatory changes, design changes, product recalls, or an audit from the authorities on short notice, can put the entire production on hold.

Whether a production plan is ready for these challenges strongly depends on the flexibility of its planning strategies. The old production and operations management strategy was a rule-based system relying on a set of rigid rules, like order priorities and work step sequences, which production managers had to create from scratch so the system could correctly validate their plans.

Undoubtedly, a medical device product plan created from this obsolete approach is hardly reliable nowadays because of the dynamic nature of the sector.

The modern strategy of medical devices production management is an algorithm-based planning system that observes the production principles, such as:

• Schedule Adherence: Making sure the production will not exceed its delivery date.
• Capacity Utilization: Making sure there is enough capacity for the production.
• Resource Availability: Making sure the needed resources are available during production.

Unlike the old approach, the algorithm constantly maintains these principles within the medical device product plan. All deviations will be immediately flagged as “Conflicts” and shown in a list format, making them instantly noticeable so interventions can be conducted.

Simply put, if any sudden changes appear, the algorithm can instantly show how it impacts the current plan, allowing planners to swiftly review their production and operations management, with no revalidation, re-scanning, or data reentries needed.

Utilizing Traceability and Accountability in eQMS

In medical devices production management, traceability and accountability are regulatory necessities. Capturing the detailed digital trail of development and operation is the core mission of eQMS software.

Yet, beyond its legal role, the modern eQMS system is also a de facto source of production data within a medical device product plan. It offers real-time updates of the operations, documents, and standard operating procedures (SOPs), and records the start and end of an approved operation.

That means, through seamless integration between a modern PPC system and a manufacturing-enabled eQMS, the PPC system can generate a medical device product plan by utilizing the data provided by the eQMS solution.

For instance, in terms of production and operations management, an eQMS primarily automates, oversees, and executes processes at the operation level (e.g., labeling) and phase level (e.g., applying a shrink band), and at last, confirms and ends the operation at the unit procedure level (e.g., packing). Here, the PPC system can pick up the approved completion at the unit procedure level and update the current plan and production progress.

Special cases, such as operations that require additional approval or corrective actions/preventive actions (CAPAs), can also be efficiently managed via the eQMS before being transmitted to the PPC system to update the medical device product plan.

Regain Efficiency and Transparency in Production

With a future-oriented PPC system, even manufacturers from a highly regulated sector like medical device manufacturing can regain efficiency and transparency in their production and operations management processes.

For example, if you aim to shorten production time in your medical device product plan, you can utilize the “Process Efficiency” KPI to see the time you wasted in non-value-adding processes – all before the production takes place in reality.

As a result, modern production planning is not merely a means to meet deadlines, but also an essential tool to give a transparent overview of how a manufacturer improves the plan to meet its goal and continuously optimizes its production and operations management.

Just-in-Time Inventory Management

Many medical devices are legally required to have an expiration date based on their shelf life, which requires a just-in-time inventory strategy to shorten excessive storage time. Core features of modern PPC systems, such as backward scheduling and order splitting, can not only minimize the time for storage but also save precious space in warehouses, boosting the effectiveness of production and operations management to the next level.

In addition, with integrations, the PPC system can also help write in and write out inventory data, such as finished products, material, and work-in-process (WIP) products to enterprise resource planning (ERP) and warehouse management systems, extending an automated and lean process from the medical device product plan to the hands of its users.

Conclusion

Modern medical device production management is challenging due to the strict regulatory environment, traceability and accountability issues, limited shelf-life, and documentation requirements.

However, thanks to the integration between PPC and eQMS systems such as MasterControl and planeus, even a highly regulated medical device product plan can now be optimized with regards to maintaining legal compliance. Not only it has fully enhanced the medical device production management workflow, but it also comes with an intuitive and modular operation for all production roles.