In the world of medical device manufacturing, precision and efficiency aren't just buzzwords — they're essential for success. Yet many manufacturers are stumbling when it comes to a critical aspect of their operations: resource planning. This oversight is costing them dearly, both in terms of efficiency and their bottom line.
So, what exactly is manufacturing resource planning, and why is it so crucial?
At its core, resource planning is about making the most of what you have — your equipment, your people, and your materials. It's the art and science of ensuring everything is in the right place at the right time to keep production humming along smoothly.
Let's break it down:
It has not been a problem to explain manufacturing resource planning in some countries where the art of production planning has been highly academicized, and where modern concepts like production resources were already learned by executives and managers back when they were first in the business.
However, it is not the case in some countries where the majority of manufacturers have produced practically or for generations without much theorical training. Many have been using outdated manufacturing resource planning systems, pen-and-paper, or simply by “gut feelings.”
Here is a brief explanation of what “production resources” are in modern manufacturing methodologies:
Machines are the one of the most important production assets in medical device manufacturing. To making planning easy, there are certain resource types that you can use to define your machines, such as:
Standard Resources: Performs in one kind of task within a single order, e.g., a packaging machine.
Multifunctional Resources: Capable of performing different kind tasks, e.g., a lathe-mill that can be used for both lathing and milling.
Multi-Assignable Resources: Capable of working on multiple orders at the same time, e.g., a multi-head injection molding machine that can make different parts simultaneously.
Parallel Resources: A secondary or side resource that follows the main resource, e.g., a test bench and a testing specialist.
Once you have defined who type of resources your machine would be, the manufacturing resource planning system will know which machine should be assigned at which time — when it is not occupied by other tasks.
Even a little tool or mold can break a production in medical device manufacturing.
Imagine you have an urgent injection molding order coming up, but that specific mold is being used in another machine. Even if you have the entire machine at your disposal, there is no way you can make it on time.
In this case, you can also define the mold as a parallel resource. In manufacturing resource planning, a parallel resource is a secondary resource linked with the primary resource. In this example, the schedule and availability of such a mold will affect when you should place your injection molding tasks, ensuring workers can start their work smoothly.
Many medical device and pharmaceutical manufacturers have already switched to various IoT devices to secure traceability, accuracy, and efficiency in their daily operations.
In manufacturing resource planning, industrial internet of things (IIoT) devices are able to automatically relay key machine statuses like start, stop, and interruption to the manufacturing execution system (MES). These shop floor data will then also be caught by the manufacturing resource planning system, where the production planner adaptively and proactively provide more buffer time for workers or reschedule the upcoming tasks, instantly optimizing upcoming production based on real-time feedback in the current progress.
Labor is the general staff in the medical device manufacturing environment. They could be workers, qualified operators, supervisors, and managers. They clock in and clock off based on regular shifts and have stable availabilities. With exchangeable tasks, multiple individuals with similar skills can also be grouped together and simplify the planning process.
Specialists are qualified personnel who have exclusive rights to perform a task. They could be engineers, quality control inspectors, maintenance staff, and safety officers. Their availability is limited, yet they must be available to prevent bottlenecks.
For example, to sign off a special quality inspection, you need a qualified manager to be on site. If no one in this qualified group of people are available for this, the inspection as well as the operations that come after will all have to be postponed. Therefore, this group of people is also a special resource that a planner has to pay extra attention to and make sure these specialists will be there to finish their jobs.
Different processes handle materials differently. Discrete manufacturers, such as medical device producers, can flexibly request additional materials if current supplies are insufficient to meet order deadlines. In contrast, process manufacturers, such as those in the chemical industry, have a more stable yet restrictive material requirement, ensuring the entire batch is completed on time with minimal production runs.
Different production models also treat materials differently. In the make-to-order (MTO) model, materials are typically claimed by the production order before it was released. Therefore, MTO manufacturing resource planning needs to keep the materials in mind and make sure there are enough materials to fulfill the orders.
In the make-to-stock (MTS) model, materials are the main driving force of the production plan. The more materials you have, the more you should produce. Therefore, material would be one of the dominant resources in the MTS model.
These include pre-fabricated parts, partially finished products (commonly known as work-in-process products), and completed products. Without proper manufacturing resource planning, these items can clog production lines or occupy storage spaces.
Manufacturers can prevent this by adjusting their scheduling strategies thusly:
In medical device manufacturing, the challenges with resource planning often not come from the tools or software used, but from inefficiencies in information flow. No system can run efficiently if the information flow is blocked. To enhance manufacturing resource planning and overall efficiency, manufacturers must first evaluate and optimize their current information flow.
Rather than simply adopting new tools and hoping for improvements, it's crucial to adjust and streamline the information flow. This might involve realigning your data sources into a single source of truth and ensuring better synchronization among stages of management.
Effective resource planning begins with understanding and perfecting the information flow. This effort will ultimately lead to reduced costs, shorter timelines, and smoother operations.
With advancements like cloud-based quality management systems (QMS) and MES, manufacturers in the industry have been investing heavily in medical device MES and QMS solutions. These technologies promise to streamline operations and improve compliance, but there’s a common pitfall many manufacturers face when looking into these solutions.
Often, manufacturers prioritize software that matches specific keywords like “planning,” “scheduling,” or “calendar view” without considering how these tools will practically improve resource utilization and productivity. While it’s important for the software to include these features, it's more important that they are effective and practical, with functionalities that truly enhance efficiency and workflow.
Integrating modern cloud-based production manufacturing resource planning systems with electronic quality management systems (eQMS) and electronic batch records (EBR) is essential. Integrations like these allow for automated quality checks, real-time management of nonconformances, and seamless regulatory compliance.
Real-time batch record creation and updates, streamlined approval processes, and enhanced transparency and accountability are achieved through these systems. This synergy supports continuous improvement, regulatory adherence, and operational efficiency, ensuring product quality and sustainable profitability for medical device manufacturers.
Digital transformation aims to streamline operations, enhance visibility, and empower employees with data-driven decision-making.
Transitioning to such systems often requires a change in mindset. Manufacturers must learn how to set goals, map paths, and make continuous adjustments to ensure production aligns with desired outcomes, rather than shooting in the dark and hoping your orders can be done on time.
Successful technology implementation hinges on active engagement from all organizational levels, especially frontline workers.
Prioritize training, communication, and feedback mechanisms to ensure everyone understands and accepts new tools and processes that impact manufacturing resource planning. Implement user-friendly shop floor control solutions to secure worker buy-in, facilitate a smooth transition, enhance productivity, and accelerate return on investment (ROI).
Unlike traditional on-premises solutions, which are static and unchanging, cloud-based solutions are always evolving by incorporating user-generated feedback. If you need functionalities or features that are not yet available in your cloud-based solution, you can communicate your needs to the development teams of progressive software providers.
Reputable providers maintain an ongoing list of user suggestions that they review and use to enhance their solutions. Sometimes, it could be done during a “hackathon,” where customers and users decide which features they want to see most. Many providers also offer community forums where users can ask questions, discuss issues, and collaborate with both the development team and other users to find solutions.
In summary, there are reasons why many medical devices manufacturers are struggling to increase their profitability. Effective manufacturing resource planning is pivotal for maintaining profitability, overcoming common pitfalls and achieving sustainable success.
Addressing these strategies holistically with a formal manufacturing resource planning system not only enhances resource utilization but also drives continuous improvement, regulatory compliance, and overall efficiency, securing a competitive edge in the medical device industry.
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