Steve Bieszczat, Brand Marketing Leader & CMO, DELMIAWorks02.03.23
Sometimes it seems like medical device manufacturers are marked by more differences than similarities.
Medical device companies and contract manufacturers operate in multiple economic models, ranging from high-volume, highly cost-conscious production environments to scenarios where product performance and risk trump all other factors.
Further, their production processes are as varied as the products they produce. Plastic processing, metal fabrication, wiring, electronics, assembly, sterilization, and packaging are all unique processes core to the industry. Moreover, some companies specialize in one process, others in multiple processes, and still others in all.
Medical device manufacturers also operate in a number of different production lifecycle models. For example, commodity products have stable product lifecycles while more sophisticated devices, such as diagnostics equipment, have lifecycles that are constantly evolving. Additionally, there are prototype production operations intended to establish the viability of a new device.
Despite these differences, there are four key requirements common across the industry:
In contrast with a more complex device such as a portable defibrillator, quality and proof of performance are the overarching priorities. Not that price doesn’t matter, but price is secondary. Every step in the materials acquisition process is scrutinized; every step in production is crucial; and every product is tested, re-tested, and documented. Risk is high; absolute efficiency is secondary to product performance.
Regardless of medical device classification or the determination of risk versus efficiency, each project requires a case-by-case, product-by-product business decision that must be constantly monitored and evaluated. Manufacturing software provides the tools, controls, and visibility to do just this.
All of this is true. Manufacturing software certainly addresses the disciplines of ERP, MRP, CRM, and QMS, plus supply chain management (SCM) and warehouse management (WMS). What really separates manufacturing software from general enterprise software solutions, however, is the focus on manufacturing labor, processes, quality, and documentation—particularly those operations performed by lower skilled or less tenured employees that work directly on the shop floor. The performance of these workers has a profound impact on the ultimate quality and cost of the finished product. Manufacturing ERP software that can inform, guide, and manage on the shop floor is required to manage quality, risk, and production costs in the medical device industry.
Financial control and effective resource utilization are important to all businesses, but in medical device manufacturing, failure to execute on cleanliness, traceability, quality, documentation, and risk management can upend even the best financial control and resource utilization strategies.
The key requirements in medical device manufacturing can be summarized as the need for flexibility to adapt to diverse requirements while at the same time maintaining absolute end-to-end control and visibility of the manufacturing operations. This is where shop floor-oriented medical device manufacturing ERP software comes into focus.
The following sections discuss six core workflows central to medical device manufacturers, and in particular directly impact the ability to oversee the production activities of direct labor on the shop floor. By automating these workflows with a manufacturing ERP system that provides broad visibility across the entire manufacturing operation, companies can more effectively mitigate risk while increasing profitability.
Serialization applies tracking numbers at the lot and item level to all essential raw and processed materials used in final goods production. This might include the batches of plastic resin, the galvanized sheet, the circuit boards, and tooling used to build a medical device. Serialization provides a data link back to multiple information points in the medical device supply chain, which in turn, provides the foundation for the ability to track medical devices throughout the product lifecycle.
The first link back is to the validation of the incoming materials shipment. When the raw materials were received: Were they inspected? How were they inspected? Who inspected them, and what were the results of the inspection? All of these steps are part of maintaining a complete audit trail of the manufacturing lifecycle.
These questions are a good time to introduce an essential and broad reaching role of ERP in the medical device manufacturing environment: process guidance, enforcement, and visibility.
In the case of materials receipt from a vendor, the steps and personnel required to validate the materials are prescribed in the manufacturing ERP system. The proof that the validation steps were performed, by whom, and the results of the inspection are, in effect, demanded by the ERP system before the downstream production with those materials is allowed to proceed. Many times, those validation steps will require multiple approvers and signatures. Dual signature authorization is required for 21 CFR Part 11 compliance. The ability to administer this type of compliance is a fundamental requirement for medical device manufacturing ERP software.
Unless properly managed, the validation phase of incoming materials (as well as its analog, final goods validation) can introduce uncertainty in raw materials and final good inventory management. Without proper inventory visibility, materials held in incoming inspection (sometimes called quarantine) can appear to be not-on-hand while they are indeed on-hand; they are also marked as unavailable (pending validation). This can cause ill-equipped inventory management systems to attempt to re-order the same raw materials.
Proper medical device inventory management systems will be aware of materials held in quarantine and alert the purchasing team to not reorder materials without first determining the status of those in quarantine. The same is true at the back end of the process when a sales order is being processed and the finished goods are in final goods inspection quarantine. The quantity available can be incorrectly interpreted as insufficient, even though sufficient inventory is very likely to be available once the final inspections are completed. Knowledge and alerting of material status in both incoming and final inspection holds is vital to accurate inventory, purchasing, and sale operations. For this reason, medical device inventory software must be aware of at least four inventory status situations in order to be fully functional:
Generally speaking, one of an ERP system’s key roles in the manufacturing of medical devices is to alert management and supervisors when problematic situations are about to arise. Alerts allow for automated management by exception. They effectively serve as management’s eyes and ears in the business so hundreds of business conditions can be monitored automatically instead of having to use rote human supervision to detect and respond to every business need.
The ERP system’s role in performing inline quality inspection is invaluable. Similar to alerts, inspection points are set as triggers in the production process. When an inspection point is reached, the ERP system triggers the inspection and the recording of the results. When the results are within specification, they are automatically recorded as part of the chain of production documentation. But when they are out of specification, supervisors and auditors are alerted, and production is typically halted until the problem is corrected.
This discussion of inline quality inspections starts to reveal the true power of manufacturing ERP software. When an ERP system is aware of all aspects of the business, it has the ability to monitor events across multiple disciplines, record those events as part of the product’s production documentation, and alert management to issues. It performs an oversight role that goes beyond what is practical with only manual supervision, and it delivers an automated audit trail and management-by-exception alert system.
Good Manufacturing Practices (GMPs) and International Standards Organization (ISO) certifications are invaluable practices and controls. Without expensive and sometimes manual supervision and documentation, however, they can become little more than passing words on paper without actual implementation on the shop floor. Manufacturing ERP software puts the teeth in GMP and ISO certifications through the automated control and visibility it brings to medical device manufacturing operations.
Now, the discussion of manufacturing ERP control and oversight can be elevated to next level, particularly on the shop floor: production and process monitoring.
Automated production monitoring functionality is commonly part of an MES, and its capabilities are central to automated shop floor control and visibility. The rate of production is the fundamental heartbeat of the manufacturing process. Knowing how many parts are made in a given time period ultimately informs all the upstream activities of provisioning materials, machinery, and labor, as well as all of the downstream activities of final quality assurance, inventory management, order fulfillment, and shipping.
The direct partner of production monitoring on the shop floor is process monitoring, another central component of MES functionality. Process monitoring focuses on measuring conditions at the time of, or just after, a production step. If a part is being stamped, it might track what the pressure distribution was across the die. For injection molded parts, it could track the temperature at the tip of the barrel. If a part is being assembled, it may, for instance, monitor the torque necessary to rotate the spindle.
In process monitoring, machine and workstation sensors record the actual conditions at the time of production and constantly compare them to the production process specifications. As in the practices of inline quality inspections and production monitoring, when the process parameters deviate or trend outside of process specifications, one or more alerts are issued, and production is halted until corrections are made.
Production and process monitoring are two more examples of using manufacturing software to serve as automated supervisors on the shop floor. Like previous examples of manufacturing ERP at work in the factory, all the results of production and process monitoring are automatically recorded and linked to the lot and serial numbers of the product, further documenting the production lifecycle of the medical device or part.
The information captured as part of production and process monitoring is stored as a time series of data related to specific lots and periods of production. Known as histograms, they not only offer a useful visual record of production parameters, they also provide the data for statistical analysis of production quality, and if necessary, for the root cause analysis of production issues. With production and process monitoring, quality issues can be identified early, and events can be wound back in time to understand what changed and when during the production process in order to determine the underlying factors that led to the problem.
This is where the concept of the human-machine interface (HMI) comes into play. An HMI is the user interface between the job, the equipment, and the supporting manufacturing infrastructure. An HMI typically validates that trained operators are present and it provides work instructions, inspection parameters, and capture inputs of inline quality inspections and other job-related parameters. Often called shop floor interfaces or connected worker devices, HMIs are the primary point of contact between the manufacturing software system and the direct labor on the shop floor. Not only do they direct the progress on the job, they provide the control that ensures the correct procedures are being followed and they document those procedures were followed as part of the production lifecycle record of the product.
Orders come in, products are built to the exacting details demanded by their medical application, and ultimately, they end up as finished goods in a warehouse space. At the end of the process, a pick ticket is issued to pull that stock and ship it to the customer. At least three things are essential at this point. First, the fact proper product is being selected must be double validated. Second, the shelf life of the product must be validated, particularly for biomedical devices that can degrade or become contaminated over time. Third, all of production lifecycle documentation that has been so carefully created during the production process must be packaged and delivered with the product.
With manual systems or even generalized ERP or warehouse management systems, the required cross checks and document consolidation are time consuming and error-prone. Manufacturing systems designed to run medical device operations achieve these goals automatically because they have the end-to-end visibility and records to cross validate, evaluate expiration dates, and package information in digital formats that are readily available for customer review and record keeping (e.g., making track and trace real and efficient).
Steve Bieszczat is the brand marketing leader and CMO at DELMIAWorks (IQMS), a division of Dassault Systemes. He has worked in the enterprise software industry for over 25 years, with the last 10 years spent specifically in mid-market manufacturing software. Bieszczat has prior leadership experience at enterprise software companies Epicor, Activant, and Triad. He earned an engineering degree from the University of Kansas and an MBA from Rockhurst University. Prior to his work in the software industry, Bieszczat was a manufacturing engineer in the electronic test equipment industry.
Medical device companies and contract manufacturers operate in multiple economic models, ranging from high-volume, highly cost-conscious production environments to scenarios where product performance and risk trump all other factors.
Further, their production processes are as varied as the products they produce. Plastic processing, metal fabrication, wiring, electronics, assembly, sterilization, and packaging are all unique processes core to the industry. Moreover, some companies specialize in one process, others in multiple processes, and still others in all.
Medical device manufacturers also operate in a number of different production lifecycle models. For example, commodity products have stable product lifecycles while more sophisticated devices, such as diagnostics equipment, have lifecycles that are constantly evolving. Additionally, there are prototype production operations intended to establish the viability of a new device.
Despite these differences, there are four key requirements common across the industry:
- Proven product performance and quality
- Broad and comprehensive traceability
- Rigorous documentation
- Ability to balance product risk with production cost
In contrast with a more complex device such as a portable defibrillator, quality and proof of performance are the overarching priorities. Not that price doesn’t matter, but price is secondary. Every step in the materials acquisition process is scrutinized; every step in production is crucial; and every product is tested, re-tested, and documented. Risk is high; absolute efficiency is secondary to product performance.
Regardless of medical device classification or the determination of risk versus efficiency, each project requires a case-by-case, product-by-product business decision that must be constantly monitored and evaluated. Manufacturing software provides the tools, controls, and visibility to do just this.
A Spectrum of Medical Device Manufacturing Software
Medical device manufacturing software covers a wide spectrum of business processes. Some manufacturers think of it as core ERP functions, such as finance and accounting, material resource planning (MRP), and customer relationship management (CRM). Other companies think of it as manufacturing execution software (MES) that manages production on the shop floor. Still others think first of quality management software (QMS) that provides the framework, processes, and record keeping necessary to ensure product performance and risk are managed.All of this is true. Manufacturing software certainly addresses the disciplines of ERP, MRP, CRM, and QMS, plus supply chain management (SCM) and warehouse management (WMS). What really separates manufacturing software from general enterprise software solutions, however, is the focus on manufacturing labor, processes, quality, and documentation—particularly those operations performed by lower skilled or less tenured employees that work directly on the shop floor. The performance of these workers has a profound impact on the ultimate quality and cost of the finished product. Manufacturing ERP software that can inform, guide, and manage on the shop floor is required to manage quality, risk, and production costs in the medical device industry.
Financial control and effective resource utilization are important to all businesses, but in medical device manufacturing, failure to execute on cleanliness, traceability, quality, documentation, and risk management can upend even the best financial control and resource utilization strategies.
The key requirements in medical device manufacturing can be summarized as the need for flexibility to adapt to diverse requirements while at the same time maintaining absolute end-to-end control and visibility of the manufacturing operations. This is where shop floor-oriented medical device manufacturing ERP software comes into focus.
The following sections discuss six core workflows central to medical device manufacturers, and in particular directly impact the ability to oversee the production activities of direct labor on the shop floor. By automating these workflows with a manufacturing ERP system that provides broad visibility across the entire manufacturing operation, companies can more effectively mitigate risk while increasing profitability.
1. Handling Goods and Materials Received From Suppliers
Most medical device manufacturers are dependent on suppliers and the goods and materials they provide. The performance of these materials is a critical factor in the final product’s quality and performance. Therefore, the validation, tracking, and serialization of those materials must start the moment they are received into the business.Serialization applies tracking numbers at the lot and item level to all essential raw and processed materials used in final goods production. This might include the batches of plastic resin, the galvanized sheet, the circuit boards, and tooling used to build a medical device. Serialization provides a data link back to multiple information points in the medical device supply chain, which in turn, provides the foundation for the ability to track medical devices throughout the product lifecycle.
The first link back is to the validation of the incoming materials shipment. When the raw materials were received: Were they inspected? How were they inspected? Who inspected them, and what were the results of the inspection? All of these steps are part of maintaining a complete audit trail of the manufacturing lifecycle.
These questions are a good time to introduce an essential and broad reaching role of ERP in the medical device manufacturing environment: process guidance, enforcement, and visibility.
In the case of materials receipt from a vendor, the steps and personnel required to validate the materials are prescribed in the manufacturing ERP system. The proof that the validation steps were performed, by whom, and the results of the inspection are, in effect, demanded by the ERP system before the downstream production with those materials is allowed to proceed. Many times, those validation steps will require multiple approvers and signatures. Dual signature authorization is required for 21 CFR Part 11 compliance. The ability to administer this type of compliance is a fundamental requirement for medical device manufacturing ERP software.
Unless properly managed, the validation phase of incoming materials (as well as its analog, final goods validation) can introduce uncertainty in raw materials and final good inventory management. Without proper inventory visibility, materials held in incoming inspection (sometimes called quarantine) can appear to be not-on-hand while they are indeed on-hand; they are also marked as unavailable (pending validation). This can cause ill-equipped inventory management systems to attempt to re-order the same raw materials.
Proper medical device inventory management systems will be aware of materials held in quarantine and alert the purchasing team to not reorder materials without first determining the status of those in quarantine. The same is true at the back end of the process when a sales order is being processed and the finished goods are in final goods inspection quarantine. The quantity available can be incorrectly interpreted as insufficient, even though sufficient inventory is very likely to be available once the final inspections are completed. Knowledge and alerting of material status in both incoming and final inspection holds is vital to accurate inventory, purchasing, and sale operations. For this reason, medical device inventory software must be aware of at least four inventory status situations in order to be fully functional:
- Available quantity on hand
- Quarantined quantity on hand
- Committed, but not shipped, quantity on hand (allowing for last-minute substitutions)
- Quantity on order (and arrival date)
2. Management by Exception via Alerts
The previous section introduced the alerts. As a tool of visibility, alerts are indispensable in a medical device manufacturing operation. They effectively automate announcements of a situation in the business that are prompted when the ERP system detects a condition set-up as a trigger—for instance, when raw material inventory reaches a critically low level, or a machine has stopped running.Generally speaking, one of an ERP system’s key roles in the manufacturing of medical devices is to alert management and supervisors when problematic situations are about to arise. Alerts allow for automated management by exception. They effectively serve as management’s eyes and ears in the business so hundreds of business conditions can be monitored automatically instead of having to use rote human supervision to detect and respond to every business need.
3. Inline Quality Inspection
Using alerts leads to a discussion of inline quality inspection, the quality assurance practice of making inspections as the production process proceeds from its starting point to its completion point. Inline quality inspections are made at crucial and logical points in the production process, for instance, at the completion of an injection molding cycle or after the completion of an assembly process.The ERP system’s role in performing inline quality inspection is invaluable. Similar to alerts, inspection points are set as triggers in the production process. When an inspection point is reached, the ERP system triggers the inspection and the recording of the results. When the results are within specification, they are automatically recorded as part of the chain of production documentation. But when they are out of specification, supervisors and auditors are alerted, and production is typically halted until the problem is corrected.
This discussion of inline quality inspections starts to reveal the true power of manufacturing ERP software. When an ERP system is aware of all aspects of the business, it has the ability to monitor events across multiple disciplines, record those events as part of the product’s production documentation, and alert management to issues. It performs an oversight role that goes beyond what is practical with only manual supervision, and it delivers an automated audit trail and management-by-exception alert system.
Good Manufacturing Practices (GMPs) and International Standards Organization (ISO) certifications are invaluable practices and controls. Without expensive and sometimes manual supervision and documentation, however, they can become little more than passing words on paper without actual implementation on the shop floor. Manufacturing ERP software puts the teeth in GMP and ISO certifications through the automated control and visibility it brings to medical device manufacturing operations.
Now, the discussion of manufacturing ERP control and oversight can be elevated to next level, particularly on the shop floor: production and process monitoring.
4. Production and Process Monitoring
Production monitoring, which measures the throughput and rate of production, tracks such factors as how many parts per minute a machine is producing, how many assemblies per hour a team is completing, and how many hours of operation a machine has logged. Knowing production rates is the key to accurate scheduling (when a job will actually complete), understanding costs (how much labor time went into the assemblies), and red flagging potential problems (this equipment needs maintenance).Automated production monitoring functionality is commonly part of an MES, and its capabilities are central to automated shop floor control and visibility. The rate of production is the fundamental heartbeat of the manufacturing process. Knowing how many parts are made in a given time period ultimately informs all the upstream activities of provisioning materials, machinery, and labor, as well as all of the downstream activities of final quality assurance, inventory management, order fulfillment, and shipping.
The direct partner of production monitoring on the shop floor is process monitoring, another central component of MES functionality. Process monitoring focuses on measuring conditions at the time of, or just after, a production step. If a part is being stamped, it might track what the pressure distribution was across the die. For injection molded parts, it could track the temperature at the tip of the barrel. If a part is being assembled, it may, for instance, monitor the torque necessary to rotate the spindle.
In process monitoring, machine and workstation sensors record the actual conditions at the time of production and constantly compare them to the production process specifications. As in the practices of inline quality inspections and production monitoring, when the process parameters deviate or trend outside of process specifications, one or more alerts are issued, and production is halted until corrections are made.
Production and process monitoring are two more examples of using manufacturing software to serve as automated supervisors on the shop floor. Like previous examples of manufacturing ERP at work in the factory, all the results of production and process monitoring are automatically recorded and linked to the lot and serial numbers of the product, further documenting the production lifecycle of the medical device or part.
The information captured as part of production and process monitoring is stored as a time series of data related to specific lots and periods of production. Known as histograms, they not only offer a useful visual record of production parameters, they also provide the data for statistical analysis of production quality, and if necessary, for the root cause analysis of production issues. With production and process monitoring, quality issues can be identified early, and events can be wound back in time to understand what changed and when during the production process in order to determine the underlying factors that led to the problem.
5. Job Control via Human-Machine Interface
Shop floor labor has been a long-term issue for manufacturers that find it difficult to hire and retain reliable, trained operators. This problem is compounded in the medical device industry where, in addition to basic operator training, many shop floor personnel must be technically certified in the jobs they are running. This adds another layer of complexity to labor scheduling at the work center. Not only must properly certificated labor be assigned, the certification of operators assigned to the task must also be validated at the time of production.This is where the concept of the human-machine interface (HMI) comes into play. An HMI is the user interface between the job, the equipment, and the supporting manufacturing infrastructure. An HMI typically validates that trained operators are present and it provides work instructions, inspection parameters, and capture inputs of inline quality inspections and other job-related parameters. Often called shop floor interfaces or connected worker devices, HMIs are the primary point of contact between the manufacturing software system and the direct labor on the shop floor. Not only do they direct the progress on the job, they provide the control that ensures the correct procedures are being followed and they document those procedures were followed as part of the production lifecycle record of the product.
6. Accurate Shipping
One additional factory workflow to consider is shipping. On the surface, it can seem routine, but shipping—in particular, the pick and pack aspects—is, in fact, critical for medical device manufacturers to execute perfectly.Orders come in, products are built to the exacting details demanded by their medical application, and ultimately, they end up as finished goods in a warehouse space. At the end of the process, a pick ticket is issued to pull that stock and ship it to the customer. At least three things are essential at this point. First, the fact proper product is being selected must be double validated. Second, the shelf life of the product must be validated, particularly for biomedical devices that can degrade or become contaminated over time. Third, all of production lifecycle documentation that has been so carefully created during the production process must be packaged and delivered with the product.
With manual systems or even generalized ERP or warehouse management systems, the required cross checks and document consolidation are time consuming and error-prone. Manufacturing systems designed to run medical device operations achieve these goals automatically because they have the end-to-end visibility and records to cross validate, evaluate expiration dates, and package information in digital formats that are readily available for customer review and record keeping (e.g., making track and trace real and efficient).
Conclusion
The challenges of medical device makers are unique, and they are amplified both by roles these devices play in the health and safety of so many people and the risks assumed by the companies that manufacture them. The oversight, control, and visibility that end-to-end manufacturing ERP systems can provide to ensure the quality, lower the cost, and increase the availability of medical devices is transformational—in a digital sense, in a business sense, and in the lives and health of the customers served.Steve Bieszczat is the brand marketing leader and CMO at DELMIAWorks (IQMS), a division of Dassault Systemes. He has worked in the enterprise software industry for over 25 years, with the last 10 years spent specifically in mid-market manufacturing software. Bieszczat has prior leadership experience at enterprise software companies Epicor, Activant, and Triad. He earned an engineering degree from the University of Kansas and an MBA from Rockhurst University. Prior to his work in the software industry, Bieszczat was a manufacturing engineer in the electronic test equipment industry.