Oliver Rapp, Engineering Manager, NN Inc. Precision Engineered Products Group09.19.16
Drug delivery devices are one of the most rapidly growing segments of the medical device manufacturing market. Substantial R&D efforts are being focused on new drug formulations and the most appropriate designs for the drug delivery mechanisms. Good designs, however, do not automatically ensure that these devices can be assembled consistently with near zero rejects.
Beyond solid designs and well-conceived assembly systems, there is a critical need for a component management process that offers on-time delivery of interrelated components that not only meet specifications but also have tolerance bands aligned for efficient assembly.
In addition to ensuring that the devices can be assembled efficiently, the component management process can have a favorable impact on multiple factors, including:
Why Good Parts Don’t Always Fit
Although manufacturers may create well-crafted parts, there is an undeniable disconnect that can occur by using multiple manufacturers, which sometimes results in products that will not fit together. OEMs should be aware of these issues in order to mitigate such risks.
One of the most significant issues is off-spec parts that fail to measure up to design requirement specifications. Plastics or metals may be improperly formulated with off-spec contaminants or fail to meet dimensional tolerances. Stacking errors in where the parts fall within their respective tolerance bands may be misaligned, even when all of the parts supplied for a particular drug delivery device fall within acceptable limits. So if eight or a dozen components have to be assembled into a single device, misalignments make it difficult to get particular groups of “in spec” components to click into place smoothly. This can slow down production, impact yields, and increase costs.
Working with multiple manufacturers for device parts also increases the likelihood of communication gaps, which can add unnecessary complexities, reduce efficiency, and lead to errors in the assembly process.
Solving problems that impact the performance of a device, the ease of the assembly process, or the component cost may require resources that some suppliers do not have—such as advanced levels of engineering expertise and specialized analytical and manufacturing equipment. For example, while parts subcontractors may have perfectly adequate basic molding and stamping capabilities, they may not have the ability to go deeper to scientifically analyze and correct component-level drug delivery problems. This is why it is recommended for drug delivery device makers to choose a single parts provider that has well-integrated, resident core competencies and an efficient component management process in place for every part supplied.
Multi-Layered Core Competencies
For the drug delivery market segment, it is ideal for core manufacturing competencies to be housed within one company. Though, not common, there are some manufacturers who offer this option for drug delivery device production. When selecting a single manufacturer for all design production capabilities, OEMs should look for certain core competencies that include a focus on making all of the components and subassemblies required for producing high-yield drug delivery devices.
Specifically, these core competencies comprise of:
When a component provider works with an OEM to design an exceptional multi-part drug delivery device with significant market potential, requirements for precision, micro-molded and metal stamped components manufacturing should be scaled rapidly in tandem to meet the anticipated demands.
Select manufacturers have now developed processes for producing drug delivery components that are insightfully designed, thoroughly tested, highly automated, and well integrated—all using advanced equipment and applying validation best practices. These processes are in place to make sure parts are assembled efficiently and perform in a coordinated fashion to enhance the structural integrity and performance of devices.
For example, metal stampings incorporated into devices are often geometrically complex and have to be held within extremely tight tolerances. A manufacturer using an optimized component management process early on can develop tooling that would provide exceptional tolerances where needed but also allow for cost-effective manufacturability.
Scaling Up From Zero to Millions
The demand for well-crafted products is growing rapidly and with effective component management processes, manufacturers can quickly plunge into scaling up production efficiently to deliver increasingly large quantities without sacrificing quality. This is generally an easier task for the stamped components since they are delivered via a standardized manufacturing complex that provides fast-turns of components for a large number of OEMs.
The manufacturing processes for molded and micro-molded parts is more challenging and requires designing a modular complex of automated molding cells that can be scaled up incrementally by adding more cells. Through this management process, the complex can be installed within several months to be qualified and producing parts 24/7. The complex incorporates automated presses equipped with high-speed robotic part removal with custom end- of-arm tooling, automatic runner and part separation, and traceability to individual cavities.
By focusing on these critical details up front, a contract manufacturer can rapidly scale from zero to millions—sometimes even hundreds of millions—of high-quality parts per week for customers’ drug delivery devices.
Considerations for Micro-Molding Operations
Some of the major considerations to address along the way during micro-molding operations include:
Single-Cavity Mold Designs: With a part design still in flux, manufacturers should start out by designing single-cavity molds. Any design changes to the part can be incorporated at this stage.
Nailing Down Critical Molding Process Variables: A DOE (design of experiments) protocol should be developed to determine the most critical process variables, an ideal range of settings, and the widest window of variability for these settings so that, if necessary, the process can be adjusted to allow for normal variation in process and material variability.
Tooling Development and Validation Processes: Even at an early stage, engineers representing tooling, processing, and quality should be actively engaged in projects to provide exceptional tolerances where needed and allow for cost-effective manufacturability.
Close Supply Chain Coordination: Some manufacturers have close relationships with their supply chain to secure commitments from a mold machine manufacturer and ancillary equipment providers to achieve coordinated deliveries and uniformity throughout the complex. OEMs should look for this relationship to comply with component management processes.
Compliance and Certification Procedures: Any assembly of drug device components requires appropriate attention to regulatory compliance, such as adherence with U.S. Food and Drug Administration (FDA) medical device guidelines, as well as International Organization for Standardization ISO 13485 certification for quality management system compliance. It is also critical for compliance that products are assembled in appropriate cleanroom environments. It is important to select a manufacturer committed to having an adequate cleanroom capacity ready and waiting to coincide with increased component production in order to decrease the downtime of waiting for new cleanrooms to be constructed as needed.
Management Level Commitment: Management commitments include doing what it takes to get all customers’ products to market expeditiously. Manufacturing drug delivery devices is a complex process that begins with a concept and proceeds through many stages until a viable product is being manufactured, and management should be informed and involved at every stage.
Conclusion
Overall, scalability is a key aspect in drug delivery device manufacturing. Key elements should be in place to ensure that all parts meet necessary specifications and are inter-assembled efficiently. For this to happen, successful component management processes must be put in place to enable consistent, cost-effective, extremely scalable, and high-yield part production.
Working with a single component manufacturer who has the resources, in-house expertise, and component management processes in place to take on a project and scale up as needed is essential for the delivery of parts that consistently meet critical dimensions on time and for assembly operations that perform flawlessly.
Oliver Rapp is the engineering manager at NN, Inc. Precision Engineered Products Group (PEP), a global manufacturer of highly engineered precision customized solutions serving the medical market.
Beyond solid designs and well-conceived assembly systems, there is a critical need for a component management process that offers on-time delivery of interrelated components that not only meet specifications but also have tolerance bands aligned for efficient assembly.
In addition to ensuring that the devices can be assembled efficiently, the component management process can have a favorable impact on multiple factors, including:
- Drug delivery device performance
- Time to market
- Assembly process trouble-shooting
- Component traceability
- Consolidated supply chain management
- On-going manufacturing cost management
- Efficient scalability for high volume production
Why Good Parts Don’t Always Fit
Although manufacturers may create well-crafted parts, there is an undeniable disconnect that can occur by using multiple manufacturers, which sometimes results in products that will not fit together. OEMs should be aware of these issues in order to mitigate such risks.
One of the most significant issues is off-spec parts that fail to measure up to design requirement specifications. Plastics or metals may be improperly formulated with off-spec contaminants or fail to meet dimensional tolerances. Stacking errors in where the parts fall within their respective tolerance bands may be misaligned, even when all of the parts supplied for a particular drug delivery device fall within acceptable limits. So if eight or a dozen components have to be assembled into a single device, misalignments make it difficult to get particular groups of “in spec” components to click into place smoothly. This can slow down production, impact yields, and increase costs.
Working with multiple manufacturers for device parts also increases the likelihood of communication gaps, which can add unnecessary complexities, reduce efficiency, and lead to errors in the assembly process.
Solving problems that impact the performance of a device, the ease of the assembly process, or the component cost may require resources that some suppliers do not have—such as advanced levels of engineering expertise and specialized analytical and manufacturing equipment. For example, while parts subcontractors may have perfectly adequate basic molding and stamping capabilities, they may not have the ability to go deeper to scientifically analyze and correct component-level drug delivery problems. This is why it is recommended for drug delivery device makers to choose a single parts provider that has well-integrated, resident core competencies and an efficient component management process in place for every part supplied.
Multi-Layered Core Competencies
For the drug delivery market segment, it is ideal for core manufacturing competencies to be housed within one company. Though, not common, there are some manufacturers who offer this option for drug delivery device production. When selecting a single manufacturer for all design production capabilities, OEMs should look for certain core competencies that include a focus on making all of the components and subassemblies required for producing high-yield drug delivery devices.
Specifically, these core competencies comprise of:
- Injection molding
- Injection micro-molding
- Metal stamping
- Tooling for stamping, molding, and micro-molding
- Metal machined parts
- Medical quality machined plastic
- Cleanroom subassembling, kitting, and packaging
When a component provider works with an OEM to design an exceptional multi-part drug delivery device with significant market potential, requirements for precision, micro-molded and metal stamped components manufacturing should be scaled rapidly in tandem to meet the anticipated demands.
Select manufacturers have now developed processes for producing drug delivery components that are insightfully designed, thoroughly tested, highly automated, and well integrated—all using advanced equipment and applying validation best practices. These processes are in place to make sure parts are assembled efficiently and perform in a coordinated fashion to enhance the structural integrity and performance of devices.
For example, metal stampings incorporated into devices are often geometrically complex and have to be held within extremely tight tolerances. A manufacturer using an optimized component management process early on can develop tooling that would provide exceptional tolerances where needed but also allow for cost-effective manufacturability.
Scaling Up From Zero to Millions
The demand for well-crafted products is growing rapidly and with effective component management processes, manufacturers can quickly plunge into scaling up production efficiently to deliver increasingly large quantities without sacrificing quality. This is generally an easier task for the stamped components since they are delivered via a standardized manufacturing complex that provides fast-turns of components for a large number of OEMs.
The manufacturing processes for molded and micro-molded parts is more challenging and requires designing a modular complex of automated molding cells that can be scaled up incrementally by adding more cells. Through this management process, the complex can be installed within several months to be qualified and producing parts 24/7. The complex incorporates automated presses equipped with high-speed robotic part removal with custom end- of-arm tooling, automatic runner and part separation, and traceability to individual cavities.
By focusing on these critical details up front, a contract manufacturer can rapidly scale from zero to millions—sometimes even hundreds of millions—of high-quality parts per week for customers’ drug delivery devices.
Considerations for Micro-Molding Operations
Some of the major considerations to address along the way during micro-molding operations include:
Single-Cavity Mold Designs: With a part design still in flux, manufacturers should start out by designing single-cavity molds. Any design changes to the part can be incorporated at this stage.
Nailing Down Critical Molding Process Variables: A DOE (design of experiments) protocol should be developed to determine the most critical process variables, an ideal range of settings, and the widest window of variability for these settings so that, if necessary, the process can be adjusted to allow for normal variation in process and material variability.
Tooling Development and Validation Processes: Even at an early stage, engineers representing tooling, processing, and quality should be actively engaged in projects to provide exceptional tolerances where needed and allow for cost-effective manufacturability.
Close Supply Chain Coordination: Some manufacturers have close relationships with their supply chain to secure commitments from a mold machine manufacturer and ancillary equipment providers to achieve coordinated deliveries and uniformity throughout the complex. OEMs should look for this relationship to comply with component management processes.
Compliance and Certification Procedures: Any assembly of drug device components requires appropriate attention to regulatory compliance, such as adherence with U.S. Food and Drug Administration (FDA) medical device guidelines, as well as International Organization for Standardization ISO 13485 certification for quality management system compliance. It is also critical for compliance that products are assembled in appropriate cleanroom environments. It is important to select a manufacturer committed to having an adequate cleanroom capacity ready and waiting to coincide with increased component production in order to decrease the downtime of waiting for new cleanrooms to be constructed as needed.
Management Level Commitment: Management commitments include doing what it takes to get all customers’ products to market expeditiously. Manufacturing drug delivery devices is a complex process that begins with a concept and proceeds through many stages until a viable product is being manufactured, and management should be informed and involved at every stage.
Conclusion
Overall, scalability is a key aspect in drug delivery device manufacturing. Key elements should be in place to ensure that all parts meet necessary specifications and are inter-assembled efficiently. For this to happen, successful component management processes must be put in place to enable consistent, cost-effective, extremely scalable, and high-yield part production.
Working with a single component manufacturer who has the resources, in-house expertise, and component management processes in place to take on a project and scale up as needed is essential for the delivery of parts that consistently meet critical dimensions on time and for assembly operations that perform flawlessly.
Oliver Rapp is the engineering manager at NN, Inc. Precision Engineered Products Group (PEP), a global manufacturer of highly engineered precision customized solutions serving the medical market.