Medical Injection Molding: Manufacturing Insights

Apr 14

Plastic injection molding is a crucial manufacturing process in the medical industry, allowing for the production of high-quality, precise, and consistent medical devices and equipment. Whether you need products or components for diagnostic, cardiovascular, surgical, or dental, medical injection molding delivers reliable and cost-effective medical products that improve patient outcomes and quality of life.

Excelling at Medical Injection Molding Didn’t Happen by Accident

You have choices when it comes to selecting an injection molder, and choosing the best partner will be critical for getting your product to market on time and safely. Now, while we can’t define “best partner” for you, we can share with you what we feel has been critical for and appreciated by our customers. After decades of developing relationships with medical and life science manufacturers, we have come to understand the importance of collaboration, scalability, on-time delivery, and meeting quality requirements while mitigating activities and issues that lead to higher costs for our customers.

Collaboration From the Start

Right from the start of the sales process, our engineering team is brought in to ensure that any technical questions can be answered quickly. An engineer is assigned to the project and becomes the point of contact for the program. This is a critical element because responsiveness is required for success in the medical industry. Communication and transparency are engrained into our company culture. For example, we frequently communicate with our customers concerning automation data. Our approach to communication allows us to make timely improvements, keeps the program on track, and helps to further solidify our relationship.

We collaborate with you so that we clearly understand your product requirements, specification, and expectations upfront, and we document these to hold ourselves accountable. Once the purchase order is accepted, we review design files and perform design for manufacturability (DFM) and mold flow analysis. This approach ensures the product can be efficiently manufactured while maintaining quality and minimizing costs. Key DFM considerations include wall thickness, draft angles, ribs, and undercuts. If required, we can also review material selection, including its properties, biocompatibility, sterilization compatibility, and cost implications and help you choose the most suitable material for your application and requirements.

Tight Tolerances

We understand that achieving tight tolerances and ensuring dimensional accuracy and consistency throughout the production process is vital for maintaining the highest quality of patient care. Material selection, mold design, and process control are all critical factors for achieving tight-tolerance parts. Using automation (40 high speed robots and 15 vision systems) and automated process controls, we promise to deliver zero defects on tight-tolerance parts.

Our engineering team works closely with customers to ensure the polymer chosen will meet the needs of the part. Our DFM processes and mold flow analysis ensure we meet your tight tolerance requirements. Starting with high-quality molds, we have a regular preventative maintenance schedule and can provide a detailed report that includes the use, service records, and pending repairs.

What sets us apart is our award-winning automation, which provides better control over process parameters which is critical for consistent part quality. Automation allows for real-time monitoring and feedback, enabling immediate adjustments to maintain optimal conditions for molding. Integrated process control and an automated visual quality inspection system further enhance quality control by detecting and rejecting out-of-tolerance parts early in the production process and shutting down the system to prevent additional defective parts from being molded. If a particular mold cavity creates a defective part, they are quickly contained because the system sends parts from each cavity into its own chute. Process automation has dramatically cut reject rates and decreased contamination in part handling and inspection.

Scalability

The challenges with scaling production can be costly. If your initial injection molder doesn’t have the capacity to scale up, you risk losing out on opportunities or having to work with multiple vendors, leaving yourself open to variations in quality. One area is with tooling. Tooling at one facility may be in better shape than in another, which can lead to flashing or quality spec issues in the poorer tooling because they’re not maintaining the tooling correctly.

By working closely with our sister company Omega Plastics, which injection molds low-volume medical products, we have experience with scaling projects efficiently. We have aligned our new product implementation and DFM processes to incorporate scalability. Even when projects come to us from other molders, we have a well-defined road map that smooths out the process. We look at the transfer tooling and incorporate it into our formula to scale, even if it wasn’t built initially to support high volume. We use hot runners and valve gate systems with high-volume tooling because they offer better control over the molding process, improved cycle times, and reduced material waste. Some low-volume tooling incorporates runners, which requires removing the runners from the part after it is molded. If we must use tooling that has runners, we can build automation to remove the runners and send them for regrinding. Overall, we look to build consistency in our processes.

In addition, we have the infrastructure to support scalable programs. We can offer from bags of resins to railcar quantities. We have the equipment, the space, and the ability to run 24/7 when needed.

On-time Delivery

On-time delivery is non-negotiable. If you aren’t getting your products, your customers aren’t getting theirs, and they will waste no time finding another solution. We have the capability of 24/7 operations, so capacity restraints are never an issue. During the pandemic, when many struggled to get workers, we felt it, but we could maintain our delivery status because our processes rely heavily on automation for non-skilled labor. We also have full redundancy from chiller air systems to high-tonnage machines. We have eliminated single-point failures from our processes, so having a system down will not hold up our production.

We have a mold inspection checklist for each tool, and a mold preventative maintenance (PM) program is established and documented. Our systems track in real time how many hours have been run, and every time a mold opens and closes, it records the shots so that it can generate traceable PM work orders based on the frequencies of use. We have some molds with over 20 million shots that look brand new. We have an in-house tool room that helps us to protect our customer’s assets- we understand the investment they have made, and keeping them pristine helps us deliver on time and deliver a consistent product.

Meeting Quality Requirements

Meeting quality requirements should be a given in for medical injection molding. We like to think we take it up a notch. Not only are we ISO 9001:2015 and ISO 13485:2016 certified, but we are also only one of a handful of processors to be MedAccred® accredited for injection molding, over molding, and mechanical assembly. MedAccred accreditation is a process that ensures medical device manufacturers and suppliers meet the highest quality standards in the industry. This accreditation is granted after thoroughly evaluating a company’s processes, procedures, and capabilities. MedAccred aims to minimize risks, improve patient safety, and enhance product quality and reliability within the medical manufacturing sector.

From a design perspective, we build quality into our processes through DFM and mold flow analysis. We use Advanced Product Quality Planning (AQPQ) to ensure quality through the planning and validation stages, which includes Process Failure Mode and Effects Analysis (PFMEA) to identify any risks and take action to minimize the likelihood of impact and Product Part Approval Process (PPAP) to validate that our production process has demonstrated the potential to produce products that fulfill all requirements.

Installation Qualification, Operational Qualification, and Performance Qualification (IQ, OQ, PQ) activities ensure our presses operate as intended and are stable over time. Once the part is in production as part of our automation, we have incorporated vision systems and process controls, including real-time electronic data logging of SPC data, rejects, and shot-to-shot process conditions. We also have automation to send reject signals if specific parameters are not met in the press. Parts are tested for quality at regular intervals.

When required, we have an ISO 14644-1 Class 8 controlled and compliant clean room environment, a Class 7 clean room, and a white room for product molding and assembly.

Costs

Costs are one of the biggest concerns for any company. Unnecessary costs reduce profitability or cause you to pass the costs onto your customers. We look to remove costs in the part during our design review, ensuring the part will run as efficiently as possible. We rely heavily on automation which can work continuously and without human error that can unintentionally drive up costs and increase scrap rates. We take advantage of economies of scale and can buy resin by rail carloads when we have stocking agreements in place with the customer.

All our actions are working to reduce your total costs. Transparency and responsive communication allow us to get answers quickly and adjust quickly. When we get your product to market on time, we reduce your total costs. When we increase efficiency, we reduce total costs. When we produce consistent quality parts, we reduce total costs.

High Precision Medical Injection Molding with Total Quality, Reliability, and Consistency

Take the next step towards manufacturing success. You now have an overview of our approach to medical injection molding and how our focus on collaboration, scalability, on-time delivery, meeting quality requirements, and cost reduction can positively impact your medical product’s success. It’s time to take the next step in ensuring your medical devices and equipment are manufactured with the utmost precision and reliability. Partner with a medical injection molding expert who truly understands your needs and has the experience, certifications, and commitment to deliver exceptional results.

JD Eaton