4 Advice to Choose a medical molds

Injection-molded parts are critical, yet fundamental, components in many of today&#;s medical devices. Using plastic injection molding for medical devices means protecting products that meet stringent hygiene requirements and helping to lower the cost of devices without compromising performance. Moreover injection molding parts are an integral part of tomorrow&#;s innovative device designs.

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The medical device tooling and design options available for injection-molded parts used in medical applications can seem very complicated. 

Here are the key pieces of information that will help make it a little easier to choose the Injection Mold Tooling that works for your medical project.

1. PROJECT SCOPE

The scope of your medical project is the most important element in defining which tooling method to leverage.

For example, if the part is for pre-production and requires low quantities, then it is best to start with a low-cost, single-cavity material tooling. This is common when the medical contract manufacturing requires the part to be made from the same material as the injection mould for final production. Such tools offer lower costs and faster lead times. If the requirement for the same material is not needed then alternative options such as 3D printing can be considered.

2. PART SIZE AND VOLUME

Part size and volume of the part in question are important in determining the injection mold tooling. If we are dealing with a medical device with large parts and aesthetic requirements, then we will need a standalone mould capable of providing the maximum capacity of the medical injection molding machines in terms of both injection volume and clamping force. On the other hand, smaller parts that fit within the dimensional parameters may be subject to a cheaper (more efficient) alternative; insertion tools (same mold base with interchangeable core and cavity) or a family mold (several parts put together in the same core and cavity) are extremely popular for smaller parts.

3. PRODUCTION VOLUME

Production volumes can affect tools especially when they reach a higher level. The standard instrument has a single cavity for low volumes from about 200 to 2.000 parts per year, but when production volumes are higher one can try to add more cavities on the instrument to produce parts more economically. When the annual quantities of medical devices and the total duration of the project are unknown, you can always start with single-cavity tools. This gives the possibility to integrate some improvements before building multi-cavity tools later on. Multi-cavity instruments involve more upfront costs, but can greatly lower the price of the part.

4. PART MATERIAL

The material of the medical device affects the tooling for a few reasons. Mild injection molding resins such as Polypropylene are much easier to use and help make the tool more durable. Harsher injection molding resins such as Glass Filled Nylon or polymers with additives to make them flame retardant or non-flammable (e.g. UL94/V0) will wear out a tool much more easily. This can be a central factor in making a decision on which tooling material to choose.

5. PART GEOMETRY

Part features such as undercuts, cores, surface finish requirements (e.g. grained, polished, textured) influence the decision on the type of injection mold tooling to be used. The more complex the part is, the more likely it is to need a standalone steel tool.

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6. TIMELINE FOR BUILDING THE TOOL

Every new medical device has a deadline to be brought to market and therefore the tooling phase also has a timeline to be met, which can influence the tool choice. 

Usually, injection molding tools can be built in anywhere from 4-6 weeks for small parts and 6-10 weeks for larger parts.

7. COST 

The material of which a tool is made is an important factor in its cost and also influences its market price. A cheap starter tool costs less than a high quality hardened (multi-cavity) steel, but it will also last much less and the cost of maintaining it will be much higher in the long run. Tools that deteriorate quickly are not of high quality and may have aesthetic flaws. In addition, cheaper plastic injection molding for medical devices means that slower cooling occurs in the mould, which can increase costs due to higher cycle times and more downtime.

When looking at long-term costs, the quality of the tools is crucial. Quality tools require a higher initial investment, but they have many positive aspects: they produce acceptable parts right from the start, reduce machining problems that can arise and help you meet cycle and production times.

A medical contract manufacturing expert offering a high level of service can guide you through the tooling and design options available for injection-molded parts used in medical applications. This process will ensure the tooling and design options which best meet your needs in a cost-effective manner providing the best return on tooling investment.

By performing a mould flow analysis to understand how the plastic flows through the mould and fills a part, additional cost-saving information can be obtained. Such analyses save time and money by avoiding the need to retool or redesign the part later in the process. 

If you need expert advice on developing your next medical device, contact us and we will advise you on the best tools and materials to use to meet your medical device requirements and guide you through the entire medical contract manufacturing process.

Creanova has long experience in manufacturing medical devices with high-precision medical injection molding housings, so we can help you with your medical project at any stage of development and we can support you with a 360° solution: from design, engineering, prototyping to contract manufacturing (including medical device tooling, production and final assembly, ISO certified).

Want more information on medical molds? Feel free to contact us.

Did you know that injection molding is transforming the medical device industry? This advanced process empowers designers to create high-quality and cost-effective products, ranging from common medical items to highly regulated devices. As products move through various stages of development&#;from initial prototyping to full-scale production-they must consistently meet stringent compliance, safety, and functionality standards. This ensures that each medical device aligns with critical industry requirements at every step. If you&#;re considering taking the next step in medical injection molding, this article will guide you through 4 key considerations in medical injection molding, from understanding device classifications and regulations to selecting suitable materials and preparing your design.

Key Considerations in Medical Injection Molding

1. Regulatory Compliance: Meeting Corresponding Standards Food and Drug Administration (FDA) guidelines in the U.S. mandate rigorous tracking and documentation at every production stage to guarantee the traceability of each component. Meanwhile, Medical Device Regulation (MDR) standards in the EU emphasize consistent product safety across the device&#;s entire lifecycle, pushing manufacturers to follow stringent standards. Medical devices are divided into three classifications, by both FDA and MDR, based on associated risk, each with specific regulatory requirements: Class I Medical Devices: These low-risk devices pose minimal harm to users, often including items like bandages, gloves, and hand-held surgical instruments. Regulatory requirements are relatively basic, focusing mainly on general safety and quality.
Class II Medical Devices: Moderate-risk devices, such as syringes, infusion pumps, and diagnostic equipment, require additional regulatory controls. These may involve special labeling, performance standards, and post-market supervision.
Class III Medical Devices: High-risk devices, including pacemakers, defibrillators, and implants, require the highest level of regulatory supervision. This includes rigorous premarket approval, extensive testing, and clinical trials to confirm safety and effectiveness. For instance, a diagnostic device used for detecting infectious diseases needs each plastic component to withstand various sterilization processes without degrading or releasing harmful substances. Even minor contamination could compromise the device&#;s accuracy or pose risks to patients, underscoring the importance of these strict regulatory standards. Ensuring regulatory compliance is essential in medical injection molding, as incorrect categorization or non-compliance can lead to delays, increased costs, and a longer time to market. 2. Certifications: Guaranteeing Quality and Safety
Certification is a standard, ensuring the products meet or exceed industry requirements. Key certifications in the medical industry include: ISO : This certification ensures a quality management system is in place, maintaining consistency across production batches. For example, if producing IV systems or ventilators, ISO certification is critical. ISO : For parts that come in direct contact with bodily fluids or tissues, ISO ensures biocompatibility. This certification is essential when manufacturing parts such as catheter tips or implantable device housings, where material safety directly impacts patient health. ISO : This cleanroom certification is crucial for preventing contamination. A cleanroom-certified facility, for instance, can safely produce surgical device components that require a sterile environment, ensuring they meet hospital and surgical standards. ISO : ISO : This certification ensures risk management processes are in place, crucial for medical devices. For example, it&#;s essential when manufacturing parts like infusion pumps or pacemakers, where rigorous risk controls are necessary to protect patient safety. 3. Material Selection: Biocompatibility and Durability Choosing materials for medical applications involves considerations beyond standard injection molding. Examples include:
&#; Polycarbonate (PC): Due to its strength and transparency, often used for housing devices requiring internal visibility, such as blood analyzers.
&#; Polyethylene (PE): Known for chemical resistance and flexibility, PE is used in IV bags and tubing, ensuring durability and low moisture absorption.
&#; Polypropylene (PP): With strong impact resistance and sterilization stability, PP is used in syringes and medical containers, offering long-term reliability.
&#; Polystyrene (PS): Widely used for disposable labware, PS offers rigidity, transparency, and easy sterilization, making it suitable for laboratory applications.
&#; Polyether Ether Ketone (PEEK): Widely used in implantable devices due to its strength, stability under sterilization, and biocompatibility.
&#; Thermoplastic Elastomer (TPE): Its flexibility makes it suitable for soft-touch surgical instrument handles that withstand repeated sterilization. Every material choice has specific trade-offs. For instance, while PE and PP are cost-effective and chemically resistant, they might lack the strength needed for parts exposed to high-stress environments. Therefore, understanding these nuances helps in material selection, optimizing for both performance and cost. Click Here to explore more material choices. 4. Prototyping to Production: Ensuring a Smooth Transition
Transitioning from prototypes to full-scale production isn&#;t always straightforward. During prototyping, designs may feature thinner walls or more complex geometries than standard injection molding processes can easily reproduce at scale. For example, a prototype with sharp corners that&#;s achievable created by vacuum casting process, but requires design optimization, such as adding radii, and adding draft angle for efficient injection molding without sacrificing quality. When scaling up, an experienced injection molding partner with expertise and capabilities can help optimize these designs for manufacturability without compromising on quality. At RPWORLD, we assist clients in this crucial transition, helping optimize part design, select the most suitable materials, finishing options and more to support efficient and regulatory-compliant production.

Why Choose RPWORLD Injection Molding for Your Medical Development

At RPWORLD, we integrate material expertise, one-stop manufacturing services, in-depth DFM analysis and ISO-certified process to help bring medical devices to market faster. Our services cover the entire lifecycle-from prototyping to mass production-tailoring to meet the unique needs of each medical device. &#; 20+ years of experience in medical device injection molding, from prototyping to end-use production. &#; Mold flow analysis, and in-house tools design and fabrication. &#; A wide variety of post-processing options to perfect your parts. RPWORLD Injection Molding Service &#; Design for Manufacturing (DFM) guidance, including design optimization, material selection, finishing selection and more to avoid costly rework and save time up to 80%. &#; State-of-the-art quality inspection equipment and stringent quality control including real-time process monitoring to ensure consistency. Ready to elevate your medical device manufacturing? Connect with RPWORLD today and see how we can support your production journey from concept to reality.