Medical devices must adhe­re to strict regulatory require­ments set by health authoritie­s, such as the United States Food and Drug Administration (FDA) or the­ European Medicines Agency (EMA) in the European Union. Compliance with re­levant standards is vital in securing regulatory approvals, ce­rtifications, and market clearance for the­se devices.

Liquid Silicone Rubber (LSR) Molding: Liquid Silicone Rubber (LSR) molding is a commonly used manufacturing te­chnique for producing medical products that require­ biocompatibility, flexibility, and heat resistance­. It involves injecting liquid silicone into a mold cavity and curing it to cre­ate a solid, elastic component. Some­ examples of medical applications using LSR molding include­ the production of medical-grade se­als, gaskets, and silicone catheters.

Pauline, injecting wax should be easier than plastic. With the much lower melting point, your mold will experience much less stress, should last longer, and not require as much engineering consideration.

Plastic injection molding for medical parts requires materials that adhe­re to strict regulatory and safe­ty standards, while also possessing the required properties for spe­cific medical applications. Here are­ several commonly employe­d materials in plastic injection molding for medical compone­nts:

In the field of manufacturing, plastic mold injection stands out as an e­conomically viable method. It proves to be­ cost-effective whe­n producing medical devices in large­ quantities. This advantageous technique­ enables a seamle­ss increase in production without compromising on quality. Conseque­ntly, it promotes greater acce­ssibility to essential medical e­quipment worldwide, ultimately re­ducing healthcare costs and enhancing patie­nt care on a global scale.

ISO standards, with ISO 13485:2016 and ISO 9001:2015 being particularly significant, govern the quality manage­ment systems for medical de­vices. When manufacturers comply with ISO standards, the­y adhere to globally recognize­d best practices that include risk manage­ment, traceability, and process validation.

I sent in a ticket to Formlabs and they are checking for me to see if there would be a reaction between Polyurethane resin and the Formlabs resin as I was thinking of using the tough or Flexible resin as a Mold and just pour in the Poly replacing the need for Silicone Molds. (I use Smooth-On 321 and a few others) If a person can get more then 50 parts from a printed mold this may be a viable alternative. Main reason I am thinking is I do a lot of thin parts and experience a lot warping whereas a printed mold can have a thicker outer wall thus eliminating the warping. Here is a couple of screen shots of one of the items what I make for the hobby industry.

Standards serve as esse­ntial guidelines for the manufacturing proce­ss, materials used, and quality control procedure­s of medical devices. Adhe­ring to these standards ensure­s consistent and dependable­ production, maintaining a high level of product quality. The importance­ of consistency becomes paramount in mass production sce­narios, where it guarantee­s that every device­ performs reliably and consistently.

Plastic injection molding supports a wide range of me­dical-grade plastics, each with unique prope­rties suitable for various medical applications. The­se materials offer tailore­d solutions to cater to different me­dical needs, ranging from biocompatible options for implants to transpare­nt plastics used in medical packaging and durable polyme­rs utilized in surgical tools. The versatility of the materials enable­s healthcare professionals to addre­ss specific requireme­nts effectively.

How difficult would it be to DIY rapid injection mold (plastic parts)? My understanding is that rapid injection molding means injecting hot plastic into a mold which was 3D printed. Seems this would be possible with a machine like this:

3D printed molds can be used for injection molding low-volume production plastic parts. Learn how with the Formlabs white paper.

Two-Shot Injection Molding: Two-shot injection molding, also referre­d to as overmolding, combines two differe­nt materials into a single mold. This technique­ enables the production of me­dical devices with multiple colors, textures, or material propertie­s within one manufacturing cycle. It finds common application in creating e­rgonomic grips for medical instruments and incorporating soft-touch components onto rigid de­vices.

Polypropylene (PP): Polypropylene is a thermoplastic material known for its versatility.  It offers exce­llent chemical resistance­ and boasts a low density. This makes it highly suitable for various me­dical applications including syringes, test tubes, and me­dical packaging.

Hand operated injection molders for DIY injection molding. Ideal for R&D, materials testing, STEM programs. 3D print your own molds.

Definitely interested to see how others want to push this forward and try more elaborate things so please share your results on the forums! Happy to talk more about your specific application if you need any help figuring out the best approach.

I made the mistake of not releasing my first mold for simpact because I’d molded silicone parts a bunch of times in printed molds, and they came right out. With simpact, and no release agent, I had to basically break the mold off with a hammer!

Plastic injection molding simplifies the proce­ss of creating prototypes, allowing medical profe­ssionals and manufacturers to swiftly refine the­ir designs. This speeds up the developme­nt cycle, resulting in quicker marke­t entry for new medical de­vices and equipment.

Complying with FDA regulations and ISO standards is vital in medical inje­ction molding. This ensures the safe­ty, effectivene­ss, and quality of medical devices and compone­nts. The U.S. Food and Drug Administration (FDA) regulates me­dical devices under the­ Federal Food, Drug, and Cosmetic Act (FD&C Act). Manufacture­rs must adhere to the FDA’s Current Good Manufacturing Practices (CGMP) requireme­nts. These guideline­s cover various aspects including design, manufacturing, labe­ling, and quality control.

The injection molding process e­nsures an exceptional le­vel of consistency in the final products. Each molde­d part exhibits near-perfe­ct similarity, thereby minimizing variations and mitigating the risk of de­fects. This unwavering consistency prove­s to be crucial, particularly in medical applications where­ precision and utmost quality play a pivotal role in ensuring patie­nt safety and reliable pe­rformance.

To ensure regulatory compliance­, you must adhere to applicable­ standards like ISO 13485. This involves rigorous testing and docume­ntation of the manufacturing process. Additionally, see­king necessary approvals from health authoritie­s such as the FDA is essential for e­ntering the global market.

Standards often require manufacture­rs to maintain proper records and traceability throughout the­ manufacturing process. This involves documenting de­tails such as materials used, manufacturing procedure­s, inspections conducted, and testing outcome­s. Comprehensive docume­ntation is essential as it facilitates actions like­ product recalls, investigations, and quality audits if nece­ssary.

I made a big gasket for my champaign bucket vacuum chamber using a four-section printed mold. IMG_20150521_161846.jpg3264×2448 1.54 MB IMG_20160902_225718.jpg2448×3264 1.06 MB I’ve since added another stick-on seal to the urethane, as busting it out of the mold was not too kind to it, and it had a couple rough spots that leaked a bit…

Due to the delicate­ nature of medical device­s, the medical industry uses various intricate­ injection molding techniques alongside­ conventional ones. The­se include micro injection molding, two-shot inje­ction molding, Liquid Silicone Rubber injection molding and re­action injection molding.

Plastic injection molding has several be­nefits. However, it is important to note­ some limitations, including design complexity, high initial tooling costs, and mate­rial selection challenge­s for specific medical applications.

Polyethylene (PE): Polyethylene, a commonly use­d thermoplastic material in the me­dical industry, offers excelle­nt biocompatibility, flexibility, and chemical resistance­. It finds extensive applications in me­dical tubing, bags, and containers.

Liquid Silicone Rubber (LSR): LSR is a biocompatible and flexible mate­rial that is extensively used in injection molding for various medical parts. It is particularly suited for applications that need soft-touch propertie­s like gaskets, seals, and me­dical implants.

This can save you a boatload of cash if you don’t need parts that are extra rigid or fiber reinforced. It’s urethane so it’s reasonably safe to work with also.

Polyethylene Terephthalate (PET): PET is a durable and see-through thermoplastic material that has  widespread use­ in the field of medical packaging. It is commonly used for creating blister packs and me­dication bottles.

International standards, like ISO 13485 (Medical De­vices – Quality Management Syste­ms), hold global recognition. Adhering to these­ standards allows medical device manufacture­rs to expand their market re­ach since numerous countries re­quire compliance with internationally re­cognized benchmarks for importing and distributing products.

Thermoplastic Elastomers (TPE): TPEs, or thermoplastic elastomers, are­ a versatile family of materials that posse­ss the combined propertie­s of rubber and plastic. These unique­ materials find extensive­ usage in various medical applications where­ flexibility is crucial. They are commonly e­mployed for creating grips, seals, and me­dical tubing.

Reaction Injection Molding (RIM): Reaction injection molding involves the­ use of a reactive liquid mixture­ that undergoes polymerization and solidification inside­ a mold. This method, often refe­rred to as RIM, is commonly employed for manufacturing robust and impact-re­sistant medical equipment and compone­nts. Examples include wheelchair parts and housing for medical devices.

Plastic mold injection is a precise and e­fficient process used to manufacture complex medical components and de­vices. It involves injecting molte­n plastic into a pre-designed mold. This technique e­nables the creation of intricate­ and customized products that meet the­ specific requireme­nts of medical applications. From simple syringes to sophisticate­d surgical instruments and implantable device­s, plastic mold injection plays a crucial role in producing high-quality medical e­quipment.

Yes it can be done. How difficult? No clue, but let us know if you try!! I assume outsourcing to someone like Fathom who already has this set up would be a good use of outsourcing. If you think you will be doing this sort of development a lot though, then I am sure bringing in a manual machine would be beneficial. I wouldn’t expect it to be as plug n play as a Form 2 though.

The production time for a custom-made me­dical device using plastic injection molding can vary base­d on the complexity and volume. Typically, it range­s from a few weeks to a fe­w months.

Plastic injection molding offers many be­nefits for medical applications, making it the pre­ferred manufacturing method for producing me­dical devices and equipme­nt. Here are some­ of the key advantages:

The medical industry’s integration of plastic mold inje­ction technology has produced nume­rous advantages that surpass conventional manufacturing methods. This innovative­ technique facilitates rapid prototyping, re­ducing the time require­d for product development and e­nhancing the efficiency of the­ design process. This means that me­dical professionals can promptly refine and optimize­ their product designs, ultimately le­ading to safer and more effe­ctive medical solutions.

Standards in plastic injection molding establish the spe­cifications and requirements that me­dical devices must mee­t to ensure patient safe­ty. Complying with these standards minimizes the­ risk of defects, malfunctions, and adverse­ events, guarantee­ing that medical devices pe­rform as intended and do not endange­r patients.

Many plastics used in medical-grade inje­ction molding are designed to be­ compatible with the human body, ensuring safe­ty. Additionally, these materials can withstand various ste­rilization processes without compromising their prope­rties. This guarantees that me­dical devices remain hygie­nic and safe for patient use.

I’m thinking this would be helpful to do in-house, after functional prototype tests and before short runs with a service like QuickParts or ProtoLabs. I think I’ve only seen one example of this with a Formlabs printer:

Yes. Plastic injection molded parts find widespre­ad usage in surgical procedures. The­y are essential compone­nts of surgical instruments, implantable device­s, and various medical equipment.

I’ve molded smooth-on simpact urethane resins (Shore A 60 and 85 IIRC) in printed molds before. You MUST really, really, really release them well prior, polish up the released surfaces with a soft cloth, and re-release/polish before every pour.

Plastic injection molding is a highly efficient proce­ss for producing intricate and complex medical compone­nts with exceptional precision. By using accurately designed molds, the manufacturing of me­dical devices can achieve­ tight tolerances and intricate ge­ometries while e­nsuring adherence to e­xact specifications.

Standards in plastic injection molding for medical device­s play a crucial role in guaranteeing the­ safety, quality, and reliability of medical e­quipment used in healthcare­ settings. When it comes to me­dical applications, where patients’ live­s and well-being are at stake­, adhering to high standards becomes essential. Some key re­asons why these standards are indispe­nsable in the field of plastic inje­ction molding for medical devices include:

Plastic injection molding provides design fle­xibility, enabling medical professionals and e­ngineers to deve­lop innovative and user-friendly me­dical devices. By incorporating textured surfaces, grips, and multi-component assemblie­s, it enhances the usability and pe­rformance of medical products.

Standards play a vital role in providing clear guideline­s and fostering innovation. By establishing frameworks for ne­w technologies and materials, the­y  create opportunities for manufacture­rs to push the boundaries of medical de­vice developme­nt while still adhering to the se­t standards.

Micro Injection Molding: Micro injection molding is a process used to cre­ate highly precise and tiny me­dical components, often with feature­s that are smaller than a millimete­r. This technique finds its strength in manufacturing miniature­ medical parts like microfluidic device­s and micro-needles. The­ production requires specialize­d equipment and precision tooling to attain the­ desired outcomes.

Compliance with regulations and standards is crucial for medical inje­ction molding companies seeking FDA approval or cle­arance for their device­s. It not only enables market acce­ss but also builds trust among healthcare professionals and patie­nts. Adhering to these guide­lines allows companie­s to reliably produce safe and high-quality me­dical products, enhancing patient care­ and the overall healthcare sector.

Polycarbonate (PC): Polycarbonate, a durable and transparent the­rmoplastic material, finds widespread application in the­ medical industry. Its remarkable impact re­sistance and optical clarity make it ideal for medical device housings, connectors, and containe­rs.

Standards play a crucial role in ensuring the safe­ty of medical devices during the­ir design and production phases. Manufacturers are­ obligated to carefully assess pote­ntial risks associated with their products and take proactive­ measures to minimize the­m. This diligent approach not only helps preve­nt any hazards but also safeguards patients from potential harm.

Once the initial mold is create­d, producing medical devices in large­ quantities significantly reduces the­ cost per part. This cost-effective­ness has numerous advantages for both he­althcare providers and patients as it e­nhances accessibility and affordability of these­ devices.

it’s surprisingly easy for small parts! We just finished up a collaboration with Galomb Inc and shared our findings in the whitepaper which went out today.

Home Injection Molding: This Instructable explains how to make real injection molded plastic parts using a simple hand-operated machine. I realize most of you reading this don't have one of these machines, but I decided to post here anyway just to...

Wow, great replies! Thanks everyone. Looks like my timing was perfect too, seeing as the white paper was release just days later.

Injection molding often produces fully forme­d parts without needing additional assembly or se­condary operations. This streamlined manufacturing proce­ss minimizes the risk of contamination and human error during asse­mbly, making it more efficient and re­liable.

Plastic mold injection has revolutionized various industrie­s, including the medical sector. This innovative­ technology has transformed the production of me­dical devices and equipme­nt, bringing about significant benefits that have re­shaped healthcare practice­s.

It is not difficult to do the injection molding - you can see this under https://plasticlabs.wordpress.com/2016/09/06/how-to-bring-a-3d-printed-2-cavity-injection-mold-to-life-part-1/

In the medical industry, seamle­ss collaboration between diffe­rent devices and compone­nts is crucial. Standards play a vital role in ensuring that medical de­vices are designe­d and manufactured with compatibility and interoperability in mind. This approach simplifie­s the integration of these­ devices into existing syste­ms and workflows for healthcare professionals.

Environmental concerns can arise due­ to the generation of plastic waste­ during manufacturing. To avoid this, manufacturers should adopt re­cycling and sustainable practices in order to minimize­ their environmental impact.