Medication Delivery Systems
Insulin Pumps
Pain Medication Delivery
Intravenous Delivery
TIGHT TOLERANCE INJECTION MOLDING
FOR MEDICATION DELIVERY
The specialized components we produce for medication delivery systems are integral to today’s healthcare industry—and product failure is not an option for OEMs whose products are used when a patient’s life is on the line. Customers depend on our parts because we can ensure the quality, on-time deliveries, and support necessary from a precision medical injection molder.
Every day, Micro Mold, Plastikos & Plastikos Medical work tirelessly to provide life-changing innovation in the form of components for pain medication delivery, insulin delivery, intravenous therapy (IV), and more. Often, these single-use devices experience extremely high volumes, exceeding tens-of-millions of parts annually, with product tolerances as low as 0.001” in some cases.
PROCESS DEVELOPMENT
During process development, our team will scrutinize all aspects of a new mold to ensure all cavities are filling equally and a robust molding process is established. This includes steel verification to ensure spare cavities and cores can be interchanged with minimal disruption to production.
CAVITY SEPARATION
Often, with high-volume medical molding, individual cavities will need to be separated in the event that further review is required on a specific cavity without interrupting production.
CYCLE TIME OPTIMIZATION
The mold cycle time can have a major impact on the total yield that a multi-cavity mold can produce. It’s crucial to design the tool with maximum cooling to produce the lowest cycle time possible. Any additional automation will need to be considered, as it could impact overall cycle time.
MOLD LONGEVITY
When dealing in high-volume manufacturing, we have developed a robust mold maintenance routine, which is tied directly to our ERP system. It’s common to experience a mold that may exceed 10 million cycles over its lifetime.
CUSTOMER SPOTLIGHT
MEDICATION DELIVERY SYSTEMS
To satisfy the demand of patients with T1 Diabetes, a high-tech medical device company began development of an easy-to-use miniature insulin delivery pump that functions much like a smartphone. The innovative pump needed to deliver a slow, continuous supply of basal insulin to control blood glucose levels at a rate as low as 1 microliter/hour. Additionally, the pump needed to deliver a quick bolus dose of insulin during meals or when the patient’s blood glucose levels are elevated—with doses as low as 0.1 microliters.
The stringent performance qualifications of the miniature device would push the engineering and manufacturing limits of the customer as well as their entire supply chain. The molding partner selected needed to meet the following criteria:
- Hold sub ±0.001″ tolerances on features to 0.010″ up to 32 cavities.
- Preserve cosmetic surfaces while meeting functional micro‑fluidic geometry (no flash, no knit‑line fragility in flow paths).
- Validate a Class II drug‑delivery device under formal IQ/OQ/PQ with complete documentation and auditability.
- Build cavity‑level traceability and automated separation into the process to de‑risk field investigations.
- Scale from pilot tools to continuous, tens‑of‑millions/year output without drift
Why it mattered: Microliter‑level dose precision leaves no margin for dimensional creep, seal damage, or particulate introduction, any of which can alter basal flow or bolus accuracy
OUR APPROACH (DESIGN-BUILD-RUN)
1) Precision Tooling Development
- Micron‑level cavity interchangeability with custom mold bases; cooling channels tailored to part geometry for cycle stability.
- Complete 2D/3D documentation and individual steel tracking in ERP for rapid insert service and spares.
- The proximity of our tooling and molding operations shortens iteration and mold time to complete mold validation.
2) Scientific Molding & Validation
- Master Molder‑led development with eDART cavity‑pressure on every press; pressure signatures used for setup confirmation and drift alarms.
- Formal IQ/OQ/PQ, with capability studies (Cpk) on critical‑to‑function dims and Gage R&R to confirm metrology uncertainty.
- Automated cavity separation to maintain shot‑to‑cavity traceability.
3) Cleanroom Production at Scale
- ISO 7 cleanroom presses (66–350 tons) with 3‑axis robotics and mold‑protect vision.
- Micro‑shot control and resin handling tailored to shear‑sensitive, medical‑grade materials.
- Standardized press platforms to enable capacity flexibility and continuity planning.
STRATEGIC SUPPLIER PERFORMANCE
- 100% YEAR-OVER-YEAR ON-TIME DELIVERY PERFORMANCE
- 100% PRODUCT TRACEABILITY THROUGH CAVITY-PRESSURE MONITORING
- TENS OF MILLIONS OF PLASTIC COMPONENTS SHIPPED ANNUALLY
- LARGEST GLOBAL INJECTION MOLDING SUPPLIER
Customer Response
“EXCELLENT customer service. Exactly what I expect in a business partnership. They (Micro Mold and Plastikos) allowed us to meet some very challenging dimensions in multi-cavity tooling. I am not sure we could have accomplished this with any other supplier.”
— Jim L., Vice President of Operations
LESSONS LEARNED
PRODUCT DEVELOPMENT ENGINEERS
- Design for Scale: Consider how your device will be assembled as volumes increase. Going from manual assembly to fully automated can and likely will impact yields when converting from manual assembly to fully automated.
- Material selection: Again, as volumes increase, you will want to pay close attention to the cost of resin. While unique grades of material may offer certain attractive properties, the cost for a custom material will have a direct impact on your COGS. It is also extremely difficult to change materials once they are qualified.
- Tooling Wear & Tight tolerances: Have a plan in place to replace high-running molds (over 1 million cycles annually), especially molds that contain tight tolerances under +/- 0.001”. As molds age, it will become more difficult to consistently meet that tolerance over time.
- Metrology & Print Dimensions: Be mindful when creating 2-D prints and the number of dimensions that are required. Products that tend to be over-dimensioned can impact the time to validate a mold and pass a FAIR, especially over a multi-cavity tool.
- Prototyping: If you have prototyped the device, you will want to make that prototype closely match your intended production tool in terms of gate type, location, etc. This will increase the likelihood of success when scaling to a multi-cavity tool.
- Be transparent: If you have experienced issues during the prototype (no-fills, sinks, dimensions issues, etc.) be sure your supplier is aware of these issues as to not repeat them on the production-level tool.
PIONEERING THE FUTURE OF MEDICAL DEVICE MANUFACTURING WITH PRECISION, CARE, AND INNOVATION
If you’re ready to elevate your project with top-tier injection molding services, contact us today.
Contact Us
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