High-performing Pens and Autoinjectors: What Today’s Market Demands From Manufacturers

As biologics become more complex and patients increasingly choose at-home care, demand for pens and autoinjectors continues to surge. GLP-1 therapies have accelerated this growth even further, pushing device programs from thousands of units into the millions.

This scale has fundamentally changed what the market expects from manufacturers. Producers must increasingly deliver precise, reliable components that meet regulatory requirements around repeatability, dimensional accuracy, and patient safety. Medical-grade mold engineering and system-level integration are no longer competitive advantages. They are prerequisites for manufacturing the next generation of pen and autoinjector devices.

In this article, we answer the key questions about producing high-performing pen and autoinjector components at scale.

What has changed in pen and autoinjector device requirements?

Device requirements have become significantly stricter as the industry has evolved from traditional syringes and vials to modern autoinjectors. Regulators now look closely at wall thickness consistency, dimensional tolerances, and how parts interact under load. Each of these factors can affect how the device behaves in a patient’s hands.

Even a slight deviation in the dimension of a plunger rod can affect dose accuracy. An autoinjector housing with uneven wall sections can deform under stress. These are not cosmetic concerns—they are risks that compromise device safety and performance. Scaling production while managing these risks requires partners who understand both medical standards and the realities of high-volume molding.

Why does mold design matter for pen and autoinjector components in medical applications?

Mold design directly determines whether autoinjector components can achieve the micron-level tolerances that medical applications demand. To meet these requirements, molds must deliver predictable wall thickness, stable cavity-to-cavity behavior, and long-running dimensional consistency from startup onward.

Schöttli medical molds are engineered for these conditions. Backed by more than 72 years of precision mold development, Schöttli molds produce consistent parts from the first qualification shot through extended production runs. Their performance is reinforced by local manufacturing in California and Switzerland, which reduces logistical risk and shortens collaboration cycles.

Schöttli molds provide technical performance that aligns with real production environments, including:

• Uniform wall thickness and optimized gate placement reduce variation that can trigger validation failures.
• Alignment features and optimized clamp force that extend mold life and minimize maintenance.
• Simulation and validation before shipment prevent unexpected behavior during ramp-up.
• Maintenance reminders and optical detection readiness that support robust quality control.

How does Husky’s end-to-end approach improve autoinjector production?

Husky's end-to-end approach provides expert guidance and a proven roadmap from concept to production, eliminating the validation delays, troubleshooting complexity, and reliability risks that occur when molds, hot runner systems, and thermal control are designed separately

This becomes even more critical with medical-grade resins such as PP, PBT, POM, PC, and ABS. These materials have narrow processing windows, and small deviations in temperature or flow can generate subtle defects that only appear in assembly or end-use. When each subsystem comes from a different vendor, isolating issues becomes slow and difficult.

Husky’s integrated medical manufacturing ecosystem eliminates these friction points. Mold, hot runner, and controls are engineered together, and each system is tuned to the specific application and material. Process testing also occurs before shipment, ensuring that validation begins with a stable baseline. 

The result is a unified, predictable molding process with one accountable partner that scales reliably as device volumes increase.

What support infrastructure do high-volume medical producers need?

High-volume medical device producers need stable, validated processes, rapid issue resolution, and continuous system monitoring. 

That level of support typically does not exist in-house, where spare parts availability determines recovery speed, regulatory requirements demand transparent process control, and engineering expertise must be connected to the realities of regulated manufacturing.

Husky provides support specifically designed for these conditions, including: 

• A wide range of hot runner technologies with comprehensive support from consultation through validation documentation
• Global service and refurbishment network that ensures uptime and reliability
• Dedicated medical engineering teams that understand the nuances of device manufacturing
• Expert support throughout the lifecycle of the equipment rather than just during installation

Over time, plants with proactive support maintain higher overall equipment effectiveness than those relying on reactive service models. The performance gap widens as systems age and product volumes increase.

Choosing the Right Medical Manufacturing Supplier

As device complexity increases and regulatory expectations tighten, the difference between manufacturers with medical-grade infrastructure and those without will become more visible. Industry leaders are moving away from fragmented vendor models and toward partners that deliver precise molds, integrated systems, and long-term technical support.

If you are planning or scaling pen and autoinjector programs, contact Husky to discuss medical system solutions designed for regulated device manufacturing.