Stephan Vogel, Head of Global Industry Development / Industry Lead MedTech & Pharma at Kistler, explores how the company’s measurement technology and process monitoring systems help meet the increasing quantity and quality demands of MedTech manufacturing.
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In recent years, medication formulations have become more effective and patient-friendly and so have drug delivery systems such as insulin pens and other auto-injectors. Beyond the rise in self-administered insulin therapy, the demand for auto-injectors is driven by improved drug formulations that now enable the subcutaneous delivery of medications for various other diseases.
Previously, such drugs were limited to slow intravenous use due to their high viscosity or the quantity required. This shift to self-administered therapies via mechanical insulin pens and other auto-injectors offers substantial benefits to healthcare systems. It reduces treatment costs and helps to address medical staff shortages – provided the pens are safe, easy to use and equipped with appropriate safety features, such as covered needles or on-demand dosing.
However, their growing spread presents manufacturers with major challenges, including a sharp rise in legal regulations, such as the supply chain law, increasingly detailed global regulations, such as from MDR and FDA and rising pressure to reduce waste, accelerate time-to-market and lower costs. High-quality standards further increase cost pressure, with manufacturers sorting out possible faulty parts at every stage of the production process without losing good parts.
Advanced measurement technology and process control for pen production
Two issues are crucial when producing plastic components: the rapid ramp-up of production capacities and cost-efficient, reliable processes for part release. Measuring the cavity pressure and mould temperature in-line during production helps manufacturers visualise each shot as a complete process curve.
Kistler’s measurement technology includes highly accurate sensors for different needs. Direct cavity pressure sensors with melt contact deliver high-resolution data, making them ideal for fine-grained process feedback. Indirect sensors placed behind ejectors enable quality monitoring without affecting the part’s surface, while non-contact strain sensors behind the cavity walls are suited for retrofitting. When combined with intelligent process monitoring systems, these sensors can trace each part individually and document many quality-relevant parameters.
This helps manufacturers detect deviations early on and accurately predict part quality during the moulding cycle. Thanks to Kistler’s precise advanced measuring technology, pressure curves can be used to draw conclusions about the dimensional accuracy of the manufactured parts, eliminating the need for time-consuming remeasurement.
Vision systems close the gaps in quality monitoring
Despite the advantages of cavity pressure and temperature monitoring, certain product characteristics – surface quality, colour fastness and dimensional tolerances – require additional inspection. Kistler’s latest generation of vision systems combines advanced 2D, 2.5D and 3D imaging technologies to deliver high-resolution data on critical features. These include precise measurements of geometric dimensions, verification of assembly integrity and the detection of surface defects on plastic and metallic components.
These real-time systems operate in-line, ensuring every part meets defined quality standards without interrupting the production flow. They assess various visual characteristics, compress the resulting data efficiently into records and forward it to higher-level systems for seamless documentation and analysis. The result is a consistent quality assurance concept that covers nearly all auto-injector components, even in high-volume, cross-continental production scenarios.
Challenging force measurement in high-speed assembly
While optical systems are essential to close remaining quality gaps left by process monitoring, they can’t provide information about the forces acting within the assembly process itself. This is a critical gap in high-volume production settings, where cameras often assess component height before and after press-fit operations without monitoring the actual joining process or verifying force compliance with set tolerances.
Measuring these forces in high-speed environments presents a technical challenge. When sensors are mounted on rapidly moving actuators, the effects of acceleration and deceleration interfere with the force signal, making accurate measurements nearly impossible. This is true especially with tight force tolerances required to protect the glass vial with the drug within the autoinjector, for instance. To overcome this, a fully integrated solution combines a high-speed magnetic drive with synchronised force and acceleration sensors, controlled by Kistler’s maXYmos process monitoring system. This setup dynamically compensates for inertial influences, isolating the true joining force in real time and comparing it directly with specified tolerance windows. It can regulate the process by force or position, ensuring repeatability and enabling cycle times of under half a second, even for strokes of up to 200 millimeters and more.
Data integrity as a foundation for reliable manufacturing
All resulting process curves, whether cavity pressure or joining force, can be saved, analysed and compared across sites and production lines. This enables consistent quality data management worldwide and rapid process validation. Thanks to closed-loop control, integration into existing PLC environments is straightforward, and the absence of external software simplifies deployment. This approach provides direct, precise feedback at the part level, allowing for immediate sorting of faulty components without disrupting overall throughput.
Complete data integrity is a core requirement in medical device production. Each component must be traceable, verifiable and reproducible across shifts and sites to meet regulatory requirements. All data collected during manufacturing and assembly processes can be transferred either pre-analysed or as raw data in any MES, ERP or quality data management system. If no centralised analysis software is installed yet, platforms like AkvisIO on shopfloor level or JBeam with MaDaM on the global level are available.
This not only ensures full traceability in line with regulations but also forms the basis for predictive improvements, faster line validation and resource-efficient production. New production lines can be benchmarked against existing reference curves to allow consistent product quality worldwide. Thus, data integrity becomes more than a documentation requirement: it becomes a driver of product safety, cost efficiency and technological scalability.
Empowering the value chain
Sustainable success in MedTech manufacturing means more than technical precision. It requires a fully connected value chain that translates process data into actionable knowledge and links decentralised production stages via standardised quality logic, ensuring every unit produced anywhere complies with internal targets and external regulations.
When technology and know-how converge across the value chain, manufacturers gain more than process control. They create resilient, globally consistent production systems that can reliably, rapidly and at scale deliver high-quality, patient-safe devices.
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