Real-time insights and scalable automation for cutting-edge medical device production

For medical device manufacturers, scaling production is not just about building a functional production line but also about making sure that millions of devices are produced flawlessly. Yet, many conventional assembly processes remain a “black box”, with quality assurance limited to pre- and post-assembly inspections. These legacy methods create significant challenges: they consume valuable floor space and require numerous specialized tools. Beyond operational inefficiencies, they affect regulatory compliance, yield, and scalability. To meet stringent standards such as FDA 21 CFR Part 11 and EU MDR, manufacturers must demonstrate consistent product qualityby providing fully traceable and audit-ready process data. Optimized layouts and minimal downtime are also key factors. 

To address these challenges, ATS LSS and Kistler Group collaborated for an automated assembly line that makes previously invisible aspects of production measurable and controllable. The system integrates ATS LSS’ expertise in digitally synchronous motion and modular automation with real-time force and displacement sensing from Kistler, enabling assembly and in-line verification of medical devices at speeds exceeding 300 parts per minute and the flexibility to handle multiple product types on a single line. These improvements reduce overall cycle time from 3,750 ms to 750 ms, delivering rapid, precise, and traceable in-line process monitoring.

From assumptions to assurance through real-time data 

At the same time, the real-time force and displacement monitoring from Kistler allows Symphoni™ to measure and verify critical steps of medical device assembly as it happens. In-line waveform analysis detects potential failure modes, while a patent-pending inertia compensation system neutralizes the effects of high-speed motion on force measurements. These capabilities enable precise evaluation of force and distance, reducing false positives and negatives and eliminating the need for separate inspection stations. All collected real-time data can be stored across multiple databases, supporting process optimization, regulatory compliance, and rapid ramp-up of new production lines.