MDA is shifting to digital, personalized devices - shrinking batch sizes and raising assembly complexity. To keep Overall Equipment Effectiveness (OEE) high within tight cleanroom footprints, manufacturers must automate manual tasks and adapt processes on the fly.
B&R’s innovative and adaptive machine portfolio combines open architecture with mechatronics like ACOPOStrak, SCARA robotics and ACOPOS 6D, vision – and software solutions for contact‑free, sterile handling and parallel processing, boosting throughput without compromising quality.
Make small batch assembly profitable! Let’s adapt your MDA line for batch size one with full traceability.
The challenge
Medical devices are becoming more complex, variants are numerous and batch sizes smaller. Conventional, rigidly linked assembly lines are reaching their limits while profitability suffers, and enhanced complexity demands agility and precision while increasing scale- and traceability.
The solution & key technologies
B&R's answer is the Adaptive Machine. We provide machine builders and manufacturers with the technological foundation for production systems that can handle product changes "on the fly" and eliminate errors before they occur.
The result: flexible, precise assembly lines that reconfigure quickly for new stock keeping units (SKUs), scale efficiently, and deliver consistent, compliant quality at lower total cost of ownership.
Ready for any medical environment
With ACOPOS 6D, your medical devices float magnetically through the system. Since there is no mechanical friction, no abrasion or particles are generated – perfect for ISO-certified cleanroom classes.
Designed to adapt to your assembly processes
Mass production with batch size one flexibility: Our track systems decouple process stations. Slow processes (e.g. UV curing) no longer slow down fast processes like vision check.
Integrated Robotics & Vision
Synchronising key technologies like vision and integrated robotics unlocks innovative solutions for pick & place, quality control and kitting.
Microsecond synchronization
B&R integrates the processing of delta and SCARA robots as well as image processing directly into the controller.
Precise tracking
Robots grip components from moving track shuttles with the highest accuracy – essential for assembling multi-part devices.
Quality assurance
Integrated camera systems inspect each assembly step in real time and save the data for the Device History Record (DHR).
Why choosing B&R for your Medical Device Assembly journey?
Benefits for the machine manufacturer
- With track systems and 6D technology, customers can save up to 50% of cleanroom area maximizing space efficiency.
- Certified mapp Technology software modules simplify audit trails, user management, and alarm systems, which streamline the GAMP 5 validation process.
- Machines feature a modular design, so customers can easily expand their system capabilities with additional modules whenever needed.
Benefits for the end user
- Multi-format lines make it easy to produce various product variants - such as different pen colors or needle lengths on a single line. This enables swift changeovers with minimal downtime instead of lengthy reconfigurations.
- Regulatory compliance is achieved by seamlessly fulfilling standards, including Food and Drug Administration (FDA) Code of Federal Regulations (CFR) 21 Part 11 and Unique Device Identification (UDI) requirements, through integrated data acquisition solutions.
- Investment protection comes from having an adaptive production line that remains future-proof and continuously adjusts to accommodate new products and market demands.
References and success stories
Insights into real-world applications and partnerships: See how companies worldwide are benefiting from our solutions.
Biotechnology
Biotech labs need automation that is precise, sterile, and flexible. Discover how B&R enables adaptive, fully compliant lab workflows that scale with future therapies.
Pharmaceutical
Pharma manufacturers need speed without compromising compliance. Discover how B&R enables agile, data-driven production with full traceability and future-proof automation.
