Prototype to Production: A Proof of Concept that Transformed Operations
For medical device manufacturers, precision isn’t optional–it’s everything. A single inefficiency can lead to costly downtime, compliance delays, and production bottlenecks.
For one prominent healthcare company, they knew they needed high-speed automation, but they had one major concern: finding a partner who could meet their strict requirements.
The Challenges:
This leading medical device manufacturer needed a system that could:
minimize product handling to reduce contamination risk,
achieve ultra-fast cycle times for higher throughput,
reduce validation for faster compliance, and
fast deployment to accelerate time to market
They didn’t just need automation; they needed proven automation that would seamlessly integrate into their processes.
So, instead of just offering a solution, we proved it.
Validated Proof of Concept
Our Proof of Concept (PoC) wasn’t just theoretical—it delivered measurable results upfront:
Minimal Product Handling – We designed a custom robotic system with precision end-effectors, reducing manual intervention and ensuring delicate yet efficient product movement. By optimizing product flow and reducing robots from three to one, we minimized contact, a critical factor for the client, while also cutting costs.
High-Speed Automation – Our PoC achieved a pick-and-transfer rate of 350 parts per minute, surpassing expectations. This was enabled through a mix of AI vision, encoders, specialty grippers, and product flow redesign, validated using simulation software.
A Proven Solution in Action
Accelerated Time to Market – Leveraging our modular U2R Chassis, designed with GMP and cleanroom standards, we enabled rapid deployment—reducing delivery time by eight weeks.
Streamlined Validation – Our approach incorporated pre-validated components and automated data logging, cutting validation time by 40%. With GAMP 5- and FDA 21 CFR 11-compliant Secure PLC and HMI coding, along with a structured IQ, OQ, PQ checklist, we simplified and accelerated the FAT and SAT processes, allowing the customer to market their product faster.
Safety System Compliance – We applied a structured, standards-based safety validation process centered on process discipline, technical rigor, and compliance-driven results. Our engineering team performed a task and hazard-based risk assessment aligned with ISO 13849-1. We utilitzed a TÜV-recognized SISTEMA software to evaluate all safety functions for the required Performance Level (PL), Diagnostic Coverage (DC), and Category architecture and designed and validated safety architecture using Safety PLCs, redundant e-stops, and interlocked gate switches, compliant with Category 3 / PLd. Our team also developed a detailed audit-ready validation report including SISTEMA analysis, I/O validation, wiring diagrams, and risk mitigation strategies, all while working with the customer’s quality and regulatory teams to align documentation with medical device QMS standards.
Before commitment, we earned their trust.
By proving our solution before commitment, we removed uncertainty, built confidence, and won the project. Today, our client operates a fully automated, high-speed production line—exceeding their initial expectations.
Are you facing similar challenges in medical device automation?
Let’s prove what’s possible—before you commit.