Scale up

Our commitment to in-house manufacturing enables us to build flexible, scalable solutions that meet customer needs throughout the product lifecycle.

Scaling up manufacturing

Our fully in-house manufacturing model gives us the speed, flexibility, and scale to support customers across the entire product lifecycle and global supply landscape. As a trusted, global partner to pharma and biotech, we accelerate time to market with tailored support from pre-clinical through commercial stages. End‑to‑end integration, from design and project-specific injection molding to automated testing, assembly, and final assembly, enables us to rapidly adjust production velocity and deliver with confidence, even as demand shifts. 


How scale up works

 

Our fully in‑house manufacturing strategy enables flexible, scalable solutions that support customers across the full product lifecycle and global supply strategies. From low‑volume pre‑clinical builds to clinical supply and high‑volume commercial production, SHL Medical seamlessly manages changing volume demands, ensuring a smooth, reliable scale‑up at every stage.
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Pre-clinical, clinical, and commercial supply

From low‑volume pre‑clinical builds to clinical supply and high‑volume commercial production, SHL Medical seamlessly manages changing volume demands to ensure a smooth, reliable scale‑up at every stage. Leveraging our proven platform device portfolio and modular device development strategy, we support a wide range of production needs with speed and flexibility.

High process and technology integration, decades of prototyping expertise, and a fully streamlined production strategy enable efficient transitions, predictable performance, and scalable manufacturing from early development through commercialization.
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Tooling

SHL Medical's comprehensive mold manufacturing program is powered by our subsidiary, SHL Advantec, which guarantees the timely delivery of precise, reliable, and high-performance plastic injection molds. Investing in the most advanced equipment and technologies, paired with our proven expertise in design and innovative engineering, we ensure high-quality mold manufacturing and exceptional mold longevity. We work closely with our customers at the very early stages to fully understand their requirements and ensure that our molds are designed to the highest possible standards.

 

  • State-of-the-art mold production equipment and processes
  • High-precision, multi-cavity mold development
  • Extensive mold design and manufacturing experience
     
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Mold commissioning and production scaling

SHL Medical understands that our customers’ production needs may vary across a product’s lifecycle. That’s why we offer flexible mold design solutions, individual stack units are identical in varying cavity configurations, to support our customers’ need for volume-driven demands. Our in-house mold manufacturing allows us to engineer a wide range of high-performance, multi-cavity molds of up to 96 cavities. Robotic automation supports round-the-clock production, while every manufacturing step is persistently monitored for dimensional accuracy. 

 

  • Integrated tooling program
  • High-performance, multi-cavity tools enabling run-to-run consistency
  • Vast experience in production scale-up programs
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Automation

SHL Medical is in a unique position among medical device companies, having established our automation systems at SHL Advantec. We take pride in being a truly end-to-end solutions provider with a full range of automated systems to support any scale of product industrialization.

 

Our automation engineers lend their expertise to develop a full range of manual, semi-, and fully automatic testing, assembly, and final assembly machines to address every stage of the product lifecycle.

 

 

  • Modular platforms for cross-project compatibility 
  • Equipment commercialized for 40+ self-injection products 
  • Scalable solutions for production between 1-160PPM
  • Container-free testing machines
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Fully automated assembly and testing equipment

SHL Medical is an industry leader not only in device design and development but also in product industrialization. Our automation systems sub-group at SHL Advantec develops advanced testing and sophisticated assembly and final assembly machines, allowing us to offer fully automated solutions for rigorous testing and production needs. Designed from the ground up to facilitate modularization, these modular assembly and testing machines feature customizable stations and interchangeable fixtures supporting complex and high-volume production with shortened lead times.

 

  • Modularized, fully automatic testing and assembly machines
  • Self-developed software and integrated robotic systems
  • Comprehensive servicing and maintenance support 
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Test method transfer to customer site

If customers choose to conduct testing at their own site, SHL Medical provides technical support to ensure accurate test method transfer. We develop and validate test methods at SHL Medical facilities, then partner closely with customers to transfer them on site. Test Method Transfer (TMT) is completed through comparative testing and co‑validation to ensure aligned, reliable results.

 

  • Risk mitigation due to the equivalent test method used as SHL Medical (avoiding differences in test results for same batches)
  • Access to strong expertise in TMD and TMV
  • Time savings due to exclusive focus on TMT for the customer

 

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