From idea to IVD product – individual lab on a chip solutions

The past pandemic has shown that smart lab on a chip solutions are stronger in need than ever, for infectious disease control, but also for routine diagnostics that require quick responses or automation of demanding sample preparation workflows. Start-ups and established companies often face the challenge to transform their product idea into initial prototypes and industrial series production with limited resources in terms of time, capacities and decentralized development processes.

Hahn-Schickard offers the ideal solution from a single source. As development and manufacturing service provider of medical and diagnostic products, Hahn-Schickard accompanies customers through the entire process of product development in accordance with DIN EN ISO 13485, provides support with partners in the planning of approval studies in accordance with IVDR specifications (EU Regulation 2017/746) through to the launch of the CE-IVD product and supports transfer to mass production. 

From idea to functional model

Being experts in microfluidics, Hahn-Schickard automates and miniaturizes complex laboratory workflows. On an individual level and independent from assay type, whole or partial assay workflows can be implemented in microfluidic systems, offering optimal solutions for central laboratories or for the use at the point of care. Such automation solutions not only save valuable resources in terms of hands-on time but also precious sample material and expensive reaction materials. On top, automation strongly reduces cross-contamination risks.

Hahn-Schickard offers R&D and prototyping services allowing for fast product development cycles. Customer specific ideas and workflows are translated into microfluidic designs and realized in first functional models, with a focus on using the final material from the beginning to avoid major changes at late product development stages. 

From functional model to prototype to production

The upscaling of production processes is a core competency of Hahn-Schickard. We offer a broad range of standard processes and infrastructure that can flexibly be adapted to realize product specific processes. 

This includes 

• the packaging of liquid reagents (e.g. buffers in stickpacks),
• the coating of surfaces,
• the integration of components (stickpacks, magnetic beads, lyophilized reagents), '
• the dispensing of liquid reagents,
• the fluid-tight sealing of cartridges including product-specific quality control,
• printing of product information (e.g. UDI)
• as well as primary packaging.

During the scale-up phase, Hahn-Schickard can provide prototypes for the final phase of the product development and consecutive approval studies. Once the production line is established after the design transfer, production numbers can be ramped up to 200.000 parts per year to test the product on the market. In parallel, Hahn-Schickard supports the transfer to mass production with a strong network of expert partners.

Customer support

Hahn-Schickard also offers its services as part of the "MDR & IVDR Competence Center (MIK)" and supports startups as well as small and medium-sized enterprises in the initial implementation of regulatory requirements for new product developments. This includes the establishment of a quality management system according to DIN EN ISO 13485, the selection of appropriate software solutions, or the implementation of a standard-compliant hygiene management.

Hahn-Schickard, Freiburg, Deutschland

https://www.hahn-schickard.de/

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