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How a Smart IVD System Architecture Enables Flexibility

In-Vitro Diagnostics (IVD) instruments are complex systems that require a transdisciplinary engineering approach that includes all disciplines, such as mechanical, electrical, fluidical, optical, software, as well as biological and chemical components. The complex interaction between the different subsystems, their biological material, and their technical environment, is realized by a corresponding system architecture.

With growing complexity in requirements and customer needs in the IVD industry, reducing early risk and increasing efficiency during development is the highest priority. Leveraging a systems engineering provides a holistic and deliberate method, to identify and reduce risk factors early in the process while increasing efficiency throughout the entire product development life cycle. To stand out from the pure standards of these definitions, it is not essential to set the focus to sorely fulfill user needs on a short-term scale, rather, it is key to focus on providing future flexibility. The outcome is not only a higher quality product, but it also allows clients an easier integration and enables a future adaption of the assay workflow and its associated and supporting technology, considering the regulatory framework.

Automation is Driving a Smart System Architecture

A prime example of leveraging systems engineering to generate cost-savings while enhancing product functionality is the automation of assay-specific manual process flows. While manual processing requires extensive labor support that is prone to human errors and imprecision, an automated solution gives you full chain-of-custody management with minimum operator intervention, while delivering high quality, repeatable, results. To automate a process flow, many process variables must be accurate and precise. This includes pipetting volumes for the required liquids, incubation temperature of the biomaterials used, and carry-over of highly active substances and liquids. Keeping these variables under control, while enhancing reproducibility and scheduling of assay-specific actions, leads to tremendously high throughput. Consequently, taking a systems engineering approach is not only increasing the diagnostic efficiency but is also downscaling the product-related costs to deliver clients the most competitive healthcare system. Furthermore, the automated solution offers more flexibility and enables easier future integration.

Benefits of a Smart Architecture

Taking a system engineering approach when developing a new IVD device translates into cost-savings for the client throughout the whole product development life cycle.

(1) Decrease of Product Complexity

Developing a less complex product while enhancing functionality can be achieved by reducing the number of parts. The outcome is a decrease in the level of intensity of all product-related activities during the device lifecycle. In addition, it results in a better-quality product.

(2) Increase of Design Robustness

Making the design more robust will ultimately enhance the reliability and supports the consistent performance of the instrument.

(3) Increase of Manufacturability and Serviceability

Designing and developing an instrument for ease of manufacturing, will not only smoothen and shorten transfer into manufacturing but also cuts labor costs through more efficient assembly processes and furthermore supports the reliability of the device during operation.

Leveraging BIT’s Development Expertise

Developing a smart system architecture that enables future adaptability, requires an experienced engineering group that consists of experts from all engineering disciplines. Their deep understanding and profound knowledge of the complex interactions between all disciplines will guarantee that market and client demands are met. The result is a high-quality system architecture that enables the future success of the application.

Several decades of development activities made BIT’s engineers experts in systems engineering, covering deep expertise in robotics, electronics, fluidics, software, chemistry, and biology. BIT’s development group consists of more than 100 engineers and scientists, holding over 30 internal patents, focusing on translating market needs into measurable physical and chemical properties. One of the core competencies is the automation of complex assay process flows for a clientele ranging from blue-chip organizations to medium-size companies, and start-ups in future growth markets such as molecular diagnostics, hematology, and immunology.

Project Examples
  • Macro Array Diagnostic (MADX) partnered with BIT in 2017 to develop the first IVD multiplex allergy diagnostic device with an allergen panel close to 300 allergen extracts and molecular allergens. The main reason for the success of the project was the rapid development (in less than three months) of the ImageXplorer, a manual cartridge-based imaging solution. The ImageXplorer was architected in a way, that could be easily implemented in the next generation automated solution with nearly no adaptions from mechanic, electronic, and software. The fully automated diagnostic platform, the MADX 45k, has been launched as a CE-marked instrument in March 2020 after a little less than two years of development. Click here to read the full case study.
  • BIT’s R&D team successfully developed a fully-automated benchtop analyzer for its client DRG Instruments, which entered the market in 2013, and is available for sale in Europe and the US. The goal was to develop an innovative instrument with high flexibility within the testing principles. BIT’s development group created a smart system architecture, which allows for the first time the simultaneous measurement of immunoassays and clinical chemistry parameters in one work routine.