CASE STUDIES

Leica Biosystems: Leica BOND-III Fully Automated IHC & ISH Staining System

An innovative robotic architecture delivers superior throughput for automated IHC & ISH staining and provides diagnosis up to 50 percent faster than previous generation stainers.

Client: Leica Biosystems

Product: Leica BOND-III Fully Automated IHC & ISH

Awards

2011 Medical Design Excellence Award, IVD

Regulatory Requirements

UL 61010, EN 61326, FDA Class III

Expertise Used

Fluidics, Motion, Industrial Design, Usability/HFE, Connectivity & Systems Integration, Consumable Design

Breaking into the histology market

We have now developed three generations of the Bond tissue staining platform, the most recent iteration being the Leica Biosystems BOND-III, a fully automated immunohistochemistry (IHC) and in-situ hybridization (ISH) staining system that improves speed, efficiency and quality to histopathology laboratories and hospitals throughout the world.

We developed the original BOND platform for our sister company, Vision Biosystems. Now known as Leica Biosystems, this staining platform has experienced considerable commercial success with more than 5,000 placements worldwide across the three product generations. The BOND instrument family has become the backbone of Leica Biosystem’s business and has enabled them to expand to supply about one-third of the histology market.

The Leica BOND-III instrument enables laboratories to meet increasing workloads using existing resources, allowing laboratories to save time, and ultimately, reduce cost.

Developing a unique consumable

At the core of the BOND system is the unique Covertile™ consumable we created. This patented technology facilitates gentle, even reagent flow over tissue samples, preventing reagent evaporation and minimizing waste generation. There were many subtleties within its design to ensure it met the requirements across the full range of fluid properties. These included viscosity and environment conditions like operating temperate and altitude, together with tight engineering tolerances down to 10µm in areas.

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Covertile™ technology produces improved staining outcomes

Listening to customers & end users

In developing the BOND-III, we focused on end-user interaction to incorporate a range of high-efficiency features for less user intervention. We accompanied Leica Biosystems on lab visits in the United States and the United Kingdom to collect voice of customer research and identify opportunities for innovation. As we developed the instrument, we constructed product prototypes from foam and software prototypes to assess instrument usability, which included recruiting representative users from local labs. 

We helped reduce reagent use and hazardous waste to levels lower than any other fully automated staining system. New high-capacity containers were introduced, requiring less reagent and waste management, and designed to be filled without removal from the instrument. Maintenance reduction and waste disposal costs being the positive outcomes.

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High capacity containers ensure a better user experience

Platform innovation to deliver better results faster

A core innovation was the addition of dedicated bulk fluid robots (BFRs) to the staining platforms—one robot for each of the three platforms. These deliver fluids to 10 slides on each rack, leaving the main robot arms to deliver the primary reagents to the (maximum) 30 slides that can be on an instrument at a time. Complex control software was required to efficiently schedule each of the robot’s actions to significantly reduce protocol run times.

To ensure the robots did not interfere with instrument usability or maintenance, a unique retractable mechanism was developed. The robot can be completely retracted into the rear of the instrument, allowing easy access to the work surface for cleaning and maintenance.

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Bulk fluid robots enable class-leading staining

More Case Studies

Below are a selection of case studies highlighting the range of problems we’ve solved to deliver innovation and business value for our clients.