BOND-PRIME fully automated IHC system

The entire design and development phase was conducted under the rigorous design controls expected of a system that is intended for clinical diagnostic purposes with the required clearances and approvals.

The design phase of the BOND-PRIME program was anchored around extensive Voice of Customer surveys that identified the “pain points” experienced by both laboratory users and pathologists with existing IHC staining systems.

The feedback was used to quantify what level of "breakthrough" would be necessary to create meaningful impact to their operations. For example, it was determined that the diagnostic process would greatly benefit if staining times were reduced from the existing average of 2.5 hours to a 90-minute average.

The development team used iterative ideation and rapid concept development to ascertain which technologies could be adopted with incremental innovation, and which would require “breakthrough” innovation.

Key sub-systems were rapid prototyped to demonstrate feasibility against the design criteria, with incremental iterations necessary to achieve the target performance. Critical-to-quality subsystems were identified, and performance improvements "allocated" to different teams to ensure the finished product remained aligned with the design brief. For example, it took a coordinated effort from individual specialist teams to achieve quality and increased speed: a software team for the robotic scheduler, a mechatronics team for the robotics, and a science team to optimize the staining protocols.

With feasibility of the sub-systems proven, the product design team brought together the complete technical solution in iterative releases. Parallel verification testing was conducted to ensure the detailed integrated system continued to deliver not only the high-level product requirements, but also quality, reliability, and cost targets.

Leica Biosystems has built on Victoria's established medical device design and manufacturing expertise in combination with in-house design tools to deliver world class products for cancer diagnostics.

The BOND-PRIME IHC system elevates medical-device design excellence through:

• Human-centred design that helps productivity and reduces the potential for errors. Examples include an on-board user interface with critical information right where it’s needed; and a scanning system for bulk reagents that reduces the potential for reagent mix-ups by only allowing access to the container for the scanned reagent while refilling.
• Careful selection of external and internal materials to ensure longevity and staining quality in an environment where harsh chemical compounds are in routine use.
• Premium design elements that allow users to be productive in what can be a stressful and busy environment. Examples include a tactile feel for user touch points such as damped input and output drawers, gas-strut assisted hood and clean interior work surface design – elements new to this class of medical device.

To deliver on the ambitious design brief, the BOND-PRIME program team needed to deliver multiple design innovations and package them together in a complete system – including the instrument hardware, instrument and controller software, and associated reagents.

The design process has generated more than 50 patent applications (39 currently granted) covering features and functions that assist in attaining the brief’s core attributes of quality, speed, and productivity.

Design innovations incorporated into BOND-PRIME system include the following:

Quality is primarily achieved through a unique sealed Active Reagent Control (ARC) staining chamber which allows for precise metering, application, and removal of reagents as part of each staining protocol.  A key part of the ARC technology is a semi-permanent Covertile, which creates the staining chamber. This part required extensive process innovation, with an Australian-based specialist supplier, to successfully achieve a design which could be manufactured in significant volumes. The Covertile includes an over-moulded 15-micron silicone seal on a polycarbonate base, requiring reliable seal adhesion over the target life whilst maintaining extremely tight tolerance stability in the base part. The ARC design also introduces an industry-first reagent agitation process using a chamber port to accelerate the staining protocol while also ensuring a high-quality stain.

Speed is achieved through high-speed robotics controlled by a highly optimized software scheduler. The scheduler is controlled by an algorithm that monitors the main robot utilisation to ensure that each slide is stained as quickly as possible while also maintaining quality.

Productivity is achieved through a package of innovations that create a unique “Universal Access” workflow. Principal amongst these is a slide drawer system – with a Preload Drawer and a hydrated Unload Drawer. In combination with the advanced robotics, the drawer system creates a free flow of slides which constantly adapts to incoming workloads to maximize throughput while minimizing operator labour.

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020. In addition, the economic impact of cancer is both significant and increasing. To meet these dual challenges, Leica Biosystems set out to create a platform that will help diagnostic teams make a faster diagnosis for their anxiously waiting patients.

The quality of BOND-PRIME’s staining assists pathologists making the critical diagnostic decisions. The speed of BOND-PRIME compacts the diagnostic timeline so anxious patients may begin the next phase of their treatment sooner. And the productivity of the BOND-PRIME platform allows limited healthcare resources to stretch further.

With previously unattainable levels of quality control, speed, and productivity, the new BOND-PRIME IHC system has the attributes that diagnostic teams have been asking for.