G&H | ITL Case Study: TREK Diagnostic Systems

Overview

TREK Diagnostics is a global provider of microbiology solutions, including blood culture, microorganism identification, and Antimicrobial Susceptibility Testing (AST). TREK initially contracted ITL to manufacture its fully automated AST system, Sensititre. The Sensititre System is a scalable and flexible AST solution, accommodating microbiology laboratories of all sizes, which utilizes both in vitro diagnostic (IVD) and research use only (RUO), 96-well microtitre plates for broth microdilution.

Requirements

Our relationship with TREK started with a manufacturing contract for the full range of Sensititre instruments, including:

• Sensititre ARIS 2x a bench-top automated microplate incubating and reading system
• Sensititre AIM an automated inoculation delivery system to quickly dispense accurate doses in 96 well plates.
• Sensititre Nephelometer a simple solution to automate inoculum density measurements and standardize inoculation preparation.
• Sensititre OptiRead an automated fluorometric plate reading system. It utilizes fluorescence detection technology to automate 96 well microplate reading, delivery fast, accurate results.
• Sensititre Vizion a digital viewing system for use in AST. It captures and stores easy-to-read digital plate images for optimized manual reading and traceability.

After years of successful manufacturing, components within the devices were beginning to become obsolete. Having worked on solving smaller scale obsolescence on an ‘as-needed’ basis, we were challenged with future-proofing the range.

Results

One of the main issues we encountered was that FDA regulations for the redesigned devices dictate that performance must be directly equivalent to their predecessors. We developed concepts based on detailed requirement specifications from TREK for the overhaul of the instruments that would become the AIM, OptiRead, ARIS, and Vizion. The concepts were based on the need to make the devices smaller, more efficient, more aesthetically pleasing and to embrace modern technologies that were expected to supersede those currently employed.

G&H | ITL was successful in meeting all of TREK’s requirements by delivering the following:

• Design of a common X-Y mechanism to be used in both the AIM and OptiRead, thus significantly reducing costs of production and lead-times
• Footprint reduction of the AIM while maintaining plate handling capabilities
• Upgrading of the AIM user interface to include a touch screen
• Use of LED and photodiode technology to replace the more expensive and less robust photomultiplier tubes previously used
• Ensuring interfacing of new devices with existing software
• All design work fully compliant with FDA regulations
• Reduced manufacturing costs by design

For each of these solutions, we provided TREK with:

• Proof of principle instruments where new technology was implemented
• Engineering prototypes for in-house testing by TREK
• Supported regulatory applications
• Tooling, testing, and quality assurance for components and casework

Having exceeded TREK’s expectations, we became their trusted manufacturing partner for the new and improved Sensititre system. Our in-house Production Engineering team supported the transfer into manufacture to ensure a seamless handover of the redesigned products.

In 2011, TREK Diagnostics was acquired by Thermo Fisher Scientific. Thermo decided to keep G&H | ITL as its manufacturing partner and has since collaborated with us on other R&D projects.