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A world leader in low-temperature sterilization technology came to us for help with developing an improved version of their popular sterilizer. Our client challenged the team to design and engineer several subsystems. We created a tailored development process by integrating engineering, industrial design and ergonomics and including quality assurance, risk management, regulatory compliance and manufacturing documentation.

We incorporated an innovative automatic door system and hands-free ergonomic footpad into their original product. We optimized the electrical system and improved the thermal management of the sterilization chamber. We also collaborated with the client to improve both the consumable primary and secondary packaging. Our innovative enhancements allowed our client to leverage their revenue and become one of the world leaders in their market.

Infection-related issues in endoscope cleaning and reprocessing are an important concern in the health sector and many efforts have been made to develop more efficient automated endoscope reprocessors (AER).

A world leader in high-level disinfection reached out to us asking to develop an engineering solution to overcome infection-related issues. We conducted extensive research, including interviews with hospital staff responsible for reprocessing endoscopes to better understand the critical elements of the existing design.

Our goal was to create a reprocessor that would increase the number of back-to-back cycles that could be performed in a single day. The processing basin was re-designed to overcome existing corrosion issues and shadow areas. We optimized the anti-backflow system that prevents contamination of the facility water system. We developed the channel connectors and block and leak test unit. After developing a more efficient reprocessor unit, we performed feasibility studies in-house by inoculating endoscopes with artificial soils and processing them in the newly developed AER to determine cleaning efficacy.

Beyond helping world leaders in low-temperature sterilization and high-level disinfection develop a range of sterilizers and automatic endoscope reprocessors, we completely engineered and manufactured their latest generation of Bacterial Indicator Evaluator Resistometers (BIER). BIER units are mainly used by sterilizer and biological indicator (BI) manufacturers when monitoring their sterilization process to determine resistance characteristics of bacterial spores within BIs. This technology relies on the rapid and precise exposure and removal of samples to a sterilizing agent to determine the BI D-value. We identified critical elements of the existing design and developed a new BIER unit that offered significant improvements while exceeding FDA performance guidelines.