Carrying out full medical device design and development, working closely with Nanosonics throughout R&D, the team’s first task was to ascertain the efficacy of the technology. Extensive research at the end user level, along with segmenting processes to generate laboratory subsystems for validation–parallel to efficacy experimentation–would eventually influence the exact parameters within which the physicists, biologists and designers could work.
As much as getting these results on efficacy, and understanding the end users, Tiller Design also needed to get results on the systems architecture to make a product that would meet projected size and functionality requirements, while also being designed for manufacture.
With the immediate need to situate the new product in often tiny sonographer labs, some just 2x1 metres in size, enough for a bed and somebody to sit next to it, the end product needed to be as small and as fast as possible. In addition, it needed to be safer than existing methods of disinfecting.
The speed, safety and efficiency of disinfection methods predating the Trophon EPR were, even given best practice, unsatisfactory–mainly because because topical sprays and most disinfecting wipes are unable to achieve a high-level disinfection of ultrasound probes. Moreover, the old practice of taking ultrasound probes to air controlled rooms and immersing them in toxic glutaraldehyde was slow and dangerous. The newly designed Trophon EPR, in carrying out the cleaning process within a closed system, immediately dispensed of the need for separate, air-controlled rooms and exposure to hazardous substances.
By internally nebulising hydrogen peroxide and pumping it into a sealed chamber, the Trophon EPR successfully and repeatedly eradicates all bactericidal, virucidal and fungicidal pathogens, many of which are unique to hospitals. These include Clostridium difficile, Methicillin-resistant Staphylococcus aureus (MRSA), Vancomycin-resistant Enterococcus (VRE) and Mycobacterium tuberculosis, which causes tuberculosis, along with many others.
Subsequent extensive microbiological testing performed to AOAC, EN and ASTM International standards today shows that the Trophon EPR achieves a 6 log reduction (106) in bacterial contamination and a 4 log reduction (104) in viral contamination. In addition a chemical indicator visually confirms that all disinfecting parameters have been met.
Working out how to first nebulise hydrogen peroxide and then convert it to harmless the by-products of oxygen and water, achieving ultrasound probe disinfection and chamber evacuation in just seven minutes, was a major breakthrough.
To do this, intricate experimental tools had to be created, requiring the integration and collaboration of the product and research design teams. From a project management perspective this was a fresh and innovative approach. Bringing physicists, industrial designers, biologists, chemical engineers, marketing executives, financiers and accountants, regulatory compliance operatives and heads of R&D under one roof and into one room also proved to be a stroke of inspiration, without which the Trophon EPR may not have become the success it is today.
Through working collaboratively, experimentally and iteratively with such a diverse team, breaking new ground on a weekly basis, with every individual wholly invested in the single vision of the end product, Tiller Design and Nanosonics achieved what many other product design houses may have considered unachievable. And, in doing so, it has changed the working practices of sonographers and healthcare institutions worldwide.
CEO, Tiller Design
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