G&H | ITL Case Study: Vivacta

Overview

Vivacta, formerly PiezOptic initially developed a gas monitoring system for identification and quantitative analysis of environmental and chemical gas exposure. The company pioneered piezofilm sensors using technology licensed by the Defence Science and Technology Laboratory (DSTL).

Requirements

The system comprised of a disposable cartridge that utilized novel piezofilm technology and a reader for measuring the electrical charge produced when gases react with reagents on the polymer film. Vivacta began to explore other applications for the technology and discovered that the patent from DSTL could be extended to testing biological fluids.

This new application required significant research and development input to convert the system and develop the diagnostic chemistries. In the early stages of the project, G&H | ITL provided support for the adaption of the piezo sensor, including concept development, testing, and verification of solutions for:

• Illuminating the reagents
• Controlling electrical effects
• Managing liquids within the disposable
• Electrical and fluidic connection methods
• Securing of the disposable with minimal interference

Vivacta successfully secured the patents for biological applications and aimed to utilize the innovative technology within a sensitive, cost-effective, and user-friendly in vitro diagnostic device for point of care testing. We provided a prototype Chemistry Development System (CDS) to facilitate fundamental research and prototype design. The prototype development included the following:

• Design of test strips to accommodate Vivacta chemistry
• Development of complex optics solutions required to excite the chemistry
• Design of robust electrical contact systems between the cartridge and the instrument
• Vibration-isolation mechanisms to control the effects of environmental noise which included testing and validating the system at the University of Southampton Institute of Sound and Vibration Research (ISVR)
• Designing a microfluidic cartridge and an on-instrument custom fluid pump mechanism for moving and mixing chemicals within the device
• Developing a custom bar code reader from camera chip level with a target cost of one-tenth of the industry standard
• A study and subsequent implementation of a method of avoiding counterfeiting and reuse of disposables

With the principles of the concept proven, the focus shifted to the challenge of designing an instrument to incorporate the system. G&H | ITL worked jointly with a third-party product design consultancy, Maddison, to integrate the vibration-isolation mechanisms into an aesthetically pleasing package, incorporating usability and ergonomics.

As well as mechanical and systems engineering support, Vivacta also enlisted the help of our software and firmware engineers for coding and implementation of the necessary software elements.

Results

We were contracted to manufacture 50 engineering prototypes. Having R&D and production in-house allowed our engineers and production staff to work together to produce a batch of Vivacta prototypes to almost pre-production standards. Following the build of the 50 prototypes, Vivacta then placed a second order for a further 50 units.

Vivacta was able to utilize these devices for further in-house chemistry development, the results of which led to a $90m acquisition by the healthcare giant Novartis in 2012.