Working in partnership during the product lifecycle to develop and prototype a Point-of-Care diagnostic device and microfluidic cartridge
ITL has worked with Vivacta for many years, starting with their first technology platform for personal gas dosimetry in 1994 under the name PiezOptic. The company had developed pioneering piezofilm sensors using technology licensed from the Centre for Applied Microbiology Research (CAMR) (Now the Defence Science and Technology Laboratory (DSTL)) at Porton Down.
This gas sensing system comprised a disposable badge (worn on the person) which incorporated their piezofilm technology and a reader for measuring the electrical charge produced when gasses reacted with chemistries deposited on the film. This system monitored the level of exposure that the individual has had to specific gasses.
At this time, ITL invested in PiezOptic and worked with them to further develop both the badge and the reader.
A significant research and development programme in order to convert the system and develop the diagnostic chemistries
Soon, ITL and PiezOptic began to explore other applications for their technology and discovered that the patent from CAMR could be extended to testing biological fluids.
This new application required a significant research and development programme in order to convert the system and develop the diagnostic chemistries. In the early stages ITL provided the engineering support necessary for the adaption of the sensor.
This included developing concepts, testing and verifying 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
A highly sensitive yet cost-effective and user-friendly point-of-care in-vitro diagnostics device
During this development, PiezOptic were renamed PanOpSys and patents were secured for the biological applications. Their aim was now to utilise their innovation within a highly sensitive yet cost-effective and user-friendly point-of-care in-vitro diagnostics device.
ITL provided PanOpSys with a prototype Chemistry Development System (CDS) to facilitate fundamental research and prototype design.
The prototype development included the following elements:
- Design of test strips to accommodate
- PanOpSys 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 microfluidics 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.
PanOpSys then became Vivacta and, with the principles of the concept proven, the focus shifted to the challenge of designing an instrument to incorporate the system.
At Vivacta’s request ITL worked jointly with a third party industrial design agency to integrate the mechanisms described above into an aesthetically pleasing package, incorporating usability and ergonomics into the device.
Alongside the mechanical and industrial design, Vivacta enlisted the skills of ITL’s software and firmware engineers for the writing and implementation of the necessary software elements of the system.
To accommodate Vivacta’s marketing plans ITL was contracted to build 50 advanced 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.
$90m aquisition by the healthcare giant Novartis in 2012
Vivacta were then able to utilise these devices for further in-house chemistry development, the results of which lead to a $90m acquisition by the healthcare giant Novartis in 2012.