Aston University supports Sarissa to scale-up their production line processes to ensure their stroke detection device can enter clinical trials

Company Background:

Formed in 2002 as a spinout from the University of Warwick, Sarissa specialises in the development and production of novel biosensors for measurement of neuroactive chemicals. 

The company has developed a novel biosensor which enables the detection of a stroke through a finger prick blood test. This ground-breaking medical device has the potential to advance the administering of life-saving drugs, avoid costly scanning, and cut waiting times which will release capacity in the NHS.

The Challenge:

Sarissa successfully developed their ‘SMARTChip/Stroke’ device and tested it on a small subset of patients to confirm the accuracy. The next stage was to undergo clinical trials to ensure it continually provided accurate and robust measures. However, the production process at the time (making the devices by hand) meant that it was not possible to produce enough tests needed for the clinical trial, or in the long-term, to ‘go to market’. The company lacked sufficient capacity to effectively manufacture the required quantity of their SMARTChip quickly.

The Solution:

Sarissa engaged with Aston and explained their problem, and that they were looking for a partner to help them scale-up their production. Aston’s representative swiftly realised that this could become a Knowledge Transfer Partnership (KTP), a Government-funded initiative that allows companies to access the expertise of a universities academic base. A KTP specialist evaluated their project needs, successfully secure grant funding, and recruited the best academic minds to complete their project.

The Sarissa/Aston Team:

The KTP Associate, Radovan Gallo, worked closely with Sarissa to understand the precise manufacturing requirements of the device and thoroughly researched what possibilities were available to speed up production.

This development was supported by Dr Antonio Fratini from the Biomedical Engineering Group at Aston University, who applied his expertise in medical device design and certification, electronics engineering and data analysis / processing to develop a robust solution. 

Radovan, implemented a ‘best-in-class’ production line which incorporated the use of multiple robots, as well as the design and development of a unique Capillary Fill Cap which was re-designed to improve device usability and reliability radically.

During the project, Sarissa had to change the supplier of the SMARTChip, a critical component of the device, to be compliant with ISO13485 quality management system. Changing this component, slightly delayed the progression of the project, but the flexibility of the KTP process enabled Radovan to undertake essential redesigns and ensure reliability and consistency in usage.

The Results:

From a company perspective, Sarissa was able to obtain funding, specialist knowledge and university support that they would otherwise not have been able to access. At the close of the KTP, Sarissa developed a robust manufacturing process; increasing their production capacity from approximately 20 to over 200 per day! In February 2020, a few months after the conclusion of the KTP Project, Sarissa successfully produced 3000 of their devices for use in clinical trials, which are ongoing.

In the UK alone, there are more than 100,000 strokes each year (State of the Nation Stroke Statistics, 2017). By accessing positive results at the bedside in a matter of seconds, this device means drugs can be administrated much sooner, improving the chances of thousands of patients. 

As a result, Radovan’s contribution during the project was recognised in the KTP Best of the Best Awards 2019, where he won the Future Innovator Award. At the end of the project, he was appointed as Chief Engineer to lead the development and delivery of all engineering aspects in the company’s activities. The overall project was awarded an “Outstanding” grading by Innovate UK for their achievement in exceeding the project objectives.

“For me, the best thing about being a KTP Associate is the number of opportunities I had to be involved and make a noticeable impact on the company. Winning the award is not only a reflection of my work and initiative but also a recognition of the support and trust I have received from my company and academic supervisors.” - Radovan Gallo, KTP Associate

Company Quote:

“Our KTP was an excellent opportunity to bring new skills and ways of thinking into Sarissa to devise novel methods of automated production. The work of Radovan in developing the commercial design of the SMARTChip was directly responsible for £300k in sales during the project.” - Professor Nick Dale, Company Supervisor