A new kind of bubble
Ultrasound is a very well-known technique in healthcare. Hospitals have hundreds of devices to perform ultrasound examinations quickly and easily. For the past 20 years, there has been a contrast agent for ultrasound, in which microscopic bubbles are introduced into a bloodstream to image the blood flow to organs, such as the heart, kidneys, liver and prostate, and in breast cancer research. The disadvantage of these bubbles is that they vary in size from 1 to 20 micrometers. Each bubble behaves differently, which is detrimental to the image quality.
Wim van Hoeve is Managing Director of Solstice and explains what their innovation entails: "By making the bubbles the same size, the size of a red blood cell, each bubble reflects in exactly the same way and you get much more echo signal. In this way, measurement methods become much more sensitive, which is a major step forward for healthcare. You can even use the bubbles as small sensors to measure blood pressure locally in the body, for example. Or you can use it to deliver medicines to hard-to-reach places such as the brains of Parkinson's patients."
Highly reliable
"To make this possible, we have redesigned the current process and fully coordinated hardware, software and the chemical aspects of the contrast fluid. To do this, we use a cartridge that allows you to produce a dose of contrast fluid with bubbles of constant size in a few minutes on location, for example in the hospital.
In this way, we remove the variability of the existing production process, because with manual or machine shaking, you can never control the size of the bubbles as we do now.
The production process must be reliable, because it is a medical product for which the highest requirements apply, ISO 13485 for medical devices and IEC 62304 for medical device software. And that's where ICT Group's knowledge and experience with medical products provides the added value we need to be able to market this product worldwide. ICT Group's software controls the production of the bubbles and monitors the entire process. The result is an extremely robust preparation system with microfluidics."
“ICT Group delivered 100% of what we needed. Their input will also be decisive in the future.”
Solid development process
"When we invited ICT Group to this project in 2022, we already came up with a prototype and developed some software. But, of course, it did not meet the requirements for medical products. ICT Group set up a separate team with a project leader, designers, engineers, quality experts and specialists in medical rules and regulations that worked closely with the hardware supplier. We started an intensive process to clarify the requirements. When the embedded software was developed in June 2023, we set up a very extensive test process, in which they continued to implement improvements in sprints until the product was complete and the risks were minimal. The preclinical tests have now been completed and we are on the eve of clinical trials."
Highly experienced partner
"By engaging ICT Group, we acquired a very experienced partner, which is indispensable for the development of such a complex medical product. The technology no longer holds any surprises for them. They understand what we are doing, no challenge is too big and that has the great advantage that you can continue to develop and be sure that you are doing the right thing. The constructive atmosphere and the pleasant cooperation have also contributed to where we are today. ICT Group delivered 100% of what we needed. Their input will also be decisive in the future. A product like this has never been fully developed. There will be new applications, new legislation and then ICT Group's software expertise and knowledge of healthcare is again crucial."
About Solstice Pharmaceuticals
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