Novel device brings benefits to bowel cancer patients
As a result of cancer or inflammatory bowel disease, output from the bowel often has to be redirected to the abdomen, with the creation of an ostomy. This involves surgery to create a new opening for bodily waste. Output is collected externally in an ostomy pouch, secured to the skin. “This output can be quite corrosive and fluidic,” notes Kevin Kelleher, CEO of Ostoform, Ireland. “When it flows from the ostomy into the pouch, it can leak onto the skin, causing complications.” Around 40 % of ostomy patients report skin problems. “If you can imagine adhering an ostomy pouch onto broken, damaged skin, it’s painful,” continues Kelleher. “The landing site for the pouch is damaged, so the security of adhesion is compromised. This means that the pouch might fall off, causing the patient to suffer indignity. This issue can have a major impact on patient quality of life.”
Improving patient care
The EU-funded OSTOFORM project sought to address this issue by developing and bringing to market a novel bag seal. This directs the flow of stoma output away from the patient’s skin and into the bag, keeping the skin healthy and improving patient quality of life. “We began with an element of user-focused design,” says Kelleher. “This involved developing a device that was easy to put on, and compatible with all ostomy pouches. We also conducted a patient study, which helped to demonstrate the benefits of our device.” The Ostoform Seal uses a unique, patented combination of absorbent and non-absorbent materials to prevent corrosive output from contacting the patient’s skin. A 6-week study involving 12 patients revealed a 45 % reduction in skin complications. Patient benefits include healthier skin, better usability, increased patient confidence and improved quality of life. The device can also cut costs for healthcare systems by reducing visits to ostomy nurses, and by reducing the frequency at which patients have to change their ostomy bags. The project team also ensured that the device could be easily manufactured to achieve cost-competitiveness. By the end of the project, a high-volume production method had been developed. “We recently published a clinical study in a top, peer-reviewed ostomy journal, demonstrating the benefits of our device,” adds Kelleher. “With a production line established and CE mark and FDA registration secured, we can now begin to commercialise the Ostoform Seal.”
Bringing innovations to market
Commercialisation of the device is being carried out through Ostoform, a spin-off medical device company from the University of Limerick, Ireland. Kelleher is confident that the business can become a global leader in the area of ostomy skin health. He estimates that around 1 million patients in the EU and United States could potentially benefit from the Ostoform Seal. “We have spent the past few months undergoing a pilot launch in the Netherlands and the United States,” he explains. “Feedback has been very encouraging, and we have begun to line up commercial partnerships, to get our product to the people who most need it.” With the product now on the market, Kelleher hopes that this will be the first of many exciting innovations in patient care. “We plan to continue to build our pipeline and grow the business, with the goal of becoming a world leader in the area of ostomy skin health,” he says.
Keywords
OSTOFORM, bowel, cancer, ostomy, health, skin, patient, healthcare
