New device could ‘revolutionize’ the lives of people living with ostomy bags

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A new device invented on an attic sewing machine could revolutionize the lives of thousands of people living with ostomy bags and save the NHS time and expense with an injection of specialist support from a Scottish university.

In the UK alone, one in 400 people having surgery have an ostomy bag to create an opening in the body to remove waste. The technique is used to treat and manage a range of medical conditions, including several cancers, Crohn’s disease and bowel incontinence.

While individuals are encouraged to lead normal lives, bag leaks are common despite a range of products on the market. Leaks or fear of leaks lead to embarrassment, loss of confidence and dignity, and in some cases reluctance to socialize or participate in activities that people previously enjoyed such as sports. Leaks can also have a serious impact on the skin, causing painful sores that require regular treatment.

For hospital patients, changing a soiled bed is a 38-step process that can happen several times a day, while an operation must be interrupted to sterilize the area and equipment if it happens during surgery. Elderly patients cannot be discharged from hospitals if their bag leaks, which can block hospital beds. Skin management is also an ongoing issue.

Now a South Lanarkshire woman has developed an invention that contains ostomy bag leakage, keeping it away from the skin and giving people time to change their bag without embarrassment. Working with Heriot-Watt University to get the device listed on prescription, thousands of people seem set to benefit from the resulting reduced costs.

Anne Inch, 67, a former director of an energy company, and her husband Iain, 68, both carry ostomy bags. A particularly upsetting hospital stay for Iain motivated Anne to tackle the problem head-on.

Anne said: ‘Iain was in hospital and in one day his bag leaked nine times. Changing hospital sheets has a huge impact on nursing time and Iain was understandably distressed. I went home that night and designed ConfiPlus using a disposable sheet. That was in 2015 and it was finally patented in 2020. It’s a device for dignity so individuals like Iain and I, no matter how old they are or what they’re carrying a bag for, can live a life ordinary with more confidence.

“It allows people to go to work wearing a white shirt, play school or go out to dinner happy knowing they won’t have an embarrassing moment. It’s often the fear of a leak that destroys someone’s trust, so we’ve created an insurance policy. Because ConfiPlus is so absorbent, the user has time to get changed even if their bag leaks because the waste is absorbed by ConfiPlus. When I brought my design to the hospital the next day and Iain tried it out, everyone on the ward wanted one and the nurses couldn’t believe how effective it was.

In 2019, Anne enlisted the help of her longtime friend, Lisa Crombie, to help set up Confidence Plus Ltd, the company that brought ConfiPlus to market.

Crombie added: “There hasn’t been a redesign of products on the market for years and there is little investment in design and development. Current accessories try to prevent leaks from happening in the first place with sticky bandages. However, this means people don’t know they’ve leaked until it’s too late and skin irritation sets in quickly. We want to bring the device to everyone who needs it by making it available on prescription and in nursing homes but, for a small business like ours, it’s difficult to navigate the avenues to get the device adopted by the NHS. This is why we called on the specialized support of Heriot-Watt University. »

The donut-shaped device fits around the ostomy bag and is suitable for a colostomy, ileostomy or urostomy. If a leak occurs, the medical grade absorbent material sucks it into the foam. At 2mm thick, soft and discreet, the device contains odors and can absorb up to half a pint of liquid. This allows the user to change before anything reaches their clothes.

The global market for ostomy drainage bags is expected to reach nearly $4.1 billion by 2027, driven by the increasing number of ostomy operations, owing to the aging of the global population coupled with more chronic diseases such as colorectal cancer, bladder cancer, Crohn’s disease and intestinal inflammation. diseases. Cutting through this billion dollar market requires specialist support.

Professor Marc Desmulliez, Director of the Medical Device Manufacturing Center (MDMC) at Heriot-Watt University, said: “We recognize the incredible game-changing potential of this device for patients and healthcare professionals, so we support ConfiPlus helping them get the product into clinical settings as quickly as possible. Navigating the clinical evaluation process is difficult and tortuous for new businesses. The NHS regulatory landscape is necessarily complex to protect patients, but it is also slowing the introduction of products that could save the NHS big money, reduce nurse intervention and free up hospital beds.

“The MDMC was created to help people like Anne and Lisa navigate the difficult path of medical device regulation and prepare product cases to help new items become available on prescription. Our support is free for SMEs to support innovation in Scotland and beyond. Although ConfiPlus is currently available over-the-counter, we firmly believe that everyone should be able to wear their ostomy bag with dignity and that it should not depend on the financial ability to pay for such a product.

“Usually when you make a medical device for a hospital, you can compare it to similar products, but this product is unique. Setting up a clinical evaluation is very difficult for an SME, so this is where the MDMC can step in, find the right experts to advise the company, find the right hospital for the trials and maximize the chances of adoption quickly. ConfiPlus is the first company in Scotland to use the new tool developed by NICE to prepare an effective health technology assessment document.

Lisa Crombie concluded, “The support provided by MDMC has been invaluable, helping us meet the challenges of bringing this product to the mainstream much faster. The MDMC team at Heriot-Watt University helps us access expert advice. They fill a much-needed gap for companies like ours. We also plan to collaborate on future designs to combine the ConfiPlus with ostomy bags for greater ease of use.

“ConfiPlus is a game changer for patients, nurses and the NHS. Companies that make ostomy supplies have a vested interest in ensuring hospitals use company-specific products, but ConfiPlus aims to shake up that approach.

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