A new device invented on an attic sewing machine could revolutionise the lives of thousands living with stoma bags as well as saving the NHS time and expense with an injection of specialist support from a Scottish university.  

In the UK alone, one in every 400 people undergoing a surgical procedure have a stoma bag to create an opening in the body to discharge 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 a normal life, leaks from bags are common despite a range of products on the market. Leaks or the fear of leakage leads to embarrassment, loss of confidence and dignity and, in some cases, a reluctance to socialise or participate in activities people previously enjoyed like sport. Leaks can also seriously impact the skin causing painful sores which require regular treatment.

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

Now, a woman from South Lanarkshire has developed an invention that contains stoma bag leaks, drawing it away from the skin and allowing people time to change their bag without embarrassment. Working with Heriot-Watt University to have the device listed on prescription, thousands look set to benefit from the resulting reduced costs.

Anne Inch, 67, previously an energy company manager and her husband Iain, 68, both wear stoma bags. A particularly upsetting hospital stay for Iain motivated Anne to tackle the issue head-on.

Anne said: “Iain was in hospital and in a single 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 bedsheet. That was in 2015 and it was finally patented in 2020. It is a device for dignity so individuals like Iain and I, regardless of age or the reason for wearing a bag, can live ordinary lives with greater confidence.

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

In 2019, Anne enlisted the help of her long-time friend, Lisa Crombie to help her create Confidence Plus Ltd, the company that has brought ConfiPlus to market.

Crombie added: “There hasn’t been a shake-up of the products on the market in years and there is little investment going back into design and development. Current accessories try to stop leaks happening in the first place with sticky dressings. However, this means people don’t know they’ve leaked until it’s too late, and skin irritation occurs quickly. We want to bring the device to everyone who needs it by making it available on prescription and in care homes but, for a small company like ours, it is a difficult process to navigate the pathways to have the device adopted by the NHS. That is why we have enlisted specialist support from Heriot-Watt University.”

The donut-shaped device fits round the stoma bag and is suitable for a colostomy, ileostomy or urostomy. If a leak happens, the absorbent medical grade material draws it into the foam. At 2mm thick, soft, and unobtrusive, the device contains smells and can absorb up to half a pint of liquid. It allows the user time to get changed before anything reaches their clothes.

The global market for ostomy drainage bags is set to reach nearly $4.1 billion by 2027, driven by increasing number of ostomy surgeries, due to the world’s ageing population coupled with more chronic conditions such as colorectal cancer, bladder cancer, Crohn’s disease, and inflammatory bowel diseases. Cutting through this billion-dollar market requires specialist support. 

Professor Marc Desmulliez, manager of the Medical Device Manufacturing Centre (MDMC) at Heriot-Watt University, said: “We recognise the incredibly life changing potential of this device for both patients and healthcare practitioners, so we are supporting ConfiPlus by helping them to introduce the product into clinical settings as quickly as possible. Navigating the process of clinical evaluation is difficult and tortuous for new companies. The NHS regulatory landscape is necessarily complex to protect patients, but it also slows down the introduction of products that could save significant money for the NHS, reduce nurse intervention and free hospital beds.

“The MDMC was set up to help people like Anne and Lisa to navigate the challenging path of medical device regulation and prepare product cases to help new items to become available on prescription. Our support is free to SMEs as a way of supporting innovation in Scotland and beyond. While ConfiPlus is currently available over the counter, we strongly believe that everyone should be able to wear their stoma bag with dignity and it shouldn’t be down to financial ability to pay for a product of this type.

“Usually when you make a medical device for a hospital, you can benchmark it with similar products, but this product is unique. Putting together 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 trials and maximise the chance of adoption quickly. ConfiPlus is the first company to use in Scotland the new tool developed by NICE in order to prepare an effective healthcare technology assessment document.” 

Lisa Crombie concluded: “The support provided by MDMC is invaluable, helping us to navigate the challenges of bringing this product to the wider public far more quickly. The MDMC team at Heriot-Watt University is helping us with access to specialist advice. They fill a much-needed gap for companies like ours. We also plan to collaborate on future designs to combine the ConfiPlus with stoma bags for greater ease of use.

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