Addressing unmet needs through innovation

It is estimated that there are around three million people living with a stoma bag around the world. Of these, it is believed that 80 per cent suffer from stoma-based skin complications. Most products available for ostomates are based on a 40-year-old adhesive technology, hydrocolloid, which can have a detrimental impact on their long-term skin health, comfort, relationships and mental wellbeing. It represents a significant area of unmet clinical need as so many ostomates struggle every day due to improper products.

This was something I had personal experience of, with my niece and uncle both living with a stoma. It inspired the venture that has grown to become Trio Healthcare. As a company, we focus on new advancements in silicone technology to push boundaries in stoma care. This commitment to innovation has enabled us to make a true difference to patients and the ostomy market.

When introducing a new product to the healthcare market, it does not stop with an innovative idea, however. From an initial plan, to prototype, to full scale manufacturing, careful attention must be paid to the team, the technology, the equipment and the capability to bring a new product to market.

Developing a unique technology

Hydrocolloid is typically used as an adhesive for stoma bags. It was originally designed to absorb moisture from the skin to create a sticky seal. This can, however, lead to skin damage and risks creating wounds around the stoma site. Ostomates have often said that it is also uncomfortable or painful to wear.

Recognizing this, my team and I began searching for a breathable material that could adhere to the skin without absorbing body waste, and could stay on securely throughout the day and overnight. It also needed to remove easily, so as not to damage the skin. These criteria were somewhat contradictory, so we had set ourselves a real challenge.

After researching a broad range of materials, we settled on silicone. It is a material that has been used in medicine for decades, particularly in wound care as its fundamental properties are beneficial for the skin. It had never been used in stoma care before due to its lack of ability to manage moisture and its inability to provide secure adhesion.

We needed a formulation that managed moisture by allowing the skin to breathe, which would have clear benefits as a material in stoma care. We began small-scale trials to alter the molecular structure of the material. After 548 derivatives, we successfully developed a formulation which allowed the silicone to manage moisture from the skin while maintaining a strong bond that would remove with low peel force. It became Sil2™ - the world’s first breathable silicone material.

Scaling innovation

Developing the formation of Sil2™ was challenging, but the next hurdle to overcome was establishing a new manufacturing process to scale the production of our products. As our plans for the material grew and we began looking into producing the first stoma bag in the world to offer a silicone adhesive, we knew we needed to scale further. To do this, we needed sufficient funding and organisational structure – the right people, talent and production capacity.

The novelty of the innovation meant we were able to attract interest from funders and investors who recognised the transformative promise the material had within stoma care. We sought to partner with other industry pioneers, who had taken a similar journey with an innovative material in wound care. This support enabled us to move from the small-scale manufacturing process of creating lab protypes, to building a commercial machine capable of producing hundreds of thousands of products.

We partnered with a UK-based engineering company which took our initial design concepts and helped us to design, build, test and validate a bespoke, cutting-edge manufacturing line; as we were creating a completely new material formulation, we needed a completely new manufacturing method to produce it. We also doubled our in-house R&D teams and grew our manufacturing teams tenfold, bringing in talented, experienced people to support us as we scaled production.

Evaluating innovation

The investment in our own R&D capabilities, through the expansion of our teams and the introduction of new machinery, enabled us to begin production of our first stoma bag, since named Genii^TM. By using a silicone-based adhesive, it tackles the issues many ostomates have battled with over the years: leaks, skin damage, soreness and discomfort.

With any new medical innovation, careful clinical evaluation is paramount. Over the years, we have worked closely with leading universities to assess the validity of our developments. Just last year, the University of Bradford in England published a study investigating silicone’s applications in stoma care, and measuring the effectiveness of Trio products to protect sensitive stoma skin.

International ambitions

After developing an innovative product, establishing a cutting-edge manufacturing process and gathering promising clinical evaluations, the final piece of the puzzle is often to contend with rigorous product validation and patent processes – made more complex if dealing with multiple global territories.

Establishing worldwide protection can be time-consuming and costly, but as we had a product that could disrupt the ostomy market and have wider applications beyond this, robust protection was needed. Finding the right legal team to support this is crucial, especially as different countries have their own nuances in terms of the validation process and granting patent approval.

It is especially important in healthcare to challenge norms, as it can drastically improve the quality of people’s lives around the world. We did not want ostomate patients to settle for the same old products, so we created something new. Our commitment to innovation and to the factors that play a key role in bringing new innovations to market, has enabled us to offer ostomates greater choice and access to better care. It is ultimately helping them to feel more comfortable in their own skin – something we all deserve.

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