Periodic Reporting for period 1 - Osto.Me (Ostomy Market Disruption: First Leak Proof Ostomy Appliance removing the need for Accessories in the Ostomy Market) Reporting period: 2020-04-01 to 2020-09-30 Summary of the context and overall objectives of the project From annual international health record research, and considering various factors, there are an estimated 10m ostomates around the world. Each day these ostomates, rely on a pouching system to collect and manage their urinary or digestive waste as a result of illnesses such as colorectal or bladder cancer, irritable bowel diseases (IBD) , trauma and many others. During surgery, a spout of intestine in brought through the abdominal wall and stitched in place, this spout is called a stoma. A baseplate is cut to fit the stoma at each application (avg. 2-3 days) and a pouch is attached.Industry and clinical research identifies the shortcomings of these pouching systems (appliances) and in response, has supported the development of various accessories such as pastes, tapes, belts and seals, to reinforce the base appliance and reduce the incidence of leakage and peristomal skin irritations. The reality for ostomates is that each application requires a “recipe” of accessories to fill in crevices and scarring indents with these pastes and seals to ensure the baseplate seals entirely and no waste can affect their peristomal skin. As enzymatic waste is excreted, it is absorbed into the baseplate and seal materials (typically hydrocolloid), which swells until saturated and begins to degrade allowing this effluent to irritate the peristomal skin. Degradation of the seals and baseplate is now a normalised attribute of these current day appliances and so “leakage” is a catastrophic failure of the appliance leading to embarrassing situations and moments of low self-esteem and confidence. In fact, this degradation of the seal, impacting peristomal skin, even slightly, is a concern for ostomates who rely on these appliances to live full and varied lives, as an otherwise healthy and active community within society. The dignity, wellbeing, and long-term health of all communities within our population should be a shared priority. With pressure to manage healthcare budgets and the introduction of “smart” measuring technologies, ostomy care is, like all aspects of health, subjected to scrutiny and cost management efforts by national governments and their stakeholders. Today a typical ostomate monthly allocation is 10 baseplates and 30 pouches, in line with the average 3-day change period. However, this allocation does not consider the need for ostomates to participate in exercise and require additional changes. For example, a weekly swim introduces an additional 4 changes per week and yet would not meet the recommended weekly level of exercise for a healthy lifestyle.It is important to review the cause of cost rather than develop policy which restricts the current expenditure. The project objectives were:• To identify the minimum performance thresholds that must be met for ostomy appliances to be considered successfully functional, economically viable, and environmentally sustainable• To calculate the market price of the proposed solution against competitive offerings based on established performance related premium pricing in the ostomy market today• To define the challenges in scaling and the overall resources needed to commercialise should a solution be identified Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far Three key tasks were developed to address these objectives:• A team of proven, highly technical specialists was assembled to investigate and test existing appliances within real life scenarios for their performance, limitations, strengths, and design aspects. In addition to this, freedom to operate reviews were conducted on the general ostomy care landscape to identify heavily patented areas of development and map potential areas for exploit. • A global team of ostomates – ileostomates, having a stoma formed from the ileum part of their intestine- was assembled to conduct analysis, interviews, focus groups and needs assessments throughout the project. Ileostomates were chosen as the hardest test case to solve with both higher more enzymatic output that can be both liquid and solid. • A commercial and clinical advisory board was assembled to inform, guide and connect the investigating team with key opinion leaders, areas of innovation in materials, design and concept development, as well as access to industry partners and specialists in R&D, market entry and commercialisation strategy. A full analysis of market leading appliances was conducted with findings on their limitations, thresholds of reliability and materials. A component analysis to understand their role in the pouching system and performance within average wear time and varying lifestyle needs. Highly iterative focus groups and interviews were conducted to understand the requirements of users within different needs. Clear design goals highlighted aspects for technical review and confirmed the impact of shortcomings as well as defining minimum performance expected by users.A review of potential materials and designs were identified within the project, prototyped, and tested as well as formative evaluations to examine their suitability. Specific prototypes were analysed further with the commercial advisory team to understand their economic feasibility, suitability for mass manufacturing and potential environmental aspects which could be improved for a more sustainable long-term solution. Following this feasibility study and the identification of a potential solution, the company will proceed to secure funding to support a robust development phase finalising the appliance and completing the manufacturing process. A pilot trial will be conducted before final design freeze and a clinical trial will be conducted with remote participants within their active lifestyles to truly reflect the use environment and evidence the improvement in design and materials for ostomates. A roadmap for evidencing the health economic advantages for payers and societal impacts is also developed and will be conducted within this next phase of development. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) Current state of the art is developed to be passive, inflexible solutions but are used within highly active environments considering both regular and erratic movement, enzymatic output, clothing restrictions and body compositions of adipose fat all adding their own complexities. Our solution is developed as an active appliance to work with the body and actively react to environmental changes ensuring an appliance which delivers peristomal skin protection and security to the user for a defined period.In addition to our solution is the development of a minimum performance testing threshold that should be adopted as a new standard in ostomy care ensuring appliances brought to the market can demonstrate this minimum performance for users and promote their long-term peristomal skin health and active lifestyles. The feasibility project has resulted in:• To deliver a solution within the existing healthcare budgets but delivering long-term outcomes to reduce clinical care costs and ancillary illnesses caused by sedentary lifestyles, negative mental health challenges• Reduction of product related issues for specialist nurses redirected to skin health education and emotional support for new ostomates post-surgery• The mobilisation of the ostomy community to engage in full employment, healthier lifestyles in their community and wider society• Demonstration of value-based outcomes and the benefits of holistic problem solving through supporting innovation Issue of leakage being addressed
