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IRIS Feasibility Study – Phase 1

Periodic Reporting for period 1 - IRIS-1 (IRIS Feasibility Study – Phase 1)

Reporting period: 2015-05-01 to 2015-10-31

The deliverable for this action constitutes a business plan for IRIS and a report on the project management, administration, and reporting activities.

Based on the positive outcome of the IRIS feasibility study the IRIS business plan evolved from these findings to form a plan to manage IRIS and the operations for phase 2. The business plan includes a roadmap for taking IRIS towards TRL9 and a comprehensive business analysis of the current market situation. This analysis includes an in-depth investigation of current industry trends and forces, SWOT, identification of market opportunities, including detailed descriptions of several specific niches, competitors, and market sizes. This is followed by developing strategies for tackling challenges such as market entry, including a deep analysis of the domestic market, operating on a niche market, sales and business model (Commercialisation), and promotion and dissemination. The business plan also includes a risk management plan that identifies the most pertinent risks for IRIS in several categories from technical over managerial to legal. The risk management plan also lays out a strategy for implementing the ISO14971:2012 protocol (Risk Management for Medical Devices Development) for IRIS. Furthermore, the business plan contains a comprehensive guideline for the process of getting IRIS CE marked for the European markets. The business plan concludes with a financial analysis of the projected return on investment of IRIS for the next seven years.

The findings from the business plan shows that IRIS will be a unique offering on the market with a high potential for establishing a solid initial niche. The analysis of the market situation reveals that IRIS needs to address two main groups to attain a successful wide market adoption. The first is through the implementation of IRIS on proprietary hardware such as Rinicare PRIME to meet the needs of the i.e. first responders and long-distance transportation market niches. Secondly, IRIS will integrate with existing legacy hardware from other manufactures to penetrate the international markets. The business model chosen to achieve this is a licensing model that will allow IRIS to expand the market opportunities and market reach significantly. To facilitate the market uptake and raise awareness about IRIS a series of dissemination activities have been planned that includes a number of industry events, exhibitions, and conferences plus dissemination through publication through a list of identified medical journals. To support these activities a marketing promotion plan details a strategy to address the customer segments in an optimum way, including a strategy for communication and branding of Rinicare to market IRIS on export markets.

The IRIS business plan consolidates the sum of business activities to bring IRIS successfully to market though leveraging the unique selling proposition of IRIS.
The first set of activities undertaken during the reporting period were market research to investigate the potential for IRIS. The research included collecting and scrutinising market business reports from analyst consultants, research available literature regarding certification processes for various markets, researching and analysing local and global competitors and competitive products, collecting feedback from industry and clinical contacts in relation to support of IRIS, and the extraction of quantitative market data.

The second set of activities focused on the developing appropriate strategies to exploit the market opportunities and to position IRIS most favourable in the market. A significant finding discovered through the market research and analyses was a market barrier involving the changing buying behaviour of a large number of prospective customers, in particular hospital administrators and regulators, who is shifting from a focus on local efficiencies to population-level effectiveness. Therefore, the analysis of the current market situation resulted in a recommendation to pursue a licensing strategy as the main business model for IRIS. The strategy is in part to use existing hardware manufacturers as a distribution channel for the wide adoption of IRIS with prospective customers with legacy systems, in part to offer IRIS on Rinicare's proprietary PRIME hardware solution to cater to segments without an established hardware solution. Furthermore, the licensing strategy will also support the promotional strategy for IRIS with the goal of building increased brand awareness about IRIS on the broader markets. In support of this strategy the business plan outlines a series of steps to promote IRIS that includes communicating a consistent value proposition around the cost-benefits of IRIS and how IRIS differentiates from the existing solutions on the markets. This strategy was deemed feasible, suitable, and acceptable to Rinicare in support of the efforts to move IRIS beyond traditional selling through functionalities of the product alone and move focus on to value-creation marketing with a holistic attitude to understand customers' needs.
Rinicare expects IRIS to bring a significant change to the market of patient monitoring systems and the connected niches. Rinicare envisions IRIS in use across a diverse set of segment from critical care patients over nursing and care homes to prisons and long-distance passenger transports such as airlines, ferries and cruise ships. The potential for IRIS is substantial particularly in the current economic climate with national healthcare budgets across Europe are under pressure to decrease costs and improve efficiencies. While in fundamental purpose of IRIS is to save patients from common complications through pre-emptive intervention, research into the costs of the NHS in the UK indicates that the predictive capability of IRIS will also be able to substantially reduce the cost of care for the healthcare services by reducing the length of hospital stays and the need for rehabilitation.

By branding IRIS as a remote consultation and critical decision support tool for both medical professionals such as cardiovascular surgeons and paramedics/first responders Rinicare envisions IRIS to become a factor in the next generation of healthcare technology. For example, through IRIS a trained caretaker in a nursing home could use IRIS to monitor a non-critical un-well patient in the nursing home and consult with a clinician at a hospital to determine the best course of action for the patient. This hospital does not necessarily need to be the nearest hospital either, but through a system of remotely available consultants the patient could actually be attended faster through IRIS than by conventional means of going to the local hospital. Or in more serious cases be attended by the best available specialist, who might not be local.

Rinicare acknowledges that IRIS will not revolutionise healthcare over night, but there is potential to make some significant changes to benefit both patients, clinicians, and healthcare providers. The main practical challenge towards the ultimate implementation of IRIS is to establish a system and model for organising the remote consultations with the medical experts.
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