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.
