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A novel solution to eliminate long wires during Intraoperative Neurophysiological Monitoring [WIONM] - Phase 1

Periodic Reporting for period 1 - WIONM (A novel solution to eliminate long wires during Intraoperative Neurophysiological Monitoring [WIONM] - Phase 1)

Okres sprawozdawczy: 2017-06-01 do 2017-11-30

Problem/issue addressed.
Intraoperative Neurophysiological Monitoring [IONM] is an innovative technology that involves the use of IONM devices to monitor nerve function integrity in the surgeries in a number of fields, such as vascular surgery, neurosurgery, orthopaedic surgery, cardiac surgery, genitourinary surgery and other general surgeries. IONM plays a crucial role in these surgeries, providing a quick warning to surgeons prior to internal nerves injuries.
Despite its advantages, IONM is not problem free. IONM uses recording electrodes connected to long wires distributed on the patient under general anaesthesia. These long wires translate into several drawbacks, including: long IONM wires that limit the manoeuvrability of surgeons during the operation; wired IONM forces neurophysiologists to monitor only one surgery per time as they have to be physically present in the operating room; or space constraints that require routing the wires, making wires behave as antennae and causing Electromagnetic Interference.

Importance for society.
There is a clear market pull for a wireless IONM solution that could solve the issues mentioned above, making IONM surgeries even more convenient and helping to spread their use.

Overall objectives.
Our goal is to bring to market WIONM, a novel wireless IONM data link.
The current Feasibility study seeks to ensure that the best approach is taken to do it. This study includes the technical, commercial and financial aspects of the project, aiming to see the viability of the proof-of-concept pre-prototype of WIONM.
This feasibility study aims at analysing the current situation of WIONM from the technical, commercial and financial points of view.
In the technical area, we updated a breakdown of WIONM’s basic components, an analysis on how these components will be successfully placed into industrial-scale production, and a revision of the parameters to fulfil in terms of standards and regulations. We found few technical issues, all of them solvable. We didn't find any serious risk that threatens the technical feasibility of the project. Some features still need to be reviewed, specifically the adaptation to the final testing and manufacturing procedures.
Regarding the IONM market, we acquired a Market Study that helped us to complete our preliminary study of WIONMs stakeholders, an identification of major market trends, drivers, restraints and opportunities. We also included a freedom to operate section that includes a patent analysis, and the IP protection and consolidation strategy. The results suggest that there is a solid market in which WIONM fits. None of the current IONM solutions uses wireless technology for data transmission, so WIONM lacks serious market threats. WIONM is, therefore, a novel approach that provides a unique solution to the final users. We will add more specific claims in our patent to strengthen our IP strategy.
The financial part evaluates the effectiveness of WIONM for creating, delivering and capturing economic value. For this, we updated costs according to the estimations of the previous tasks. We refined Soinde’s initial projections of revenues, costs, viability margin and cash flow. Numbers show that WIONM represents an excellent business opportunity not only for Soinde but also for suppliers, licensees and manufacturers. The project's financial success will also benefit Europe, as the associated investment will contribute to creating high-quality long-term direct and indirect employment related to sales and manufacturing of WIONM.
By gathering the information generated until here, we have defined the basic structures of a Business Plan, addressing the current situation of the Project, its challenges and the proposed ways to tackle them. For this, we included several market analysis planning methods (SWOT, PEST, Porter 5 forces) and summarized the key points of the Business Plan.
The conclusion of this feasibility study is that WIONM project is technically sound, a clear market pull exists, and it makes sense to pursue an application for the Phase 2 of the SME Instrument from the technical, commercial and financial point of view. Once into the market, WIONM will be the only commercial wireless IONM data link that allows full monitoring of the patient condition, recording all kinds of electrophysiological modalities while being compatible with the main IONM commercial devices.
WIONM is not only novel in the EU context, but also among global IONM solutions. WIONM will expand EU’s IP-portfolio through the development of a new technology base – directly contributing to regaining the EU’s position in the world med-tech arena, increasing innovation capabilities across related sectors.
Also, the increased profitability, competitiveness and growth of Soinde and the associated suppliers in the value chain will have a positive impact in terms of jobs and economic growth. The successful outcome of this project will attract new investors interested in this breakthrough solution. The associated investment will thus contribute to creating high-quality long-term employment related to manufacturing, sales, installation and maintenance of WIONM.
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