NG-Sure®

 

Medipex is project managing the technical development of a device that can provide an accurate assessment of the position of medical feeding tubes, with a £1m grant from the MRC.

Bradford Teaching Hospitals NHS Foundation Trust

Clinical Need

Nasogastric tubes (NG-tubes) are vital pieces of medical equipment that help provide vital fluids to patients who cannot swallow or need surgery/intensive care. NG-tubes are passed through the nose and oesophagus to deliver medication, liquid food or other fluids directly into the stomach. However, in 1-3 times out of 100, an NG-tube is misplaced into the lungs and ~19 times out of 100 the end of the tube is located incorrectly in the oesophagus, through misplacement or movement. Such misplacement can cause serious harm or death of liquid is then administered (known as a Never Event).  Since 2011 there have been 132 Never Events and, despite warnings, the number of reported cases has not decreased.  Current methods of checking NG-tubes are placed correctly include testing the pH of aspirated fluid from the tube using pH paper, where there is only a 50-85% chance of success in obtaining the fluid and a risk that pH is altered by a patient’s medication, or by X-ray, which is expensive, time-consuming and can be incorrectly interpreted (as seen in 57% of never events). Other organisations are in the process of developing alternative testing devices, but since these all either require gastric aspirate or rely on pH, these solutions do not address all of the issues with current methods.

Solution

Our solution, under development, is a portable, sensor-based device that can provide an accurate assessment of the position of the NG-tube through detecting unique mixtures of chemicals in vapour at the end of the NG-tube ‘smell fingerprints’ as well as measuring pH in order to comply with current guidelines. The device will be a low-cost alternative to current bedside tests, providing a clear result that does not require specialist interpretation.  This will give greater confidence to individuals responsible for checking correct tube placement and will reduce the number of patients requiring an X-ray and the associated issues, such as delays to administering medication, patient exposure to radiation and additional burden on the busy X-ray department.

Medipex’s Role

Medipex played an important role in providing expert advice on Intellectual Property (IP) for the new device and assessing the demand for the idea and the feasibility of the solution suggested. This included an assessment of the market and competitors and ultimately establishing a strategy for commercialisation. Medipex assisted in the overall project planning, including providing advice on working with third-party organisations and assisting with the determination of costs and timelines involved in taking the device to market. We also provided assistance with writing grant applications and business plans to attract investment, resulting in successfully obtaining the proof of concept funding from NIHR CLAHRC and the Yorkshire and Humber AHSN that was used to complete the feasibility studies.  Medipex has also obtained positive feedback on the market potential of the device from potential investors in NG-Sure and secured an expression of interest in investment.

Impact

A ~£1m grant from the MRC DPFS scheme was successfully obtained to develop a prototype device, following a user-centred design approach, and to conduct a clinical investigation with 200 patients. During the funded project, Medipex are managing the delivery of the technical build of prototypes (based on desired timescales and quality) and the documentation of device design, testing and clinical evaluation that is necessary to carry out the clinical investigation and for future regulatory approval. We are compiling a detailed package of information that would be attractive to a commercial partner, including the technical documentation, regulatory plans, health economic data and IP strategy together with a business case. Medipex will continually refine the strategies, collate and analyse the information required for reports and lead on identification and protection of any arising Intellectual Property. After the end of the project, Medipex will continue to support the development of NG-Sure to successfully place the device on the market.

Contact

For more information please contact lindsay.georgopoulos@medipex.co.uk, Head of Innovation at Medipex or Dr Angela Grange, Chief Investigator, Head of Nursing, Research and Innovation, Bradford Teaching Hospitals NHS Foundation Trust

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