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Demonstration action for an Easy POSitioning for patients with reduced mobility

Final Report Summary - EPOSBED-DEMO (Demonstration action for an Easy POSitioning for patients with reduced mobility)

Executive Summary:
Project Overview

The EPOSBED DEMO project aims to bring into the market a Specialty or Medical Bed for hospitals that assist patients with limited mobility in bed.

EPOSBED lab-scale prototype has been successfully developed in the FP7-SME-2007-1, EPOSBED project nº 222064, although we only could perform those tasks devoted to its research development.

In EPOSBED DEMO we aim to use the advanced knowledge, complementary skills, and technological developments acquired in former EPOSBED project to successfully bring the product into a commercial stage by performing a series of Demonstration activities needed for its success in the market. After having dedicated time and resources for the successful development of EPOSBED lab scale prototype, we must not underestimate the importance of the necessary activities to bring it to the next level: the market. It will require a series of trials, adjustments and market activities that need to be carefully planned and coordinated. Giving the characteristics of this product as medical equipment, manufacturers must provide clinical data of product efficacy involving a series of clinical trials that are needed before it can be placed into the market. These trials also imply that we must train and educate clinical staff on the product use and advantages. This is only one part of the complex process of bringing our innovation to the market.

Project Context and Objectives:
Project objectives.

The main objectives of the project can be summarized as following:

A. Eposbed Industrial Prototype construction and Clinical Trials

• Sensor matrix: finding a commercial sensing device more cost efficient that the currently used commercial sensor blanket or prepare a new sensor device based on low cost capacitive load cells.

• Software: adjustment. The Intelligent Software will need to be adjusted to have it functioning only at the desired times instead of permanently, avoiding false positives or undesired movements. The software currently installed in a PC need to be embedded in the bed to reduce space and adapt to the hospital facilities. It needs to be adjusted to the new sensor matrix and the servo-actuator system.

• Servo-Actuator: adjustment of the Servo-actuator system. This system needs to be adjusted by installing commercial motors adapting them to the EPOSBED system

• Structure: the bed frame developed on the FP7 project needs to be adjusted to reduce its weight and to accommodate a different range of commercial motors to adapt to the obsolescence of the elements with time.

• Clinical Trials: to design and conduct the clinical trials to collect safety and efficacy data of EPOSBED taken with real patients in a hospital situation.

B. EPOSBED Market Requirements

• Industrial validation: adapt the production system to bring the lab scale prototype to industrial production levels, achieving the CE mark.

• Market strategies and Feasibility studies: Demonstrate the final viability of the product to make sure the project result satisfy the identified need:

• Training and Procedures: training of the nurses and personal handling the equipment. Develop the manual of basic use of the product and provide training to nurses, doctors, and vendors.

Project Results:
Below, a brief description of the work performed during the project and the main results achieved:

• Meetings with commercial actuators manufacturers in order to select one to work on the redesign of the actuators. In this regards, the German company LIMOSS has been selected although especial care has been put on the design of the control box of the actuators so they could be substituted for an equivalent as planned on the DOW.

• New bedframe structure to accommodate the new commercial actuators, to eliminate the excess of weight and particular pieces with difficulties either in longevity or maintenance. Also, some other pieces, compulsory by the medical regulations, such as head and foot boards and handrails have been implemented. Further simplification of the main frame structure yielding in an optimized design providing an easier and cheaper manufacturing.

• Redesign of the new sensor blanket using much more efficient and economic technologies that will make the final product much more competitive in the market.

• Manufacturing of the first sensor pads.

• Update of the intelligent software to the new sensor matrix and actuators system.


• License of operation by the Spanish Health Authority AEMED (Agencia Española del Medicamento - Spanish Agency of Medicaments) for Industrias TOBIA as manufacturer of Medical Devices Class I.

• CE Mark compliance according to the new EN 60601-2-52, which substitutes this year the former EN 60601-2-38:1996. The test were performed by the external laboratory CETEM. Verification of the good performance of EPOSBED.

• Ethical clearance by the ethical committee of La Rioja (CEICLAR).

• Protocol and all bureaucratic process ready to perform the clinical trial at the Hospital San Pedro (La Rioja, Spain).

• Definition of the manufacturing process of EPOSBED at Industrias Tobia facilities in compliance with the ISO 9001.

• Production of the relevant document to commercialize EPOSBED: Technical manual and End user manual, which contain information about the handset, the way to operate the bed in either manual or intelligent mode, but also some other recommendations related to the risks associated with the operation of the bed, the maximum weight, the working mode of the actuators or even the way to assemble the hand rails if the bed is not installed by a technician.

• Detail market and feasibility studies. Development of the market strategy and definition of the distribution channels during each commercialization phase.

• Press release and other dissemination activities, which have led to awake the commercial interest of some big customers.

• Other important achievement that we would like to highlight are the application for the European and USA patents once the period of the 18 months of the PCT had expired, that supposed a big negotiation with the former members of the original EPOSBED project that have not participated on this DEMO phase. This negotiation solved some of the concerns issued on the mid-term review of the project, being the property of the new patents now exclusive of TOBIA, LINCIS and FOS on the terms agreed on the CA, maintaining the former members just free-license rights over the product as the CA signed with them in that moment stated.

Potential Impact:
EPOSBED will have an an important impact in the field of assistive technologies for patients with reduced mobility. Our main markets foreseen are public and private hospitals, nursing homes, residences, healthcare mutualities and also private homes.

There are several factors that will determine the market acceptance of Eposbed. The system has a major social impact related to the well being of the patients, which in the case of private hospitals can be translated in customer satisfaction and therefore increase demand of their services. This component is rather subjective and hard to translate into economical terms.
A direct impact related to the prevention in work related injuries in nurses and care givers can however be estimated in economic terms. At present, more than one third of back injuries among nurses are attributed to handling patients and the frequency at which they are required to manually move patients. The Eposbed newly developed system will allow eliminate an 80% of the need of handling for in bed positioning, which is responsible of a 20% of these injuries.
Besides, the manual turning of patients in bed has also an economic impact on hospitals related to labour cost. In average, a patient with limited mobility needs to be turned in bed 12 times daily.


Regarding the potential impact on the SME’s participants, these are the main aspects:

• A broad knowledge of the sensor technologies and a cost effective and reliable pad has been acquired. This pad and experience has without any doubt a big value for the consortium members since its utility for other projects and products is obvious.
• The authorization to manufacture and commercialize medical beds has been obtained by Industrias Tobia. This will allow the company not only sell this bed but other beds, being this point and strategic milestone on the development of the future of the company
• A patent for the USA and the UE has been applied. Although this is still on period of revision, if obtained, that patent could open markets for all the three SME’s involved, not only with this but with other projects and/or products
• Some good commercial contacts that hopefully would rapidly convert on orders have been made
• Thanks to the dissemination and the good outcome of the project the image of the SME’s has been positive reinforced what is expected to bring positive outcomes in any aspect of their daily business apart form the specifically related to EPOSBED
• As envisioned EPOSBED is being seen as a way to improve the quality of life of patients and the people that take care form them, those that have the most severe lack of mobilities and their families that take care of them at home.

List of Websites:
www.eposbed.com

Project Main Contact:

Óscar Valdemoros (Industrias Tobía S.A.)
Tel: +34 941 211 296
Fax: +34 941 211 444
E-mail: ovaldemoros@spaldin.com