Con esta herramienta te facilitamos un acceso a todas las ofertas y demandas de tecnología europeas y a búsquedas de socios para participar en propuestas europeas de I+D publicadas en la red Enterprise Europe Network, pudiendo filtrar los resultados para facilitar las búsquedas más acordes con tus necesidades.

¿Quieres recibir estos listados de oportunidades de colaboración en tu correo de forma periódica y personalizada? Date de alta en nuestro Boletín

Para optimizar los resultados de la búsqueda, se recomienda utilizar términos en inglés.

PS-H2020-FTIPilot-2016: Búsqueda de expertos en electrónica y desarrollo de software para dispositivos médicos implantables con el fin de rediseñar un dispositivo implantable para corregir la escoliosis

Resumen

Tipo:
Búsqueda de socios
Referencia:
RDES20160114001
Publicado:
18/01/2016
Caducidad:
18/01/2017
Resumen:
Una empresa española lidera una propuesta (StimulAIS) dentro de la convocatoria H2020-FTIPilot-2016. El objetivo es fabricar un estimulador muscular implantable para corregir la escoliosis según el reglamento europeo de dispositivos implantables activos. Este dispositivo se desarrolló en un proyecto del 7º Programa Marco. Se busca un socio con experiencia en desarrollo de software y electrónica de dispositivos médicos implantables activos, excepto en Alemania, Suiza y España. La fecha límite de la convocatoria es el 15 de marzo de 2016 y el plazo para presentar expresiones de interés finaliza el 5 de febrero.

Details

Tittle:
PS-H2020-FTIPilot-2016: Experts in electronics and software development for active implantable medical devices are sought for redesigning an implantable device for scoliosis correction.
Summary:
A Spanish company is leading a proposal (StimulAIS) for the H2020-FTIPilot-2016 call. The main goal of StimulAIS is manufacturing an implantable muscular stimulator device for scoliosis correction accordingly to European regulation of active implantable devices. The device was developed in the frame of a FP7 project. A partner with experience in developing software and electronics of active implantable medical devices is sought (Non-targeted countries: Germany, Switzerland and Spain).
Description:
· Project Introduction

Adolescent idiopathic scoliosis (AIS) is a progressive structural spinal deformity that affects around 2-3% of children aged between 10 and 16 in the world. Current conservative treatments (bracing and physiotherapy) are not sufficiently effective in stopping curve progression, so that more than 40.000 patients per year need an invasive fusion surgery that eliminates spine mobility. Recent studies evidenced that the spine deformity is a musculoskeletal expression of a central nervous system disorder that affects the paraspinal muscles inducing an imbalance of forces acting over the vertebral segments. The results of these studies and the work of a renowned clinical research group participating in the project constitute the basis for a previous project developed in the frame of a FP7 program, whose main objective was the development of a novel device for the treatment of AIS by muscular electro-stimulation of the deep paraspinal rotator muscles. Now, once finished this part of the project the goal is to build new prototypes in validated conditions to establish clinical trials.

This novel system will provide a customized treatment protocol to each patient, with targeted stimulation and real time control to maintain stimulation effectiveness and maximize treatment outcome. This device will be capable of stopping progression of the curvature and of correcting it, avoiding the side effects of current solutions, reducing the rate of surgery, and being cost effective compared to the abovementioned methods

· Project´s aims

1. System´s overall redesign and optimization
2. Establish the fundamental requirements of the production line of the device.
3. Assembly of the production line including acquisition of any necessary manufacturing equipment. Installation Qualification (IQ) and Operation Qualification (OQ) validation.
4. Performance Qualification (PQ) validation of the neurostimulator device in the established production line.
5. Prototype manufacturing for homologated testing applicable.
6. Prototype Testing.
7. Animal study.
8. Establishment of the Clinical Validation Protocol to be presented to the Clinical Research Ethics Committees.
8.1. Management and coordination of:
8.1.1. Main researcher, monitor, coordinator and promoter
8.1.2. Participant health facilities (Hospitals)
8.1.3. Inclusion´s criteria.


· The program:

Horizon 2020 Fast Track to Innovation Pilot 2015 Program.
The FTI pilot (2015-2016) is the only fully bottom-up measure in Horizon 2020 promoting close-to-the-market innovation activities that is open to all types of participants.

· The partnership:

The expertise and know-how of the organizations/companies sought for the consortium is focused on:

o Experience in electronics and software development (active medical devices).

The other expertise that are already covered by other members of the consortium are:

o Experienced manufacturers of active implantable medical devices.
o Experienced manufacturers of implantable electrodes and lead wires.
o Certificated and homologated laboratories to perform all the validation testing of the active implantable medical device accordingly to the essential requirements of 93/42 and 90/385 Directives.
o Referral Hospital to perform clinical trials.

· Timescales

o Official call Deadline: 15-03-2016 17:00:00 (Brussels local time)
o Cut-off dates: 01-06-2016 and 25-10-2016
o Internal deadline for EOIs: 05-02-2016
Advantages and Innovations:
The expected potential market for the StimulAIS device is about 400M-Y-euro; in Europe and total Consortium´s turnover expected within four years after implementation will reach over 45M-Y-euro;, being around 9M-Y-euro; the consortium benefits.
Stage of Development:
Proposal under development
IPR Status:
Trade Marks
Comments Regarding IPR Status:
Trade agreements with the two SME involved in StimulAIS when the product is on the market.

Partner sought

Partner Sought:
Partners with the following profile is sought: - Type: Enterprise - Activity: Electronic design and development of active implantable medical devices. - Role: Electronics -Y- software redesign and optimization of overall system´s components to be used in animal study and pilot clinical trial in humans: subcutaneous device, wireless charger -Y- reader, console.
Type of Partnership Considered:
RDR

Client

Type and Size of Client:
Industry SME <= 10
Already Engaged in Trans-National Cooperation:
Si
Languages Spoken:
English
Portuguese
Spanish

Dissemination

Programme-call

Evaluation Scheme:
Continuous submission scheme. Three cut-off dates
Coordinator Required:
No
Deadline for Call:
15/03/2016
Project Duration:
130
Project title and Acronym:
StimulAIS