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Barcelona, 27 de octubre, 2015
Carlos Sisternas
Director FENIN Catalunya
MEDICAL DEVICE INNOVATION
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FENIN, Federación Española de empresas de TecnologíaSanitaria, es la asociación empresarial que representa enEspaña a las empresas de Tecnología Sanitaria.
Representar y promocionar, a todos los niveles, los intereses del sector, resaltando su
“VALOR” y fomentandosu “USO RACIONAL”.
Qué es FENIN?
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Mercado de Tecnología Sanitaria
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Mercado de Tecnología Sanitaria
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Más de 575.000 empleos
Fuente: EUCOMED, European Medtech Market 2012
Sector de Tecnología Sanitaria en Cifras
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Eficiencia de los Sistemas Sanitarios
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Evolución Gasto I+D+i
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Qué sectores patentan más?
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Leaders
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10
Navegar buscando ideas es divertido…
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Sólo que es difícil encontrarlas…
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DE
SP
AIR
EC
STA
SY
We have a fix
It works
It doesn't always
New costs are better
Time
Failures reported in the field
We need documen-tation???
Failures in field trial
It‘s tooexpensive
The investor hates the project
The investor wants how much?
We don't have enough resources
The market estimate was all wrong
No, he loves it!
We have an order!
We‘re behind schedule
We'llmake it
Users like itCosts are better
Documentation is done!
We can make it reliably
Regulatory approval!
We have enough
More orders!!!
I have an idea!
It works!
Someone else
cares!
It's alreadypatented
No, itisn‘t!
The field trial worked!
We have a problem
It was just an installation problem
Source: R. J. Saldich
Es un viaje lleno de altibajos
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Team
Marketing
Quality
R&D Engineering
Operations
Clinical / Regulatory
IP
Proposal Definition Development Validation
IdeaConcept Team
Update IBP Project Close-out &Review
Manufacturing Scale-Up
DesignVerification
Design Output& Product Specification
Labeling Specs Dev
Clinical TrialsClinical & Regulatory Strategy Clinical & Regulatory Planning
Supply-Chain Development Supply-Chain Implementation
IP Generation
Design Validation
Manufacturing Process Validation
Development of Testing Methods
Regulatory Preparation
Feasibility Animal Studies
Core Team
CustomerNeeds & Market
Assessment
Concept Options / TechnologyAssessment
Design Input & Market Specification
Product ConceptFeasibility & Selection
Manufacturing ProcessFeasibility & Requirements
Mfg Supply Chain Strategy & Planning
Initiate post-market surveillance
Global Market Launch Strategy & Planning
Global MarketLaunch Preparation
Global MarketLaunch Execution
Regulatory Submission & Approval
Update IBPCreate Integrated Business Plan
Contract Contract Contract
Primary/FunctionalLead
Charter Proposal
Contract
Mfg Process / S-C Capability Review
Clinical TrialPlanning
Process Control Planning
Quality Strategy
DevelopMarketing Plan
Legal & IP Assessment
BoardReview
Initial Risk Analysis Complete Pre-Market Risk Management
GLP Animal Studies
BiocompatibilityStudies
Sterility Validation
Manufacturing Process Development
Packaging Dev & Verification
Shelf-life Testing
Labeling Content Dev
Supplier Quality Assessment Supplier Quality Approval
Draft IFU
Make / Buy Production
Process Control Implementation
Labeling Translation
Develop MRA
TechnicalReview
Design Freeze Review
DVT Review
ValidationReview
Sales Training
Post-ApprovalClinical Trials
Post-ApprovalReg Activities
Commercialization
Customer Use Evaluation
BoardReview
Board Review
BoardReview
Clinical / Regulatory Assessment
PhaseReview
PhaseReview
PhaseReview
PhaseReview
En el que necesitas un sistema de navegación…
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But changes happen if they
have real sense!
La Industria busca cooperación con la Ciencia
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“Open Innovation” es una necesidad, no una moda
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La innovación es…
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Tecnologías Convergentes…
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Tecnologías Convergentes…
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UIMP, 3 de julio 2015
Nanote
cnolo
gía
Tecnologías Convergentes…
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Nanote
cnolo
gía
y M
icro
fluíd
ica
Tecnologías Convergentes…
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Tecnologías Convergentes…
Realid
ad A
um
enta
da
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UIMP, 3 de julio 2015
3D Printing
Tecnologías Convergentes…
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3D Printing
Tecnologías Convergentes…
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Avances Tecnológicos: Algunos ejemplos
Automatización y Robotización (pasado-presente-futuro)
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Avances Tecnológicos: Algunos ejemplos
Automatización y Robotización (pasado-presente-futuro)
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Avances Tecnológicos: Algunos ejemplos
ADN Circulante
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Avances Tecnológicos: Algunos ejemplos
Lab on a Chip
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Avances Tecnológicos: Algunos ejemplos
Nuevos Biomarcadores
Historia natural de un nuevo test diagnóstico de laboratorio
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Avances Tecnológicos: Algunos ejemplos
Point of Care Testing
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Avances Tecnológicos: Algunos ejemplos
Espectometría de masas
iKnife or intelligent knife
Combines electrosurgery with
new mass spectrometry
techniques
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UIMP, 3 de julio 2015
Cómo será el Futuro (I)
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UIMP, 3 de julio 2015
Cómo será el Futuro (II)
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FENIN y la Innovación
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2ª Foro CIBER
BBN
diagnóstico y
terapias en
oncología
2º Foro Innovación
Horizonte 2020 en Madrid
1er Foro CIBER BBN Imagen Biomédica
I Foro Innovación CIEBERES
VI Conferencia Plataformas Biomédicas
I Foro Innovación Críticos
� 14 foros empresariales organizados� 1000 Asistentes� 392 Entidades participando en la Plataforma� 1200 Reuniones entre los participantes� 30 Proyectos de colaboración en marcha
2º Foro empresarial e-
Health en Londres
Nuestro compromiso en la actualidad
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HEALTHCARE
ECOSYSTEM
HEALTHCARE
ECOSYSTEM
INDUSTRY ACADEMIA
TECHNOLOGY TRANSFER
EVENTS
INDUSTRY ACADEMIA
TECHNOLOGY TRANSFER
EVENTS
MEDINTECHMEDINTECH
BUSINESS INTELLIGENCE
PLATFORM
BUSINESS INTELLIGENCE
PLATFORM
IN HOUSE INVESTMENT
FORUMS
•FOPI+I
IN HOUSE INVESTMENT
FORUMS
•FOPI+I
OUT-OF-HOUSE INVESTMENT
FORUM
OUT-OF-HOUSE INVESTMENT
FORUM
PUBLIC PROCUREMENT
PUBLIC PROCUREMENT
TRAINING
•TECHNO CAPSULES
TRAINING
•TECHNO CAPSULES
R&D INTERNATIONALITATION
R&D INTERNATIONALITATION
Nuestro Programa de Innovación
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Medintech
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Entrepreneur
Healthcare Professional
R&D Providers
Admin
Qué significa Medintech?
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Tool
Patents
News
Regulatory
PublicTenders
LegislationEvents
R&D Calls
Technologyand Demand
Offers
Technicalarticles/ journals
Plataforma de Inteligencia Competitiva
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Qué sectores atraen al capital privado?
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UIMP, 3 de julio 2015
Foros de Emprendedores
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Por Qué?
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Innovative Procurement (PPI & PPC)
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De forma que, al final…
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Mi sueño “Made in Spain”
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Análisis Coste-Beneficio
Por cada euro invertido en tecnologías médicas se
obtiene un beneficio en términos de reducción de la
estancia hospitalaria, reducción de la tasa de
morbilidad y descenso del número de defunciones de:
� 1,47 € en enfermedades cardiovasculares
� 1,36 € en enfermedades oncológicas (sin contar tto.)
� 1,11 € para las enfermedades neurológicas
Informe “Aportación de valor de las tecnologías en el sector sanitario”. PWC 2014.
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Por lo tanto…