MEDICAL DEVICE INNOVATION - Fira de...

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Barcelona, 27 de octubre, 2015 Carlos Sisternas Director FENIN Catalunya MEDICAL DEVICE INNOVATION

Transcript of MEDICAL DEVICE INNOVATION - Fira de...

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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…