A single point of access for Accelerating your Innovation in MedTech

www.hub4aim.comWith the support of

RATIONALE

• Key issues for the pre-industrialization of innovative Medical Devices (MD)

• A long and complex process between expression of needs and the new healthcare solution

• Technologies, biology & data integration and maturation

• Regulatory framework

• Clinical studies, testing in real life conditions

• → Recommendations of several reports on healthcare : need for a collaborative public-private platform for sharing equipment and expertise *

* “MEDECINE DU FUTUR” medicine of the future report (NFI) – April 2017 “Attractivité de la France pour les entreprises de santé” attractiveness of France for Healthcare companies CGE report – Nov. 2017

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Technological, regulatory, clinical and industrial processesaccessible via a single entry point

OBJECTIVE: SECURE AND SPEED UP MD MATURING FROM TRL 4 TO 7

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Research Pre-industrialization Industrialization

Source: Aviesan

Your productCE mark / FDA approval and

industrialization

An innovative medical

device proof of concept

Your company(Market &

Business Plan)

Research Pre-industrialization (TRL 4 to 7) Industrialization

Technological, regulatory, clinical and industrial processes

Micro-nano-bio technologies

maturation

Software development

Usability study, clinical studies,medical service

evaluation

Design, integration,

supply chain, pilot lines & prototypes

YOUR PROJECT

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FROM POC TO READY FOR APPROVAL MEDICAL DEVICE

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ACCESS TO A UNIQUE SET OF EXPERTISES AND RESOURCES

Software development under quality

assurance

Innovative, connected and miniaturized

sensors

Project management under quality

and regulatory assurance

Plastic and silicone

injection molding, molds

design

System integration of diagnostics, monitoring,

delivery, assistance MD

ISO7 & ISO8 clean rooms,

ISO 9001, 13485, 15378 certificationProduct and

machines / equipment

design, assembly & prototyping

Usability study, clinical studies, medical service

evaluation

Manufacturing processes and supply chain

definition

Electronic design under

quality assurance

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FACILITIES AND EQUIPMENT

NANO-CHARACTERIZATION

SILICON & PLASTIC

HETEROGENOUS PACKAGING

SURFACE CHEMISTRY, MICROFLUIDICS, BIOLOGY

CLINICAL STUDIES (CIC-IT)

USABILITY PLATFORM

PROTOTYPING EQUIPMENT

INJECTION MOLDING

ISO7 & ISO8 clean rooms,

ISO 9001, 13485, 15378, EN62304

certification

CamiTK SOFTWARE PLATFORM INTEGRATION , PROTOTYPING AND CHARACTERIZATION

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HUB4AIM NETWORK

• An alliance between 7 companies

• 2 research institutes - Micro-nano-biotechnologies and software

• A medical devices clinical research center and its network

1900 employees 8500 m² of clean rooms350 industrial partners in 201711 MedTech start-ups

510 employees Open source CamiTK430 industrial partners since 201327 MedTech start-ups

A networks of 8 CIC-IT in France :116 employees114 industrial partners265 ongoing clinical studies

Prototyping to industrialization of innovative medical devices

Design and manufacturing of innovative production equipment

Design and manufacturing of customized and innovative MD

Industrial strategy and project management

Injection molding and mold fabrication

LSR silicone injection molding

850 employees 11 manufacturing facilities3000 m² of clean roomsISO 13485, 15378, 62304

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OUR EXPERIENCE

More than 30 years of experience in Medical Devices

IN VITRO DIAGNOSTIC POINT OF CARE

DRUG DELIVERYWEARABLE FOR MONITORING AND THERAPY

COMPUTER-ASSISTED SYSTEMS IN THE MEDICAL AND SURGICAL FIELDS

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A COMPLETE AND UNIQUE OFFER

• A unique proposal…

….including technology innovation, manufacturing companies and clinical studies expertise

• A dedicated project team to answer to your specific needs

• A complementary and flexible offer, adapted to your PoC

• A streamlined process to mitigate risks and optimize costs

• An access to network’s expertise and facilities

• An offer not restricted only to consultancy but including design and implementation

• A possible extension to industrialization (outside of hub4AIM) with JBT HubUp

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HUB4AIM IN A NUTSHELL

• Hub4AIM is a technology and clinical-driven hub to minimize risks in the maturation of your Innovative Medical Device

• Hub4AIM offers a single entry point to help you from proof of concept to CE mark preparation

• Hub4AIM provides services in design and manufacturing

www.hub4aim.comolivier.peyret@hub4aim.com With the support of

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