A single point of access for Accelerating your Innovation...
Transcript of A single point of access for Accelerating your Innovation...
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
[email protected] With the support of
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