Summary
- Profile Type
- Technology offer
- POD Reference
- TOFR20240102004
- Term of Validity
- 15 January 2024 - 14 January 2025
- Company's Country
- France
- Type of partnership
- Research and development cooperation agreementCommercial agreement with technical assistance
- Targeted Countries
- All countries
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General information
- Short Summary
- A French company specialised in R&D phases in different fields such as mechanics, electronics and software for medical devices is seeking cooperation with start-ups developing innovative healthcare products. Tailored R&D, prototyping and manufacturing services are offered but also assistance with regulatory requirements to get CE or FDA approval in full compliancy to standards allowing the start-ups to achieve schedule milestone imposed by investors and answering sucessfully markets needs.
- Full Description
-
The French company offers a large spectrum of applications in medical R&D. It covers all stages of medical device R&D projects, assisting customers from start to the end.
Since 2010, the company has acquired an extensive experience in the biomedical field, in applications such as heart surgery, cardiology, neurosurgery, spinal surgery, ENT, urology, treatment of obesity, cosmetic surgery and ophtalmology. It is an expert in minimally invasive surgery thanks to its proficiency in microtechnology and materials with superelastic properties such as Nitinol and silicones. The best solution, whatever the specialisation area, is provided to healthcare professionals or manufacturers.
Combining expertise in microtechnology and electronics allows the French company to bring customers' projects to completion with various services from feasibility stage to industrialisation, such as CAD definition with SolidWorks, digital simulation, designing and creation test benches and design verification prior to manufacturing and assembly in a controlled environment.
And thanks to its expertise in electronics and software, it also develops and manufactures embedded electronic systems for medical applications. It can bring projects to life by designing electronic boards or sub-sets and complete sets or offering 3D CAD and mechatronic systems, designing benches or running tests to validate the compliance of medical devices with NF60601-1 and IEC 62304 standards.
Manufacturing can either be processed in clients' premices when adapted or externally in a controlled environment. A clean room of 250 m2 enables manufacture and assembly of highly technical devices.
As a critical contract manufacturer, the French company also offers a wide range of other services such as :
-5-axis laser welding,
- laser marking,
- metallographic cutting,
- acrylic UV, cyanoacrylate or epoxy bonding,
- assembly of electrical components under hygrometric control,
- helium leak detection,
- accelerating aging tests,
- plasma processing,
- crimping,
- microsoldering of electronics components,
- resistance micro-soldering.
Processes implemented for medical devices manufacturing:
- realisation of proofs of concept, prototypes, pre-series and series
- cleanrooms (ISO 5 and ISO7) incorporating several innovative processes, allowing tailor-made services :
Silicone processing:
- overmoulding,
- injection,
- spraying,
- dipping,
- assembly by silicone gluing,
- silicone colouring,
- marking on silicone,
- polishing
Epoxy resin casting :
- over moulding,
- encapsulation
Welding:
- 5-axis laser in a clean room,
- Resistive welding on ESD table,
- High-frequency welding,
- Leak testing
Marking:
- silicone deposition,
- laser marking in clean room (logo, batch and serial number, QR code),
- management of serial numbers and UDI
Heat treatment:
- NITINOL shaping by heat treatment,
- Plastic components shaping by heat treatment
Surface activation:
- Plasma
Polishing:
- Optical fiber,
- Silicone
Assembly:
- Mounting and electronic board assembly,
- Connectors,
- Micro-assembly by gluing,
- Micromechanical assembly,
- Inspection using mechanical and electronical test benches (leak tests, ...)
Cleaning and packaging:
- Ultrasonic cleaning,
- Pouches/blister
The French company can assist in all regulatory or normative procedures, drafting medical device certification applications and implementing quality management system to obtain certification for all medical device classes, which includes dealing with notifed body.
Drafting and/or updating regulatory files for European (EU Regulations 2017/745 and 2017/746) or US, Canada, Brasilian markets are also possible.
Specific issues such as biocompatibilty, risk management are also covered.
The company can deploy each step separately or in complementarity and has the ability to manage globally the projects in full accordance to its customers' needs.
The French company is seeking cooperation with start-ups or other companies. - Advantages and Innovations
-
Advantages rely on very complementary know-how, fields of expertise and all the chain covered to put advantageously innovative medical devices on the market and to set-up, monitor and validate new processes
Materials such as Nitinol and silicone management
High level of engineering
Strong International experience with successful European projects led in Belgium, Norway, Italy, Spain, Japan, Switzerland, Israël - Stage of Development
- Already on the market
- Sustainable Development Goals
- Goal 3: Good Health and Well-beingGoal 9: Industry, Innovation and Infrastructure
- IPR description
- The company is open to any kind of collaborative project, funded or not. Eurostar projects are also possible.
Partner Sought
- Expected Role of a Partner
-
Start-ups and spin-offs, SMEs, companies willing to be supported in the development of their medical innovations or Universities, surgeons, health laboratories with products to be developed in the following fields : heart surgery, cardiology, neurosurgery, spinal surgery, ENT, urology, treatment of obesity, cosmetic surgery and ophtalmology.
The support offered to start-ups is really convenient as they need to rely on a strategic partner able to help them to design, realise proof of concepts or prototypes, to industrialise, to manufacture their medical devices.
The French company can deploy a full package of R&D services (global offer) or assist them at each step of development and help them to save time in this development. - Type and Size of Partner
- SME <=10SME 50 - 249SME 11-49Big company
- Type of partnership
- Research and development cooperation agreementCommercial agreement with technical assistance
Call details
- Coordinator required
-
Yes
Dissemination
- Technology keywords
- 006001012 - Electromedical and Medical Equipment006001002 - Care and Health Services
- Market keywords
- 05003003 - Surgical implants05007007 - Other medical/health related (not elsewhere classified)05003005 - Drug delivery and other equipment
- Sector Groups Involved
- HealthElectronics
- Targeted countries
- All countries