RESCOLL - BioNanoNet. +335 47 74 69 00 contact: [email protected] Biomaterials et Medical...
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Tel. +335 47 74 69 00 contacts: [email protected] [email protected] RESCOLL AQUITAINE 8 allée Geoffroy Saint Hilaire 33600 Pessac RESCOLL RHONE ALPES 43 boulevard du 11novembre 1918 69100 Villeurbanne ISO 9001 ISO 13485 Impossible d’afficher l’image. RESCOLL Leading to competitiveness through innovation in polymers, composites, surface treatments, bonding technology and processes www.rescoll-medical.com
Transcript of RESCOLL - BioNanoNet. +335 47 74 69 00 contact: [email protected] Biomaterials et Medical...
Tel. +335 47 74 69 00contacts: [email protected]
RESCOLL AQUITAINE8 allée Geoffroy Saint Hilaire
33600 Pessac
RESCOLL RHONE ALPES 43 boulevard du 11novembre 1918
69100 VilleurbanneISO 9001ISO 13485
Impossible d’afficher l’image.
RESCOLL Leading to competitiveness through innovation in polymers,
composites, surface treatments, bonding technology and processes
www.rescoll-medical.com
1000 customers
France, Europe, world
7,5 M€ turnover (2014)
80 persons
01234567
Turnover
50 patents
12 PhD students trained by RESCOLL
50 conferences, technical articles ..
M€
3G++ Rating Banque de France
10 to 15 new hires / year
Dynamic R&D
~30 Collaborative Projects
~300 B2B contracts/year
1 patent / year
Business Activity30%10%
5%
45%
10%
AerospaceHealth
Bonding Technologies
Energy
Others
RESCOLL is a service company specialized in the characterization and development of biomaterials (polymers,composites & metals) and medical devices. Over 20 years of scientific and technical experience give us theexpertise to support the development of your medical devices and biomaterials.
RESCOLL can help you with your chemical and physiochemical analysis, stability validation and mechanicalcharacterization thanks to our COFRAC ISO 17025 and ISO 9001 accredited laboratories.
RESCOLL Manufacturing allows us to offer a wide range of services to control and manufacture your medicaldevices and instruments. All control and manufacturing stages are conducted in an ISO 13485 certifiedenvironment.
The combined expertise of RESCOLL and RESCOLL Manufacturing allows us to propose a unique offering in France and in Europe. To offer a wide range of tools to help you develop your innovative projects and reach
your market as quickly and safely as possible.
Medical activities
MANUFACTURINGTESTING DEVELOPMENT
Training
ISO 9001 – ISO 17025 COFRAC ISO 9001 – ISO 13485Technology Transfer
Tel. +335 47 74 69 00contact: [email protected]
STATIC AND FATIGUE TESTING
SPECIMENS : Tensile, Compression, Shear, Peeling, Torsion, Rotation, Abrasion, …
PRODUCTS : Spine, Knee, Hip, Shoulder, Dental, …
BIOLOGICAL MATERIAL AND Explanted devices
Failure analysis, aging, defects prematurely encountered in products or materials
Analysis and comparison of materials used
Process validation
Purity validation
MATERIALS AND PRODUCTS ANALYSIS
PRODUCTS AND PACKAGING VALIDATION
MECHANICAL TESTING AND VALIDATION
EXPERTISE
Chromatographic AnalysisSpectroscopic AnalysisSurface Analysis Chemical and Physical AnalysisAging StudyThermo-mechanical Analysis
Degradation of products analysis (ISO 10993-13)
Chemical characterization of Materials (ISO 10993-18)
Morphological and Topographical analysis of materials (ISO 10993-19)
Cleaning validation (XP Pr NF S 94-091)
Packaging and stability validation (NF EN ISO 11607 -09, ASTM F1929 & EN 868-5, ASTM F1980-07)
Analysis for heavy metals (USP< 232> ; USP< 233> ICH Q3D)
Residual solvent content & residual monomer content (USP <467> ; ICH Q3C )
Identification and quantification of endocrine disruptor chemicals
Biomaterials and Medical devices
Rescoll Testing provides analysis services for evaluating the physico-chemical, chemical, physical and morphological properties of biomaterials and medical devices. RESCOLL canhelp you meet your needs for product stability, packaging and cleaning validation. All work is performed inISO 17025 and ISO 9001 laboratories.
Impossible d’afficher l’image.
BIOMATERIAL DEVELOPMENT PRODUCT DEVELOPMENT EQUIPEMENT
Literature Review
Polymeric Resorbable Implants
Polymeric Non-Resorbable Implants
Composite Implants
Metallic Implants
Reverse Engineering
Risk Analysis & Regulatory Issues
Literature Review
Gel Formulation
Composite Formulation
Adhesive Formulation
Surface Treatment and Bioactive Coating
Reverse Engineering
Risk Analysis & Regulatory Issues
PROTOTYPAGE – SCALE-UP
Injection
Extrusion
Freeze Drying
Supercritical Carbon Dioxide
Coating
Machining
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Rescoll development, with 15 years of experience, Rescoll hasbecome a leader in innovative biomaterial and medical device development. With a team of over 50doctors, engineers and technicians, RESCOLL is involved in medical device development for orthopedic,ophthalmic, cardiovascular, dental, gastrointestinal, and dermal applications.
Biomaterials and Medical devicesImpossible d’afficher l’image.
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Biomaterials et Medical devicesImpossible d’afficher l’image.
Examples of Innovation
Orthopedic IMPLANTSH&M (FUI 17)NEWBONE (FP6)HOBBIT (FUI8)CREASPINE, IMPLANET, MEDACTA, CONMED, NORAKER...
Dental IMPLANTSRIBIO (FUI11)
Global D (TEKKA), Septodont, ...
Vascular and cardiovascular IMPLANTSChitoart (ANR)TEH Tube (FP7)CARDIO 3, CARMAT
Optical IMPLANTSCorneal, Ioltech...
Cosmetics and Skin CareL’Oreal, Yves Saint Laurent, Santé Beauté…
Speciality AdhesivesBBraun, Pierre Fabre…
Intestinal IMPLANTSAnastomoSEAL (FP7)
Diabetes Diagnostic SPIDIMAN (FP7)
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Biomaterials et Medical devices
H&M : Development of metallic biomaterials bearing surfaces functionalized withantibiotics and able to release active molecules only when infection occurs. Themechanism of action is based on the fixation of antibiotics via covalent bonds whichare cleaved during infection due to the decrease of pH.Project will be supported by FUI 17
RIBIO : Development of homogenous and adhesive surface coating using polymer ontitanium in order to enhance healing and antiseptic properties.Project supported by FUI 11, F1106038V
HOBBIT: Innovative composite material (organic /bioactive ceramic) with gradientsof mechanical properties and resorption to develop resorbable implants.Project supported by FUI 8, 092906353
December 2009 – 48 month
March 2011 – 36 month
June 2014– 36 month
Examples of Innovation
Tel. +335 47 74 69 00contact: [email protected]
Biomaterials et Medical devices
ARDENT : Synthesis and characterization of pharmaceutical microspheres for dentaltissue regeneration using new biocompatible materials, their completemicrostructural characterization, and the study of their degradability and release ofactive substances.Project supported by Institut Carnot I@L
CHITOART : The objective of this project is to develop a tissue-engineered vascularconduit that remains in-situ physiologically functional over the long term, containingthe core elements of a vascular tissue.Project will be supported by ANR (TecSAN)
March 2011 - 36 month
May 2012 - 36 month
Examples of Innovation
Tel. +335 47 74 69 00contact: [email protected]
Biomaterials et Medical devices
http://teh-tube.eu/indexJanuary 2014 – 36 month
Examples of Innovation
November 2012 – 48 month
2012 – 36 month http://www.anastomoseal.fr/
http://www.spidiman.eu/
TEH-TUBE : Tissue Engineering of the right Heart outflow tract by a biofunctionalized bioresorbable polymeric valved TUBE. Project co-funded under FP7 : 604049
SPIDIMAN : Development of a new surface treatment and glucose sensitivefluorescent coating technology applied onto a standard insulin catheter andincorporated into a single port artificial pancreas system.Project co-funded under FP7 : 305343
ANASTOMOSEAL : Development of biomaterials with adhesion properties forimplantable medical devices. Perform mechanical characterization of adhesionover inert and biological substrates. Project co-funded under FP7 : 280929
Metal : Titanium (TA6V4 ELI, T40/T60 ; Tantale ; Stainless steel (316LVM) ; Steelfor instrument (316L, 17.4PH, X30CR13, CUSTOM 455) ; Refractory (CoCr, PHYNOX);
Polymer : PEEK, ERTACETAL, TEFLON, POM,PROPYLUX, RADEL
Composite : PEEK CARBON FIBER
PRODUCTS PROCESS MATERIALS
Swiss Turning
Milling
Turning/ Milling Multiaxis
Polishing
Laser Marking
Cleaning
Packaging (ISO 7)
Metrology
Tel. +335 47 74 69 00contact: [email protected]
Spine
Knee
Hip
Maxillofacial
Cardiac
Dental
Ancillary
Rescoll Manufacturing can help you to solve your problems andmeet your needs in prototyping, manufacturing, finishing and controls. All stages are conducted in an ISO13485 certified environment.
Medical devices and instruments
ISO 9001ISO 13485
Our ambition is to offer a wide range of tools to help you develop your innovative projects and reach yourmarket as quickly and safely as possible.
ISO 9001ISO 13485
Rescoll approvals and certifications:
Our design & management tools:
Rescoll Manufacturing certifications:
ISO 9001 / ISO 17025 (COFRAC)CIR (Crédit d’Import Recherche)Court appointed expert by first instance and commerce court of Bordeaux
ISO 13485ISO 9001
All testing, development and manufacturing are conducted in a secure environment.
2010
2012
Demain
NEWBONE
TEH-TUBE
ANASTOMOSEAL
SPIDIMAN
2014
CHITOART
ARDENT
HOBBIT
RIBIO
H&M
Before 2010 : Turnover 3,9 M€Company with high technology and working mainly for aerospace industry.Continuous and substantial growth with good profitability.
Today: Turnover 6 M€Strategy of diversification in the medical New chain of medical manufacturing (Extrusion) Clean room for packaging & Coating medical (ISO 7) Founding member MEDPHARMPLAST EC Experts to establish the project roadmaps for call 2017_2020 (Biomaterials)
Acquisition of a company specializing in the manufacture of MD= Rescoll Manufacturing Extend the possibilities of
processes; manufacture of innovative products (ATMP, intelligent link ....) - Additive Manufacturing for Polymer & Composite - Electrospinningto be recognized as must subcontractors for medical devices
Accreditedfor testingMD (ISO 17025)
Holzapfel BM, et al, How smart do biomaterials need to be? A translational science and clinical point of view. Adv Drug Deliv Rev. 2013 Apr;65(4):581-603. 2012
strategies:
Cells and / or biomaterials functionalized
SUPPORTE / STIMULATE/ SUPPORTER
Endogenous regeneration of functional tissue
Regenerative Medicine
Molecules
Tissue
Relevance of Rescoll development : in line with Biomaterialsevolution
2 sites : Pessac and Lyon
DepuyCreaspineImplanetS14 ImplantSpineVisionStrykerMedicreaTeknimedBiometBBRaunNorakerMedactaConMedGlobal-DSeptodontFx Solutions
AscuelapGalenixdéveloppementL’Oréal rechercheLaboratoires Santé beautéCardio3CevaCardialCousin BiotechActeonEllipsePierre fabreTextile Hi-TecARTHexabio
References
More informationKonstantin Sipos
Email : [email protected] : +336 28 33 02 57
&
Lyon: Elodie PACARDe-mail: [email protected]
Tel: +336 45 06 21 36
