Your Partner for Innovative Medical Devices

Transcription

1 Your Partner for Innovative Medical Devices Polymers and Microtechnology Expertise Contract R&D Contract Manufacturing 1

2 STATICE GROUP OVERVIEW Founded in 1978 in Besançon Around 100 employees Turnover of 10 M STATICE Innovation (R&D) 30 people / 2,8 m Turnover STATICE Manufacturing (Production) 70 people / 7,2 m Turnover ALPINIA Mauritius (Production) BESANCON 2

3 STATICE GROUP OVERVIEW OUR CUSTOMERS Big players SME Startup or Doctors Labs J&J MEDTRONIC ST JUDE MEDICAL COUSIN BIOTECH TRACOE FCI SAS BESS GmbH Venture capital companies DEFYMED CEA CNRS INSERM For a sustainable relationship 3

4 From Idea to Production Research European collaborative projects, projects through equity finance, feasibility, early CAD, first mockup Development DHF (Mechanical CAD, FEA, Electrical Block Diagram / PCB, software), prototypes, early tests Design transfer Design frozen - production tools, - DMR : VMP, validation report, IQ/OQ/PQ, Process flowchart, Instructions, Contract Manufacturing FAI, Medical Devices ready to be sterilized Traceability, CoC 4

5 R&D expertise 25 Doctors, Engineers & Technicians Strong Background in Medical Devices Development Skills in biomaterials transformation & micro-technology Cutting-edge technology implemented In compliance with regulations and standards (ISO13485, Directive 93/42/CE, ISO & ASTM standards) 5

6 R&D expertise Long term implants Bioresorbable Implants Advanced Intraluminal technologies Class I to III Medical Device Active Medical devices IVD Devices 6

7 R&D expertise CARDIOLOGY NEUROLOGY UROLOGY IN ALL MEDICAL FIELDS OPHTALMOLOGY ORTHOPAEDICS LABORATORY 7

8 R&D expertise Biomaterials transformation / assembly Silicones transformation (LSR, HCR, LCE, gel, dispersion, ) Silicone parts Complex device in silicone: Urinary sphincter Silicone parts Including: stainless steel spring, cable, fabric, NiTi, PP mesh 8

9 R&D expertise Biomaterials transformation / assembly Bioresorbables molding (PLLA / PLGA / PDO ) screws, rivets, anchors, plates, drug delivery devices 9

10 R&D expertise Biomaterials transformation / assembly Bioresorbable and non-bioresorbable polymer electrospinning: PLLA / PLGA / PDO / PCL / PU. Electrospinning of polymer with a drug: drug release monitoring Electrospun fibers Complex shape graft (like artery), scaffold, patch 10

11 R&D expertise Biomaterials transformation / assembly Collaborative projects in the field of electrospinning and drug delivery : REVAMED (National project) Regeneration and evaluation of soft tissues by drug loaded electrospun patch TEH TUBE (European project) FP7-NMP Tissue engineering of the right heart outflow tract by a biofunctionalized bioresorbable polymeric valved tube 11

12 R&D expertise Biomaterials transformation / assembly Collaborative project in the field of catheters and endoscopes ESOTRAC(European project) H2020-ICT /H2020-ICT Hybrid optical and optoacoustic endoscope for esophageal tracking 12

13 R&D expertise Biomaterials transformation / assembly Micro-mechanic (stainless steel, Nitinol, thermoplastics, ) Ancillaries 13

14 R&D expertise Biomaterials transformation / assembly Complex assembly of biomaterials Endoscopy EP Catheter RF / µwave ablation catheters steerable, with sensors (T, P, ) / balloons / snare / camera 14

15 R&D expertise Active Medical Devices & Electro-medical equipment Electronic (PCB) / Software From left to right pictures: - Slide detector - Nitrogen Monoxide dispenser - «eye care» device 15

16 R&D expertise In Vitro Diagnostics µ-fluidic / Optical controls / Automation / Temperature management Fluid analysis Devices (blood, saliva, urine,...) 16

17 R&D expertise / Machine Shop - Conventional machine - CNC machine - EDM machine Reactivity in prototyping (Stainless Steel or plastic parts, molds, ) 17

18 R&D expertise / Electronics Shop - Micro-coiling - Micro-wiring - CMS PCBs 18

19 Design transfer Process validations following IQ/OQ/PQ standards Molding process & Assembly process (i.e.: US welding, UV Gluing ) Metrology (critical dimension) Gage R&R Cp/Cpk calculation 19

20 Design transfer Process validations following IQ/OQ/PQ standards Cleaning process (US cleaning + soap or alcohol, surface cleaning before packaging) Bioburden test LAL Test (endotoxin) HCT & COT test 20

21 Design transfer Process validations following IQ/OQ/PQ standards Packaging process (conform to ISO standard) (blister or Tyvek pouch) Leak test Pelability test Pull test 21

22 Design transfer - DMR file: production flowchart, instructions, - VMP (Validation Master Plan) + Test Reports - Raw material biocompatibility proof - Labelling design & printing (w/ or w/o bar code) 22

23 Contract Manufacturing - Production managed by an ERP - CoC provided with each batch delivered - Traceability guarantee (bar code) 23

24 Contract Manufacturing 1000m² ISO 5 CER for Class III implants, IVD devices and all medical devices requiring sterilization (ETO, gamma beam) 24

25 Contract Manufacturing 300 m² workshop for mechatronics devices production 25

26 Thank you for your attention Contacts: Benoit STUDLÉ (CEO): Sébastien PERROT (R&D Manager): Florent GUYON (Business Developer): 26