Contract R&D Contract Manufacturing - statice.com · 4 Research European collaborative projects,...
26
1 Your Partner for Innovative Medical Devices Polymers and Microtechnology Expertise Contract R&D Contract Manufacturing
Transcript of Contract R&D Contract Manufacturing - statice.com · 4 Research European collaborative projects,...
1
Your Partner for Innovative Medical Devices
Polymers and Microtechnology Expertise
Contract R&D Contract Manufacturing
2
STATICE GROUP OVERVIEW
STATICE Innovation
(R&D) 30 people / 2,8 m€ Turnover
STATICE Manufacturing
(Production) 70 people / 7,2 m€ Turnover
ALPINIA – Mauritius
(Production)
Founded in 1978 in Besançon – Around 100 employees – Turnover of 10 M€
BESANCON
3
STATICE GROUP OVERVIEW
For a sustainable relationship
Big players
• J&J
• MEDTRONIC
• ST JUDE MEDICAL
• …
SME
• COUSIN BIOTECH
• TRACOE
• FCI SAS
• BESS GmbH
Startup or Doctors
• Venture capital companies
• DEFYMED
• …
Labs
• CEA
• CNRS
• INSERM
• …
OUR CUSTOMERS
4
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
From Idea to Production
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
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)
6
R&D expertise
Class I to III
Medical Device
Long term implants
Advanced Intraluminal technologies
IVD Devices Active
Medical devices
Bioresorbable Implants
7
R&D expertise
IN ALL MEDICAL FIELDS OPHTALMOLOGY
ORTHOPAEDICS LABORATORY
UROLOGY
NEUROLOGY CARDIOLOGY
8
R&D expertise Biomaterials transformation / assembly
Silicones transformation (LSR, HCR, LCE, gel, dispersion,…)
Complex device in silicone: Urinary sphincter
Silicone parts Including: stainless steel spring,
cable, fabric, NiTi, PP mesh…
Silicone parts
9
R&D expertise Biomaterials transformation / assembly
Bioresorbables molding (PLLA / PLGA / PDO…)
screws, rivets, anchors, plates, drug delivery devices …
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
Complex shape graft (like artery), scaffold, patch Electrospun fibers
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
http://www.revamed.fr/
TEH TUBE (European project)
FP7-NMP-2013-2.2-1
Tissue engineering of the right heart outflow tract by a biofunctionalized
bioresorbable polymeric valved tube
http://teh-tube.eu/
12
R&D expertise Biomaterials transformation / assembly
Collaborative project in the field of catheters and endoscopes
ESOTRAC(European project) H2020-ICT-2016-2017/H2020-ICT-2016-1 Hybrid optical and optoacoustic endoscope for esophageal tracking http://esotrac.eu/
13
R&D expertise Biomaterials transformation / assembly
Micro-mechanic (stainless steel, Nitinol, thermoplastics,…)
Ancillaries
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
15
R&D expertise Active Medical Devices & Electro-medical equipment
From left to right pictures:
- Slide detector - Nitrogen Monoxide dispenser - « eye care » device
Electronic (PCB) / Software
16
R&D expertise In Vitro Diagnostics
µ-Fluidic / Optical controls / Automation / Temperature management
Fluid analysis Devices (blood, saliva, urine,...)
17
R&D expertise / Machine Shop
- Conventional machine - CNC machine - EDM machine
Reactivity in prototyping (Stainless Steel or plastic parts, molds,…)
18
R&D expertise / Electronics Shop
- Micro-coiling - Micro-wiring - CMS PCBs
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
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
21
Design transfer Process validations following IQ/OQ/PQ standards
Packaging process (conform to ISO 11607 standard) (blister or Tyvek pouch)
Leak test Pelability test Pull test
22
- DMR file: production flowchart, instructions,… - VMP (Validation Master Plan) + Test Reports
- Raw material biocompatibility proof - Labelling design & printing (w/ or w/o bar code)
Design transfer
23
Contract Manufacturing
- Production managed by an ERP - CoC provided with each batch delivered - Traceability guarantee (bar code)
24
Contract Manufacturing
1000m² ISO 5 CER for Class III implants, IVD devices and all medical devices requiring sterilization (ETO, gamma beam)
25
Contract Manufacturing
300 m² workshop for mechatronics devices production
26
Thank you for your attention
Contacts:
Benoit STUDLÉ (CEO): [email protected] Sébastien PERROT (R&D Manager): [email protected]
Florent GUYON (Business Developer): [email protected]
www.statice.com
