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Le scandale liés aux implants PIP en France fin 2011 a permis de mettre en lumière un ensemble de faiblesses liées au contrôle et au suivi des implants. Depuis lors, de nombreux efforts ont été réalisés tant à l’échelle européenne qu’au niveau belge pour adapter la législation en la matière, mais aussi pour dégager des moyens financiers importants pour en faciliter la mise en place. A la suite de la table-ronde LIEGE CREATIVE organisée en mars 2012 sur ce même sujet, cette nouvelle réunion permettra de faire l’état des lieux sur ces changements en écoutant des acteurs-clés du secteur : représentants de l'Agence Fédérale des Médicaments et des Produits de Santé, industriels, cliniciens et chercheurs.
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Parole d’expert
Christian GRANDFILS, ULg-CEIB, Vanessa BINAME, DG Post | AFMPS, Françoise SCHLEMMER, Quasys Consult, Henri DECLOUX, MEDI-LINE
Matériaux médicaux implantables : le point aujourd’hui
Avec le soutien de :
« Experts in medical products »
http://www.mediline.be
Liège Créative 19-‐03-‐2013
1
Liège Créa+ve – Program
� Medi-‐Line presentation � Who We Are
� Where we work
� What we do
� Regulation evolution impacts � Past � Future
2
MEDI-‐LINE : Who We Are
� Plastic Medical Devices Experts � … that develops and manufactures plastic medical devices for
major pharma and/or medical companies.
� Human Size Company � … based in the center of Liege Science Park, near Liege University.
All the 50 employees are commited to continously improve Quality, Efficiency and Flexibility to meet our client requirements.
� Our credo : High Quality and Professional Services
3
MEDI-‐LINE : Where we work
4
MEDI-‐LINE : Extrusion
All operations are made in clean room Class D (ISO 8) � Equipment
� 2 Double lines + Hopper dryers � #1 Main: 30mm secondary: 20mm � #2 Main: 45mm secondary: 30mm
5
MEDI-‐LINE : Extrusion
All operations are made in clean room Class D (ISO8)
� Equipment � 2 Double lines + Hopper dryers
� #1 Main: 30mm secondary: 20mm � #2 Main: 45mm secondary: 30mm
� Capacity � Size : from 0,22mm up to 15mm OD � Output: up to 50Kg/h � Speed: up to 100m/min
� Raw Material � Most of thermoplastics: PVC, PP, PE(LD,HD), PA, Acrylics, PUR,PEBAX…
� TechniquesI
� Coextrusion: X-‐Ray lines , multilayer, … � Bubble tube: variable cross section � Multilumen: 2 to 9
6
MEDI-‐LINE : Injec+on Molding
All operations are made in clean room Class D (ISO8)
� Equipment � 2 Molding machines
� #1 55 Tons clamping force Full Electric � #2 80 Tons clamping force Mix Hydraulic (clamping)/ Electric (injection)
7
MEDI-‐LINE : Injec+on Molding
All operations are made in clean room Class D (ISO8)
� Equipment � 2 Molding machines
� #1 55 Tons clamping force Full Electric � #2 80 Tons clamping force Mix Hydraulic (clamping)/ Electric (injection)
� Capacity � Shot Weight : up to 60 cm³ � High accuracy and full CR compatibility � High Temperature : up tu 450°C
� Raw Material � Most of thermoplastics: idem extrusion+ Polysulfone, TPX, COC…
� TechniquesI
� Hot runners: 16 Zones � Mold T° regulators: from 16°C to 160°C � Automatic sprue picker � Desionized air blowing on conveyor belts
8
MEDI-‐LINE : Clean room Manufacturing Class C(ISO7) � Finishing
� Tip forming: inside/ outside, HF heating � Hole punching � Printing � Validated cleaning processes: US bath,..
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MEDI-‐LINE : Clean room Manufacturing Class C(ISO7) � Finishing
� Tip forming: inside/ outside, HF heating � Hole punching � Printing � Validated cleaning processes: US bath,..
� Operations � Laser cutting � Vacuum forming : blister, trays… � Wire post-‐processing: molecular chain orientation � Balloon forming : blower
10
MEDI-‐LINE : Clean room Manufacturing Class C(ISO7) � Finishing
� Tip forming: inside/ outside, HF heating � Hole punching � Printing � Validated cleaning processes: US bath,..
� Operations � Laser cutting � Vacuum forming : blister, trays… � Wire post-‐processing: molecular chain orientation � Balloon forming : blower
� Assembly � Gluing: UV, Cyanoacrylate, solvent � US welding � Mechanical attachment � Micro-‐assembly: microscope
11
MEDI-‐LINE : Clean room Manufacturing Class C(ISO7) � Finishing
� Tip forming: inside/ outside, HF heating � Hole punching � Printing � Validated cleaning processes: US bath,..
� Operations � Laser cutting � Vacuum forming : blister, trays… � Wire post-‐processing: molecular chain orientation � Balloon forming : blower
� Assembly � Gluing: UV, Cyanoacrylate, solvent � US welding � Mechanical attachment � Micro-‐assembly: microscope
� Packaging � Pouches : paper/film � Blister + tyvek sealing � Tray: film/film pouches + vacuum � Final pack: inner, outer carton
Double pack, validated processes
12
MEDI-‐LINE : Clean room Manufacturing Class C(ISO7)
13
MEDI-‐LINE : Products
� Disposable devices : -‐ Catheters « like » products -‐ Radiopharmacy single use supplies -‐ Surgical devices
� Implants active & non active
14
� Catheters « like » products
MEDI-‐LINE : Products
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� Catheters « like » products
MEDI-‐LINE : Products
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� Catheters « like » products
Medical Devices
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� Complex assembly
MEDI-‐LINE : Products
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� Radiopharmacy single use supplies
MEDI-‐LINE : Products
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� Radiopharmacy single use supplies GE Tracerlab Mx cassette
MEDI-‐LINE : Products
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� Radiopharmacy single use supplies
MEDI-‐LINE : Products
GE Fastlab cassette
21
MEDI-‐LINE : Products � Active implantable devices
Sorin Group – vagus nerve stimulation
22
MEDI-‐LINE : Products • Non-‐active implantable devices TVT products family • TVT – O and TVT-‐O Laser cut • TVT – Abbrevo • TVT – Exact
23
MEDI-‐LINE : Quality System � MEDI-‐LINE has a reliable quality system
� Certified EN ISO 9001: 2008 and EN ISO 13485: 2012
� Quality system tuned to customer specific requirements.
� Audits by our customers : 9 on 18 months = one every two months !
� This system has multiple levels – Medi-‐Line’s one is close to GMP requirements
� Audit from GEHC and radiopharmacy laboratories audits against GMP.
24
MEDI-‐LINE : ERP System
F0380115 step 10 links to PP0380107 ed 1.6
Gamme – follow-‐up revision
Robust ERP System for manufacturing
25
MEDI-‐LINE : ERP System
Traceability per lot and work order
Laser Gun in mfg clean room
Robust ERP System for manufacturing
26
MEDI-‐LINE : ERP System
Full tracability per lot and Production Order
Robust ERP System for manufacturing
27
Regula+on evolu+on
� Prolift® story. � Ethicon WHU stops their developments in « mesh » products area.
� TVT Secure® removed from market, two other new products ready for marketing thrown away.
� Why : � Lawyers pressure � Mediatization � FDA demands
28
Regula+on evolu+on
� Americanization of the control system � Does the industry need a “police” or a “partner”
� Entrepreneurship is a risk � Assessment “advantages / drawbacks” � Risk increase ð cost increase � Time is money
29
Regula+on evolu+on
� A common mission « Veiller à ce que chacun puisse disposer de produits de santé …………. fiables »
� An opportunity
30