matériaux médicaux implantables : le point aujourd’hui par henri decloux | liege creative,...

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

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Liège Créa+ve – Program

� Medi-‐Line presentation � Who We Are

� Where we work

� What we do

� Regulation evolution impacts � Past � Future

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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

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MEDI-‐LINE : Where we work

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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

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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

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MEDI-‐LINE : Injec+on Molding


�  Equipment �  2 Molding machines

�  #1 55 Tons clamping force Full Electric �  #2 80 Tons clamping force Mix Hydraulic (clamping)/ Electric (injection)

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MEDI-‐LINE : Injec+on Molding


�  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

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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,..

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�  Operations �  Laser cutting �  Vacuum forming : blister, trays… �  Wire post-‐processing: molecular chain orientation �  Balloon forming : blower

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�  Assembly �  Gluing: UV, Cyanoacrylate, solvent �  US welding �  Mechanical attachment �  Micro-‐assembly: microscope

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�  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

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MEDI-‐LINE : Clean room Manufacturing Class C(ISO7)

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MEDI-‐LINE : Products

� Disposable devices : -‐  Catheters « like » products -‐  Radiopharmacy single use supplies -‐  Surgical devices

�  Implants active & non active

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� Catheters « like » products


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Medical Devices

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� Complex assembly


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� Radiopharmacy single use supplies


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� Radiopharmacy single use supplies GE Tracerlab Mx cassette


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� Radiopharmacy single use supplies


GE Fastlab cassette

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MEDI-‐LINE : Products � Active implantable devices

Sorin Group – vagus nerve stimulation

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MEDI-‐LINE : Products • Non-‐active implantable devices TVT products family •  TVT – O and TVT-‐O Laser cut •  TVT – Abbrevo •  TVT – Exact

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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.

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MEDI-‐LINE : ERP System

F0380115 step 10 links to PP0380107 ed 1.6

Gamme – follow-‐up revision

Robust ERP System for manufacturing

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Traceability per lot and work order

Laser Gun in mfg clean room


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Full tracability per lot and Production Order


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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

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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

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Regula+on evolu+on

�  A common mission « Veiller à ce que chacun puisse disposer de produits de santé …………. fiables »

�  An opportunity

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matériaux médicaux implantables : le point aujourd’hui par henri decloux | liege creative,...

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