We bring smart solutions to life
Presentation for: MedikitDate: 17th August 2009
Medisize Corporation - Basic Medisize Corporation - Basic factsfacts
• Combined Net Sales 106 M Euros in 2008• Main owner Ratos • about 900 People
Headquarters in Vantaa, FinlandCEO: Willem van den Bruinhorst
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Main owner is Ratos.
Ratos is a Nordic family-controlled private equity company
• Industrial player in multiple sectors• History dating back to 1866• Listed on the Stockholm Stock Exchange since
1954• Strong emphasis on the core values:
professional, active and responsible exercising of its ownership
• Does investments from own balance sheet• Long term strategy for investments
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Medisize Corporation - Basic Medisize Corporation - Basic factsfacts
History in briefHistory in brief
1953Perlos was founded
1984 Start of
pharmaceutical production
2001UK plant opened
2006Medifiq started
1981Medisize NL was founded
2002Medisize CZ
plant opened
2002Acquisition of
Donegal Healthcare,
Ireland
2006Medisize
Holding on Swiss Stock Exchange
2004Acquisition of Createchnic, Switzerland
2008Medisize
Corporation
1990Kontiolahti
plant opened
Manufacturing: European Manufacturing: European focusfocus
Headquarter: Vantaa, Finland
Production plants
Manufacturing: PlantsManufacturing: Plants
FinlandBased in Kontiolahti
Drug Delivery Devices
Ireland Based in Letterkenny
SwitzerlandBased in Nürensdorf
Primary Pharmaceutical
Packaging
Com
pete
nce
The NetherlandsBased in Hillegom
Czech RepublicBased in Trhové Sviny
Medical & Diagnostic Devices
Airway Management
Finland plant detailsFinland plant details
Constructed in 1990• Plant was built for the production of medical devices• Extended in 1992 and 1999
Floor space 19 000 m2
• Clean room area is approx. 4500m2
• Other manufacturing area ca. 500m2
• 11 production halls
• 300 employees
• Injection Moulding, manual and automated assembly
• ISO 9001 / ISO 13485 / ISO 14000 certified
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Ireland plant detailsIreland plant details
• Based in Letterkenny
• Clean rooms Class 7, 2.400 m2
• 170 employees
• Injection Moulding, film welding, manual and automated assembly, packaging
• In-house gamma sterilisation
• ISO 13485 certified
• FDA registered site
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Switzerland plant detailsSwitzerland plant details
• Based in Nürensdorf (near Zürich)
• Clean rooms Class 7 & 8, 900 m2 and dedicated laminar flow units
• 115 employees
• Injection moulding, injection blow moulding, stretch blow moulding, manual and automated assembly
• Packaging
• ISO 13485, BRC IoP certified
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Phar
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Netherlands plant detailsNetherlands plant details
• Based in Hillegom (near Amsterdam)
• Clean rooms Class 7, 1.350 m2
• 135 employees
• Injection Moulding, manual and automated assembly
• Packaging and sterilisation services
• ISO 13485 certified
• FDA registered site
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Czech Republic plant detailsCzech Republic plant details
• Based in Trhové Sviny
• Clean rooms Class 7, 900 m2
• 75 employees
• Injection Moulding, extrusion, manual assembly
• Packaging
• ISO 13485 certified
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Medisize Medisize Corp. - OrganisationCorp. - Organisation
QA
CEO
Sales Development & Manufacturing
SalesAirway
Management
Compt. CentreDrug Delivery
Devices
Compt. CentrePrimary Pharma
Packaging
Compt. CentreMedical & Diagn.
Devices
LegalFinance, IT
& Purchasing
ExcellenceCentre
NL
CZ
IRL
CHDrug
DeliveryDevices
Medical &Diagnostic
Devices
Primary Pharma
Packaging
D
NL
IT
ProjectManagement
R&D
ProcessEngineering
Tooling
Marketing FIN
International Sales
Focus on people and qualityFocus on people and quality
Corner stones of Medisize :• customer focused• open communication• continuous improvement• regulatory compliance• environmental awareness
Skilled, trained and motivated personnel create the basis for Medisize’s operations.
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Medisize qualityMedisize quality
• Certified global processes according to:
– ISO 13485: 2003– ISO 9001: 2000– ISO 14001: 2004
• Continous improvement by Six Sigma methods guided by Black Belts
• Creation of– Design History File during product
development– Regulatory documentation e.g. Drug Master
Files
Certified processes
Qua
lity
Operations based on regulatory requirements:
– FDA Quality System Regulations (21 CFR Part 820)
– Medical Devices Directive (MDD) – In Vitro Diagnostic Directive (IVDD)
Regulatory Compliance
Medisize business lines Medisize business lines
Medisize has the expertise to deliver innovative, high quality and cost effective solutions to the healthcare market with the focus on development and manufacturing of:
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Drug Delivery DevicesDrug Delivery Devices
Product examples:– Inhalers– Injector pens– Contraceptive devices
Characteristics:– Complex medical engineering– High quality requirements for
tooling and manufacturing– High volume production– Automatic assembly– Custom made
Project: insulin pen for diabetes patients for sanofi-aventis
The pen consists of 12 plastic and 1 metal component. Given the successful production by Medisize, a second production line will be set up at the Kontiolahti plant in Finland to increase the production capacity by the end of 2009.
Primary Pharmaceutical Primary Pharmaceutical PackagingPackaging
Characteristics:– High volume production– Special manufacturing
technologies required– Standard products and custom
made– Close to customer
Product examples:– Bottles– Closures– Single and multi chamber bags
(flexible containers)
Medical & Diagnostic devicesMedical & Diagnostic devices
Characteristics:– Very diverse, disposable– Finished product / part of finished
product– Design & development– 100% custom made
Product examples:– Pumps– Tube sets– Catheters– Surgical devices– Diagnostic arrays– Pipette tips for clinical diagnostics
Airway ManagementAirway Management
Airway Management products for:– Anaesthesia– Critical Care
Delivering and climatizing the breathing gasses from ventilator to patient
Product examples:Finished products with Medisize brand:
– Bacteria filters, with or without humidification paper– Breathing circuits– Infusion systems– Breathing bags
Customized in-house servicesCustomized in-house services
As a full service contract manufacturer we offer the following services:
LogisticsPackaging SterilisationAssemblyComponent
ManufacturingTooling
Industrialisation
Prototyping Pre-production
Design & Development
1. Design & Development1. Design & Development
In-house product and mechanical designers ensure fast development
• Transforming product design to manufacturing design– concept creation – industrial & mechanical design– materials selection for required applications– technology integration– functional design and verification– prototyping– functional testing– testing & validation– approvals
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2. In-house Tooling2. In-house Tooling
• In-house tool design
• In-house manufacture:– Representative 1-cavity hardened steel trial
tools– Multi-cavity hardened steel mass production
tools– High-precision machinery for tool manufacturing
in 24/7
• On-site maintenance of production tooling
Speed and flexibility through in-house tool making
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3. Manufacturing3. ManufacturingSe
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• Injection moulding (179 machines)• Injection blow moulding / Stretch blow
moulding (27 machines)• 2K moulding• Insert moulding• Silicon moulding/liquid injection
moulding• Film welding (Radio Frequency /
Thermal)
Medisize offers the following manufacturing technologies:
4. Clean room assembly 4. Clean room assembly
From manual to high speed automated assembly solutions:
Automated Assembly– Equipment specification and build management – Sophisticated high-volume production lines – In-line Vision control systems
Manual Assembly– Experienced, well trained and conscientious
staff – Multi solvent bonding services include Cyclo
bonding, UV bonding and THF bonding.All assembly activities take place in clean rooms class 7 & 8
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5. Packaging services5. Packaging services
Packaging Services for the needs of the pharma, medical and diagnostic markets
All primary packaging is undertaken in class 7 (10,000) clean room conditions
The products are individually packaged; in blisters, medical peel pouches or according to our client's wishes
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6. Sterilisation 6. Sterilisation
In-house Gamma sterilisationWith over 2 decades operational experience in validation, sterilisation and control. In-house microbiologists are available for sterilisation validation services.
Sterilisation services offeredExperienced external process management for: - Ethylene Oxide (EtO)Validations and EtO residue determinations.
- Electron beam (E-beam)Experienced external process management.
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Medisize Medisize Corp. PurchasingCorp. Purchasing
CFOSemi Korpela
PurchasingB+P
Mr.Ralf Hoenighausen
Purchasing Medisize BV
Mr. Andre Schreurs
PurchasingMedisize CZ
Mrs. Martina Remiasova
PurchasingMedisize IE
Mrs.Liz McCarron
PurchasingMedisize CH
Mr. Peter Baumann
Corporate Purchasing ManagementRon van Lokven
PurchasingMedisize FI
Mrs. Susanna Sammalisto
Trade Products AWM ProductsOEM Products
Corporate Purchasing
• Corporate Purchasing Organization with decentralized buyers– 6 Buyers reporting to corporate Purchasing Management
• Total Purchasing Spend in the Group approx. 75 mln €, growing into 90 mln € by the end of 2012
• Overall split is 70% direct materials, 30% in indirect materials and services– Resins, Packaging materials, Trade products, IT, Consultancy,
Travel, Business services, etc.
• Category Management approach in Purchasing in line with the ambition and goals as in our strategic plan for the Medisize Group
• No local strategies without alignment to the corporate strategy.
Supplier Quality Statement
Medisize is committed to provide a total quality performance for all our customers. This can only be achieved when our Suppliers have the same commitment towards us.
This means that Medisize wants their Suppliers to be ambitious in their goals and targets concerning quality level and improvements. Our Suppliers should be able to bring the latest quality innovations in order to contribute to the overall commitment Medisize is providing to its customers.
Our Suppliers should understand the environment where Medisize and its customers are in. Suppliers should aim to be better as “industry standard” and bring forward their quality improvements and developments to Medisize. All suppliers are expected to supply products and services to Medisize with zero defects. Products and services shall meet all relevant specifications and function with no abnormalities. Suppliers are encouraged to use error prevention processes and techniques and implement improvement tools such as Lean, Six Sigma, in their manufacturing procedures to meet this quality goal.
Medisize wants its Suppliers to fully comply with all applicable legal and regulatory rules, regulations and directives. Naturally all our Suppliers should have a quality management system in place, suitable for the products or services delivered to us.
Medisize emphasizes that reliability of Suppliers is an essential element in the relationship. Reliability is also expressed by the flexibility that Suppliers show in order to follow Medisize and the customer needs, within the agreed framework between our companies. Suppliers are required to have effective manufacturing practices and procedures to ensure a continuous and on-time flow of high quality
We bring smart solutions to life. What can you do for us?
Topics
•CE and change control•Specifications and notifications•Last buy order due out of assortment•Exclusitivity agreement on product area’s•Short or long term contract•Order lead times•Stock or non stock products•Prices, turnovers and stepth overriders / volume rebates•Incoterms and terms and conditions