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Presentation for: Medikit

Date: 17th August 2009
 Medisize Corporation - Basic
facts
Basic facts

• Combined Net Sales 106 M Euros in 2008

• Main owner Ratos
• about 900 People

Headquarters in Vantaa, Finland

CEO: Willem van den Bruinhorst
 Medisize Corporation - Basic
facts
Basic facts

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
History in brief

2006 2006
2008
Medifiq Medisize
started Medisize Holding on
Corporation Swiss Stock
Exchange
2001
UK plant
opened 2004
Acquisition of
Createchnic,
Switzerland
1990
Kontiolahti 2002
plant opened Acquisition of
Donegal
Healthcare,
Ireland
1984
Start of 2002
pharmaceutica Medisize CZ
l production plant opened

1953 1981
Perlos was Medisize NL
founded was founded
Manufacturing: European
focus

Headquarter: Vantaa, Finland

Production plants
 Manufacturing: Plants
Competence

Primary
Drug Medical & Diagnostic
Pharmaceutical Devices
Delivery
Packaging Airway Management
Devices

Finland Ireland The Netherlands

Based in Kontiolahti Based in Letterkenny Based in Hillegom

Switzerland Czech Republic

Based in Nürensdorf Based in Trhové Sviny
 Finland plant details
Drug Delivery Devices

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

 Ireland plant details
Primary Pharmaceutical Packaging

• 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

 Switzerland plant details
Primary Pharmaceutical Packaging

• 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

 Netherlands plant details
Devices
Medical & Diagnostic

• 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

 Czech Republic plant details
Airway Management

• Based in Trhové Sviny

• Clean rooms Class 7, 900 m2

• 75 employees

• Injection Moulding, extrusion,

manual assembly

• Packaging

• ISO 13485 certified

Medisize Corp. - Organisation

CEO

Finance, IT
QA Legal
& Purchasing

Sales Sales Compt. Centre Compt. Centre Compt. Centre

Excellence
Development & Airway Drug Delivery Medical & Diagn. Primary Pharma
Centre
Manufacturing Management Devices Devices Packaging

Project
Marketing D FIN NL IRL
Management

Drug
Delivery NL CZ CH R&D
Devices

Medical &
Process
Diagnostic IT
Engineering
Devices

Primary
International
Pharma Tooling
Sales
Packaging
 Focus on people and quality
Commitment

Skilled, trained and motivated personnel

create the basis for Medisize’s operations.

Corner stones of Medisize :

• customer focused
• open communication
• continuous improvement
• regulatory compliance
• environmental awareness
 Medisize quality
Quality

Certified processes

• 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
Regulatory documentation e.g. Drug Master
Compliance
Files
Operations based on regulatory
requirements:
– FDA Quality System Regulations (21 CFR Part
820)
– Medical Devices Directive (MDD) 
– In Vitro Diagnostic Directive (IVDD) 
 Medisize business lines
Commitment

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:
Drug 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
Packaging
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 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 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 services

As a full service contract manufacturer we offer the following

services:
Tooling
Design & Prototyping Component Packaging
Assembly Logistics
Development Pre-production Manufacturing Sterilisation
Industrialisation
 1. Design & Development
Services

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
 2. In-house Tooling
Services

Speed and flexibility through in-house tool making

• 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

 3. Manufacturing
Services

Medisize offers the following manufacturing technologies:

• 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)
 4. Clean room assembly
Services

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
 5. Packaging services
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
 6. Sterilisation
Services

In-house Gamma sterilisation

With over 2 decades operational experience in
validation, sterilisation and control. In-house
microbiologists are available for sterilisation
validation services.

Sterilisation services offered

Experienced external process management
for:

- Ethylene Oxide (EtO)

Validations and EtO residue determinations.

- Electron beam (E-beam)

Experienced external process management.
 Medisize Corp. Purchasing

CFO
Semi Korpela

Corporate Purchasing Management

Ron van Lokven

Purchasing Purchasing Purchasing Purchasing Purchasing Purchasing

B+P Medisize BV Medisize CZ Medisize CH Medisize IE Medisize FI
Mr.Ralf Hoenighausen Mr. Andre Schreurs Mrs. Martina Remiasova Mr. Peter Baumann Mrs.Liz McCarron Mrs. Susanna Sammalisto

OEM Products
Trade Products AWM 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