Presentation

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

Basi

c fa

cts

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

Basi

c fa

cts

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

Dru

g D

eliv

ery

Dev

ices

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

Prim

ary

Phar

mac

euti

cal P

acka

ging

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

Prim

ary

Phar

mac

euti

cal P

acka

ging

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

Med

ical

& D

iagn

osti

c D

evic

es

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

Airw

ay M

anag

emen

t

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.

Com

mit

men

t

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:

Com

mit

men

t

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

Serv

ices

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

Serv

ices

3. Manufacturing3. ManufacturingSe

rvic

es

• 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

Serv

ices

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

Serv

ices

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.

Serv

ices

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