mölnlycke health care - kompetensinstitutet...kuala ketil, malaysia jkt, poland countries where...

Develop Customer Solutions “DCS”

Mölnlycke Health Care

Så Säkrar vi Regulatoriska Krav i

Produktutvecklingsprocessen

Claes-Göran Andersson

PLM & Business Process Director

System Owner PLM


Company Overview

Mölnlycke Health Care is a world leading manufacturer of

single-use surgical and wound care products and services for

the professional health care sector

Owned by Investor

7200 employees

The headquarter is based in Gothenburg, Sweden


Mölnlycke Health Care's Global Presence

Head Quarters, Göteborg, Sweden

Europe/Middle East/Africa,

20 offices (incl. head office)

4 Representative offices

North America, 2 offices

South America, 1 office

Asia/Pacific, 5 offices

Production of wound care products

Mikkeli, Finland

Oldham, UK

Wiscasset, US

Brunswick, US

Production of surgical products

Bangkok, Thailand (2)

Karviná, the Czech Republic

Waremme, Belgium incl.

Customer & Distribution Centre

Kulim, Batang Kali,

Kuala Ketil, Malaysia

JKT, Poland

Countries where

Mölnlycke Health

Care's products are

sold


Mölnlycke Health Care History

1849 The company was first established as a textile

manufacturer

1975 Mölnlycke was acquired by SCA

1998 Mölnlycke Health Care was established (main owner

Nordic Capital)

2005 Acquired by Apax Partners, merged with Regent

Medical and Medlock Medical

2007 Investor acquires Mölnlycke Health Care


Company Structure

Mölnlycke’s business is divided into two divisions:

Surgical Division, which develops and

manufactures a wide range of single-use

surgical products that can help minimize

the risk of postoperative wound infections

for both patients and health care workers

Wound Care Division, which develops

and manufactures wound care products

for chronic and surgical wounds, burns

and complementary products in

compression therapy, dermatology and

electro stimulation.


Building QA/RA for the Product

Development Process


PLM Maturity – Support for QA/RA in Development Processes


The Evolution to PLM E

xte

rnal

Invo

lve

men

t

PLM

Product Lifecycle Management Collaborative Strategic Sourcing

Requirements Management

Program Management

Supplier Relationship Management

Process Integration across Value Chains

Full lifecycle support

Process Coverage

PDM

Product Data Management Bill of Material Engineering Change CAD Vaulting

Document Management CAD Integrations ERP Integrations

CAD

Vaulting

CAD Vaulting

CAD file handling

2D & 3D Viewing / Markup

Simple Change Mgmt


Focus on Innovation

•A PLM aligned company see development of new products

as a central activity

•The steps to make PLM an efficient tool for You:

•Organize the Product information

- A single source to all product data

- Structured and classified information

- Full history of all product data

- Documentation Control

• Create Efficient Development Processes

- Change Management Support

- Global access to product data

- Earlier involvement of critical functions

- Integration of Suppliers / Partners and Functions

- Tools for Project/Program Management

- Integration to/from critical systems (ERP, Design Tools, etc)

•Make the right Innovation Decision

- Knowing what products we have today – strengths and weaknesses

- Structured Requirements Management

- Traceability from requirement to realized product

- Product Portfolio Planning / Product Management

•Make the right Innovation Decision

•Create Efficient Development Processes

•Organize the Product information


E N 4 6 0 0 1 - M D D

Description of:

• Operational processes

and activities.

• Vision, Mission, Aims and

Goals

• Follow-up of performance

vs. strategic aims, goals

• Organisation • Job descriptions • Authority and

responsibility • Organisational chart

• Design Control

• Contract review

• Documents • Control • Form

• Content

• Supplier agreement

• Complaint handling

• Methods

• Audits

• Quality records

Business Developm.

Technology Product Supply

Market

- -

_

Processes

President

Human

Res. Market Finance

Technical

Develop.

Bus.area

Surgical Bus.area

Wound M.

Material

Develop.

DPD Lab.

Product

Care

Product

Develop.

Factories

Packaging

TG

1

TG

2

TG

3

TG

4

TG

5

Project model WHAT HOW DO CLOSE

AT2

AT2

AT4

AT2

AT4

AT1

AT2 AT3

AT3

699040-70

79040-70

AT4

- - -

Customer

- - -

- - -

MF

Mach. Doc.

Proj. Doc.

- - -

- - -

Claims

Tech.doc file

- - -

- - -

- - -

MF

Proj. Doc.

- - -

MF

- - - MF

- - -

- - -

- - -

Supplier Evaluation

Frame Agreement

Supplier Information

Supplier


Roles and Responsiblities Activity

Pro

ject

Ma

na

ger

Co

mp

on

en

t O

wn

er

Reg

ula

tory

Aff

air

s

Ha

nd

ler

Desi

gn

Ch

an

ge

Ad

min

istr

ato

r

Ma

ster D

ata

Co

ord

ina

tor

Item

Ow

ners

Ma

nu

factu

rin

g P

ro

cess

Ow

ner

Pro

du

ct

Ow

ner

Su

pp

ly C

ha

in P

lan

ner

3 Description, Manual Transfer R C C A C

3.1. Create Component R A

3.2.1 –3.2.24 Attributes in PDM R A C C** C**

3.2.25. Tab Manufacturing R A

3.2.26. Tab Quality Properties R A

3.2. 27 Component Specification R A

3.2.28. Manufacturing Specification R A

3.2.29. Labelling Specification R A

3.2.30. Packaging Specification R A

3.2.31. Packaging and Transport

Evaluation

R A

3.2.32. Stability Report R A

3.2.33. Environmental Product Report R A


The Process Model describes how the work flows within

Mölnlycke Health Care

Sha

re

hol

de

r

Va

lue

Cu

st

ome

rs

Cu

st

ome

rs

Supply

CustomerSolutions

CustomerManagement

Plan & Manage Operation

Manage Human Capital

Provide Supporting Infrastructure

DevelopCustomer

Solutions


Generate Explore Develop

Business

Concept

Delivery Capacity

Market Awareness

Validated Product

Selling Capacity

Develop

Platform

Detailed

Design Implement

Follow

Up

TG1 TG2 TG3 TG4 TG5 TG6

What is the DCS Process

Regulatory security

Efficiency, Time to Market

Project

Cross functional

Industrialization

Launch to

Market


PRIME supports the DCS process

• Authority control and roles

• Life cycle management

• Automation of repetitive work

• Search and reuse of information

• Approvals and recording of activities

• Manage all documents in the DCS process

• Communication and transfer of product data to

SAP

• Fulfil regulatory requirements


Document

Document

Document

Simplified data model

Product Delivered Item

Component

Material Supplier

Material

Composition

Machine

Pre-sterile

Component

PRIME objects


PRIME object type trees


Research & Plan

Concept Design &

Development Sourcing Marketing Sell/Produce Support/Retire

Develop

Customer

Solution

Aftermarket

Provide

Customer

Solution

Develop Design

Handle Industrialisation

Handle Distribution

Handle Internal Launch

Sourcing

Pre-Market Authorisation

Handle Clinical Research

Management

Project Management

Validate added services

Contracts &pricing

Marketing approval

Basic practice regulations and compliance

Account planning

Handle complaints

Field service

Supply Chain Planning

Manufacturing

Manage customer supply

Manage

customer

Needs

Tender


Product Development and

Change Management

Document

Management

Project Management

Work Breakdown Structure

Procurement

Supplier Quality

Integration to:

•SAP

Manufacturing

- Internal

- External

Product data

DBOM & MBOM

Areas In Place Or To Be Implemented

External PLM

access

Regulatory and Marketing

Release

Clinical Research Laboratory Process /

Test Methods


Information Perspective


Sales & Regulatory Release

Dossier

Registration

Authority

Country Regulatory

Release

DI Variant DI Variant Product

Release For

Project

Sales

Release


Sales & Regulatory Permission

21

REGULATION

IN VITRO

DIAGNOSTICS

PHARMA

MEDICAL

REGULATION

CATEGORY MEDICAL

DEVICE

PERSONAL

PROTECTIVE

EQUIPMENT

COSMETICS

BIOCIDES

UNCLASSIFIED

QUASI DRUG

BIOLOGICS

OTHER

REGULATION

CATEGORY

MDD

REGULATION

CFR

REGULATION

MDD

Class I

MDD

Class IS

MDD

Class IM

MDD

Class IIA

MDD

Class IIB

MDD

Class III

CFR

Class I

CFR

Class II

CFR

Class III


View of the End User - Example

• To work and display Regulatory Release and Sales release Grid

Browser will be used.

• One example below where Sales Release for Products are visualised

in context of countries.

• The same Grid could be used to Manage

Regulatory Release

22


View of the End User - Example

• Another Example – Rows Products

with connected Classifications

– Columns – All Classifications Rules

23


Challenges for Mölnlycke

• PLM As-Is built on Objects, Types, Attributes

• How to work with information in context of: – Number Id. system – Workflow – Life cycles – Promotion rules – Ownership – Roles – Etc.

How can we manage Information and keep control in the same manner as today with Documents?


Challenges for Mölnlycke cont.

How to go from:

• Document Management – Document Types – Everything in context – Text document – Templates and layout

To:

• Content Management? – Part of document – Chapters – Still layout

Or even preferred:

• Information Management – Context free? – No layout – Text reused in interfaces or with a report generator where MHC

decide to use the information from context and layout in a structured and controlled way.


One Version of the Truth - RA in DCS


Thank You!

[email protected]