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28.09.2015 Page 1
COCIR WEBINAR Monday 28 September, 10.30 to 12.00
ENVIRONMENTAL, HEALTH AND SAFETY
LEGISLATION IN EUROPE
Trends and threats for the Medical Sector
28.09.2015 Page 2
COCIR WEBINAR Monday 28 September, 10.30 to 12.00
CIRCULAR ECONOMY IN MEDICAL DEVICE
INDUSTRY CHALLENGES, SOLUTIONS AND OPPORTUNITIES
Freimut Schroeder
COCIR EHS Committee Chair
28.09.2015 Page 3
Status of Medical Devices among EEE
Due to their important function MDs have to
• be functional, safe and extremely reliable
lives are at stake, product failure not an option!
• comply with more laws, safety regulations and
industry standards than devices of other EEE
categories
process of MD redesign very long, followed by years
of verification, validation and licensing procedures
Medical devices serve to
• save lives
(early diagnosis, disease treatment,
etc.)
• improve quality of life
(therapy, disease prevention, etc.)
28.09.2015 Page 4
Environmental Legislation (worldwide) - Impact and Activities of the Medical Device Industry
Topic Business Impact Activities / Solutions
ErP
Ecodesign of products to minimize
environmental aspects
Increase of 2 – 4 % manufacturer costs (e.g. for design
changes); worst case: no market access
“COCIR ErP Self-Regulatory Initiative” to
protect degrees of freedom in product
design and choosing internal processes
RoHS
Replace hazardous substances, e.g.
lead, cadmium
Affects 80% of total revenue; extra costs to replace
RoHS substances; worst case: no market access
Ask for exemption
Replace hazardous substances
REACH
Evaluate and register chemicals
Approx. additional 350.000 EUR per substance/
application for additional evaluation and registration
procedures
Establishing practical solutions (e.g.
BOMcheck) to ensure compliance and
reduce costs
Dodd-Frank-Act
Conflict minerals Extra cost for getting evidence about conflict minerals
Establishing practical solutions , together
with trade associations
WEEE
Reduce, collect, and recycle old
electric and electronic equipment
Extra costs for additional take back processes
Establishing practical solutions for
product take back systems; sharing
COCIR best practice on refurbishment
GPP
Green Public Procurement Criteria Additional requirements for PLM, extra costs and time
Working closely with European
Commission to get reasonable criteria
Resource Efficiency
Road Map from Europ. Commission Additional requirements for PLM, extra costs and time
Developing Road Map “Resource
Efficiency at Healthcare”
28.09.2015 Page 5
Impact to the Medical Device Industry
Specification Design Production Use End of Life
Specification Design Production Use End of Life
Hazardous Substances
Resource Efficiency
Waste
2000
2010
2020
Incre
asin
g im
pact of environm
enta
l re
gula
tions to p
roduct lif
e c
ycle
28.09.2015 Page 6
Spare parts Upgrade
Reuse Refurbishment
Recycling
REPLACEMENT
OF CRITICAL MATERIALS
Concerned by legal
requirements
Affected by acute supply
risks
SUSTAINABLE
MATERIAL USE
Platform design
Standardization
Lean Supply Chain
Management
System/Architectur
engineering
Alternative Technologies
Circular Economy from three different angles with its huge business potentials and benefits
EXTENSION
OF LIFETIME
Perform competitive intelligence and search for substitutes to ensure future demand is met.
Implementing standardization results in a great
cost performance and in an exemplary
sustainable image.
Optimizing extension of lifetime process allows
internal and external growth by
gaining/extending market shares.
28.09.2015 Page 7
BOMCheck Material Atlas Life Cycle
Assessment
Product Lifecycle Management Tools – (e.g. SAP, TeamCenter) Influencing of environmental aspects is only possible during product specification and design
Outcome • List of hazardous substances in components and parts
• Declaration of Conformity (e.g. for EU)
• List of all substances in components and parts (future)
Business Benefit • Ensure market access
• Support Circular Economy
Outcome • Get quick overview about critical materials and provide
substitution to replace critical substances
• Receive „early warning“ during the design phase
Business Benefit • Ensure market access
• Avoid extra costs by acting early on material
compliance
Outcome • Knowledge about significant environmental aspects /
impacts
• Environmental Product Declaration
Business Benefit • Support market access
• Cost reduction by way of EcoDesign
• Positive image (sustainable products)
Centralized web database to get necessary
information on hazardous substances in
components and parts from the supply chain
e.g. regarding RoHS and REACH
Information system on critical materials (e.g.
regarding RoHS and REACH) to
• Find the most sustainable materials at the
beginning of product development
• Manage risks related to critical materials
• replace critical materials (where applicable)
• Optimize design cost regarding material selection
During the design phase of a new product
collect environmental aspects and evaluate
their environmental impacts across the entire
product life cycle
Product Eco Excellence at Siemens Healthcare
The Need of strong links to PLM and PLM Tools
28.09.2015 Page 8
BARRIERS (examples)
To restrictive and unnecessary legal requirements on Medical Devices, in particular on the content
of hazardous chemicals:
RoHS ban of substances
REACH restrictions and authorizations
REACH article 33: communication along the supply chain
Conflict with reuse and repair of used Medical Devices.
28.09.2015 Page 9
Circular Economy
“A circular economy is one that is restorative by design, and which aims to keep products,
components and materials at their highest utility and value, at all times.
1. Circular economy is a global economic model that decouples economic growth and
development from the consumption of finite resources;
2. Focuses on effective design and use of materials to optimise their flow and maintain or
increase technical and natural resource stocks;
3. Provides new opportunities for innovation across fields such as product design, service and
business models, food, farming, biological feedstocks and products;
4. Establishes a framework and building blocks for a resilient system able to work in the longer
term.”
- Ellen McArthur Foundation -
28.09.2015 Page 10
What do we really need …
• Freedom and flexibility in innovation
• Hazardous substances used if for technical
reason required
• Fast RoHS exemption process
• Strong support from authorities for Circular
Economy (focus on reuse: recovered parts for
repair, refurbishment and manufacturing)
• Harmonization of global regulation and
standardization
28.09.2015 Page 11
Thanks for your attention!
Freimut Schröder
Vice President Environment, Health, Safety
Siemens Healthcare GmbH
Henkestraße 127
91052 Erlangen
Tel.: +49 (9131) 84-2023
Fax: +49 (9131) 84-6002
Mobil: +49 (173) 97 535 86
E-Mail:
Answers for life.
