COCIR WEBINAR Monday 28 September, to ENVIRONMENTAL, HEALTH AND SAFETY LEGISLATION IN EUROPE Trends and threats for the Medical Sector

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1 COCIR WEBINAR Monday 28 September, to ENVIRONMENTAL, HEALTH AND SAFETY LEGISLATION IN EUROPE Trends and threats for the Medical Sector Page 1

2 COCIR WEBINAR Monday 28 September, to CIRCULAR ECONOMY IN MEDICAL DEVICE INDUSTRY CHALLENGES, SOLUTIONS AND OPPORTUNITIES Freimut Schroeder COCIR EHS Committee Chair Page 2

3 Status of Medical Devices among EEE Medical devices serve to save lives (early diagnosis, disease treatment, etc.) improve quality of life (therapy, disease prevention, etc.) 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 Page 3

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 RoHS Replace hazardous substances, e.g. lead, cadmium REACH Evaluate and register chemicals Dodd-Frank-Act Conflict minerals WEEE Reduce, collect, and recycle old electric and electronic equipment GPP Green Public Procurement Criteria Resource Efficiency Road Map from Europ. Commission Increase of 2 4 % manufacturer costs (e.g. for design changes); worst case: no market access Affects 80% of total revenue; extra costs to replace RoHS substances; worst case: no market access Approx. additional EUR per substance/ application for additional evaluation and registration procedures Extra cost for getting evidence about conflict minerals Extra costs for additional take back processes Additional requirements for PLM, extra costs and time Additional requirements for PLM, extra costs and time COCIR ErP Self-Regulatory Initiative to protect degrees of freedom in product design and choosing internal processes Ask for exemption Replace hazardous substances Establishing practical solutions (e.g. BOMcheck) to ensure compliance and reduce costs Establishing practical solutions, together with trade associations Establishing practical solutions for product take back systems; sharing COCIR best practice on refurbishment Working closely with European Commission to get reasonable criteria Developing Road Map Resource Efficiency at Healthcare Page 4

5 Increasing impact of environmental regulations to product life cycle Impact to the Medical Device Industry 2020 Specification Design Production Use End of Life Hazardous Substances Resource Efficiency 2010 Waste 2000 Specification Design Production Use End of Life Page 5

6 Circular Economy from three different angles with its huge business potentials and benefits REPLACEMENT OF CRITICAL MATERIALS SUSTAINABLE MATERIAL USE EXTENSION OF LIFETIME Concerned by legal requirements Affected by acute supply risks Platform design Alternative Technologies Spare parts Upgrade Lean Supply Chain Management System/Architectur engineering Reuse Refurbishment Standardization Recycling Perform competitive intelligence and search for substitutes to ensure future demand is met. Page 6 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.

7 Product Eco Excellence at Siemens Healthcare The Need of strong links to PLM and PLM Tools Centralized web database to get necessary information on hazardous substances in components and parts from the supply chain e.g. regarding RoHS and REACH BOMCheck 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 Material Atlas During the design phase of a new product collect environmental aspects and evaluate their environmental impacts across the entire product life cycle 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) Page 7

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. Page 8

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 - Page 9

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 Page 10

11 Thanks for your attention! Freimut Schröder Vice President Environment, Health, Safety Siemens Healthcare GmbH Henkestraße Erlangen Tel.: +49 (9131) Fax: +49 (9131) Mobil: +49 (173) Answers for life. Page 11