24-25 September 2014

Hotel Marriott Zurich Switzerland

The European Orthopaedic Design and Manufacturing Conference and Exhibition

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Conference Programme 2012

Download the 2012 conference Brochure here


Day 1 - Wednesday 12th September

Session 1

9.00 – 10.30 Global regulation update and the impact for orthopaedic industry
Moderator: Maria E. Donawa, M.D. President, Donawa Lifescience Consulting (Bio)

Impact of the MDD changes on orthopedic devices
Elisabethann Wright, Partner, Hogan Lovells International LLP, Belgium (Bio)

S1.2 Impact on the European Market - Standpoint of a Notified BodyAn extended manner to implement the new regulation
• Notified Bodies Control (European Commission Directorate-General for Health and Consumers measures)
• Notified Bodies position and prospective
Charles-Alban Grandière, Projet Certification Manager, LNE-G-Med, France (Bio)
S1.3 US FDA regulatory and enforcement update
• New standards and guidelines
• Trends in recalls and warning letters
• Outcome of FDA public meeting on metal-on-metal implants 
• Other news from FDA
Maria E. Donawa, M.D. President, DONAWA LIFESCIENCE CONSULTING, Italy (Bio)
S1.4 Regulatory trends from Great China
• China regulatory approval update 
• Clinical data
• UDI (unique device identification) Implementation
Zeli (Scott) Yu, Vice President, Healthcare Service & Medical Device Regulatory Affairs, Shanghai Hail Fellow., China (Bio)


Session 2

11.00 -12.30 Round table: Emerging market: Opportunities, challenges and key drivers
Moderator: Hervé Reignac, CEO, BioStep, France & Council Member, Gerson Lehrman Research (Bio)

• Which today are the local market dynamics & key drivers for a successful introduction in an emerging market?
• How local regulatory requirements might impact foreign players?
• Which are the main difficulties for foreign companies to adapt their business to local cultural sensitivities?
• Does long-term & close relationships of local surgeons with EU or US universities/scientific institutions help to leverage market entry?
• How can EU manufacturers protect their technology transfers?

- Serdar Omur Goren, Vice General Manager, Sayan Orthopaedics, Turkey (Bio)
- Ajay Pitre, Managing Director, Sushrut Surgicals Pvt. Ltd, India (Bio)
- Zeli (Scott) Yu, Vice President, Healthcare Service & Medical Device Regulatory Affairs,
Shanghai Hail Fellow., China (Bio)
- Caroline de Mareüil-Villette, European Patent Attorney, ICOSA, France (Bio)

Workshops : (click here to see the full workshops programme)

Workshop A
13.30 -15.00
Cleaning Validation for Surgical Instruments
Workshop B
15.15 – 16.45
Cleaning and Packaging Validation for Implant

• • •

Day 2 - Thursday 13th September

Session 3

9.00 -10.30 Innovation in materials
Chairperson: Dr. Cyril Voisard, Group Manager Materials & Surfaces, SYNTHES Gmbh (Bio)
Material challenges in orthopaedics
Dr. Cyril Voisard, Group Manager Materials &Surfaces, SYNTHES Gmbh (Bio)
S3.2 Towards polymer implants in orthopaedics and trauma surgery
Metal-free new approaches and new options for meeting bone elasticity more precisely by implants. New approaches will be shown
Dr.med. Urs Schneider, Head of Department Orthopaedics & Systems in Motion, Fraunhofer Institute for Manufacturing Engineering and Automation (IPA)
S3.3 Manipulating Osseointegration Through Material Surface Modification
This talk will describe cell and tissue specific responses to metal internal fixation materials with specific emphasis on a surface microtopographical approach to alleviating removal related morbidity and also touch on how these principles apply to polymers, in this case PEEK.
Prof. RG Richards, Director AO R&D, AO Research Institute Davos
S3.4 Implant corrosion: From unwanted localized attacks to biodegradable metallic Implants
Dr. Patrick Schmutz, Laboratory for Joining Technologies and Corrosion, Swiss Federal Laboratories for Materials Science and Technology – EMPA (Bio)
S3.5 Electro-mechanical effects in bone and bone-like synthetic structures and their relation to osteogenesis.
A critical overview of the reports on electro-mechanically and electrically induced bone healing, bone growth and cell differentiation and use of electro-mechanically active materials in medical implants.
Prof. Dragan Damjanovic, Ceramics Laboratory, Swiss Federal Institute of Technology – EPFL (Bio)


Session 4

11.00-12.40 New approaches for advanced manufacturing
Chairperson:Dr. Roland Hauert, Head of Surface Technology, Swiss Federal Laboratories for Materials Science and Technology – EMPA (Bio)
Integrative approaches to R&D and manufacturing in ortho & spine, considerations of mechatronics
Clemens Troche, Vice President / Principal Client Advisor, VALTRONIC (Bio)
S4.2 Important Parts in Life – Engineering Plastics used in Medical Instruments [Properties and Compliance]
• Engineering plastics: why choose stock shapes
• How to be successful designing with plastic shapes
• Evolution of plastics and application examples
Bernd Beigel, Business Development Engineer, Life Science Applications, Quadrant PHS Deutschland GmbH (Bio)
S4.3 Diamond-like carbon coatings for articulating orthopaedic implants
Dr. Roland Hauert, Head of Surface Technology, Swiss Federal Laboratories for Materials Science and Technology – EMPA (Bio)

Thermal plasma spray innovations - New coatings
In addition to well established applications, thermal Plasma Spray can nowadays be used to realise highly macroporous titanium surfaces, to coat thermally sensitive materials and to realise unexpected couplings of different biomaterials.
Francesco Robotti, Eurocoating Spa (Bio)

S4.5 Nano-Coating on all implants
• Wet chemical-based coating technology of nano-sized hydroxyapatite crystals
• A coating for all materials from metals and ceramics to pyrocarbon and PEEK
• Coating of micro porous implant materials without clogging the pores
• The impact of hydrophilic surfaces on the integration with bone
• Moving the coating procedure to the implant production line
Ulf Brogren, CEO, Promimic AB (Bio)

State of the art coatings applied on polymeric medical implants
Coatings of implants applied with different technologies have been in continuous development in the last fifteen years in order to improve fixation in bones, to protect against wear and for anti-allergy applications.
Recently a new generation of coatings have been developed providing a considerable new spectrum of potential applications in the future endo- prostheses. Among these innovations are the coatings for cement-free bonding applied on high performance plastics like PEEK or UHMW-PE. These kind of coatings provide osseo-integrative functionality to the plastics implants and offer a complete new application horizon into the orthopaedics market.
Finally the presentation provides some estimations of the market potential for such products.
Sylvie Ruch, Project manager – Coating Technologies, Alhenia AG (Bio)

Workshops :
(click here to see the full workshops programme)

Workshop C
13.30 - 15.00
Design and Stimulation
Workshop D
15.15 – 16.45
Additive Manufacturing

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