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EuroMedtech™ 2014 Program Overview

www.ebdgroup.com/emt/program
Tuesday, May 6, 2014
13:00–18:00
Pre-conference Business Development Workshop

Courtyard by Marriott Linz Hotel
Europaplatz 2
4020, Linz

Sponsored by:
CatenionCatenion

Effective Innovation Portfolio Management for Medical Device Projects and Portfolios

This complimentary workshop will be open to all EuroMedtech attendees. The workshop will give an introduction to assessing risk, return and strategic fit for early stage vs. late stage projects based on partial assessment of a fictitious project case study. Experiences with portfolio consolidation, prioritization and project assessment will be shared. Please RSVP to Simon Englhart via email: senglhart@ebdgroup.com.

18:30
EuroMedtech™ 2014 Welcome Reception
FESCH Lounge

All attendees are cordially invited to join us for the Welcome Reception.

FESCH Lounge
Courtyard by Marriott Linz Hotel
Europaplatz 2
4020, Linz l (map)

You will be able to pick up your name badge at the Welcome Reception.

Wednesday, May 7, 2014
08:00
Foyer
Registration opens
08:00
Exhibit Hall
Exhibition opens
09:00–10:00
Panel Discussion
Balancing improved healthcare technology and cost through innovative approaches to medical device development

Wednesday, 09:00–10:00
Congress Hall

The demand to provide better healthcare at lower cost has become a driving force in product development and an efficiency which is critical to attracting investment in emerging medical device companies. Ensuring compatibility of new products with existing structures and anticipating further organizational and systemic integration is seen as a key driver of this demand. It is now essential to consider the challenges and benefits of increasingly holistic treatment approaches in the development of new products, and how these new approaches reflect both patient and user needs, often manifested in the application of eHealth tools. This panel will discuss the importance of developing a well-aligned and coordinated product development strategy that addresses product design, patient and user needs, clinical research, and reimbursement, in order to fully maximize return on investment.

Moderator:
Regina Hodits – General Partner, Wellington Partners

Panelists:
  • Vicki Anastasi – Senior VP, Medical Devices, Aptiv Solutions
  • Dr. Mark Charny – Managing Director, Translucency
  • Gabriele Ettenberger-Bornberg – Pharma, Medical Devices and Hygiene, OFI
  • Christian Haller – President, RavenOye Group
EuroMedtech™ 2014
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09:00–18:00
One-to-one Meetings ►
10:15–10:30
Welcome Remarks

Wednesday, 10:15–10:30
Congress Hall

Speakers:
  • Florian Schoenhammer – Group Managing Director, EBD Group
  • Werner Pamminger – Managing Director of Clusterland Upper Austria
EuroMedtech™ 2014
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10:30–11:40
Opening Plenary Session
Collaborating with payers: New patterns of engagement

Wednesday, 10:30–11:40
Congress Hall

With new technologies come new partners. As healthcare systems struggle to manage older populations with chronic illnesses such as diabetes and obesity, insurers are engaging in new ways with companies who develop tools to manage these conditions. Previously, working with payers was relevant mainly for reimbursement questions but some insurers are now engaging with companies at earlier points in the product development process, especially in sectors such as eHealth. One of the key ways that they are doing this is through the funding of clinical trials or by directly investing in companies. How can medtech companies explore possible partnerships? What kinds of technologies are attracting payer attention? And can this new payer role create a bridge between sectors to increase efficiencies within healthcare systems?

Moderator:
Raman Minhas – Country Manager, UK, Hygieia

Panelists:
  • Christian Krey – CEO, Emperra
  • Anne Portwich – Partner, LSP
  • Klaus Stoeckemann – Managing Partner, Peppermint VenturePartners
EuroMedtech™ 2014
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11:40–11:50
Special Address

Wednesday, 11:40–11:50

Speaker:
  • Michael Strugl – Minister of Economy, State Government of Upper Austria
EuroMedtech™ 2014
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12:00–13:00 Company Presentations ►
13:00–14:00
Exhibit Hall Stage
Luncheon with Moderated Table Discussions
Novelties of evidence requests for medical devices in Europe

Moderator:
Hubertus Rosery – CEO, AiM GmbH – Assessment-in-Medicine

An alternative investment model in a constricted financial environment

Moderator:
Gilad Peleg Lorberbaum – COO, Rainbow Medical

The eHealth conundrum

Moderator:
Thom Rasche – Partner, Earlybird Ventures

Transatlantic medical device updates

Moderator:
Reinhard Merz and Kenneth West – Partners, TCG

14:00–15:00
Panel Discussion
The MDR bottom line: What will the new European Medical Device Regulation cost your firm?

Wednesday, 14:00–15:00
Congress Hall

Medical device policy in Europe is being watched closely by companies and regulatory bodies around the globe. Majors changes will be implemented this year which could promise wide ranging effects for the industry. In the midst of the debate, the very practical consideration of cost has remained largely in the shadows. While the new regulations outline the establishment of a number of new bodies (eg. ACMD) or the expansion of the role of existing ones (eg. EMA), how these changes will be funded is still unknown. Higher compliance requirements for both companies and notified bodies, including clinical trials for devices in new categories, will also call for additional resources. Decisions on re-processing of devices will have a long-reaching impact on OEMs. And future implementation of initiatives like the UDI indicate the need for still further company capabilities to be allocated to regulatory adherence. The industry concern that the additional administrative and financial burden being placed on SMEs will not necessarily result in greater safety for patients, will stifle innovation, and will impact the industry's competitiveness reflects the uncertainty around these issues. What will the impact of the new MDR on a company's bottom line be? Who can companies look to for advice? And in the end, will the new regulations actually result in better protection for patients?

Moderator:
Ashley Yeo – Editor and Principal Analyst, Informa Healthcare

Panelists:
  • Martin Penver – Operations and Technical Manager, LRQA
  • Bernard Sweeney – Senior VP, Aptiv Solutions
  • Ashley Wallin – Executive Director, Emerging Growth Company Council, AdvaMed
EuroMedtech™ 2014
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15:00–15:30
Afternoon break
15:30–16:50 Company Presentations ►
17:00–18:00
Panel Discussion
Pharma friend or foe: Blurring the border between drug and device treatments

Wednesday, 17:00–18:00
Congress Hall

There is increasing use of devices where drugs used to be the only treatment. For these companies the challenge lies in translating biological understanding into engineering specifications. However, does this mean medtech and pharma will be competing in the same markets or could entry into these new therapies provide new partners or M&A opportunities for medtech companies? Join this panel to explore:

  • how companies identify the sweet spot of medtech development where drugs have failed or can offer greater value and a better treatment
  • the process of developing a technology good enough to compete in a market predominated by drugs
  • particular challenges, such as reimbursement, for companies that straddle the medtech/pharma border
  • the best business development strategy for these companies. How does identifying solely with one industry or the other impact strategy? Could collaboration give these companies an edge?

Moderator:
Tina Tan – Editor, Clinica Medtech Intelligence

Panelists:
  • Gillian Davies – VP Healthtech Strategy, Sagentia Ltd
  • Jon Hoem – CEO, Cardiac Impact
  • Matthias Krings – Senior Partner, Catenion
EuroMedtech™ 2014
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19:00–22:00
Evening Networking Reception with Buffet Dinner
Redoutensäle

Redoutensäle
Promenade 39
4020 Linz
Austria l (map)

The "Redoutensäle" are the former festival halls of the nobles and aristocrats of Upper Austria and are located in the city center of Linz. They were designed and built beginning in 1695 and were extended in 1773.

Sponsored by:

AWS AWS GC GC TMG TMG

18:15–19:00 Shuttle trains will transport guests to the evening event
22:15 Shuttle trains will transport guests to conference hotel

Yellow Trains
Thursday, May 8, 2014
08:00
Foyer
Registration opens
08:00
Exhibit Hall
Exhibition opens
09:00–10:00
Panel Discussion
A new source of buying power: The trend of outward investment from China

Thursday, 09:00–10:00
Congress Hall

The Chinese medtech market is developing rapidly. New regulatory policies are making clear how foreign companies can operate effectively within the national market, and companies are increasingly looking at China as a viable next step in new market entry. But the traffic is not all going in one direction. Chinese companies are now looking outside of the domestic market for small companies to support their growth within China and provide a presence internationally. Could this be an opportunity for companies raising capital and seeking to expand? What kinds of companies are being targeted and what are the implications for the M&A landscape? How does Chinese outgoing investment change the possibilities for companies interested in entering the Chinese market? Join this panel to discuss this emerging trend in international medtech strategy.

Moderator:
Regina Hodits – General Partner, Wellington Partners

Panelists:
  • Michael Alper – Managing Director, NeuvoMedica
  • Stephan Wehselau – CFO, JenaValve
EuroMedtech™ 2014
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09:00–16:00
One-to-one Meetings ►
10:10–11:20 Company Presentations ►
11:30–12:30
Financing instruments for a market under pressure

Thursday, 11:30–12:30
Congress Hall

The upheaval in global financial markets since 2008 has made waves in the medtech sector as well. Innovative new ways of financing have emerged to match the technologies developed to meet the needs of healthcare and financial systems under pressure to deliver more. This panel of medtech and finance professionals offers an indepth look at the innovative investment structures that have developed in response, such as venture loans, royalty models and differently structured exits, as well as examining whether these new models are serving the strategic goals of both investor and investee.

Moderator:
Naveed Siddiqi – Partner, Edmond de Rothschild Investment Partners

Panelists:
  • Nooman Haque – Director Life Science, Silicon Valley Bank
  • Julien Michaux – Director, Head of Venture Investments, Norgine Ventures
  • Martin Pfister – Partner, High-Tech Gruenderfonds
  • Rodney Turner – RWT Consulting
  • Jürg Zürcher – Partner, EMEIA Biotechnology Leader, Ernst & Young
EuroMedtech™ 2014
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12:30–13:30
Exhibit Hall
Luncheon
13:30–15:30
Congress Hall
Special Session
Focus on Diagnostics Afternoon

Join this special extended afternoon session on the pressing issues in the Diagnostics space. Professor Mehdi Tavakoli, Technical Director of Health KTN in the UK will introduce and chair this session. Leading clinicians, academic and industry experts will present current unmet clinical needs, the challenges faced by clinicians, academic and industry utilizing new materials and technologies, hurdles to effective collaboration at all points of diagnostic development and touch upon how emerging new regulations may impact the successful implementation of new products. New collaboration opportunities with leading clinicians, academic and industry will be presented. A panel discussion Q&A will further explore specific examples of the unique role diagnostics play as diverse European health systems seek to achieve integrated, efficient treatment pathways.

Keynote: Diabetes: Growing unmet needs

  • Professor Colin Dayan – Director, Institute of Molecular and Experimental Medicine, Cardiff University School of Medicine

Keynote: Academic and clinical challenges in in vitro diagnostics

Keynote: Measurement challenges in clinical diagnostics

Keynote: The challenges of converting innovation to products in the in vitro diagnostics markets

Panel discussion

Moderator:
Mehdi Tavakoli – Technical Director, HealthTech and Medicines KTN

Panelists:
  • Professor Peter Corish – Head, Business Development, BBI Group
  • Professor Colin Dayan – Director, Institute of Molecular and Experimental Medicine, Cardiff University School of Medicine
  • Professor Carl Heneghan – Director, Centre for Evidence-Based Medicine, University of Oxford
  • Dr. Max Sonnleitner – Head, Rapid Testing Technologies and Business Development, Greiner Bio-One Diagnostics
  • Professor Pankaj Vadgama – IRC Biomedical Materials, Queen Mary University of London, UK
Measurement Challenges in Clinical Diagnostics

There has been a quiet revolution in the way hospital care has changed, along with its interface with primary care. Seamless patient management, reduced in-patient stay and consultant led continuous support are becoming norms for healthcare systems in industrialized countries, in part a response to the complexities of contemporary medicine and patient expectations. Underpinning this capability has been the more immediate availability diagnostic data, whether generated at the patient's bedside, doctor's office or the central laboratory. To an extent this has been delivered not so much through changes in measurement chemistries, but their re-engineering within analytical systems, variously dependent on flow and automated processing. There is no single attribute that can be regarded as having driven the analytical revolution, but certainly biological reporter and minaturisation have played a part. There are now on the horizon new bioaffinity constructs such as genetically engineered proteins, aptamers, imprint polymers and modified affinity ligands achieving radically different binding properties to add to the palette of medical analytical science. Our directed modifications of these are likely to be much more rationally based with complementary advances in macromolecular science. Also, further miniaturisation, simplification of optical pathways, incorporation of nano-structures into assay cascades and precision engineering of detection interfaces are likely to furnish low intrusion measurement and once integrated into controlled microfluidics, the 'lab on a chip', more discussed than used, thus far. Through this, data immediacy may well be extended to complex targets, but the scene is also set for invasive systems able to track biochemical variables continuously; the hidden information in the dynamics of biochemical changes may establish an entirely new approach to assessing patient status, especially those requiring aggressive therapies. Tuning to biology in this way could well change the diagnostic paradigm, but the need, as ever, will be for the innovations that encompass multiple disciplines.

EuroMedtech™ 2014
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Mehdi Tavakoli – Technical Director, HealthTech and Medicines KTN

Prof Tavakoli is a Technical Director of the Health KTN. He has worked closely with the Technology Strategy Board, Department of Health, and Research Councils as well as with other UK government departments, healthcare companies, academics and clinicians and other stakeholders to support and accelerate innovation and commercialization in healthcare and medicines in UK. One of his main responsibilities for the Health KTN has been to lead and facilitate clinicians/industry collaborations addressing unmet clinical needs in many clinical areas. Mehdi has over 20 years' experience in research, training and consultancy on polymeric materials with particular interest on development of novel applications of polymers as medical and biomaterials for a variety of medical device and healthcare applications. He has worked on developments of a range of medical and implantable materials and devices, particularly for cardiovascular, orthopedic and regenerative medicine applications.

He joined TWI Ltd in 1989 and is a Technology Manager and a Consultant with particular focus in medical industry.  He is also a Visiting Professor of Medical Devices and Materials at the Bioengineering Unit, University of Strathclyde and published over 70 papers and patents. He is an active Technical Advisory Board and Steering Committee Member of a number of major UK life sciences schemes.

EuroMedtech™ 2014
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Keynote: Diabetes: Growing unmet needs

There are over 380 million people worldwide with diabetes and many more in whom the condition remains undiagnosed. It is the fastest growing non-communicable disease with prevalence rates increasing 5 fold in developed nations in the last 20 years and up to 10 fold in developing countries. A recent survey in China suggested that over 9% of the adult population was affected. Long-term complications include heart disease, kidney failure, blindness and foot ulceration. The majority of the recent increase is driven by economic growth resulting in increased calorie availability and reduced need for physical activity, but there have also been increases in type 1 diabetes which is an immune mediated disorder. Prof Dayan will discuss the unmet needs to address this huge challenge, both in terms of preventive measures and therapeutic interventions.

EuroMedtech™ 2014
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Professor Colin Dayan – Director, Institute of Molecular and Experimental Medicine, Cardiff University School of Medicine

Colin Dayan trained in medicine at University College, Oxford, and Guy's and Charing Cross Hospitals in London, UK before obtaining a PhD in the immunology of Graves' Disease in Laboratory of Marc Feldmann. He then spent a year as an endocrine fellow at the Massachussetts General Hospital in Boston, USA before completing his specialist training in diabetes and endocrinology as a Lecturer in Bristol. He became a consultant senior lecturer in medicine (diabetes/endocrinology) at the University of Bristol in 1995 and Head of Clinical Research at the Henry Wellcome Laboratories for Integrative Neuroscience and Endocrinology in Bristol in 2002. In 2010, he was appointed to the Chair of Clinical Diabetes and Metabolism and Head of Section at Cardiff University School of Medicine, and became Director of the Institute of Molecular and Experimental Medicine in 2011. He has a long established interest in translational research in the immunopathology of type 1 diabetes and is currently an EU FP7 SME program coordinator and conducting early phase clinical trials in the development of antigen specific immunotherapy. Prof. Dayan is Director of the Cardiff Postgraduate Diabetes Education program which is a leading provider of online advanced training in diabetes with over 250 students internationally and hubs in Dubai and Chennai.

EuroMedtech™ 2014
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Keynote: Academic and clinical challenges in in vitro diagnostics

The process of development, validation and adoption of new diagnostic technologies historically is recognized as being a lengthy process, and one that does not always meet the intended expectations. This experience contributes to the increasing focus on fast tracking the innovation process in healthcare, which is being developed in many healthcare systems. It is also recognized that, on the one hand, investment in technology represents a significant proportion of healthcare spend, while on the other hand there is substantial evidence of emerging problems due to over-requesting of investigations. Innovation in healthcare results from a collaboration among clinicians, scientists, entrepreneurs and commercial organizations—as well as managers and policymakers in healthcare. Defining present standards of care and utilizing new technology to redefine products and services will allow new best practices to be implemented and audited across healthcare systems. To foster innovation there is a need to develop more effective ways of identifying diagnostic testing needs from different perspectives (patient/caregiver, clinicians, laboratory services, commissioners, industry) and develop an agreed set of evidence criteria, aimed at decision makers across Europe, while developing incentives for manufacturers to develop high quality evidence.

EuroMedtech™ 2014
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Professor Carl Heneghan – Director, Centre for Evidence-Based Medicine, University of Oxford

Carl Heneghan is Director of the Centre of Evidence-Based Medicine, a General Practitioner and a Fellow of Kellogg College. His research interests cover NonCommunicable Diseases (NCDs) and he is currently chair of a number of guidelines for the World Health Organization (WHO) on self-care in NCDs and CVD risk. He is also a co-applicant on the GBP 3.5 million NIHR funded Centre for Monitoring and Diagnosis in Oxford (MADOX), and he is a chief investigator or a co-applicant on four mutli-center randomized trials. He is also clinical director of the new NIHR, Diagnostic Evidence Co-operative, Oxford. His work involves investigating the evidence base for publication bias and drug and device regulation, and he works alongside the BMJ on a number of projects related to the regulatory and evidence requirements for devices and drugs. He is also a founder of the alltrials campaign.

As a clinical epidemiologist, Prof Heneghan has extensive experience in systematic reviews, observational and quantitative methodologies. He is also a Co-Director of the Oxford Diagnostic Horizon Scanning Centre, an effective early warning system that identifies innovations in the field of health technology likely to have a significant impact which is published as a series in the BJGP. He also has an active interest in diagnostic reasoning and its impact on decision making, and collaborates on monitoring methods and articles related to teaching of research methods and Evidence-Base Practice.

EuroMedtech™ 2014
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Professor Pankaj Vadgama – IRC Biomedical Materials, Queen Mary University of London, UK

Professor Pankaj Vadgama CSi, MB BS, BSc, PhD, FRCPath, FRSC, FInstP, FSB, Qualified in Medicine and completed a degree in Chemistry in 1976 at Newcastle University. He was MRC Training Fellow at the University of Newcastle; a Registrar in Clinical Biochemistry at Newcastle General Hospital; Director of the Biosensor Research Group, University of Newcastle. He has been Professor of Clinical Biochemistry at the University of Manchester; Research Dean, Faculty of Medicine; Professor of Biomedical Materials. He was also Head of the Department of Clinical Biochemistry, Hope Hospital, Salford. Since 2000 he has been Director of the Interdisciplinary Research Centre in Biomedical Materials, Queen Mary, University of London and Professor of Clinical Biochemistry. He is Honorary Consultant Chemical Pathologist at Barts Healthcare NHS Trust, London. His main research interest is in biomaterial surface interactions and the design of medical biosensors for continuous monitoring.

EuroMedtech™ 2014
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The challenges of converting innovation to products in the in vitro diagnostics markets

The drive for innovation in organizations to drive economic development is relentless and insatiable. However, in markets that are highly regulated and traditionally conservative, how can businesses and research organizations work together to deliver creative and innovative products and commercial models into these arenas? This presentation will discuss the areas that present the greatest challenges while using examples where collaboration and open innovation have worked successfully. The different balance required between innovation and process control will be considered at the inter-organizational and intra-organizational levels, while also raising the question of whether our current approaches to IVD regulation, development and manufacture are fit for healthcare's 21st century requirements.

EuroMedtech™ 2014
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Professor Peter Corish – Head, Business Development, BBI Group

Dr. Pete Corish is Head of Business Development for BBI Group and leads the internal technology acquisition group, BBInnovations. Based in Cardiff, UK, Pete is responsible for the sourcing, development and commercialization of new technologies to maintain BBI's position as the leading lateral flow assay developer and the acquisition of reagent-based products that underpin future IVD markets. This includes the extension of BBI's core gold nanoparticle reagents into life science and novel biosensing applications. As part of Alere (formerly Inverness Medical Innovations) he also maintains a watching brief on the rapid developments in molecular and immunoassay point-of-care and the increasing role of personalized medicine and companion diagnostics in 21st century healthcare provision. In previous roles, he has been involved with the identification, development and commercialization of a variety of early stage, transformational micro and nanotechnologies for genome and transcriptome and protein analysis with several UK technology companies in both the pharma and in vitro diagnostic sectors.

EuroMedtech™ 2014
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15:30
Exhibit Hall
Closing Reception
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