Event Overview

In the increasingly cost-contained world of medical device market access, Payers (including ministries of health, insurers private & public, hospitals and local governments) are seeking to justify investment in new medical technologies. Health Technology Assessment (HTA) agencies are now widely spreads across Europe assess new technologies and interventions not only on the grounds of clinical effectiveness, but also based on cost-effectiveness, cost-utility and cost-benefit, to ensure the payers’ limited funds are well invested. This HTA and value demonstration requirement has evolved the “commercialisation” landscape of medical devices across the world and this next barrier is one that all medical device companies seeking to gain reimbursement and approval from payers and tendering bodies, need to overcome.

The variety of commercial channels, customers and payers within the medical device space is as diverse as the different business models being used for the different product types (e.g. Imaging Vs Surgical products) and only increases the complexity and specificity of the “value message” which needs to well-delivered, in order to ensure an optimal outcome. This three-day event is the “must-attend” event for all senior directors at medical device companies who are looking to enhance market access for their products. We look forward to meeting you in Berlin!

Speakers List

PAYERS, HTA AGENCIES & POLICY MAKERS

Deputy Institute Director
Institute for Quality and Efficiency in Health Care (IQWiG), Germany

Legal & Policy Officer
European Commission

Lise Grove

Vice President - Strategic Procurement and Supply of Pharmaceuticals and Medical devices
Amgros, Procurement Service for Regional Authorities, Denmark

Director
Health Technology Wales, UK

Scientific Adviser
RIZIV-INAMI, Belgium

Head of service
Healthcare-associated infections & antimicrobial resistance (Sciensano), Belgium

Rossana Alessandrello

Value Based Procurement Director
Catalan Agency for Health Quality and Assessment – AquAS

Scientific Coordinator, Agenas HTA Projects
Agenas (Agency for Regional Health Services), Italy

Head of Clinical Engineering Service
Humanitas Research Hospital, Italy

Former Chief Innovation Officer
America’s Health Insurance Plans (AHIP), USA

Borja Garcialorenzo

Health Economist
Hospital Clinic of Barcelona

Industry Experts

Head Global Market Access & Health Policy, Roche Diagnostics International
Chair “VODI (Value of Diagnostic Information)” WG & HTA for IVD WG, Medtech Europe

Senior Director, Global Health Economics & Reimbursement
Edwards Lifesciences, USA

Vice President International Access, Policy & Advocacy
Myriad, Germany

Vice President, Global Reimbursement & Market Access
Second Sight Medical Products, USA

Senior Director, Head of Health Economics, Market Access & Policy Affairs Europe, Middle-East and Africa
Fresenius Medical Care, Germany

Cristina Manzano Galán

Government Affairs Manager, Iberia
Stryker, Spain

 

Christelle Saint Sardos

Director, Government Affairs and Access Policy EMEA, Canada & LATAM
Edwards Lifesciences, France

Director, Global Market Access
Intuitive Surgical, USA

Director, Market Access & Economic Policies
MedTech Europe, Belgium

Director, Government Affairs, Policy & Health Economics
GE Healthcare, Italy

Director Payers & Health Economics
Coloplast, Germany

Marcus Simon

Director, Market Access – EMEA
Teleflex, Belgium

Senior Manager in Health Economics, Market Access & Policy Affairs
Fresenius Medical Care, Germany

Head of Health Economics and Healthcare Management Division, Kozminski University
Principal Senior Consultant, Global Market Access, Straub Medical, Switzerland

Market & Business Insights Manager EMEA
Smith & Nephew, Switzerland

Reimbursement Manager, Cardiac Management Solutions
Zoll, Germany

 

Johannes Schaeferhoff

Senior Health Economics Manager
Arthrex, Denmark

General Manager
Alifax, Italy

CEO
Oxford Endovascular

Secretary General
EUCOPE – the European Confederation of Pharmaceutical Entrepreneurs, Belgium

Loon Lee

Senior Pricing Manager Patient Care and Monitoring Solutions
Philips Healthcare, Germany

Experienced Solution Provider

CEO and Founder
ValueConnected

Director Value-Based Healthcare
ValueConnected

Principal and Founder
Hull Associates, USA

Founder & CEO
MTRC – European Med Tech and IVD Reimbursement Consulting

Head of MedTech Consulting
Huron Consulting Group

Director, Life Sciences
Huron Consulting, UK

CEO
Device Access UK

Michael Weisser

CEO
AIM Gmbh (Assessment-in-Medicine), Germany

Event Structure

Photo Gallery

Event Program

MedTech: International Payer & HTA Forum

Day 1 - 3rd December, 2019

Stream Overview

Global healthcare systems are evolving daily. At a time of increased health economic reform, ageing populations and budget austerity, leaders in medical technology look to achieve optimal market access and commercialization of their products. As payers worldwide demand more value for money on the medical devices they fund, the importance of achieving patient access by demonstrating cost effectiveness and enhanced health outcomes is of the utmost importance. With payers in both developed and developing countries under extreme budgetary pressure, we will provide a platform for attendees to examine how health technologies are assessed, tough decisions are made and how we define “value”. This exclusive forum is the opportunity to meet and network with a broad spectrum of senior representatives who wish to encourage innovation whilst managing a limited budget.

08.30
Registration & Coffee
08.40
10-Minute Mindfulness Session (Optional)
09.00
Chairperson’s Opening Remarks

Director Value-Based Healthcare
ValueConnected

PAYER & HTA VIEWS & EXPERIENCES

09.10
MedTech evaluation initiatives in Denmark
  • Moving from regional to national evaluation processes: Pilots, challenges and opportunities.
  • How will the new MedTech regulation impact the assessment of devices in Denmark?
  • Which HTA models are being followed? Which devices should be evaluated?  
Lise Grove

Vice President - Strategic Procurement and Supply of Pharmaceuticals and Medical devices
Amgros, Procurement Service for Regional Authorities, Denmark

09.40
Principles of MedTech Market Access - how to to get technologies to patients faster

The principles of market access differ greatly from traditional 4 P  product price place promotion Marketing. The winning combination of clear demonstration of Patient, Provider Payer and Product benefits (Optimizing price but maximising the availability to patients who need the technology most) to HTA’s leads to faster adoption meaning patients receive great technologies sooner.

CEO
Device Access UK

10.10
Italy: Evidence sources and market access for HTA used by Agenas
  • Sources of evidence for device assessment are numerous. However, as technology assessment is a multidimensional and complex activity, no single source encompasses the whole evidence-base required. In addition, only few HTA agencies have access to registration dossiers.
  • The session will focus on the obstacles and opportunities to carrying out a fair assessment and the practical ways used by Agenas to overcome the problems.

Scientific Coordinator, Agenas HTA Projects
Agenas (Agency for Regional Health Services), Italy

10.40
Networking & Coffee Break
11.10
MedTech assessment in Germany: IQWIG’s perspective

Deputy Institute Director
Institute for Quality and Efficiency in Health Care (IQWiG), Germany

11.40
Europe's MDR and proposed pan European HTA process for reimbursement

While evidence requirements have changed under the new European framework for CE arking, the movement towards pan-European Health Technology Assessment also has gained traction, prompting greater conformity of HTA evidence requirements and "transplantation" of evidence reviews across geographies within the European Union.  Companies can expect CE Mark requirements to be more aligned with the demands of HTA bodies for reimbursement, but the challenges for medical device firms are greater, as local HTA bodies may be commissioned to implement assessments that have a pan-European impact. 

Principal and Founder
Hull Associates, USA

12.10
Panel discussion: Implementing devices & diagnostics value-based models to satisfy payer needs and build trust
  • What can the industry do to better reflect the product’s value in the product’s dossier?
  • Overcoming measurement, monitoring & implementation difficulties in reality.
  • How can companies adjust their value demonstration in global markets? What are the different ‘’value’’ requirements in different markets?
Lise Grove

Vice President - Strategic Procurement and Supply of Pharmaceuticals and Medical devices
Amgros, Procurement Service for Regional Authorities, Denmark

Scientific Coordinator, Agenas HTA Projects
Agenas (Agency for Regional Health Services), Italy

Head of Clinical Engineering Service
Humanitas Research Hospital, Italy

Director, Market Access & Economic Policies
MedTech Europe, Belgium

12.50
Luncheon Break
13.50
Optimization of medical device reimbursement in Belgium: Initiatives and future trends
  • Optimisation of care: centers of excellence, uniformity of health data registries, uniform services for the home care environment.
  • Revision of the legislation: The role for the scientific associations.
  • Measures for budget overrun.
  • Improved accessibility: Introduction of novel technologies, e.g. mobile health applications.
  • Exchange of knowledge: e.g. interaction  with European partners

Scientific Adviser
RIZIV-INAMI, Belgium

14.20
Realizing the Value of MedTech Innovation
  • Most significant challenges for medtech companies to deliver value-based care
  • Innovation and capabilities required to meet stakeholder needs
  • Reality gap – perceptions of success and metrics to measure progress
  • How to win in delivering value-based care across geographies

Head of MedTech Consulting
Huron Consulting Group

14.50
Implementing hospital-based HTA as a part of the procurement process
HOSPITAL PERSPECTIVE

Head of Clinical Engineering Service
Humanitas Research Hospital, Italy

15.20
Coffee & Networking Break
15.50
Real-World Experience and Collaboration for Hospital-Based HTA

Senior Manager in Health Economics, Market Access & Policy Affairs
Fresenius Medical Care, Germany

Borja Garcialorenzo

Health Economist
Hospital Clinic of Barcelona

16.20
Translating market needs into actual value stories
  • Identifying decision-makers’ needs
  • Assessing the relevant data to support claims
  • Building a concrete value story
  • Next steps: Teams, not tools, demonstrate value

CEO and Founder
ValueConnected

16.50
Mock Payer Panel Workshop

Before our panel of Subject Matter experts and practitioners, participants will prepare short briefs to demonstrate the value of several fictional case study products to a panel for approval.
As all MedTech market access industry practitioners know, you only get one chance to make a great first impression on payers and procurement decision makers, so this workshop will allow participants to practice their presentations in a safe environment.

Assessors will look at: Content of the presentation & Evidence used in order to give constructive feedback.

Participants will be grouped into product specific areas which will enable them to tailor their learnings for their products.

The product natures will be:

  • Capital Equipment
  • Surgical/Implantable Devices
  • Hospital Consumables

Chairperson:

Stephen Hull
Principal and Founder
Hull Associates, USA

The Panelists will be:

Deputy Institute Director
Institute for Quality and Efficiency in Health Care (IQWiG), Germany

Scientific Adviser
RIZIV-INAMI, Belgium

Scientific Coordinator, Agenas HTA Projects
Agenas (Agency for Regional Health Services), Italy

Senior Director, Head of Health Economics, Market Access & Policy Affairs Europe, Middle-East and Africa
Fresenius Medical Care, Germany

18.20
Chairperson’s closing remarks
18.30
End of day one

19.00 Networking Dinner

MedTech: Access through HTA Pathways

Day 2 - Stream 1 - 4th December, 2019

Stream Overview

Medical device firms are increasingly under pressure from payers, HTA agencies, healthcare providers and other stakeholders to provide real evidence of their product’s benefit. Increasingly, especially when a technology is expensive, the CE Mark alone is no longer sufficient to gain market access. Robust health economic evidence demonstrating the clinical and economic value of a device is either becoming mandatory, or at least can be a source or competitive advantage to differentiate apparently similar products. Evidence can still be generated from scientific publications, but on top of this, sophisticated and expensive clinical trials and even real-world studies are now being designed and implemented. Getting the trial design right from the beginning is essential, so that the right research questions are being asked and robust methodologies are used to demonstrate improved health outcomes. Protocols must also be operationally feasible to ensure not just messy data is developed, but real evidence so that payers can gain insights into the value and make better reimbursement decisions. This stream will detail  how clinical, real-world, economic and scientific publication data sources can be integrated to prepare a sophisticated value dossier to demonstrate value to payers and other key stakeholders.

 
08.30
Registration & Coffee
08.40
10-Minute Mindfulness Session (Optional)
09.00
Chairperson’s Opening Remarks

Director, Life Sciences
Huron Consulting, UK

09.10
Regional HTA considerations

Director
Health Technology Wales, UK

09.50
Leveraging a single clinical study to demonstrate value to multiple payers
  • Determining clinical practice patterns across several European markets
  • Identifying and estimating cost parameters for economic model
  • Demonstrating health economic value for an innovative product
Cristina Manzano Galán

Government Affairs Manager, Iberia
Stryker, Spain

 

10.30
Saving lives, curing brain aneurysms: Demonstrating efficacy, safety & economic value
  • The Oxford Endovascular spinout story so far
  • Developing technology from user needs
  • Building evidence for economic value

CEO
Oxford Endovascular

11.10
Networking & Coffee Break
11.40
The impact of European assessments on American payers

Director, Global Market Access
Intuitive Surgical, USA

12.20
Evidence development for HTA purposes Scandinavian markets
Scandinavia
  • Overview of HTA processes and evidence requirements
  • The increasing impact of HTA on market access for devices
  • Overcoming lack of evidence challenges
Johannes Schaeferhoff

Senior Health Economics Manager
Arthrex, Denmark

13.00
Luncheon Break
14.00
Thoughts on evidence generation and the conduction of HTA - pitfalls and suggestions

Reimbursement Manager, Cardiac Management Solutions
Zoll, Germany

 

14.40
A journey through the UK reimbursement process
United Kingdom
Marcus Simon

Director, Market Access – EMEA
Teleflex, Belgium

15.20
Networking & Coffee Break
15.50
Panel Discussion: The impact of MDR on Market Access for high-value devices
Spotlight on MDR
  • What evidence levels are considered sufficient for which classes?
  • Leveraging recent existing RCTs to accelerate through MDR approval
  • What to do when you're faced with delays due to MDR commencement?
  • What will your pre and post-marketing evidence strategy be going forward?
  • What can companies do to better develop evidence in a cost-effective manner?
  • Data to evidence: What data sources are available that add value? (i.e. clinical, real-world, publications)

Director Payers & Health Economics
Coloplast, Germany

Marcus Simon

Director, Market Access – EMEA
Teleflex, Belgium

Reimbursement Manager, Cardiac Management Solutions
Zoll, Germany

 

Cristina Manzano Galán

Government Affairs Manager, Iberia
Stryker, Spain

 

16.40
Chairperson’s closing remarks
16.50
End of day Two

MedTech: Procurement & Tendering Excellence

Day 2 - Stream 2 - 4th December, 2019

Stream Overview

Medical devices are coming under greater scrutiny by payers and hospital procurement directors than ever before. Manufacturers today are required to understand and quantify the cost savings for hospitals & payers based on the direct & indirect savings their products deliver. Changes to the European directives on public procurement are directly impacting the way medical device companies communicate and market their products via public procurement channels for high-value products. This one-day event will bring together procurement experts from European Policy-level, leading industry associations, hospitals (procurers) and the MedTech industry to join the conversation and to understand better the needs of their strategic partners. It will enable all participants the opportunity to benchmark procurement processes and tender approaches at a regional, local and hospital perspective. Medical device companies will understand in greater detail what their customers are looking for as drivers of value, and what is attractive for them to enhance their tender and public procurement strategy.

 
08.30
Registration & Coffee
08.40
10-Minute Mindfulness Session (Optional)
09.00
Chairperson’s Opening Remarks

DEMONSTRATING VALUE IN EUROPE’S BIG 5

09.10
Value-based procurement: Experiences and initiatives in Europe

Director, Market Access & Economic Policies
MedTech Europe, Belgium

09.50
Recent developments from the EU

Legal & Policy Officer
European Commission

10.20
A systemic perspective of value-based procurement
  • Communicate value around the quadruple aim
  • An approach to identifying and presenting direct and indirect impacts
  • Making the right investment in value, not in Cost - quantitative and qualitative assessments
Loon Lee

Senior Pricing Manager Patient Care and Monitoring Solutions
Philips Healthcare, Germany

10.50
Networking & Coffee Break
11.20
The use of real-world evidence for developing new contracting / reimbursement solutions
  • What Statutary Health Insurance claims data can tell us
  • Conclusions for healthcare / product / service offerings
  • Outcomes measurement and development
  • Creating value for patients and payers
  • Outcomes / value-based reimbursement
  • Evaluation

Director Payers & Health Economics
Coloplast, Germany

12.00
Local Market Access in Germany
  • Addressees & Purposes
  • Challenges in compiling the right data
  • Current solutions and suitable data sources
  • Outlook to the future: a new claims data treasure through the digital care act?
Michael Weisser

CEO
AIM Gmbh (Assessment-in-Medicine), Germany

12.30
Value demonstration experiences in Italy for medical imaging equipment
Diagnostics Perspective
  • Medical devices and technology imaging equipment, two faces of the same coin?
  • Adding a third face to the coin: Pharmaceutical contrast media for radiological procedures
  • Italian healthcare system for diagnostic imaging procedures, the rules and the code of conduct of the national / regional providers
  • Counteract the complexity of the reimbursement national system: The Italian job

Director, Government Affairs, Policy & Health Economics
GE Healthcare, Italy

13.10
Luncheon Break
14.10
Market Access – just or unjust?

Product and service offerings need to follow the legal requirements of a country. But additionally a big grey exists - called corruption. Market Access activities might be legally allowed but still negatively impact companies’ reputation. It is important to be aware of potential traps. Examples will be discussed to increase awareness and sensitivity for the benefit of companies’ offerings.

Market & Business Insights Manager EMEA
Smith & Nephew, Switzerland

14.40
Innovative public procurement processes and policies: A view from the Catalan HTA agency (AQuAS)
HTA PERSPECTIVE
  • Experiences with PCP (pre-commercial public procurement) and PPI (public procurement of innovation) projects.
  • Ongoing value-based procurement projects and first results.
  • The unique role of the Catalan HTA agency in public procurement as a decision maker.
Rossana Alessandrello

Value Based Procurement Director
Catalan Agency for Health Quality and Assessment – AquAS

15.20
Overview: Market access for devices in the US
USA
  • Trends & initiatives in medical device technology assessment.
  • Value-based pricing in action: Private & Public Payer examples.
  • Evidence generation methods to build the value story.

Senior Director, Global Health Economics & Reimbursement
Edwards Lifesciences, USA

16.00
Networking & Coffee Break
16.30
Payer – Industry collaborations: Experiences from North America

Former Chief Innovation Officer
America’s Health Insurance Plans (AHIP), USA

17.00
Panel discussion: Shifting to Value-based pricing and procurement
  • How is value-based procurement viewed by external stakeholders?
  • How can ‘’added value’’ be demonstrated and is it a factor for payers?
  • What is the impact of internal stakeholders on value demonstration?

Senior Director, Global Health Economics & Reimbursement
Edwards Lifesciences, USA

Christelle Saint Sardos

Director, Government Affairs and Access Policy EMEA, Canada & LATAM
Edwards Lifesciences, France

Market & Business Insights Manager EMEA
Smith & Nephew, Switzerland

Legal & Policy Officer
European Commission

Loon Lee

Senior Pricing Manager Patient Care and Monitoring Solutions
Philips Healthcare, Germany

17.40
Chairperson’s closing remarks
17.50
End of day Two

Market Access for Molecular Diagnostics

Day 3 - Stream A (AM) - 5th December, 2019

Stream Overview

As the product nature of In Molecular and companion diagnostics becomes increasingly complex, so too is the market access process surrounding these essential tests
and procedures. These diagnostics bring unique market access & procurement challenged through DRG coding, bundling and procurement for laboratory test service
providers. As the cost of these tests increases, so too does the requirement to justify the value and ROI to all necessary stakeholders. For companion diagnostics, partnering and strategic alliances with pharma (if not already vertically integrated) provides a strong market access vector, but achieving this has been proven difficult with only a handful of successful examples to date. As payers, procurers, HMOs and purchasers demand more evidence to justify costs, the challenges surrounding market access for molecular diagnostics to bring their benefit to clinical settings have never been greater. This stream will discuss the market access challenges affecting In Vitro diagnostics and companion diagnostics globally with case studies of successful

08.30
Registration & Coffee
08.40
10-Minute Mindfulness Session (Optional)
09.00
Chairperson’s Opening Remarks

Vice President International Access, Policy & Advocacy
Myriad, Germany

09.10
Molecular diagnostics market access overview and trends

Vice President International Access, Policy & Advocacy
Myriad, Germany

09.40
Regulatory update for molecular diagnostics in Europe: How should manufacturers get ready?

Secretary General
EUCOPE – the European Confederation of Pharmaceutical Entrepreneurs, Belgium

10.10
Molecular diagnostics prioritisation: surveillance evaluation in Belgium

Head of service
Healthcare-associated infections & antimicrobial resistance (Sciensano), Belgium

10.40
Networking & Coffee Break
11.10
Demonstrating the value of IVDs to European HTA agencies

Head Global Market Access & Health Policy, Roche Diagnostics International
Chair “VODI (Value of Diagnostic Information)” WG & HTA for IVD WG, Medtech Europe

11.40
Building strategic partnerships for molecular diagnostics in Italy

General Manager
Alifax, Italy

12.10
Panel discussion: Funding channels for in-vitro diagnostics
  • Public & private payers, hospitals & HTA agencies: What makes them prioritise molecular diagnostics in their reimbursement decisions?
  • The impact of diagnostics / pharma partnerships on market access.
  • Ways to demonstrate value: Data generation, economic modeling, stakeholder communication
  • What is unique for molecular diagnostics and what can be implemented from other device areas?

Head of service
Healthcare-associated infections & antimicrobial resistance (Sciensano), Belgium

Vice President International Access, Policy & Advocacy
Myriad, Germany

General Manager
Alifax, Italy

Secretary General
EUCOPE – the European Confederation of Pharmaceutical Entrepreneurs, Belgium

12.50
Luncheon Break

MedTech: Key Market Briefs – EU Big 5

Day 3 - Stream B (AM) - 5th December, 2019

Stream Overview

09.00
Chairperson’s Opening Remarks

Founder & CEO
MTRC – European Med Tech and IVD Reimbursement Consulting

European Overview

09.10
MedTech innovation funding in EU5
Christelle Saint Sardos

Director, Government Affairs and Access Policy EMEA, Canada & LATAM
Edwards Lifesciences, France

09.40
European market access landscape for medical devices & diagnostics
  • Payment models for hospital procedures in 11 EU countries
  • Emerging innovation payment and coverage with evidence development models
  • Comparative time to market
  • Typical evidence requirements & Impact of MDR

Founder & CEO
MTRC – European Med Tech and IVD Reimbursement Consulting

England

10.00
Reimbursement and funding pathways for medical devices & diagnostics in England
  • Key stakeholders
  • Aspects of market access in England
  • Brief overview of National Tariff Payment System
  • Innovative landscape after Accelerated Access Review (Accelerated Access Collaborative, Innovative and Technology Payment)
  • Role of health technology assessment at NICE
  • Key reimbursement pathways
  • Introduction to funding: NHS England and Clinical Commissioning Groups
  • Key funding pathways

Founder & CEO
MTRC – European Med Tech and IVD Reimbursement Consulting

Germany

10.30
Reimbursement and funding pathways for medical devices & diagnostics in Germany
  • Key stakeholders
  • Aspects of market access in Germany
  • Brief overview of German DRG system
  • Innovation funding (NUB), early benefit assessment
  • Basics of reimbursement in ambulatory sector
  • Key reimbursement pathways
  • Introduction to funding: coverage decisions of the Federal Joint Committee (G-BA)
  • Selective contracts
  • Innovation Fund at G-BA
  • Government-co-sponsored studies according to the §137e of the German Social Code Book V (Erprobungsstudie)

Founder & CEO
MTRC – European Med Tech and IVD Reimbursement Consulting

11.10
Networking & Coffee Break

France

11.30
Reimbursement and funding pathways for medical devices & diagnostics in France
  • Key stakeholders & Brief overview of French DRG system
  • Add-on reimbursement for implants and invasive medical devices via LPPR List
  • Innovation funding landscape
  • Hospital Program of Clinical Research (PHRC)
  • Health Economic Research Program (PRME)
  • Innovation funding (forfeit innovation)
  • Article 51 of Social Security Financing Act
  • Key reimbursement pathways

Founder & CEO
MTRC – European Med Tech and IVD Reimbursement Consulting

Italy

12.00
Reimbursement and funding pathways for medical devices & diagnostics in Italy
  • Key stakeholders
  • Aspects of market access in Italy
  • Inclusion into national health benefit catalogue (LEA services)
  • Brief overview of Italian DRG system at national and regional level
  • Key reimbursement pathways
  • Role of health technology assessment

Founder & CEO
MTRC – European Med Tech and IVD Reimbursement Consulting

Spain

12.30
Reimbursement and funding pathways for medical devices & diagnostics in Spain
  • Key stakeholders
  • Aspects of market access in Spain
  • Brief overview of funding model at regional level
  • Inclusion into national health benefit catalogue
  • Role of health technology assessment

Founder & CEO
MTRC – European Med Tech and IVD Reimbursement Consulting

12.50
Closing remarks
13.00
Luncheon Break

MedTech: Market Access for Digital Interventions & SAAMD

Day 3 - (PM) - 5th December, 2019

Stream Overview

Connected Healthcare is now a reality, as well as Digital Interventions and Software as a Medical Device (SaaMD). “Digital patients” are increasingly being “connected” to the IoMT ecosystem through digitally-enabled devices, their mobile phones and electronic health records data. There is a treasure trove of information out there from a multitude of sources which promise both exciting opportunities and daunting challenges. Not surprisingly, physicians are now starting to see the clinical value of such technologies and payers increasingly realise there can be great health economic benefits worth paying for, yet they are extremely difficult to define, measure and value.

This unique event will discuss:

  1. How to define and demonstrate the real economic value of Digital interventions and SaaMD techs
  2. What are the business models for medtech companies with unique digital applications
  3. What are the reimbursement possibilities and models for apps as either stand-alone techs or bundled with a medical device
14.00
Chairperson’s Opening Remarks

Head Global Market Access & Health Policy, Roche Diagnostics International
Chair “VODI (Value of Diagnostic Information)” WG & HTA for IVD WG, Medtech Europe

14.00
Demonstrating the value of MedTech digital solutions to Payers and HTAs

Head Global Market Access & Health Policy, Roche Diagnostics International
Chair “VODI (Value of Diagnostic Information)” WG & HTA for IVD WG, Medtech Europe

14.30
Digital healthcare and artificial intelligence today and in the future: The ongoing tremendous developments in digital healthcare for the blind and other areas.

Vice President, Global Reimbursement & Market Access
Second Sight Medical Products, USA

15.00
Market access challenges and payer willingness to pay for digital health solutions

Head of Health Economics and Healthcare Management Division, Kozminski University
Principal Senior Consultant, Global Market Access, Straub Medical, Switzerland

15.30
Networking & Coffee Break
16.00
Panel discussion: Who should pay for supportive applications?
  • Overcoming customer-adoption challenges
  • The advantages and disadvantages of being the first product on the shelf
  • Generating clinical & economical evidence to support your value proposition
  • Linking software to your core business analytics
  • Defining endpoints for SaaMD: Quantifying the real value of your application
  • Willingness to pay: Pay per customer / pay for performance (outcomes)

Scientific Coordinator, Agenas HTA Projects
Agenas (Agency for Regional Health Services), Italy

Head Global Market Access & Health Policy, Roche Diagnostics International
Chair “VODI (Value of Diagnostic Information)” WG & HTA for IVD WG, Medtech Europe

Vice President, Global Reimbursement & Market Access
Second Sight Medical Products, USA

Senior Director, Head of Health Economics, Market Access & Policy Affairs Europe, Middle-East and Africa
Fresenius Medical Care, Germany

Head of Health Economics and Healthcare Management Division, Kozminski University
Principal Senior Consultant, Global Market Access, Straub Medical, Switzerland

16.40
Chairperson’s closing remarks
16.50
End of day Three

Medical Device & Diagnostic Companies: Market Access, Health Economics, Pricing & Reimbursement, Government & Stakeholder Relations, Payer Relations, Value Strategy, Regulatory Affairs, Strategic Marketing, Commercial Excellence, Business Unit and Country Managers Regulatory Affairs

External Stakeholders: Health Plans & Insurers, Payers, Health Technology Assessors, Hospitals, Health Ministry, Regulatory Agencies, Independent Health Economists, Academics, Physicians and Patient Groups

Solution providers & consultants: CEOs, Business Development, Senior Consultants, Global and Regional Heads, Independent Academics, Health Economists

 

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Speaker Biographies

Stefan Lange

Deputy Institute Director
Institute for Quality and Efficiency in Health Care (IQWiG), Germany

Stefan Lange completed his medical studies at the Heinrich-Heine-University in Düsseldorf in 1989 and received his MD in 1994. From 1989-1993 he was initially in practical training at the Ferdinand-Sauerbruch-Clinic in Wuppertal, then assumed the position of intern/resident physician. In 1993 he joined the department of medical biometry at the Ruhr-University in Bochum and was appointed to the position of research assistant in 1995. In 2003 he received his Habilitation (qualification for a professorship) and venia legendi (award of title of Privatdozent) in Medical Biometry and Clinical Epidemiology.

He joined the Institute for Quality and Efficiency in Health Care in 2004, and has held the position of Deputy Director of the institute since 2005.

An Baeyens

Legal & Policy Officer
European Commission

An holds a Belgian law degree issued by the University of Leuven as well as a master of laws issued by the Albert-Ludwig University of Freiburg im Breisgau (Germany). Prior to the Commission An has worked in the area of health law, first an assistant at the University of Leuven and thereafter in the private sector. Since more than twelve years, An has been working for the Commission dealing with different internal market issues.  Since three years she works in the field of public procurement. In particular, she deals with Austrian and German complaints. She also is responsible for the policy work related to the application of public procurement rules in the health and waste management sector.

Susan Myles

Director
Health Technology Wales, UK

Susan Myles is Director of Health Technology Wales (HTW) a new body established to deliver a strategic national approach to the identification, appraisal and adoption of new technologies into health and care settings. Susan holds qualifications in Economics (BA, Strathclyde) Health Economics (MSc, York) Epidemiology (PgDip, Edinburgh) and Health Economics (PhD, Edinburgh). She has been engaged in applied health technology assessment for over 25 years. Susan is a previous recipient of a Harkness Fellowship in Health Care Policy based at Johns Hopkins University in the USA. In the 10 years prior to joining HTW, Susan led the work of the Scottish Health Technologies Group (SHTG) in NHSScotland.

Eva D’Haese

Scientific Adviser
RIZIV-INAMI, Belgium

Eva D’Haese graduated from Ghent University as a pharmacist. She obtained a PhD in the field of pharmaceutical sciences and she continued working as a research scientist at Ghent University during several years.
In 2005, she joined the Scientific Institute of Public Health (WIV-ISP) in Brussels as a scientific collaborator. At the Belgian Competent Authority for IVD she was responsible for vigilance matters.
She started working at the RIZIV-INAMI in 2009. There, she is mainly involved in the scientific evaluation and the reimbursement of medical devices.

Boudewijn Catry

Head of service
Healthcare-associated infections & antimicrobial resistance (Sciensano), Belgium

Boudewijn Catry (DVM ° 2000, PhD ° 2005) is a researcher with a special interest in antimicrobial resistance with regard to both veterinary and human medicine. Between 2000 and 2007, he combined ambulatory practice & obstetrics as a veterinary surgeon with laboratory research (Ghent University). He started to work at Sciensano in 2007, the Belgian Scientific Institute of Public Health,  where he has headed the Care Infections & Antimicrobial Resistance Service since 2009 (www.nsih.be). He is involved in several committees on the prudent use of antimicrobials and infection prevention. He is co-founder (° 2013) of the outbreak support team for multidrug resistant organisms in Belgian hospitals (MDRO-OST). Since 2018 he is lecturer epidemiology at the Free University of Brussels (Université libre de Bruxelles, ULB).

Tom Jefferson

Scientific Coordinator, Agenas HTA Projects
Agenas (Agency for Regional Health Services), Italy

Tom Jefferson is a physician, epidemiologist and researcher. Tom’s field of expertise is evidence synthesis applied to Cochrane and other systematic reviews and Health Technology Assessment.  Tom is a Senior Associate Tutor at the University of Oxford, a researcher at the Nordic Cochrane Centre and the scientific coordinator for the production of HTA reports on non-pharmaceuticals for Agenas, the Italian National Agency for Regional Healthcare.

Paolo Oliva

Head of Clinical Engineering Service
Humanitas Research Hospital, Italy

Paolo joined Humanitas Research Hospital in July 2017. He graduated from University of Naples Federico II with a Bachelor’s degree in Biomedical Engineering. He completed his Master’s degree in Clinical Engineering at the same University and subsequently completed his second level Master’s degree in Health Economics at SDA Bocconi School of Management. Prior to joining Humanitas Research Hospital, Paolo worked for 3 years as Clinical Engineer and Operation Manager at PLV Fatebenefratelli private Group of Hospitals.

Rahul Dubey

Former Chief Innovation Officer
America’s Health Insurance Plans (AHIP), USA

Rahul is currently responsible for collaborating with C-level executives at his Health Plan/IDN collaborating organizations as well as across multi-institutional stakeholders to develop and implement innovative frameworks and unique approaches that lead to accelerated adoption of mission critical initiatives that ensure the delivery of high quality care and improve consumers ability to receive needed care all while driving down the cost of care received. Rahul has extensive practical knowledge in creating new, multi-stakeholder, collaborative innovative models and solutions as well as integrating next gen digital health solutions that optimize the utilization of appropriate care measures.  His role expands to include the creation of innovative care pathways, normalizing and sharing of data assets for proper segmentation, developing actionable and personalized programs and tools that ensure measurable behavior change imperative for desired health outcomes.  He continues to help develop, test, measure and iterate innovative initiatives that increase efficiencies for all key Healthcare stakeholders as they collectively focus on outcomes-centric care. Rahul's most recent brainchild was The AHIP Innovation Lab based in Chicago's West Loop and the quantifiable co-innovation methodology he and the team have proven viable across the ecosystem. He is responsible for creating the Lab's one of a kind concept, continues to fulfill its mission of delivering an invaluable resource for Payers, Providers, Consumers and other essential entities and solution providers. He has led all of the Lab’s 100+ collaborative and confidential Solution Working Groups that involve individual payers, providers, employers, consumers, manufacturers, MedTech, innovative solution providers and the Lab's trusted and crucial thought leaders and SME partners. Prior to joining AHIP, Rahul held a leadership role as a founding employee of a successful digital Healthcare start-up based in Washington DC. Along with the company's co-founders, Rahul was instrumental in developing a multifaceted consumer tool as well as leading the company's "go to market" strategy resulting in successful market penetration and revenue growth for the industry's first consumer-led shared decision making and treatment selection platform. Rahul was recently named one of the Smart Health’s 2018 Excellence In Healthcare Transformation award, the American Journal of Health Promotion's 2017 Innovators and Game Changers and is recognized as Accenture PerspectivesMinds Driving the Future of Business. In 2017, Frost & Sullivan presented Rahul and his Lab with one of their highest honors, their Global Visionary Innovation Leadership Award. He is a graduate of the University of Michigan-Ross School of Business and lives in Washington DC.

Markus Ott

Head Global Market Access & Health Policy, Roche Diagnostics International
Chair “VODI (Value of Diagnostic Information)” WG & HTA for IVD WG, Medtech Europe

Markus A. Ott is a Global Medical Technology Professional with more than twenty years successful experience in international/global commercial & non-commercial roles he has become a highly effective and creative industry leader with extensive knowledge of the healthcare market.

Currently he is leading the Market Access & Health Policy department at Roche Diagnostics International (CPS) based in Rotkreuz/Switzerland.

His passion are all aspects of his job but primarily Value Based Healthcare & the digitalization of our industry.

He is/has been a member of global Management teams for various companies and associations. So, Markus has been member of the Executive Board of MedTech Europe as well as the Swiss Diagnostic Association. He acted as Chair Elect and Executive Board Member of EPPOSI (European Platform for Patient's Organizations, Science & Industry). Currently he chairs the HTA IVD & Value of Diagnostics Working groups @ MedTech Europe.

Finally, he is author of multiple publications as well as chair, panelist and speaker at many global conferences.

Seth Clancy

Senior Director, Global Health Economics & Reimbursement
Edwards Lifesciences, USA

Seth has worked in the field of Market Access for more than 15 years – primarily in support of medical device and biopharmaceutical companies.  In his current role, Sr. Director, Global Health Economics & Reimbursement at Edwards Lifesciences, he leads the development and implementation of evidence generation and market access strategies for transcatheter heart valves.  Seth has helped to address a complex and growing set of global challenges related to value-based payment, health technology assessment, health economics and hospital procedural optimization.  Prior to joining Edwards in 2008, Seth worked at Cerner Lifesciences, where he served as Senior Research Associate, consulting with biotech and pharmaceutical companies in the areas of comparative effectiveness research, evidence-based medicine and health economics.

Seth received a Bachelor of Arts degree from the University of California, Irvine and a Master of Public Health, from the University of California, Los Angeles.

Benjamin Gannon

Vice President International Access, Policy & Advocacy
Myriad, Germany

Benjamin Gannon joined Myriad Genetics in March 2019 and is responsible for international market access, policy and advocacy.  Mr Gannon has over 20 years of European and international experience with the life sciences and biotech sector.   Before joining Myriad, he was responsible for international government affairs, policy and patient engagement with Vertex Pharmaceuticals.  In this role he established and led government affairs and patient engagement for Vertex’ operations internationally – this included support to market access strategy and regulatory policy.  Mr Gannon is a Board member of EUCOPE, the European Confederation of Pharmaceutical Industries.
Before joining Vertex, Mr Gannon was Vice President for Group Public Affairs for SCA and has held senior government affairs and policy roles with Gilead, Johnson & Johnson and GlaxoSmithKline.  He is a dual German/ UK national and holds Bachelor and Masters degrees in Biology from Southampton University  (UK) and Imperial College (UK) respectively.

Amit Kukreja

Vice President, Global Reimbursement & Market Access
Second Sight Medical Products, USA

Amit is currently the Vice President, Global Reimbursement & Market Access at Second Sight. Over last several years Amit successfully expanded reimbursement coverage across EMEA, USA and Canada. Prior to joining Second Sight, Amit worked as Market Access Consultant where he executed reimbursement & pricing strategy for several innovative medical devices. As Consultant and Business Development executive, he held positions of increasing responsibility at Synergus MedTech Consulting, Sweden (as Associate Director, Project Leader and Project Manager- Global Market Access), Simon-Kucher & Partners, Germany (as Pricing Strategy Consultant), as Freelancer and Godrej & Boyce (as Sales Rep.). From 2014-2016, he was a member of Eucomed Ophthalmology Group and also led the European MedTech Reimbursement Program at RAPS, Switzerland Chapter. Amit holds a Bachelor of Mechanical Engineering from Manipal University, India and an MBA from WHU–Otto Beisheim School of Management, Germany including management modules from Kellogg School of Management, USA, CEIBS, China and IIM Bangalore, India.

Christian Apel

Senior Director, Head of Health Economics, Market Access & Policy Affairs Europe, Middle-East and Africa
Fresenius Medical Care, Germany

Christian has an academic background in human medicine, biomedical sciences, health policy & health economics. Before joining Fresenius Medical Care, Christian worked in different strategic and management positions of a medium sized care provider in Germany. In Fresenius Medical Care he is heading the Health Economics, Market Access & Policy Affairs activities for Europe, Middle-East and Africa.

Ben Forrest

Director, Global Market Access
Intuitive Surgical, USA

Ben currently serves as Director, Global Market Access at Intuitive Surgical. He previously worked with HeartFlow as Director of Health Economics and as an Investment Analyst with Citigroup, where he focused on Emerging Medical Technologies. Ben received degrees in Economics and International Studies from Brigham Young University and a Masters in Business Administration from Stanford University.

Yves Verboven

Director, Market Access & Economic Policies
MedTech Europe, Belgium

Graduated in 1987 as Electro-Mechanical Engineer with specialty electronics at the Catholic University of Leuven,  followed by a post-graduate year of Master of Business Administration. A first working experience in the field of Clinical Engineering at Intermedics, a US based pacemaker and implantable defibrillator company. Build out and directed the European Clinical Research Department. Holder of 5 patents in field of cardiac stimulation in health failure and co-author of 3 publication in this period. Joined in 1999 Medtronic to head the European Heart Failure clinical outcomes & research department ensuring the development of Clinical and Health Economic Outcome Evidence. In close cooperation with Clinical Community landmark trials were designed, conducted and published  in the Int’l journals as New England Journal of Medicine, Circulation and others with a high impact factor. A contribution of to 8 publication of which 3 as co-author. This evidence based ensured : Cardiac Resynchronization therapy obtained a class I indication level of evidence A in clinical guidelines; Cardiac Resynchronization therapy obtained a positive HTA appraisals for the full population studied . In September 2008, took on the responsibility of Assistant Director Health Economics, EurMEA at Alcon in the field of Ophthalmology for both medicinal and medical devices ranging from treatments of bacterial conjunctivitis, dry eye and glaucoma to Implantable Ocular Lenses. Developed comprehensive Patient Report Outcomes instrument to support patient diagnosis and assessing the outcome value of dry eye treatment to patients. Supported and co-authored to an additional 8 publications. As of 1st May 2012, head of Market Access and Economic Policies for  MEDTECH EUROPE to strive to balanced pro-innovation policies and to shift to a Value based Access model within EU frameworks.  Initiatives in dialogue with  procurers, payer, HTA member states representatives and other stakeholders are MEAT Value Based Procurement, Value of Diagnostic Information,  Modern HTA Cooperation in Europe,  new evidence and financing schemes to shift to access of medical technologies of value for patients, healthcare, society and our economy.

Massimo Barberio

Director, Government Affairs, Policy & Health Economics
GE Healthcare, Italy

MASSIMO G. BARBERIO is actually GovernmentAffairs, Policy& Health Economics Director Italy in GE Healthcare Italy He started his career working in the commercial department of a medium size pharmaceutical company, dealing with diagnostic hospital pharma products. After several assignments in marketing field for several large pharmaceutical companies, in 2007 he joined GE Healthcare, as South Europe Marketing Director for the Pharmaceutical Division.Since 2011Massimocovers the role of GovernmentAffairs, Policy& Health Economics Director Italy in GE HealthcareMedical Systems, dealing with the technological and pharmaceutical product portfolio and managing the Market Access activities in General Electric Healthcare. In his activity he managesthe Company official relationships with Institutions like Government and Parliament members, Health and University Ministry, Government Agencies, Professional Societies. He is in the staff of the Southern Europe President of GE Healthcare. He is member of the Italian Society of Clinical Radiology since 1995, and he is also part of the Italian Association of Nuclear Medicine, Massimo obtained also several academic assignments: appointed as Visiting Professor at the Radiology School of the Medicine Faculty at the Milano Bicocca University and as lecturer at the MBA courses at L. Bocconi University and Management School in Milan and at LUISS University in Rome, he is actually Visiting Professor at the Research Centre for study on Healthcare Management at the LIUC University of Castellanza and member of the steering committee and Professor atthe School of Finance and Management at Universitàdel Piemonte Orientale di Novara. He is author of several clinical and pharmacoeconomy papers published on some national and international peer reviewed journals, as the Italian Journal of Radiology and the California Management Review. He has a master’sdegree in Biology and a Master in Strategic Marketingandalso MasterinHealthcareEconomy and Management Born in Milan 60years ago,Massimo is married with Angela and they have one son, Daniele, 31years old and one daughter, Martina 27years old. He enjoys spending his time with his family and reading, and after a brilliant career as Italian major league Handball referee, actually his sport activity is limited todiscussions with friends on soccer games seen on TV.

Christian Grete

Director Payers & Health Economics
Coloplast, Germany

Christian spent the first half of his career in the German Statutory Health Insurance, covering different positions and ended up with the project lead of one of the first huge Managed Care models in the country. As a consultant, Christian supported sickfunds to introduce the German DRG system and Managed Care approaches before he started with his first market access projects. Prior to joining Coloplast in 2017 he held different national and international market access positions at Johnson & Johnson, Accuray and in a pharmaceutical startup. Christian holds a Bachelor of Science degree in Health Communication and Healthcare Management. As a Director Payers & Health Economics at Coloplast, Christian is now responsible for Regulatory Affairs, Public Affairs and Payer Managenment.

Ellen Busink

Senior Manager in Health Economics, Market Access & Policy Affairs
Fresenius Medical Care, Germany

Ellen is a senior manager in the Health Economics & Market Access (HEMA) department, in the EMEA region of Fresenius Medical Care, the world’s largest provider of products and services for renal patients. The HEMA activities are therefore not limited to products only, but are performed across the entire lifecycle from development to provision of care.
Ellen is responsible for the HEMA Community in the EMEA markets, ensuring the implementation of value-sales argumentation, localization and other local market access / reimbursement support. On a strategic level, she is focused on EMEA reimbursement monitoring, developing value documentation and assessing health policy developments on EU level in HTA and value-based procurement.
Ellen is originally from the Netherlands and holds a BSc and MSc in European Public Health from Maastricht University (the Netherlands) and a MLitt in Management from St. Andrews University (Scotland).

Katarzyna Kolasa

Head of Health Economics and Healthcare Management Division, Kozminski University
Principal Senior Consultant, Global Market Access, Straub Medical, Switzerland

Katarzyna Kolasa has more than 20 years of academic and business experience in the healthcare sector. She holds a PhD degree in health economics and is an author of more than 60 publications. Katarzyna Kolasa reviews manuscripts submitted to Health Policy, Value in Health, Expert Review of Pharmacoeconomics & Outcomes Research, International Journal for Equity in Health and International Journal of Technology Assessment.

Katarzyna Kolasa heads the Health Economics & Healthcare Management Division (HeM) at the Kozminski University. She is the leader of the International Master Program Health Economics & Big Data at the Kozminski University financed by the research grant of the National Center for Research and Development which was listed as the best project in the POWER 2018 call.

In the past, she worked at both global and regional Health Economics & Outcomes Research (HEOR) functions at AstraZeneca and BiogenIdec being based in Sweden and Switzerland respectively. At Bristol Myers Squibb and Lundbeck she was leading Market Access teams in Central Eastern European (CEE) and Nordic Region. Her practical skills in the field of health economics were developed at the Kalmar County Council in Sweden as well.

For the last five years, she has been developing experience with the pricing &reimbursement challenges in the field of medical devices. Since 2016, Katarzyna has been representing Straub Medical as Global Market Access Lead being the External Principal Consultant for that Swiss family owned company. Before that, Katarzyna was employed as a Senior HEOR Director at GE Healthcare.

Her extensive knowledge in the field of health economics was acquired at University of York, University of Lund, and University of Bergen as well as during International Doctoral Courses in Health Economics and Policy organized by the Swiss School of Public Health.

Katarzyna was nominated by the Ministry of Science to represent Poland in the COST Action CA17117, COST Association „Towards an International Network for Evidence-based Research in Clinical Health Research”. Since January 2019, she is working on the establishment of Global Special Interest Group for Digital Health at ISPOR.

Berit Dahl

Market & Business Insights Manager EMEA
Smith & Nephew, Switzerland

Berit Dahl is a market and business insights manager for Smith & Nephew in the Europe and Canada region. This role supports the decision-making process on strategic commercial projects. She works for 5 years in the MedTech industry and collected extensive experience as finance business partner for the sales and marketing organisations in B2C and B2B environment of FMCG and Food before. The driver for
work is the continuously striving for better insights in the decision-making process for
all participants. Berit received a diploma in business informatics and holds an MBA in International Management. She is German and currently lives in Switzerland.

Frank Semrau

Reimbursement Manager, Cardiac Management Solutions
Zoll, Germany

 

My name is Dr. Frank Semrau, I was born and went to school in the northern part of Germany (Lüneburg near Hamburg). I studied Biology in Göttingen and got the Diploma in Biology (Biochemistry, Microbiology) at the Georg-August University of Göttingen. I conducted my thesis at the University Hospital of Göttingen, Center for Hygiene and Human Genetics and got a PhD from Georg-August University of Göttingen (Biochemistry, Medical Microbiology), as well.

I started my business career at, then, one of the 10 biggest pharmaceutical companies Pharmacia which merged with Pfizer some years later, as a Regional Manager Health Politics, dealing with Associations of Statutory Health Insurance Physicians which control ambulatory prescriptions of pharmaceuticals.
In 2004 the DRG system was introduced in Germany and I attended and supported the implementation as a Manager Health Economics/Government Affairs with Boston Scientific (Medical devices) for almost nine years, the last years as a department deputy. While I started with responsibility for all products, with growing department I specialized in vascular and cardiac medical technologies like stents, ICDs and pacemaker.
Since 2012 I am with ZOLL CMS as a Strategic Reimbursement Manager for European countries. I am responsible for European market access and reimbursement of the wearable cardioverter defibrillator (WCD) “LifeVest” with a strong focus on Germany. From this point of view I have a very broadly defined idea of MA & Reimbursement, including preparation and optimization of reimbursement applications and coding, as well as initiating support by physicians, clinical studies, guidelines, patient organizations, health economic assessments and models, HTAs, pricing, politics, PR and social opinion. Currently my main goal is the seamless protection of patients with high risk for sudden cardiac death (SCD) in and particularly outside the hospital.

Gianpiero Spezzotti

General Manager
Alifax, Italy

Current Position in the Company:
Since April 2004:
International Marketing Manager of Alifax Srl and R&D project coordinator for the bacteriology product line of SIRE Analytical Systems (R&D and manufacturing company of the Alifax Group).
Since September  2015
Managing of Alifax srl after the incorporation of SIRE Analytical Systems in the company with the responsibility of the Nimis plant (R&D and instrument and reagents manufacturing unit of the Alifax group) and Microbiology division.  
Professional Skills:
Twenty years experience in sales and marketing of innovative microbiology IVD systems (rapid bacteriology systems), competence in phenotypic and genotypic methods (molecular device) for sensitivity to antimicrobial tests (AST) , bacterial Identification , Resistance Mechanisms detection.

June 2008  
I was appointed by SIRE Analytical Systems as General Manager of the company with the responsibility of the Bacteriology Division R&D activities and instrument and reagents manufacturing   
September  2015
Appointment as General Manager of Alifax srl after the incorporation of SIRE Analytical Systems in the company with the responsibility of the Nimis plant (R&D and manufacturing unit of the Alifax group) and Microbiology division. 

Mike Karim

CEO
Oxford Endovascular

Mike is the CEO and co-founder of Oxford Endovascular Ltd, a spinout from Oxford University.

The company is developing a revolutionary medical device for patients suffering from brain aneurysms; a life-threatening disease affecting 1 in 50 persons. In 2017 it won ‘Best Med-Tech Start-Up’ at the Oxford Bio Network awards, 1st place at the BioTrinity ‘Perfect Pitch’ competition and an award at the ‘European Health Catapult’ finals. 

Mike is a business leader in with over 25 years strongly growing international businesses in large corporations, start-ups & SMEs, including Boston Scientific & HeartWare.

Experienced in strategic planning, execution, team building, marketing programs, gaining regulatory approvals & fund raising. Mike also mentors business students, start-ups and is a presenter and panellist at European life science conferences.

Mike studied Pre-Clinical Medicine, Physiology & Pharmacology at Southampton University before entering industry and later gaining his MBA at Henley Business School.

Alexander Natz

Secretary General
EUCOPE – the European Confederation of Pharmaceutical Entrepreneurs, Belgium

Alexander Natz is the Secretary General of the European Confederation of Pharmaceutical Entrepreneurs (www.eucope.org) in Brussels and works as a lawyer in the healthcare boutique law firm NOVACOS in Düsseldorf (www.novacos-law.com). He advises innovative pharmaceutical and biotech companies, including start-ups, in regulatory and pricing & reimbursement matters from the EU law and German law perspective.

From 2008 to 2013, he was Head of the Brussels Office of Bundesverband der Pharmazeutischen Industrie e.V. (BPI). Before, he has been a lawyer at Sträter Law Firm in Germany with a special focus on managed entry agreements and licensing of pharmaceuticals. Alexander has also worked in the field of competition law with the European Commission and in the pharmaceutical industry. As a research assistant at Duke University (USA) he has dealt with international pharmaceutical law. His doctorate was supervised by the former judge at the European Court of Justice, Prof. Dr. Dr. Ulrich Everling.

Alexander represents innovative life sciences companies at the EU institutions, before national authorities, HTA agencies, payers and courts. Alexander has a particular expertise in EU regulatory law such as GMP, lifecycle management, distribution and clinical trials, as well as in pricing and reimbursement procedures in Germany. He advises serveral US biotech and medtech companies in market access & government affairs related issues in Germany, offering strategic advice on value demonstration, pricing, tendering and other reimbursement matters. Alexander offers full-service legal support throughout all phases of the AMNOG-procedure, including drafting of dossier, G-BA benefit assessment, price negotiations with the GKV-Spitzenverband and arbitration board proceedings. He has a particular expertise in orphan drugs, medical devices as well as gene & cell therapies. His work also focuses on strategies for early value demonstration towards payers and national HTA bodies next to early patient engagement.

Ernesto M. Nogueira

CEO and Founder
ValueConnected

Ernesto is the Founder and Managing Director of ValueConnected. He has over 23

years of experience leading healthcare strategies to drive access and expansion for new products, developing value propositions for both public and private stakeholders and assessing global market opportunities. He has worked for both government agencies and global healthcare companies in roles ranging from strategic marketing and new product development to health economics and reimbursement. Ernesto has led several Market Access projects across Europe, US, Middle East and Latin America. Ernesto holds an MBA from the University of Texas at Austin and is fluent in English, Spanish and Portuguese.

Richard Charter

Director Value-Based Healthcare
ValueConnected

Richard has over 15 year of industry experience across both the Healthcare and Financial services sectors. Richard is currently the Director of Value Based Healthcare at ValueConnected, a company focusing on implementing Value Based Healthcare.  Richard was formerly at Becton Dickinson, where held various senior roles in Market Access & Pricing.  Richard is currently the Co-Chair of the ISPOR Medical Devices Interest Group, where he also teaches the short course on Market Access for Medical Devices.  Richard is also the co-chair of HTAi Medical Device Interest Group, where he is frequently called on as a guest speaker.  Richard is currently the industry Advisor to COMED, an EU funded consortium measuring outcomes and costs in medical devices.  Richard graduated from SDA Bocconi in Italy with a Masters in Healthcare Management, Economics & Policy, as well as from the University of Guelph in Canada, in Management Economics & Public Policy.

Stephen Hull

Principal and Founder
Hull Associates, USA

Stephen Hull is Principal and Founder of Hull Associates LLC, a specialized global reimbursement and market access consultancy. He and his firm leverage over 25 years of experience in US and global reimbursement and in-market expertise on behalf of pharma, medical device and diagnostics Clients. Prior to forming Hull Associates in 2007, he served as SVP for Global Reimbursement at AdvaMed, in Washington, D.C. and as chair of the ISPOR Medical Devices Council. Stephen holds a Master’s degree in health policy from the Johns Hopkins Bloomberg School of Public Health, and a bachelor’s degree in international relations and French from Colgate University.

Oleg Borisenko

Founder & CEO
MTRC – European Med Tech and IVD Reimbursement Consulting

Oleg is a recognized expert in the field of market access for medical devices in Europe. His experience derives from the several hundreds of projects in market access and health economics he has worked on. His specific areas of expertise include European reimbursement pathways, evidence requirements for approval by payers and sound value stories for medical technologies.

Anne Smart

Head of MedTech Consulting
Huron Consulting Group

Anne has over 20 years of broad healthcare experience from leadership positions spanning the life sciences industry, hospital management, and strategy consulting.

At Huron, she leads the medtech business within the Life Sciences Strategy practice. Her expert knowledge of the clinical and market dynamics and trends impacting medical devices, technologies, and tools enables her to develop customized growth strategies and value creation opportunities. Working closely as a thought partner with clients, she has delivered actionable strategic insights to medtech companies and investors that support them in achieving their business objectives. Her specific areas of expertise include: Business development and investment support (diligence, forecasting, portfolio strategy); Commercial / go-to-market strategy; and Market access / market development strategy.

Prior to joining Huron, Anne was a Managing Director at ClearView Healthcare Partners, where she built and led the global Medtech strategy business. She also spent several years at Navigant in the Life Sciences Strategy practice (formerly Easton Associates) and was a core member of the Medtech leadership team. Previously, Anne managed the Neurosurgery Department at The University of Chicago and the Pulmonary and Critical Care Medicine Division at NYU. She started her career at Vertex Pharmaceuticals as part of the original Strategy and R&D Planning groups.

Sotiris Rompas

Director, Life Sciences
Huron Consulting, UK

Sotiris has been working with market access, marketing and policy teams of Fortune 500 Life science companies to assess health system trends and stakeholder needs, develop value propositions for innovative medical technologies and develop Access strategy.
Prior to joining Huron, Sotiris held senior positions at Boston Healthcare Associates and GfK Market Access where he lead teams on various commercial, pricing & market access and marketing engagements at the product- and portfolio- level. 
Sotiris started his consulting career at IMS Consulting group working in the Pricing and Market Access practice.
Sotiris has expert working knowledge in various quantitative and qualitative methodologies and research tools (e.g., conjoint, MaxDiff, MCDA, virtual ad boards, IDIs, scorecards).

Focus areas
• Access strategy
• Payer and Provider dynamics
• Value proposition development
• Innovative Business models

Education
• PhD in Strategic Management, Warwick Business School (Economic & Social Research Council fellow)
• M.Sc. International Health Management, Imperial College London

Michael Branagan-Harris

CEO
Device Access UK

Michael Branagan-Harris is the CEO of Device Access UK, and IGES Group Company. Michael has been involved with Medical Devices for 30 years and founded  Device Access UK in 2010. Since then he and his team have helped over 30 companies successfully though NICE leading to guidance or advice on adoption to hospitals across NHS England. 

Page part title: Previous Attendees at MedTech Access Leaders Forum - Berlin, Germany, 2018

Company
Job Title
3M
Commercialization and Market Access Lead EMEA
Abbott
Global Market Access Manager, EMEA
Agenas (Agency for Regional Health Services), Italy
Scientific Coordinator, Agenas HTA Projects
Agnitio
Product Marketing Manager
Agnitio
Director, Client Services
AgNovos Healthcare GmbH
Vice President Global Sales
AgNovos Healthcare GmbH
Vice President Global Marketing
Air Liquide Healthcare
Global Market Access Director
Alcon
Market Access Manager, Glaucoma and Vitreoretinal, EMEA
Arjo
Sr. Director Marketing & Academy Europe
BD Medical
Head of Market Access & Pricing, BD Diabetes Care EMEA
Biotronik
Health Economics and Market Access Manager
Biovica International AB
Market Access & QA Director
Boston Healthcare Associates
Director
Boston Healthcare Associates
Manager
Boston Healthcare Associates
Vice President
Boston Healthcare, USA
President
Boston Scientific
Senior Fellow, R&D
Boston Scientific
Sr Manager HEMA EMEA
Boston Scientific International SA
Manager HEMA EMEA
BRAHMS
Manager Health Economics and Pricing
Carl Zeiss
Strategic Marketing & Customer Insights
Center of Healthcare Quality Assessment and Control, The Ministry of Health of the Russian Federation
Chief of development and communications
Cetas Healthcare
Managing Director
Coloplast
Director Payers & Health Economics
Cooper Surgical
European Business Manager
CytoSorbents
Health Economics manager
CytoSorbents
Manager Reimbursement
CytoSorbents Europe
Senior Manager Reimbursement & Health Economics
Erasmus School of Health Policy and Management (ESHPM) Institute for Medical Technology Assessment (iMTA)
Associate Professor, Economic Evaluations in Health Care
European Commission
Legal & Policy Officer
European Commission
Programme Officer European Commission eHealth, Well-being and Ageing (DG Connect)
European Med Tech and IVD Reimbursement Consulting Ltd.
Director
Fresenius Medical Care
Senior Director, Head of Health Economics, Market Access & Policy Affairs, Europe, Middle-East and Africa
Fresenius Medical Care
Health Economics, Market Access and Policy Affairs Central & North Eastern Europe
Fresenius Medical Care
Health Economics, Market Access and Policy Affairs Western Europe
Fresenius Medical Care
Senior Director, Head of Health Economics, Market Access & Policy Affairs EMEA
Fresenius Medical Care
Market Access Expert Italy
Fresenius Medical Care
Product Manager
Fresenius Medical Care
Senior Manager Regional Management, Russian Federation
Fresenius Medical Care
Head of Strategic Initiatives Germany
Fresenius Medical Care
Health Economics, Market Access and Policy Affairs Eastern Europe, Middle-East and Africa
Fresenius Medical Care
Health Economics, Market Access and Policy Affairs - Germany, Austria and Switzerland
Fresenius Medical Care
President Fresenius Poland
Genomic Health Int'l Sarl
Head of Market Access, France and Italy
Glaukos
Market access Director
Health Technology Wales
Senior Health Economist
Hull Associates
Senior Vice President, Europe
Hull Associates
Principal & Founder
Humanitas Research Hospital
Director, Clinical Engineering Service
Huron Consulting
Director, Life Sciences
Impact HTA
Member
Inspire Medical Systems
Vice President, Global Market Access
Institute of Applied Economics & Health Research
Senior Consultant
iThera Medical
CEO
iThera Medical
Marketing Associate
iThera Medical
Business Development Manager
Johnson & Johnson
Market Access Manager
Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA)
Director
Main Association of Austrian Social Insurance Institutions
Head of Department of Economic Evidence-based Health Care
MD squared
Consultant and Owner
MED-EL
Head of Tenders
MED-EL
Head of Reimbursement & HTA
MedTech Economics
Managing Director
MedTech Europe
Manager Market Access and Economic Policies
Medtech4Health
Program Director
Medtronic
Global Scientific Communications Director, Medical Affairs
Medtronic
Vice President, Market Access, Latin America
Merit
Market Access Director
Merit Holdings Inc
VP Market Access and Commercial Excellence
Myriad Genetics GmbH
Chief Commercial Officer, Europe
National Institute for Health and Care Excellence
Senior Scientific Adviser
NHS
Associate Director of Medicines Optimisation, DGS & Swale CCGs
North Star
Director
Ottobock SE & Co. KGaA
Vice President Strategic Marketing Unit Prosthetics Lower Limb
PARI GmbH
Medical Affairs Manager
Philips Healthcare
Senior Manager Hospital Economics
Philips Healthcare
Vice President Research
Philips Healthcare
Global Pricing Manager, PCMS Pricing Team
Qvella Corporation
VP Business Development EMEA
Region Jämtland Härjedalen
Director of Research and Education, Professor in Medical Biophysics
Roche Tissue Diagnostics
Senior Director, Market Access
Roche Diagnostics
Vice President, Head of Global Market Access
Santen
Associate Director Market Access EMEA
Straub Medical
Global Market Access Director
Stryker
Director Clinical Strategy
Stryker
Snr Director Clinical Affairs
ValueConnected
Director of Operations, Europe
ValueConnected
Managing Director
WIMENCO
Senior Consultant
Zoll
Business Development Manager EMEA
Zoll
Strategic Reimbursement Manager

EVENT TESTIMONIALS

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Senior Scientific Advisor
NICE

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Scientific Coordinator, Agenas HTA Projects
Agenas, Italy

Related Videos

Presentation

Enabling value selling for Surgical & Implantable Devices

Related topics: MedTech, Market Access & HEOR
Availability: FREE
  • What is the role of market access in economic selling?
  • The challenge of quantifying value.
  • Building effective tools and training methods.
  • Partnering with commercial teams.
  • Case studies: Selling value in the UK and Germany.
Speaker

Ernesto M. Nogueira
Managing Director
ValueConnected

Presentation

Triggering incremental funding for medical innovations

Related topics: MedTech, Market Access & HEOR
Availability: FREE
  • Are traditional reimbursement systems adequate for innovation?
  • Rewarding value, not only cost or evidence
  • Innovative Payment Mechanisms in Europe
  • Implications to Market Access Strategy
Speaker

Ben Modley
Director of European Operations
ValueConnected

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2 Day Delegate Pass
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After 20% discount
3 Delegates
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After 30% discount
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After 40% discount
Solution Provider/Consultant
1 Delegate
2,290 EUR
2 Delegates
2,061 EUR
After 10% discount
3 Delegates
1,946 EUR
After 15% discount
4+ Delegates
1,832 EUR
After 20% discount
Academic
1 Delegate
950 EUR
2 Delegates
950 EUR
3 Delegates
950 EUR
4+ Delegates
950 EUR

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