This three-day forum is the “must attend” event for those senior executives looking to drive-forward their medical device market access departments, develop superior evidence and enhance their reimbursement, HTA & tender market strategies internationally.

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.

The first day will feature Europe’s leading Payers, HTAs and market access KOLs discussing what they want to see from medical device manufacturers bringing new products to the market and will be a perfect opportunity to engage these key stakeholders. The second day of the event will contrast market access strategies for medical devices in key Markets to enable market access and product managers to sequence and prioritise their product launch. The third day of the event will examine in detail case studies on the very different business models and market access Processes of Surgical & Implantable Devices and Diagnostics and Capital Equipment.

The different stakeholders involved in each market access process and the varying ways to engage them and demonstrate “value” for your technologies will be show from leading companies in the field for you to learn and benchmark from. Participants will leave this event armed with real-life, best practice examples of what is working and not working for your specific product type; what Payers and HTAs consider as essential and “nice to have” information to create “value”; and will have established relationships with the peers from the industry as well as influential decision-makers & KOLs in this sector. We look forward to meeting you in Berlin!

Download agenda here for complete speaker list

PAYERS & HTA AGENCIES

Chief of Innovation, Research and Development Department
Agenas (Agency for Regional Health Services), Italy

Member of the Board, President of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS)
HAS–Sante, France

Director, Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA), Austria
Member, EUnetHTA

Technical Analyst, NICE Scientific Advice Program
National Institute for Health and Care Excellence, UK

Vice-President of Medical Devices and Clinical Interventions
CADTH, Canada

Head of Clinical Engineering Service
Humanitas Research Hospital, Italy

Medical Adviser
RIZIV-INAMI, Belgium

Scientific Evaluator
RIZIV-INAMI, Belgium

Medical Devices - Clinical Lead, Medical Physics & Clinical Engineering
Nottingham University Hospitals NHS Trust, UK

Vice-Chair
Scottish Health Technologies Group


INDUSTRY EXPERTS

Director, Market Access & Economic Policies
MedTech Europe, Belgium

Senior Director, Global Pricing Strategy, Contracting & Tender
Medtronic, Switzerland

Head of Market Access & Pricing Diabetes Care EMEA
BD, Switzerland

Global Head Market Access & Policy
Ascensia Diabetes Care, Switzerland
Board member
EDMA (The European Diagnostics Manufacturers Association)

Director Market Access, Urology & Pelvic Health Health Economics & Market Access Europe
Boston Scientific, Germany

Global Director Scientific Communications | Medical Affairs
Medtronic, France

Legal Council
Medtronic, Portugal

Global Pricing Manager PCMS Pricing Team
Philips, Germany

Member of the Market Access Working Group
BVMed, The German MedicalTechnology Association
Senior Manager, Health Economics & Market Access
Johnson & Johnson Medical, Germany

Associate Director, Germanic Countries & Turkey Market Access Government Policy & Health Outcomes
Medtronic, Germany

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

Vice President, Global Business Development
POC Medical Systems

Senior Manager Reimbursement & Health Economics
CytoSorbents Europe, Germany

Medical Affairs Manager EP, Europe
Boston Scientific, Germany

Chief executive
Swedish Medtech (The association for medical technology), Sweden


POLICY RESEARCHERS & ACADEMICS

Senior Scientist
RAND Health, USA

Program Director, Executive MBA Healthcare Management
SRH University, Berlin (SRH Hochschule), Germany


SOLUTION PROVIDERS

Managing Director
Value Connected, Netherlands

Vice President
Boston Healthcare

Managing Director
ClearView Healthcare Partners

Download agenda here for complete speaker list

Pictures from recent Medtech Access Leaders Forums. Imagine being there...

Enhancing evidence-based decision making, to prioritise reimbursement, achieve budget effectiveness and patient access

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.

Speaker List - Day 1

Technical Analyst, NICE Scientific Advice Program
National Institute for Health and Care Excellence, UK

Chief of Innovation, Research and Development Department
Agenas (Agency for Regional Health Services), Italy

Vice-President of Medical Devices and Clinical Interventions
CADTH, Canada

Medical Adviser
RIZIV-INAMI, Belgium

Medical Devices - Clinical Lead, Medical Physics & Clinical Engineering
Nottingham University Hospitals NHS Trust, UK

Managing Director
ClearView Healthcare Partners

Director, Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA), Austria
Member, EUnetHTA

Director, Market Access & Economic Policies
MedTech Europe, Belgium

Head of Market Access & Pricing Diabetes Care EMEA
BD, Switzerland

Global Director Scientific Communications | Medical Affairs
Medtronic, France

Vice-Chair
Scottish Health Technologies Group

Senior Director, Global Pricing Strategy, Contracting & Tender
Medtronic, Switzerland

Developing strong evidence and demonstrating clinical and economic value to payers and HTAs to achieve patient access

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 en-sure 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 details 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.

Speaker List - Day 2 (AM)

Chief executive
Swedish Medtech (The association for medical technology), Sweden

Member of the Board, President of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS)
HAS–Sante, France

Managing Director
Value Connected, Netherlands

Director Market Access, Urology & Pelvic Health Health Economics & Market Access Europe
Boston Scientific, Germany

Vice President
Boston Healthcare, USA

Vice-Chair
Scottish Health Technologies Group

Associate Director, Germanic Countries & Turkey Market Access Government Policy & Health Outcomes
Medtronic, Germany

 

Understanding what health economic evidence payers value, to achieve reimbursement and market access

Surgical device reimbursement & market access now requires more data and value justification than ever before. The good news is that with value adding benefits (minimally invasive procedures; less frequent implant replacement; faster recovery times and greater long-term health benefits), manufacturers have a real opportunity to show what their product can deliver in terms of cost effectiveness to HTAs & Payers. The requirement for existing products to defend their place in the market as well as new products to show true innovation is now a reality. With the data alone now telling the story, it provides large medical device manufacturers the ability to permanently solidify their place in the market and it gives smaller device companies the ability to break into this massive marketplace. This one day stream will give best practice examples on value demonstration and market access approaches for surgical devices and implantables.

Speaker List - Day 2, Stream 1 (PM)

Senior Director, Global Pricing Strategy, Contracting & Tender
Medtronic, Switzerland

Vice-Chair
Scottish Health Technologies Group

Medical Affairs Manager EP, Europe
Boston Scientific, Germany

Senior Scientist
RAND Health, USA

Medical Adviser
RIZIV-INAMI, Belgium

Navigating health system tendering and procurement pathways to achieve value-based market access

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 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.

Speaker List - Day 2, Stream 2 (PM)

Head of Clinical Engineering Service
Humanitas Research Hospital, Italy

Global Head Market Access & Policy
Ascensia Diabetes Care, Switzerland
Board member
EDMA (The European Diagnostics Manufacturers Association)

Legal Council
Medtronic, Portugal

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

Managing Director
Value Connected, Netherlands

 

Clarifying complex DRG and HTA systems to streamline market access in Europe’s largest medical device marketplace

The German market for medical technologies is the largest in Europe and one of the largest globally. German medtech companies are marketleaders in various device sectors and niches, however there is also intense completion with foreign manufacturers. There has been recent regulatory reforms and other developments into how advanced medical technologies are being evaluated by the German healthcare system and these must be understood by manufacturers to ensure access. For example, the introduction of the new “Coverage with Evidence Development model” (CED) and the German “Care Provision Strengthening Act.” On one hand this is a positive for medtech companies, ensuring initial patient access to advanced care, whilst evidence of improved outcomes can be developed in the real-world. However, how early benefit assessment will be conducted in practice is a question mark. There may also be a contradiction in the DRG system versus newer Health Technology Assessment methodologies and processes. Approval in one area does not necessarily mean success in another and nor does it mean that budgets are available. This important event will bring together stakeholder groups from the German healthcare system, as well as the medtech industry, to discuss how, within the new framework, patient access can be achieved and superior health outcomes can be delivered most effectively.

Speaker List - Day 3 (AM)

Associate Director, Germanic Countries & Turkey Market Access Government Policy & Health Outcomes
Medtronic, Germany

Member of the Market Access Working Group
BVMed, The German MedicalTechnology Association
Senior Manager, Health Economics & Market Access
Johnson & Johnson Medical, Germany

Senior Manager Reimbursement & Health Economics
CytoSorbents Europe, Germany

Global Pricing Manager, PCMS Pricing Team
Philips, Germany

Medical Affairs Manager EP, Europe
Boston Scientific, Germany

Understanding the myriad of pathways and health systems in order to achieve market access for high-value IVDs

As the product nature of In Vitro 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 In Vitro diagnostics to bring their benefit to clinical settings have never been greater. This one-day stream will discuss the market access challenges affecting In Vitro diagnostics and companion diagnostics globally with case studies of successful launches and cautionary tales of those which were not, to provide benchmarking and learning opportunities for all participants.

Speaker List - Day 3 (PM)

Scientific Evaluator
RIZIV-INAMI, Belgium

Global Head Market Access & Policy, Ascensia Diabetes Care, Switzerland
Board member, EDMA (The European Diagnostics Manufacturers Association)

Vice President, Global Business Development
POC Medical Systems

Program Director, Executive MBA Healthcare Management
SRH University, Berlin (SRH Hochschule), Germany

Vice-Chair
Scottish Health Technologies Group

 

This event will provide all delegates the chance to meet one another through our many networking opportunities. With pre-event, mid-morning and mid-afternoon breaks as a standard, this event will also feature a complimentary networking dinner for all participants.

This evening will allow you to meet with our expert speaker panel who represent many stakeholder groups in a less formal setting. Our networking lunches will also allow you plenty of time to meet with your peers and colleagues whilst you refuel through the event.

Device manufacturers & distributors:
Marketing, Market-access, Business Development, Country Managers, Health Economics, Pricing & Reimbursement, Government & Stakeholder Relations, Regulatory Affairs 

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

“It was my first participation after I have heard lots of good things about the meeting from current and former colleagues in the business. I appreciated the good balance between authorities/agencies and industry, while managing a relatively compact group of participants focused on medical devices. The atmosphere was open and inclusive that allowed good questions to be brought up and exchanges fostered in and out of the sessions. The content of the talks was usually real-world and practical. They could serve as a good training and refresher, as well as practical sharing of hands-on initiatives. I believe it is of good direct benefit for the participants. It will be a pleasure to be there again!”
Health Economics Manager
Olympus Europa

“Obviously, it was a very useful and interesting conference for everybody, from scientific societies, working in the field of HTA, to Market Access & Strategic Affairs specialists from medical device companies. Each type of participant was able to gather something new for him/herself. I believe it is rather relevant for me to take part in this type of conference not only for following the latest legislative trends in the medical devices procurement process, but also for improving my network of business connections.”
Senior Health Economics & Reimbursement Specialist
Johnson & Johnson

“I have recently participated and presented in Berlin and was very impressed about the quality and relevance of the meeting and presentations.”
Director Medical Affairs, CRM EMEA
Boston Scientific

“NextLevel Life Sciences provides one of the best platforms for opinion exchange in the area of medical device regulation and HTA in Europe and worldwide. I believe that participation in forums organized by NextLevel is a must for medical device business leaders since it is a unique opportunity for candid and open discussion of a lot of complex problems of the medical device industry.”
Center for HTA,
Presidential Academy of National Economy & Public Administration, Russia

“A very informative and well organized meeting with several key discussion areas in the diagnostic, and medical device areas. I would highly recommend this conference to my colleagues who are trying to anticipate marketplace change”
Director, Business Development
Myriad RBM

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