2023 Conference programme

Steered by a prestigious Committee, the MedFIT conference programme brings together bright minds to discuss the latest trends in MedTech, Diagnostic and Digital Health, to debate on innovation-driven topics, to foster learning and spark conversations that matter. International experts will address current industry issues related to collaboration, financing, market access and regulation as well as digital health and medicine.

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PLENARY SESSION

DAY 1 - Tuesday, October 11^th, 2023

10:30 AM
11:30 AM

MedTech start-up governance: What makes a good foundation for a company to deliver and grow?

One of the most important indicators of a startup’s later success is the founding team. What does it mean to be a founder? When the time comes of building a team around the founder(s), how to identify the right people and is the founder always the best option to run the company? What is the ideal composition for the board, the scientific committee, and the executive committee? What are the most prevalent governance problems start-ups face while scaling and how to address them? How to keep the initial team motivated and invested when the company is growing?

Moderator: Lamya Rezig, Startup & Board Advisor in Healthtech and Tech

John Bethell, CEO, LUKA GLOBAL GROUP
Eva van Rooijen, CEO, Foveo Fertility
Fei Tian, Principal, MIG Capital
Matthieu Leclerc-Chalvet, CEO, Therapixel

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TRACK 1 – COLLABORATE TO INNOVATE

Fostering new collaborations is key to fuelling innovation and supporting R&D needs in MedTech. As global healthcare evolves to deliver more value to patients, partnerships with hospital leaders, technology experts, payers and innovators are the cornerstone of the medical technologies’ evolution. What are the elements to forgather to merge the scientific, academic, and industry spheres? How is innovation sourced through collaboration with academia? What are the main drivers and favoured models for big players/early-stage companies’ partnerships?

DAY 1 – Tuesday, October 10^th, 2023

2:00 PM
3:30 PM

Panel discussion

What are the main drivers and favoured models for big players/early-stage companies’ partnerships?

Big MedTech companies are more and more looking for external projects to invest in. While early-stage companies may detain convincing science and promising ideas, they often lack the means and expertise that big players can offer. How do corporates identify value in early-stage companies? What drives them to choose one project over the other? The options in early-stage partnerships are diverse: licencing, co-development, collaboration… What options are best depending on the nature of the project and the players involved? How to find a convergent interest and build a shared value for both parties? What are the criteria to evaluate the success of these collaborations? How are these strategic partnerships evolving and are there novel models of collaborations emerging?

Moderator: Svetlana Stotskaya, Independent Consultant, Marketing and Brand Strategist

Beat Lechmann, Early Innovation Partner MedTech EMEA, Johnson & Johnson Innovation
Frédéric Le Roy, Director, Chaire Coo-innov
Lisa Tschalenko, Senior Ecosystem Manager – Digital Health & Pharma, 5-HT Digital Hub – Chemistry & Health
Pia Schmiedel, Business Development Manager, Printed Electronics, Henkel

DAY 2 – Wednesday, October 11^th, 2023

10:30 AM
11:30 AM

Panel discussion

What are the best practices for involving healthcare professionals in the early stages of innovative product development?

A successful innovation must answer an unmet need for patients and/or a real issue faced by practitioners. This is not only a matter of “what” the technology addresses but also of “how”, so that it can be easily usable by health professionals and integrated in their practice. How to further involve healthcare professionals in the innovation process and how to best access them? How to make sure practitioners develop the skills necessary to exploit the potential of the innovations? To what extent can incorporating physician insights help in securing approvals and clearance? How to ease access to real-world observations and supporting data? What are the examples of lasting industry/HCP collaborations and what is the impact on innovation development and patients?

Moderator: Carole Absil, HealthTech Strategist

Nayeli Schmutz, Co-Founder & Chief Medical Officer, PIPRA
Ryan Ramkhelawan, Co-Founder & Managing Partner, Lasting Machine Ventures
Hatim Abdulhussein, Medical Director // National Clinical Lead for AI and Digital Workforce, Kent Surrey Sussex Academic Health Science Network // NHS England
Anna Erat, Medical Director of Preventive Medicine, Longevity Center Europe

11:45 AM
12:45 PM

Panel discussion

From bench to market: Let’s hear about successful tech transfer journeys

A successful project starts with consistent science. Yet, the path to bringing an innovation to market is not without its pitfalls. From IP to commercialisation, this session will focus on successful tech transfer stories and look at the key ingredients for a successful spin-out or out-licensing process. How to decide whether to licence a technology to an existing company or set up a spin-off company to develop it? How to identify the route to market with the optimum chance of success? What can the research group, university of origin or TTO concretely bring to the equation? Are there ideal routines and guidelines for creating a profitable and sustainable collaboration for both parties?

Moderator: Florent Detroy, Founder & Director, POC Media

Stuart Hannah, CEO, Microplate Dx
Sabine Kaiser, Venture Manager, RWTH Innovation
Roy Kolkman, Head Knowledge & Technology Transfer Office, Novel-T
Engin Vrana, CEO, SPARTHA Medical
Julie Rachline, CEO, Braintale

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TRACK 2 - FINANCING INNOVATION

Seed and Series A investments are crucial to transforming new ideas into products and making start-up teams into small businesses. Finding the right funding sources and equity partners to get from early stage to regulatory approval is far from straightforward. How to identify the initial sources of funding for MedTech R&D projects? What method should you use to fund your start-up? How to attract ventures for early-stage financing?

DAY 1 – Tuesday, October 10^th, 2023

4:00 PM
5:00 PM

Toolbox session

What’s new in grant financing across Europe and how to prepare for it?

Early-stage financing paves the path to success for an innovative asset. Grant financing is a lower-risk option, maintaining the company’s independence in the first steps of its development. The EU is an instrumental source of non-dilutive funding for innovative MedTech companies. It recently issued the new Innovative Health Initiative (IHI) to foster innovation through public-private partnership between the European Union and MedTech industry companies. How can a company benefit from this program? How to build a successful European funding strategy? What are the other available grant options in Europe and how to benefit from them?

Moderator: Jeroen Schuermans, Senior Grant Consultant Life Sciences, Akkodis

Hugh Laverty, Executive Director ad interim, Innovative Health Initiative
Engin Vrana, CEO, SPARTHA Medical
Enric Claverol, Head of the Medical Technologies Programme, European Innovation Council (EIC)
Manon Pommier, Entrepreneurship Lead, EIT Health France

DAY 2 – Wednesday, October 11^th, 2023

9:00 AM
10:00 AM

Panel discussion

The funding gap in MedTech: From Discovery to First-In-Human studies, how do we fund this early-stage in Europe?

There exists a major issue that affects almost all early-stage startups – the gap in funding and expertise between their seed and Series A rounds and beyond. With component shortages and enhanced regulatory requirement, European MedTech start-ups may face a longer time-to-market and increased need for cashflow. How is the current investment landscape for early-stage MedTech in Europe? Which alternative funding options to VCs exist for MedTech start-ups facing a funding gap and how prevalent are corporates today? How to avoid a chicken and egg problem if you cannot de-risk your asset without sufficient funding?

Moderator: Adriana Diaz, Communities Manager, ECHAlliance

Esther Reynal de St-Michel Richardot, Managing Partner, THENA Capital
Cyril Teixeira da Silva, Investment Officer, Growth Finance & Venture Debt, European Investment Bank (EIB)
Jan Engels, Investment Manager, High-Tech Gründerfonds
Laura Achach, Healthtech Investment Analyst, Kurma Partners
Nina Lameule, Investment Manager, NLC - The European Healthtech Venture Builder

2:00 PM
3:00 PM

Panel discussion

Funding medical device start-ups: CEOs’ Perspective

In this session, seasoned CEOs will share their experience to help you succeed in your early-stage financing. Get inspired by the perspective of executives who succeeded in the MedTech industry. Where did they seek their seed and pre-seed investment? How to pitch your project to raise interest in your proposition? What are the guarantees investors are looking for? Are there frequent mistakes to avoid? How to limit the risks for your own company and for the investors?

Moderator: Arezki Yaïche, Head of Coverage France, Mergermarket (ION Group)

Javier Jiménez, Founder & CEO, New Born Solutions
Olivier Decuypere, CEO, CorQuest MedTech
Elie Lobel, CEO, RDS (Rhythm Diagnostic Systems)
Luis Valente, CEO & Co-Founder, iLoF – Intelligent Lab on Fiber

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TRACK 3 - FROM INNOVATION TO MARKET

Planning a market access should start early in the product development process, increasing the chances of successfully bringing an innovation to market. How to keep track of market trends and regulatory requirements while building your strategy? How can a company accurately anticipate market access, pricing and reimbursement related issues? This track aims to give a comprehensive approach to the pathway to market for emerging medical technologies.

DAY 1 – Tuesday, October 10^th, 2023

5:15 PM
6:15 PM

Panel discussion

Tips and tricks from entrepreneurs on the regulatory journey for MedTech start-ups

Hearing from the learnings of the regulatory approval processes of MedTech entrepreneurs or advisors, this session will highlight a few critical things to take care – early on – in your regulatory journey. What are the key steps to follow to make this journey successful? When to get experts on board and how to source the right ones? How to implement the right processes in terms of requirement management, risk assessment and clinical validation? How to manage the increased spendings induced by MDR regulation? To what extent can a good regulatory approval management be a strategic advantage for your start-up?

Moderator: Patricia Gruffaz, Director, MedUniq Center

Elodie Brient-Litzler, Co-Founder & COO, AVATAR MEDICAL
Kalina Mihaylova, Head of Medical Innovation, Daye
Ozlem Budakli, Quality Manager - Medical Device Cybersecurity, Irdeto
Eric Horesnyi, CEO, Matrix Requirements

DAY 2 – Wednesday, October 11^th, 2023

11:45 AM
12:45 PM

Toolbox session

Looking to expand or launch outside of Europe: Insights into approaching the US market

Many MedTech companies decide to first target their home geographic market, building on their familiarity with it. Yet, a multitude of factors – such as competition, market value, probability of reimbursement, regulatory framework, cultural differences – are to be considered to fully capture the commercial potential. This session will focus on the US market with the aim of providing practical guidance on how to successfully first enter or expand into the US market. Why is it interesting to access the United States market and what makes it relevant in certain cases to give this market priority? What is the best timing to enter the US market? What are the main differences and common points between US and Europe markets?

Moderator: Charlotte Puechmaille, Country Manager France, Kranus Health

Przemek Czerklewicz, Founder & Partner, milepoint.
Haider Alleg, General Partner, Allegory Capital
Arjan van Manen, Chief Strategy Officer, SkylineDx
Matthieu Leclerc-Chalvet, CEO, Therapixel

3:30 PM
4:30 PM

Toolbox session

From idea to market access: Best practices in aligning your regulatory and reimbursement strategies

A significant degree of overlap exists between reimbursement and regulatory approval of medical devices with sometimes a lack of integration of the processes. An early-stage company may have competing priorities and areas of focus, preventing it from achieving the major milestones of commercialisation. Making decisions and pursuing regulatory pathways without considering the company’s reimbursement goals can ultimately interfere with the reimbursement process, delay product launch and result in substantial losses for the company. How to ensure the reimbursement strategies are coordinated with regulatory strategy throughout the planning process? When best to research reimbursement and financial return options? How should clinical research planning fit into this? This session will focus on best practices in the early integration of regulatory, reimbursement and clinical research planning to secure commercial success.

Moderator: Artur Olesch, Founder & Editor-in-Chief, about Digital Health

Kristine Morrill, Founder & President, Medevise Consulting SAS
Jessica Garestier, Of Counsel – Life Sciences, Dentons
Thom Rasche, Managing Partner, Earlybird Venture Capital

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TRACK 4 – Digital health and medicine innovation

This track aims to explore further the digital health and medicine sector in itself, including new challenges and players emerging in the field.

DAY 1 – Tuesday, October 10^th, 2023

9:15 AM
10:30 AM

Panel discussion

Scaling digital health companies and creating commercially viable business models

The growth of digital health solutions has accelerated rapidly in recent years, expanding the market for healthcare services and technology, creating new stakeholders, opportunities, and business model considerations. While many innovative ideas have been developed and sparked investor interest, digital health investments are now slowing down and lots of companies are still struggling to move beyond promising technologies to large-scale deployment. What are the business models behind the recent developments in digital health? How to define and demonstrate a clear value proposition to stakeholders and customers? How can these innovations be smoothly integrated into existing regulatory and care pathways? To what extent is it possible to explore and test different business models simultaneously? What is the right ecosystem for digital health companies to thrive?

Moderator: James Somauroo, Co-Founder & CEO, SomX

Charles-Eric Winandy, Co-Founder & Director, moveUP
Sylvain Piquet, Co-Founder, Five Lives
Samantha Jérusalmy, Partner, Elaia Partners
Pim Hollestelle, Investment Analyst, , LUMO Labs

2:00 PM
3:30 PM

Toolbox session

Getting a digital therapeutic approved and reimbursed in Europe

The EU describes Digital Therapeutics (DTx) as “evidence-based therapeutic interventions driven by software to prevent, manage, or treat a medical disease.” DTx are increasingly recognised and adopted into national frameworks worldwide to improve patient care: they can now be prescribed, opening new business model for digital health applications. However, they must first be approved for reimbursement, with no specific regulation existing at EU level. Drawing inspiration from the German DiGA Fast Track, France and Belgium have also taken steps to implement reimbursement processes for DTx. Thus, approval rules for DTx are being created by single countries, resulting into a fragmentation in terms of requirements and regulatory standards. How to succeed in this fragmented regulatory landscape? How to facilitate market entry for your DTx? What are the shared requirements among EU members? What are the basics in terms of data protection and security compliance? Where are in the creation of a unique and centralised set of frameworks in Europe?

Moderator: Przemek Czerklewicz, Founder & Partner, milepoint.

Vincent Vercamer, Project Director, Digital Health Delegation (DNS), French Ministry of Health
Jörg Trinkwalter, CFO & Partner, ProCarement
Kathrin Pfeiffer, Head of Market Access, Sympatient
Edouard Gasser, Co-Founder & CEO, Tilak Healthcare

4:00 PM
5:00 PM

Panel discussion

Are digital biomarkers the future of personalised medicine?

As healthcare continues its digital transformation, more and more health data from diverse populations are becoming available. Digital biomarkers are objective and quantifiable physiological and behavioural data that are collected and measured using digital devices, such as smartphones, wearables and implantables. What is the current acknowledge range for digital biomarkers and why are they useful? To what extent are they currently used to generate evidence and value? How are regulators and payers looking at digital biomarkers? How are they changing how future medicines might be developed and how can this lead to more personalised treatments?

Moderator: Jessica Smith, Co-Founder & CXO, SomX

Henk Stapert, Chief Technology Officer, smartQare
Piotr Sokolowski, Chief MedTech Strategist, S3 Connected Health
Guy Fagherazzi, Director of the Department of Precision Health, Luxembourg Institute of Health
Monika Zbytniewska-Mégret, Digital Biomarkers Scientist, Roche

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PROJECT - CEO MATCHMAKING

Having the right team is essential for the development of a MedTech project or start-up. The Project – CEO matchmaking activity offers a conference session to get inspired and explore the best ways to find the right talent for a successful project.

DAY 2 – Wednesday, October 11^th, 2023

10:30 AM
11:30 AM

MedTech start-up governance: What makes a good foundation for a company to deliver and grow?

John Bethell, CEO, LUKA GLOBAL GROUP
Eva van Rooijen, CEO, Foveo Fertility
Fei Tian, Principal, MIG Capital
Matthieu Leclerc-Chalvet, CEO, Therapixel

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DAY 1 – Tuesday, October 10^th, 2023

10:00 PM
10:30 PM

The MedTech Industrial Campus, an industrial accelerator for MedTech start-ups

DAY 2 – Wednesday, October 11^th, 2023

9:30 PM
9:45 AM

Cybersecurity for Medical Devices : Keeping up with the evolving regulatory landscape

“Secure by design” practices are no longer optional. Regulators are now holding manufacturers accountable to build secure devices and show how they plan how to keep those devices secure throughout their lifecycle. In this session, Irdeto, leader of platform security, will provide insights on the evolutions of the regulatory landscape and hands-on advice on good practices for medical device manufacturers to enhance the cybersecurity posture of their devices.