PDA Medical Devices and Connected Health Conference 2024

From Pilot to Population – A Roadmap for Successful Digital Health

Antwerp, Belgium
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Program Highlights

The agenda is now published!

TWO FOR ONE
The conference will take place in parallel with the PDA Good Digitalization in Pharma Conference 2024! Don't miss this special 2-for-1 offer!

Dear Colleagues,

On behalf of the Scientific Program Planning Committee and PDA, we are proud to present the third edition of the PDA Medical Devices and Connected Health Conference and warmly invite you to join us in Antwerp/Belgium.

Digitization and digitalization are transforming the healthcare industry, and connected health solutions are at the forefront of this revolution. These solutions, which involve data platforms, software, and sensors, have the potential to empower patients to manage their diagnosis and treatments more effectively, while at the same time reducing the burden for healthcare professionals, resulting in increased efficiency in healthcare systems.

However, digital health is also confronted with the variety and complexity of medical device and pharmaceutical regulatory schemes as well as the management of data security to ensure privacy and inhibit misuse.

The theme of ‘From pilot to population - a roadmap to successful digital health’ is particularly relevant in this context. It highlights the need for a comprehensive and systematic approach to digital health at a scale that takes into account the entire healthcare ecosystem, from patients to healthcare providers, regulators, and insurance companies. As the shift of healthcare from hospital to home continues, there are also opportunities for digital solutions to leave a positive impact on the environmental footprint.

We believe that an open dialogue and experience exchange between all parties involved is the most appropriate way to create a roadmap to successful digital health that benefits everyone involved.

We would like to thank the Scientific Program Planning Committee and PDA for setting up this conference as well as all contributors and submitters for their insightful input into the conference. We have received excellent speaker abstracts so far and believe that we will put together an engaging conference program that focuses on patient-centricity, handling of data, regulatory challenges, and commercialization of medical devices and connected health.

Discover the emerging benefits of digital health and engage in fruitful exchange and discussions with fellow healthcare professionals at our two-day conference! 

Sincerely,

The Co-Chairs

Stephanie Göbel, Roche/Genentech, Co-Chair
Paul Upham, Roche/Genentech, Co-Chair

SCIENTIFIC PROGRAMM PLANNING COMMITTEE:

  • Stephanie Göbel, Roche/Genentech
  • Paul Upham, Roche/Genentech
  • Eric Chanie, Merck Group
  • Geraint Davies, F. Hoffmann-La Roche
  • Paul Greenhalgh, Team Consulting
  • Arnaud Guillet, Biocorp
  • Philippe Müller, Ypsomed
  • Egmont Semmler, TÜV Süd
  • Iain Simpson, Phillips Medisize
  • Andrei Yosef, LTS Device Technologies
  • Josh Eaton, PDA
  • Falk Klar, PDA Europe
  • Caroline Lynar, PDA Europe, Manager Programs and Events

Standard Registration

Member Price

€ 2.250

GovernmentMember Only

€ 1.080

Health AuthorityMember Only

€ 1.080

Early Career ProfessionalMember Only

€ 1.080

StudentMember Only

€ 1.080

AcademicMember Only

€ 1.080

Non-Member

€ 2.550

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. registration-europe@pda.org

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact registration-europe@pda.org before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1

Tuesday, 04 June 2024

09:00 | Welcome and Introduction
Stephanie Göbel, Roche/Genentech
Paul Upham, Genentech/Roche

Opening Plenary: From Project to Product - Key Aspects for Your Roadmap
Moderator: Stephanie Göbel, Roche/Genentech

The opening is going to stimulate your thinking about the entire healthcare ecosystem, from patients to healthcare providers, regulators and insurance companies. We will cover challenges in regulatory pathways that need to be addressed to ensure the final commercial success of a product. These regulatory considerations are accompanied by two presentations that discuss the commercialization of digital solutions:
In the keynote presentation use cases and reimbursement strategies in different markets will be discussed - sharing emerging best practices on how to address the needs of healthcare providers as well as of patients. Related to patients, learn about the interaction of patient behavior and environmental impact and how to address these aspects to result in a connected product solution that improves patient outcomes while reducing the environmental footprint and related healthcare costs.

09:15 | Keynote: Show Me the Money – Commercialization, Business Models and Case Studies
John Mulcahy, S3 Connected Health

09:40 | Regulatory Pathways for Connected Combined Products
Christoph E. Joosten, F. Hoffmann-La Roche

10:05 | Remote Patient Monitoring: A Win for Patients and the Environment?
Daniel Nickalls, TTP & Anna Wilson, 52North Health

10:30 | Plenary Discussion

11:15 - 11:45 | Networking Coffee Break, Poster Session & Exhibition

Session 1: Data Management (Cybersecurity)
Moderator: Paul Upham, Genentech/Roche

Learn about how data are used in the different components of connected systems, how their use is viewed by health authorities, as well as the risks, mitigations, and regulations for ensuring that all of those data are secured and protected.

11:45 | New FDA Premarket Submission Requirements for Cybersecurity in Medical Devices
Paul Gardner, Ypsomed/Congenius

12:05 | When Ransomware Halts Your Factory and Supply Chain
Kevin Fu, Northeastern University

12:25 | Meeting the Evolving Requirements of SaMD and AI in Healthcare
Thomas Watts, Team Consulting

12:45 | Q&A, Discussion

13:15 - 14:30 | Networking Lunch Break, Exhibition & Poster Session

14:00 - 14:30 | LIVE Guided Poster Walk - Engage with our Poster Presenters in our Exhibition Hall

Session 2: Patient Centricity
Moderator: Arnaud Guillet, Biocorp

Connectivity offers a technical solution to tackle the issue of non-adherence, but user acceptance is not a given. Any new solutions will inevitably create some minor disruptions for patients, which can be barriers to adoption. Therefore, health industrials must master all aspects of patient-centric design to come up with solutions that provide immediate benefits to patients, while minimizing impact to their current habits. This session will present concrete use cases of collaborations between pharma & MedTech/digital health players on how to effectively design and implement connected solutions. The first one will describe the deployment of a connected ecosystem in the GH space. Second will present insights from HIV patients engaged with a connected device and associated App, analyzing user opinions on features within a controlled testing setting. The last presentation will demonstrate how introducing behavioral diagnosis into a digital service allows more effective interventions in response to changing patterns of medication adherence.

14:30 | Interactive Questionnaire
via Mentimeter

14:40 | Exploring Patient and Pharma Perspectives on Selfcare and Self-injection
Philippe Müller, Ypsomed

15:00 | Deploying Connected Drug Delivery Devices for Caregivers and Patients with Growth Hormone Deficiency
Liam McMorrow, Novo Nordisk & Fanny Sellier, Biocorp

15:20 | The Role of Connected Health in Responding to Changing Patterns of Medication Adherence
Kevin Dolgin, Observia Group & Ashwani Kumar, Phillips Medisize

15:40 | Q&A, Discussion

16:10 - 16:40 | Networking Coffee Break, Poster Session & Exhibition

Session 3: Behavior Science - Designing for Engagement
Moderator: Geraint Davies, F. Hoffmann-La Roche

Changing people’s behavior is hard. Changing people’s health behavior is REALLY hard! The health industry has always struggled with patient adoption and adherence to medications, monitoring, exercise, and a host of other lifestyle changes, despite their proven benefits. Digital Health is no different, and those in the industry for a while know that sustained engagement with a product is one of the biggest barriers to success.
Behavior Design is the systematic application of the behavioral sciences to the development of products and services. It helps us understand the deeper reasons why people make the decisions they do and how to overcome subconscious and emotional barriers that prevent us from achieving the outcomes we desire.
The talks in this session will not only introduce the core concepts of behavior design but also provide real-world examples to help the audience understand how to apply it and why this approach is fundamental to developing successful products.

16:40 | Rethinking Patient Engagement: The Untapped Potential of Behavioral Design in Digital Health
Richard Mathera, Irrational Labs

17:00 | How to Translate Behavioral Science to the Design of Tools that Benefit Patients Learning to Self-Inject
Ben Cox, Team Consulting & Sabine Krawietz, Novartis

17:20 | Building an Engagement Architecture in Medical Devices
Andrew Zimmermann, Behavior Design Group

17:40 | Q&A, Discussion

18:10 | End of Conference Day 1 and Networking Event

Day 2

Wednesday, 05 June 2024

09:00 | Welcome back by the Co-Chairs
Stephanie Göbel, Roche/Genentech
Paul Upham, Genentech/Roche

Session 4: Commercialization
Moderator: Andrei Yosef, LTS Device Technologies

09:05 | Strategies for Enhancing Adoption of Connected Combined Products in the Digital Health Landscape
Jenny Estermann & Lina Abu-Qaoud, Kymanox

09:25 | Assessing the Potential Value and Barriers to Adoption of Connected Drug Delivery Devices and Associated Digital Solutions: A Detailed Perspective from Pharmaceutical Stakeholders
Aaron Swick & Mehul Desai, Enable Injections

09:45 | Breaking Barriers in Clinical Decision Support Systems: Navigating the Challenges of Regulation, Reimbursement, and Interoperability
Miriam Schulze, BAYOOMED

10:05 | Q&A, Discussion

10:35 - 11:05 | Networking Coffee Break, Poster Session & Exhibition

Session 5: Case Studies - Using the Data
Moderator: Iain Simpson, Phillips Medisize

In this session, we will explore how the data collected from connected medical devices can be utilized to provide insights into device performance as well as medication use. The session starts with an overview of the importance of medication adherence and how connected devices can provide more accurate, real-time data to support this. Then subsequent talks will focus on 2 device-related case studies and consider how data transmitted from connected injection devices can provide important information on their performance as well as on medication use. It will be shown how these data can be used to improve device design and patient training as well as support adherence. The session will also explore some of the challenges and considerations in gathering and processing such data. The case studies will include both clinical and commercial examples of the use of connected devices.

11:05 | Optimizing Medicines Through Connected Devices: Dosing History Data is Key!
Bernard Vrijens, AARDEX Group

11:25 | Unveiling the Power of Injection Devices Transmitted Data: Use cases
Rodrigue Chatton, Merck KGaA

11:45 | Unveiling Insights Through Wearable Drug Delivery Devices and Data Management
Tal Ohev Zion, LTS Lohmann Therapie Systeme

12:05 | Q&A, Discussion

12:35 - 13:35 | Networking Lunch Break, Exhibition & Poster Session

Closing Plenary: Navigating the Future: Sustainability, Handling Regulatory Compliance, and Reimbursement for Medical Devices and Connected Health
Moderator: Paul Upham, Genentech/Roche

In this dynamic plenary session, industry experts will delve into the critical aspects of sustainability, handling regulatory compliance, and reimbursement for medical devices and connected health solutions. This session will provide comprehensive insights into the evolving landscape of medical devices, offering practical guidance and innovative strategies to navigate these challenges effectively.

13:35 | Interactive Questionnaire
via Mentimeter

13:45 | Care Pathways: A Holistic Approach to Understanding the Sustainability Impacts and Benefits of Medical Devices and Encouraging Innovation
Simon Aumonier, Consultant

14:10 | Wondering How to Navigate the MDR GSPR's for Your PFS? Help Is Out There!
Bettine Boltres, West

14:30 - 15:05 | Networking Coffee Break, Poster Session & Exhibition

15:05 | Passport Raffle

15:10 | Unlocking Reimbursement for Connected Medical Devices in Europe and the US: Key Success Factors
Alexandre Habib, Simon Kucher

15:35 | Plenary Discussion

16:15 | Conference Summary from the Co-Chairs

16:25 | Closing Remarks & Farewell

16:30 | End of Conference

Agenda is subject to change.

Featured Presenters

Presenters

  • Eric Chanie

    Merck Group

    Read Bio
  • Geraint Davies

    F. Hoffmann-La Roche

    Read Bio
  • Stephanie Goebel, Dipl. Ing.

    Roche/Genentech

    Read Bio
  • Paul Greenhalgh

    Team Consulting

    Read Bio
  • Arnaud Guillet

    BIOCORP

    Read Bio
  • Egmont Semmler, PhD

    TÜV Süd

    Read Bio
  • Iain Simpson, PhD, MBA

    Phillips Medisize

    Read Bio
  • Paul Upham

    Roche/Genentech

    Read Bio
  • Andrei Yosef, PhD

    LTS

    Read Bio

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

PDA recommends the reservation at the following hotel

Hilton Antwerp Old Town
Groenplaats 32
B2000 Antwerp
Belgium

PDA Europe has reserved a limited number of rooms by 1st April 2024.

Book your room at the PDA Group Rate via the above-mentioned reservation button.


How to Get Here
By Air

There are two airports close by, Antwerp International Airport which is around 20 min by car or Brussel International Airport (Airport Zaventem) which is an hour away.

By Car On site parking is available, please contact the hotel for further information.
By Other Options It only takes 30 minutes by train from the airport to Antwerp Central station with the Intercity Direct. Here you take the metro to the "Antwerpen Groenplaats Metro Station", where the hotel is located.
Travel and Exclusive Discount Information
Special Lufthansa Group Airlines Fares
Special Lufthansa Group Airlines Fares

The Lufthansa Group airlines bring people together – every day, all around the world.The global route network of Austrian Airlines, Lufthansa, SWISS, Brussels Airlines and Eurowings offers optimal connection and combination options, so you will benefit from quick and direct flights to the event.

You will reach the booking platform via this link https://www.lufthansa.com/de/en/meetings-and-events-delegates and with the event code DEAPILH. The reduced fares are automatically displayed.

Note: Please enable pop-ups permanently in your browser while booking, otherwise the window in the booking platform will not open.

Of course, you can also book through your IATA travel agency. The travel agency can request the ticketing instructions by sending an email to lufthansa.mobility@dlh.de, stating the event code DEAPILH.

Book Flight
Special Deutsche Bahn Train Fares
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Get there relaxed – get there sustainable – travel CO2-free. Your Event Ticket at a fixed price throughout Germany. From any Deutsche Bahn station to our event, with the City-Ticket included.

Event Ticket one-way and specific train (subject to availability):

  • 1st class 89,90€ (seat reservation incl.)
  • 2nd class 55,90€

Event Ticket one-way and fully flexible:

  • 1st class 112,90€ (seat reservation incl.)
  • 2nd class 77,90€

Book online now and get the lowest price for your preferred route – guaranteed. For technical questions, please contact the service number +49 (0) 30 58 60 20 901. Create the perfect start for your sustainable event: Make active use of your journey to work or just relax and enjoy the high-speed travel experience – with 100% renewable power on regional and long-distance services.

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Area Attractions
We are in the heart of Antwerp, overlooking the Cathedral of Our Lady and the Old Town square. Shops, restaurants, and the Plantin-Moretus Museum are a short walk from our door. Antwerp Zoo and Antwerp Central Rail Station are within four kilometers. Enjoy all-day dining and drinks, 24-hour room service, fitness center access, and the rooftop sun deck.