PDA Medical Devices and Connected Health Conference 2024
From Pilot to Population – A Roadmap for Successful Digital Health
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Program Highlights
The agenda is now published!
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
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Member Price
€ 2.250GovernmentMember Only
€ 1.080
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€ 1.080
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€ 1.080
StudentMember Only
€ 1.080
AcademicMember Only
€ 1.080
Non-Member
€ 2.550
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. [email protected]
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 [email protected] 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 |
Opening Plenary: From Project to Product - Key Aspects for Your Roadmap |
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: 09:15 | Keynote: Show Me the Money – Commercialization, Business Models and Case Studies 09:40 | Regulatory Pathways for Connected Combined Products 10:05 | Remote Patient Monitoring: A Win for Patients and the Environment? 10:30 | Plenary Discussion |
11:15 - 11:45 | Networking Coffee Break, Poster Session & Exhibition
Session 1: Data Management (Cybersecurity) |
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 12:05 | When Ransomware Halts Your Factory and Supply Chain 12:25 | Meeting the Evolving Requirements of SaMD and AI in Healthcare 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 |
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 14:40 | Exploring Patient and Pharma Perspectives on Selfcare and Self-injection 15:00 | Deploying Connected Drug Delivery Devices for Caregivers and Patients with Growth Hormone Deficiency 15:20 | The Role of Connected Health in Responding to Changing Patterns of Medication Adherence 15:40 | Q&A, Discussion |
16:10 - 16:40 | Networking Coffee Break, Poster Session & Exhibition
Session 3: Behavior Science - Designing for Engagement |
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. 16:40 | Rethinking Patient Engagement: The Untapped Potential of Behavioral Design in Digital Health 17:00 | How to Translate Behavioral Science to the Design of Tools that Benefit Patients Learning to Self-Inject 17:20 | Building an Engagement Architecture in Medical Devices 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 |
Session 4: Commercialization |
09:05 | Strategies for Enhancing Adoption of Connected Combined Products in the Digital Health Landscape 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 09:45 | Breaking Barriers in Clinical Decision Support Systems: Navigating the Challenges of Regulation, Reimbursement, and Interoperability 10:05 | Q&A, Discussion |
10:35 - 11:05 | Networking Coffee Break, Poster Session & Exhibition
Session 5: Case Studies - Using the Data |
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! 11:25 | Unveiling the Power of Injection Devices Transmitted Data: Use cases 11:45 | Unveiling Insights Through Wearable Drug Delivery Devices and Data Management 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 |
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 13:45 | Care Pathways: A Holistic Approach to Understanding the Sustainability Impacts and Benefits of Medical Devices and Encouraging Innovation 14:10 | Wondering How to Navigate the MDR GSPR's for Your PFS? Help Is Out There! |
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 15:35 | Plenary Discussion |
16:15 | Conference Summary from the Co-Chairs
16:25 | Closing Remarks & Farewell
16:30 | End of Conference
Featured Presenters
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Simon Aumônier
Consultant
Read BioSimon Aumônier
Consultant
Simon Aumônier has spent 35 years addressing the sustainability needs of business and government using life cycle assessment (LCA), carbon footprinting and risk assessment. After an early career in R&D, Simon joined global consultancy ERM, leading its product sustainability practice in supporting clients in improving the sustainability performance of products and services and developing strategies to address the low carbon transition. Simon was a member of the steering committee of the Greenhouse Gas Protocol Product Life Cycle and Corporate (Scope 3) Accounting and Reporting Standards and he directed the development of health sector guidance on: footprinting pharmaceuticals and medical devices; appraising care pathways; and assessing the footprint of clinical trials. Simon has worked with many healthcare companies establishing the footprint of products and portfolios, improving their performance through the development and application of eco-design tools, and assessing the Scope 3 emissions associated with their value chains. He is particularly interested in examining 'avoided emissions', those that are offset as a result of the improved efficacy of drugs and devices. In December 2022, Simon left ERM for a work pattern including freelance sustainability consultancy and advisory work, volunteering, study of prehistoric archaeology, remaining an ERM external project director and coach.
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Bettine Boltres, PhD
West Pharmaceutical Services
Read BioBettine Boltres, PhD
West Pharmaceutical Services
As Director Scientific Affairs & Technical Solutions, Glass Systems, Dr. Bettine Boltres is supporting the scientific exchange between West and the pharmaceutical industry. This is complementing her work as Product Manager for Schott Pharmaceutical Tubing, where she provided scientific consulting for glass primary packaging. Since 2015 Bettine is an active member of the USP Packaging and Distribution Expert Committee as well as the ISO TC76/WG 2 on rigid container systems and WG 4 on elastomers. Additionally, in 2018 joined the European Pharmacopoeia Commission Group of Experts 16 (elastomers and plastics) and the GLS Working Party (glass).
Since January 2019 she is also a member of the PDA Board of Directors, actively supporting the role of PDA in the global pharma world. She was part of the PDA Glass Handling Task Force finalizing TR 87 and is actively involved in the Task Force working on an Annex to TR 73 addressing MDR GSPRs for PFS, is part of the Pharmacopeia Interest Group. In 2015 she published the book "When Glass Meets Pharma", which builds the bridge between glass for pharmaceutical primary packaging and drug substances.
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Rodrigue Chatton
Merck KGaA
Read BioRodrigue Chatton
Merck KGaA
Rodrigue Chatton holds an engineering degree specializing in micro-engineering and optics, followed by a MBA. During over eight years, he worked in teg development of medical device software and equipment, particularly in the realm of electrophysiology force sensing ablation catheters during his tenure at Endosense – St. Jude Medical. In 2015, Rodrigue transitioned to Merck KGaA, where he embarked on a journey shaping the future of connected electro-mechanical autoinjectors and their life-cycle management. His focus recently centers on leveraging transmitted data from autoinjectors, with a particular passion for unlocking the insights these data streams offer.
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Benjamin Cox
Team Consulting
Read BioBenjamin Cox
Team Consulting
Ben is Head of Digital Design at Team Consulting, where he works with a highly cross-functional group of designers, researchers and engineers to craft engaging and intuitive interfaces and optimise the user experience of medical devices. Ben has previously worked in a number of design consultancy roles in London and as a clinical scientist and design engineer in the NHS. He has also conducted extensive research for DePuy Johnson & Johnson. Ben has a BEng degree from Cardiff University and an MSc and PhD in Biomedical Engineering from the University of Leeds.
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Mehul Desai
Vice-President of Medical Affairs, Enable Injections
Read BioMehul Desai
Enable Injections
Mehul Desai, PharmD, MBA, serves as Vice-President of Medical Affairs at Enable Injections. His experience includes development and execution of tactical plans, driving strategic direction through key opinion leader insights, supporting clinical trial execution and contributing to business development activities across various therapeutic areas. His background includes being the Associate Medical Director for the haematology franchise at argenx. Prior to this, his experience included field medical assignments in rare disease for haematology at argenx, haematology/nephrology at Alexion, and nephrology/neurology at Mallinckrodt Pharmaceuticals. Mr. Desai holds a Bachelor’s degree in Biochemistry and Business Foundations from Indiana University (Bloomington, IN, US); a PharmD from Purdue University (West Lafayette, IN, US); and an MBA in Pharmaceutical and Healthcare Business from the University of the Sciences (Philadelphia, PA, US).
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Kevin Dolgin
Co-founder, Observia
Read BioKevin Dolgin
Observia
Kevin Dolgin is the co-founder of Observia, a French company specializing in digital patient behavioral interventions. Prioviously, he was a co-founder of Areks, as well as a number of other companies, as well as having been a Senior Principal at IMS Health. He has worked in healthcare since 1992, in over sixty countries. Kevin is also an Affiliate Professor at the University of Paris (IAE – Paris I, Panthéon-Sorbonne), where he teaches behavioral science and entrepreneurship. He has been widely published in both trade and scientific publications around the world, and has spoken at, and chaired, numerous trade conferences in healthcare. Kevin has a BA in economics from Fordham University, an MBA from INSEAD and a Master of Research from the Sorbonne. He is currently finishing his PhD at Saclay University (Paris).
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Jenny Estermann
Kymanox
Read BioJenny Estermann
Kymanox
Jenny Estermann is a consultant at Kymanox. She is a medical engineer specialising in design control. During her studies, she acquired knowledge in biology and chemistry as well as in quality management (ISO 13485), risk management (ISO 14971), usability engineering (ISO 62366) and requirements engineering. At Kymanox, she supports various combination product projects from early development to submission. Jenny has a BSc in Medical Engineering and soon an MSc in Biomedical Engineering.
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Kevin Fu
Northeastern University
Read BioKevin Fu
Northeastern University
Kevin Fu is Professor of Electrical and Computer Engineering, the Khoury College of Computer Sciences, and Bioengineering at Northeastern University, where he directs the Archimedes Center for Health Care and Medical Device Cybersecurity. Fu previously served as the United States' Acting Director of Medical Device Cybersecurity at U.S. FDA’s Center for Devices and Radiological Health. His research envisions cyberphysical systems resilient to cyberthreats: pharmaceutical manufacturing, medical devices, healthcare delivery. Fu is most known for his research on defibrillator cybersecurity. His research led to a decade of revolutionary improvements at medical device manufacturers, global regulators, and international healthcare safety standards bodies, foreseeing the risks of ransomware disrupting clinical workflow. Fu has been recognized as an IEEE Fellow, ACM Fellow, AAAS Fellow, Sloan Research Fellow, and MIT Technology Review TR35 Innovator of the Year. Fu serves on the White House's President’s Council of Advisors on Science and Technology (PCAST) Working Group on Cyber-physical Resilience. He served as the inaugural co-chair of the AAMI cybersecurity working group to create the first FDA-recognized consensus standards to improve the security of medical device manufacturing. He founded the Archimedes Center for Health Care and Medical Device Cybersecurity. Fu received his BS, MEng, and PhD from MIT.
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Paul Gardner
Head of HW and SW Development, Ypsomed AG
Read BioPaul Gardner
Ypsomed AG
Paul Gardner studied in Cambridge, UK, where he completed a B. Eng. in Electronic Engineering. Paul has over ten years’ recent experience with medical devices development and more than forty years’ experience of safety critical systems design and implementation. He is Head of HW and SW Development at Ypsomed AG who provide a complete range of technologies and services for reliable and user-friendly injection systems for self-medication and was formerly Head of the CoE eHealth and a senior consultant at Congenius AG, where he led a team providing SaMD and Cybersecurity consultancy services to pharma and medical devices manufacturing companies.
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Alexandre Habib
Simon-Kucher
Read BioAlexandre Habib
Simon-Kucher
Alexandre Habib is a Director in the Life Sciences and Healthcare Division of Simon-Kucher and a member of the company's Health Technology Competence Center. Alexandre supports pharma, medtech and pureplay digital health players to unlock better growth through winning access, pricing and commercial strategies across the world.
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Christoph Joosten, PhD
F. Hoffmann-La-Roche
Read BioChristoph Joosten, PhD
F. Hoffmann-La-Roche
Christoph Joosten obtained a Ph.D. in Chemical Engineering from Cornell University (USA) in 2003, then worked as upstream process development engineer at Bristol-Myers Squibb (USA) and at Novartis (Switzerland). From 2009 to 2012, he held a CMC regulatory affairs role at Novartis. Since 2012, he has been employed at Roche (Switzerland) where he has led or supported several market authorization applications for biopharmaceuticals, with a focus on drug delivery devices and digital solutions.
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Ashwani Kumar
Phillips Medisize
Read BioAshwani Kumar
Phillips Medisize
Ashwani Kumar is Senior Project Manager, Connected Health, at Phillips Medisize, Denmark. He has over 4 years of experience working within connected medical device development. Before Phillips-Medisize, Ashwani worked at Novo Nordisk focusing on digital technologies enabling an enhanced drug delivery system. His interest lies in connected medical devices and patient centric design.
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Richard Mathera
Irrational Labs
Read BioRichard Mathera
Irrational Labs
Richard Mathera solves real-world problems in health, tech, and finance using behavioral science. He leads Irrational Labs’ healthcare practice, overseeing behaviorally-informed collaborations with partners such as Optum, Talkspace, TytoCare, Belong Health, and One Medical. As a Senior Behavioral Scientist at Duke’s Common Cents Lab, Richard developed products and strategies that merged technology and behavioral insights. Richard holds an MPA in Advanced Policy and Economic Analysis from Columbia University’s School of International and Public Affairs and a BA in Economics from the University of Virginia. His expertise in combining behavioral economics, technology, and patient care place him at the forefront of health innovation.
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Liam Mc Morrow
Novo Nordisk
Read BioLiam Mc Morrow
Novo Nordisk
Liam Mc Morrow is the Novo Nordisk Global Launch Lead for Connected drug delivery devices for Growth Hormone. He is supporting teams across the world to deploy a connected drug delivery device device for caregivers and patients with growth hormone deficiency. Liam also has experience working with digital health companies in obesity and digital therapeutics in diabetes,. Prior to joining Novo Nordisk, Liam completed a PhD and postdoctoral research in health economics.
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John Mulcahy
S3 Connected Health
Read BioJohn Mulcahy
S3 Connected Health
John Mulcahy works with leading biopharma, healthcare providers, and medical device companies to enable the delivery care enabled by digital health from strategy through to deployment of services at scale. John is currently VP of Product at S3ConnectedHealth. Prior to this, John led HealthGenuity a Digital Health strategy consultancy, was chairman of a digital health startup, and global head of eHealth, patient care and software engineering in Merck KGaA. Altogether, John’s teams have developed and launched digital health solutions to 40 healthcare systems across 20 therapeutic areas.
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Philippe Müller
Ypsomed
Read BioPhilippe Müller
Ypsomed
Philippe Müller is Innovation and Business Development Manager at Ypsomed Delivery Systems. His responsibilities include the definition and development of new platform devices and business models, with a particular emphasis on connected device systems. As such, he has been actively involved in the design and development of YpsoMate On – the prefilled connected autoinjector. Beside that he is part of Ypsomed’s Scientific Research & Communication Program with the goal of creating new insights around self-injection devices that are relevant to both industry and academia. In this context he contributed to several articles in peer-reviewed journals. Philippe holds an MSc in Applied Economic Analysis from the University of Bern, Switzerland.
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Daniel Nickalls
TTP
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Tal Ohev-Zion
LTS Lohmann
Read BioTal Ohev-Zion
LTS Lohmann
Tal Ohev-Zion currently serves as the Director of Software at LTS, where he oversees the development of innovative software solutions. With a strong background in software management, Tal has successfully led projects through all stages, from initial design to regulatory approvals and market launch. His professional journey includes impactful leadership roles in the medical device and digital printing industries, spearheading cutting-edge technology integrations and regulatory compliance efforts. Tal's expertise is backed by a B.Sc. in Software Engineering from Afeka Engineering College and early leadership experience in the Air Force's UAV Training Department. Tal is passionate about leveraging technology to drive progress and efficiency in the software sector.
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Miriam Schulze
CEO, BAYOOMED
Read BioMiriam Schulze
BAYOOMED
Miriam Schulze is the CEO of BAYOOMED GmbH, a leading company in the field of medical software development for MedTech, LifeScience, and pharmaceutical industries. She holds a background in computer science from Dresden and has accumulated over 14 years of experience in the medical technology sector. Her expertise spans across software engineering, quality management, risk management, and technical documentation, particularly in the development of safety-critical medical software and mobile medical apps compliant with IEC 62304. Throughout her career, Miriam Schulze has been instrumental in driving innovation within BAYOOMED, focusing on digital health technologies such as Clinical Decision Support Systems (CDSS) and reimbursable digital health applications (DiGA). She is recognized for her strategic leadership in integrating cutting-edge technologies with healthcare solutions, emphasizing patient outcomes and compliance with regulatory standards. Her work includes significant contributions to the fields of Diabetes Care, Women's Health and many other therapuetic areas where she has guided the product lifecycle from conception to CE marking and FDA approval of digital health applications. Miriam Schulze is also a noted speaker at conferences, where she shares insights on the challenges and innovations in medical software development, emphasizing the importance of documentation, and regulatory compliance in creating effective medical technologies.
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Fanny Sellier
Biocorp
Read BioFanny Sellier
Biocorp
Fanny Sellier is Vice-President, Strategic Marketing & Alliance Management at Biocorp, responsible for managing the collaboration with our key partners, as a main focus. She joined the company in 2021. A graduate from the ISEG business school in Strasbourg and the IUT de Chimie (chemical sciences), Mrs Sellier worked for 7 years for Rhodia (now Solvay) in the US in Marketing, Lean enterprise and business development. She also spent 8 years with Nemera in charge of the ophthalmic products, promoting the preservative-free technology.
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Aaron Swick
Senior Staff Engineer for Research and Development, Enable Injections
Read BioAaron Swick
Enable Injections
As a Senior Staff Engineer for Research and Development at Enable Injections, Aaron Swick leads the connected healthcare program, driving collaborating with pharmaceutical partners to shape the evolution of enFuse technology. With over 15 years of experience in medical device and healthcare innovation, Mr. Swick leverages his extensive background in user and market research to steer product strategy and design. His diverse portfolio of work encompasses various healthcare technologies, including surgical instruments, diagnostics, capital equipment, consumer health and drug delivery products. He earned his MSE and BSE in Biomedical Engineering, and completed a post-graduate fellowship in medical innovation, all from the University of Michigan.
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Bernard Vrijens
AARDEX Group
Read BioBernard Vrijens
AARDEX Group
Bernard Vrijens is Chief Executive Officer at Advanced Analytical Research on Drug Exposure (AARDEX Group). He is also Professor of Biostatistics at Liege University, Belgium. Dr. Vrijens holds a PhD from the Department of Applied Mathematics and Informatics at Ghent University, Belgium. He has pioneered a research program focused on a simple but robust taxonomy of common dosing errors, along with exploring optimal measurement-guided medication management that can drive adherence and maintain long-term persistence. With over 100 peer-reviewed scientific papers and six patents to his name, Dr. Vrijens is also a founding member of the International Society for Medication Adherence (ESPACOMP) and an active member of several EU- and US-funded collaborative projects around the theme of adherence to medications.
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Thomas Watts
Senior Software Consultant, Team Consulting
Read BioThomas Watts
Team Consulting
Thomas is responsible for the design and implementation of embedded systems, smartphone apps, and cloud hosted applications. He has over 8 years experience developing medical and diagnostics software and has developed a strong understanding of the software and cybersecurity requirements and regulations across global markets.
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Anna Wilson
52North Health
Read BioAnna Wilson
52North Health
Dr Anna Wilson is Head of Operations at 52North Health, creators of Neutrocheck. Neutrocheck® is a transformative solution designed to improve the management of neutropenic sepsis (NS), the most emergency complication of cancer chemptherapy. Neutrocheck enables chemotherapy patients to be assessed for risk of NS from home for the first time. The solution is a small, portable finger-prick blood test and app that patients can use to rapidly measure two key markers (neutrophils and an infection-related marker). Combined with a telephone consultation, Neutrocheck enables safe home-triaging of NS. Anna joined the 52North team as first employee in 2020 when Neutrocheck was still a concept. As Head of Operations, Anna leads the Neutrocheck programme, QMS development and finance. Prior to 52North, Anna worked as an Innovation Consultant at Innovia Technology, working to develop breakthrough innovations with Front End Innovation teams at companies including J&J and Medtronic. And prior to that, Anna trained and qualified as a veterinary surgeon, providing a strong theoretical and practical understanding of biomedical sciences, clinical skills and medical technology.
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Andrew Zimmermann
Behavior Design Collective
Read BioAndrew Zimmermann
Behavior Design Collective
Andrew Zimmermann is the Founder and CEO of Behavior Design Collective a Behavior-First Design Firm. He is also a Behavior Science Researcher in the Stanford Behavior Design Lab. As a Behavior Design consultant, he helps healthcare companies build habit-forming products, programs, and services that support sustainable behavior change at scale. He has over a decade of experience supporting organizations as they apply leading behavior science models, methods, and frameworks to research, strategy, and product design.
Presenters
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Eric Chanie
Merck Group
Eric Chanie
Merck Group
After an electronic engineering degree in France complemented by an MBA in Marketing, Eric Chanie joined a start-up company as Research & Development director involved in gas analysis for odor measurement. The company grew from 3 people to more than 100 with a successful IPO on the Paris stock exchange. In 2007, He then joined a medical device company developing miniaturized sensors for hemodialysis and neurosurgery (biosensing, intracranial pressure measurement) in which he leads the Research and Development team. He joined Merck Serono in 2010 as Medical Device innovation manager to strengthen product portfolio and contribute to the new generation of electronic devices. He was then appointed head of innovation in the newly created “Global Business Franchise Medical Devices” and got much more involved in business development and technology scouting in the space of digital health, AI & digital therapeutics. Eric joined a research organization in 2020 and co-founded a company called Epios, providing precision care for brain disorders enabled by implantable long-term brain sensing technology. In 2023, Eric joined back Merck as the head of device engineering and core team leader for connected pens.
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Geraint Davies
F. Hoffmann-La Roche
Geraint Davies
F. Hoffmann-La Roche
Geraint is a Principal Human Factors Engineer and Behaviour Design Specialist at Roche. He has 20 years experience of Medical Device and Digital Health development, and predominantly works on connected Medical Devices, SaMD, Digital Biomarkers and Digital Therapeutics. With a background in Product Design and more recent education in the behaviour sciences, Geraint focuses on bridging the gap between the opportunities offered by digital technology and the realities of human behaviour.
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Stephanie Goebel, Dipl. Ing.
Roche/Genentech
Stephanie Goebel, Dipl. Ing.
Roche/Genentech
Stephanie Goebel Senior Regulatory Program Director PTR Devices and Combination Products at Roche / Genentech Stephanie Goebel is a medical engineer with more than 15 years of experience in medical devices and combination products. She worked as auditor, technical documentation reviewer (MDD and ISO 13485) as well as product specialist on Article 117 (MDR) for a notified body and was a member of the Team NB (European Association of Notified Bodies) working group on Article 117 (MDR). As consultant, Stephanie supported clients in their transition to the MDR and/or quality system related activities though regulatory analysis, readiness audits/checks, document creation and personalized trainings. In her new role at Roche / Genentech, Stephanie will support end-to-end management of device regulatory strategies and implementation as well as building respective inernal regulatory capabilities.
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Paul Greenhalgh
Team Consulting
Paul Greenhalgh
Team Consulting
Paul has 20 years’ experience in the development of medical devices. Since joining Team Consulting in 2001 he has worked for some of the largest pharma companies and most innovative MedTech start-ups, developing ground-breaking solutions to improve the way healthcare is delivered. His experience spans a broad range of sectors, focusing on patient use products such as inhalers, injectors and consumer medical devices, as well as professional use systems including point of care diagnostics, surgical devices, and larger critical care systems for use in a clinical setting.
As Design Director at Team, Paul has grown a group of specialists in industrial design, graphics and information, digital UX/UI and innovation – enabling them to create a coherent experience across all elements of a system and to tackle the complex human centred challenges that healthcare design brings.
Paul is driven to develop solutions which provide the level of user experience we’ve come to expect from the very best consumer products, all while working within the tight constraints of a highly regulated industry.
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Arnaud Guillet
BIOCORP
Arnaud Guillet
BIOCORP
Currently VP Business Development at BIOCORP, in charge of seeking partnerships with pharma companies or disease management platforms to customize BIOCORP’s existing range of connected devices in the fields of injection and respiratory, and exploring opportunities for on demand programs. Before joining BIOCORP, he was a consultant for a firm specialized in Healthcare. He also worked in the pharma industry for Sanofi, and in the health insurance sector at AXA. In terms of academic background, he graduated from HEC, a European business school, with a major in strategy. He also has a degree in political sciences and public affairs.
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Egmont Semmler, PhD
TÜV Süd
Egmont Semmler, PhD
TÜV Süd
Dr. Egmont Semmler joined TUV SUD in 2019 as an expert in aseptic processing, sterilization and packaging with a strong focus on non-standardized applications in the medical device field and was appointed Team Lead Sterile Manufacturing in 2022.
Before joining TUV SUD, Egmont was Director R&D Pharmaceutical Processes for Groninger & Co. GmbH driving developments in machine vision and connectivity, advanced sensor solutions and gas plasma decontamination barrier systems for isolator syringe tub transfer. His responsibilities included strategic R&D, technology scouting and quality assurance of single-use aseptic filling components. As a technical advisor he held internal and external trainings on regulatory requirements, pharmaceutical processes and best practices in the aseptic fill & finish area.
Building on an experience of more than 10 years in the regulated pharma & life science sector he held different positions in technology transfer and science-to-business operations with a strong focus on medical and pharmaceutical applications, which also resulted in several patents.
He earned a PhD in Plasma Technology and holds a diploma in Electrical Engineering from Ruhr University Bochum.
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Iain Simpson, PhD, MBA
Phillips Medisize
Iain Simpson, PhD, MBA
Phillips Medisize
Iain Simpson is a Commercial Director at Phillips-Medisize, where he is part of a global team developing industry leading solutions and platforms for drug delivery, digital medicine and connected health. He has more than 30-years’ experience in multi-disciplinary technology and product development; the last 20 years have in healthcare and increasingly focused on the use of devices and digital technologies to create product differentiation, improve patient engagement and better measure clinical outcomes in real world settings.
He has a degree and PhD in physics both from University College London and an MBE in Technology Management from the Open University. He has published and presented at conferences on drug delivery, digital biomarkers, healthcare technology and technology licensing. He is an associate lecturer at the University of Cambridge in Bioscience Enterprise.
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Paul Upham
Roche/Genentech
Paul Upham
Roche/Genentech
Paul is the Head of Smart Devices at Roche / Genentech. Paul has 20+ years of experience in medical device R&D, strategic marketing, product management, clinical research, and medical informatics.
Prior to Roche / Genentech, Paul was with Becton Dickinson(BD), as Worldwide Director of Strategic Marketing in their Pharmaceutical Systems business.
Paul was also the head of Product at WellDoc, Inc., where he led the product management activities for WellDoc’s portfolio of mobile health solutions. He was responsible for WellDoc’s landmark BlueStar™ product, a class II medical device and the world’s first reimbursed, prescription-only software for diabetes.
Paul’s prior experience includes 10 years in BD’s Diabetes Care business. Paul was responsible for the award-winning BD InterActiv® Diabetes Software, and was a member of the BD / Medtronic team that launched ParadigmLink®, the world’s first wireless blood glucose meter.
Paul holds four issued patents in medical software and drug delivery devices and has multiple patent applications. He is also an author of numerous peer-reviewed articles in medical informatics and diabetes. His education includes undergraduate studies in cognitive science and graduate work in health informatics and finance at the University of Minnesota and New York University.
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Andrei Yosef, PhD
LTS
Andrei Yosef, PhD
LTS
Dr. Yosef ist the General Manager of LTS.
Leading expert in drug delivery device market and high end technologies. Dr Yosef applies his industry knowledge in both technology and business to steer forward Eitan Medical to develop and commercialize novel drug delivery device. Dr Yosef founded several startup companies in the field prior to him joining Q Core Medical. He served in several executive positions at Q Core for a decade, before taking the helm at pharmaceutical solutions of Eitan Medical including Sorrel’s wearable injectors products. Dr Yosef holds a PhD in Biomedical Engineering and an MA in Mechanical Engineering, both from the Technion – Israel Institute of technology.
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