2023 PDA Smart Devices and Digital Solutions Workshop

Gothenburg, Sweden
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Program Highlights

Join this one-day interactive workshop preluding the 2023 PDA Universe of Pre-Filled Syringes and Injection Devices Conference, and join the discussion with industry experts on smart devices and digital solutions!

Dear Colleagues,

The past 15 years have seen a rapid increase in the introduction of drug-device combination products driven by a move towards more self-medication. This has included the adoption of a relatively small number of electronic drug delivery devices but with the arrival of low cost wireless connectivity, there is an opportunity to accelerate the adoption of new technology and introduce digital services that can provide better patient support, either by enabling patients to take more control of their medication and disease management to provide remote access to healthcare support. The Covid situation has impacted us in many ways over the past 18 months and for medication and disease management, it has demonstrated both the need and the potential for telemedicine and remote monitoring.

A key aspect in improving disease management is the need to address medication non-adherence – it is estimated that for many medications, adherence is less than 50%. Connected drug delivery devices provide a particular opportunity to gather medication use data in near real time that can be used to provide better patient support and also to capture the data into healthcare management systems. Medication non-adherence is principally a behavioral issue that requires appropriate interventions. The combination of behavioral science and connected health can offer a promising route forward whether to provide better, actionable data to support current interventions such as patent support programs or to develop digital interventions such as patient facing apps.

The aim of this workshop is to facilitate a practical and hands-on approach to the development of digital combination products with the active participation of attendees and the sharing of practical experience. We will base the workshop on a case study that focuses on a digitally enable patient support program and look at the perspectives of the design and introduction of behavioral interventions, the commercial opportunity for digital health and the challenges that need to be address in areas such as cyber security.

We look forward to welcoming you to the workshop!

The Workshop Lead

Iain Simpson, Phillips Medisize


  • Iain Simpson, Phillips Medisize  - Workshop Lead
  • Geraint Davies, Roche
  • Arnaud Guillet, Biocorp
  • Paul Upham, Roche/Genentech
  • Niamh Ward, Atlantis Health
  • Falk Klar, PDA Europe
  • Caroline Lynar, Manager Programs & Events, PDA Europe

Standard Pricing

Standard Member Price


GovernmentMember Only


Health AuthorityMember Only


Early Career ProfessionalMember Only


StudentMember Only


AcademicMember Only




See Qualifying Criteria for Member Types.


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

Monday, 16 October 2023

Morning Coffee


Welcome and Introduction
Introduction to the Workshop Format and the Case Study: Designing a Digitally Enabled Support Program Using Smart Devices and Digital Solutions for The Benefit of Stakeholders
Iain Simpson, Phillips Medisize


Topic 1: The Patient

The Behavioral Challenge of Medication Adherence
Debbie Cooke, Atlantis Health

  • The nature and determinants of medication non-adherence
  • Why most apps fail to change adherence
  • Using behavior change theory to design targeted adherence interventions

The Theory of Behavioral Change Interventions
Patient Support Programs in Practice
Niamh Ward, Atlantis Health

  • Implementing personalized solutions to change behavior
  • Introduction to Patient Support Programmes (PSPs)
  • PSPs and the integration of SMART devices

Workshop on the Case Study: About Patient Engagement
Following topics will be evaluated with inputs from the audience
  • Use a behavior framework to understand adherence challenges
  • Review BCT opportunities for identified behavior challenges
  • Consider how to incorporate the Behavior Change Technique into a digital PSP

Iain Simpson, Phillips Medisize
Geraint Davies, Roche

Topic 2: The Opportunity

Value Creation with Smart Devices and Digital Solutions – An example with connected injectors in the field of rare diseases
Eric Dessertenne, Biocorp and Sönke Johannsen, Novo Nordisk

Workshop on the Case Study: About the Opportunity
Following topics will be evaluated with inputs from the audience
  • How to identify the stakeholders and relevant value drivers?
  • How to link patient engagement and commercial success?
  • What are the expected impacts and return on investment?

Iain Simpson, Phillips Medisize
Geraint Davies, Roche

Lunch Break

Topic 3: The Challenges

Regulatory Challenges for Smart Drug-Delivery Devices under the MDR
Juan Carriquiry, Beyond Conception

  1. What are some of the unique regulatory challenges for smart drug-delivery devices?
  2. How has the change from MDD to MDR impacted smart drug-delivery devices?
  3. What are some practical recommendations for teams that are hoping to launch a smart solution?

Workshop on the Case Study: Regulatory and Compliance Challenges
Following topics will be evaluated with inputs from the audience
  1. What are some of the unique considerations for hardware and softwaresystems under the MDR?
  2. How has the change from MDD to MDR impacted smart drug delivery device solutions?
  3. Which features and functionality of the system drive significant regulatory and compliance challenges?
    a. Regulatory identity of the system components (hardware, apps, cloud analytics, portals)
    b. Data privacy and cybersecurity laws and regulations
    c. Differences across countries and between the EU and the US?

Paul Upham, Roche/Genentech
Arnaud Guillet, Biocorp

Panel Discussion on Global Implementation Consideration
Moderator: Iain Simpson, Phillips Medisize

Workshop on the Case Study: Global Implementation Consideration
Following topics will be evaluated with inputs from the audience
  • Mapping internal stakeholders - a participant activity
    • Create a list of stakeholders with key roles and what actions do you expect from them?
    • Localization and Customaization
    • Training and Customer Support
    • Legal and Compliance Approvals
    • Customer Engagement Strategy

Paul Upham, Roche/Genentech
Arnaud Guillet, Biocorp


Coffee Break

Key Take-Aways and Learnings from Discussions - Final Q&A and Audience Feedback


Farewell & End of Workshop
Iain Simpson, Phillips Medisize


Agenda is subject to change without notice,

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.

The Swedish Exhibition & Congress Centre - Gothia Towers Hotel

Mässans Gata 24
Gothenburg, Sweden , Sweden

PDA recommends the reservation at the following hotel

Gothia Towers Hotel
Mässans Gata 24
41294 Gothenburg,

PDA Europe has reserved a limited number of rooms until the 15th August 2023.

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

For group requests over 6 bedrooms please send an email to [email protected]

Attn. Emelie Sandell

Just a 20-minute walk from the hotel you will find The Garden Society of Gothenburg - one of Europe's best-preserved 19th-century parks. At the other end of town you will find the Botanical Garden, a world-class botanical garden with over 16,000 species to admire.

How to Get Here
By Air Airport buses travel to and from Landvetter Airport (appox. 20 min. journey) stopping at Korsvägen/Svenska Mässan. They run directly between these stops.
By Car E6 / E20 (from north) and road 45 (from Karlstad): On arrival at Gothenburg, turn off at the sign “Mässan Scandinavium Liseberg”. Take the first exit on the left, turn right onto Örgrytevägen and then take the next exit right towards Svenska Mässan. E6 / E20 (from south) and road 40 (from Borås): On arrival at Gothenburg, turn off at the sign “Mässan Scandinavium Liseberg”. Then take the second exit right towards the hotel.