PDA Miniverse: Medical Devices, Combination Products and Connected Health Conference 2025
Integrated Innovation: Designing the Future of Drug Delivery
Educational Sessions, Networking Opportunities, Exhibit Area
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Introducing the PDA Miniverse
The PDA Miniverse: Medical Devices, Combination Products and Connected Health Conference 2025 is coming to Indianapolis, IN on 25-26 June 2025. This high-level gathering is a mid-year event in the U.S. in anticipation of the annual PDA Universe of Pre-Filled Syringes and Injection Devices conference in Vienna this October. The Miniverse will offer the same experience that delegates knowledge and love with great speakers, relevant insights, fantastic networking and top-notch exhibition to mingle -- just on a smaller scale.
Are you asking the right questions?
How do you know if you have mastered the nuances of health tech that is faced with a variety and complexity of combination products and pharmaceutical regulatory systems?
How do you know if you are delivering connected systems that protect your patients’ data security to ensure privacy and prevent misuse?
Let’s face it, innovation in healthcare is as exciting as it is risky. And we’ve got you covered on both fronts. High-level expertise and forward-looking guidance on combination products and connected healthcare is on its way to Indiana, an
emerging hub for breakthrough pharma innovation.
A roadmap to successful patient care needs a comprehensive and systematic approach to connected health at a scale that considers 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. Also,
as more injectable drugs will be administered at patients’ homes, the opportunity for the industry to facilitate and improve processes is manifold.
Here's What's at Stake
- Connected solutions have the potential to empower patients to manage their diagnosis and treatments more effectively.
- Connected healthcare solutions can reduce the burden for healthcare professionals, resulting in increased efficiency.
- The need for a comprehensive and systematic approach to combination products that accounts for the entire healthcare ecosystem.
- The shift of healthcare from hospital to home opens the need for solutions that improve patient outcomes and have a positive impact on the environmental footprint.
The PDA Miniverse Promise
At the core of connected solutions is the need for open dialogue and trusted exchange of ideas and innovations among peers at the top of their game. The PDA Miniverse Medical Devices, Combination Products and Connected Health Conference 2025 is a premium event that brings together industry leaders, innovators, and experts to explore the future of combination products and connected health technologies.
In an intimate setting, we have curated top thought leadership presentations, a group of impressive solution providers, and an efficient, highly networked experience designed to maximize your time and investment. Expect the unexpected to inspire and stimulate cutting-edge breakthroughs. As a community with a shared purpose, we will address industry trends that are shaping the health tech landscape with a focus on combination products, patient centricity, regulatory topics, and large volume systems.
An open discussion on the latest advancements and regulatory updates sets the scene for meaningful explorations of connected healthcare and developments.
Register Today!
Who should attend? Pharmas and biotechs of all sizes, primary container and injection device companies, CDMO's, equipment manufacturers, consultancies/service providers and all professionals who value vital thought leadership and innovative solutions.
If you want to be at the forefront of the revolution that is transforming the healthcare industry, attend this event that is driving the future of healthcare innovation.
Agenda
Discover What's Happening Each Day
EDT Daylight Time (UTC -4:00)
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PDA Site Visit to Stevanato Group’s New Fishers Facility (Free for PDA Miniverse Attendees – Limited Seats Available and Advance Sign Up Required)
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PDA Night at the Ballpark (Ticket Required)
EDT Daylight Time (UTC -4:00)
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Continental Breakfast
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Registration Open
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P1: Connected Health: Mindset Shifts, Market Trends, and the Future of Combination Products (Griffin Hall)
Griffin Hall
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Moderator:
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Welcome Remarks
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President & CEO:
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Local Welcome Speaker:
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Co-Chair:
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Co-Chair:
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Mindset Shifts for Developing Medical Devices in Connected Health
In this session, Luke Wellington draws on personal experience and professional insight to explore how the convergence of pharmaceutical rigor and technological agility can transform patient care. Beginning with a powerful story about his grandfather’s experience with insulin, Luke sets the stage for a conversation about how connected health solutions could have changed the outcome—and how they still can for millions today. Attendees will gain a fresh perspective on the mindset shifts required to bring medical devices and digital health tools to market. From the long-term stability focus of pharma to the rapid iteration cycles of tech, Luke will highlight how these contrasting approaches can be harmonized to deliver better user experiences and health outcomes. -
The Future of Injectable Drug Delivery Devices: What is Likely to Emerge and Why
This presentation will briefly review key drug delivery innovation history, define the device technologies likely to emerge (and not emerge), and the key elements that help enable prediction of new drug delivery device evolution and market success. -
Q&A
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Networking Break in the Exhibit Hall
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Poster Presentations in the Exhibit Hall
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(#1) Inspection Beyond the Visible - Pulsed X-ray Technology for Medical Devices and Pharmaceutical Products
Modern medical and pharmaceutical products often come in highly diverse and complex packaging, presenting significant challenges for quality inspection. Many critical features—such as correct assembly or the presence of key components—are not detectable with the naked eye or standard camera systems, especially when dealing with opaque materials. Pulsed X-ray technology offers a powerful alternative, enabling non-destructive inspection of even the most challenging products. By emitting brief, precisely timed X-ray pulses, this method minimizes radiation exposure while delivering highly detailed internal images. It allows manufacturers to detect hidden defects and verify product integrity without slowing down high-speed production lines. In contrast to continuously active scanner systems, the pulsed approach is energy-efficient, easier to maintain, and particularly well-suited for inspecting sensitive pharmaceutical containers. This makes it a valuable tool for improving safety and compliance in modern pharmaceutical manufacturing. -
(#2) NeoFlex™ Worldwide: How Datwyler's Innovative Plunger Portfolio Addresses the Latest Trends in Drug Delivery
Large-volume auto-injectors and wearable devices exceeding 2.25mL play a crucial role in the transition from hospital-based intravenous (IV) treatments to self-administrated drug delivery via subcutaneous (SC) injection. These devices are especially pivotal in the treatment of oncological, immunologic, and neurodegenerative diseases, where they are often tasked with delivering high-viscosity and delicate biologics to patients in need.
Ensuring the highest standards of quality and purity in elastomers, along with flawless functional performances, is imperative to guarantee the reliability of administration and patient safety. A balance of functionality, machinability, and product safety are essential for the entire device system to function. In this presentation, we will delve into the technical hurdles encountered in designing and manufacturing larger coated plungers for pre-filled syringe (PFS) and cartridge containers intended for device integration.
We will showcase our journey from conceptualization to commercialization of these coated plungers, as well as evaluating their performance throughout the entire value chain to the patient. Additionally, we will underscore the significance of fostering an open collaboration with the container manufacturer and among the additional stakeholders involved in the development of the final combination product. -
(#3) CSR, ESG, and Sustainable Strategies Enhancing Growth in Combination Products: What Can we Learn From the World Class Amongst us and why Does it Matter?
Time Magazine recently released its 2024 list of the Most Sustainable companies. There are several combination product manufacturers on the list and the industry can learn from these leading companies. I will display the Triple Bottom Line strategic approach to balance people, the planet, and profit to sustainably grow. Novartis, a Mordor Intelligence top 5 Drug Combination Product Manufacturer, is #17 on Time’s list and is in the top 3% on Sustainalytics’ Environmental, Social, and Governance (ESG) ranking. I will list how Novartis and other combination product manufacturers have added these important programs to their strategies. Many pharmaceutical companies are consistently challenged with price pressure for their products and are called upon to look for ways to make their products more accessible globally. Community and industry research foundation support can help a company’s social reputation. Employee benefits packages, DEI programs in talent acquisition and career development, and professional development all drive retention and lead to innovations. I will touch on these and will provide examples of environmental initiatives the best-in-class companies focused on. The poster will also show how these can impact all companies in our industry if embraced, including sustainable growth, leading to reduced impact on the planet. -
(#4) Biobased and Renewable Polymer Grades for Drug Delivery
Bio-based and renewable grades of polymer resins are critical for meeting sustainability targets. Proper selection, characterization, and qualification in combination drug delivery/medical device applications allows for improved sustainability and greater supply chain flexibility. This poster examines a case study related to material characterization and effective strategies for comparative leachables and extractables studies.-
Poster Presenter:
-
-
(#5) Navigating the Regulatory Landscape for Connected Combination Products: Challenges, Gaps, and Forward Strategies
As medical devices become increasingly integrated with digital technologies and drug components, the regulatory landscape for connected combination products presents new complexities. This poster highlights regulatory challenges in aligning device, drug, and software requirements for connected autoinjectors, smart inhalers, and wearable injectors. It explores the intersection of 21 CFR Part 820, 21 CFR Part 4, and evolving FDA guidance on software as a medical device (SaMD). Through case-based discussion and a regulatory gap analysis, we propose a framework for early regulatory planning, risk management, and submission readiness. The role of human factors, cybersecurity, and postmarket surveillance is also examined. Practical recommendations are shared to support RA professionals in preparing combination product submissions that involve digital or connected health components.-
Poster Presenter:
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P2: Ensuring Success in Drug-Device Development: Overcoming Design Challenges and Third-Party Risks (Griffin Hall)
Griffin Hall
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Moderator:
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Risk Mitigation Strategies for Management of Third-Party Resources
In this presentation, I will discuss the critical importance of mitigating risks when using third-party sources and suppliers for pharmaceutical development programs, specifically drug-device combination products. Given the complexities when managing multiple 3rd parties, that may include professional services firms, CDMOs, and other suppliers, there are significant considerations and risks that need to be managed. We will explore the key areas where risks can arise, including quality control, regulatory compliance, supply chain disruptions, program management, and cybersecurity threats. The presentation will outline effective strategies for mitigating these risks, such as comprehensive due diligence, continuous monitoring, and establishing robust contractual agreements. Additionally, I will share real-world case studies that highlight successful risk mitigation efforts and provide valuable lessons learned. Appropriate risk mitigation leads to streamlined programs, cost reduction for Sponsors, and acceleration of projects to ensure products get into the hands of patients faster. Finally, we will look at future trends and innovations in third-party risk management, including the use of advanced analytics and AI to enhance risk assessment and monitoring. By the end of this talk, participants will have a deeper understanding of how to effectively manage third-party risks and ensure the success of their development programs.-
Presenter:
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From License to Operate to License to Collaborate: Getting Drug and Device to Work Together at Last for Combination Product Success
Despite over a decade of combination product growth, many drug-device teams remain misaligned resulting in costly delays, regulatory friction, and preventable inefficiencies. This session explores the recurring mistakes that persist across development, supplier oversight, and global regulatory engagement, even among mature organizations. Rather than focusing on technical failures, this talk highlights the structural and cross-functional missteps that quietly undermine combination product programs. Drawing from real-world examples and industry best practices, the session presents three key areas where alignment is needed: • Internal coordination between drug and device teams, where risk models, documentation timelines, and ownership often conflict • External alignment with partners and suppliers, where expectations around design control, testing, and usability are frequently misunderstood or misapplied • Global regulatory strategy, where regional inconsistencies and lack of QMS convergence continue to cause duplicate work and confusion Attendees will walk away with ideas for improving coordination, reducing waste, and enabling combination product teams to operate with more confidence, not just compliance. -
Q&A
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Networking Lunch in the Exhibit Hall
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Poster Presentations in the Exhibit Hall
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(#1) Inspection Beyond the Visible - Pulsed X-ray Technology for Medical Devices and Pharmaceutical Products
Modern medical and pharmaceutical products often come in highly diverse and complex packaging, presenting significant challenges for quality inspection. Many critical features—such as correct assembly or the presence of key components—are not detectable with the naked eye or standard camera systems, especially when dealing with opaque materials. Pulsed X-ray technology offers a powerful alternative, enabling non-destructive inspection of even the most challenging products. By emitting brief, precisely timed X-ray pulses, this method minimizes radiation exposure while delivering highly detailed internal images. It allows manufacturers to detect hidden defects and verify product integrity without slowing down high-speed production lines. In contrast to continuously active scanner systems, the pulsed approach is energy-efficient, easier to maintain, and particularly well-suited for inspecting sensitive pharmaceutical containers. This makes it a valuable tool for improving safety and compliance in modern pharmaceutical manufacturing. -
(#2) NeoFlex™ Worldwide: How Datwyler's Innovative Plunger Portfolio Addresses the Latest Trends in Drug Delivery
Large-volume auto-injectors and wearable devices exceeding 2.25mL play a crucial role in the transition from hospital-based intravenous (IV) treatments to self-administrated drug delivery via subcutaneous (SC) injection. These devices are especially pivotal in the treatment of oncological, immunologic, and neurodegenerative diseases, where they are often tasked with delivering high-viscosity and delicate biologics to patients in need.
Ensuring the highest standards of quality and purity in elastomers, along with flawless functional performances, is imperative to guarantee the reliability of administration and patient safety. A balance of functionality, machinability, and product safety are essential for the entire device system to function. In this presentation, we will delve into the technical hurdles encountered in designing and manufacturing larger coated plungers for pre-filled syringe (PFS) and cartridge containers intended for device integration.
We will showcase our journey from conceptualization to commercialization of these coated plungers, as well as evaluating their performance throughout the entire value chain to the patient. Additionally, we will underscore the significance of fostering an open collaboration with the container manufacturer and among the additional stakeholders involved in the development of the final combination product. -
(#3) CSR, ESG, and Sustainable Strategies Enhancing Growth in Combination Products: What Can we Learn From the World Class Amongst us and why Does it Matter?
Time Magazine recently released its 2024 list of the Most Sustainable companies. There are several combination product manufacturers on the list and the industry can learn from these leading companies. I will display the Triple Bottom Line strategic approach to balance people, the planet, and profit to sustainably grow. Novartis, a Mordor Intelligence top 5 Drug Combination Product Manufacturer, is #17 on Time’s list and is in the top 3% on Sustainalytics’ Environmental, Social, and Governance (ESG) ranking. I will list how Novartis and other combination product manufacturers have added these important programs to their strategies. Many pharmaceutical companies are consistently challenged with price pressure for their products and are called upon to look for ways to make their products more accessible globally. Community and industry research foundation support can help a company’s social reputation. Employee benefits packages, DEI programs in talent acquisition and career development, and professional development all drive retention and lead to innovations. I will touch on these and will provide examples of environmental initiatives the best-in-class companies focused on. The poster will also show how these can impact all companies in our industry if embraced, including sustainable growth, leading to reduced impact on the planet. -
(#4) Biobased and Renewable Polymer Grades for Drug Delivery
Bio-based and renewable grades of polymer resins are critical for meeting sustainability targets. Proper selection, characterization, and qualification in combination drug delivery/medical device applications allows for improved sustainability and greater supply chain flexibility. This poster examines a case study related to material characterization and effective strategies for comparative leachables and extractables studies.-
Poster Presenter:
-
-
(#5) Navigating the Regulatory Landscape for Connected Combination Products: Challenges, Gaps, and Forward Strategies
As medical devices become increasingly integrated with digital technologies and drug components, the regulatory landscape for connected combination products presents new complexities. This poster highlights regulatory challenges in aligning device, drug, and software requirements for connected autoinjectors, smart inhalers, and wearable injectors. It explores the intersection of 21 CFR Part 820, 21 CFR Part 4, and evolving FDA guidance on software as a medical device (SaMD). Through case-based discussion and a regulatory gap analysis, we propose a framework for early regulatory planning, risk management, and submission readiness. The role of human factors, cybersecurity, and postmarket surveillance is also examined. Practical recommendations are shared to support RA professionals in preparing combination product submissions that involve digital or connected health components.-
Poster Presenter:
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P3: Smart Devices, Smarter Outcomes: Digital Health in Drug Delivery (Griffin Hall)
Griffin Hall
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Moderator:
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Why Healthcare Cybersecurity is Hard
In 2001, Professor Ross Anderson published a paper titled “Why Information Security is Hard”. In that paper, Prof. Anderson describes the market forces that make information security hard. This talk will explore the healthcare version of Prof. Anderson’s key economic insights that make healthcare security hard and what we can do about it. -
Living Digital Models for Platform Device Development, Faster Speed to Market, and Lifecycle Product Management
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Behavior Driven Digital Health – Redefining the Patient Experience Through Smarter Digital Support
Digital patient support is increasingly recognized and adopted as an important tool to help patients living with chronic conditions. Designing effective digital patient support requires a rich understanding of user capabilities, motivations, and behavior. This talk will introduce a behavior design framework to optimize combination product use and explore how a personalized approach can redefine the patient experience. -
Q&A
-
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Networking Break in the Exhibit Hall
-
Poster Presentations in the Exhibit Hall
-
(#1) NeoFlex™ Worldwide: How Datwyler's Innovative Plunger Portfolio Addresses the Latest Trends in Drug Delivery
Large-volume auto-injectors and wearable devices exceeding 2.25mL play a crucial role in the transition from hospital-based intravenous (IV) treatments to self-administrated drug delivery via subcutaneous (SC) injection. These devices are especially pivotal in the treatment of oncological, immunologic, and neurodegenerative diseases, where they are often tasked with delivering high-viscosity and delicate biologics to patients in need.
Ensuring the highest standards of quality and purity in elastomers, along with flawless functional performances, is imperative to guarantee the reliability of administration and patient safety. A balance of functionality, machinability, and product safety are essential for the entire device system to function. In this presentation, we will delve into the technical hurdles encountered in designing and manufacturing larger coated plungers for pre-filled syringe (PFS) and cartridge containers intended for device integration.
We will showcase our journey from conceptualization to commercialization of these coated plungers, as well as evaluating their performance throughout the entire value chain to the patient. Additionally, we will underscore the significance of fostering an open collaboration with the container manufacturer and among the additional stakeholders involved in the development of the final combination product. -
(#2) Inspection Beyond the Visible - Pulsed X-ray Technology for Medical Devices and Pharmaceutical Products
Modern medical and pharmaceutical products often come in highly diverse and complex packaging, presenting significant challenges for quality inspection. Many critical features—such as correct assembly or the presence of key components—are not detectable with the naked eye or standard camera systems, especially when dealing with opaque materials. Pulsed X-ray technology offers a powerful alternative, enabling non-destructive inspection of even the most challenging products. By emitting brief, precisely timed X-ray pulses, this method minimizes radiation exposure while delivering highly detailed internal images. It allows manufacturers to detect hidden defects and verify product integrity without slowing down high-speed production lines. In contrast to continuously active scanner systems, the pulsed approach is energy-efficient, easier to maintain, and particularly well-suited for inspecting sensitive pharmaceutical containers. This makes it a valuable tool for improving safety and compliance in modern pharmaceutical manufacturing. -
(#3) CSR, ESG, and Sustainable Strategies Enhancing Growth in Combination Products: What Can we Learn From the World Class Amongst us and why Does it Matter?
Time Magazine recently released its 2024 list of the Most Sustainable companies. There are several combination product manufacturers on the list and the industry can learn from these leading companies. I will display the Triple Bottom Line strategic approach to balance people, the planet, and profit to sustainably grow. Novartis, a Mordor Intelligence top 5 Drug Combination Product Manufacturer, is #17 on Time’s list and is in the top 3% on Sustainalytics’ Environmental, Social, and Governance (ESG) ranking. I will list how Novartis and other combination product manufacturers have added these important programs to their strategies. Many pharmaceutical companies are consistently challenged with price pressure for their products and are called upon to look for ways to make their products more accessible globally. Community and industry research foundation support can help a company’s social reputation. Employee benefits packages, DEI programs in talent acquisition and career development, and professional development all drive retention and lead to innovations. I will touch on these and will provide examples of environmental initiatives the best-in-class companies focused on. The poster will also show how these can impact all companies in our industry if embraced, including sustainable growth, leading to reduced impact on the planet. -
(#4) Biobased and Renewable Polymer Grades for Drug Delivery
Bio-based and renewable grades of polymer resins are critical for meeting sustainability targets. Proper selection, characterization, and qualification in combination drug delivery/medical device applications allows for improved sustainability and greater supply chain flexibility. This poster examines a case study related to material characterization and effective strategies for comparative leachables and extractables studies.-
Poster Presenter:
-
-
(#5) Navigating the Regulatory Landscape for Connected Combination Products: Challenges, Gaps, and Forward Strategies
As medical devices become increasingly integrated with digital technologies and drug components, the regulatory landscape for connected combination products presents new complexities. This poster highlights regulatory challenges in aligning device, drug, and software requirements for connected autoinjectors, smart inhalers, and wearable injectors. It explores the intersection of 21 CFR Part 820, 21 CFR Part 4, and evolving FDA guidance on software as a medical device (SaMD). Through case-based discussion and a regulatory gap analysis, we propose a framework for early regulatory planning, risk management, and submission readiness. The role of human factors, cybersecurity, and postmarket surveillance is also examined. Practical recommendations are shared to support RA professionals in preparing combination product submissions that involve digital or connected health components.-
Poster Presenter:
-
-
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P4: Enhancing Patient-Centricity, Sustainability, and Usability (Griffin Hall)
Griffin Hall
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Moderator:
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Approach and Considerations in Developing and Managing a Platform
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A Study of Factors Impacting User Perceptions of Reusable and Disposable Autoinjectors
This study examined the different factors that may influence patient and health care professional perceptions on the ease of use and overall preferability of different autoinjector types (single-use disposable, reusable electro-mechanical and reusable mechanical).
Factors examined included reusability, environmental impact, ease of use, number of steps, cost and connectivity amongst others.
The study comprised 52 participants, including experienced and naïve adult and adolescent users, as well as healthcare professionals across 3 different areas of the US, intending to cover a wide spectrum of potential viewpoints.
The data gathered provides insight into whether and how perceptions of the relative importance of these different factors and preferences change with increased exposure to information:- When provided with specifications and descriptions of devices only
- When provided with samples that could be looked at and touched, but not used
- Following use experience with each device
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Connected Devices and Digital Health: Impact on Patient Adherence and Experience
In response to the COVID-19 pandemic, home-based patient care and connectivity have become increasingly important. This transition aims to engage users more effectively through the provision of data that benefits manufacturers, healthcare providers, and patients. This trend is particularly pertinent for self-administration and the integration of connectivity in injectable devices. This presentation will explore the various benefits and challenges of incorporating connectivity into injectable devices. Topics will include how connected solutions can improve patient adherence and meet user requirements, the advantages and opportunities presented by this integration, as well as the technical and usability challenges associated with integrating connected technology into existing injectable devices, with a particular focus on understanding the implications of connected technology and human factors.
Attendees will gain insights into the upcoming trends in connected injectable devices and understand the challenges related to usability of these advanced products, ultimately recognizing their potential to significantly improve patient health experiences.
This presentation is tailored for human factors practitioners, employees of manufacturers with connected devices, regulatory personnel on connected devices, digital health representatives, and system engineers. Join us to advance your knowledge and stay at the forefront of innovation in connected injectable devices. -
Q&A
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Networking Reception in the Exhibit Hall
EDT Daylight Time (UTC -4:00)
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Continental Breakfast
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Registration Open
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P5: Regulatory Strategy and Market Entry for Combination Products (Griffin Hall)
Griffin Hall
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Moderator:
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Regulatory Approaches to Utilizing Prior Knowledge for Combination Products
This presentation covers strategies and considerations for utilizing prior knowledge for a combination product. There will be case studies of the ideal use of prior knowledge, a retrospective case study demonstrating challenges and suggested best practices. -
Launching a Biosimilar in an On-Body Injector: Lessons from a Device Manufacturer
In 2024, the launch of Udenyca™ marked a significant milestone in the biosimilar landscape as the first biosimilar drug delivered via an on-body electromechanical pump. This presentation will explore the possible advancements allowed by the FDA, in the design and functionality of an on-body device to be used for delivery of a biosimilar compared to its originator. Key enhancements include a reduced injection time and the introduction of an auto-deploying needle, replacing the traditional healthcare professional-inserted cannula, thereby streamlining the patient experience. Attendees will learn how biosimilar companies are investing in cutting-edge delivery technologies that rival those of innovator products. This leap forward not only enhances patient convenience but also demonstrates a proactive approach to differentiation in the competitive biosimilar market. For instance, a 5mL drug traditionally administered in the innovator product through multiple injections could now be delivered in the biosimilar combination product via a single on-body device, showcasing the potential for innovative delivery methods that outpace those of originators. Join us to understand the collaboration between our team, our pharmaceutical partner, and the FDA to elevate the patient experience with a biosimilar combination product, reinforcing the importance of innovation in the evolving landscape of drug delivery. -
Q&A
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Networking Break in the Exhibit Hall
-
Poster Presentations in the Exhibit Hall
-
(#1) Inspection Beyond the Visible - Pulsed X-ray Technology for Medical Devices and Pharmaceutical Products
Modern medical and pharmaceutical products often come in highly diverse and complex packaging, presenting significant challenges for quality inspection. Many critical features—such as correct assembly or the presence of key components—are not detectable with the naked eye or standard camera systems, especially when dealing with opaque materials. Pulsed X-ray technology offers a powerful alternative, enabling non-destructive inspection of even the most challenging products. By emitting brief, precisely timed X-ray pulses, this method minimizes radiation exposure while delivering highly detailed internal images. It allows manufacturers to detect hidden defects and verify product integrity without slowing down high-speed production lines. In contrast to continuously active scanner systems, the pulsed approach is energy-efficient, easier to maintain, and particularly well-suited for inspecting sensitive pharmaceutical containers. This makes it a valuable tool for improving safety and compliance in modern pharmaceutical manufacturing. -
(#2) NeoFlex™ Worldwide: How Datwyler's Innovative Plunger Portfolio Addresses the Latest Trends in Drug Delivery
Large-volume auto-injectors and wearable devices exceeding 2.25mL play a crucial role in the transition from hospital-based intravenous (IV) treatments to self-administrated drug delivery via subcutaneous (SC) injection. These devices are especially pivotal in the treatment of oncological, immunologic, and neurodegenerative diseases, where they are often tasked with delivering high-viscosity and delicate biologics to patients in need.
Ensuring the highest standards of quality and purity in elastomers, along with flawless functional performances, is imperative to guarantee the reliability of administration and patient safety. A balance of functionality, machinability, and product safety are essential for the entire device system to function. In this presentation, we will delve into the technical hurdles encountered in designing and manufacturing larger coated plungers for pre-filled syringe (PFS) and cartridge containers intended for device integration.
We will showcase our journey from conceptualization to commercialization of these coated plungers, as well as evaluating their performance throughout the entire value chain to the patient. Additionally, we will underscore the significance of fostering an open collaboration with the container manufacturer and among the additional stakeholders involved in the development of the final combination product. -
(#3) CSR, ESG, and Sustainable Strategies Enhancing Growth in Combination Products: What Can we Learn From the World Class Amongst us and why Does it Matter?
Time Magazine recently released its 2024 list of the Most Sustainable companies. There are several combination product manufacturers on the list and the industry can learn from these leading companies. I will display the Triple Bottom Line strategic approach to balance people, the planet, and profit to sustainably grow. Novartis, a Mordor Intelligence top 5 Drug Combination Product Manufacturer, is #17 on Time’s list and is in the top 3% on Sustainalytics’ Environmental, Social, and Governance (ESG) ranking. I will list how Novartis and other combination product manufacturers have added these important programs to their strategies. Many pharmaceutical companies are consistently challenged with price pressure for their products and are called upon to look for ways to make their products more accessible globally. Community and industry research foundation support can help a company’s social reputation. Employee benefits packages, DEI programs in talent acquisition and career development, and professional development all drive retention and lead to innovations. I will touch on these and will provide examples of environmental initiatives the best-in-class companies focused on. The poster will also show how these can impact all companies in our industry if embraced, including sustainable growth, leading to reduced impact on the planet. -
(#4) Biobased and Renewable Polymer Grades for Drug Delivery
Bio-based and renewable grades of polymer resins are critical for meeting sustainability targets. Proper selection, characterization, and qualification in combination drug delivery/medical device applications allows for improved sustainability and greater supply chain flexibility. This poster examines a case study related to material characterization and effective strategies for comparative leachables and extractables studies.-
Poster Presenter:
-
-
(#5) Navigating the Regulatory Landscape for Connected Combination Products: Challenges, Gaps, and Forward Strategies
As medical devices become increasingly integrated with digital technologies and drug components, the regulatory landscape for connected combination products presents new complexities. This poster highlights regulatory challenges in aligning device, drug, and software requirements for connected autoinjectors, smart inhalers, and wearable injectors. It explores the intersection of 21 CFR Part 820, 21 CFR Part 4, and evolving FDA guidance on software as a medical device (SaMD). Through case-based discussion and a regulatory gap analysis, we propose a framework for early regulatory planning, risk management, and submission readiness. The role of human factors, cybersecurity, and postmarket surveillance is also examined. Practical recommendations are shared to support RA professionals in preparing combination product submissions that involve digital or connected health components.-
Poster Presenter:
-
-
-
P6: Big Shots: The Future of Large-Volume Systems (Griffin Hall)
Griffin Hall
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Moderator:
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High-Dose High-Volume SC Delivery: Current Trends and What to Expect Next
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Challenges in the Technical Development of High-Volume Subcutaneous Delivery Devices
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Unlocking the LVSC Autoinjector Market Through Pre-Establishing Supply Chain Partnerships
Autoinjector combination products are setting the standard for enabling patients, healthcare providers, and pharmaceutical companies to reduce the burden of chronic diseases by bringing treatments to the home setting. Established supply chains have significantly reduced time to market approval for conventional combination products, thereby setting new standards and expectations for the pharmaceutical industry. So how can suppliers of the parenteral drug market meet these customer expectations when entirely new approaches to drug treatment and drug delivery are developed, such as large volume subcutaneous injections?
Through industry wide partnerships, market leaders; SHL Medical, SCHOTT Pharma, Datwyler, and Grand River Aseptic Manufacturing, will outline how the benefits of market access to an innovative large volume drug delivery solution have been unlocked and de-risked through up-front investment and platformatization of key components and services. By taking a holistic view of what it takes to bring a new drug delivery solution to market, the current standard expectations of having validated and commercialized infrastructure in place during early phase drug development are now being met so that novel large volume treatments can be brought to market with the same level of confidence as current conventional combination products. -
Q&A
-
-
Networking Lunch in the Exhibit Hall
-
Poster Presentations in the Exhibit Hall
-
(#1) Inspection Beyond the Visible - Pulsed X-ray Technology for Medical Devices and Pharmaceutical Products
Modern medical and pharmaceutical products often come in highly diverse and complex packaging, presenting significant challenges for quality inspection. Many critical features—such as correct assembly or the presence of key components—are not detectable with the naked eye or standard camera systems, especially when dealing with opaque materials. Pulsed X-ray technology offers a powerful alternative, enabling non-destructive inspection of even the most challenging products. By emitting brief, precisely timed X-ray pulses, this method minimizes radiation exposure while delivering highly detailed internal images. It allows manufacturers to detect hidden defects and verify product integrity without slowing down high-speed production lines. In contrast to continuously active scanner systems, the pulsed approach is energy-efficient, easier to maintain, and particularly well-suited for inspecting sensitive pharmaceutical containers. This makes it a valuable tool for improving safety and compliance in modern pharmaceutical manufacturing. -
(#2) NeoFlex™ Worldwide: How Datwyler's Innovative Plunger Portfolio Addresses the Latest Trends in Drug Delivery
Large-volume auto-injectors and wearable devices exceeding 2.25mL play a crucial role in the transition from hospital-based intravenous (IV) treatments to self-administrated drug delivery via subcutaneous (SC) injection. These devices are especially pivotal in the treatment of oncological, immunologic, and neurodegenerative diseases, where they are often tasked with delivering high-viscosity and delicate biologics to patients in need.
Ensuring the highest standards of quality and purity in elastomers, along with flawless functional performances, is imperative to guarantee the reliability of administration and patient safety. A balance of functionality, machinability, and product safety are essential for the entire device system to function. In this presentation, we will delve into the technical hurdles encountered in designing and manufacturing larger coated plungers for pre-filled syringe (PFS) and cartridge containers intended for device integration.
We will showcase our journey from conceptualization to commercialization of these coated plungers, as well as evaluating their performance throughout the entire value chain to the patient. Additionally, we will underscore the significance of fostering an open collaboration with the container manufacturer and among the additional stakeholders involved in the development of the final combination product. -
(#3) CSR, ESG, and Sustainable Strategies Enhancing Growth in Combination Products: What Can we Learn From the World Class Amongst us and why Does it Matter?
Time Magazine recently released its 2024 list of the Most Sustainable companies. There are several combination product manufacturers on the list and the industry can learn from these leading companies. I will display the Triple Bottom Line strategic approach to balance people, the planet, and profit to sustainably grow. Novartis, a Mordor Intelligence top 5 Drug Combination Product Manufacturer, is #17 on Time’s list and is in the top 3% on Sustainalytics’ Environmental, Social, and Governance (ESG) ranking. I will list how Novartis and other combination product manufacturers have added these important programs to their strategies. Many pharmaceutical companies are consistently challenged with price pressure for their products and are called upon to look for ways to make their products more accessible globally. Community and industry research foundation support can help a company’s social reputation. Employee benefits packages, DEI programs in talent acquisition and career development, and professional development all drive retention and lead to innovations. I will touch on these and will provide examples of environmental initiatives the best-in-class companies focused on. The poster will also show how these can impact all companies in our industry if embraced, including sustainable growth, leading to reduced impact on the planet. -
(#4) Biobased and Renewable Polymer Grades for Drug Delivery
Bio-based and renewable grades of polymer resins are critical for meeting sustainability targets. Proper selection, characterization, and qualification in combination drug delivery/medical device applications allows for improved sustainability and greater supply chain flexibility. This poster examines a case study related to material characterization and effective strategies for comparative leachables and extractables studies.-
Poster Presenter:
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(#5) Navigating the Regulatory Landscape for Connected Combination Products: Challenges, Gaps, and Forward Strategies
As medical devices become increasingly integrated with digital technologies and drug components, the regulatory landscape for connected combination products presents new complexities. This poster highlights regulatory challenges in aligning device, drug, and software requirements for connected autoinjectors, smart inhalers, and wearable injectors. It explores the intersection of 21 CFR Part 820, 21 CFR Part 4, and evolving FDA guidance on software as a medical device (SaMD). Through case-based discussion and a regulatory gap analysis, we propose a framework for early regulatory planning, risk management, and submission readiness. The role of human factors, cybersecurity, and postmarket surveillance is also examined. Practical recommendations are shared to support RA professionals in preparing combination product submissions that involve digital or connected health components.-
Poster Presenter:
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P7: Speed to Market: Best Practices for Scalable Success (Griffin Hall)
Griffin Hall
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Moderator:
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From Bulk to Ready-to-Use: The Evolution of Fill/Finish Processing for Combination Products
Over the past decade, we’ve seen a rapid increase in the adoption of ready-to-use (RTU) commodities in lieu of bulk primary containers across the pharmaceutical manufacturing industry. The selection of RTU commodities shifts the burden of cleaning and sterilization to the commodity vendor, reducing in-house risk, shrinking utility consumption, and saving cleanroom footprint. While manufacturers of drug products filled into pre-filled syringes have realized the benefits of a RTU presentation for many years, RTU cartridges and vials are less common, particularly for high output applications. However, recent innovations in equipment design, improved breadth of RTU offerings and market-driven pricing have opened the door to high speed RTU filling. This presentation will provide a holistic look at the benefits and drawbacks of both primary container presentations, including the shifting ROI breakeven point for bulk vs RTU containers, and other points to consider when evaluating a fill/finish strategy. -
De-Risking Autoinjector Integration with High-Performance Pre-Fillable Syringes
Recent new generation auto-injectors and syringes are advanced, flexible platforms designed to meet the increasing demand for subcutaneous delivery of high value injectables. In particular, the innovative approach of a single auto-injector solution accommodating both 1mL and 2.25mL syringes provides high flexibility without requiring additional development. The expanded capability of an integrated solutions provider related to device and primary packaging demonstrates how a well-integrated development strategy can mitigate compatibility challenges by design. This presentation highlights how high-performance syringe platforms can fully meet device compatibility requirements in terms of design and critical dimensional attributes. In addition, it will be shown that a consistent break loose and glide forces along shelf-life, enable smooth and controlled drug delivery. This study includes syringes performance data, such as break loose force and glide force, alongside autoinjector performance metrics (i.e., cap removal force, dose accuracy, and injection time). Ultimately, the presentation shows how syringes featuring an advanced cross-linked coating mitigate silicone oil particle release which might impact the safety and efficacy of the drug. This work highlights how the combination of Stevanato Group’s high-performance PFS (Alba® & Nexa®) and the Aidaptus® auto-injector offers pharmaceutical companies a reliable, scalable, and patient-centric drug delivery solution, supporting the accelerated development of biologics and other advanced therapies. -
Breaking Silos: Aligning Teams Around a Unified Platform Vision
Acceleration through product lifecycle from TPP to Marketing License requires both clarity of intent and strategic alignment of “ways of working “ across teams and partners selected for execution along the CMC pathway. Assets and technologies selected to serve the platform are the “hardware” or the architecture enabling a platform and its vision to serve a portfolio of products. Aligning the teams engaged to deploy the selected assets towards a new product/combination product works similar to a “software”; better the software is written and installed, faster the execution and data quality. Examples of platforms and practices to achieve alignment and effective integration of “ways or working” cultures that resulted in acceleration of accelerate time to clinic and time market for injectables will be covered in this presentation. -
Q&A
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Closing Remarks from the Conference Co-Chairs
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Posters
(#1) Inspection Beyond the Visible - Pulsed X-ray Technology for Medical Devices and Pharmaceutical Products- Sebastian Mayer, Product Manager Pharma Inspection Solutions, HEUFT SYSTEMTECHNIK GMBH
(#1) NeoFlex™ Worldwide: How Datwyler's Innovative Plunger Portfolio Addresses the Latest Trends in Drug Delivery
- Yitian Xiao, MEng, Technical and Scientific Expert, Datwyler Pharma Packaging
(#2) Inspection Beyond the Visible - Pulsed X-ray Technology for Medical Devices and Pharmaceutical Products
- Sebastian Mayer, Product Manager Pharma Inspection Solutions, HEUFT SYSTEMTECHNIK GMBH
(#2) NeoFlex™ Worldwide: How Datwyler's Innovative Plunger Portfolio Addresses the Latest Trends in Drug Delivery
- Yitian Xiao, MEng, Technical and Scientific Expert, Datwyler Pharma Packaging
(#3) CSR, ESG, and Sustainable Strategies Enhancing Growth in Combination Products: What Can we Learn From the World Class Amongst us and why Does it Matter?
- Roger Ouimet, MS-PM&O, Global Director, Program and Project Management (PPM), CAI
(#4) Biobased and Renewable Polymer Grades for Drug Delivery
- Matthew Heidecker, PhD, Vice President/Principal Scientist, PSN Labs
(#5) Navigating the Regulatory Landscape for Connected Combination Products: Challenges, Gaps, and Forward Strategies
- Afrah Mujeeb, AM, Regulatory and Quality Co-op, Access Vascular Inc
Activities and Networking Opportunities
Connect and Collaborate with Purpose
Make the most of your conference experience by participating in social events and tours designed to foster meaningful connections, spark new ideas, and expand your professional network.
The following events can be added to your conference schedule by selecting the events during registration or at any time prior to or during the meeting, depending on availability. Some activities are complimentary but require a reservation, while others include an additional fee.
Whether you're interested in expanding your network, sharing insights, or simply enjoying time with fellow attendees, these events provide a variety of ways to connect and engage.
Already Registered? No problem, use the links below to log in to your registration account and add the event to your existing registration.
Site Visit to Stevanato Group’s New Fishers Facility
Visit Stevanato Group’s new U.S. hub in Fishers, IN! This new Indiana hub will host amongst others the production of drug containment solutions, including our EZ-fill® pre-sterilized platform, device manufacturing, and an after-sales support center for equipment.
After the groundbreaking ceremony in September 2021 the new production plant in Fishers is now operational. The facility houses state-of-the-art production lines equipped with advanced process technologies to produce drug containment solutions and drug delivery devices, and an after-sales support center for equipment.
PriceFree with Advance Sign-Up! – includes roundtrip transportation and Fishers site visit
Tickets50
Start12:30 ET – participants will meet in the JW Marriott Indianapolis lobby to board the bus and promptly depart at 12:45 ET
End17:00 ET – participants will arrive back at the JW Marriott Indianapolis
NotesBy signing up for this Site Visit, participants understand that their contact information will be shared with Stevanato Group
Already Registered?
PDA Night at the Ballpark
Network with fellow PDA Miniverse attendees while enjoying a night at the ballpark. Located directly across the street from the conference hotel, Victory Field has been recognized as the "Best Minor League Ballpark in America " by Baseball Americaand Sports Illustrated. Participants will watch Indianapolis’ minor league baseball team take on the Omaha Storm Chasers. A section of Victory Field’s Yuengling Landing will have reserved seats for PDA.
Price$60 – includes a reserved seat at Yuengling Landing and a $25 concession voucher
Tickets50
Start19:05 ET – the game starts at 19:05 ET, but Yuengling Landing will open prior to the start of the game (exact time TBD)
EndMinor league baseball games typically last about 2.5 hours. Participants may depart the game at any time to walk back to the JW Marriott Indianapolis (directly across the street).
NotesPlease note that the seats at Yuengling Landing are private, reserved 4-person tables vs. traditional grandstand seats.
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Venue Details and Accommodations
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.
JW Marriott Indianapolis
10 S West StIndianapolis, IN
Reservation Instructions
The JW Marriott Indianapolis is the official headquarter hotel for the PDA Miniverse: Medical Devices, Combination Products and Connected Health Conference 2025. The hotel reservation cut-off date has passed, but rooms may still be available.
How to Get Here
Registration
Pricing Options
Standard Registration
Member Price
$1,995GovernmentMember Only
$995
Early Career ProfessionalMember Only
$1,495
StudentMember Only
$695
Non-Member
$2,395
Tuesday Site Visit at Stevanato Group
Free with Advance Sign-Up
Tuesday, 24 June
12:45-17:00 ET
50 tickets available
Complimentary tickets are available for PDA Miniverse participants thanks to the generous support of Stevanato Group. Includes roundtrip transportation and site visit.
Tuesday Evening Baseball Game at Victory Field
$60 per person
Tuesday, 24 June
Game starts at 19:05 ET
50 tickets available
Includes a reserved seat at Yuengling Landing and $25 concession voucher.
Victory Field is located across the street from the hotel.
GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.
GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.
CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].
Presenters
Meet the Experts
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Maggie Bandel, MBA
Johnson & Johnson
Global Head, Lifecycle Management MSAT
Co-Chair
Moderator
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Ronald Forster, PhD
Amgen
Head of Manufacturing Sciences and Technologies for Combination Product Operations
Committee Member
Moderator
Presenter
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Sebastian Mayer
HEUFT SYSTEMTECHNIK GMBH
Product Manager Pharma Inspection Solutions
Poster Presenter
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Laura R. Moody, PhD
Syntegon
Director of Product Management Pharma, North America
Presenter
Read Bio -
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Roger Ouimet, MS-PM&O
CAI
Global Director, Program and Project Management (PPM)
Poster Presenter
Read Bio -
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Renato Ravanello
Genentech
Senior Director, Device & Packaging Development
Presenter
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Subhi Saadeh
Gilead Sciences
Associate Director-MDCP QA
Presenter
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Jean-Christophe Veilleux, PhD
Eli Lilly and Company
Senior Director - Mechanical & Materials Engineering (Delivery, Devices and Connected Solutions)
Committee Member
Moderator
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Lucas (Luke) Wellington, MBA
Eli Lilly and Company
Associate Vice President for Drug Delivery Systems & Medical Device Development
Presenter
Read Bio -
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Yitian Xiao, MEng
Datwyler Pharma Packaging
Technical and Scientific Expert
Poster Presenter
Read Bio -
Sponsors
Sponsors and Collaborators
Silver Sponsor
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Exhibitors
Exhibitors and Innovators
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Boost your brand and visibility by becoming an exhibitor at the PDA Miniverse: Medical Devices, Combination Products and Connected Health Conference 2025! Connect with industry influencers, showcase your products and services, and position your company as a key player in the field.
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