PDA Miniverse 2025 Posters

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.

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.

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.

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.