The expansion of the injectable drug market is prompting pharmaceutical companies to integrate device expertise earlier in the drug development process, according to industry leaders who participated in a recent virtual discussion. This shift aims to reduce development timelines and improve alignment between drug and device developers.
Oliver Eden, Senior Business Unit Director at Jabil, and Travis Webb, Chief Scientific Officer at Pharmaceutics International Inc (PII), emphasized that combining capabilities across the supply chain can help avoid delays in bringing products to market. They noted that this approach also facilitates regulatory interactions.
Eden and Webb highlighted the increasing demand for autoinjectors that are automated, user-friendly, and comfortable. Webb explained that long lead times affect various components in pharmaceutical manufacturing, from excipients and active pharmaceutical ingredients (APIs) to primary packaging and devices. He stated that "a drug-device revision can add months to programs," with combination product development costs ranging from tens of millions up to $2.6 billion.
Eden pointed out that some drugs require custom devices due to specific requirements like viscosity, which may not be met by standard options. This situation often leads companies to weigh the benefits of keeping device development in-house versus outsourcing. According to Eden, there are three key elements in combination products: formulation, primary packaging such as cartridges or prefilled syringes, and delivery devices like auto-injectors or pen injectors.
He said, “In isolation, you might create what you consider to be the best drug product, but if it doesn’t play nicely with the primary pack or the device,” the product could fail.
Webb outlined other considerations for combination products including dose volume, administration route, shelf life, material compatibility (such as polymers and adhesives), and environmental factors like sensitivity to oxygen or light. He observed two main approaches over 25 years: designing a device around an existing drug or adapting a formulation for an available device—each presenting its own challenges.
Managing multiple vendors can increase risks of miscommunication or incompatibility issues discovered late in development. Eden argued that working with integrated providers such as Jabil can reduce these risks by unifying processes under one organization.
Regulatory guidance remains broad rather than prescriptive. “Regulatory bodies don’t publish clear instructions,” Webb said. “They don’t say do steps 1-2 and three. They make very general suggestions, but behind that there’s a specific intent.”
Webb described how the FDA’s Quality by Design (QbD) framework now applies not only to drugs but also devices and combination products—encouraging manufacturers to build quality into designs proactively rather than relying on trial-and-error testing later in development.
Webb also noted PII's experience supporting more than 60 New Drug Application filings over three decades of product development work. He said having all capabilities within one entity simplifies regulatory management and accelerates time-to-market while potentially lowering costs—a critical factor amid rising tariffs and shipping expenses.
The injectable market has shifted from predominantly oral therapies toward biologics requiring alternative delivery methods due to poor absorption via the digestive tract. Eden explained this transition led companies to consider patient self-administration needs much earlier during preclinical phases—including decisions about single-use versus multi-dose platforms.
Jabil’s Qfinity Platform offers a reusable auto-injector designed for ease of use while reducing manufacturing footprint by 50% compared with competitors; it also cuts carbon emissions by 80%, since each unit is used for up to three years instead of being single-use only. Eden added that their Qfinity+ autoinjector logs dosing information automatically without needing screens or smartphone pairing—a feature intended for older patients—and transmits data via cellular networks for remote monitoring during decentralized clinical trials.
Recent discussions about U.S. tariffs have sparked increased interest in reshoring pharmaceutical manufacturing operations back to domestic facilities despite higher costs involved. Some companies are considering duplicate production sites both domestically and abroad as part of a "local for local" strategy aimed at mitigating global supply chain disruptions.
“This article was written in partnership with PII.”
