The pharmaceutical supply chain and device development have become intricately linked. Harmonizing formulation development with drug delivery device design—and leveraging a single‐vendor ecosystem—can deliver significant time, cost, and regulatory advantages for US‑focused drug products, according to industry experts.
The growth of the injectable drug market has pushed pharma companies to incorporate device knowledge earlier in drug development to shorten development timelines, said device industry leaders during a recent virtual discussion.
Integrated capabilities are the best avenue to ensure alliance between drug and device developers and can cut down on delayed market entry, agreed Oliver Eden, Senior Business Unit Director at Jabil, and Travis Webb, Chief Scientific Officer at Pharmaceutics International Inc (PII). Regulatory interactions can also be more easily addressed.
A notable trend is the consideration for autoinjectors to be automated, more intuitive and comfortable to use, they added.
Unique Drug-Device Challenges
Long lead times are common across pharmaceutical materials, Webb said, so simplified, integrated supply chains can minimize delays. Long lead times are experienced with excipients, and APIs, he added, but can also filter down to primary packaging and devices.
A drug-device revision “can add months to programs,” Webb said, noting that developing combination products costs tens of millions to $2.6 billion.
Top pharma companies are often torn between a desire to keep device development in-house versus outsourcing, Eden said. But some drug products require custom devices due to viscosity or other requirements where off-the-shelf options don’t exist, which can be expensive and time-consuming for a pharma player to engage with a lack of expertise, he added.
There are three critical elements in combination products, Eden explained: formulation, primary packaging (cartridge or prefilled syringe) and the delivery device (auto-injector or pen injector).
The interplay among these components is crucial to the combination success, 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, he explained.
Other combination considerations present include the formulation dose volume, route of administration, shelf life, material compatibilities (polymers, silicones, lubricants, adhesives), and environmental factors (oxygen/light sensitivity), Webb said.
Over 25 years, two scenarios have emerged: drug development stand-alone, with a device design around that; or trying to fit a drug formulation to an existing device, Webb explained. The former requires extensive time and expense, and the latter can limit formulation options.
Developers can end up coordinating 5-6 different vendors, Webb said. There is a risk of misinterpretation between parties, Eden added.
Potential negative outcomes can be that drug-device incompatibility is spotted before launch, which can cause delays or subtle inconsistency discovered later (e.g., tolerance stack issues after tool validation), Eden explained. The latter could lead to elevated patient complaints or devices not functioning as intended, affecting adherence and compliance.
Eden noted that going to a “one-stop shop” like Jabil (serving both drug product and device sides) can remove failure nodes and enhances communication. When capabilities are unified, there is a simplified regulatory path, he added.
Regulatory Considerations
“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.”
The FDA’s Quality by Design (QbD) approach now extends to devices and combination products, Webb explained. In laymen’s terms, QbD is a format that by which instead of developing a drug and discovering its qualities through trial and error, quality is built into its design at the start. Developers are also proactive rather than reactive about quality and performance.
Regulators expect companies to understand drug-device interactions as a whole system, Webb noted. PII has supported 60+ NDA filings over 30+ years of drug product development experience, he added.
Any proposed drug-device changes would be easier to manage under one entity versus multiple parties, Webb explained. Also, there is increased speed to get products to market, as well as a simplified supply chain that can lower costs. In terms of tariffs and rising shipping costs as well as material constraints, this is crucial, Webb said.
Injectable Market Shift
Decades ago, most therapies were oral tablets, Eden said. But as biologics grew, their inability to be taken orally, and as stomach acids affect the API absorption, jumpstarted drug-device makers’ discussions.
Conversations about autoinjectors now happen much earlier than in the past; even during preclinical phases, Webb said. Now, companies explore platform options (e.g., single-use versus multidose systems) from the outset.
But as injections are inherently more difficult than swallowing a pill, drug makers realized they would have to develop injectors that empower patients for self-care and self-administration, Eden said. Patients must be willing to repeat device use, especially for chronic medications, Webb said.
As an example, Jabil’s Qfinity Platform includes a reusable auto-injector called Qfinity. Human factors studies showed loading the primary pack didn’t place excessive burden on patients, Eden said. The device also has a 50% lower manufacturing footprint than competitors, as well as an 80% reduction in carbon footprint (the device is used up to three years versus single-use), Eden said.
In tune with technological advancements, Jabil has also developed the Qfinity+. The autoinjector automatically records the drug time and date stamps and indicates whether a full dose is delivered, Eden said. Keeping in mind many older patients who may not be technologically savvy, the device has no visible screen or smartphone pairing required. Data is transmitted to the cloud via a cellular network.
The technology is particularly beneficial for decentralized clinical trial settings, so study managers can monitor compliance, Eden added.
Reshoring and U.S. Manufacturing
The conversations on U.S. tariffs the past year have meant an uptick in conversations about reshoring, Webb said. Companies either actively doing it or making plans based on global developments. Those contract manufacturing in other countries are now considering U.S. operations, despite the expense, he added.
Another option is to create duplicate manufacturing (one in US, one in Europe) for “local for local” solutions, Webb explained.
This article was written in partnership with PII.
