Special Delivery: A Discussion of Drug Delivery Devices

Something was wrong. Very wrong. 

Carter Beall could feel it in the pit of his stomach—a nagging, raging pressure low in his gut. Though he was too young to understand it at the time, that dull, hard-to-describe discomfort was not borne of fear nor anxiety, but rather an immunological ambush on his healthy intestinal bacteria.

The skirmish raging within Beall’s microbiome prompted gastrointestinal swelling and irritation, generating recurrent belly pangs and other nondescript bodily sensations. The bacterial casualties induced the overgrowth of harmful microbes—an imbalance that can lead to lifelong digestive troubles.

Among those troubles are chronic conditions like Crohn’s disease and ulcerative colitis, both of which are characterized by overlapping symptoms: fatigue, weight loss, malnutrition, bloody stools, diarrhea, and abdominal pain. The two afflictions—forms of inflammatory bowel disease (IBD)—can be difficult to manage and pose an elevated cancer risk. And while their cause remains unknown, researchers agree that a complex interplay of genetic, environmental, and immunological factors all contribute significantly to the onset of Crohn’s disease and colitis.   

Having exhibited many of IBD’s symptoms, Beall eventually was diagnosed with Crohn’s disease as a pre-pubescent.

“I was first diagnosed when I was 12. Prior to that, I had so many other GI symptoms that I couldn’t identify or didn’t know were part of Crohn’s,” Beall said in an online video. “When I was diagnosed, I was unable to gain weight, unable to grow. I was shorter than all the other kids in my grade, and I was really emaciated—you could see all of my ribs. Crohn’s impacted my life in a lot of ways. There are the things people think about offhand, like you’re going to have digestive distress and you’re not going to be able to eat certain kinds of foods, but Crohn’s also affects your mental state and your energy. A lot of people with Crohn’s—like I did—experience some extreme fatigue. It was just difficult to try to live normally.” 

A normal life (physically) was out of reach for Beall until his doctor suggested treatment with Skyrizi, a drug approved to control inflammatory diseases such as moderate to severe plaque psoriasis, active psoriatic arthritis, ulcerative colitis, and Crohn’s disease. Developed by AbbVie, the biologic is designed to mimic naturally occurring immune system proteins and works by targeting the interleukin-23 protein, a key driver of Crohn’s-associated inflammation.

Beall uses an on-body injector recently acquired by AbbVie to administer his Skyrizi doses. The SmartDose 3.5mL On-Body Delivery System consists of a battery-powered, wearable on-body injector and a separate, pre-fillable polymer-based cartridge. 

“I had some concerns about the effects of drugs being more generalized to the rest of the body and the susceptibility to infection and those kinds of things,” Beall explained. “Instead of going to a center every eight weeks and having to block out two hours as I know some friends with Crohn’s have had to do, with Skyrizi, you can just get this device [delivered] to your door. You slide your medication in there, it clicks, you close the door, pull off the adhesive, put it on, push a button, and in five minutes, it’s done.” 

The convenience offered by devices like AbbVie’s SmartDose is one of the key forces fueling growth in the global drug delivery device sector, an industry worth $278.5 billion last year and forecast to balloon 11.5% annually over the next six years to reach $599.7 billion by 2032, Research and Markets data indicate.

Other growth engines besides patient convenience include the planet’s aging population, increasing demand for simple, patient-centric solutions, and technological advancements that enhance precision and efficacy, and allow for real-time patient monitoring and targeted therapy.

“We don’t want to add burden to our patients, right? We also have to remember that patients don’t want to be reminded every day that they have a disease,” said Anya Harry, M.D., Ph.D., a physician-scientist and chief medical officer/vice president of Applied Research and Clinical Affairs at West Pharmaceutical Services, maker of the SmartDose On-Body System that sold the device’s manufacturing and supply rights (and associated facilities) to AbbVie in January for $112.5 million.

“If we can come in and provide a solution with a delivery device that’s very simple to use, that delivers the medication accurately and reliably—what a burden that takes off of the patient,” Dr. Harry continued. “So, for many of those reasons, I think it’s important for us to innovate and to listen to patients like Carter. But I think just as important, it’s helpful to understand the impact our device has had on this patient.”

With that objective in mind, Medical Product Outsourcing spoke with several experts over the last few weeks to better comprehend the ways drug delivery devices are shaping both the patient experience and the overall market. Participants in this discussion included:

• Brian Boschetti, vice president, OEM/International, sales and marketing, B. Braun
• Matt Giza, senior vice president and general manager of Arterex Mansfield & Rochester; Jeffrey Goble, Arterex CEO; Michael Kanis, vice president of Business Development, Arterex; P.J. O’Connor, vice president of Technology, Arterex; and Robert Olsen, chief commercial officer, Arterex
• Rebecca Hones, business development manager, SMC Ltd.
• Josh Lowth, marketing manager, Pharmaceuticals and Drug Delivery, Ensera

Michael Barbella: What main market forces are at play and shaping your corner of the drug delivery device market?

Matt Giza, Jeffrey Goble, Michael Kanis, P.J. O’Connor, Robert Olsen: More specific targeted locations such as the brain, eyes, liver, spine, and tumors. These can include drug, gene, and cell therapy.

Rebecca Hones: The main market forces at play are following along with the move towards personalized medicine. There is an increase in injectables for complex biologics and biosimilars to meet the rise in chronic diseases, such as diabetes, cancer, and respiratory diseases. Patient preference is easy-to-use at home care, decreasing visits to hospitals and clinics and bolstering the demand for auto-injectors, pens, and on-body injectables. This shift requires manufacturers to develop advanced drug delivery systems with novel technologies that are minimally invasive. 

Josh Lowth: Several forces are converging at the downstream end of the drug delivery device market. Demand for self-administered therapies continues to rise, driven by biologics, biosimilars, orphan drugs, and GLP-1s, pushing autoinjectors and prefilled syringes into the mainstream. At the same time, capacity across fill-finish, assembly, and packaging is increasingly allocated to high-volume programs, leaving low-to-mid volume programs exposed to delays despite their clinical or commercial importance.

Regulatory convergence is amplifying this pressure. Combination products now sit firmly at the intersection of pharmaceutical and medical device regulation, particularly in Europe under MDR Article 117. Device-grade evidence, packaging validation, and sterilization strategy can no longer be treated as secondary considerations. Together, these forces mean that success is increasingly determined by how well late-stage complexity and variability are planned for and executed, rather than by scale upstream.

Barbella: What trends are most impacting your business and in what way(s)?

Giza, Goble, Kanis, O’Connor, Olsen: The delivery of immunotherapy drugs directly into tumors, including overcoming the blood-brain barrier. Dosage accuracy and the use of globally accepted propellants to drive implantable drug delivery systems. Arterex is well-positioned to address these trends.

Hones: The surging demand for autoinjectors and pens is driving expansion of facilities, operations, and new business offerings.

• Standardization across primary containers, drug delivery auto-injectors pen, and on body injectable systems manufacturers, filling, and packaging equipment builders
• Selecting machinery and platforms that process the popular standard 1 mL and 2.25 mL syringes
• Demonstrating flexibility and allowing customization for drug delivery systems 
• Establishing partnerships, and working closely with primary container suppliers, device suppliers, and equipment manufacturers to meet the needs of the ultimate end user—the patient

Lowth: One of the most significant trends we see is the widespread adoption of platform-based drug delivery devices, particularly as these evolve to support a wider range of dose volumes. While these platforms accelerate development and simplify regulatory pathways, they often shift complexity downstream into final assembly, packaging, labeling, and market localization, where product differentiation and SKU variation now sit.

Another important trend is demand volatility persisting late into programs, particularly for biosimilars, orphan drugs, and multi-market launches. Forecasts, artwork, and country allocations frequently continue to change close to launch, increasing the need for flexible operations that can absorb change without breaking compliance or timelines. We are also seeing growing pressure around sterilization capacity and coordination. For some combination products for certain therapy areas such as ophthalmology, the requirement for sterilization is tightly coupled with assembly and packaging and must be planned as an integrated workstream rather than a standalone step. Across all of this, agility and integration matter more than maximum throughput.

Barbella: How are smart drug delivery systems reshaping the market?

Giza, Goble, Kanis, O’Connor, Olsen: Controlling the delivery dosage (sometimes down to microliters) to meet specific drug or patient treatment needs.

Hones: Smart drug delivery devices are attractive to patients. Everyone is becoming more accustomed to data at their fingertips and digital connectivity. Sophisticated design features offer patients the convenience of saving travel time to hospitals and clinics while simultaneously allowing healthcare professionals to monitor real-time data and adjust dosing. All of this can be done at home without interruption to daily routines. 

Barbella: How is the shift to patient-centric care influencing drug delivery device innovation?

Brian Boschetti: Patient-centric care is driving a strong focus on usability, safety, and convenience across care settings. We see increasing demand for solutions that are easier to administer, intuitive to use, and compatible with the healthcare setting. At B. Braun, this translates into human-factors-driven design, simplified workflows, and modular platforms that can be adapted to different patient populations without compromising reliability or regulatory robustness. 

Giza, Goble, Kanis, O’Connor, Olsen: Long-term implantable devices lead to an extended time between the need for follow-on surgical treatments. Smart devices are enabling customized solutions based on patients’ physiology.

Barbella: What are OEMs looking for most in their drug delivery products?

Boschetti: OEMs are looking for trusted partners, not just component suppliers. They value proven quality systems, regulatory expertise, scalable manufacturing, and design for manufacturability from day one. Increasingly, customers expect early collaboration to de-risk development, accelerate time to market, and ensure long-term supply continuity—especially for complex combination products.

Giza, Goble, Kanis, O’Connor, Olsen: Patient safety, dosage accuracy, precision, ease of use for the clinician, and platform technology to pursue other indications.

Hones: Scalability and speed are most requested. The platform approach has tremendously streamlined the development process, minimizing the risk and accelerating the speed of drugs to patients. Standardizing and leveraging platforms for drug delivery devices replaces the mindset of one device for one product, reducing risk and complexity during scale-up. Instead, it allows for more innovative device technology, providing solutions to fully optimize the end-user experience.

Barbella: What manufacturing challenges are unique to drug delivery devices compared to other medical products, and how is your company helping to overcome those challenges? 

Boschetti: One significant challenge in drug delivery device manufacturing is materials compliance, because device materials are in direct and often prolonged contact with the drug product. Beyond basic biocompatibility, manufacturers must manage extractables and leachables risk, chemical compatibility, regulatory traceability, and increasingly global material disclosure requirements—often across long product lifecycles and multiple markets.

Giza, Goble, Kanis, O’Connor, Olsen: Experienced technical staff helps the development of complicated drug delivery with strict regulatory requirements.

• The QMS system is built to handle risk mitigation
• Drug compatibility
• Drug stability
• Structural integrity

Hones: Biologics and biosimilars can be challenging to manufacture. More viscous, larger volumes (5 mL up to 20 mL)

• Long development cycle 
• Regulatory compliance 
• Scalability
• Supply chain disruptions 
• Maintaining an effective cold chain throughout processing

Lowth: Drug delivery devices are uniquely complex because they combine a pharmaceutical product, a medical device, and user interaction within a single system. That complexity is most acute at the final stages of manufacture, where variability, regulatory oversight, and commercial risk converge.

Programs involving low or mid volumes, multiple configurations, country-specific labels, and complex kits still demand the same levels of control, validation, and traceability as large commercial programs. Traditional high-throughput manufacturing models are rarely designed for this reality. Sterilization adds further challenge, particularly where terminal sterilization or sterile barrier systems must be carefully sequenced and evidenced alongside assembly and packaging.

Our response has been to design downstream operations around variability rather than consistent scale. By integrating assembly, labeling, serialization, kitting, secondary packaging, and sterilization management within flexible, modular operations able to more easily adapt to shifting or non-standard demand, we reduce handoffs, maintain control, and protect timelines when complexity peaks.

Barbella: How are companies addressing environmental concerns and device disposal?

Giza, Goble, Kanis, O’Connor, Olsen: Minimizing the need for disposable accessories

• Minimize packaging
• Material selection
• Environmentally-friendly propellant selection for implantable pumps

Barbella: Can you share some examples of drug delivery products or processes your company developed to meet customer requests? 

Giza, Goble, Kanis, O’Connor, Olsen: Our products and processes include the following technologies: 

• Active and non-active Class 3 implantable and external drug delivery systems
• Cell diffusion therapy devices 
• Programmable capabilities to control and adjust dosage
• MRI compatible designs
• Microdose syringe pump design and development
• Ports and catheter design and development 

Barbella: What role will AI and automation play in future drug delivery device innovation?

Giza, Goble, Kanis, O’Connor, Olsen: We are early in our adoption of AI and automation.

Barbella: What technological breakthroughs could most disrupt the drug delivery device industry in the next five years?

Giza, Goble, Kanis, O’Connor, Olsen: The development of MEMS technology reduces the size of parts, the number of parts, and the cost.

• Nanoparticles, cell-membrane-coated carriers, stimulus-responsive hydrogels
• Implantable additive manufacturing capabilities

Hones: Increased virtual care leading to more personalized, targeted and painless/needle-free delivery systems:

• AI integrated on-body delivery systems (OBDS), pens, autoinjectors to allow continuous monitoring of real time data and personalized patient dosing
• Transdermal technology replacing painful needle injections
• Sustainability—The U.S. is exploring opportunities to align with Europe’s 2025 adoption of The Packaging and Packaging Waste Regulation (PPWR)