Disease or dread? That was the grim choice Rebecca Palmer faced 15 years ago as she grappled with the harsh reality of a newly-detected chronic illness.

The diagnosis was decades in the making—the consequence of an unrelenting barrage of upper respiratory and ENT infections. Proper treatment might have been equally as elusive if not for the multi-drug-resistant lung infection that forced Palmer’s health insurer to cover her therapy.

The dreaded therapy.

Therapy for Common Variable Immune Deficiency (CVID), a disorder caused by low antibody (immunoglobulins) levels in the blood. The rare winners of this unfortunate genetic lottery—one in 25,000—are susceptible to recurrent and severe infections (thus explaining the merciless assault on Palmer’s respiratory tract). 

The standard treatment for CVID is immunoglobulin (Ig) replacement therapy, given intravenously or subcutaneously, using healthy donor blood to replace the missing antibodies. Not the most ideal treatment per se, but certainly not the most nerve-racking.

Not for non-trypanophobiacs, anyway. But for people like Palmer with a fear of needles, subcutaneous IgG infusions can be terrifying, triggering panic attacks, nausea, heart palpitations, and fainting, according to a Harvard Health blog.

Disease or dread?

Neither one, actually. Unwilling to acquiesce to a chronic disease, Palmer faced her phobia and learned to give herself immunoglobulin injections. “When I started my subcutaneous IgG infusion, I did it at home,” she explained in an online video. “A nurse coordinator came in twice to show me how to inject myself. That was pretty nerve-racking…a lot of supplies. Injecting yourself is never easy. She showed me once, and then I had to do it myself, and then I was completely on my own from there.” 

Being left on her own, Palmer quickly mastered the necessary steps to administering her immunoglobulin therapy. She starts by loading 40 mg of medication into a spring-loaded handheld pump with a syringe; next, Palmer inserts two inch-long butterfly needles into a pinched inch of her abdominal tissue (finding a spot is difficult, as she can’t use the same injection site twice). Once the needles are inserted, Palmer secures them with tape and then lies immobile for at least an hour to prevent the additional tubing connecting the needles to the pump from entangling with household objects.

“There are lots of limitations. You’re not going to be getting up and moving,” Palmer noted in the video. “You really have to watch and not get the tubing caught on anything because as I have done in the past, I have yanked them out accidentally which is exceedingly painful. You lose the drug, there’s no way you can get it back because you cannot pause or stop the syringe once the Freedom pump goes. The pump will go to completion, you can’t stop it or pause it at any time so you’re out of commission for that whole time.”

Although the infusion itself is not painful, the injection site can be sore because the pump forces medication into her tissue at a constant rate. 

Palmer’s infusions take about 65 minutes to administer from start to finish. And while an hour each week may seem like reasonable penance for a normally functioning immune system, it nevertheless requires meticulous planning and sacrifice from Palmer. Besides managing all the supplies, Palmer must also plan her life—travel, work, parenting, hobbies, etc.—around her infusions.

“Definitely travel around infusion is really difficult. All of this stuff takes up a lot of space. For holidays and travel, I will actually extend the time or reduce the time between my infusions so that I can always infuse at home. This is far too much stuff to take around,” she said. “To have other options besides what I have today would be really meaningful because I think it would help free me up from the burden of having to schedule these [infusions] and manage all the supplies. If I could do it on the go, I wouldn’t have to worry about planning the infusions around trips—planning the infusions at all, since they are so time consuming. I think it would take a great strain off my mind to be able to have other options…”

Those “other” options have become more commonplace in recent years as patients like Palmer seek more streamlined, simplified, and convenient drug delivery systems to accommodate their busy lifestyles. One such system is the enFuse wearable platform from Cincinnati-based Enable Injections Inc. The investigational-stage company touts enFuse as the first purely mechanical wearable drug delivery device technology designed to deliver large volumes of small molecule and biologic medications subcutaneously. enFuse patients receive their treatment in a simple injection under the skin rather than intravenously. 

The palm-sized enFuse has no flashing lights or sounds and can easily be hidden under clothing during use. It also features a small hidden needle design so trypanophobiacs never actually have to see the needle during drug administration. And, because it has no wires or tubing, users can perform light to moderate activities while their medication is being administered.

“When I look at the enFuse, I think of freedom,” Palmer says. “I think it will give me time—time back that I don’t have today.”

Recovering lost time is just one of the many factors driving growth in the worldwide drug delivery device market. To gain a better understanding of the sector’s expansion catalysts and its unique dynamics, Medical Product Outsourcing spoke to several experts over the last few weeks. Input came from:

• Oliver Eden, senior business unit director, Pharmaceutical Solutions, at Jabil.
• Josh Gonzalez, vice president of Sales and Marketing at SMC Ltd.
• Shane Sheedy, head of Business Development – Porex Membrane Technology, at Porex.

Michael Barbella: What trends are you noticing in the drug delivery device market, and what factors are driving these trends?

Oliver Eden: There is a significant growth in parenteral drug delivery driven by innovators’ pipelines and the opportunity for genericization of the first generation of biologics. Parenteral drug delivery refers to drugs delivered outside the digestive tract, and includes intravascular, intramuscular, subcutaneous, intratumorally, etc. Jabil is enjoying a rapid period of increased business with new projects for injectable biologics and peptides like GLP-1s, delivered in self-administered autoinjectors and pen injectors.

The growth in parenteral drug delivery is being driven by the growth in biologics as a percentage of the programs in clinical development. Biologics are molecules that cannot be manufactured via chemical synthesis, including, but not limited to, mAbs, ADCs, MRNA, siRNA, proteins, peptides, etc. These classes of molecules currently cannot be administered via the oral route because of their inability to survive hepatic metabolism or due to poor bioavailability. If a formulation technology or alternate drug delivery technology could be designed that would mitigate those challenges, it could be a game-changer. For pharma companies, the ideal, least complicated form of drug delivery happens via a small, white pill. 

Within the parenteral drug delivery space, providers are working toward solutions that support self-administration of biologics. Some of these new biologics require higher volume delivery with higher viscosities. There has also been significant growth in the number of clinical programs in development by small biotech companies that are reliant on CDMOs for the transition of preclinical assets into clinical development due to the companies’ limited access to formulation expertise or installed manufacturing capacity. Outside parenteral administration, the opportunities are relatively niche for inhaled, intranasal, ocular, and transdermal drug delivery.

There is also significant discussion about such topics as sustainability and connected health, but as yet there is limited translation into strategy and thereafter development and/or commercial programs. Outside the inhaled drug delivery space, with the transition from HFAs to lower global-warming-potential propellants, pharma companies seem to be trying to understand which opportunities offer a compelling business case—delivering sustainable solutions cost-effectively, in a way that meets patients’ needs for intuitive and easy-to-use devices.

Josh Gonzalez: In the contract manufacturing space, we have seen significant growth in demand for proprietary drug-delivery devices, particularly in the past two to three years. This surge is largely driven by the rapid global adoption of GLP-1 receptor agonists for diabetes and weight management, which has placed immense pressure on existing manufacturing capacity. As a result, pharmaceutical companies are increasingly turning to contract manufacturers like us (SMC Ltd.) to scale production and ensure supply chain reliability.

Shane Sheedy: What we have been hearing from our customers is there are several key trends impacting the drug delivery device market, driven by patient’s needs, regulatory shifts, and broader technological advancements including improvements in material science.

One of the most significant trends is the growing emphasis on connected drug delivery devices. These devices are generally focused on how end-users interact with the products themselves with connected drug delivery devices (smart inhalers, insulin pens, etc.) improving adherence and tracking. This supports an increase in self-administration while personalized medicine developments appear to be leading to an increase in demand for targeted and patient-specific drug delivery solutions.

Technological advancements have supported the rise of broader therapeutical treatments, including the use of biologic drugs. These have introduced new challenges in material selection. With more sensitive drug formulations entering the market, there is a heightened focus on materials that do not interact with these delicate compounds, while often being required to filter the materials to ensure there are no contaminants being delivered to the patient. 

Lastly, the shift toward home-based treatment and miniaturized smart delivery systems has led to a demand for high-precision micro-material formats. As devices become smaller and more lightweight, materials must deliver multi-functional benefits such as venting, filtration, and barrier protection while maintaining performance in compact, intricate designs. Together, these trends are reshaping the drug delivery device landscape, driving innovation in materials and design to support the next generation of patient-centric solutions.

Barbella: What role do smart drug delivery systems (connected devices) play in helping improve patient outcomes?

Eden: The barrier is not a “technical” barrier but is demonstrating a value proposition strong enough to overcome the aversion to change. We have presented at international conferences that in the short- to medium-term there is a compelling value proposition for the use of smart technologies to monitor and empower clinical development. Automated data collection and transmission could be a game-changer for clinical trials. New devices like our connected Qfinity+ autoinjector support smaller, shorter, more powerful clinical studies by relying on the device itself to measure and report on patient adherence/compliance without any burden on the patient. Adherence is managed through automated alerts for non-compliance that can trigger trial managers to get participants back on track quickly. 

The challenge in commercial supply is again not a “technical” challenge per se, but more about how it can be adopted in the real-world clinical setting. Considerations such as the volume of data, data security, and the ability of clinicians to access that data, potentially from multiple sources, must be addressed to affect real world outcomes without becoming a barrier to adoption.

Gonzalez: Smart drug delivery systems, or connected devices, have the potential to significantly improve patient outcomes by enhancing adherence, providing real-time monitoring, and enabling data-driven treatment decisions. However, while there have been notable product launches, the long-term impact of connected devices on patient outcomes remains an open question. Success depends on more than just the technology itself—it requires a well-integrated ecosystem that includes healthcare providers, payers, regulatory bodies, and digital infrastructure. Without seamless integration into clinical workflows and patient lifestyles, adoption may be limited.

Challenges such as data privacy concerns, regulatory hurdles, and the need for standardized interoperability across healthcare systems also need to be addressed. Additionally, reimbursement models must evolve to incentivize the use of connected devices in routine care.

Sheedy: Our customers have been telling us that smart drug delivery devices enhance patient outcomes by the reduction in dosing errors, real-time monitoring, and improved patient engagement with their care. Our advanced filtration materials have been core to supporting the reduction in dosing errors through the filtration of the drug before administration, ensuring the correct dose is administered every time while ensuring any contaminants are captured. 

Barbella: How is your company navigating the complexities of obtaining market approval for combination products (e.g., devices combined with drugs)?

Eden: Our customers—leading pharma companies—carry this responsibility. As a partner to multiple regulated industries, Jabil maintains a robust QMS to help support our customers with their regulatory approvals. In the pharma sector, we have partnered on 11 commercial drug delivery product families for combination products and delivered, annually, more than six billion molded components and are approaching two billion device sub-assemblies. Jabil has a dedicated focus on and invests in our global quality systems so that no matter where you are manufacturing with Jabil, your products follow the same quality procedures and programs. We strictly follow regulatory standards such as FDA, EMA, ISO, and ICH. Multiple sites have earned MedAccred accreditation for plastic injection molding, PCBA, and plastics mechanical assembly. Our recent acquisition of the CDMO Pharmaceutics International Inc. (Pii), will increase our involvement in drug formulations and clinical trials, which will also rely on strict adherence to regulatory requirements.

Gonzalez: As a contract manufacturer of proprietary drug-delivery devices, we play a critical role in supporting our pharmaceutical partners in bringing combination products to market. However, since our customers retain ownership of the combination product and are responsible for regulatory submissions to global health authorities, our role focuses on ensuring compliance with relevant medical device regulations and providing the necessary technical and quality support.

We adhere to stringent medical device manufacturing standards, including ISO 13485 and applicable Good Manufacturing Practices (GMP), to ensure our components and assembled devices meet the required specifications for combination product applications. Our quality management system is designed to align with regulatory expectations, enabling seamless integration with our customers’ regulatory strategies.

Sheedy: We support our customers with their product development through our close innovation partnerships. By engaging early and collaborating to clearly define performance and regulatory requirements, we can help customers with selection of precise materials to reduce development iterations and successfully navigate complex landscapes to obtain approval for their devices.

Barbella: How are cost pressures and reimbursement policies influencing the development of drug delivery device solutions?

Eden: According to the Organization for Economic Cooperation and Development (OECD), the rise in healthcare costs is outstripping the rise in GDP. As aging demographics and the associated increase in chronic diseases increase pressure on prices, reimbursement will become ever more important. The challenge for ourselves and our pharma partners will be to design drug delivery systems with a compelling value proposition with respect to patient outcomes. Jabil helps its customers to manage costs starting with the bill of materials (BOM) by choosing components and materials that are economical and long-lived. With manufacturing sites across the world, we can help our customers develop cost-effective logistics and distribution strategies. Our Qfinity autoinjector offers cost-savings as a reusable, modular platform that reduces per-injection costs in half versus single-use autoinjectors that are used once and then thrown away.

Gonzalez: Cost pressures and evolving reimbursement policies play a critical role in shaping the development and manufacturing strategies for drug delivery devices. As a contract manufacturer, SMC works closely with our pharmaceutical partners early in the development process to align on cost expectations and develop an industrialization plan that optimizes efficiency without compromising quality or regulatory compliance.

To manage cost pressures, we explore various manufacturing strategies, including increased automation to enhance scalability, reduce labor costs, and ensure process consistency. Additionally, production transfers to lower-cost regions may be considered where it aligns with supply chain logistics, regulatory requirements, and risk management strategies.

Sheedy: Our partners do a considerable amount of work evaluating opportunity spaces before coming to us. Given that we partner with them so early in the development process, we can see how the patient is at the very core of any development process. Improving patient outcomes is the key driver of any development process with additional key considerations being the economics of the project as well as the key technical challenges. Cost pressures do appear to be leading to more holistic solution evaluation, with health economics being at the core of this emphasis on value-based care. 

Barbella: What opportunities exist in the drug delivery device market for emerging technologies such as 3D printing and AI?

Eden: The current pharma market business model is informed by molecules, which typically need to be administered frequently and are broadly applicable to a disease and/or a broad subset of patients with such a disease. Within this context, successful products are typically manufactured in the millions each year. This level of demand is not practicable with current 3D printing technologies. Opportunities may come if additive manufacturing evolves to compete with the scalability of injection molding and/or the pharma business model shifts to personalized medicine, which target a much narrower patient population with specific device needs that are not available from standard platform technologies. Today, 3D printing helps to accelerate device development during the prototyping and initial testing phases. Jabil turns to its additive manufacturing capabilities to shorten development lead times and to assure progression through the sequential stages of device design and development.

As far as AI is concerned, we are seeing more investment in pharma companies touting the use of machine learning and data generation in the development of therapeutics, e.g., $1 billion investment in Xaira Therapeutics (Fierce Biotech, source). At Jabil, we are using AI and machine learning to improve and maintain our manufacturing lines in ways that save time and human intervention. This is a continuous improvement effort deployed across our global sites. As a manufacturing partner, our top goals are to keep our employees safe on the floor and keep products moving on the production line. There are exciting opportunities for continuous improvement with smart applications of AI in production.

Gonzalez: Emerging technologies such as 3D printing and AI are creating new opportunities in the drug delivery device market, particularly in product development, manufacturing optimization, and supply chain management.

3D printing has become an invaluable tool in early-stage development, enabling rapid prototyping and design iteration. It allows for quick validation of form, fit, and function, reducing development timelines and costs. Additionally, as 3D printing technologies advance, there is potential for customized drug delivery devices tailored to individual patient needs, particularly in niche therapeutic areas.

AI is increasingly being explored for industrialization and production planning. While our direct experience with AI in this area is still evolving, its applications in predictive maintenance, process optimization, and quality control are becoming more prevalent. AI-driven analytics can help identify process inefficiencies, predict potential equipment failures, and enhance yield optimization, ultimately improving overall manufacturing efficiency.

Sheedy: It is still very early to truly understand the impacts of many of these emerging technologies. Working directly and with our partners, we have seen how 3D printing has accelerated prototyping in product development cycles, but it is still quite early to predict if there will be a broader impact on large scale production. 

It’s little more challenging to define what AI’s impact will be, given the breath of opportunities and unique use cases. Given the importance of these drugs to patients, patient safety is imperative. The rapidly changing regulatory environment will provide both challenges and opportunities, given the rapid development of this technology. Today, we see the benefit of AI more likely to be in optimizing internal processes, while also becoming a tool to support the product development cycle.