SPECIAL FEATURE - Injection Devices: Faster, Integrated, and Flexible for the IV to SC Transition

The global injectable drug delivery market was valued at $633.77 billion in 2024, currently stands around $690 billion, and is forecast to reach $1.03 trillion by 2030.¹ Use of wearable injectors, autoinjectors, and needle-free systems is being driven by the rising prevalence of chronic diseases, an increasing demand for biologics, and patient preference for self-administration. Additionally, the move towards personalized medicine and combination therapies has spurred more tailored and smarter delivery solutions for complex drug regimens.¹

According to the World Health Organization, diabetes, cardiovascular diseases, and cancer account for more than 74% of all deaths annually, highlighting the need for injectable drug delivery technologies. Infectious diseases are also increasing, driving demand for injectable delivery.¹

“The future of injectable delivery is incredibly promising, particularly as we see rapid advances in combination product design, device technology, and patient engagement tools,” says Dawn Manley, Director Global Technical Sales at PCI Pharma Services. “From a development standpoint, I’m particularly excited about the growing alignment between formulation science and device engineering, which will allow for faster, more integrated development pathways and greater flexibility in delivering therapies that improve lives globally.” Additionally, industry experts see a need for more flexible and expanded design that enables complex subcutaneous drug delivery.

This annual, exclusive Drug Development & Delivery magazine report highlights how device developers are addressing these challenges while still ensuring precise dosage control and patient compliance.

Artcraft Health: A Transfer of Knowledge Ensures Safe & Accurate Self Injections

Did you ever get a new TV and could­n’t get the remote to work? It looked like your last remote so you assumed it would work the same, but it didn’t. Now, imagine a busy nurse practitioner about to train a patient on how to use an on-body injector that looks like the one she’s used hundreds of times. After a few tries, she can’t get the new device to function properly, and that means lost time and patients put at risk.

“Ironically, it may be injection-experi­enced clinicians who make more errors than patients when adopting new or re­tooled devices,” says Marty Mason, Senior Director, Demo and Training Devices at Artcraft Health, a full-service health edu­cation company. “Whether due to muscle memory or ingrained expertise, it’s not un­common for an HCP to wrongly predict that a new device should work the same as a previous one.”

This tendency, known as negative transfer, can lead to errors and incorrect dosing. While some experienced patients may also make negative transfer errors, “injection-naïve” (first-time) users may be more cautious and make fewer er­rors.

Says Todd Zimmermann, Managing Director of Artcraft, “We’ve learned from our deep experience in patient education and human factors studies that when a demo device accurately mimics an actual device through seamless reverse engineer­ing, error-free training is possible. We aim to match the commercial experience as closely as possible for a smooth transition from training to real use. That’s why we developed demoX™, an electromechanical device with built-in sensors that replicate the physical, visual, and auditory cues of an injection device.”

Mason notes that the demoX autoin­jector, which delivers five times as many demo cycles as traditional mechanical demo devices, can be adapted for on-body injectors as well. He says that Art­craft Health is well-versed in on-body device training, having engineered and produced thousands of demo device kits as part of a client’s global training initia­tive for a combination therapy that uses on-body injectors. As biosimilar and new drugs emerge for similar indications that use on-body injectors, the risk of negative transfer increases because patch injectors look similar, but may have different func­tionality. For example, clinicians may in­correctly attempt to bottom fill a device that now fills from the top, since they’re used to a previous delivery method.

“Our solution to mitigate negative transfer is to educate users right from the beginning using a cross-platform ap­proach that successfully transfers their knowledge from one device to another,” says Stephanie Murrin, Chief Creative Of­ficer, Artcraft Health. “For example, we would create a demoX on-body training device in tandem with our customizable eLearning training system, checkEd™, to capture all the features and nuances of a device. That way we can facilitate success­ful onboarding by HCPs and help patients feel confident self-administering their drugs from the start.”

BD: Partnering to Bring Complex Molecules to Market

One of the biggest challenges in in­jectable delivery from BD’s perspective is balancing drug formulation requirements with available device solutions to deliver high-dose biologics. High-dose formula­tions can have a high viscosity profile (30 centipoise or more) or higher volume dose (greater than 2mL) or even both. These types of formulations can be challenging to deliver subcutaneously with device com­ponent options developed for use within a narrower design space. Because many of the new biologic drugs in the pharma de­velopment pipeline, as well as commer­cially approved biologic drugs, being transitioned from intravenous (IV) to sub­cutaneous (SC) delivery are in high-dose formulations, BD sees this challenge con­tinuing if not growing, going forward.

“Based on that, we see pharma seek­ing components that expand the design space for subcutaneous delivery of high- dose biologics while leveraging existing in­frastructure in the pharma ecosystem,” says Beth McBride DiLauri, Director of Global Marketing, BD Medical – Pharma­ceutical Systems.

BD is actively collaborating within the pharma ecosystem to offer multiple op­tions for pharma to increase flexibility as they develop high-dose drugs in drug-de­vice combination products. These device collaborations enable pharma flexibility within an expanded design space for high-dose biologics while leveraging existing in­frastructure for fill, finish and final assembly.

First, BD is partnering with autoinjec­tor companies such as SHL and Ypsomed to enable handheld delivery of viscous bi­ologics using an autoinjector within the traditional injection time constraint of ≤15-20 seconds. These collaborations are fo­cused on allowing a wider design space for higher viscosity drugs by enabling compatibility of BD Neopak™ XtraFlow™ Glass Prefillable Syringe with commercially available autoinjectors. Studies of these configurations have demonstrated re­duced injection time while using BD Neopak XtraFlow syringe with their com­mercially available autoinjectors, when compared to syringes with 27G thin-walled, ½-inch needle, says Ms. McBride DiLauri.

Second, BD is integrating its larger volume delivery solution, BD Libertas™ Wearable Injector, into the pharma supply chain infrastructure for drug-device combination products. BD is currently col­laborating with multiple Contract Manu­facturing Organizations (CMOs) to establish fill, finish, and final assembly op­tions within pharma’s supply chain net­work. In addition to the BD-sponsored clinical trial completed with BD Libertas Wearable Injector that was pub­lished in 2020, which successfully demon­strated the ability to deliver 5mL drug volume with BD Libertas wearable Injector, BD is also enabling pharma’s evaluation of a complex biologic in a pharma-spon­sored clinical trial with BD Libertas Wearable Injector.“ These collaborations demonstrate another approach BD is tak­ing to support pharma in delivering high-dose biologics to the market,” she says.

Credence MedSystems, Inc.: Supporting Shortened 5mL Barrels for 3mL Dosing

The growing shift toward biologics and long-acting injectables has created strong demand for subcutaneous (SC) de­livery of larger volumes, approaching the 3mL to 5mL range. While SC injections were once limited to 1mL, developers now seek devices that can extend this boundary without compromising patient comfort, manufacturability, or safety. One practical approach is the use of cut-down 5mL bar­rels to deliver 3mL volumes, allowing ex­isting filling lines to be used without costly retooling, while avoiding the handling and injection challenges associated with longer syringe barrel geometries.

“The Credence MedSystems Com­panion® Syringe System offers advantages to address the challenges created by this trend,” says John A. Merhige, Chief Com­mercial Officer, Credence MedSystems, Inc. “Unlike traditional exoskeleton-based devices, which require an entirely new platform for each barrel size, the Com­panion integrates its safety and usability features directly into the syringe. By keep­ing the safety technology integral, the Companion platform applies seamlessly across 1mL, 2.25mL, 3mL, and 5mL sy­ringe barrels – including shortened 5mL barrels used for 3mL delivery. This consis­tency reduces development risk, simplifies supply chains, and ensures a uniform user experience across a drug portfolio. In con­trast, exoskeleton approaches add bulk, drive operational inefficiency, and often in­timidate patients with their unfriendly han­dling and appearance – creating hurdles for both manufacturers and end users.”

Patient comfort and adherence re­main critical considerations with higher SC volumes. The Companion system supports user-controlled injection, minimizing the impact of force variability and enabling more tolerable delivery of viscous formu­lations. Its automatic needle retraction and passive safety features protect patients and caregivers alike, while maintaining the fa­miliar handling of a prefilled syringe. “For therapies transitioning from infusion to SC injection, this combination of safety and familiarity is essential to adoption,” he says.

The sustainability advantages of the Companion platform are also magnified as syringe size increases. By avoiding bulky exoskeletons or disposable add-on devices, Companion significantly reduces plastic waste and overall material usage – the benefits of which scale exponentially in larger barrel formats. Mr. Merhige says:
“Pharmaceutical partners benefit not only from cost savings in packaging and logis­tics, but also from aligning with corporate and regulatory sustainability commit­ments.”

As biologics pipelines continue to ex­pand, manufacturers require platforms that combine scalability, patient-centric us­ability, and operational efficiency. “The Credence Companion Syringe System sits at this convergence, enabling application of integrated safety and usability features across the full syringe range, supporting industry trends such as shortened 5mL barrels for 3mL dosing, and delivering measurable sustainability benefits,” he says.

Datwyler Healthcare: Ensuring Integrity & Functionality

The biggest challenge in injectable delivery is ensuring the integrity and func­tionality of the primary packaging compo­nents to protect increasingly sensitive and complex drug formulations, especially bi­ologics, explains Carina Van Eester, Global Platform Leader, Prefilled Syringes and Cartridges, Datwyler Healthcare. “This challenge goes beyond just produc­ing a good component; it’s about a ‘zero defect’ philosophy that recognizes the crit­ical role of primary packaging in the drug’s safety, stability, and efficacy,” she says.

Additionally, she says that regulations like USP<382>, which focuses more on the system instead of the component, and Annex 1, which requires a holistic ap­proach to contamination control, require the support of knowledgeable suppliers who can work with the customers to bring new injectable drugs faster to the market.

“In close collaboration with partners, Datwyler has pioneered an industry-first: fully coated plungers in 5, 10, and 20mL formats—sizes that were not previously available on the market,” she says. “This expansion of our NeoFlex™ portfolio, which already included 0.5mL, 1mL long, 1–3ml PFS, and 3mL cartridge plungers, was developed with system thinking aligned to USP <382> requirements.”

She explains that large-volume plungers were once designed mainly for manual use or infusion pumps with small molecules that required no coating. With the shift toward subcutaneous administra­tion of biologics, the demand for fully coated plungers has grown. These plungers are critical to safeguard sensitive biologics from rubber extractables while ensuring consistent device functionality and accurate dosing.

“Our NeoFlex large-volume plungers are a critical component to guarantee good functionality of the new injection de­vice,” says Ms. Van Eester. “NeoFlex plungers are also integral to the shift from traditional intravenous (IV) infusions to subcutaneous (SC) injections for patient self-injection. This advancement signifi­cantly improves patient comfort and con­venience by eliminating the need for frequent visits to a hospital or clinic. Ulti­mately, this move toward at-home self-ad­ministration offers substantial benefits for the entire healthcare ecosystem. By reduc­ing the reliance on costly clinical resources and professional healthcare staff, it leads to a total cost savings for both healthcare systems and insurers. The result is a more efficient, patient-centric, and cost-effective approach to long-term chronic disease management.”

Lifecore: Incorporating New Drug Delivery Technologies Into Clinical & Commercial Manufacturing

New drug delivery technologies are transforming treatments within the injecta­bles space by enabling new therapeutic options for previously unmet patient needs. For example, new technologies allow for higher concentrations of biolog­ics to be delivered via injectables. While this is positive for patients, it poses manu­facturing challenges. Higher concentra­tions can result in the formation of suspensions, which can increase formula­tion viscosity. Also, suspensions are difficult to maintain due to the potential for prod­ucts to settle, creating complexity at multi­ple points in the manufacturing process and affecting the long-term stability of a product. With decades of expertise in ster­ile filtration and filling of highly viscous and complex products, Lifecore supports these types of delivery technologies and the formulations that incorporate them.

The novel use of polymers is also ad­vancing the capabilities of injectables. Polymers are tunable and can thereby form delivery depots with improved target­ing and sustained/controlled release of products. “Some of the formulations we manufacture use Lifecore’s hyaluronic acid (HA) to create a drug delivery depot that offers controlled release of a drug,” ex­plains Ryan Swanson, PhD, Director of Process Development, Lifecore. “HA is often selected for these formulations be­cause it is a naturally occurring biopoly­mer found throughout the human body, offering a safe vehicle for drug delivery. To date, Lifecore’s premium, pharmaceutical-grade HA has been incorporated in more than 150 million doses of injectable prod­ucts worldwide. We continue to support the novel use of HA for clinical and commer­cial requirements by working with drug de­velopers to create custom modifications for their unique formulations.”

Nemera: Continuous Drug Delivery Accommodates Demanding Biologics

The biggest challenge in injectable delivery remains balancing patient com­fort, safety, and adherence with the in­creasing complexity of current injectable therapies. Many new biologics, such as large-molecule drugs, require higher vol­umes, higher viscosity, and longer injection time.

“Conventional autoinjectors relying on spring forces to push drug quickly (in 10–15 seconds) could become impractical and painful for the patient as volume or viscosity increases,” says Corinne Malica, Marketing Global Category Manager, Ne­mera. “On-body delivery system devices address these challenges by allowing de­livery of large volumes (up to 30 mL) over extended periods (several minutes up to an hour), at controlled flow rates that poten­tially mitigate patient pain and tissue stress, which eventually improves patient adherence.”

Nemera’s reusable on-body injector platform, Symbioze®, for continuous drug delivery is designed to accommodate the demanding requirements of biologic de­livery – high-viscosity and large-volume formulations – with minimal patient dis­comfort, she describes. “Symbioze tackles this with a powerful miniaturized motor that can sustain controlled flow rates for very viscous solutions. It also allows pro­grammable delivery profiles to accommo­date drug characteristics and minimize injection force. Moreover, it integrates sev­eral key features – a reusable/disposable hybrid architecture for sustainability as­pects, for large volume capacity and con­nectivity – setting it apart from other leading platforms.”

Symbioze provides audible and visual feedback to reassure the user that the dose is being delivered correctly. Large, tactile button and intuitive indicators make the in­jection experience as seamless as possible for patients of all ages, including those with limited dexterity. Finally, the combina­tion of controlled flow, user-friendly, and intuitive interface is aimed at maximizing comfort and confidence during longer subcutaneous injections.

Ms. Malica says: “This platform was designed with connectivity in mind, featur­ing built-in Bluetooth and integration with a dedicated app or cloud system to man­age injection schedules, to send reminders and training prompts.”

In fact, she says that the future of in­jectable delivery is moving toward con­nected, intelligent devices that not only administer medication but also provide ac­tionable insights for personalized care.

“As therapies become more complex, injectable delivery will evolve to be more comfortable, precise, and data-driven, ul­timately improving patient outcomes and reducing the burden on healthcare sys­tems,” she says. “By combining electro­mechanical reliability with digital connectivity, the device supports both pa­tient adherence and clinician oversight. This addresses the dual challenge of im­proving patient experience while ensuring accurate, consistent drug delivery.”

PCI Pharma Services: Early Integration of Drug Product With Device

One of the most persistent challenges in injectable drug delivery is balancing the increasing complexity of drug formulations such as biologics, high-viscosity com­pounds, and novel modalities with the need for user-friendly, patient-centric de­livery systems. As therapies shift toward self-administration and home use, delivery devices must accommodate larger vol­umes and more sensitive formulations without compromising ease of use, injec­tion comfort, or dose accuracy. This is par­ticularly critical for patients with limited dexterity or chronic conditions requiring regular injections.

“From a development and manufac­turing perspective, integrating the drug product with the right device early in the lifecycle is essential, yet it remains a chal­lenge due to evolving regulatory require­ments, variable regional preferences, and device availability,” says Dawn Manley, Di­rector Global Technical Sales at PCI. “We see the greatest success when there is early collaboration between formulation, de­vice, packaging, and regulatory teams to ensure the final product is safe, scalable, and aligned with patient needs across diverse therapeutic areas and global markets.”

As a CDMO, PCI Pharma Services partners with a range of biopharma com­panies and injection device manufacturers to support the development, sterile fill-fin­ish manufacturing, assembly, testing, la­beling and packaging of diverse drug-device combination products, includ­ing prefilled syringes (PFS), autoinjectors, pens, and on-body injectors. “PCI’s de­vice-agnostic approach, combined with technical and regulatory guidance, en­ables clients to align their drug products with the most suitable delivery systems, en­suring a seamless path from development to commercialization in both North Amer­ica and Europe,” she says.

The increasing complexity of in­jectable therapies demands flexible, scalable solutions that can accommodate var­ied formats across therapeutic areas and global markets. PCI’s integrated services span clinical to commercial supply, man­aging intricate workflows and patient-cen­tric design considerations while maintaining rigorous quality and compli­ance standards. Its capabilities support both high-volume treatments and person­alized medicines.

PCI’s recent acquisition of Ajinomoto Althea in San Diego significantly expands its sterile fill-finish capabilities in North America, particularly in syringe and car­tridge filling, bolstering the CDMO’s ability to support the increasing drug-device combination products across biologics, peptides, and small molecules. “Our adaptable tooling and assembly lines are designed to accommodate a wide range of device designs, materials, and configu­rations, enabling us to support clients in bringing life-changing injectable therapies to market with agility, precision, and patient-focused innovation,” says Ms. Manley.

Singota Solutions: Meeting the Multifaceted Challenges of Injectable Delivery

Despite advancements in biologics and drug delivery technologies, the biggest challenge in injectable delivery continues to be improving the patient ex­perience sufficiently to maximize patient acceptance during the administration of complex molecules, according to Tim Wil­son, Business Development Manager at Singota Solutions. This requires thought­fully integrating formulation science, de­vice engineering, usability, and regulatory compliance while ensuring product quality, safety, and accessibility.

As an injectable medicine CDMO based in the US, Singota Solutions special­izes in formulation development and asep­tic filling. Singota serves as a one-stop-shop for early-stage, growing biopharma clients, offering cGMP cold chain services, including DSCSA-compli­ant 3PL, transportation testing, sample and dispense in Grade C suites, three sites in Europe, and labelling, packaging, and kitting services.

“The rapid growth of biologics, in­cluding monoclonal antibodies, gene ther­apies, and long-acting injectables, has redefined therapeutic possibilities, but in­troduced significant delivery hurdles,” he says. “These molecules often demand high-concentration formulations with ele­vated viscosities and injection volumes, which can cause patient discomfort, re­quire extended injection times, and test the limits of current device and container sys­tems. Reformulation may help, but fre­quently impacts drug stability or shelf life, requiring extensive analytical and compat­ibility studies.”

Drug-device combination products further compound the challenge, he adds. Devices must be mechanically sound and intuitive for self-administration, especially for patients with chronic conditions, limited dexterity or needle anxiety. Designing de­livery systems that meet user needs without compromising performance is a human factor and engineering challenge. This topic will take on increasing importance as healthcare continues to shift toward de­centralized, home-based care, says Mr. Wilson.

Regulatory expectations around in­jectable drug products are increasingly rig­orous. Developers must demonstrate safety and efficacy of the drug and its de­livery system under real-world conditions. Human factors validation, extractables and leachables testing, and stability under intended-use scenarios all contribute to ex­tended timelines and add development costs.

Cold chain logistics represent another challenge. Many injectable therapies re­quire stringent temperature controls. Maintaining product integrity while en­abling flexible and responsive supply chains, particularly for personalized ther­apies, demands robust quality systems and operational agility.

Accessibility must remain at the forefront. Injectable delivery technology inno­vation must be accompanied by strategies to scale manufacturing, streamline fill-fin­ish operations, and reduce costs to support broader patient access, especially in re­source-limited settings. “Meeting the multifaceted challenges of technical and operational complexity as Singota accelerates client pathways to the clinic requires close collaboration across formulation, quality, and operational do­mains,” says Mr. Wilson.

SCHOTT Pharma: Scaling Biologics Volumes to 5mL

One of the biggest challenges in in­jectable delivery lies in scaling biologics therapies to volumes of 5mL and more without compromising patient comfort, drug stability or operational efficiency. As biologics become more complex and po­tent, the need for high-volume subcuta­neous delivery grows. Ready-to-use cartridges for large volumes are emerging as a transformative solution. These car­tridges are designed to integrate seam­lessly into wearable injectors or advanced autoinjectors, enabling subcutaneous de­livery of viscous formulations over ex­tended durations.

“Their robust design supports high fill volumes while maintaining container clo­sure integrity, extractables/leachables compliance, and compatibility with high-throughput fill-finish operations,” says Dr. Robert Lindner, Global Product Manager Cartridges, SCHOTT Pharma. “Technically, these cartridges must balance several crit­ical parameters: dimensional precision for device compatibility, barrier properties to protect sensitive biologics, as well as reli­able break-loose and gliding forces to guarantee the consistent injection of bio­logics.”

Moreover, the shift toward nested, ready-to-fill formats is reducing line com­plexity and contamination risk during fill and finish, while supporting automation and scalability. As injectable therapies be­come increasingly personalized and data-driven, the supporting infrastructure, including the primary packaging, must evolve to enable seamless integration with intelligent delivery systems, he says. Smart cartridges with embedded data-matrix codes or RFID tags could enable real-time tracking of dose history and drug identity, enhancing pharmacovigilance, traceabil­ity, and personalization.

“SCHOTT Pharma is excited about the convergence of material science, device engineering, and digital health,” says Dr. Lindner. “Large-volume ready-to-use car­tridges are no longer passive containers – they are enablers of next-generation therapies. As pharma moves toward de­centralized care and patient self-adminis­tration, these cartridges will be central to delivering complex biologics safely, effi­ciently, and intelligently.”

Stevanato Group: Addressing the Growing Complexity of Subcutaneous Delivery

The key to a successful launch and market penetration of biologics is the selection of the appropriate device like pens, autoinjectors or on-body delivery systems in combination with the most suitable container. The need to accommodate higher volumes, viscous fluids, an increasing number of longer-acting injectables with weekly, monthly or even longer dosing intervals, smaller batches, and the omnipresent need to reduce healthcare costs call for innovative and adaptable solutions. In addition, a user-friendly design with an ergonomic grip, an intuitive injection mechanism and safety features that prevent accidental needlestick injuries are just some of the additional challenges that need to be solved.

“An example that encompasses these features is the Aidaptus® autoinjector, developed by Owen Mumford and Stevanato Group,” says Adam Stops, Head of Product Management for Drug Delivery Systems, Stevanato Group.

Aidaptus is a two-step, single-use autoinjector compatible with prefilled 1mL or 2.25mL glass syringes. “These product features offer added value to pharmaceutical companies by delivering class-leading flexibility and adaptability in the development and manufacture of combination products,” he says.

Aidaptus ensures drug visibility through the device’s large window, allowing dose verification. It is designed to prevent needlestick injuries through a passively deployed needle shield, giving reassurance to patients with needle phobia by hiding the needle before, during, and after use. And, it features audible and visual notifications as clear feedback to the user for patient confidence and reassurance.

The ongoing trend of shifting from intravenous (IV) to subcutaneous (SC) drug delivery, which requires expanded treatment options with higher injection doses and more concentrated and highly viscous formulations, demands solutions that reduce the frequency of injections as offered by on-body delivery systems (OBDS). The Vertiva® OBDS, developed by Stevanato Group, uses a versatile platform technology, capable of delivering micro-precision basal doses or full-content bolus injections. The core technology consists of a disposable injection unit called pod, a reusable smart controller that governs the activation process, and a proprietary, magnetically coupled drive mechanism connecting the pod to the smart controller enabling contactless power transmission between the two.

“One of the main advantages of OBDS is its ability to address the key challenge of medication adherence, part of the treatment effectiveness estimated to affect 30-40% of long-term patients,” says Mr. Stops. “Vertiva stands out for its modular design and adaptability, supporting a wide range of therapies and delivery profiles within a single platform. Its flexible configuration – available in 3 and 10mL format – allows pharmaceutical companies to tailor the device to specific drug characteristics and patient needs, while maintaining ease of use and manufacturing efficiency. This makes it a practical solution for addressing the growing complexity of subcutaneous drug delivery.”

Terumo Pharmaceutical Solutions: Bridging the Gap in Ophthalmic Drug Delivery

The injection device represents a crit­ical advancement in enabling the effective administration of injectable therapies for vision impairing diseases. Verified and val­idated for intravitreal applications, it serves as the essential link between pharmaceu­tical innovation and clinical implementa­tion. Pharmaceutical researchers and drug developers have long recognized the sig­nificant burden of ophthalmologic condi­tions, responding with therapies that demonstrate proven clinical outcomes. Many of these treatments require precise delivery directly into the eye, a challenge that demands specialized technology. In alignment with its mission to support med­ical progress, Terumo has leveraged its deep expertise in injection systems to de­velop an intravitreal needle, facilitating re­liable drug administration for ocular therapies.

“Current market offerings for medical devices validated for intravitreal injection often fall short of meeting the stringent re­quirements of pharmaceutical companies and regulatory authorities,” says Thomas Isaac, Product Manager for Injection Devices at Terumo Pharmaceutical Solutions. “In response, Terumo has developed a so­lution that addresses these critical needs: a fully validated injection device supported by robust documentation. Leveraging its expertise in cannula design, needle man­ufacturing, and integrating advanced fea­tures – such as integrated filter – Terumo demonstrates a holistic approach to the unique challenges of parenteral oph­thalmic therapy.” He adds that the inclusion of a filter within the fluid path directly addresses concerns widely discussed in scientific lit­erature regarding the presence of both ex­trinsic and intrinsic particulate matter in injectable formulations.

West Pharmaceutical Services: Aligning All Facets of the Combination Product Lifecycle

One of the most persistent challenges in pharmaceutical packaging lies in align­ing fragmented knowledge across stake­holders. While confidentiality is a necessary pillar of the life science industry, it can also hinder open dialogue. Companies are un­derstandably cautious when it comes to sharing proprietary insights – yet without some degree of transparency, it’s difficult to collaboratively address common obstacles. Creating environments where trust and discretion coexist is essential to moving forward.

This becomes particularly evident in the context of combination product devel­opment, where pharmaceutical companies often rely on several different suppliers for their device constituent part, says Dr. Bettine Boltres, Director, Scientific Affairs, Inte­grated Systems at West Pharmaceutical Services. “These collaborations frequently involve burdensome confidentiality agree­ments (often even 3-way CDAs), inconsis­tent data sets, and a lack of synchroniza­tion across partners. As a result, it’s not uncommon to see delays, miscommunica­tion, and inefficiencies that could have been avoided with better-integrated work­flows.”

With the rise in biologics, there is a concurrent rise in combination products – integrating drugs with device parts such as prefillable syringes. “Historically, pharma­ceutical development and medical device engineering have followed distinct paths, each with its own regulatory logic, devel­opment priorities, and risk and quality frameworks. But as the two domains con­verge, a new paradigm will be emerging – one that demands alignment across all facets of the product lifecycle. Our industry is in the midst of a turning phase.”

Dr. Boltres says small companies, in particular, may struggle to navigate these complexities as they often lack experience with regulatory expectations or technical in­terdependencies, making it hard to antici­pate issues before they arise. On the flip side, large global organizations can face challenges of their own – such as internal silos, overlapping responsibilities, or diffi­culty aligning across multiple business units.

This shift isn’t limited to regulatory compliance. It begins much earlier, at the development stage, where a shared under­standing of performance, safety, and qual­ity objectives must guide design decisions. It also extends into risk management, where integrated assessment methodolo­gies are increasingly needed to meet global expectations.

This evolution also affects the packag­ing sector. It’s not just about protecting the product – it’s about ensuring functionality, compatibility, and regulatory readiness across an integrated platform. As such, the role of packaging suppliers is expanding into true system manufacturing, with re­sponsibilities that mirror those traditionally held by device companies.

“The mindset of ‘component supplier’ no longer suffices. We are now responsible for delivering functional systems – fully ver­ified and ready to support both pharma­ceutical and device-level requirements,” she says.

In the end, the true hurdle is not a lack of expertise, but the scattered nature of that expertise. “Our goal should be to consoli­date critical information, streamline com­munication, and support pharma partners in gaining a clear, system-wide under­standing of their packaging choices,” she adds. “Only then can we reduce friction and deliver reliable, high-quality solutions that meet both technical and patient needs. In the coming years, this convergence will continue to reshape how therapies are de­signed, built, and regulated around the world. These currently parallel worlds – pharma and medtech – will eventually op­erate as one cohesive ecosystem.”

Reference

1. Injectable Drug Delivery Market: Growth, Size, Share, and Trends, Mar­ketsandMarkets, May 2025.