In the US alone, the number of people over 50 with at least one chronic disease is expected to nearly double over the next three decades, increasing from 71.5 million in 2020 to 142.7 million by 2050.1 This is just one of the factors that has led to soaring patient demand for injectable drug-device combination (DDC) products with improvements in usability, convenience, and safety.
These products must prioritize patient needs while ensuring scalability and quality. This is where Contract Development and Manufacturing Organizations (CDMOs) step in. In partnership with bio-pharma businesses, the right CDMO brings the expertise and resources necessary to navigate the complexities inherent to this evolving, competitive field.
This playbook highlights six critical challenges for injectable format DDC producers, offering practical guidance to overcome them. With expert guidance on regulatory compliance, supply chain management, and patient-first development, this playbook serves as a roadmap for bringing successful DDC products to market in a way that maximizes business value and, most importantly, patient outcome.
Led by Patients, Underpinned by Data
A patient-centered approach to DDC development ensures devices are intuitive and tailored to the unique needs of each patient population. If patients’ needs are prioritized early in the design and testing phases, this results in practical improvements in real-world settings. Manufacturers can make essential design and functionality choices that anticipate potential challenges and minimize risks in everyday use.
But evaluating patient needs – putting patients first – is a process that has to go beyond the qualitative. In fact, data is the backbone of this patient-first development strategy, driving precision and reliability at each stage of the DDC lifecycle.
The Benefits of a Robust Data-Driven Approach to Development:
Identify potential improvements quickly, for faster optimizations.
Recognize and anticipate potential design flaws and patient mis-use ahead of time.
Establish greater consistency across production.
Support regulatory compliance by demonstrating repeatability and quality across all phases, from clinical trials to commercial production.
But for DDC developers, the centrality of patient-first design thinking and the data that enables it raises a question: How can manufacturers access these insights? The answer is by partnering with a best-in-class CDMO that prioritizes both patient needs and has the data resources, development and final assembly, package design, pack and testing experience to deliver DDCs that make a difference to patients’ lives.
The 6 Critical Challenges in Drug-Device Combination Product Development – and How to Overcome Them
Developing drug-device combination products comes with primary challenges that can impact quality, scalability, and time-to-market. Successfully navigating these demands requires a CDMO with the expertise, infrastructure, and adaptability to address each challenge effectively.
Human factors studies are a foundational step necessary to meet requirements for regulatory filing when seeking DDC product approval. These studies demonstrate that the enduser is fully capable of self-dosing with minimal instruction.
Additionally, the device itself must meet standards based on stability studies that indicate it is capable of safely delivering the intended medication in a sterile and shelf-stable way. While Phase 1 of development and any separate dosing studies will be best served by vials, the correct next step is to establish a container and device implementation strategy. Waiting until later phases of the trial to introduce the device extends the time and cost to bring the product to market.
An intelligent CDMO offers comprehensive support in stability and human factors studies as well as prototype and device development as early in the process as possible. To support the human factors study, the CDMO should provide a holistic view of the patient experience created by the DDC product, packaging, and labeling.
“From an infrastructure and science and capability perspective, these are things that PCI has been investing in to help enable this process on behalf of our clients, so they have the benefit of using the device in the clinical study,” says Justin Schroeder, Global Vice President of Technical Services. “This can accelerate the pathway to device approval.”
As previously noted, regulatory compliance in drug development is highly complex, involving adherence to stringent guidelines from multiple agencies like the FDA and EMA. Specialized knowledge is needed to successfully navigate evolving regulations, ensure product safety and efficacy, and manage detailed documentation, all while facing varying global requirements and timelines.
An ideal CDMO partner will demonstrate:
A proven track record in sterile drug product manufacturing and DDC product development
A deep knowledge of relevant regulations and experience with regulatory agencies
A detailed understanding of relevant ISO standards and associated testing
A history of successful submissions and product launches
A solid quality management system
Quality and regulatory solutions should extend throughout the drug product lifecycle. Changes can be minimized by setting the strategy early for correct selection of drug container, device, and the inevitable need to scale up. Across this process, a dedicated regulatory affairs team and certified quality management system — as is the approach at PCI — ensures a DDC product meets the highest standards
When developing a DDC product, it’s important to be able to respond to market dynamics and scale rapidly if necessary, all while maintaining product quality, managing costs, and meeting patient demands. Additionally, it can be challenging to clarify clinical and commercial goals, including target patient populations, geographic markets, and timelines.
Achieving this requires a CDMO that has the flexibility and capacity to not only produce small product batches for clinical trials, but to then scale to commercial market needs. Initially, early in the clinical trial process, the final device and drug container format should be selected for production, reducing the possibility of unexpected issues or duplicated efforts.
From there, the CDMO should be able to seamlessly transition to a larger-scale commercial manufacturing process to avoid delays and maintain consistent quality. This requires state-of-theart facilities, diverse device-agnostic equipment, extensive, readily available tooling, and a track record of delivering high-quality combination products at any scale.
Given the complexities of the global pharmaceutical supply chain, managing risks, including supplier networks, sourcing strategies, and disruption adaptability is critical. A strong CDMO can carefully evaluate client opportunities to determine the most efficient supply chain structure, identifying where redundancy can be strategically built in. From a sustainability perspective, they should also consider ways to minimize unnecessary transportation, cold chain, and reduce waste throughout the process.
“We are very mindful as we look at client opportunities to see what the best supply chain structure is. Where might we try to have redundancy? Certainly from a sustainability perspective — where can we mitigate unnecessary transportation or waste in that process as well?” says Justin Schroeder. “These considerations differ across clinical and commercial contexts, so we often raise these questions early to ensure clients are thinking strategically.”
Keeping drug development projects within budget is a constant challenge, as unforeseen factors like regulatory changes, extended timelines, and evolving technical requirements can lead to cost overruns. Managing these variables while maintaining quality and compliance makes controlling project costs particularly difficult, while being particularly mindful to manage supply chain and project risks.
Companies should choose a CDMO with precise timelines, project management and pricing models to control costs and maximize ROI. By streamlining operations, recommending process improvements, and optimizing workflows, the right partner can help reduce waste and control costs without compromising quality or timelines.
Established platforms, validated device agnostic equipment lines, and readily available tooling can minimize operational inefficiencies, reduce lead times with minimized validation effort, and ensure cost-effective scalability.
Crucially, a manufacturing strategy that employs multiple capacity bands minimizes the need for validation of equipment, processes, and products while consistently meeting regulatory standards.
In addition, a CDMO that considers long-term lifecycle management and market dynamics can provide strategies to support sustainable cost efficiency across a DDC product’s lifecycle.
Schroeder explained, “We have an ecosystem that’s set up to optimize cost for whichever patient population is in scope, whether that’s millions or whether that’s sometimes hundreds, if it’s a rare disease. What PCI brings is an ability to manage the uncertainties of the market and being able to mitigate those impacts to a biopharmaceutical company.”
Pharmaceutical companies face immense pressure to bring products to market quickly, driven by fierce competition, patient needs, and regulatory timelines. Balancing speed with safety and efficacy is a constant challenge, often creating tension between innovation, compliance, and time-sensitive demands in an everevolving industry.
The goal of the CDMO should be to support faster time-to-market by investing in flexible clinical to commercial device-agnostic assembly equipment together with pre-existing assembly and test tooling for common device formats across multiple equipment scales, in addition to early introduction of the DDC into the clinical trial process.
CDMOs Should Be a Consultative Partner
Ultimately, CDMOs should guide clients in developing long-term manufacturing strategies that optimize time, safety, and cost across clinical and commercial stages. “This is a very data-driven area of the business,” explained Justin Schroeder. “Because of the inherent risks of self-administration, very sophisticated and precise final assembly and testing is fundamental to DDC manufacture. Part of what PCI offers is extensive experience, expansive testing, rigor around data management, and the demonstration of repeatability and safety.”
This is the advantage of leveraging a CDMO: the developer gains support navigating the complexities of DDCs and associated regulatory requirements. An experienced CDMO can provide tailored guidance on device selection, advising whether to choose innovative custom devices or proven platforms based on patient needs. Overarching the whole process is proactive communication, in which any potential issues in supply chain and development are raised ahead of time to prevent costly mistakes.
By optimizing every stage of the DDC manufacturing process – from clinical development to commercialization – pharma companies in partnership with CDMOs can bring these life changing products to patients with precision, safety, and speed. PCI provides the experience and infrastructure to ensure that the complex process of developing a DDC product is as smooth and barrier-free as possible, advancing healthcare and transforming lives.
This article from Bill Welch and Justin Schroeder was published in Biopharma Dive in June 2025
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