The Rise of Combination Products: How Life Science Contract Manufacturers Can Prepare

Combination products — therapeutic and diagnostic products that integrate drugs, devices, and/or biological products — are surging within the life sciences industry. From insulin pens and auto-injectors to drug-eluting stents and pre-filled syringes, these integrated therapies are becoming the new standard in patient care. It's estimated that the global drug/device combination product market size will increase from \$165.26 billion in 2025 to \$355.84 billion by 2034 (a CAGR of 8.91%).¹

But as the market accelerates, so does the complexity. Life science contract manufacturing organizations (CMOs) are under increasing pressure to adapt. Developing, producing, and delivering combination products means navigating overlapping regulatory frameworks, managing various supply chain elements, and ensuring all quality systems are airtight. This evolution isn't just about scaling up — it's about rethinking how manufacturing systems, processes, and technologies work together to bring safe, compliant, and innovative products to market.

So, how do CMOs prepare? Below, we'll explain three key areas that life science contract manufacturers must focus on to keep pace with the rise of combination products, from tackling unique manufacturing challenges to deploying integrated systems that support next-generation production.

Top 3 Challenges in Drug-Device Manufacturing

Integrating drugs and devices into single therapeutic products (while innovative and helpful for patients) introduces a myriad of challenges. Each component — be it pharmaceutical or mechanical — must function independently and synergistically within the final product. More simply, each component must work well on its own as well as with the final product. That means CMOs need a comprehensive understanding of drug formulation and device engineering.

For example, ensuring material compatibility is critical. The drug must remain stable and effective when in contact with device materials, which may require specialized coatings or barrier layers. Additionally, the manufacturing process must accommodate the unique requirements of both components, often leading to the need for customized product lines or facilities.

The regulatory landscape adds another layer of complexity as well. Manufacturers must navigate overlapping regulations, including 21 CFR Part 4, which outlines current good manufacturing practice (cGMP) requirements for combination products and is enforced by the U.S. Food and Drug Administration (FDA).² This "streamlined approach" aims to harmonize drug and device regulations but requires meticulous documentation and compliance strategies.

As manufacturing becomes more intricate, the need for complete visibility of the entire supply chain becomes more critical, especially when it comes to tracking, tracing, and maintaining control over every material and component in action.

Improving Tracking and Tracing Within Supply Chains

Combination products introduce a heightened level of supply chain complexity that traditional tracking systems were never designed to handle. Each product often involves multiple suppliers, discrete lot tracking, serialized packaging, and temperature-sensitive components. For life science contract manufacturers, that means a greater responsibility to trace every material and component across its lifecycle.

This is where advanced tracking and tracing systems come in — not just as regulatory necessities but as essential operational tools. The Drug Supply Chain Security Act (DSCSA), for example, mandates full electronic product traceability for all manufacturers that distribute pharmaceutical products in the U.S. This includes transaction history, transaction information, and transaction statements, with serialization and verification requirements that impact every stakeholder in the chain.³

To meet these expectations, manufacturers must invest in interoperable digital platforms that capture and centralize data at every handoff. Real-time serialization, barcode scanning, and cloud-based lot control allow contract manufacturers to:

• Ensure authenticity and detect counterfeits early.
• Pinpoint bottlenecks or temperature excursions during transit.
• Quickly isolate affected batches during recalls.
• Maintain precise compliance documentation during audits.

Beyond compliance, modern contract manufacturing software enables deeper insights into process efficiency, supplier reliability, and material use trends. These insights help CMOs stay ahead of issues and optimize for future demand. As product portfolios diversify and new therapies enter the pipeline, traceability isn't a checkbox but a competitive advantage.

MasterControl's eBook, Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends, provides more information. Download now.

Improving Quality Management System Performance

In the development and manufacture of combination products, quality management isn't a one-size-fits-all. Each component — whether drug, device, or biologic — has its own design controls, risk profiles, and post-market obligations. Integrating these into a single, unified quality management system (QMS) is not only a regulatory requirement, but a business imperative.

For life science contract manufacturers, this means moving beyond traditional quality models and establishing systems that meet the requirements of both 21 CFR Parts 210 and 211 (for drugs) and 21 CFR Part 820 (for medical devices). The FDA's guidance on combination products urges manufacturers to establish a comprehensive QMS that ensures alignment across design validation, manufacturing process controls, compliance handling, corrective action/preventive action (CAPA), and change management processes.⁴ More simply, each of these quality processes must be integrated and flexible enough to manage complex product requirements. Disjointed systems can delay production, trigger audits, or create compliance risks.

Modern contract manufacturing software offers a centralized way to manage quality events, documentation, and supplier oversight. This is crucial, especially as 78% of manufacturers report expanding quality data efforts to meet evolving regulatory expectations.⁵ A digital QMS ensures compliance and enables trend analysis and continuous improvement — critical for long-term success with combination products.

How Integration Simplifies Complex Production

As combination product portfolios grow, so do the challenges of coordinating various manufacturing processes. From aseptic filling to injection molding and final assembly, production often spans multiple technologies, workflows, and facility types. Without integration, it's easy for delays, errors, or miscommunications to disrupt processes.

This is where integrated digital infrastructure comes in. Modern contract manufacturing software enables real-time collaboration between departments and sites, linking quality management, inventory, production scheduling, and compliance data within a single platform. This kind of connected architecture is essential when managing combination products with narrow process windows or strict traceability requirements.

Synchronization isn't just operationally efficient — it also directly supports regulatory compliance. Many combination products' regulatory challenges stem from disconnected data sources or siloed documentation. Integrated systems close these gaps, creating a single source of truth that can be easily audited and scaled across product lines.

As the industry continues to move toward more modular and flexible manufacturing, integrated platforms give contract manufacturers the agility to pivot. Whether scaling production for a new auto-injector or incorporating a new device partner, a digital-first approach makes it possible to adapt without compromising quality or compliance.

See where else the industry is predicted to pivot to — check out MasterControl's Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends.

Embrace the Future of Combination Products With Confidence

As combination products continue to change the life sciences industry, the expectations placed on contract manufacturers are only getting more complex. Success in this space isn't just about technical capability — it's about operational adaptability, regulatory foresight, and digital integration. The contract manufacturing leaders who invest in proven integrated technologies and agile frameworks will be better positioned to meet regulatory expectations and deliver value to partners at every stage of development.

To dive deeper into where the industry is headed and how your organization can stay ahead, download MasterControl's trend brief, Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends. Explore how leading manufacturers are preparing for what's next — today.

Resources:

1. "Drug Device Combination Products Market." Rohan Patil, Aditi Shivarkar. Precedence Research.

2. "Combination Products - Development Challenges & Solutions." Tom McLean. Drug Development and Delivery.

3. "Drug Supply Chain Security Act (DSCSA)." Food and Drug Administration.

4. "Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products." Food and Drug Administration.

5. "Seventy Percent of Manufacturers Still Enter Data Manually." Manufacturing Leadership Council.