Drug-device combination products are becoming increasingly common as innovation in medical devices continues to accelerate. From prefilled syringes to wearable drug-delivery systems, these products offer clear patient benefits but also introduce significant design and compliance challenges.
Because combination products sit at the intersection of pharmaceutical and medical device regulations, development teams must manage overlapping requirements, multidisciplinary risks, and specialised expertise needs. Understanding these challenges early is critical to avoiding delays, rework, and regulatory setbacks.
What Are Drug-Device Combination Products?
Drug-device combination products combine a drug and a device into a single therapeutic solution. These products are classified by their primary mode of action (PMOA), which determines whether the lead regulatory pathway applies to drugs or devices.
Unlike standalone medical devices, combination products must demonstrate compliance across multiple regulatory frameworks, making early planning and specialized expertise essential.
Key Design Challenges in Combination Products
Integrating Drug and Device Requirements
One of the primary design challenges is aligning drug formulation requirements with device functionality. Teams must ensure that:
- The device delivers the drug safely and consistently
- Materials are compatible with the drug product
- Performance remains stable across the product lifecycle
Design decisions that work for devices alone may not be suitable when combined with drug components, thereby increasing development complexity.
Design Controls Across Disciplines
Design controls are mandatory for most medical devices, but combination products require coordination between engineering, quality, and regulatory teams with different backgrounds.
Challenges often include:
- Inconsistent documentation between the drug and device teams
- Misalignment of design inputs and outputs
- Late identification of compliance gaps
Without experienced oversight, these issues can lead to redesigns that slow progress and increase costs.
Compliance Challenges Unique to Combination Products
Navigating Overlapping Regulatory Expectations
Combination products are subject to both drug and device regulatory requirements. This can include:
- Quality system regulations
- Risk management and safety assessments
- Validation and verification activities
Failing to align these requirements early often results in delays during regulatory review or inspection readiness.
Risk Management and Human Factors Complexity
Risk management for combination products must account for:
- Device performance risks
- Drug stability and delivery risks
- User interaction and usability risks
Human factors and usability engineering are particularly important, as incorrect use can impact both drug dosing and device safety. Addressing these risks late in development can significantly extend timelines.
Why Staffing Is a Critical Challenge for Combination Products
Specialized Expertise Is Hard to Hire
Combination product development requires professionals with experience across both medical devices and pharmaceuticals. These roles are challenging to fill through general hiring channels.
Common staffing gaps include:
- Regulatory affairs specialists with combination product experience
- Quality engineers familiar with dual compliance requirements
- Validation and human factors professionals
Delays in hiring the right expertise can stall development and increase compliance risk.
Flexible Staffing Supports Faster Progress
Many companies developing combination products do not need full-time specialists at every stage. Contract and project-based staffing allows teams to:
- Access niche expertise when needed
- Scale resources based on the development phase
- Avoid long hiring cycles
This approach helps maintain momentum while controlling costs.
For organisations facing complex hiring needs, staffing and recruiting support tailored to regulated environments can provide immediate access to experienced professionals.
How the Right Team Reduces Design and Compliance Risk
Early Involvement of the Right Experts
Engaging experienced professionals early helps ensure that design decisions support both drug and device requirements. Early expertise reduces:
- Documentation rework
- Late-stage design changes
- Regulatory submission delays
This is especially important for early-stage or fast-growing companies.
Coordinated Teams Improve Regulatory Outcomes
When regulatory, quality, and engineering functions are properly staffed and aligned, teams can address compliance requirements proactively rather than reactively. This coordination is critical for complex medical devices like combination products.
For companies needing broader guidance beyond staffing, working with experienced consultants can also support regulatory strategy and lifecycle planning.
Preparing for Long-Term Success
Design and compliance challenges do not end at product approval. Combination products require ongoing support for:
- Post-market changes
- Quality system maintenance
- Future product iterations
Building the right team early, whether through direct hires or flexible staffing, helps ensure long-term compliance and scalability.
Managing Complexity Through the Right Expertise
Drug-device combination products offer significant innovation opportunities, but they also demand careful coordination across design, compliance, and staffing. The complexity of medical devices combined with pharmaceutical requirements makes specialised expertise essential at every stage of development.
By addressing design and compliance challenges early and ensuring the right talent is in place, companies can reduce delays, manage risk, and move toward approval with greater confidence.
Frequently Asked Questions
What makes drug-device combination products more complex than standard medical devices?
Combination products must meet both drug and device regulatory requirements. This creates additional design, documentation, and compliance challenges that do not apply to standalone medical devices.
Why is staffing essential for combination product development?
Combination products require specialised expertise across regulatory, quality, and technical disciplines. Without experienced professionals, teams may face delays, compliance gaps, or rework.
When should companies consider staffing support for combination products?
Staffing support is most valuable during early development, regulatory strategy planning, validation, and periods of rapid growth or transition.
Can staffing agencies provide short-term support for combination products?
Yes. Many companies use contract or project-based staffing to access niche expertise without long-term hiring commitments.
How does early staffing reduce compliance risk?
Early access to experienced professionals helps ensure that design controls, risk management, and regulatory requirements are addressed correctly from the start, reducing costly changes later.
