The greatest challenge in combination product development isn’t technical – it’s organizational.

Why organizational integration, not technical execution, is often the defining factor in combination product success.

Combination product development has become remarkably sophisticated. Organizations routinely bring together experts in pharmaceutical development, medical device engineering, human factors, manufacturing, quality, regulatory affairs, clinical development, and supply chain management to solve deep cross-functional challenges. Despite this concentration of expertise, experienced leaders know an uncomfortable truth: programs with exceptional technical talent still miss timelines, repeat testing, revisit regulatory strategy, and absorb millions of dollars in avoidable rework. 

The instinctive explanation is complexity. Combination products are, after all, technically demanding. But technical complexity rarely tells the whole story. In practice, most engineering problems are solved. Most formulation challenges are overcome. Most regulatory questions eventually find an answer. 

What consistently distinguishes predictable programs from unpredictable ones is something else entirely: organizational integration. 

Combination products are not simply drug programs with devices attached, nor are they device programs carrying a pharmaceutical payload. They are integrated systems whose success depends on hundreds of decisions made across disciplines that operate with different objectives, timelines, governance structures, and definitions of success. A seemingly modest formulation adjustment may alter device performance. A sourcing decision may reshape human factors strategy. A manufacturing optimization may require new regulatory evidence. Individually, each decision is rational. Collectively, they determine whether a program advances efficiently or becomes trapped in cycles of rework. 

Over time, Suttons Creek has observed that these challenges consistently emerge at five organizational integration points. They are rarely technical failures. Instead, they are leadership moments where governance either creates alignment or unintentionally allows complexity to multiply. 

The Suttons Creek Five Critical Integration Points 

1. Organizational Silos 

Functional specialization is both necessary and valuable. Scientists should focus on formulation. Engineers should optimize device performance. Quality teams should protect compliance. The difficulty begins when those functions optimize independently rather than collectively. 

Consider a formulation improvement intended to extend shelf life. The drug product team appropriately evaluates stability, safety, and manufacturability. From its perspective, the decision is complete. Months later, device verification identifies higher injection forces caused by increased viscosity. Human factors assumptions change, verification protocols are affected, risk analyses require revision, and regulatory documentation grows. No individual decision was flawed. The governance model simply failed to recognize that the decision belonged to the integrated product rather than a single department. 

Organizations that consistently avoid these outcomes establish governance around integrated decisions. Cross-functional reviews occur before—not after—technical work progresses. Engineering, regulatory, quality, and human factors leaders are invited into discussions while alternatives remain available. 

Leadership takeaway: Communication is not the objective. Shared ownership of integrated decisions is. 

Questions leaders should ask 

• Who owns integrated product decisions? 

• Which functions must review changes before approval? 

• Where are cross-functional tradeoffs documented? 

2. Supplier Alignment 

Device suppliers influence far more than component availability. Their engineering decisions shape verification strategies, manufacturing readiness, risk management, and regulatory evidence. 

When suppliers receive only today’s requirements, they naturally optimize around today’s objectives. Months later, commercial strategy evolves, intended users expand, or clinical assumptions change. Suddenly prototypes no longer represent commercial reality, forcing redesign, repeated usability studies, and additional verification. 

The strongest sponsors do not manage suppliers transactionally. They integrate suppliers into governance, sharing evolving program objectives rather than static technical specifications. 

Leadership takeaway: The level of supplier alignment is often determined long before the first purchase order is issued. 

Questions leaders should ask 

• Are suppliers receiving future-state requirements? 

• Who owns design inputs across organizations? 

• How are supplier changes governed? 

3. Regulatory Strategy 

Many organizations still treat regulatory affairs as reviewers of completed work. High-performing organizations treat regulatory strategy as a design input. 

A seemingly modest engineering refinement may appear technically insignificant. Later, regulatory assessment determines the modification changes the evidence required to support approval. Engineering was successful; organizational sequencing was not. 

Regulatory thinking should influence engineering priorities, verification planning, human factors strategy, supplier decisions, and risk management from the earliest stages of development. 

Leadership takeaway: Regulatory strategy creates value when it shapes decisions—not when it documents them. 

Questions leaders should ask 

• Does regulatory strategy influence technical planning? 

• Have FDA interactions been timed appropriately? 

• Will today’s decisions support tomorrow’s submission? 

4. Late-Stage Design Changes 

Late-stage design changes rarely become expensive because they are technically difficult. They become expensive because completed work depends upon them remaining unchanged. 

A replacement component differing by only a few millimeters may alter injection characteristics, labeling assumptions, usability validation, manufacturing instructions, verification evidence, and elements of the Design History File. The engineering effort may require days. The organizational consequences may require months. 

Experienced leaders evaluate every change through an enterprise lens before evaluating it through a functional lens. 

Leadership takeaway: Small engineering changes frequently become large organizational events. 

Questions leaders should ask 

• Has every downstream function assessed the change? 

• Could prior verification become invalid? 

• What documentation must be updated? 

5. Hidden Program Dependencies 

The most important relationships in a development program often do not appear on the project schedule. They exist between activities, assumptions, and decisions. 

An analytical method slips by several weeks. Soon process validation, sterilization activities, packaging validation, submission readiness, and commercial manufacturing all begin moving. The delay was never contained because the dependency network was invisible. 

The most effective integrated master schedules are not reporting tools; they are decision-support systems that expose downstream consequences before they occur. 

Leadership takeaway: Milestones matter. Dependencies determine whether milestones survive. 

Questions leaders should ask 

• What truly sits on the critical path? 

• Which dependencies are invisible on the schedule? 

• Where could one delay create many others? 

A Different Definition of Project Leadership 

This perspective fundamentally changes the role of project management. Traditional project management emphasizes schedules, budgets, action items, and reporting. Those responsibilities remain important, but they are not what determines the success of complex combination product programs. 

Effective program leadership is the ability to recognize how today’s decisions reshape tomorrow’s program. It requires understanding where engineering intersects with regulatory strategy, where supplier decisions affect human factors, where manufacturing influences verification, and where seemingly isolated changes create enterprise-wide consequences. That visibility cannot be generated by software or process alone. It comes from experience leading integrated programs. 

Conclusion 

Technical excellence remains indispensable. Without strong science and engineering, no combination product reaches patients. Yet technical excellence alone has never guaranteed program success. 

Organizations that consistently outperform their peers do something different. They invest as deliberately in organizational integration as they do in technical innovation. They recognize that governance, decision-making, and cross-functional leadership are strategic capabilities—not administrative functions. 

At Suttons Creek, we believe that is where the greatest opportunity exists. By identifying critical integration points early, organizations can reduce unnecessary rework, strengthen regulatory readiness, improve supplier collaboration, and bring innovative therapies to market with greater predictability. Ultimately, the greatest competitive advantage in combination product development may not be solving technical problems faster—it may be preventing organizational ones before they occur. 

Interested in seeing how your organizational integration currently scores with Suttons Creek’s experts? Take the below, no-obligation online assessment. 

AUTHOR

Jonathan Amaya-Hodges, Vice President, Technical Operations, Suttons Creek – Jonathan has over 16 years of multidisciplinary experience in regulated medical products (drugs, biologics, medical devices, and combination products) at multiple global companies. He has practical experience in Development/Engineering, Quality Assurance, and Regulatory Affairs for various types of combination products with a focus on drug delivery. Additional background includes digital health (including smart packaging/connected devices and software as a medical device, or SaMD) and in vitro diagnostics, along with clinical development (bridging) and lifecycle management for combination products. Jonathan engages with the global combination product community by speaking at conferences, lecturing in courses, serving key roles within prominent industry organizations, and interfacing with regulators on a variety of topics.