Case Study

From Urgent Fixes to a Structured Development Program: Stabilizing a Combination Product Initiative

Background

A clinical-stage biotechnology company developing therapies for metabolic disease was advancing its lead asset through Phase 2 clinical development. The company was well funded but operated with a lean internal organization, typical of emerging biotech firms.

The internal development team had deep experience in early-phase drug development but limited exposure to combination product programs – The broader organization had not previously managed the full scope of medical device development within a drug program.

The team had selected a commercially available auto-injector platform for the therapy and had begun initial engagement with the device supplier. However, foundational device development infrastructure had not yet been established. The program also faced aggressive clinical timelines driven by leadership’s desire to maintain development momentum.

Initial Situation

At the time of engagement, several structural challenges were already shaping the program:

Device strategy had not yet been translated into operational processes.
Although a device platform had been selected, the organization had not yet established the design control framework or risk management processes required to begin formal device development.

Quality infrastructure was still evolving.
A medical device–aligned quality system had not yet been implemented, and the company’s internal quality leadership was still evolving.

Documentation needed to initiate development was not yet in place.
The device supplier required formal design inputs and related documentation before initiating development activities.

Internal understanding of device development scope was still forming.
Because the organization was new to combination products, leadership initially viewed device support as a narrow documentation exercise rather than a multidisciplinary development effort. (A highly common misconception of the work until you’ve been through it once.)

The supplier relationship had begun to strain.
The lack of development readiness created misalignment between the biotech team and the device supplier, increasing tension and slowing progress.

Early Engagement

The work began with a series of short-term engagements focused on resolving immediate program barriers and the most pressing requirements needed to initiate device development.

During this period, Suttons Creek supported:

• Development of the Design Input Requirements (DIR) documentation required by the device supplier
• Creation of design control and risk management procedures necessary to begin formal development work
• Structured documentation support

Navigating Program Complexity

As the program progressed, Suttons Creek expanded its role to help stabilize both technical execution and program coordination.

Several practices proved critical to maintaining forward momentum.

Structured communication and accountability
Regular working sessions were established with key client stakeholders to monitor dependencies, maintain visibility into evolving program risks, and ensure deliverables alignment with the development schedule.

Breaking complex deliverables into manageable stages
Device development activities were organized into smaller, structured milestones. This approach helped the client team absorb the complexity of combination product requirements while maintaining progress toward near-term objectives.

Transparent schedule management
Development timelines were continuously reviewed and updated to reflect program realities. This allowed the team to manage expectations internally and externally while protecting key clinical milestones.

Flexibility in execution
Given the evolving internal organization and shifting quality leadership, the team fostered flexibility in how workstreams were structured and delivered.

Vendor Coordination and Relationship Recovery

A critical component of the engagement involved restoring productive collaboration between the client and the device supplier.

Suttons Creek played an active role in:

• Mediating technical and operational discussions between the organizations
• Clarifying development expectations and documentation requirements
• Helping both parties align around a realistic development path

These efforts helped de-escalate tensions that had developed earlier in the program.

In parallel, the team also evaluated alternative vendor options to ensure the client had contingency pathways if needed. This provided additional confidence to leadership while strengthening the negotiating position with the existing supplier.

Over time, communication between the organizations improved and collaboration stabilized.

Results

Through a combination of structured development support, vendor coordination, and program management, the initiative regained momentum.

Key outcomes included:

• Establishment of the design control and risk management framework required for device development
• Completion of foundational documentation enabling the initiation of supplier development activities
• Stabilization of the device supplier relationship and improved collaboration
• Creation of a more structured development program capable of supporting clinical progression
• Expansion of Suttons Creek’s role to support clinical and commercial development planning

Perhaps most importantly, the organization developed a clearer understanding of the operational requirements associated with combination product development.

What began as a request for short-term documentation support ultimately evolved into a broader partnership supporting the program’s continued advancement.

Takeaway

Combination product development often introduces complexity that pharmaceutical and biotechnology organizations encounter for the first time—particularly in lean clinical-stage environments where teams are experienced in drug development but newer to medical device processes.

In these situations, early gaps in strategy, documentation, and quality infrastructure can quickly ripple into negative effects on vendor relationships, timelines, and program confidence.

With the right structure, communication, and technical guidance, however, these programs can be stabilized and repositioned for long-term success.

This case illustrates how focused early intervention—paired with pragmatic program management—can transform a reactive situation into a sustainable development pathway.

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.