Combination Product Industry News & Guidance

Case Study:

How do you prepare for an IND submission when your team is highly skilled in biologics—but has never touched combination product regulations? For one small but ambitious biotech firm, this was the reality. As they approached their first Phase 1 IND submission, uncertainty loomed. What exactly did the FDA expect for the delivery device? Were their documents compliant? Could they afford to overbuild—or worse, underprepare?

The client, a small biologics company preparing to submit their first Investigational New Drug (IND) application, was stepping into unfamiliar territory. As a first-time sponsor, they had significant expertise in biologics, but little understanding of the regulatory landscape or documentation requirements for drug-device combination products. Their overarching goal was to complete their first IND submission—including a delivery device component—with confidence and minimal regulatory risk.

The project focused on developing a streamlined Design History File (DHF) and generating submission-ready content that would satisfy regulatory expectations without overengineering the program. Yet the client faced several key challenges. Their internal team had minimal experience with combination product development, and the regulatory pathway for such products remained unclear to them. Moreover, they lacked the internal resources and processes necessary to build compliant documentation from scratch.

These challenges led to tangible concerns. The team worried whether their documentation would withstand regulatory scrutiny and recognized the risk of delays and rework that could potentially jeopardize their IND timeline. Upon engaging with the client, Suttons Creek discovered that although the team had strong technical knowledge of the molecule and its delivery requirements, there was no shared framework for regulatory expectations or product development principles across departments. This lack of cohesion created inefficiencies and uncertainty. The client was leveraging a pre-established platform but had not finalized a delivery platform. They wanted to ensure that their documentation efforts were appropriately scaled and adaptable to their eventual product.

To address these needs, Suttons Creek implemented a pragmatic and appropriately scaled strategy. They developed a lean, baseline DHF specifically tailored to the needs of the client’s Phase 1 program. They also created a comprehensive, phased combination product strategy and laid out a clear, scalable pathway for development and documentation that would avoid the need for rework in later stages.

This strategic, right-sized approach allowed the client to proceed with clarity and confidence. Not only were they prepared to meet their immediate IND milestone, but they also gained a solid foundation upon which to build future development phases. By unifying the client’s approach across functions, Suttons Creek accelerated decision-making, reduced ambiguity, and laid a strong foundation for effective regulatory engagement.

AUTHOR

Alan Humphrey, Principal Consultant, Suttons Creek –Alan is an R&D and Product Development specialist with more than 10 years of experience in the Medical Devices, IVD/Diagnostics and Combination Products industries. He has led successful programs in a wide range of applications, including complex electromechanical systems (Dialysis machines, Surgical robotics), implantable devices (Catheter-Based Delivery Systems, Vascular Access Catheters, Stents), and combination products (On-body injectors, Infusion & Insulin Pumps, Pre-filled syringes, Autoinjectors). As both an individual contributor and technical lead, Alan is passionate about diving into programs and working collaboratively toward creative solutions that meet the needs of each individual technology, client, or platform.