A Preventable Pattern: Where Early Integration [of Toxicology and Device Development] Pays Off

There’s a quiet pattern that shows up again and again in combination product programs. Not in the obvious places like timelines, budgets, or execution plans, but in how different functions move in relation to one another.

Teams are capable. Science is sound. The intent is right.

And yet, somewhere during development, program velocity slows. Questions that could have been avoidable surface, work is revisited, and confidence erodes; not because something was done incorrectly, but because critical pieces were not linked early enough.

In practice, this misalignment can reflect a broader disconnect between the core elements of product innovation and development, and nonclinical strategy for demonstration of safety and performance (efficacy). Within combination products, the nonclinical workstream is inherently interconnected, spanning material selection and characterization (including extractables and leachables), toxicology and biocompatibility, in vivo models for safety and function, and the unique interactions between device and drug.

Often, the heart of this slowdown pattern can be a specific kind of misalignment: Toxicology and device strategy are both present but they are not advancing together.

In most organizations, presumptive efficiency is gained by treating toxicology and device development as parallel workstreams. While this enables teams to focus on their areas of excellence, insufficient cross-over means poor end-to-end integration. When small gaps begin to form, they widen over time. These gaps often start subtly:

• Device construction materials are selected, without considering biocompatibility or toxicological strategy
• Extractables and leachable study designs are scoped before delivery strategy is finalized
• In vivo models are developed without reflecting on clinical delivery context

None of these decisions are inherently wrong, but when made in isolation, they create downstream friction. Because the effects emerge gradually, it makes identifying this challenge particularly difficult. Programs can move forward for months under the assumption that everything is aligned, until they reach a breaking point:

• Are the materials fully characterized in a way that supports the intended use?
• Do non-clinical studies truly reflect real-world system performance?
• Is a coherent, connected, strategy self-evident?

By the time these questions surface, teams are often deep into development. Resolution shifts from refinement to rework. Timelines stretch. Decisions become conservative. Program and asset confidence waver. Not because the team lacks expertise, but because the expertise was not aligned early enough.

This Isn’t a Toxicology Problem. It’s a Timing & Alignment Problem

Most teams have access or identify the need for strong toxicology expertise. The issue is not absence but timing. When toxicology is brought in after key device assumptions are already embedded, it becomes reactive or limiting:

• Assessing high-risk materials already implemented in the design
• Justifying nonclinical study designs misaligned with device realities
• Responding to regulatory questions rather than shaping the narrative

Strong biocompatibility and toxicology justification cannot fully correct for earlier misalignment. The program is forced to adapt to decisions that were made without full integration.

However, when toxicology and device strategy are aligned from the outset, the dynamic shifts in a meaningful way.

• Material selection is informed not just by performance, but by a clear understanding of biological risk and characterization strategies.
• Nonclinical plans are built to reflect how the device will function mechanically, clinically, and in real-world use.
• Analytical characterization, in vivo models, and regulatory positioning are developed as part of a single, connected program and not as separate deliverables.

The outcome is better documentation and smoother regulatory submission and reviews. Programs that move with greater clarity experience fewer late-stage surprises, greater confidence in decision-making, a coherent narrative for external reviewers, and less of revisiting foundational assumptions. In simple terms, everything downstream gets easier and more predictable.

Bridging the Gap Between Functions and Moving Forward

Achieving this level of alignment requires more than coordination. It requires perspective. Individuals and teams who understand how device design decisions, material science, nonclinical strategy, and regulatory expectations intersect in practice, not just in theory, thrive and deeply integrate their experiences.

For many teams, this insight comes mid-program when independent workstreams are tightly interdependent. The earlier that connection is recognized and acted upon, the more it changes the trajectory of the program. In combination product development, success is rarely determined by whether the right functions are involved. It is determined by when, and how well they are brought together.

At Suttons Creek, we work alongside our BlueRidge Life Sciences colleagues at ToxStrategies to support combination product programs with a fully integrated approach. We are professionals who have spent our careers working specifically at the intersection of medical devices, drug delivery and combination products, biocompatibility, and toxicology and bring a different lens to program development. We don’t just help you execute studies or support isolated decisions; we help shape a cohesive strategy encompassing the entire design cycle.

The addition of David W. Eaker, Ph.D., DABT to the Tox Strategies team further strengthens this capability. With more than 35 years of experience supporting medical devices and drug delivery systems, David’s work has consistently focused on developing nonclinical strategies that are not only scientifically rigorous, but fully aligned with how products are designed, used, and evaluated throughout their lifecycle. His experience reflects the very principle that the most effective programs are not built through isolated expertise, but through integration. He joins a broader ToxStrategies team with deep, cross-disciplinary expertise, allowing programs to draw on the right capabilities at the right time.

Rather than treating device development and toxicology as separate efforts to be coordinated later, we approach them as inherently connected from the beginning. We align device strategy, with the full nonclinical framework—material science, biocompatibility, in vivo evaluation, and regulatory positioning as part of a unified program.

To talk to an expert about how we can work together to support your unique project, click here.

AUTHOR

Max Lerman, PhD, Associate Director, Solutions Engineering, Suttons Creek – With over three years at the FDA as a member of the infusion devices team, Max has deep experience in developing and setting review practices for infusion, life-critical drug delivery, and electroporation systems and was also a member of AAMI ID and IP infusion pump committees. Prior to the FDA, Max spent over two years at Medtronic developing and maintaining electrocautery platforms. This industry experience and insider knowledge can be critical support to Suttons Creek clients and their combination product development and regulatory approval success.