The Importance of Cross-Disciplinary Knowledge: Combining Clinical Science with Regulatory Strategy

The development of drug-device combination products (DDCs) demands more than just scientific innovation—it requires seamless collaboration between clinical researchers, engineers, and regulatory experts. Because DDCs merge two different domains—pharmaceuticals and medical devices—their success depends on how well scientific understanding aligns with regulatory planning. Integrating these disciplines helps sponsors design safer, more effective products while avoiding costly delays in approval.

From a clinical science perspective, DDCs aim to improve patient outcomes by ensuring targeted drug delivery, enhanced safety, and ease of use. Scientists and engineers focus on designing devices that can accurately control dosage, minimize side effects, and ensure consistent drug performance. Clinical studies then confirm the product’s safety and effectiveness through preclinical trials, pilot studies, and large-scale pivotal investigations. However, even the best-designed study can fail if it does not meet the expectations of regulatory agencies.

That is where regulatory strategy becomes essential. Agencies like the FDA, EMA, PMDA, and Health Canada follow different frameworks to evaluate combination products. Understanding these requirements early allows sponsors to plan studies that generate the right type of evidence. For example, identifying the Primary Mode of Action (PMOA)—whether the main therapeutic effect comes from the drug or device—determines which regulatory center will lead the review. Submitting a Request for Designation (RFD) or seeking Pre-RFD guidance helps clarify this pathway and ensures that development follows the correct procedures.

Cross-disciplinary collaboration also ensures that clinical testing aligns with regulatory expectations. Clinical scientists provide data on pharmacokinetics, pharmacodynamics, and human factors, while regulatory specialists interpret how that data supports safety and efficacy under the law. This cooperation helps sponsors design fit-for-purpose trials, where only necessary studies are conducted—avoiding redundant or overly complex tests. For instance, bioavailability or bioequivalence studies are required only if the device could alter the drug’s absorption, saving time and cost.

Additionally, a combined clinical-regulatory approach promotes early identification of risks. Human factors experts analyze usability to prevent medication errors, while regulators ensure labeling and instructions meet safety standards. Together, they create a “totality-of-evidence” strategy, integrating bench testing, biocompatibility, clinical trials, and real-world evidence to build a complete safety profile.

Without this cross-disciplinary knowledge, sponsors may face regulatory setbacks, delayed approvals, or even product reclassification. Aligning clinical goals with regulatory strategy from the start leads to smoother approvals and a more predictable path to market. Contract Research Organizations (CROs) with experience in both areas can further bridge the gap by guiding sponsors through complex submission processes and optimizing study design.

In essence, successful development of DDCs lies in the harmony between science and regulation. Clinical science drives innovation and patient benefit, while regulatory strategy ensures compliance, safety, and public trust. When both disciplines work together, they create a foundation that accelerates innovation, reduces risk, and ultimately delivers advanced, life-improving therapies to patients worldwide.

Bio of the author: Meenal Bukkawar a clinical and preclinical research expert with over 12 years of experience in regulatory documentation for medical devices and therapeutic drugs. Strong background in molecular biology, cellular biology, and immunology, with proven expertise in clinical evaluation, regulatory submissions, and compliance. Published researcher in Scopus-indexed journals and recognized Subject Matter Expert (SME) in pharmacology and pharmacy, delivering high-quality documentation to support global approvals.