As the global regulatory landscape for in vitro diagnostics (IVDs) becomes increasingly complex, regulatory strategy has evolved from a late-stage requirement to a critical driver of success. Organizations must now navigate expanding clinical evidence expectations, global market considerations, and emerging technologies such as artificial intelligence, all while accelerating innovation and maintaining compliance.

We spoke with Natasha Griffin about her journey into IVD regulatory affairs, the importance of early regulatory engagement, and the trends shaping the future of diagnostic regulation.

What attracted you to a career in IVD regulatory affairs?

My career began in microbiology and infectious disease research, including a Ph.D. and two postdoctoral fellowships focused on bacterial virulence and antimicrobial resistance. While I loved the science, I realized I wanted to apply my skills in a way that could have a more immediate impact on patient needs and public health. That led me to regulatory affairs, first at the FDA and later in consulting. What appealed to me about IVD regulation was that it sits at the intersection of science, medicine, innovation, and public health.

Clinical and regulatory teams often work closely together. What distinguishes organizations that do this well?

Successful organizations bring clinical and regulatory teams together early and treat them as strategic partners. Both groups are ultimately working toward the same goal: generating evidence that supports safe, effective products for patients. When alignment is missing, studies may not answer the right regulatory questions, resulting in delays, additional costs, and missed opportunities.

The global IVD regulatory environment continues to evolve. What should development teams be thinking about today?

Across major markets, we are seeing increasing expectations for clinical evidence, lifecycle management, and ongoing performance monitoring. Regulatory requirements are becoming more complex, which means development teams need to think globally from the beginning rather than approaching regulatory strategy market by market. A well-planned, global clinical and regulatory strategy from the start can save significant time and resources later.

When should regulatory teams become involved in product development?

Yesterday! Some of the most important regulatory decisions are made before a product is fully developed, including intended use, regulatory pathway, and evidence generation strategy. Early regulatory involvement helps teams anticipate potential challenges and ensures studies are designed to support future claims.

What is the biggest misconception companies have about regulatory strategy?

One common misconception is that regulatory strategy begins when it is time to prepare the submission. In reality, regulatory success is often determined by decisions made much earlier in development. Common missteps include waiting too long to seek regulatory input, underestimating the importance of intended use, or designing studies that do not fully support desired claims. The most successful programs engage early, ask the right questions, and focus on generating the right evidence.

How are regulatory expectations evolving for AI-enabled diagnostics?

AI has tremendous potential to improve diagnostics, but it also introduces new challenges around transparency, validation, and lifecycle management. Companies should be thinking about dataset quality, bias mitigation, change management, and ongoing monitoring from the start. Ultimately, success will depend on showing that AI improves patient care, not simply that it is innovative.

Looking ahead, what trends will have the greatest impact on IVD regulation?

AI-enabled diagnostics, decentralized testing, and increased emphasis on clinical utility will continue to shape the regulatory landscape. Organizations can prepare by investing in high-quality evidence generation, remaining adaptable, and engaging regulatory expertise early.