Regulation, Translation, Adoption: What Makes a Diagnostic Path Complete

Many breakthrough diagnostics begin in the lab. Far fewer make it all the way into clinical practice. The difference often lies not only in scientific performance, but in how early teams understand the regulatory and market requirements that will shape the technology’s future.

“One of the main challenges in moving from a scientific idea to a marketable product is understanding the regulatory landscape”, says Emilio Llanos, quality and regulatory consultant at Complear. “Regulation is a broad and complex field, and one that is constantly changing”.

Llanos explains that one of Complear’s core activities within LaserBlood is to design and implement a regulatory strategy tailored to the project’s specific needs. “However, time and budget are also major constraints”, Llanos adds. For this reason, in LaserBlood, Complear also contributes to the broader translation strategy of the project, helping align regulatory planning with the evidence and documentation that may be required as the technology evolves.

“To accomplish this, you have to work at many different levels”, Llanos explains. Complear’s strength, he adds, lies in its multi- and interdisciplinary team, which brings together regulatory, technical, and scientific perspectives. “That means we can look at a project from the software, hardware, and scientific sides”, he says.

This scientific perspective is particularly important at LaserBlood’s current stage of development. “We are in the design and development phase of the product, so at this stage scientific knowledge is crucial”, Llanos explains. With a background in biomedicine, he sees this as the phase in which regulatory and scientific thinking need to be closely aligned. “This is the moment when we can define the boundaries within which the product will develop”.

That breadth of expertise matters because regulatory approval is not simply a final checkpoint, but the outcome of many interconnected decisions made throughout development: how the product is defined, what claims it makes, how performance is demonstrated, what evidence supports its use in a clinical setting. These questions are central to understanding what regulators and notified bodies will eventually expect to see.

Emilio Llanos

“Notified bodies first look at some of the fundamental characteristics of the product”, Llanos explains: the specimen and sample type, the analytical parameters being measured, and the intended target population.

Defining these elements early is essential, because they influence not only the regulatory assessment itself, but also the future market strategy. A product intended for Europe, in fact, may not follow exactly the same pathway – or address the same evidentiary expectations – as one developed for the United States.

One example, Llanos notes, is clinical validation. “For the FDA, clinical validation has to reflect the target population in the United States”, he explains. “In Europe, there can be more flexibility in how clinical validation studies are designed”.

The distinction shows why market strategy and regulatory strategy have to be considered together: the same technology may need to generate different kinds of evidence depending on where it is intended to be used.

But before any of these requirements can be fully assessed, regulators need to understand something more basic: what exactly is the product meant to do? “The intended use or purpose is probably one of the most important things that a notified body looks for”, Llanos notes. “This statement condenses the product’s specific functions into a short, formal description, making it a crucial piece of information for a regulator”.

From there, the regulatory pathway develops progressively, through each layer of evidence generated during the project. As Llanos puts it, the process is not about “delivering a document and finishing a race”, but about “constructing a wall brick by brick”.

Analytical testing, usability studies, and other development activities all become part of this structure, helping build confidence in the product step by step. In the long term, he explains, this trust is what can be carried “into the market and, ultimately, to patients”.