Translational Research Could Start From the ‘Translation’ of Unmet Medical Needs to the Intended Use

Translational research contributes to the improvement of healthcare technology including medical devices. There were so many attempts to improve the success rate of translational research. In this article, I want to emphasize the importance of intended use. Throughout this article, I will focus on why the researcher should translate the unmet medical needs into the intended use.

What is “translational research?” The National Center for Advancing Translational Sciences (NCATS) provides a broad definition: “Translation” refers to “the process of turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and the public — from diagnostics and therapeutics to medical procedures and behavioral changes.”1 This definition is intentionally holistic, incorporating directionality, intervention development stages, and multiple modalities.2

The target outcomes of translational research include diverse interventions such as diagnostics, treatments, procedures, and behavioral changes. The translational process remains conceptually similar regardless of whether the final outcome is a medical device, a biological product (e.g., an antibody), a medical or surgical procedure, or a behavioral change (e.g., diet).2 Despite its potential and significant investment, the translational process is often conducted empirically rather than through scientifically structured methodologies, leading to high failure rates.2 In this discussion, the various outcomes of translational research will be collectively referred to as medical products.

Key Criteria for the Adoption of Medical Products in Healthcare Practice

Developers typically initiate product development to address challenges in medical practice, unmet medical needs, with the expectation that these will improve healthcare and create market opportunities. However, from the healthcare professionals’ perspective, the decision to adopt a new medical product is not solely based on the presence of an unmet need. Their primary concern is whether the product will lead to better health outcomes for patients or minimizing foreseeable risks. Healthcare professionals carefully evaluate whether the “intended use” of a new product aligns with clinical needs and whether its benefits outweigh potential risks, typically relying on objective scientific evidence.

This divergence in perspective highlights why intended use serves as a critical factor in the adoption of medical products. While developers focus on technological innovation and market feasibility, the medical field evaluates whether the product meaningfully integrates into existing healthcare practices. Regulatory frameworks, such as the clinical evaluation requirements under the European Union’s Medical Devices Regulation (EU MDR),3 reflect this perspective by ensuring that a product’s intended use is substantiated by clinical evidence. Similarly, international standards for risk assessment of medical devices like ISO 14971 (section 3.6) emphasize the importance of defining intended use early in the development process to assess potential risks.4

Why Spotlight on the Intended Use When Planning Translational Research

Why is intended use so critical in translational research and medical product development? What does intended use truly represent in the context of medical devices and regulatory science?

In the medical field, the decision to adopt a medical product is fundamentally based on its intended use, which serves as a key criterion for evaluating its clinical appropriateness. Moreover, medical products must obtain regulatory approval from authorities such as Ministry of Food and Drug Safety (MFDS) and U.S. Food and Drug Administration (FDA) to be utilized in clinical practice. The regulatory process necessitates compliance with key ISO standards, all of which emphasize the necessity of clearly defined intended use. ISO 14971 defines intended use as “the use for which a product, process, or service is intended according to the specifications, instructions, and information provided by the manufacturer,” outlining essential components such as medical indications, patient population, use environment, and operational principles.4 Similarly, international standard for quality management systems like ISO 13485 highlights intended use as a critical design input that informs the entire development process and serves as a benchmark for risk management.5

Additionally, intended use plays a pivotal role in usability testing and clinical investigations to ensure safe and effective operation by the intended users in the expected environment.6 Clinical investigations, as defined by regulatory frameworks, assess a medical device’s clinical performance, effectiveness, and safety specifically in relation to its intended use.7 The conclusions drawn from these studies determine whether a product can proceed to market entry.8

Furthermore, the intended use is included as the first components of target product profile (TPP), a planning tool to guide development towards desire characteristics and a framework for submission of product dossiers.9,10

Conclusively, the intended use forms the central axis of all development stages—from the initial design input to the final validation of the finished medical product.

Translate the Unmet Medical Needs to the Intended Use

Translational research is based on observations of medical field, with the research plan formulated to develop products that integrate into medical practice. These observations—commonly referred to as unmet medical needs—serve as the foundation for defining the intended use of a medical product.

The starting point of all modalities in translational research could be unmet medical needs observed in clinical practice. In reality, unmet medical needs encompass a wide range of issues, from practical inconveniences and performance limitations of existing products to technological advancements that enable entirely new forms of treatment. Importantly, these unmet needs do not exist in isolation; they arise within specific medical practices and should always be analyzed within their context. For example, the transition from open surgery to robotic-assisted surgery emerged from an unmet need for minimally invasive procedures with greater precision. The intended use of robotic-assisted surgical systems had to be clearly defined in terms of patient population, clinical settings, and anticipated benefits to gain regulatory approval and widespread adoption. If the researcher or manufacturer focus to reflect unmet medical needs directly to the medical products instead of translating into the intended use, they may easily overlook the other factors and trap in the pitfall of technology centered approach. Therefore, identifying and addressing an unmet medical need requires a thorough understanding of current medical practices and how they might evolve with innovation. Ultimately, the extent to which healthcare professionals accept these changes will determine the success or failure of translational research.

Therefore, the process of translating unmet medical needs into intended use should begin at the earliest planning stages of translational research. However, this translation is rarely achieved in a single step, nor should it be. Rather, it should be a collaborative process, involving key stakeholders such as:

• - healthcare professionals, who will ultimately use the product in clinical practice,

• - engineering and development teams, who will design and refine the technology, and

• - regulatory and reimbursement experts, who understand the approval pathways and market access requirements in the target region.

Without a structured and iterative translation process, translational research risks being reduced to empirical craftsmanship where projects proceed based on trial and error rather than a strategic, evidence-based approach. Given the significant investments required for medical product development, refining this process is critical to reducing failure rates and ensuring that innovation translates into meaningful clinical adoption.

How to Translate the Unmet Medical Needs to the Intended Use

Based on personal experience to date, researchers, even most medical product companies, have not commonly practiced this translation process. Therefore, it is anticipated that establishing this translation practice in the field will be quite challenging.

Recognizing this gap, the Korean Academy of Medical Sciences (KAMS) introduced Clinical Unmet Needs-Based Intended Use Establishment (CLUE) templates in 2024 to facilitate systematic development of intended use.11 The process begins with an initial concept proposed by the developer, followed by structured consultations with medical experts to review various clinical challenges. While using the CLUE template cannot guarantee a successful establishment of intended use, we believe that fiercely analyzing the relevant content and reaching a conclusion through a consensus will ultimately lead to the successful market entry of the product.

Conclusion

To overcome the stigma of high failure rates, the translational research requires a fundamental shift in both structure and execution. As a critical first step, this paper has emphasized the necessity of translating unmet medical needs into a clearly defined intended use. The CLUE templates serve as structured tools to facilitate this process, guiding stakeholders through a systematic thought experiment to refine and establish the intended use.

Once the intended use is defined, developers must align the TPP accordingly. Undertaking these steps in the early stages of development provides a strategic roadmap for regulatory submission and clinical validation. This structured approach enhances the likelihood of a successful market entry and helps innovative medical products navigate the “valley of death” that often hinders their adoption in clinical practice.