Tailoring: What It Means

Tailoring and the Art of Usability Engineering: Haute Couture in the Medical Device Industry

What does tailoring mean? The first thing that comes to mind is likely the world of bespoke tailoring. A tailor creates clothing suited to each customer’s body type, preferences, and specifications. This is precisely the metaphor underlying tailoring in usability engineering.

What Is Tailoring?

Usability engineering refers to the process of designing products and services to be user-friendly and safe for users. Tailoring is the practice of adjusting this process in accordance with product characteristics, project scope, risk level, and complexity. In the context of international standards such as IEC 62304 (Software Lifecycle Processes for Medical Devices) and ISO 13485 (Quality Management Systems for Medical Devices), tailoring means flexibly applying the rigor and implementation methods of processes in proportion to organizational size and product risk classification.

Just as a tailor provides each customer with individually suited garments, usability engineers provide optimal design for products, contexts, and users. This approach stands in stark contrast to the notion that one size fits all. In today’s market environment, where medical device diversity and complexity continue to increase, this concept of tailoring has become increasingly vital.

Concrete Examples of Tailoring: Medical Devices

The medical device industry provides clear examples of tailoring in practice. Remarkable advances in medical technology in recent years have brought an unceasing increase in medical device complexity. Devices incorporating artificial intelligence and cloud technologies, remote healthcare systems, and in-home medical devices with embedded software exemplify the ongoing diversification of medical device forms and functions. Whether patients and healthcare professionals can rapidly yet safely use these products ultimately determines the success of such products in the marketplace.

For instance, the usability requirements for a digital thermometer used daily by the general public differ significantly from those for medical equipment employed in specialized procedures such as laser surgery. The former must be intuitively easy to use with minimal risk of misoperation. Under IEC 62304, such low-risk devices permit simplified application of design processes, and unnecessarily complex procedures are inappropriate. The latter, used by highly trained medical professionals, demands design that prioritizes precision, safety, and efficiency over ease of use for the general population. IEC 62366-1 (Usability Engineering: Part 1 – Design and Evaluation Processes for Medical Devices) explicitly requires usability evaluation tailored to the characteristics of user groups. This means that specialized design verification considering the particular needs of healthcare professionals as expert users is essential.

In this manner, usability engineers must optimize design according to product risk classification, complexity, and the professional expertise of end users. This is precisely the role of tailoring. The FDA’s 2023 Software Validation Guidance emphasizes the importance of tailoring regulatory approaches to AI/ML-equipped medical devices according to product complexity. Similarly, EU MDR (European Medical Device Regulation) requires tailoring of quality management processes according to risk classification, reflecting an emerging regulatory harmonization trend.

Contemporary Tailoring Trends: The Regulatory Environment of 2024–2025

From 2024 through 2025, the medical device industry has witnessed increasingly elevated regulatory expectations regarding the implementation of usability engineering and tailoring. The proposed amendments to FDA QMSRs (Quality Management System Regulations) explicitly require AI/ML medical devices to undergo tailored evaluation and verification processes commensurate with product complexity and learning capability.

Informed by implementation experience with EU MDR/IVDR from 2023 through 2024, regulatory authorities in member states increasingly recommend manufacturers apply tailored design management and quality assurance processes according to risk classification. Most notably, manufacturers of lower-risk devices (Class I) through moderate-risk devices (Class IIa/IIb) find that regulators favor rational, efficient tailoring approaches rather than automatic application of overly stringent procedures. This trend toward regulatory recognition of proportionate tailoring is unmistakable.

Japan’s PMDA (Pharmaceuticals and Medical Devices Agency) has likewise indicated in its 2024 industry guidance a clear policy recognizing the application of process tailoring for small and medium-sized medical device manufacturers. This development enables rational quality management structures proportionate to organizational size and resources, simultaneously reducing regulatory burden while ensuring appropriate regulatory compliance.

In conclusion, tailoring in usability engineering is not merely a technique for efficiency; rather, it represents an essential approach to ensuring the safety and effectiveness of medical devices. By comprehensively considering multiple factors—product characteristics, user expertise, organizational resources, and regulatory environment—and constructing design processes optimally suited to each situation, organizations achieve genuine regulatory compliance. Ultimately, this approach leads to enhanced patient safety and improved quality of healthcare. Though this column addresses an audience of newcomers to the field, its key conceptual frameworks and contemporary trends have received adequate coverage. Through compelling metaphor and analogy, we hope this material conveys both the professional substance and the genuine appeal of this important topic.