Medical Products Developed Correctly- With Usability and Design

Original article published November 2015 in the Fachzeitschrift MTD (Medizin-Technischer Dialog)

Authors:
Marc Ruta, Dipl. lndustrial Designer, Wilddesign GmbH & Co. KG (Gelsenkirchen, Munich),
Michael Engler, Dipl.-lnformatiker (FH), Michael Engler IT-Consulting (Essen)

Pressured for time, language differences, diversity of operating concepts, a growing amount of available information- for decades powerful marketing machinery could guarantee success in the global medical technology market. But, this is now changing due to the perceived hazards of incorrect operation and ever-significant cost pressures. Two new recipes for success have been formulated:

1. Usability – Results in safe and appropriate usage of products.
2. Design – Leads to simple, smart, and attractive products.

Combined with a solid, cost-oriented design, these factors can create superior medical product concepts, which are received by the markets with open arms.

Why Usability?

Today usability takes central importance in the medical device development process and is defined in standard ISO 9241-ll as performing effectively, efficiently, and creating a satisfactory user experience. Other important aspects should come in addition to the user experience, not only in the context of intended purpose, but surrounding the experience as a whole.

Good usability also brings tangible benefits, such as faster purchasing decisions- something that is obvious, but not immediately apparent. Additionally, manufacturers can credibly show that user productivity increases or that required training should be reduced. These are things that reward a client in a tangible way.

Recognizing the Needs and Intentions of the User

Now, a separate profession has been created: Usability Engineer. Though developers can attempt to predict the behavior of the user in their labs and how they will meet user requirements for a product, this is hardly reliable without actually speaking to users or watching them execute the intended operations. If these user related needs can be effectively identified, a manufacturer can gain a competitive advantage.

The Usability-Engineering-Process

For medical products, a usability-engineering process is the prescribed norm, because operational errors can result in injury, or in extreme cases, patient death. According to  norm IEC 62366: 2007, a focus purely on security in the usability engineering process should be applied, which is closely linked to the risk management standard ISO 14971. The usability engineering process is loved little by manufacturers, because often the necessary knowledge is not available within a company.

To add to the benefits and cover the shortfalls of purely safety driven focus, manufacturers can also follow the ISO 9241-210. Like all steps in the product development process, the activities of the usability engineering process are planned to ensure that adequate time and resources available.

First, the usability engineer analyzes the usage context, considering the user’s duties, work equipment, and relevant environment. Examples include making a diagnosis, conducting an operation, training users who conduct therapy in private or clinical environments, and considering other medical devices or tools.

User Experiences are Important

This knowledge is often held by patients or medical staff who are directly experiencing the product. It is essential that the right people be consulted or observed while performing their work. Only when this information is received, can usability engineers  determine users’ needs and define usage requirements. Thus, robust requirements arise to be implemented during the development and design phases.

Role of Design

No user wants a complicated product! Order and simplicity are two key principles for good design. Although these aren’t regulated by any standard, these so called “soft” factors contribute significantly to product acceptance. Medical design and usability are part of modern medical development and must be effectively integrated into the design process. The product manager must be able to define the basis upon which medical designers build. “Requirements management” is the key phrase. Our “24 Design Factors” is an effective method with which not only technical, normative, and user required aspects are explored, but also a holistic view into the future of the new product can be visualized, within context of the brand.

Design as an Intermediary

The designer also works as an interdisciplinary mediator: research and development provides technical specifications that define the product as innovative. Marketing defines benchmarks representing the target segment, and clinicians form user requirements, with help from the usability engineers. What factors are still responsible for the design of a medical device?

Other Thoughts and Perspectives

The designer has a clear view of existing thoughts and actions, and visualizes new perspectives on unresolved issues. Therefore, they should be included as early as possible in the project. They can then summarize market trends, and communicate the intention of the brand and user needs in a way that each party can follow. One example today: the “intelligence” of products plays a primary role because a user may determine the intelligence of medical devices from the day-to-day handling of their personal smart devices.

Even specifications from marketing and the market have an impact on a product’s appearance. Aside from corporate brand specifications, active patents may hinder the desired device concept. Even technology is  subject to acceptance by users and can cause attractive designs to fail if they do not meet expectations in terms of size, material composition, volume, weight, feel, flexibility, etc..

Observations During the Design Phase

The viability of many of a product’s properties can be checked before the end of its development. During the development phase, formative usability studies with users should be conducted. These provide feedback to developers and designers, before a product needs to be rushed to market. This requires repetitive procedures in order to identify and correct a discrepancy or unresolved flaw.

Integration of Design and Usability

If the development team and the investors are confident in a product idea, the medical designer can translate the technical description of the project into more tangible visuals to align with all stakeholders. Then, there can be seamless transition to concept studies and further development. The usability engineer should be brought into the project before the start of the concept phase.

Once the medical purpose or exact intended use is determined, the usability engineer has to examine the conditions of these applications and form requirements for the process/equipment design to ensure that usage is safe and satisfactory

Including Software

These conditions also apply to software development. The IEC 62304 states that usability requirements should also be applied to software development- but also requirements for maintenance, storage, installation, transportation, and disposal must be determined.

All disciplines involved must form effective development requirements and contribute to a successful medical outcome. Usability engineers and medical designers have risen to key positions in this expanding field.

Article appeared in Fachzeitschrift MTD (Medizin-Technischer Dialog),
November 2015 Edition

-> Salvia Medical case study

-> more about Usability

-> more about Medical Design

Originally written by Markus Wild, 02. June 2016. Last updated 23. April 2023