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The Value of Design in the Medical Device Development Process

By François

The multitude of technological devices in our lives has made users increasingly demanding and critical of specialized devices, and for the better. This new reality necessitates placing users at the center of the development process for a new product. Knowing how to listen to, observe, and decode their needs are skills essential to the success of a project and must be considered when building a high-performing design team.

However, without a clear understanding of the purpose behind a design assignment, the role of designers could be narrowly perceived as limited to the deliverables they produce, such as user research, creative workshops, concepts, and attractive presentations. This reductive view overlooks the comprehensive value of design, which is rooted in its capacity to produce quality products that excel from a user experience perspective.

François Gélinas, Director of Design at CLEIO, shares his insights on the role and value of design in medical device development.

Understanding the Role of Design in the Medical Device Development Process

To truly add value to the developed product through design, it is crucial to understand the role of this discipline and clarify the expectations of the designers’ work.

What is User-Centered Design?

User-centered design prioritizes the needs and expectations of end-users from the beginning of the design process. It advocates for thorough research to understand their behaviors and motivations, followed by usability testing to refine the product according to their feedback.

This approach seeks to develop intuitive, accessible, and effective solutions, enhancing the overall user experience.

User Needs: The Core of Design

According to ISO-13485, user needs, more commonly known as UN, act as the catalyst for the development process. This fundamental understanding enables the definition of design criteria, product specifications, and ultimately, the various tests required for product verification and validation.

Given the importance of UNs, it’s vital not only to employ robust research methods but also to master the art of articulating them effectively. Identifying a need presents its own set of challenges in itself, but formulating it in a manner that validates the achievement of the objective poses an even greater challenge.

Design Goes Beyond Aesthetics

Design quality is evaluated not solely on aesthetics but rather on how well it aligns concepts and user needs.

This means the design’s value proposition should be distilled to its most basic, verifiable form. For instance, can user X perform a specific task within a set timeframe in a chaotic, noisy, and hectic environment?

All this must be verified as early as possible in the development process to minimize the risk of late-stages, costly changes. Do you see the value now?

Evaluating Design Value One Test at a Time

Formative evaluations conducted during the development phase can rapidly identify potential usability issues, including risks. They also enhance the design process by emphasizing qualitative, intangible aspects in addition to quantifiable aspects.

Reducing Risks

Similar to technical risk analysis, it is crucial to identify, assess, mitigate and control use-related risks. While these two risk categories may overlap, addressing use-related risks demands a specific approach for solution validation.

Often, this involves mobilizing multiple experts within the identified user population, such as doctors and specialists, to conduct formative evaluations under conditions that closely mimic real-life use. Consequently, the investment in time and human resources is significant, necessitating meticulous planning beforehand.

In this context, the value of design is reflected in satisfactory results, appreciated not just by the developers, but also by all involved parties. For instance, an emergency doctor asked to test a new interventional device will be especially engaged if they find the product to be well-conceived and efficient from the outset.

“The value of design is not solely measured in monetary gains at the product’s sale. It is also evident in time savings when making necessary changes for risk reduction during development. The sooner and quicker these changes are implemented, the lower the cost.”

François Gélinas
Director of Design at CLEIO

Enhancing the Medical Device Design Process

Formative evaluations conducted during development typically yield both quantitative and qualitative data. For example, can the user complete task A in less than 5 seconds? Is the expected level of comfort rated as ‘superior’ by the majority of users?

Beyond this valuable data, it’s also crucial to understand how to interpret general appreciation, which isn’t easily quantified on a scale of 1 to 10. This involves recognizing non-verbal cues: a lingering look on a detail, a spontaneous comment of approval, or, conversely, a questioning eyebrow.

The satisfaction a designer feels when a user appreciatively acknowledges a device can be as profound as the discomfort caused by a user’s contemptuous glance at a stylistically discordant element, a poorly positioned control, or a non-intuitive interface.

Collaboration Between Design and Engineering Teams

Among the key responsibilities of Design, the delivery of high-quality and solid concepts to engineering teams stands out as essential for facilitating a smooth and seamless transition.

For the concept development process to succeed, constituting the right multidisciplinary team is crucial. This approach ensures comprehensive coverage of all aspects and minimizes technical risks. Hence, we hold the belief that Design is everyone’s responsibility.

Embracing a Design Mindset Right from the Definition Phase

In the Definition phase of our IDEAL development process, adopting a Design mindset is crucial. Whether you are a quality assurance expert, an electronics, mechanical, or software engineer, embracing a design mindset in the context of solution-finding offers an undeniable advantage.

We’ve come to understand that ‘Design’ is not exclusively the domain of industrial or UX/UI designers, whose expertise is derived from their training. It’s inconceivable for such complex products to be conceived by these experts alone. When individuals from other disciplines also embrace the designer’s mindset, it fosters the development of robust and compelling concepts.

The Design Defines the ‘Why’

As mentioned earlier, User Needs (UN) are the responsibility of Design. The activities involved in defining them aim to establish a clear understanding of the product’s requirements to fulfill its function.

For instance, whether the appliance requires portability, storage space for accessories, or resilience to specific cleaning cycle, these factors determine the “why” behind each element. This could include features as a carrying handle, wheels, or a sealed compartment, among others.

The Engineering Defines the ‘How’

After user needs (UN) are identified, the next step is to establish design inputs (DI). While UNs are validated by users, design inputs must undergo verification through tests, often conducted in a laboratory setting.

Engineering teams are responsible for ensuring that the handle can support a specified load, that the wheels can withstand abrasion, and that the hermetic compartment meets the conditions outlined by the standard.

It’s evident how the “how” becomes crucial in designing these elements to meet the requirements of the design inputs (DI).

Aligning Design with Business Objectives

The business objectives of a profit-oriented company cannot be overlooked, especially in a competitive funding environment. Budgets allocated to medical device development have felt the impact of economic uncertainty, similar to other sectors, leading investors to exercise caution. They are more hesitant to invest in companies that have not completed their market validation activities.

In light of this new reality, the value proposition of the product must align with the company’s objectives. Design also plays a crucial role in understanding these concerns. It can be risky to adhere strictly to the doctrine of ‘putting the user first’ at the expense of commercial realities and budgetary constraints.

It’s all about finding the right balance. Design, through Innovation Strategy activities, should empower the company to make well-informed decisions by considering all essential data necessary to deliver maximum impact in the market.

This is exactly what the Design team at CLEIO accomplishes: employing established methods and tools to empower clients to make informed decisions grounded in robust data.

Design is Everyone's Responsibility

To summarize, within a medical device development company like CLEIO, design must be defined in a way that is both distinct and compatible with the objectives of all disciplines.

At CLEIO, user-centered design isn’t just for industrial and UX/UI designers. It also extends to all disciplines involved in design, development, quality control, and testing.

Let’s not forget that our work truly becomes meaningful once the product is in the users’ hands, exposed to all kinds of usage conditions and, most importantly, may in some cases save lives. This is the true value of Design and the responsibility of those tasked with creating better, safer, more intuitive, more robust, and more relevant products.