PART II – HCD as a new design approach

Human Centered Design is an umbrella term for user-oriented design and product development processes. HCD derives its fundamental principles from the sociological work of Swiss design theorist Lucius Burckhardt, who focused on personal experience of living amid architecture to formulate his proposal that “Design is invisible”.

For HCD designers, this means that design is not merely shaped by process or specification, or even by aesthetics or function, but also by the direct user experience. Product design has evolved through experience design to human centered design.

In developing a new product, HCD uses broadly conceived, agile structures and heuristic processes that give voices to diverse professions and perspectives: communications, engineering, marketing, psychology and the prototype lessons of worked and what didn’t for the user.

HCD also replaces a hierarchical “top left to bottom right” design process with a more open and flexible structure that recognizes that product goals and means can and most often do change during development.

Increasing expectations

Today products and services are expected to be intuitive, but this is a criterion whose benchmarks are constantly shifting as each generation becomes more sophisticated in tis expectations. For product developers, the imperative is to talk to users and get inside their heads.

Here is where human centered design and design thinking start. It helps people in leading roles, designers, engineers and marketing specialists gain real understanding of exactly who will use these new devices or services and what that experience should be.

Design challenges

Ever-rising market expectations and requirements, fueled by internet and smartphone access, are not the only challenges facing pharma and medtech product developers. Others include increased agency for patients as decision-makers, raw material and sustainability pressures, ballooning healthcare costs, and the shift from professional to lay care settings. User groups are therefore becoming more diverse, with different backgrounds, expectations, and everyday realities.

This is partly why regulatory regimes increasingly emphasize useability in healthcare. Since 2014, the U.S. Food and Drug Administration (FDA) has stipulated that users of medical devices should be able to recognize and understand as well as interpret, eliminate or avoid special situations—such as errors or failures. Its useability guidelines stress the need for both formative and summative tests that will not only assess the ergonomics of the product under development but also its useability in practice.

Other certification agencies, such as the European Medicines Agency (EMA) rely on more general useability standards such as IEC 62366-1, expressed as DIN EN 62366-1, to enforce an iterative (continually evolving) development process for analysis, design, verification, and validation.

Further complicating the designer’s task is the reality of long product lifecycles, which means that the audiences identified at conception may have changed by the time the product finally reaches market. HCD design needs to take account of demographic developments as well as wider sociocultural trends and influences that may not be visible from individual insights.

One such trend is the way that digitalization is exerting ever growing influence on professional and private lives, now being boosted by Artificial Intelligence. But this is not a one-way street, At the same time, we are seeing pushbacks, as the overextension forced by the pace and increasing abstraction of virtual technologies spurs increased human desire for ‘real’ experiences and deceleration, exemplified by audiophiles embracing analog vinyl in preference to MP3 streaming.

“No man is an island” declared the poet John Donne, but in the digital age we are seeing increasing individualization and isolation. While the Internet has spawned new virtual communities, these are at the expense of genuine interpersonal communication. The reinforcement of community by new solidarities of common usage is thus becoming a central design challenge for the future.

HCD as a new approach

The central pillar of the HCD approach is that user requirements and therefore market acceptance can only be determined through questions and observation. The goal is to determine both explicit and implicit needs, and the new fields of opportunity and innovation these reveal. This knowledge can be turned into ideas that can then be considered from economic and organizational perspective.

The hallmark of an HCD process is that, from the start, developers experience, study and document usability in real situations together with the users. That should start from the very first concept, with developers interviewing and observing potential users to see the task from their perspective first. HCD professionals call this a “deep dive” into the world of the user to acquire impressions that might otherwise remain hidden on how the new product will become valuable.

This user-oriented approach goes beyond safety and efficacy to consider how the device might be perceived by the intended user, how it should fit into their lifestyle and work routines, and how such a device would be handled. HCD ensures that the developed solutions can be put into operation as easy-to-use tools for the corresponding work environment. A creative investigation into human needs, knowledge and experiences that aims to support the learned capabilities and thereby improving the quality of life is the basis of successful development of a product that will be welcomed by users and the market.

Resources

Click on Human Centered Design by Raimund Erdmann to access full Red Book eBook.
Click on www.erdmann.ch for further details.