Keys to successful global product design

If the devil is in the details, redemption lies in the oversight of those details—especially when it comes to successful product design. Designers and manufacturers focus on details such as interface design, user interaction, and testing because users of all levels demand products that work easily and reliably. In the medical device industry, those details take on life-or-death importance.  Furthermore, a user’s behavior is directly influenced by the user interface design. Misleading or illogical interfaces in the context of the user can induce errors even in the most proficient users.

Within the design process, it is known that designing for “everyone” is problematic, as one person’s experience will always be different than another’s.  In addition, there is rarely consensus, and indeed a high degree of variability among people.  Each individual has a unique set of needs,  perceptions, and experiences.  In essence, environmental and human variability are perpetual, and this reality must be considered when designing medical devices.  This is undoubtedly true when devices are intended for use in multiple countries, with the assumption that the fundamental practice would be identical.

Design touches every aspect of our lives, especially in the man-made products we rely on to enjoy life and complete our work.  These objects reflect our culture and often represent our personalities and values. The same is true with mass-produced medical devices, wherein the details of design take on life-or-death importance. 

A design, in itself, is an arrangement of lines or shapes created to form an aesthetic, and a product design is described in visual language as its form, referring to the visible shape or configuration of something (Kahane, 2015; Krippendorff, 2006; Norman, 2014).   It is our ability to discriminate form in graphic design (2D) and industrial design (3D) that enables usability and meaning to be derived.

Unconsciously, we attach meaning to objects in relation to a larger ecosystem, the social structures and influences with which a product is used. Meanings are always someone’s construction based on the interaction with the product and are not fixed; they are constructed through design interpretation.  Over time, they expand and drift, as does the structure and the forces impacting the experience. What was once a novel tool can be an expectation of fluency. At its essence, design interpretation is derived from a self-structured network provided by our senses (perception) - a set of possibilities (cognition) that enables action by others or oneself.  Pushing a button in itself has no meaning. However, how one responds to the ringing (the result) has a great deal to do with the options one can imagine within their context and ecosystem.

For example, infusion pumps are designed for use within a hospital system and have many safety features that prohibit an incorrect dosing of medications based on a patient’s weight and/or age. These potentially lifesaving features are challenged when a user in the US fails to recognize metric units of measure or enters the birthdate incorrectly, as it's customary to list month/day/year in the US. In contrast, in Europe, it is day/month/year. Both of these use errors have the potential to cause injury and stem from misinterpretation of icons. 

Another example is found in diabetic care. Diabetes is a global health challenge, and devices are designed with the intention of worldwide availability. This facet of medicine includes a diagnostic device that targets routine blood analysis testing and recording (termed HbA1C and/or A1C levels) to determine the optimum dosing of insulin.  A significant challenge for users in the fight against this complex disease is interpreting the displayed information. The display of the analysis results can be presented as a percentage or as a discrete measurement (e.g., 48 mmol/mol or 6.5%). For even the most health-literate user, switching the unit of measure is problematic and could lead to an under- or over-dose of insulin.  Further, there is reported debate and inconsistency regarding the assay used for diagnosis worldwide (Bloomgarden, 2009; Kim & Choi, 2013). This further complicates the matter of design interpretation, as what is acceptable in one country may not be in another due to varying clinical standards.

These situations pose a problem for patients, as the device's design is challenged in unexpected ways.  By uncovering global design interpretations within varying ecosystems, improved health and care system performance may be achieved.

References:

Bloomgarden, Z. T. (2009). A1C: recommendations, debates, and questions. Diabetes Care, 32(12), e141-7. https://doi.org/10.2337/dc09-zb12

Kahane, J. (2015). The Form of Design. Deciphering the Language of Mass-Produced Objects, 23. Retrieved from https://www.bispublishers.com/the-form-of-design.html

Kim, T. H., & Choi, S. H. (2013). Diagnosing diabetes with hemoglobin a1c: current debates and considerations for anemic patients. Diabetes & Metabolism Journal, 37(5), 340–342. https://doi.org/10.4093/dmj.2013.37.5.340

Krippendorff, K. (2006). The semantic turn : a new foundation for design. CRC/Taylor & Francis. R

Norman, D. A. (2014). The Design of Everyday Things, Revised and Expanded Edition.