As if it isn’t challenging enough to design a medical device that can be used safely and effectively by a select group of individuals in a specific environment, the complexity increases when designing for international use by operators with diverse cultural backgrounds. HE75:2009 advises medical device manufacturers considering international markets to use the following approach:

  1. Investigate the distinguishing characteristics of the target markets in terms of cultural and national factors.
  2. Generate design adaptations that address the unique requirements for that culture or nation.
  3. Develop a design that encompasses the needs of all cultures and nations.
  4. Validate the design adaptations in the target markets.

They make it sound simple, but let’s take a closer look at some examples of characteristics device designers should consider. Some are a little more obvious than others.

  • Language – Since there are hundreds of widely spoken and written languages, it would be nearly impossible for a device manufacturer to accommodate all of them. A good compromise is providing a subset of the dominant ones in the market region of interest. Once the languages for the device user interface are chosen, translations should be carefully validated because issues like literal translations of idiomatic expressions can often lead to use errors.
  • Units and numbering formats – The units chosen for any device measurements should reflect those used most commonly in the target market region. For example, if a device measuring patient weight will be marketed in the United States and Europe, it should display weight in both pounds and kilograms. The typical formats for dates, times, addresses, etc. also vary across countries.
  • Demographics and anthropometrics – Characteristics such as age and gender ratio of a given population may fluctuate over time due to changes in life span, birth rate, etc. Anthropometric characteristics like size and physical strength can vary widely between populations (e.g. 5th percentile Asian female vs. 95th percentile American male) and should be given due consideration when designing products for certain target populations.
  • Perception of value – Value or quality is perceived very differently between cultures. Small, lightweight, low profile devices may be viewed as technologically advanced by one population and low quality by another. In the same way, one population may consider larger, heavier equipment cumbersome while another population may see the same equipment as more durable or higher quality.
  • Color – The meaning of a color can run the full spectrum when considered internationally. This wheel of colors and their cultural significances illustrates just how differently a color’s connotation may be interpreted depending on the culture: http://www.informationisbeautiful.net/visualizations/colours-in-cultures/

These are only a few of the factors to think about when designing medical devices (or any product for that matter) for international markets, so check out the full list of considerations recommended in HE75. The probability of use error decreases if device operation reflects users’ expectations, customs, and experience, especially in critical situations.

-KB

Ref: ANSI/AAMI HE75:2009

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