Ryan Lee

Drawing Ponies and IEC 62366

ponyAs you start down the exciting path of developing a medical device, a good question to ask is whether you want a stylist to address the product after, or an Industrial Designer that can help discover and address critical needs for the device from the start.

At times there is a misconception that styling is Industrial Design and vice versa. There are many Industrial Designers with different honed skills. When choosing a team, it is not only important to think about what you want, but what extra skills the team can bring to the table.

There is a double-edged sword in the increasing popularity and exposure of Industrial Design. On one hand, less people ask if I design factories when I mention my title; on the other hand many people assume Industrial Design is styling. A clever and funny associate lightheartedly jested at this misconception when they referred to some form development exercises as ‘drawing ponies’.

The misunderstanding is partly due to mainstream media’s focus on styling and consumer market appeal. I can understand focusing on the visually appealing component of design, as that is the juicy part in galleries, museums, magazines, blogs and the like that quickly captivates people’s interest. Admittedly, I enjoy seeing great illustrations, forms and concepts just as much as design theory.

It’s easier to quickly excite people with a beautiful rendering than with a Usability Engineering File and thick stack of results generated from a well-executed design research phase.

Does this mean Industrial Designers should forgo form development? Absolutely not.

Starfish understands the value in that, however at the crux of our process is a user centered design approach to solve the right issues. New regulatory guidelines now address usability error. This is a notable change in medical device development when it comes to requirements. A user centered design approach is not only crucial for regulatory needs, but it also creates a better product.

Previously there were ‘use errors’ with no direct culpability to the interaction of the device and person.  They often went unchecked and unreported. Now, ‘User error’ focuses on how people interact with the device and the medical device development process must address the issue. This is not something to fear; in fact it is a win-win. The device becomes much safer, easier to use and more successful.

A longstanding part of our Industrial Design process is to investigate the user’s needs, anthropometrics, ergonomics, workflow patterns, usability risk analysis, use environments and other issues that affect the safety, reliability, manufacturability and success of a product. Using this design approach provides a head start on recent additions in ISO 60601 Ed. 3 and IEC 62366 medical devices.

The benefits of user-centered design can be seen outside of the medical industry as well. In consumer electronics, where user centered design is more of a strategic approach than a regulatory need, there are many companies that have taken on a user-centered approach with great success.

An obvious example, and common reference, is Apple.

Touted as a design leader, people quickly talk about the beauty of their devices and interfaces, but the groundwork in usability research is often overlooked.  They are proof that products with user-centered design can have a pleasing embodiment and be extremely successful.

It is important to note that looks alone do not equate to great Industrial Design or success. There are many examples of products that look nice, but fail in the market due to a lack of usability.  A user centered design approach requires more groundwork, resources and commitment. The rewards are clever, complete solutions that can then be styled. That option seldom exists the other way.

Ryan Lee is a Designer at StarFish Medical.  Over the past 5 years he has worked his Product Design and Product Development magic on variety of medical devices.  This is his first StarFish Medical blog post.  He’d enjoy hearing your comments and experiences with user-centric design.


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