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Do you Want an iHeart Pump?

It seems that people will buy any of Apple’s “i” products. While some of this is driven by fashion, most of the craze for Apple’s products is the result of a string of exceptionally well designed products. The user delighting design of these products was not by accident. Rather, they stem from Steve Jobs’s passionate belief that great products result from unwavering insistence on simple, intuitive, user focused designed. This belief will be Steve Jobs’s legacy much more so than his products.

Most technology based products are designed by teams of engineers and designers. Typically, engineers are more focused on the technological aspects of the design and designers are more focused on the aesthetics and user experience. The normal model for developing new technology products is that the product design is driven by the technology and therefore engineering trumps design.

Consider the original IBM PCs. Their designs were clearly focused on delivering computing power to the business market in a distributed fashion. While they succeeded quite well at their primary goals, they were not simple, intuitive or a pleasure to use. Imagine someone releasing a product today with an MS-DOS like user interface. It would obviously flop despite the fact that users today are much more technically adept than the target market of the IBM PC in the 1980s. Arguably the Apple and Mac are to blame for the change in expectations.

The Mac was the first of Steve Jobs’s products at Apple. True, Apple had released the Apple and Apple II before the Mac but they were really designed by Steve Wozniak. Jobs led the design of the Mac with a commitment to creating a great user experience that would become the hallmark of future Apple products. The Mac’s graphical user interface succeeded in making Macs so easy to use that Apple had to battle the perception in the business community that they were toys.

Jobs’s success with the Mac was the result of putting design ahead of engineering. It is interesting to note that if you ask the masses what they think about Apple’s products, most will use the word innovative in their description. Yet the reality is that most of Apple’s products, from an engineering perspective, have not brought new technology to market nor have they had superior specifications to competing products.

The Mac’s graphical user interface(GUI) was implemented years before by Xerox, but Xerox failed to put it together in a complete product and ultimately licensed the technology to Apple. Sony and others tried for years to make a successful iPod-like product before Apple introduced the iPod. Even the first iPhone didn’t really invent many new features. All of these products were blockbuster successes because they made technology accessible to users. It is somewhat like the adage about a tree falling in the forest with no one around to hear it: Good technology only becomes great when it can be effectively accessed by users.

So with Apple’s history delivering game changing consumer electronic products, should we be lobbying Apple to design some sort of iHeart Pump? Maybe not. Allowing design to trump engineering at Apple resulted in excesses that were often acceptable for consumer electronics but that would not be acceptable in a medical device. For example, the iPhone4 was released by Apple knowing that if people held the phone in a particular way, it would drop a call. This flaw arose from the choice to make the rim of the phone from uncoated stainless steel. There were several simple solutions but the impact on the look of the phone was considered unacceptable and the phone was released with the flaw.

Despite this flaw, the iPhone4 was a huge success. Think about that a minute. One would think that the first and foremost job of a phone is to be a phone. Yet Apple decided it was OK to compromise the phone functionality for the details of aesthetic and the market validated that decision. Now let’s imagine that instead of the iPhone4 it was the iHeart Pump. Clearly, no one would think compromising the function of the heart pump would be acceptable for an aesthetic improvement. For that matter, the function of a heart pump would trump most of the attributes that set Apple products apart.

Medical devices must be safe and effective above all else. Consequently, design cannot trump engineering in the development of medical devices. However, problems also arise when engineering trumps design. Unfortunately, patients are hurt every day as a result of medical devices with poorly designed user interfaces. In addition, poor usability of many home health care products (e.g. insulin injectors) results in poor patient compliance. The 3rd edition of IEC60601 and the June 2011 guidance from the FDA reflect a recognition by the industry of this problem.

Truly great medical products result from design processes that weigh both engineering and design equally. This includes involving users throughout the design process and carefully considering usability/human factors in the risk analysis and mitigation process. This challenge will become even more critical as more medical devices are introduced into the home health care market, where users will have little or no training. Our challenge as medical device designers and engineers is to design products that would make both Steve Jobs and Thomas Edison smile.

Scott Corey
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