Northerner
Admin (Retired)
- Relationship to Diabetes
- Type 1
Most companies understand why they need to invest in ensuring that a medical device is as safe and effective as possible. Regulatory-focused human factors work is mandated, after all. The processes to ensure safety and effectiveness are systematic, mature, and relatively well integrated into medical device development.
But the human factors activities that deliver safety and effectiveness do not necessarily deliver a good user experience or, ultimately, a good product. In fact, some industry experts have observed unintended consequences of regulating human factors and design: Regulated activities can crowd out unregulated efforts to improve device design, and consequent increases in safety and effectiveness may be at the expense of user experience.1 In other words: The device is safe, but would anyone actually want to use it?
The activities that do deliver a good user experience are not as mature—at least, within this industry—or as well integrated into marketing and product development. Nor is their financial case well understood. Because the cost of developing a medical device is high and likely to rise further, the allocation of development money is likely to be placed where the return on investment is greatest.
http://www.mddionline.com/article/medical-device-safe-would-i-use-it-07-30-2014
But the human factors activities that deliver safety and effectiveness do not necessarily deliver a good user experience or, ultimately, a good product. In fact, some industry experts have observed unintended consequences of regulating human factors and design: Regulated activities can crowd out unregulated efforts to improve device design, and consequent increases in safety and effectiveness may be at the expense of user experience.1 In other words: The device is safe, but would anyone actually want to use it?
The activities that do deliver a good user experience are not as mature—at least, within this industry—or as well integrated into marketing and product development. Nor is their financial case well understood. Because the cost of developing a medical device is high and likely to rise further, the allocation of development money is likely to be placed where the return on investment is greatest.
http://www.mddionline.com/article/medical-device-safe-would-i-use-it-07-30-2014