Leveraging technology in the right way is critical to making progress in product development. As a medical product developer technology-related concerns raise many questions, but two fundamental ones stand out:
AAMI’s HE75 and the new FDA draft guidance, “Applying Human Factors and Usability Engineering to Optimize Medical Device Design” has officially established human factors activities as a requirement throughout the development process, leading many to ask if human factors is something that their company knows how to do, has to do or can do. Because the FDA has reaffirmed the perspective that human factors is a critical dimension of safe and effective device design, human factors and usability must be considered from the outset and their ultimate verification and validation are rooted in the very same regulatory basis as technical device function. Read more
On June 22, 2011, the FDA released a new draft guidance, “Applying Human Factors and Usability Engineering to Optimize Medical Device Design.” This guidance has implications for all medical device manufacturers. Once this draft is finalized it will set a new standard for integrating HF practices within the development process, and provide a more transparent understanding of what HF considerations the FDA will be looking for when evaluating a device submission. Read more
Usability Engineering plays a critical role in medical device design with the ultimate goal of mitigating the risk of human errors that impact the system state, the operator and patient. The pervasive trend of utilizing embedded interfaces in medical devices has called a great deal of attention to the criticality of usability testing. This attention has also been fueled by an FDA spokesperson revealing that “more than one half of the recalls due to design problems can be traced to the design of the user interface.” Usability testing is not a commodity; it is a necessity. Read more
Convergence is a popular term used in discussions about business and technology, across a range of markets and industries. It is an exciting word that suggests opportunity and innovation, and yet at the same time it also connotes significant change, which can saddle an organization with uncertainty regarding how to respond. In no sense is this truer than when looking at the convergence of wireless technology and the healthcare industry. Read more
A successful brand is one that conveys a consistent message across a range of interactions with its customers. A key component of this is the visual appearance of a brand’s products and services. A Visual Brand Language Strategy (VBL) is a protocol that ensures the visual and physical aspects of your products and services align with the aspirations of their brand and enables meaningful connections between product, brand and user. Successful VBL strategies result in a strong visual consistency among offerings in a portfolio, provide a foundation for differentiation within the market and establish a unique and valued relationship between brand and user. Read more