FDA Human Factors Engineering Guidance Is Now Serious Business. Pharmaceutical companies can now have their new drugs rejected by the FDA based on how usable and understandable the delivery device and labeling is for the intended patient population. This new factor has for the first time placed professional usability testing and human factors engineering at the core of successful drug development and market acceptance. MAURO Usability Science (founded 1975) has completed a four-year development effort focused on providing leading drug device development groups with a robust new suite of highly focused and powerful new testing methods designed to meet FDA human factors guidance. These new techniques provide multi-dimensional and scientifically valid data on patient interactions with the entire drug delivery patient experience.
The Industrial Designers Society of America (IDSA) has given its highest recognition the 2017 Personal Achievement Award to Charles L. Mauro CHFP President / Founder of MAURO Usability Science. Historically the Award has been given to leading design luminaries including Sir Jonathan Ive of Apple, Raymond Loewy, Henry Dreyfuss and others…More.
Summary Charles L. Mauro CHFP delivered an invited lecture at the Cornell Tech Law School on Design Protections In The Age of Apple v. Samsung. Historically, design patents have been considered less valuable forms of IP compared to utility patents. However, in the age of Apple vs. Samsung and related appeals design patents have suddenly become highly valued corporate assets. The ascendency of design patents is running in parallel with the dramatic increase in the importance of visual design and design thinking now permeating the highest levels of corporate management. The talk discussed in detail how the Apple vs. Samsung matter and the recent Supreme Court ruling is likely to impact the value of design protections as a major corporate asset. The lecture was presented at the recently completed Cornell Tech Campus on Randall’s Island. The facility will house several thousand graduate students from the computer science, business and law schools of Cornell University. The facility has the latest technology, development labs, classrooms and conference spaces. Expect big things from this amazing contribution to NYC technology development scene. Special thanks to Bloomberg for its financial contributions to this new tech center soon to be at the heart of the NY tech scene.
Charles L. Mauro CHFP recently delivered an invited presentation to members of the combined FDA Human Factors Engineering Research groups at FDA headquarters. The presentation focused on “The integration of new high-data-rate collection methodologies into unified data streams for use in optimization of drug delivery device HFE performance”.
Summary Our latest UX Labs case study is an object lesson In Why Hardware Design is Exceedingly Difficult for Software-Based Businesses and how overlooking critical usability performance can put the success of new businesses at risk. It is always an interesting exercise to watch a software-based and cloud-delivered business, even a very clever one with a massive user base and a seemingly successful business model, attempt hardware design. There is a certain arrogance that comes from developing a successful business based essentially on machine code, server farms and prodigious levels of capital looking for the next Facebook. Such business models, when they are successful can be a lot like minting money without the attendant risks associated with producing actual physical products. With the right combination of features, social media exposure and a large measure of luck, seemingly ridiculous ideas turn into billion dollar corporations backed by Wall Street and investors. Such is the basic trajectory of SNAP…read the entire analysis (6,000 words).
Summary MAURO Usability Science announces formal integration of advanced emotional-response and related neuroscience testing methodologies to its best-in-class advanced usability testing and UX design optimization platform. We are constantly expanding and refining our capabilities, which include 3D spatial tracking, Newtonian force measurement, Electromyography (EMG), eye-tracking, cognitive workload analysis, consumer decision modeling, ergonomic framework analysis, and others. These robust new methodologies are currently being applied to sophisticated projects investigating emotional and cognitive variables for leading organizations in the high-tech and consumer product industries. For more information
As products become more complex there is increasing pressure from the marketplace to deliver fast, and supportable refinements to product usability and UX design. To meet this growing need our UX Labs has developed a testing system aimed specifically at delivering robust insights and research related to improving the usability and UX performance of products, software, and services. The new system combines our neuroscience-based testing methods to generate robust insights into feature/function engagement, user errors, and usability in near real-time. The process integrates directly with creative teams charged with enhancement of user acceptance and market penetration. The process provides data suitable for the most rigorous clients including the design of drug-device testing for the FDA. This new methodology has been exercised in critical product design and user interface programs and found to be highly reliable as an optimization framework. For more information contact Charles L. Mauro.
How Do Development Teams Produce World-Class Products? For consumer-facing hardware or software to have high levels of usability and UX quality, they must undergo rigorous professional usability testing before design freeze. Such professional testing must make use of a wide range of mockups, simulations, and functional prototypes. It turns out that such testing is a fundamental requirement of all consumer-facing hardware and software systems that will eventually deliver a high degree of consumer engagement. One can often predict the potential usability and UX performance of a hardware device or software interface simply by examining the development process and the degree to which professional human factors science and unbiased professional usability testing has been applied during development. (Read the full article)