MUS has recently been tasked, by leading pharmaceutical clients, with the execution of multiple studies focusing on drug delivery devices designed to reduce the occurrence of death due to opioid overdose. We have tested and analyzed the use of such devices among representative populations including Healthcare Providers (HCPs), First Responders (EMTs, Paramedics, Firefighters, etc.), and Addiction Clinic Personnel in order to produce robust data about the usability of these devices in the hands of these common user populations. Methods including evaluation of simulated task performance, ethnographic analysis, micro-facial expression analysis, eye-tracking, comprehension evaluation, and subjective response have been used to collect thorough and robust data that provides research-supported insights into how users of these potentially life-saving products interact with the devices, instructions for use (IFU), and package design in real-world settings. These studies provided leading pharmaceutical clients with robust enhancements for IFU comprehension and device configuration optimization.
There is an interesting phenomenon occurring in the actual real-world use of more complex drug delivery devices by patients and HCPs. The problem is there is a wide disparity between how the device performs during summative HFE testing for FDA submission and the surprising number of reported usability problems recorded after the device actually gets into the hands of patients in real-world settings. This disparity is a reason for concern because a dramatic decrease in HFE performance by a device can signal significant loss of clinical effectiveness. To address this question MUS has recently executed a complex multi-city HFE field analysis to determine the source of such disparities and to aid major clients in understanding the structure and basis for identifying and resolving such outcomes during formative and summative studies. The learnings are being applied to updated and more robust summative testing methods that will deliver to the FDA more reliable HFE performance data.
Utilizing our advanced user-centered design and usability research methodology, MUS recently executed a comprehensive cognitive task analysis and GUI design for complex decision making in large teams of investment managers, analysts, and upper management. This effort was based on the application of our advanced GUI design and usability engineering platform, which integrates formal usability engineering with navigation design, collaboration facilitation and visual design to create robust solutions to complex GUI design problems. MUS has a proven track record in complex GUI design including development of GUI solutions with robust IP protections. This program was undertaken for a leading world-class investment firm.
Copyright infringement has long been defined by the Ninth Circuit through the application of two distinct tests, an extrinsic and an intrinsic test, to determine whether two works are substantially similar. The extrinsic test is an objective test, in which consideration is given to whether the “two works share a similarity of ideas and expression as measured by external, objective criteria.” Swirsky, 376 F.3d at 845. Furthermore, the intrinsic test is applied to determine whether “subjectively[,] the ‘ordinary, reasonable person would find the total concept and feel of the [two works] to be substantially similar’”. Swirsky, 376 F.3d at 847 (internal citation omitted; (9th Cir. 2000)). While the extrinsic test is typically applied by the judge and/or an expert witness, due to its subjective inquiry, the intrinsic test is most commonly designated to the jury. MUS has recently implemented online survey methodology to simulate the jury instructions, present the works in question, and collect subjective responses for a representative sample of respondents deemed to be “ordinary, reasonable” people through strict screening criteria to examine copyright infringement among the greater population. Areas of statistically significant substantial similarity were discovered through expert statistical analysis of the data and served in support of copyright infringement.
Even though MUS is a recognized leader in advanced neuroscience-based HFE studies, we understand that many projects are still focused on traditional formative and summative studies designed to optimize device configuration and/or IFU comprehension. These types of studies do not always require sophisticated and advanced testing methods. However, there is a serious problem with these types of traditional studies and that problem is increasing cost. Recently, we have heard that the cost of these simpler studies, when quoted by qualified HFE testing vendors, is increasing at an alarming rate while the quality of services is, in some instances, decreasing. To directly address this problem, MUS has developed a cost reduction framework for formative and summative study design that reduces the cost of these studies while leveraging our vast (40-year) history of experience in formative and summative testing. Please feel free to request a rapid response quote (RRQ) for formative or summative studies you may be considering. For more information, email Charles L. Mauro directly.
Upcoming Additions to Simple Formative Studies: Please note that as the cost of our advanced neuroscience-based methodologies declines we intend to begin integrating advanced methods into our lower-cost traditional formative and summative study designs for our clients.
Charles L. Mauro CHFP was the invited keynote speaker at the recent HFES International Annual Meeting held in Philadelphia, PA on October 2nd, 2018. The speech titled: “Human factors engineering innovations in the age of Apple v. Samsung: How HF/E practice can add major value to the intellectual property assets of corporations and academic institutions” was well-received by the audience made up of HFE professionals from both academia and industry. The keynote talk focused on a detailed analysis of the far-reaching impact of the recent Supreme Court decision and its impact on device design IP theory and practice. The talk explored the use of neuroscience-based testing methods to determine infringement and to provide rigorous research-based support for IP litigation.
It is no secret that design patent law is in a major period of upset and reformation. The dramatic changes are the direct result of the recent Supreme Court decisions in several IP cases, including Apple v. Samsung. The prestigious panel including Christopher J. Renk of Banner & Witcoff Ltd., John Froemming of Jones Day and Nika F. Aldrich of Schwabe, Williamson & Wyatt was focused on the complex issues of damage calculations once infringement has been found by the jury. Mr. Mauro covered theory and practice applied to testing the impact of visual design on consumer decision making and related research.
Law firms are facing in unprecedented level of pressure from clients to integrate new and advanced legal technology applications into their practices. The primary factor in this push toward legal tech is an overriding need to reduce the cost of legal services across all types of legal matters. However, the identification, testing, licensing, training and use of advanced legal tech applications is fraught with complexity and uncertainty. To address this problem, Charles L. Mauro CHFP has joined other leading legal technology executives in the formation of the first formal platform for reducing the complexity of legal tech application implementation. The new company, Reynen Court, is supported by a consortium of the world’s most prestigious law firms including: Clifford Chance, Covington, Cravath, Swaine & Moore, Freshfields, Gibson Dunn, Latham & Watkins, Orrick, Linklaters, Paul Weiss, Ropes & Gray, Skadden Arps, and White & Case. This the first time that the world’s leading law firms have joined in support of a legal technology startup.
Charles L. Mauro has been selected as the Chief Customer Experience Officer for this new legal tech platform and will divide his time between existing consulting clients and his new role with Reynen Court. To read more about Reynen Court, visit this link.
It is well understood at the highest levels of corporate management that an aggressive commitment to design is important for creating successful products. However, there has been scant actual hard data on the real value of design in terms of impact on profitability and share price. The recently released McKinsey report proffers the view that design, if properly implemented, results in a measurable increase in revenue of 32% and an increase in returns to shareholders of 56% when compared to competitors over a five-year period. This is the first time a major management consulting firm has conducted a large sample study of design and its impact on corporate performance. Even though the study is worth noting, it suffers from several key shortcoming when it comes to providing support for how corporations actually utilize design to achieve such impressive performance gains. To read the full report, follow this link.
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)