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Podcast: What are Human Factors Blog
10 years ago, while human factors were important in consumer products, they were not necessarily a common point of emphasis in the design of a product or medical device. In layman's terms, a company or person could create something that was utterly uncomfortable,...
Podcast: I have a prototype. It Works! Now What?
For a product development firm to engage with a start-up group, they could come in at any stage really. How they’re engaged depends on the goals of the companies that come in. For startups specifically, it could mean that they need help taking their idea or their...
Podcast: Solving Complex Problems to Create State of the Art Medical Devices
Industrial design as a whole is a wide open and diverse field that touches lives every day in nearly every activity. The big differentiation between industrial design in consumer product development and medical product development are the certification processes and...
Advice for Designing Home Healthcare Devices
In-home medical devices constitute a wide range of products, from prosthetic and orthotic appliances to home monitoring devices to medical wearables. But with all the progress that digital healthcare provides, medical device designers face a new challenge: how to infuse products redolent of disease and decline with intuitiveness, comfort, and even delight.
Excerpts from 10x Medical – Mitigating User Risk
When we talk about considering capabilities and limitations, we’re talking really about how big they are, their age, their dexterity, their training and education, their experience, and their culture.
DESIGN VALIDATION VS. HUMAN FACTORS VALIDATION
Human factors and risk create a lot of confusion in the medical device industry. This Podcast talks about what you need to know from a design control perspective.
Mary Beth sheds light on the challenges with FDA 510k submissions
Dr. Mary Beth Privitera, FIDSA, Principal at HS Design responsible for human factors and research is widely known as a human factors expert. She currently serves as faculty and co-chair of the Association for the Advancement of Medical Instrumentation’s Human...
The Value of ISO 13485 in a Design Centric, Medical Product Development Firm
What is ISO 13485? This is the easy part; ISO 13485 specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical devicen development and related services that consistently meet customer and...
Good Design…its the little things
By Matt Tramontana When the design direction of a product has been established and approved by the client, working through the detailed elements of a design begins. As an industrial designer, the responsibility of applying the finishing touches to a design can be an...
The Top 10 “Musts” of Digital UX for Medical Devices
By Maureen Mullins, UX/UI Design To the UX/UI Designers at HS Design, experience design is where people meet products. At HSD, we work to streamline experiences by reducing cognitive load, minimizing tasks, and promoting desired behaviors. For digital user interfaces...
The Model is Mightier than the CAD
By Stephen Simantiras As technology evolves and shapes our industry, many industrial designers and engineers find themselves jumping straight into CAD, hoping to have 3D prototypes built quickly for rapid user testing. CAD, along with 3D printing, allows for amazing...
HSD Technology Predictions for 2017
From expanded indications for transcatheter aortic valve replacement systems to bioresorbable stents, medical technology took some big leaps forward in 2016. So what might 2017 have in store? We asked industry experts for some predictions. Here, in their own words,...
Meeting Clinical Needs in Human Factors Engineering
Check out the recent article on the MDDI Device Talk Blog discussing the new challenges involved in demonstrating use and usability of medical devices as required by the FDA. The recent white paper, co-authored by Dr. Mary Beth Privitera, M.Des, PhD, FIDSA and Tor...
How to write a good PRD
HSD recently shared an article posted on MDDI discussing the "Chicken and Egg" Problem in developing product requirement documents for fist of kind products. The article goes into detail on the importance of understanding the value proposition of new products by...
Best Practices for Cybersecurity in Medical Devices
Smart networked medical devices are on the rise, therefore demanding increased cybersecurity and closer adherence to modern cybersecurity regulatory guidelines. This white paper focuses on: Security in the era of smart networked medical devices Designing medical...