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Applied Human Factors in Medical Device Design
Dr. Mary Beth Privitera, Research and Human Factors Principal at HS Design and Co-Chair of the AAMI Human Engineering Committee joins hsDNA to introduce her new book titled Applied Human Factors in Medical Device Design. The book began with a recognition of the new...
hsDNA – ISO 13485
What is the International Organization of Standard (ISO) 13485? For some firms that develop medical devices, ISO 13485 is really important standard. For others, the standard doesn’t mean much. One thing folks think of is that an ISO certified quality management system...
Product Champion
When companies get started with a new product design project, the first question the HS Design leadership team will ask is, “Who will be your product champion?” Inevitably, the answer is, “What is a product champion?” Most are familiar with a project manager, but the...
Aesthetics in the Design Process
The medical device and life science industries have traditionally taken their design cues from other industries, such as automotive, consumer products, and commercial applications. In some ways, they still do. However, medical device designs are incorporating many of...
Checkpoints to consider for Design
When starting any project, there are checkpoints for design that help drive the end product. At a company like HSD that has always been a medical and life science product development firm, the roots of the company and leadership have always been in design. Design is...
Importance of design
The current state of Industrial Design and User Interface Design In the past, medical product design firms would get caught up in the importance of quality, ISO 13485, and human factors etc. Today medical device design is an extremely regulated industry and for most,...
Michael Quinn talks about Six Sigma Design
Six Sigma means different things to different people, depending on where they are in the product development life cycle. It'll mean something very different at the start of a program versus at the end of a program when a product reaches the manufacturing phase. Six...
What are Human Factors
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,...
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...