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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...
Designing for the Medical Device Industry: The Future – Connected Health
Another great article on the every changing landscape of the medical device industry from Core77; Designing for the Medical Device Industry: The Future - Connected HSD, Dassault Systems and Ximedica continue their insight on the changing landscape of the medical...
Designing for the Medical Device Industry
Check out the article on Core77; Designing for the medical Device Industry: Holistic Solutions - A multi-Faceted Approach HSD, Dassault Systems and Ximedica discuss the challenges of designing complex products in a regulatory environment and moving through the sea of...
The Role of Front-End Research & System Architecture in Product Design
Understand how utilizing FERSA, front end research and system architecture, speeds up the product development path. Tor Alden, Partner of HS Design illustrates the importance of the product development team's understanding the environment and workflow when designing...
Medical Design Firm Retrospective: Design of the Times
In honor of MPMN's 25th anniversary, the magazine reflected on Top 25 Medtech breakthroughs of the past 25 years. Correspondingly, MPMN asked Tor Alden of HS Design to reflect on the 25 year span of design and what influenced device design and development during...
Product Development Insight
Start-ups may have an advantage within the medical device industry because of their innovative ideas. The trick is to use those ideas effectively through user-driven design.
Unmasking the Hidden Opportunities in Design
How to use industrial design services to maximize potential. Leapfrog competition using strategic design and differentiation.