Medical Product Design
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How to Complete the User Needs Section of User Interface Requirements
by Andy Moulds Posted Jan 27, 2023 In Medical Product Design, Resource Page
To meet the FDA’s standards for medical devices, you must complete user interface specifications or requirements. These specifications, according to IEC 62366-1, “comprehensively and prospectively describe the user interface of a medical device.” And a user interface refers to all the ways a u [...]
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Example Project Plan: Everything You Need to Create Your Own Medical Device Development Outline
by Andy Moulds Posted Jan 27, 2023 In Medical Product Design, Resource Page
The success of your medical device is contingent upon having a comprehensive project plan to guide its development. To help, access our project plan example. It’s tailored exclusively to medical devices so you can keep all of the details of development straight. The document below shares a [...]
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Traceability Matrix Template: Translate User Needs into Actionable Design Inputs
by Andy Moulds Posted Jan 27, 2023 In Medical Product Design, Resource Page
Designing a medical device that meets user needs is paramount to:
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Meeting the FDA’s rigorous standards and design controls,
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Pleasing your end users, and
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Whitepaper: How to Eliminate Medical Device Project Handoffs for More Efficient Development
by Andy Moulds Posted Jan 11, 2023 In Medical Product Design
Who you hire to support your medical device’s development may actually be hindering it. Even though you need outside help to bring your product to fruition, not all development partners are created equal. That’s because most companies like yours bring on multiple teams — like an industrial [...]
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Competitive Technology Teardown – A Springboard to Meaningful Innovation
by David Giuntoli Posted Nov 17, 2022 In Medical Product Design
The process of developing and launching a medical device literally requires thousands of cumulative hours focused on deep user research, scrupulous testing and detailed reporting. And though technological advancement is always top of mind for design teams, the lengthy device development process is n [...]
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4 Services to Meet Any Medical Device Development Challenge Head-On
by Chris Ross Posted Nov 09, 2022 In Medical Product Design
As you develop a medical device, there will be moments it becomes apparent you need outside assistance. Maybe you just started a company based on a groundbreaking idea or intellectual property, so you want an external partner to help you develop the core technology. Or perhaps you’re partway th [...]
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What is a Formative Usability Evaluation? (And Why Does Your Medical Device Need It?)
by Paul Klock Posted Nov 01, 2022 In Medical Product Design, User Insights & Design Research
The most successful medical devices aren’t just safe and effective. They also make their end users’ lives easier. Unfortunately, an excellent user experience (UX) is far from inevitable. In fact, a great UX sets medical devices apart precisely because designing a truly user-centric expe [...]
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3 Steps to an FDA-Worthy Human Factors Validation Study
by Elyse Hallett Posted Nov 01, 2022 In Human Factors & Usability Testing, Medical Product Design
A human factors validation study is an exercise to prove a market-ready product’s usability and safety in the hands of representative end users. You may know this as summative usability testing. However, the FDA dislikes this term as it can “omit essential components of human factors validati [...]
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How to Achieve IEC 60601-1 Without Slowing Down Your Time to Market
by Andy Moulds Posted Sep 12, 2022 In Medical Product Design
To successfully get a medical device to market, there’s a complex network of reporting, testing, certifications and submissions that need to be completed. And then there’s the paperwork that follows in order to prove the results. All this is done in the name of safety and effectiveness. A med [...]
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Create Valuable Medical Products with Human Factors Integrated Design
by Ryan Held Posted Sep 01, 2022 In Design Strategy, Medical Product Design
Medical devices are complex to develop. The process can take months for a relatively simple product to years for something more sophisticated. As a company bringing medical devices to market, your priority is to develop a successful, safe, and effective product as quickly as possible. But before [...]
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Whitepaper: Medical Device Leaders’ Comprehensive Guide to Human Factors Engineering
by Elyse Hallett Posted Jul 29, 2022 In Human Factors & Usability Testing, Medical Product Design
Developing a medical device is already a long, involved, and often expensive process. Adding time and personnel to conduct human factors engineering (HFE) seems like a high cost addition, and for what benefit? HFE actually serves two immensely valuable purposes and vastly benefits the medical dev [...]
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Level Up Your FDA-Required IFUs for Mobile Medical Apps
by Jesse Rutherford Posted Jul 26, 2022 In Medical Product Design, User Interface Design
Smartphones have brought convenience and exciting possibilities for countless aspects of life, including tracking personal wellness and fitness. And software applications that act as medical devices offer [...]
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6 Ways to Create Stellar Consumer Health Products That Improve Quality of Life
by Chris Ross Posted Jun 03, 2022 In Design Strategy, Medical Product Design
Consumer health products are simp [...] -
Human Factors Engineering vs. UX: Are They Really All That Different?
by Chris Ross Posted May 30, 2022 In Design Strategy, Human Factors & Usability Testing, Medical Product Design
From a medical device development perspective, the goal of human factors engineering, usability, and user experience activities is the same: To release a product that meets users’ needs in a safe, effective, straightforward, and delightful way. But the technical definitions of these terms can v [...]
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Whitepaper: 4 Design Decision Pitfalls That Derail Medical Device Usability
by Paul Klock Posted Apr 04, 2022 In Design Strategy, Medical Product Design
Focusing on usability as you develop a medical device is paramount. Without properly considering user needs from the get-go, you risk creating a product that doesn’t meet user expectations and consequently falls flat in the marketplace. Unfortunately, it’s all too easy to misstep when it come [...]
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MindFlow Design is a leading medical product development firm for Medical, Life Sciences, and Consumer Health Companies and is based in Carlsbad, CA. We aspire to introduce powerful, intuitive healthcare technologies to the world.
