Medical Product Design
-
The Market Adoption Landscape Has Shifted. Here’s Who to Consider When Creating Your Medical Device Design Strategy.
by Ryan Held Posted May 03, 2023 In Design Strategy, Medical Product Design
As a leader in the medtech space, you have two primary concerns on the road to medical device commercialization:
-
Time to market — how quickly the product can realize ROI
-
Market adoption — how t [...]
-
Essentials of a Medical Device Manufacturing Plan
by MPE Team Member Posted Mar 22, 2023 In Downloads, Medical Product Design
Poor planning, late changes, supply challenges — there are a lot of potential hurdles to manufacturing a medical device on time. That’s why it’s well known in the medical device development industry that manufacturing always takes longer than expected. But that doesn’t have to be your rea [...]
-
The Only Human Factors Planning Guide You Need
by MPE Team Member Posted Mar 22, 2023 In Downloads, Medical Product Design
The FDA continues to place increasing importance on quality human factors engineering for medical devices. And that’s because they require your product to be safe and effective for your end users. Proper human factors procedures have many benefits — more than just ensuring a safe dev [...]
-
Your Guide to FDA Device Classification
by MPE Team Member Posted Mar 22, 2023 In Downloads, Medical Product Design
According to the FDA’s guidelines, there are three separate classes of medical devices: Class I, II, or III. If you don’t know which class your product falls into, you risk creating a development plan that doesn’t align with FDA requirements and doesn’t properly mitigate risk. That’s wh [...]
-
Your Medical Device Is Not Ready for a Human Factors Validation Study Until You Complete These 4 Steps
by Elyse Hallett Posted Feb 20, 2023 In Human Factors & Usability Testing, Medical Product Design
A human factors validation study is conducted to demonstrate that your medical device can be used by its intended users without serious use errors or problems. It’s required testing for most products as they’re finalized — before they go to market. And its results must be inc [...]
-
Medical Device Developers: Give IFUs and Information Design Details Their Proper Due
by MPE Team Member Posted Feb 15, 2023 In Medical Product Design
To shape a positive medical device user experience, it's critical for you to strategize how users will interface with every element of your product. And yet this type of product information design is often an afterthought. For instance, developers too frequently
-
How to Complete the User Needs Section of User Interface Requirements
by Andy Moulds Posted Jan 27, 2023 In Downloads, Medical Product Design
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 [...]
-
Example Project Plan: Everything You Need to Create Your Own Medical Device Development Outline
by Andy Moulds Posted Jan 27, 2023 In Downloads, Medical Product Design
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 [...]
-
Traceability Matrix Template: Translate User Needs into Actionable Design Inputs
by Andy Moulds Posted Jan 27, 2023 In Downloads, Medical Product Design
Designing a medical device that meets user needs is paramount to:
-
Meeting the FDA’s rigorous standards and design controls,
-
Pleasing your end users, and
-
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 [...]
-
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 [...]
-
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 [...]
-
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 [...]
-
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 [...]
-
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 [...]
-
-
ISO 13485:2016-Certified
