Medical Product Design
-
Medical Device Development and Professional External Resourcing: How to Manage Product Development in Times of Economic Uncertainty
by MPE Team Member Posted Jul 18, 2023 In Medical Product Design
Reaching innovation/development benchmarks and launching new products are critical performance indicators for companies in the medical device world. However, downsizing and reorganization are afflicting many in thi [...]
-
Your Medical Device’s User Interface Specification Is More Powerful Than You Think
by MPE Team Member Posted Jul 10, 2023 In Medical Product Design, User Insights & Design Research
[vc_row][vc_column][vc_column_text]The FDA requires user interface specifications for medical devices. But your user interface specification can and should be more than a requirement or regulatory box to check. After all, a robust specification establishes design specs, which inform the [...]
-
Risk Management Simplified: Streamline Your FDA Submission with a Hazard Analysis Worksheet
by MPE Team Member Posted Jun 26, 2023 In Downloads, Medical Product Design
As you’re preparing your medical device for market, one of the regulatory checkpoints you must pass is proving to the FDA that you mitigated any risks associated with your product to the best of your ability. The only way to show you’ve done just that is to meticulously document hazards — pote [...]
-
Does Your Medical Device Need Design Controls? Here’s What You Need to Know.
by MPE Team Member Posted Jun 20, 2023 In Design Strategy, Medical Product Design
[vc_row][vc_column][vc_column_text]New medical devices offer fresh opportunities for your company to improve health outcomes, push the boundaries of medical innovation, and grow your business. Who wouldn’t be excited about that?
But medical devices also carry varying levels of risk that [...]
-
Breaking Down the Verification and Validation Processes for Medical Devices
by MPE Team Member Posted Jun 06, 2023 In Engineering, Medical Product Design
[vc_row][vc_column][vc_column_text css=".vc_custom_1687563294992{margin-bottom: 0px !important;}"]Developing a medical device starts with identifying every user need your final product will meet. Then, those needs are translated into actionable product specifications. These are called design inpu [...]
-
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
[vc_row][vc_column][vc_column_text]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
-
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
[vc_row][vc_column][vc_column_text]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 [...]
-
Medical Device Developers: Give IFUs and Information Design Details Their Proper Due
by MPE Team Member Posted Feb 15, 2023 In Medical Product Design
[vc_row][vc_column][vc_column_text]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 [...]
-
-
ISO 13485:2016-Certified
