MindFlow Design

It’s time to give IFUs and other product information design elements their proper due during medical device development. Otherwise you risk failing summative usability testing. Here’s why:

Why a Good Medical Device IFU Matters Throughout Development Medical device IFUs have a bigger impact on development than checking off an FDA requirement. Learn how thoughtful IFUs lead to better usability testing.

There’s something unexpected delaying your medical device’s launch: project handoffs. Working with multiple teams almost always results in knowledge gaps that stall development. Our latest white paper discusses your alternative product development method.

A Full-Service Partner Accelerates Medical Device Development Avoid costly delays and knowledge gaps in your medical product’s development by working with one partner from concept to completion — idea to manufacturing.

The current US healthcare system transformation underway is an evolution being mistaken for a revolution. We are shifting from a physician to a patient centered system, and the idea of increasing Patient Engagement is at the heart of it all.

Spend five minutes on Google researching the term “Patient Engagement” and there’s

Introducing The Zero Patient Engagement Model The current US healthcare system transformation underway is an evolution being mistaken for a revolution. We are shifting from a physician to a patient centered system, and the idea of increasing Patient Engagement is at the heart of it all.

As medical product developers, we observe design every day in what we see and interact with, learning from the problems of the past and using those insights to fuel our ideas for new products. So what can we, as designers, engineers, and creators learn as COVID-19 spreads across the globe? Is there insight to gain from this tragedy

COVID-19 Lessons About Medical Device Design & Development The coronavirus pandemic has illuminated common medical products' design issues. Start at the beginning considering sterilization, reuse, device longevity.

It sounds counterintuitive, but tearing your products down allows you to build them better in the next iteration.

Learn how product teardown directs your design team toward more innovative medical devices that better serve user needs:

5 Steps to Make Your Product Teardown More Impactful Learn how a strong product teardown process enables your team to develop more innovative medical devices. It’s time to evolve your process and your product.

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 development process in

Human Factors Engineering 101 for Medical Device Development Medical device development leaders, this is the comprehensive guide to HFE you’ve been searching for. Learn why HFE is vital to developing the best products.

Prototypes are the cornerstone of medical device development. They are powerful and important tools that transform ideas, thoughts and theories into something real. Prototypes also become a catalyst for deep collaboration and clear communication.

It can be overwhelming, however trying to keep track of the variety

The Pivotal Prototypes of Medical Product Development The many prototypes of medical device development may seem daunting, but you need to de-risk your process with iterations to advance your product safely.

Developing a medical device is an arduous process with many hurdles to clear along the way. At some point, you’ll likely need outside assistance.

Consider our four service areas when you do. They’re set up to meet every development need you might have.

Best Services From Medical Device Development Partners Medical device development is an arduous process with many hurdles along the way. You’ll likely need outside help. Utilize our 4 service areas when you do.

The success of home health products can be measured in much the same way as any other medical device: How well does the product work? To what extent does it improve health outcomes? How are sales? But, unlike medical devices for clinical settings, home health products must also succeed in another category. These devices

Improve Patient Compliance in Home Health Products | Mindflow Design Learn specific design research techniques to increase patient compliance with your home health products.

Seasoned medical device developers know that the FDA cares about safety and effectiveness, and nothing more. And because of the intense focus required to meet stated FDA expectations, it’s easy to put on blinders regarding issues outside the immediate frame of reference.

Device developers that fall into this trap are surely

How to use the FDA Process to Deliver a User-Friendly Medical Device Find out how to slightly modify the process you're already using to develop your medical device to deliver a superior user experience

To ensure your usability engineering file meets the FDA’s expectations, your medical device must undergo a human factors validation study. It’s the best way to prove you’ve done your due diligence in making a safe, effective product.

But how?

Our latest article details three steps to a successful study.

3-Step Guide to Conducting a Human Factors Validation Study A human factors validation study—also known as summative usability testing—is a critical component of your FDA submission. Learn the 3 steps to conduct it.

The process of developing a new medical device is overwhelming. The sheer volume of logistics and requirements makes it extremely challenging to anticipate and plan for each of the many steps along the path to a new product launch. Companies that are attempting to produce their first medical device are likely to feel

Medical Device Project Planning: The Roadmap to FDA Approval Medical device development is complex. A comprehensive project plan makes all the difference in staying on budget and launching a successful product.