Medical Product Design

Which Regulatory Requirements Apply to My Medical Device?

by Andy Moulds Posted Feb 11, 2020 In Design Strategy, Medical Product Design

[vc_row][vc_column][vc_column_text css=".vc_custom_1687571560882{margin-bottom: 0px !important;}"]The medical device industry is highly regulated. For good reason. These regulations exist to protect patients and consumers by ensuring the safety and efficacy of medical devices.

Of course, m [...]

Don’t Just Listen to Your Users — Watch Them, Too

by Paul Klock Posted Jan 28, 2020 In Human Factors & Usability Testing, Medical Product Design

[vc_row][vc_column][vc_column_text]It goes without saying that medical devices should be both safe and effective. But those qualities are really just the baseline. If a product is safe and effective but doesn’t actually solve users’ problems, it won’t matter. To put it another way, the real [...]

After the Designs are Done: Why Your Medical Device Needs an Agency’s Support Phase

by John Salisbury Posted Jan 02, 2020 In Engineering, Medical Product Design

[vc_row][vc_column][vc_column_text]If you’re considering partnering with an agency to help you realize your vision for a new medical device, you already know you need outside expertise for the design phase of your project. But what happens after everyone signs off on a final version of the comp [...]

Demystifying the Human Factors Plan for Medical Device Projects

by Chris Ross Posted Dec 17, 2019 In Medical Product Design, User Insights & Design Research

Over the past few years the FDA has increased their emphasis on the importance of applying sound human factors procedures during medical device development. That means they’ve increased their scrutiny of submissions and their expectations for how medical device makers will ensure the safety of peo [...]

The 3 Key Ingredients Behind Every Successful Medical Device

by Chris Ross Posted Dec 10, 2019 In Design Strategy, Medical Product Design

[vc_row][vc_column][vc_column_text]When medical device companies set out to produce a new product, they are often driven primarily by one of two things: business goals or technological innovation. These are necessary elements of any well-conceived medical device. But neither should be pursued in [...]

The Top 5 Questions You Should Ask Before Developing a Medical Device

by Paul Klock Posted Nov 27, 2019 In Design Strategy, Medical Product Design

[vc_row][vc_column][vc_column_text]Medical device companies must be future-oriented and innovative in order to remain competitive. They must constantly consider how to bring new devices to market that  [...]

Speed Bumps Ahead: Medical Device Development and the Risks of Moving Too Fast

by Paul Klock Posted Nov 20, 2019 In Design Strategy, Medical Product Design

[vc_row][vc_column][vc_column_text]Competition in the medical device industry is already cutthroat. But an influx of investor-backed startups means the pressure is only ratcheting up. The investors who back these startups often don't have a background in medical devices. And they expect to captur [...]

5 Top Tips to Create Effective Quick Guides for Complex Medical Products

by John Salisbury Posted Oct 29, 2019 In Medical Product Design, User Insights & Design Research

[vc_row][vc_column][vc_column_text]The FDA recommends that all medical products with some level of complexity include appropriate instructions for use (IFU). Doing so ensures the user will be able to fully understand how to utilize the product. While the FDA’s recommendations are geared toward [...]

Designing for Two: Balancing the Needs of Prescribers and Patients for Home Health Medical Devices

by Paul Klock Posted Sep 27, 2019 In Design Strategy, Medical Product Design

[vc_row][vc_column][vc_column_text]The most successful medical devices are those designed specifically with users’ needs in mind. That’s a pretty basic tenet of product design, right? But what happens when a device has more than one group of users, each with a competing set of needs? If your [...]

The Value of Well-Crafted User Interface Design

by John Salisbury Posted Sep 17, 2019 In Medical Product Design, User Interface Design

[vc_row][vc_column][vc_column_text]Well-crafted interface design transcends being just a pretty face for software applications.

Companies often put less importance on the user interface design of a software applica [...]

Me-Too Medical Products: How to Avoid the Top Five Mistakes

by Chris Ross Posted Sep 09, 2019 In Design Strategy, Medical Product Design

[vc_row][vc_column][vc_column_text]Let’s say one of your competitors introduces a successful new medical device to the market that would make sense as part of your suite of products. If you’re like most medical device companies, you’re probably tempted to bring your own version o [...]

Project Diagnostics: Understanding the Crucial First Step in the Medical Device Development Process

by Chris Ross Posted Aug 21, 2019 In Design Strategy, Medical Product Design

Medical product development is a long and complex journey. Whether your company is an ambitious startup or an established industry leader, of course you already know you need to have a plan. But not all product development plans are created equal. In order to be successful, your development plan [...]

The Future is Now: Conceptual Product Design and the Next Generation of Medical Devices

by John Salisbury Posted Jun 12, 2019 In Design Strategy, Medical Product Design

[vc_row][vc_column][vc_column_text]The medical device industry is more competitive than it's ever been, and rapidly evolving new technologies are adding fuel to the fire. Now more than ever, innovation is a must. Your market share is what's at stake. That means you need to develop a clear vision [...]

Our Discovery Workshop – How We Uncover Essential Project Criteria

by Ryan Held Posted May 29, 2019 In Medical Product Design, User Insights & Design Research

[vc_row][vc_column][vc_column_text]Medical device companies can’t develop products without first understanding what their customers need.  (In the same fashion, physicians can’t treat patients without first understanding their ailments.)

The diagnostic phase is critical. In fact, we w [...]

How a Unified Brand Language Builds Trust in Your Products

by Chris Ross Posted May 17, 2019 In Design Strategy, Medical Product Design

[vc_row][vc_column][vc_column_text]Imagine an operating suite where a surgeon might use two of your company’s medical devices in the same procedure. She puts down one instrument and picks up the other … and pauses for a beat because the two tools feel different in her hands. They look differe [...]