Medical Devices

Bringing breakthrough diagnostics to life takes more than lab success. It takes engineering that performs in the real world. In this article, you’ll learn how to solve ten of the toughest challenges in microfluidic device design—from fluid control and contamination prevention to scaling and usability. Want the full technical breakdown? Download the white paper.

Looking to move beyond incremental product tweaks? This article breaks down the three key enablers of step-change innovation—especially in complex environments shaped by new technology, regulation, and shifting organizational priorities.

Are your alarms helping clinicians—or just adding to the noise? Learn how to design alarms that reduce fatigue, support clinical decision-making, and improve patient safety. This article will cover common design mistakes and actionable strategies—and includes a free quick-reference poster you can download for your team.

In a climate of regulatory uncertainty, there’s no room for shortcuts. Rigorous risk management, human factors, and a well-structured DHF aren’t just best practices; they're critical.

Our team relies on the Pugh Matrix to simplify complex decisions in medical device development. Learn how it works and download our customizable worksheet for free.

US regulations are complex, but navigating early testing successfully is crucial for advancing your medical device. Here's how to prepare.

Are usability and innovation inherently at odds? Here are three ways to resolve the tension.

At Delve, our design philosophy seeks emotional outcomes through rational thinking. As with all things, our slant remains pragmatic as we gain more experience with multisensory design.

To be successful and safe, automated systems need to work as a team with a human partner.

We're committed to sharing our favorite design principles. Here is part 3 from Delve's strategists, researchers, designers, and engineers.

Here are ten more of our favorite design principles, explained.

These are principles we’ve been curious about at some point during the course of our careers, and we thought others might be interested in learning more about them, too.

Now that we’ve established the value of user research, let’s talk about how to do it right.

The more it’s studied, the clearer it becomes that stress is the crucial, unseen factor in nearly any health-related situation.

When it comes to prototyping for the purposes of user research, how to build is determined by what you’re building.

Insights from our MD&M Minneapolis panel highlighted the challenges and benefits of merging hardware and software design, emphasizing how an integrated approach can improve patient outcomes and meet the evolving demands of modern healthcare.

Delve’s Philadelphia studio hosted an inspiring evening as part of the annual Design Philadelphia festival: the JeffSolves MedTech Pitch Night.

In certain industries, a poor user experience isn’t just suboptimal—it's dangerous.

We’re passionate advocates for user research and the critical role it plays in product design. But not all research is equal.

Why do we regularly transform our usability lab into a kitchen, hospital room, garage, bathroom, living room? It’s not because we’re filming a movie.

The world is better when healthcare meets people where they are. As the home evolves into a central hub of healthcare, how can we design for it in a way that delivers safe and effective healthcare for all?

ICUs need a more integrated source of relevant information to help physicians make better decisions and fewer mistakes.

Outsourcing your engineering needs can be the answer—if you do it right.

Prototyping for user research is a major consideration of product development and one that often confuses, because it’s not an exact science. There’s always a question of what to test and when, and there’s no one “right answer.”

Utilizing this role to its fullest could minimize project risk and speed your product to market.

Get to know Corin Frost, Senior Director of Communication Design at Delve.

In a research session, a moderator’s goal is to acquire as much knowledge as possible from potential users of the product based on their experience (or even a lack of experience).

Research enables you to make good decisions throughout new product development, speeding up product development and creating a product that resonates with users. Here’s what research-driven NPD looks like.

At Delve, we don’t focus on design thinking for its own sake, but rather, on design thinking and doing. What does action-oriented design thinking look like?

We will test a part, remove material, then test it again, and iterate that process until it eventually breaks. At that point, we know just how thin, light, or inexpensive a part can be.

How much agency should a machine be allowed? For both medical devices and cars, the potential to save lives is very real. But the consequences of things going wrong could be catastrophic.

Sometimes the simplest designs are the most difficult to get right. Here's how we approach the design of a low-information-density user interface.

In many areas of healthcare where AI has great potential, use of the technology is still in its infancy. In these realms where it’s slower to catch on, a common obstacle to adoption is lack of trust.

A few months ago, we discussed three UX trends reshaping medical product design. Here’s how to incorporate them into your device UX efforts.

Medical device usability testing serves different — and equally important — purposes throughout the product design process, from generative through evaluative research.

Medical device companies can boost usability by adopting these consumer product development practices.

A click is a universally recognized cue that an action is complete. Here's how to get the right sound and feel.

Why should you invest in a usable user interface?

Today’s users of medical devices expect a consumer-level experience. How can medtech firms make the shift?

Regardless of what you're designing, the options you present to users should be simple and straightforward.

Adding a sensor or touchscreen to just about any product has become cheap and straightforward. But it doesn't always make things better for the user.

The acceleration of tech, and especially the mobile revolution, has deeply impacted both the consumer and medical device industries.

Users often go rogue, using products in ways they weren’t designed to be used. Design for misuse is a way to counteract this.

These four steps for repeatable technical innovation have proven trustworthy for us on project after project.

Creating product requirements can seem like a straightforward task, but it has plenty of potential pitfalls.

Given the maze of use cases and associated certifications, designing an IoT medical device may take longer and cost more than you expect. Take the shortest path to a completed project by considering four factors.

Often, users don’t know why they made a mistake. Human Factors researches use the art of Root Cause Probing to uncover what went wrong.

You’ve vetted your MVP design through low and medium-fidelity prototypes. Now use high-fidelity prototypes to amplify your MVP into a truly compelling offering.

Affordance is the relationship between what something looks like and how it’s used. The user should be able to figure out how to use something just by looking at it.

Fresh from our webinar, AI & Medical Device Development, we'd like to share a few takeaways from the discussion.

To develop the best version of your product, have you considered leveraging softer materials?

The “fuzzy front end” of product development can pose some unique challenges for engineers.

Authentication is not appropriate for every product, but there are many applications where it's necessary for the manufacturer, end user, or both. Authenticating your consumables need not break the bank.

Medical device manufacturers need to design for a new kind of user. This has big implications not just for the devices they design but also for how they do business.

While reviewing the early data from our ongoing research on trends in the medical device industry, three unexpected findings caught our eye.

Empowered healthcare consumers bring to medical devices the high expectations formed from their experiences with highly intuitive consumer products—as well as greater risk.

We’ve been experimenting with a new methodology for designing medical devices with hardware/software interactions. Here’s what a new, holistic development process might look like.

Next-generation medical devices with hardware-software interactions need a new, holistic development methodology.

Advances in data science and machine learning are transforming healthcare and public safety. Countless lives will benefit. Here are five inspiring examples.

Home self-testing kits have played a crucial role in managing the spread of COVID-19 in the US, but a steep environmental price is hidden in the societal benefit.

Designers have a responsibility to design a world that all want to live in. Here are three principles that can help us navigate the complexities of design decision-making and truly achieve design success.

Whenever your needs require you to conduct user research remotely, these strategies will allow you to answer the same fundamental questions as in-person methods.

In 2021 you devoured blogs about looking at old problems in new ways, unlocking your professional potential, and creating products that change the world for the better.

Soaring demand for wearables has created a market saturated with the things—prompting an 18.1 percent year-over-year growth worldwide, according to Gartner.

Having trouble deciphering the FDA waterfall diagram process for medical device design and development? You’re not the only one.

A simple open-sourced design had a massive social impact—40 million face shields were produced for front-line workers fast and without expensive tooling investments.

Learn design techniques to maximize device reliability for common sterilization processes — autoclave, ethylene oxide, and ionizing radiation.

In early 2020, Abbott Laboratories recognized the need for COVID-19 testing and used their massive resources to ramp up production quickly.

Badger Shield gave me the opportunity to collaborate with an amazing group of men and women this year – designers, suppliers, manufacturers, and customers. I expect to have built lifelong collaborators and friends through this trial by virus. (For background, read the article in Wired).

We've been doing remote research since before COVID-19, but the pandemic gave given us a great opportunity to hone our craft.

I have been spending a fair amount of time thinking about the spectrum of successes and failures related to the open-source maker movement and its contributions to addressing the COVID crisis.

We are happy to publish all our design files for the project.

The goal: To outfit every health care worker with PAPRs – an amazing piece of equipment used to filter air and inflate a bubble around the wearer’s head to reject any contaminants.

The Badger Shield has shown that a distributed supply chain can create massive quantities of effective and cost-effective personal protective equipment (PPE) in a short time. Can this model translate to the developing world if COVID-19 cases start to rise in African, SE Asian and Latin American urban centers?

When in-person research needs to shift, try these remote research methods. All have yielded great insights for us at various stages of product design.

Since we posted a blog post talking about how the Open Source Face Shield project had started to supply the University of Wisconsin hospitals with this critical personal protection equipment (PPE), our team has had little time to breathe.

We are all feeling a little helpless in the face of COVID-19. We are looking for ways to help. Face shield shortages are putting health workers at risk.

Our free, on-demand webinar explains why innovation is so critical in healthcare, and introduces our Framework for Strategic Innovation: Health + Wellness.

How does the new EU Medical Device Regulation relate to human factors and usability? It depends if your medical product is existing or new.

As a high school junior, I was shown the guts of an implantable defibrillator. That day, I quit my pursuit of a career in medicine to pursue one in medical device design.

When not orchestrated well, a design review can very quickly turn into an unproductive meeting and send a team spinning with a poorly conceived action item list.

Medical devices are commonly recalled due to usability issues that can be prevented with human factors plans and uFMEAs.

There is no short map of an anticipated journey that medics can plan for while transporting a patient out of any building to the ER. Each scenario and response is unique.

“Wait. Is that it? Did the needle already go in? I can’t believe it!”

To get ready for the trip, I’ve been looking into and thinking about how human-centered design is best applied to global health solutions.

Co-creation means inviting users into your creative process. Users, instead of being subjects of study, gain agency and become active participants in the design process.

In the immediate aftermath of any newsworthy accident, we often hear the words "human error" or "user error".

In medical product design, usability research was too often an afterthought. But you simply can’t expect something to look nice and assume patients and clinicians will know how to use it.

The PCA (perception, cognition, action) method recommended by the FDA helps researchers assess and understand why a use error has occurred.

One client. Three consulting partners and 100 team members. How do you hold such a massive project together. Here are three tips.

For many entrepreneurs and inventors, focusing on patent protection may obscure the need to keep improving your product.

A simple, if provocative, question can make all the difference to a project when it's asked at the right time.

Mapping user experiences and systems can help you create more delightful healthcare experiences.

Using the Decision, Devices, Data, Design and Deployment framework, also known as the 5Ds, can help medical device companies develop connected products.

We did a thought experiment and traveled 50 years into the future to glimpse the future of healthcare and of the patient's user experience.

Our industrial design for the AmpStrip, a 24/7 heart rate and activity monitor, recently won a Gold Spark Award.

We noticed more discussion in general this year of user interface (UI) design, often in the context of smart devices. We anticipate UI becoming a stronger focus in upcoming HFES conferences as it continues to become clear that ineffective UIs represent the highest risk to safety and efficacy.

As the consumer-driven IoT culture, which moves fast and iterates frequently, meets the highly regulated med device industry, designers face new challenges.

Experience design is a field prepared to help healthcare workers effectively use new diagnostic technologies, but it is a pretty wicked problem to tackle.

Using the BioReactor we helped design and manufacture, Dr. Hopkins' team have reached a milestone in developing a process for replacing pediatric heart valves.

Manufacturers that lead the way towards sustainable medical device design will gain significant business advantages over those that sit on the sidelines.

We recently changed the name of our user interface design team to Interaction Design. The latter encompasses the dynamics of a user’s interaction with a system — including the user’s perceptual, cognitive, and physical interaction with the system, as well as the system’s response to the user.