Adhesives help devices fulfill their purpose for the intended wear time. (Credit: 3M)

We’re at an inflection point in device history. Technology and innovation have had a long legacy in medical device development, but what’s changed in recent years is the rapid acceleration and advancement of data, technology, and users’ expectations. It’s become even clearer that data is power. Tracking vital health signs to help manage a condition, the ability to improve fitness levels, or for overall well-being means people are able to proactively take control of their own health. They can have more informed conversations with health professionals and leverage data for decisions.

Body-worn wearables are better for data that needs to be medically sound, like continuous glucose monitors (CGMs) used for tracking glucose levels. (Credit: 3M)

Data can also be a confidence booster. Knowing when a change occurs, when an action is needed, or that everything is as it should be — that feeling can make a difference in the everyday lives of those who use a wearable or other medical device.

As device designers and manufacturers, we have a powerful job — to create these devices so that people are empowered and have the ability to take control of their health. And it’s our responsibility to ignite the next wave of device innovation.

It’s an exciting, yet challenging time. As someone who partners with some of the largest medical device companies, I know that the pace of innovation and creating the next generation of devices is within grasp — I’ve seen it first-hand within 3M and within the companies we partner with. Here are four areas that will help propel us into the future.

Build a Supply Chain That Turns on a Dime

Tracking vital health signs to help manage a condition or for overall well-being means people can proactively take control of their own health. (Credit: 3M

A device’s system has historically been limited to thinking in terms of the physical device. What needs to be designed in, and how does it all need to function together? But it’s not just about what we’re innovating. We need to talk more about how we’re innovating. It means broadening the definition of a device’s system to include the system around the device — how it’s going to come together.

The pandemic has taught us that a nimble supply chain is what can set a company apart from its competitors. To unlock the next level of innovation, supply chains supporting device development, and medical devices in particular, need to be able to scale to meet demand. The medical device world is laborious — and for good reason.

There are strict regulations that are important to meet. On the other hand, it’s a competitive market that would benefit from finding areas in which to take well-informed and calculated risks. Rapid prototyping is one area that’s proven successful in other highly regulated markets and could be a way to quickly understand what’s working and what isn’t, and what can be done within the confines of the device world’s regulations. Designs can be validated, manufacturing processes proven — all the while adjusting and making tweaks before anything is considered finalized and commercialized.

Balance Art and Science, Form, and Function

Knowing when a change occurs or when an action is needed can make a difference in the everyday lives of those who use a wearable or other medical device. (Credit: 3M)

Wearables worn on the wrist and wearables worn on the body each have their moments when they’re the best for the job. Wrist-worn wearables can work well, for instance, with tracking distance, calories burned, and other fitness-related metrics. Body-worn wearables are better for data that needs to be medically sound, like continuous glucose monitors (CGMs) used for tracking glucose levels.

Medical devices need both form and function. The level and type of data that a device needs to collect should influence the device’s form and where on the body it could be placed. That will help ensure that the device can fulfill its intended function. Wrist-worn wearables aren’t as secure to the body, whereas ones that connect directly to the skin are, like CGMs and patches.

We need both art and science. Creating an intuitive user experience is essential. If the intended user doesn’t understand how to use the device at any stage — from application to removal — they likely aren’t going to want to use the device again.

Many companies are already working on finding a balance between the attributes of form and function, art and science. Discovering the right combination may unlock even more possibilities.

Design the Full System

Many devices are complex systems. But historically, some components or layers of the device have been left out until the rest of the device design is practically finalized or as an afterthought to the overall device design.

Adhesives are one such layer. Whether they’re adhering components together or sticking the device to skin, they play an important role — they’re more than just another layer. They help devices fulfill their purpose for the intended wear time.

But when adhesives aren’t considered or designed-in from the start, there could be design flaws that could result in costly and time-consuming redesigns. Adhesives need to be thought of as a strategic part of the device, i.e., a connector and enabler between the device, its wearer, and the data that needs to be tracked.

That is just one component. What medical device components might you be deprioritizing to focus on other areas? Identifying what those components are and what they ultimately make possible and enable for the device user can help make your designs even stronger.

From there, increasing wear times beyond what’s possible now can be part of the conversation. And with longer wear times comes less interaction with the device and fewer device changes, unlocking savings for the user.

Acknowledging the device design complexity in a way that triggers a more holistic view and approach can create a domino effect toward innovation.

Prioritize Device Security

A big challenge in the medtech space that needs to be addressed urgently is cybersecurity. We know the threat of hacking is all too real — we see it in the news more and more frequently — and it’s going to take an entire team effort to decide how to handle it.

It’s not just new devices either. There are generations of devices already in market that should be considered. Up to now, passive security measures, like shielding films, have been sufficient. They’re likely worth keeping in the conversation moving forward. But how can we incorporate more active measures into both legacy and yet-to-be-created devices? How can regulations validate and defend?

Usher in Next-Generation Design

When devices are able to extract the needed data from the body, they’re working toward creating a health system that can prevent sickness and help keep people healthy — a system we need in the United States.

Whether you’re in supply chain, designing the devices, manufacturing them, or regulating them, we all have the power to move in the same direction, change the trajectory, and usher in innovation. Let’s build a world where devices continue to be on the cutting edge, where the people using them feel safe, confident, and empowered with the insights they’re getting and believe the results are accurate and protected.

For my part, I hope to keep collaborating through discussions and designs with device makers around the world. When it comes to your work, what are you going to do to design the world forward?

This article was written by Tony Kaufman, New Business Development Manager, 3M Medical Materials & Technologies, St. Paul, MN. For more information, visit here .

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Evaluation of Wear Time for Various Tapes on Human Volunteers: 21-day Study

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