Mathieu Turpault THUMB

Mathieu Turpault

Design

Industrial Design

Interaction Design

We now live in the age of the "medsumer." As the standard of care shifts from acute care settings like hospitals and clinics to the home, the medical device industry is facing pressure to adapt to new consumer expectations. 
How can medtech firms make the shift successfully?

We've been developing medical devices to meet rigorous standards for 55 years.

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<h2>The Age of the Medsumer</h2>

The medsumer era is characterized by the following:
<ul><li>Steeply and continuously rising healthcare costs</li><li>Consumers becoming more proactive about the management of their own healthcare</li><li>A shift in the delivery of care from traditional healthcare settings to home care.</li></ul>

We are witnessing the next healthcare evolution 880

We see&nbsp;one of the sharpest examples of this shift&nbsp;when we look at the wearables market, a large part of which is healthcare-related wearables.&nbsp;This market is set to surpass $60 billion in just a few years,&nbsp;in 2027.&nbsp; 
<div>Clearly, the medsumer era is well underway. </div>
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Onus of care

<h2>Trends Driving the Consumerization of Healthcare</h2>
Several trends are impacting this shift: 
<h3>Healthcare costs and staffing pressures&nbsp;</h3>
Data from the U.S. Department of Health and Human Services shows that the rising&nbsp;cost of healthcare, at what many perceive to be an unsustainable rate, especially in the U.S., is pushing healthcare into the hands of untrained patients and lay caregivers, in most cases in the home environment. 
<h3>60% of Americans living with&nbsp;chronic disease</h3>
According to the CDC, 60% of Americans today are living with some form of chronic health condition. About 1 in 3 American adults qualifies as obese, and mental health claims have been increasing more than 100% over the past ten years.&nbsp;The situation is further exacerbated by our aging population. By 2031, one in five people will be over the age of 65 - about 20% of the population.&nbsp; 
<h3>Cross-generational desire to receive care at home</h3>
According to the AARP, we're increasingly seeing a&nbsp;cross-generational desire and&nbsp;expectation for healthcare to be delivered at home, rather than in a traditional healthcare setting. Compared to previous generations,&nbsp;Millennials and Gen&nbsp;Z, expect&nbsp;healthcare services will be delivered just like any other consumer service. They are much less likely to need a primary care provider to coordinate their care, they are twice as likely to use telemedicine, and they are three times as likely to use a smart device for their healthcare needs.&nbsp; Seniors are not far behind. During the COVID-19 pandemic, seniors were asked to stay away from hospitals and acute care settings. Today, 44% of them view technology more positively than they did before the pandemic. Regardless of age, it seems,&nbsp;people are more comfortable using technology than ever before, and they are more likely to use technology to manage their healthcare needs.
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Medical device users expect a consumer level experience 880

When we step back and look at these trends—rising healthcare costs, an aging population living with&nbsp;more chronic conditions, and the expectation of consumer-level convenience from healthcare services—it's no surprise we are seeing a strong shift into the medsumer era.
Let's build a bit more&nbsp;on that last trend, the expectation from&nbsp;users that medical devices will deliver a consumer-level experience.
This has really important implications for those of us who are involved in designing safe and effective medical devices, because we now have to design for a completely new set of users in completely new types of environments.&nbsp;

On the plus side, patients will ultimately have more control over their care. They will be able to manage their care more conveniently, on their own schedule, instead of being restricted by their healthcare provider's availability.
But as the shift is happening, at least in the short term, what we will see is greater risk. Lay users with limited training will face challenges as they try to use medical products safely and effectively—at least until the medical device industry catches up and is better able to design effective medsumer solutions.

Healthcare decision makers think 880

<h2>Medtech Product Development Must Change.&nbsp;How Do We Navigate the Shift?</h2>
In 2021,&nbsp;SIS polled 210&nbsp;healthcare decision makers in the U.S. and internationally. They&nbsp;learned that:
<ul><li>90% of healthcare decision makers&nbsp;think consumer demands drive innovation</li><li>92% of them think healthcare companies need to act more like consumer tech companies</li></ul>
So, across the board,&nbsp;industry leaders seem to&nbsp;realize that the consumer is now in the driver's seat, and that&nbsp;big changes are needed in terms of how the industry approaches product development.&nbsp; 
But what was really surprising was the poll's third finding: 
<ul><li>Only 44% of healthcare decision makers&nbsp;think manufacturing companies with healthcare experience will lead the much-needed innovation. </li></ul>
This raises the obvious and important&nbsp;question of why? And, how might we change that?&nbsp; How can established medtech firms adapt successfully to this major industry shift?

How can medical device manufacturers make the shift 880

As we consider how we might&nbsp;design products differently for medsumer applications, I think it's fair to say that aiming to design safe and effective products is no longer enough. We need to do better.&nbsp;
And, companies with consumer product&nbsp;experience will have an advantage in designing medical devices for home use.&nbsp;This is why the entry of companies like Apple and Amazon into this category&nbsp;is likely to be very disruptive, and maybe a bit concerning as well for established medical device manufacturers.
But I&nbsp;think the focus for&nbsp;medical device manufacturers needs to be figuring out how to design for our new users and the for these&nbsp;new environments.&nbsp;

A multidisciplinary team has the edge in creating innovative, well-rounded solutions that meet the needs of all stakeholders.

Don't Miss: Why Multidisciplinary Teams Design Better Products

At Delve, our focus and expertise lies at the intersection of the medical device and consumer product industries. In my 25-year career at Delve, I've personally led the design and development of hundreds of medical devices and as well as products across different categories. Collectively, over the years,&nbsp;the Delve team has designed thousands of medical devices.&nbsp;We are experts in the FDA process and regulations. And, because our <a href="https://www.delve.com/insights/why-multidisciplinary-teams-design-better-products" target="_blank">multidisciplinary team</a> is comprised of strategists, designers, and engineers, we are able to balance both creativity and rigor in our practice.&nbsp;
Achieving the balance between creativity and rigor is&nbsp;important if we are to achieve the innovation that is urgently needed&nbsp;in medical device industry today. The challenge of the medsumer era&nbsp;is to balance both produce safety and user experience—too much of one vs. the other, and the product won't be successful.

Over the past years, our team at Delve has been watching the medsumer shift carefully, and leveraging what we know about both the medical device and consumer product industries to develop effective medsumer applications with our clients. 
We've identified&nbsp;four shifts that medical device manufacturers must make to transition successfully into&nbsp;the medsumer era.&nbsp;
<h2>Four Shifts that Medical Device Manufacturers Must Undertake</h2>
<ul><li>Shift #1: Safe & Effective -&gt; Desirable, Too</li></ul>
When our goal was strictly to design safe and effective devices, our focus was entirely on the product itself. Now, we are designing for a highly educated and discerning healthcare consumer. Our consumer expects our device to deliver an engaging user experience that will draw them back to that product over and over&nbsp;again. This requires a very different approach to design.&nbsp;We are&nbsp;no longer&nbsp;designing solely for safety and effectiveness; we're now designing for desirability, as well.
<ul><li>Shift #2: Hospital -&gt; At Home</li></ul>
For decades we've been used to designing for very normalized, carefully&nbsp;controlled healthcare settings.&nbsp;Regardless of whether we were designing for a hospital environment or a doctor's office, we could assume that the environment would function in a certain way. As we&nbsp;move into the home and the use of our products at home, we must now design for a&nbsp;larger set of&nbsp;environments, environments that are also much more complicated.&nbsp;The knowledge and the education required to get up to speed on understanding this new level of variability is pretty significant.
<ul><li>Shift #3: Trained User -&gt;&nbsp;Lay User</li></ul>
We have been used to designing for a "normed" user group what we could assume had&nbsp;a certain level of healthcare training. We now need to move from designing for this familiar user group to designing for a very wide variety of end users and their caregivers, who may have little or no healthcare training at all.&nbsp;
<ul><li>Shift #4: Digital Last -&gt;&nbsp;Digital Together</li></ul>
Digital experience design&nbsp;is an area where the medical device industry is lagging behind other industries, for several good reasons. This is an area of special interest for me, and&nbsp;I'll go into it in more detail below.

Shift 1 880

<h2>Shift #1:&nbsp;Safe & Effective -&gt; Desirable, Too</h2>
For the most part, medical device design has always been focused on regulatory compliance. Our primary concern has been to optimize for usability and reduce the risk of human error, and we have focused on&nbsp;on the functional abilities of the product to deliver as a medical device.&nbsp; The consumer product industry, on the other hand, focuses&nbsp;on experience design. If you're a designer of&nbsp;consumer products, your goal is&nbsp;to create unique branded experiences that will delight the user and bring them back over and over again&nbsp;to your products.&nbsp;This is&nbsp;a very different design approach.&nbsp;Instead of being product-centric, it views&nbsp;the product as an ecosystem. It addresses every&nbsp;touch point that shapes the user experience, starting with&nbsp;the&nbsp;way the user first discovers and engages with&nbsp;your brand and your product, to the way the user finally disposes of your product. It involves&nbsp;looking at design in a much broader way.
In the medsumer era, users are bringing their expectations of&nbsp;unique, engaging experiences, shaped by their&nbsp;experiences of&nbsp;consumer products, and applying these to their expectations of what a medical device should be able to deliver. This these heightened expectations are not limited just to lay users either. In our own&nbsp;usability studies in acute care settings and complex information systems, we have seen&nbsp;healthcare providers trying to swipe right to left on a screen because this is their expectation of how to get to the next screen level on our product. They are accustomed to very sophisticated interactions with consumer smart devices and they bring those expectations to medical devices as well.
As a result, medical device designers are being challenged to meet an entirely new set of standards in this new era. We must still design safe and effective products, but we must now&nbsp;deliver a higher level of intuitiveness and sophistication, as well as desirability.

<h3>What to Do About It</h3>
1. Change your mental model.&nbsp;Your end-user is a consumer of healthcare, not a patient or a healthcare provider. Words are powerful. Change the words you&nbsp;use and you&nbsp;can change the way you design your products.&nbsp; Historically, designing for a "patient" has been associated with the idea of designing for a passive consumer of healthcare. But if you change the terminology you use, and&nbsp;start thinking&nbsp;of your user instead as an active consumer of healthcare, it can go a long way toward driving change. The shift in terminology forces you to challenge your mental model and the assumptions you've made over the years about how to design for that user. If your end&nbsp;user is not a patient, but rather&nbsp;a consumer of healthcare, what are the design implications of this?&nbsp;I have seen this approach be very effective especially among our startup clients. Having this mental model shape their value proposition and the way they operate has enabled them to design very effective user experiences for their products.&nbsp; 

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The acceleration of tech, and especially the mobile revolution, has deeply impacted both the consumer and medical device industries. Our experience designing for both gives us a unique perspective on where the two are cross-pollinating.

Don't Miss: 3 UX Trends Reshaping Medical Device Design

2. Build internal design capabilities with strong consumer experience (CX) and user experience (UX) background as part of your R&D organization.​ In my experience, medtech companies tend to be very focused on the R&D side of innovation. Their engineers are very good at developing products that deliver on the functional requirements. But if you want to design memorable product experiences, you will need product designers, user experience designers, graphic designers, and interaction designers on your team as well. You can always call on outside design consultants like <a href="https://www.delve.com/insights/3-ux-trends-reshaping-medical-product-design" target="_blank">Delve to help you with this aspect of development</a>, but in the long run, if you want to make an impact with medsumer-era products, you need to integrate design capabilities like user experience (X) and consumer experience (CX) into your team. These need to become core competencies for you.
3. Test your product adoption and acceptance for desirability, not just usability or risk mitigation. I think of this as low-hanging fruit. Most medtech companies are already testing for usability with consumers to comply with federal regulations. It would be a relatively simple step to extend those sessions by an extra 15 minutes to ask questions about desirability. What would make this product more desirable? How could this experience be better? This additional input from the end user perspective will help you design more effective user experiences.

Shift 1 case study

While users of the Dexcom system greatly valued its enhanced ability to monitor their glucose levels, applying the subcutaneous Dexcom sensor to their bodies was an obvious pain point that was a barrier to wider adoption.

Case Study: Dexcom G6

<h3>Case Study</h3>
When you do this shift right, things just click. We saw it happen in the <a href="https://www.delve.com/work/cgm" target="_blank">work we did for Dexcom's G6</a> continuous glucose monitoring system. Dexcom came to us for help redesigning the applicator of their&nbsp;G5 device. They wanted the next generation applicator to be simple, painless, and error-proof. We accomplished this by applying the principle of "Simplexity," the idea of building&nbsp;complexity into the device itself in order to minimize steps for the user.&nbsp;
Whereas the earlier G5 device required eleven steps from the end user perspective, the G6 applicator we designed required only four. We were able to eliminate seven steps from the&nbsp;application process by integrating those steps into the device itself. This result was that those steps could be delivered very reliably without relying on an end user with limited training. It was a very intuitive solution—users could figure out&nbsp;how to use the applicator right out of the box.

Medical Alley Webinar testimonial1

Medical Alley Webinar testimonial2

Users fell in love with the Dexcom G6 because it transformed what had once been an intimidating experience to one that was painless and error-proof.

Another benefit of this approach is that people didn't feel that they were interacting with a medical device. The Dexcom G6 felt like a consumer grade product. All people could feel was the equivalent of a puff of air on their skin when they used it, when in fact a sensor was actually being pushed under their skin at very high velocity. Users fell in love with the Dexcom G6 because it transformed what had once been an intimidating experience to one that was painless and error-proof. 
The success of the G6 propelled Dexcom from being a well-funded startup to being a major player in the industry. They are now competing with some of the biggest brands in the marketplace.

Shift 2 880

<h2>Shift #2:&nbsp;Hospital -&gt; At Home </h2>
Many of our clients—established&nbsp;medical device companies—have built a ton of muscle memory when it comes to designing for&nbsp;normed, well-controlled environments. In such environments, we can rely on healthcare providers with a high level of education and expertise&nbsp;to operate devices correctly and deliver care reliably. But as healthcare moves into the home, our clients are surprised at just how much more variability we&nbsp;encounter and must now design for.&nbsp;Many factors that we never needed to consider when designing medical devices for the hospital setting are now&nbsp;realities.
The challenge is that building an understanding of these complex new home environments takes time, dedication, and a lot of&nbsp;effort. At Delve, we have done this&nbsp;over the course of many, many project engagements, and it is a constantly evolving body of knowledge.&nbsp;

<h3>What to Do About It</h3>
1. Challenge decades-old assumptions and rethink your standard product requirements.​
When we work with clients trying to launch&nbsp;medsumer applications, we often receive drafts of the product spec that still define the&nbsp;environment of use as the old clinical environments we used to design for. They fail to account for the&nbsp;high level of variability that found in a home setting.&nbsp; Keep in mind that your company's&nbsp;muscle memory templates, your product specs and product requirement documents that are set up for maximum efficiency, may actually be set up to leverage past expertise. Take a step back and challenge those assumptions.
2. Invest heavily in research.
Ideally, you would build this as an inside capability, and the&nbsp;investment would be two-fold: 
<ul><li>Build a solid understanding of the variability of home environment through contextual research and observation.​ Knowledge of the home environment will only be built over time, so make a point of including this type of research in as many projects as possible. Your environment of use will always be very specific to your user types and consumers, and&nbsp;will be a constantly evolving reality as well. Staying on top of changes to keep your understanding up-to-date will be an ongoing effort.&nbsp; </li></ul>
<ul><li>Test your product solutions in the context of home use and deprioritize controlled environments such as usability labs. You may be used to doing a lot of usability testing in simulated environments such as usability labs, which are more efficient and cost-effective, and sometimes "close enough." But the reality is that you would learn a great deal more by testing new concepts, prototypes, and solutions in the context of home use.&nbsp; Many times people come into the usability lab and tell us, "Yes, I&nbsp;will be using this device in my bathroom." Then, when we conduct research in contextual settings, we discover that they actually use the device while making dinner in the kitchen or&nbsp;while watching TV while having dinner with the rest of the family.&nbsp;The reality is that the context of use has changed dramatically, and you can only learn what you need to know by doing research in the context of home use. So, consider including this in your usability testing.</li></ul>

Shift 2 case study 880

EXOGEN® is the only FDA-approved bone healing device that uses ultrasound to stimulate the body’s natural healing process. Therapy is performed at home by the patient in a simple process that takes 20 minutes a day.

Case Study: EXOGEN® Ultrasound Bone Healing System

<h3>Case Study</h3>
When you rethink the product requirements for home use, you are more likely to design for maximum adoption. We saw this in our <a href="https://www.delve.com/work/exogen-ultrasound-bone-healing-system" target="_blank">work for Exogen</a>, a company that uses ultrasound technology to help with bone healing and tissue regeneration.&nbsp;&nbsp;People with a fracture or broken bone are able to recover more quickly if they apply this therapy for twenty minutes a day, twice a day, over the course of several months.&nbsp;
The problem was&nbsp;that the original, somewhat clinical device was being sent into the home, and users were failing at compliance. So we went into the field and conducted contextual research to discover what was causing&nbsp;the compliance issue. And we learned that users were skipping sessions or even stopping using the device altogether&nbsp;because they had no clear sense of whether it was critical to their care or not.&nbsp;
So, we redesigned the Exogen device to be super simple and&nbsp;easy to interact with, and we also&nbsp;made sure it provided&nbsp;user feedback in terms of scheduling and compliance. For example, we made sure the device&nbsp;visually communicated&nbsp;the fact that if a user missed a session, they could&nbsp;compensate for it&nbsp;in another way. This visual aid&nbsp;made a big difference in compliance. 
 The Exogen device has now been on the market for five or six years, and is still the&nbsp;number one prescribed solution for bone healing. This shows that when you do your homework with a medsumer application, it can have an enduring effect.

Shift 3 880

<h2>Shift #3:&nbsp;Trained User -&gt; Lay User</h2>
We must now design not for healthcare professionals, but for whoever the caregiver might be. The new user could be the patient's family member, a friend, or the patient themselves.
When we design for a trained user, we can rely on that user having a fairly high level of cognitive ability and education. This user might consult the device's&nbsp;instructions for use (IFU) once, then never need to refer to the document again. Moving forward, they simply apply that knowledge from&nbsp;patient to patient. This is not necessarily the case with the lay user. Lay users have a wide range of cognitive and physical abilities, and even educational levels. When you design for the lay user in the medsumer era, you need to consider all the factors that impact competence in operating a medical device. For example:<ul><li>Literacy and language barriers might cause instructions for use to be misunderstood.&nbsp;</li><li>Buttons on a device console might be too small and too hard to press for users that suffer from arthritis.&nbsp;</li><li>Text on labels and instructions for use might be too small to be legible for users with limited vision.&nbsp;</li><li>Hearing ability needs to be considered as well, since the new home use&nbsp;environment may contain much more ambient noise than a typical clinical environment, so device alarms and audible cues may get lost in the shuffle. </li><li>Learning ability and memory will vary as well. While a healthcare professional typically remembers how to use a device, some lay user may need to return to the IFU every time they use a device because they simply forget.</li></ul>

<h3>What to Do About It</h3>
1. Simplify, simplify, simplify. Your consumers are much less able than your current HCP user base.​
The consumers that we must&nbsp;design for now may have limited abilities compared to our previous user base, so apply the principle of Simplexity. Make your device so intuitive and easy to use that a lay user could probably use it without relying on the instructions for use. That should be the goal. Reduce the number of steps the user must take to operate the device. Make your device more complex in order to make it more usable.&nbsp; The effort to lower healthcare costs, a big driver behind the consumerization of healthcare, involves shifting the labor costs of healthcare away from healthcare providers onto lay users. But a consequence of this shift is that we must now build more sophistication into our devices. Devices will be more complex and more challenging to develop and more costly to produce. 
2. Design with edge cases in mind and adopt a universal design approach to development.​
Designing for the lowest common denominator would not be practical. Instead, apply the principle of Universal Design. Consider the wide variety of abilities that your users might have, then decide what is practical to design for. When you design for users that are less able, you will design a product that will be generally more usable for the entire population. There's a famous story about OXO Good Grips kitchen utensils that illustrates the&nbsp;the effectiveness of Universal Design. The company's founder decided to design a potato peeler that would be easier for his wife to use, because she suffered from severe arthritis. The resulting product was more usable for everyone. The OXO brand is successful today largely because&nbsp;their products are designed based on the principle of Universal Design, making them easy&nbsp;for most of the population to use and enjoy. Think about the edge cases and use this understanding to&nbsp;define your target design.
3. Understand your consumers deeply through empathy based methods such as contextual inquiry and observation and co-creation engagements.
It's important to&nbsp;bring your development and engineering teams into the field so they can build empathy for lay users.&nbsp;
The truth is, the level of education and cognitive ability may be much lower than they assume.&nbsp;The first time I&nbsp;went into the field to do contextual inquiry, for example,&nbsp;I was&nbsp;designing video magnifiers for people with severely impaired vision. They needed better magnifiers to read the labels on their prescription medication bottles. I will never forget how one woman I met was trying to write a check for a utility bill. She had been looking at the screen so she could read&nbsp;the magnified image of the check, and now the screen was entirely peppered with ink marks because she had&nbsp;been so tempted to write out her check directly on the screen. This is the reality of what we face in the field. After I returned from that study, I&nbsp;designed differently for the rest of my career. I invite you to do this with your team. You will build so much&nbsp;empathy for your users, become a better designer, and design much better products.
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Shift 3 case study 880

<h3>Case Study</h3>
A client once came to us with safety syringes that had been developed for use in the hospital setting. There had been an increase in chronic diseases that required regular injections of biologic drugs at home. This meant bigger molecules, more viscosity in the drugs, and harder pressure to inject the drugs. The question they asked us was, "Are our products able to deliver the standard of care we expect, at home? Will people be able to use it?" To answer this question, we conducted&nbsp;qualitative research. We worked with nine patients and consumers across the U.S., living with them for four to six hours to understand the context of use and see how they managed through the injection cycle.
We discovered many things. For example, the bottom right image above changed my approach to medical device design. I now make sure that people with really long fingernails will be able to operate the device, because that's part of the reality of what's happening in the field.
Whenever you can, bring the patients and consumers into the process. Design with them and help them design for themselves. This builds empathy and will help you design better&nbsp;medsumer applications.

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

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What the Medical Device Industry Can Learn from Consumer Product Development Practices

What the Medical Device Industry Can Learn from Consumer Product Development Practices

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