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In <a href="https://www.delve.com/insights/how-the-consumerization-of-healthcare-is-transforming-medical-device-design" target="_blank" rel="noreferrer noopener">my last post,</a> I wrote that the consumerization of healthcare has handed manufacturers of medical devices a tough challenge.
With patients increasingly taking control of their own healthcare, you need to start designing for a new kind of user—a user who grew up with the Nest thermostat, smart devices, and the Age of information, and who expects a high degree of convenience and intuitiveness from the tools you design for them.

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

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You also need to re-learn what it means to design safe and effective medical devices. Your new user has little or no medical background, may have a range of physical and cognitive abilities, and will be operating our device at home, perhaps surrounded by distractions and interruptions. 
How do you design a seamless, error-free product experience for them?

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<h2>1. Empathize with and design for your end user, not your buyer. Understand that your user is no longer a passive patient, but rather, an empowered consumer. </h2>

Your project requirements are probably heavily tailored to address the needs of Healthcare Providers (HCPs). They are the buyers of your products, after all, so designing for them makes sense. 

In a very common scenario, a medical device manufacturer’s buyer might be someone in procurement who has harsh targets for cost reduction, year over year. How might designing for this buyer impact the way a medtech firm designs their products? 
<ul><li>Cost-of-goods becomes a primary driver for design. The expectation is that every new product must turn a profit commensurate with the manufacturer’s current product lines. </li><li>If the company is a well-established brand, they might feel that they have little room for design experimentation. This pushes the company’s design and R&D teams into incremental innovation mode. </li><li>The end user is relegated to the role of passive patient, rather than the focus of a system built to serve them. Decisions about what the patient needs and ends up using are made by the HCP. </li><li>Designing an intuitive user experience is not prioritized, since the manufacturer knows they can rely on highly trained medical professionals to operate their device. </li></ul>
However, as the healthcare industry in the US gradually <a href="https://www.delve.com/insights/how-the-consumerization-of-healthcare-is-transforming-medical-device-design" target="_blank" rel="noreferrer noopener">shifts the burden of care</a> away from HCPs to patients themselves, a similar shift is occurring regarding buying decisions as well. Patients no longer see themselves as the passive end users that our product development requirements assume. Rather, they see themselves as empowered consumers who can decide for themselves whether they prefer one manufacturer’s continuous glucose monitor over another’s. Instead of simply accepting whatever device their HCP recommends, today’s patient will tell their doctor to prescribe the product they prefer. If one HCP doesn’t give them what they need, they are willing to get their care elsewhere. 
For medical device manufacturers, it’s time for a mental paradigm shift. Empathize with your end users. Make them the focus of your design process. Understand the impact of their health conditions and their context of use. Until you do this, you run the risk of designing products that your end users don’t want and will reject.

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<h2>2. Put digital first. </h2>
Many large medical device manufacturers are behind the curve when it comes to incorporating digital experience into their products. It’s easy to understand why. 

Medical devices are rightly required to meet extremely rigorous standards of safety and effectiveness, otherwise human lives are put at risk. Many large medtech firms lack literacy in digital experience design, so they view incorporating digital technology into their products as unnecessarily risky. 

It doesn’t help that regulations covering the digital aspects of medical devices are far from clear or settled. In 2022, the U.S. federal government <a href="https://www.delve.com/insights/biggest-innovations-in-2022-that-influenced-product-design" target="_blank" rel="noreferrer noopener">considered several proposals</a> to regulate medical device cybersecurity and address potential vulnerabilities in medical devices, mobile apps, and record-keeping systems that could put patient privacy and safety at risk. Most are still in various stages of consideration or amendment. It’s hard to design digital medical devices to meet federal regulations that don’t exist yet. 

It’s no surprise, then, that incorporating digital experience into medical device design has not been a priority for many companies. Why invite risk and federal scrutiny? It makes better sense to stand back, watch, and wait. Doesn't it? 

No, actually, it doesn’t. 

When medtech companies ignore digital experience in their product design, they are choosing, consciously or not, to design primarily for an older generation of users. They are ignoring, at great risk to their own business, the fact that an increasing number of today’s users—HCPs and patients alike—are Millennials and Gen Z. This generation of users are digital natives who expect from medical devices the same level of connectivity, convenience, and intuitiveness that they get from any high-end digital consumer product. They expect physical experience to be augmented by digital experience. 
For medical device manufacturers, this means: 
<ul><li>You need to put digital first. Digital experience can no longer be a secondary design consideration or a nice-to-have add-on. </li></ul>
<ul><li>A software team is not enough—you need a true digital team. If you and your team are not fully educated in all things digital, it will show in your products. A software component bolted onto a medical device just equals an unusable digital experience. </li><li>You need to become literate in digital experience design now. Bring the expertise you need in-house or find the right partner. And yes, prepare for compliance with future legislation. But do it now. </li></ul>
<a href="https://www.fastcompany.com/90724444/most-innovative-companies-medical-devices-2022" target="_blank" rel="noreferrer noopener">Medtech startups that "get" digital</a> and are ready to deliver what today’s users expect are jumping in to make it happen. Larger players must either embrace digital or continue to lose market share—and risk playing catch-up forever.

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<h2>3. Embrace the entrepreneurial spirit.</h2>
Pivoting to embrace digital technology and design new kinds of medical devices for an entirely different user will not be easy. 
Medical device manufacturers would need to: 
<ul><li>Shift the focus of their corporate culture away from cost savings and incremental, low-risk innovation. </li><li>Operate differently on the front end of document control and release themselves from the cultural burden of rigid quality management systems in order to operate more quickly. </li></ul>
<ul><li>Interpret FDA guidance more flexibly and test solutions faster. </li><li>Explore different revenue generation models that are not tied to their usual way of doing business. What devices might a company develop if their goal were to deliver products that end users want to use because they enjoy their experience, and it makes their lives better? </li></ul>
In our own client work, we have seen how challenging it can be for large, successful medical device manufacturers to achieve this type of shift. Efforts at disruptive innovation are often stifled by the company’s own corporate culture and structure. 
Taylor Cone, Delve’s Head of Innovation Enablement, <a href="https://www.delve.com/insights/stop-trying-to-innovate-try-this-instead" target="_blank" rel="noreferrer noopener">explains</a> why: “Innovation comes easier when companies are younger, smaller, and leaner. As a company matures, the bulk and weight of the very systems and processes intended to enable companies to function efficiently and effectively now get in the way of achieving innovative outcomes.” 
This dynamic leaves open a gap of opportunity for agile, digital-first medical device startups to thrive. Attentive to end users’ needs and expectations, willing to take risks and embrace new business and revenue models, they not only generate innovative medical devices and technologies—they bring them to market faster.

Let Delve's multidisciplinary medical device experts assist you with product innovation for Class II and Class III devices.

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How might a larger, established firm respond?
<ul><li>Acquire startups whose products and technology dovetail with your own long-term roadmap. You’ll sidestep the risk and burden of R&D. However, integrating a new company post-acquisition comes with its own challenges.</li><li>Establish a separate R&D division whose sole purpose is to experiment with new products, new business models, and new ways to market. This would allow you to innovate and to test market response before launching the product as part of the parent company's product line.</li><li>Outsource R&D to a trusted partner. Choose a firm that centers your users’ needs and integrates digital experience design throughout the design and development process. Ideally, the firm would have experience designing digital consumer products as well as medical devices.</li><li>Identify the barriers that are keeping innovation from thriving in your organization, then eliminate them. With the right <a href="https://www.delve.com/innovation-enablement" target="_blank" rel="noreferrer noopener">support</a>, companies of any size can build robust systems that drive innovation.</li></ul>
I recommend choosing the path that best enables you to put your users at the center of every phase of design and development. Opportunistic solutions can address your company’s needs in the short term, but your users—and ultimately, your company’s long-term outlook—will benefit most from a more strategic, holistic approach.

Learn more about&nbsp;<a href="https://www.delve.com/medical-devices" target="_blank">Delve Product Development Services for Medical Devices.</a>

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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.

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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.

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