Mathieu Turpault THUMB

Mathieu Turpault

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Medical device design and consumer product design used to be separate and distinct areas of practice. 
Historically, medical device design has been very focused on regulatory compliance. If you were a designer of medical devices, your primary concern was meeting extremely rigorous requirements of safety and effectiveness. 
By contrast, the consumer product industry has been focused on experience design. Your goal, if you were a designer of consumer products, was to create unique, branded experiences that would delight the user. 
But, as patients have become increasingly empowered consumers of healthcare, the line between medical devices and consumer products has begun to blur. 
Consumers are starting to bring to medical devices the expectations formed from their experiences with highly intuitive consumer products. Designers are being challenged to meet an entirely new set of standards. In addition to being safe and effective, medical devices must deliver a high level of intuitiveness and sophistication as well.

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<h2>Forces Driving the Consumerization of Healthcare</h2>
What we call the consumerization of healthcare is the trend in which individuals are increasingly taking control of their own medical and wellness care. The trend was accelerated by the COVID-19 pandemic, enabled by technology and information access, and has a generational component as well. 
As avid consumers of digital products and information online, Millennials and Gen Z are increasingly bringing online behavior patterns and expectations of consumer-focused convenience to the realm of healthcare interactions. Compared to previous generations, they are <a href="https://www.ebri.org/docs/default-source/fast-facts/ff-297-millennialhealthcare-5mar18.pdf?sfvrsn=433b342f_2" target="_blank" rel="noreferrer noopener">far less likely</a> to need a primary care provider to coordinate their care; they are <a href="https://www.ebri.org/docs/default-source/fast-facts/ff-297-millennialhealthcare-5mar18.pdf?sfvrsn=433b342f_2" target="_blank" rel="noreferrer noopener">twice as likely</a> to use telemedicine, and <a href="https://www.insiderintelligence.com/content/gen-z-fastest-growing-generation-among-smart-wearable-users" target="_blank" rel="noreferrer noopener">three times as likely</a> to use smart wearables.

Cost is another important driving force behind this trend. In the U.S., where healthcare is a for-profit industry, staffing shortages and the rising costs of skilled healthcare labor have been gradually pushing point-of-care from hospitals into the home. 
Shifting the responsibility for administering care from healthcare professionals to patients themselves can reduce costs, but this move has important implications for those who must now design safe and effective medical devices with an entirely different user in mind.

<h2>What the Trend Means for Patients </h2>
On the plus side, patients have more control over their care. Also, for many patients, administering their own care at home is more convenient than having to take time off work to travel to point-of-care locations. 
The downside, at least in the short term, is greater risk. As the industry shifts the burden of responsibility for administering care from trained healthcare providers to patients, we may see a higher rate of error, as well as lesser ability to deal with the adverse consequences of those errors.

<h2>What the Trend Means for Manufacturers and Designers of Medical Devices</h2>
The consumerization of healthcare has set manufacturers of medical devices on a new and unfamiliar journey. The medtech industry has always assumed that professional healthcare providers, trained to deliver a reliable standard of care, would be the end users of their products. Now, their products are being used by patients with much less training, in an unregulated home environment, with higher levels of variability and risk. Designing for this new context and a new type of user brings a tough set of challenges.

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Designs that once delivered safe and effective product experiences within a regulated clinical environment are no longer enough. Now, patients with little or no medical background, with wide-ranging physical and cognitive abilities, working in sometimes unpredictable home environments, need to be able to operate a medical device smoothly and easily, without introducing use errors along the way. At the same time, these patients are also consumers who have grown up with the iPhone, smart devices, and the Age of Information. They bring dauntingly high expectations of intuitiveness and sophisticated interaction design to the medical devices that we design for them.

Otometrics Otoscan Medical Ear Device

Delve can assist from concept to launch of Class II and Class III medical devices: creating user requirements and handling regulatory compliance, developing medical device designs, selecting materials and supply chains, and assisting with FDA submissions.

<h2>A Net Positive for Patients and for the Medtech Industry</h2>
Over the long term, I view the consumerization of healthcare as a net positive. Patients will have greater control over their own healthcare, at a lower cost. We’ll see greater competition for consumer healthcare dollars rather than large, monopolistic hospital contracts. We’ll see a lowering of the barrier to entry for startups and have greater access to care from these newly formed companies.
That said, for manufacturers and designers, re-learning how to design safe and effective medical devices in the wake of the consumerization of healthcare will not be easy. Companies that rarely prioritized intuitive design beyond what was absolutely required to comply with “safe and effective” requirements will have the toughest transition. Companies with consumer product experience will have an advantage in designing medical devices suited for at-home use.

Read next: 
<a href="https://www.delve.com/insights/how-to-design-a-medical-device-thats-as-safe-and-effective-as-an-mri-machine-and-as-intuitive-and-easy-to-use-as-a-nest-thermostat" target="_blank">How to Design a Medical Device That’s as Safe and Effective as an MRI Machine—and as Intuitive and Easy to Use as a Nest Thermostat</a>

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Patients are becoming empowered consumers of healthcare. They bring to medical devices the high expectations formed from their experiences with highly intuitive consumer products—as well as greater risk.

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Patients are becoming empowered consumers of healthcare. They bring to medical devices the high expectations formed from their experiences with highly intuitive consumer products — as well as greater risk.

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How the Consumerization of Healthcare is Transforming Medical Device Design

How the Consumerization of Healthcare is Transforming Medical Device Design

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