Designing Medical Devices for Real World Use

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Designing Medical Devices for Real World Use – A Case Study in Diabetes

by Jen Block, VP Clinical and Medical Affairs
September 25, 2018

Jen Block

A shortage of specialists, especially in endocrinology, means new technologies must become far simpler to learn and use

I’ve been fortunate to work in many different healthcare settings in my career, and during my training as a family nurse practitioner, I spent considerable time working in primary care with patients across the age spectrum.

For me, primary care created a valuable learning experience. Working with patients who present with a myriad of concerns and a wide range of health conditions, one learns to listen closely, diagnose carefully, and partner with patients to develop a treatment plan. I saw many instances where our healthcare system offered the right treatment to the right patient at the right time and where physicians had the support and the tools they needed to offer the highest possible quality of care.

I also saw areas where we face many challenges to deliver optimal care, especially in the management of people living with chronic health conditions. In a system where providers are pressured to see more patients in less time, providers have discovered this hard truth: It is a challenge to manage chronic health conditions in a 15-minute appointment.

As diabetes is largely self-managed, it’s important for healthcare providers to partner with people with diabetes to support them in managing this complex and challenging condition. For the most part, people living with chronic conditions are referred from primary care to specialists, and for people managing many conditions, this scenario works reasonably well.

But for people managing diabetes—as I have for most of my adult life—the situation is untenable. There are more than 30 million people in the U.S. with diabetes, and that number is climbing. As of 2010, the country had fewer than 6,000 endocrinologists to treat those patients, according to American Board of Internal Medicine statistics. Given the pressures of the job, and the low compensation compared to other specialties, this trend seems unlikely to reverse itself anytime soon.

This lack of access to a multi-disciplinary team or diabetes specialist creates a challenging situation as it means the majority of people with diabetes are getting medical advice and treatment in the short window afforded by the primary care setting.

A person managing diabetes might have as many as 15 prescriptions to fill, which easily takes up the entire visit. This means it falls to the person with diabetes to navigate the considerable work that goes into day-to-day management of the condition.

This is the unfortunate new reality of diabetes care. With fewer endocrinologists to treat more people with diabetes, I’m concerned about how we will support people with diabetes in the future.

New technologies have an important role to play in making this situation better, but medical devices will not have a meaningful impact on this scenario if we keep designing them for an ideal world – one where we have enough specialists to help people manage chronic conditions like diabetes. We have to recognize the challenges of implementation for the medical devices we design, and we need to design them for the real world.

Designing for the New Reality

Leading medical device companies typically design insulin pumps and other tools with the endocrinologist in mind. This continues to be the business model even as a growing number of people diagnosed with diabetes are seeing a dwindling number of endocrinologists.

These devices require a significant investment of money, time, and effort to acquire and learn how to use. Unfortunately, designing for a healthcare provider who has a multidisciplinary team or sufficient resources to support use of these complicated technologies—the way many companies are doing now—must become a thing of the past. Providers just don’t have time anymore, and we will never be successful if we expect to get more of a provider’s time or that we can design devices that ask a provider to change the way he or she currently operates.

We need to take a step back and look at what will actually fit into the healthcare delivery system – reenvision and reimagine how we can initiate, support and consider costs, time, and resources. The medical devices we design need to reflect this new world. We need to stop asking overburdened healthcare providers and busy people living with chronic disease to invest time they don’t have in learning new technologies.

We have a responsibility to make the technologies easier to prescribe and easier to train, use, and support. Medical devices used in the treatment of chronic conditions, especially diabetes, should evolve the way other technologies have. Take, for instance, camera technology.

Years ago, when I wanted to take high-quality photographs, I had to do a lot more than just buy a good camera. I took classes to learn about shutter speeds, apertures, F stops, and other important tools for getting the perfect shot.

With the release of the first smartphones, just about everyone found themselves owning a good camera. The smartphone camera has evolved into a sophisticated device that now enables people to take magazine-worthy photos without learning about F stops and apertures. Smartphone developers took all the work off the user’s plate so that the consumer today just points and clicks.

This is the same trajectory medical devices must follow because, once they are approved for sale, they will be deployed into a troubled system where no one has as much time as they might have had in the past. It is incumbent on device designers and companies to be prepared to understand the challenging healthcare system and design for change.

We have to automate the things that can be automated and find a way to reach outcomes in less time, with less training, and without asking for more engagement from either provider or user. We have to create avenues that allow for implementing changes without driving costs, such as providing for firmware-over-the-air updates so a new device isn’t needed or executing on training and onboarding in such a way that clinicians do not need retraining.

My experience in primary care is one of the things that informed my decision to join Bigfoot Biomedical, where we are building connected treatment systems that are intended to be simple for healthcare providers to train on and easy for consumers to use, but that also seek to improve health outcomes. After all, simplicity doesn’t matter if it doesn’t help with outcomes!

The shortage of endocrinologists makes me apprehensive about the quality of care in the future – for myself and for the many millions of people who also live with my condition. But new medical technologies – built with the consumer and the primary care physician in mind – make me feel a lot more hopeful.

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