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Summary
Can a software only mobile solution outperform a pharmaceutical drug in clinical trials? Is it possible to create an app only available via a doctor’s prescription? The answer to both questions is a responding YES! In this webinar, Dan walked through several medical product case studies he has consulted on. The first is the WellDoc BlueStar solution for type 2 diabetes patients. BlueStar was the first instance of Digital Medicine invented. BlueStar received both an FDA class 2 certification and a prescription drug code for insurance reimbursement. Legally speaking this 100% software only solution is a medication. In clinical trials it has proven to reduce high-risk type 2 patients A1C levels by more than 1.8 points, outperforming many commonly prescribed medications. The second case study is Bigfoot Biomedical’s artificial pancreas for type 1 diabetics. It has completed its first clinical trial rounds but is not yet in the market. This solution uses an amazing combination of AI, big data and IoT embedded in the human body to automate insulin delivery 24/7. The primary UX resides on the patients’ phone. Interfaces for doctors and insurance companies will complete the end to end system experience including an innovative direct to patients supply chain. In addition to these amazing case studies this webinar described the similarities between digital medicine design and Enterprise UX. You will be surprised to see how much they have in common as well as what else you need to know to enter this cutting-edge UX domain.
Key Insights
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Digital Medicine encompasses regulated software that qualifies as medical devices under FDA guidelines.
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The majority of diabetes management apps are data loggers with only a small percentage undergoing FDA clearance.
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Engagement with clinicians, payers, and users is essential to design effective medical products.
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The onboarding process for medical apps can be complex, requiring prescriptions and patient engagement.
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User retention can be affected by the user's health journey; some stop using apps once they achieve control over their conditions.
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There are significant differences in safety, privacy, and usability concerns between medical and enterprise UX.
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The design process for medical products requires thorough documentation to comply with FDA regulations.
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Caregivers and healthcare providers are key personas in the design process for diabetes management apps.
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Successful applications often incorporate data science, machine learning, and gamification to enhance user engagement and outcomes.
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The user experience in medical devices must consider the complex integration of multiple stakeholders and operational ecosystems.
Notable Quotes
"One reason we do these communities is to engage with the topic year-round instead of just during conferences."
"Dan was my first boss hired me out of Carnegie Mellon to come work for him at Oracle."
"There are about 200,000 digital health products available right now."
"The demographics follow the disease demographics; nobody really wants to use your app."
"We have to get a prescription renewed every year for BlueStar to continue operating on your phone."
"The impact of these products is quite transformational on people's lives."
"Most patients said this is the first time in my life I have slept through the night."
"The FDA's approval process requires documentation of every design decision made."
"The testing process in medical design looks like a usability test but is much more prescribed and rigorous."
"If a product generates a diagnosis or treats a condition, it's subject to FDA regulation."
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