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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 apps like BlueStar are legally considered pharmaceutical products requiring prescriptions and FDA clearance, vastly differentiating them from typical health tracking apps.
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Only about 0.01% of diabetes apps have FDA clearance ensuring accuracy and clinical efficacy.
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BlueStar outperforms common pharmaceutical treatments like metformin by lowering A1C levels by two points through data science and behavioral coaching.
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Bigfoot’s artificial pancreas is a closed hardware-software system with continuous glucose monitoring and insulin dosing, designed for type 1 diabetics.
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Medical digital products require multi-persona design including patients, caregivers, doctors, payers, and pharmacies, forming a complex ecosystem.
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Onboarding and provisioning involve drug prescription workflows integrated with insurance and pharmacy systems, with unique challenges like annual renewal and refill processes.
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FDA regulation imposes rigorous human factors testing, traceability of design decisions, and documentation through a design history file not typically found in enterprise design.
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Machine learning algorithms personalize insulin dosing in response to contextual data like location, activity, and environmental conditions such as altitude and temperature.
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User retention in digital medicine can be paradoxically positive when users stop using the app because their health has improved, unlike typical app churn.
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Designing regulated medical software demands far more patience and risk mitigation than enterprise UX, but mastering it allows one to succeed in less regulated domains.
Notable Quotes
"These are class of applications that are considered mobile prescription therapy."
"The line between regulated and unregulated is actually pretty simple in theory: if a product generates a diagnosis or treats, it's subject to FDA regulation."
"BlueStar can’t turn off your phone in an emergency state if you’re at risk of hypoglycemia—it essentially harasses you to take carbs."
"The insurance company won’t pay if the patient isn’t using BlueStar enough during the month; it’s a shared risk business model."
"You have to design for an ecosystem of experiences: patient, caregiver, doctor, payer, pharmacy, including complex refill and renewal workflows."
"The FDA approved agile process is closer to waterfall, with strong documentation and traceability requirements."
"If you can do medical product design, you can do anything. It’s the hardest UX domain."
"Most type 2 diabetics are treated by general practitioners, not endocrinologists, complicating education and adoption."
"It took about 10 years for BlueStar to develop a product that could charge money and scale with proven clinical results."
"Bigfoot’s pump algorithms run on the device itself so losing the phone doesn’t stop insulin dosing."
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