Insights on digital therapeutics, AI/ML in clinical development, regulatory pathways, and the future of cardiovascular-metabolic care
The landscape of cardiovascular, renal, and metabolic (CVRM) disease management is undergoing a fundamental transformation. As digital therapeutics mature from promising concepts to validated clinical tools, we're witnessing an unprecedented convergence of advanced technology, rigorous clinical science, and patient-centered care delivery.
Read More →This installment examines why automating insulin delivery isn't straightforward, highlighting the asymmetric risks of glucose dysregulation and the physiological delays that complicate control. We review the critical technologies—CGM and insulin pumps—that emerged to address the limitations of multiple daily injections, and introduce the mathematical models that form the foundation for control algorithms explored in Part 2.
Read More →In this second installment, we take deep dive into the mathematical and physiological understanding that transformed these hardware components into intelligent, adaptive systems. This journey takes us from the elegant simplicity of the minimal model to sophisticated digital twins that convinced regulators to accept virtual patients as substitutes for animal testing, much as flight simulators revolutionized aviation safety.
Read More →In this final installment, we discuss the UVA/Padova simulator's FDA acceptance in 2008 which opened the floodgates for innovation, leading to a diverse ecosystem of AID systems each employing distinct control strategies. In this concluding installment, we examine the major commercial systems that have reached patients.
Read More →Continous glucose monitoring sensors have come a long way and have truly made siginificant impact on people living with Type 1 Diabetes. But what if there were a similar continous monitoring sensor system which monitors a variety of protiens, esp those linked to inflmation such as IL-6, TN1-alpha which can signal imminnent cytokine release syndrome which can be lethal. In this blog post, we try to analyze a novel sensor being develop which can continously monitor these inflamatory markers in interstitial fluid.
Read More →In January 2024, Eli Lilly launched LillyDirect, offering direct-to-consumer sales of Zepbound at $499 per month—less than half the traditional list price of $1,059. This wasn't simply a price cut or promotional campaign. It represented a pharmaceutical manufacturer bypassing the entire established distribution infrastructure: pharmacy benefit managers, insurance formularies, retail pharmacies, and traditional prescribing patterns. Within months, Pfizer, Abbott, and Dexcom followed with their own DTC platforms. What began as an experiment has become a movement, raising profound questions about access, cost, care coordination, and the future structure of pharmaceutical distribution in America.
Read More →The Central Question: When you and your employer pay health insurance premiums totaling perhaps fifteen thousand dollars annually, where does that money actually go? How much reaches the doctors, nurses, and hospitals providing your care? How much disappears into administrative machinery? And how does America's healthcare dollar journey compare to other developed nations? This deep dive traces every dollar from premium payment through the labyrinth of intermediaries to actual patient care, revealing startling inefficiencies and offering lessons from international comparisons.
Read More →Investment Thesis: The direct-to-consumer pharmaceutical market is fragmenting as manufacturers rush to build independent platforms, e.g. Eli Lilly's LillyDirect ($499/month for Zepbound), Pfizer's PfizerForAll, Abbott's Lingo, and Dexcom's Stelo. This fragmentation creates a $10-20 billion consolidation opportunity across four distinct business models, each requiring different ownership structures and capital deployment strategies. For investors, the critical question is not whether consolidation will occur, but which model to back and at what valuation. This analysis provides a framework for evaluating these opportunities through business model canvas analysis and investment rubric scoring.
Read More →Core Premise: While direct-to-consumer (DTC) models from pharmaceutical and medical device manufacturers offer solutions for the uninsured and underinsured, they largely bypass the 310+ million Americans with traditional insurance coverage. For this insured majority, healthcare remains frustratingly broken—not due to lack of access, but due to Byzantine bureaucratic processes that plague both payers and providers. The emerging concept of harmonized administrative systems presents a rare opportunity to simultaneously improve care delivery, optimize reimbursement efficiency, and enhance appropriate utilization—the elusive healthcare trifecta.
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