Why 454 Million People Are Waiting for a Device Already in Their Pocket
Insights from Bipin Patel, CEO & Founder
January 6th, 2025
The Smartphone Revolution in Respiratory Care Has Arrived, And It Changes Everything
Here's an uncomfortable truth: we've had the technology to transform respiratory diagnostics for years. It's sitting in your pocket right now.
There are 7 billion mobile phones in circulation worldwide. Every one of them has sensors sophisticated enough to monitor respiratory function with clinical-grade accuracy. Yet 454 million people suffering from chronic respiratory disease still travel to clinics for episodic testing with equipment fundamentally unchanged since 1846 [1]. Seventy per cent of COPD cases remain undiagnosed until severe symptoms force hospital admission [2].
We've put heart rate monitors on millions of wrists. We've made glucose monitoring routine for diabetics. But the organ system that determines whether we live or die with every single breath? Largely unmonitored outside hospital laboratories. That makes no sense. And it's about to change.
The Problem Nobody's Talking About
Let me be direct. The respiratory care system is broken. Not because we lack good clinicians or effective treatments, but because we're using diagnostic tools designed for Victorian England to manage 21st-century disease.
In 1846, John Hutchinson invented the spirometer, a counterbalanced bell inverted in water that measured lung capacity. Revolutionary at the time. His insight was simple: measure lung function before symptoms appear, predict who's at risk, and intervene early. One hundred and seventy-five years later, we're still using essentially the same approach. Patients come to clinics. Blow into a device. Get a single measurement. Come back in six months or a year, if they come back at all.
This episodic testing model has failed. Studies have shown that primary care physicians routinely underuse spirometry, even for high-risk patients [3]. When they do use it, test quality is frequently inadequate. Interpretation is often wrong. And here's the fundamental problem: you cannot capture a dynamic, progressive disease with snapshots taken months apart.
The famous Fletcher-Peto curve from 1977 showed COPD as a steady decline in lung function from smoking. That model shaped decades of research and clinical practice. There's just one problem: recent studies prove it's wrong. Half of COPD patients never follow that trajectory [4]. We've been designing trials, screening programmes, and treatment guidelines based on an incorrect disease model.
"Standard spirometry misses disease in the small airways until more than 50% have been damaged. We're diagnosing obstruction only after extensive, irreversible harm has occurred." [5]
Why This Matters Right Now
For pharmaceutical executives reading this: your COPD trials have an 85% failure rate in Phase 3 [6]. You know why? You're enrolling heterogeneous populations based on 1970s diagnostic criteria, then asking whether a single therapeutic approach works across multiple distinct phenotypes. It doesn't. And it won't, until we fundamentally change how we phenotype and monitor patients.
Current trials rely on crude endpoints: exacerbation rates, modest FEV₁ changes that may not reflect real clinical benefit. In idiopathic pulmonary fibrosis, we use forced vital capacity decline as a surrogate endpoint despite ongoing controversy about whether it actually predicts mortality or quality of life. We're measuring what's convenient to measure, not what matters to patients.
Here's what continuous monitoring enables: precise patient stratification before randomisation. Trajectory analysis showing whether treatment actually alters disease progression. Early efficacy signals within weeks, not months—real-world evidence generation from day one of market authorisation.
That's not hypothetical. Companies are already exploring this. The competitive advantage will go to organisations that embrace continuous, patient-generated health data now, not five years from now.
The Technology Is Ready. The Question Is: Are You?
Three factors have converged:
Smartphones with clinical-grade sensors and computational power are ubiquitous. Seven billion devices have already been deployed globally.
AI algorithms can now process respiratory signals in real-time, interpret complex patterns, and flag deterioration before clinical symptoms emerge.
Regulatory frameworks have matured. Clear pathways exist for digital health technologies to achieve medical device authorisation.
Multiple platforms are now demonstrating that smartphone-based respiratory monitoring achieves accuracy comparable to laboratory spirometry. Clinical investigations involving hundreds of patients show >95% agreement with traditional spirometry for key diagnostic parameters. More importantly, these platforms capture what episodic testing never could: continuous tracking of respiratory function in patients' actual environments, revealing disease progression in real-time.
Think of it as a Fitbit for lungs. Continuous monitoring. Personalised baselines. Early warning when the function declines. Data that transforms how we design trials, manage chronic disease, and predict outcomes.
The Market Is Larger Than You Think
For technology companies, respiratory monitoring is the last major vital sign category yet to be digitally transformed at scale. Consider the numbers:
Five hundred and forty-five million people worldwide have chronic respiratory disease [1]. COPD alone costs over $500 billion annually in direct healthcare costs and productivity losses [7]. Asthma affects more than 300 million people [8]. The total addressable market dwarfs the combined markets for diabetes, cardiac monitoring, and sleep tracking.
This exhibits classic platform characteristics. Initial diagnostic adoption creates network effects: more users generate richer datasets, enabling better algorithms, improving accuracy, and attracting more users. The platform expands from diagnostics to continuous monitoring, from monitoring to therapeutic delivery, from therapeutics to predictive analytics for healthcare systems and payers.
The technical barriers are substantial, including clinical-grade accuracy, sophisticated signal processing, complex interpretation algorithms, and rigorous regulatory validation. High barriers protect first movers who execute well.
Market timing is compelling. Ageing populations, increasing air pollution, and long-term respiratory effects from COVID-19 are driving disease prevalence upwards [9]. Healthcare systems need solutions that shift care from hospitals to homes. Payers are embracing value-based models that reward prevention. Everything is aligned.
What Needs to Happen Now
Pharmaceutical companies:
Rethink clinical development programmes from the ground up. Continuous monitoring isn't a 'nice to have' for post-marketing surveillance; it's essential for getting trials right from Phase 2 onwards. Patient stratification, adaptive trial designs, and real-world evidence generation. This needs to be a core strategy, not an innovation theatre.
Technology platforms:
Respiratory monitoring is your next platform play. The infrastructure must be built now, including data standards, integration frameworks, and clinical validation at scale. This becomes the respiratory health operating system that everyone builds on. First mover advantage is real, but only if execution is excellent.
Healthcare systems and payers:
Reimbursement models need to evolve. Stop paying for reactive treatment of advanced disease. Start incentivising continuous monitoring and early intervention. The health economics are obvious: preventing COPD exacerbations is vastly cheaper than managing them. But payment models need to reflect that reality.
Regulators:
Clear pathways exist for digital health devices. Good. Now we need post-market surveillance frameworks that leverage continuous monitoring to detect safety signals faster, whilst allowing rapid innovation. The current paradigm, designed for physical devices with infrequent updates, doesn't fit software-based medical technologies that continuously improve.
"We're not talking about the future. Clinical validation is happening now. Regulatory submissions are progressing. Partnerships are forming. The only question is whether you'll lead this transformation or watch it happen."
This Isn't About Technology, It's About Patients
Strip away the business cases and market opportunities, and here's what matters: 454 million people are suffering [1]. Most will never be diagnosed until their disease is advanced and treatment options are limited. Many will die unnecessarily because we're too slow to adopt technology that already exists.
John Hutchinson understood in 1846 that lung function predicts mortality better than almost any measurement we make. He was right. Every longitudinal study since has confirmed it: reduced lung function in early adulthood predicts cardiovascular mortality, all-cause mortality, and functional decline decades later [4]. The lungs tell us who's at risk, if we bother to listen.
Early detection before symptoms emerge was Hutchinson's original vision. We can now achieve that at a population scale. Continuous monitoring can identify gradual, small-airways dysfunction years before clinical COPD. It can detect early restrictive changes in interstitial lung disease before intervention can modify the disease course. It can stratify cardiovascular risk through respiratory parameters.
This isn't hypothetical. It's happening. The question is: how quickly will healthcare systems, pharmaceutical companies, technology platforms, and regulators move?
The Bottom Line
The transformation from episodic to continuous respiratory monitoring isn't coming; it's here. Multiple platforms are in clinical validation. Regulatory pathways are clear. Pharmaceutical partnerships are forming. Healthcare systems are piloting programmes.
Everyone has a smartphone. Seven billion devices globally, each capable of clinical-grade respiratory monitoring. The distribution problem is solved. The technology works. The regulatory frameworks exist. The clinical need is urgent. The commercial opportunity is massive.
What's missing? Urgency. Too many organisations are waiting, watching, studying. Meanwhile, 454 million people are suffering, and 70% of COPD cases remain undiagnosed [1,2].
The question isn't whether continuous respiratory monitoring will transform medicine. The question is whether you'll lead that transformation or follow it. The organisations that move now, pharmaceutical companies reimagining trial design, technology platforms building the data infrastructure, healthcare systems piloting implementation, will define the next decade of respiratory care.
In 1846, Hutchinson had a vision: detect lung disease before symptoms appear, predict who's at risk, intervene early. We've had the technology to fulfil that vision sitting in our pockets for years. It's time to use it.
The race has started. The only question is: are you running?
