Beyond hardware: How SaMD is driving medical device innovation

“The future of medical devices won’t be built only on metal anymore. It will also be coded.” - Shilpa Gampa

Software as a Medical Device (SaMD) is no longer emerging. It has emerged, and it’s rewriting the rules of innovation in healthcare. According to a report published by the National Library of Medicine, between 2012 and 2021, the U.S. FDA approved 581 SaMD products. Nearly half of those approvals came from the U.S., making it the global epicenter of Regulatory momentum and product innovation.

In 2023, Medtech Dive report confirmed that the FDA approved 223 AI-enabled medical devices, a sharp leap from just 6 in 2015. That’s not growth. That’s acceleration. The global digital therapeutics (DTx) market, valued from $3.9B in 2022 to $17.3B by 2030 (20.5% CAGR), is projected to reach $17.3 billion by 2030. This is not a side market; it is the new frontline of medicine.

The opportunity is massive. The window is narrow. The winners will be those who realize that software isn’t support-it’s strategy in modern healthcare.

1. The shift from hardware to software

Healthcare innovation used to mean better materials, tighter integrations, and sleeker designs. It meant capital-intensive R&D cycles, long Regulatory timelines, and hardware that improved by millimeters and milliseconds.

Not anymore.

Today, value creation has moved from physical to digital. From silicon to software. From tools that do to platforms that think.

Speed: Hardware takes years to iterate. Software ships in weeks.

Scalability: One hardware unit = one patient. One algorithm = scale to millions.

Data Feedback Loops: Software learns. Traditional devices can't do that.

Even legacy medtech giants have read the writing on the wall. According to a report published by Research Gate, Siemens, GE, and Philips collectively launched 237 SaMDs from 2012–2021, accounting for 40.8% of FDA approvals. Real disruption comes from startups. Post-2012 entrants delivered 215 FDA-approved SaMDs (37% of the total), deploying AI-first strategies.

This isn’t about replacing hardware. It’s about transcending it.

2. SaMD in action – Use cases that matter

If the shift from hardware to software is the strategy-use cases are the proof.

Take diagnostic imaging. For decades, radiology relied on human expertise. Now, enter SaMD.

In 2023, AI-based SaMD systems achieved 94% sensitivity in detecting lung cancer – a leap from the 78% rate by radiologist-only methods.

Wearables are another front. The wearable medical device market hit $42.74 billion in 2024.

What’s powering that growth isn’t battery life-it’s SaMD. These devices don’t just record-they intervene.

Digital Therapeutics (DTx) is the next wave. No pills. No procedures. Just software delivering outcomes. From managing depression and substance use disorder to diabetes and insomnia, DTx platforms are providing 24/7 care-without ever stepping into a clinic.

This is where SaMD shows its hand-not as an accessory, but as the driver.

3. What’s powering the SaMD boom – enablers of scale and innovation

Behind every revolutionary shift is an invisible architecture. SaMD is no exception. Let’s start with AI. It’s the brain of modern SaMD. In diagnostic imaging alone, the AI market is projected to reach $23.65 billion by 2032.

That’s where cloud infrastructure steps in. Cloud-native SaMD platforms are pushing updates instantly, deploying patches without device recalls, and offering zero-footprint delivery models.
Enter edge computing. Think real-time seizure detection running locally on a wearable. Think cardiac arrhythmia alerts from an ECG patch.

Then comes the fourth enabler-data liquidity. SaMD thrives on interoperable, longitudinal data. That’s how DTx platforms deliver hyper-personalized regimens.

The ecosystem has aligned. The engine is running. And those who understand the enablers are already building the next category leaders.

4. Regulation and risk – Navigating the compliance maze

Every breakout technology hits the same wall: regulation. As earlier mentioned, the U.S. FDA approved 581 SaMD products between 2012 and 2021, leading the world with 45% of global approvals. With initiatives like the Pre-Cert Program, the agency is shifting from product-focused to developer-focused trust frameworks.

According to the Cognitive Market Research report Europe’s SaMD market, valued at USD 1354.56 million in 2024, is governed under the MDR. But its compliance ecosystem is fragmented. The smart players-whether Siemens or startups-understand that Regulatory navigation is now a core capability. The most successful SaMD companies are baking compliance into their product lifecycle. Regulation is a moat. If you can consistently meet FDA, MDR, and regional frameworks like Korea’s MFDS or Japan’s PMDA, you have built trust at scale.

5. The competitive landscape – giants, startups, and the race for platform dominance

Let’s talk about the players who made the cut.

Legacy titans: Scale meets safety

GE Healthcare, Siemens Healthineers, and Philips were responsible for 237 FDA-cleared SaMDs. Their approach? Incremental innovation with systemic reach.

They’re not just deploying; they’re embedding it into the healthcare operating system.

The startups: Disruption by design

Startups-many born post-2012-launched 215 SaMDs. They’re using SaMD to redefine care delivery. From AI-based mental health diagnostics to algorithmic asthma treatment plans.

Platform wars: The next frontier

The most dominant players are creating modular, scalable ecosystems.

• Think of it like this:
  A wearable captures vitals.
• A SaMD app interprets trends.
• An AI engine flags anomalies.
• A DTx module initiates intervention.
• A cloud dashboard empowers physicians to act-remotely, instantly.

And the real war? It’s not for features. It’s for data dominance.

6. What’s next – The strategic outlook for SaMD innovators

The momentum behind SaMD is not a trend. It’s a structural transformation reshaping modern healthcare.

Five Strategic Imperatives for the Next Generation of SaMD Leaders

• Adopt an AI-native mindset
• Make Regulatory excellence a core capability
• Think global, execute local
• Build trust into the technology
• Design for adaptability and scale

An expanding market, a defining opportunity

• The global medical device industry is projected to reach USD 800 billion by 2030.
• The AI in medical imaging market is forecasted to hit USD $23.65 billion by 2032.

This is not just a commercial opportunity. It’s a chance to reshape healthcare delivery at scale.
SaMD innovators who understand this convergence and build for it don’t just participate in the future of healthcare.

They will define it. As we stand at the intersection of technology, medicine, and data, the time to act is now. The future of healthcare innovation begins with those who are bold enough to lead the charge.