When I started in this industry, the device sat on a tray in the OR and a surgeon used it to fix something. That was the model. The product was physical, the customer was in the hospital, and the interaction between device and patient happened in a controlled clinical setting with a trained professional present.

That model is not going away. But a whole new model has grown up alongside it, and it is changing the industry in ways that are still playing out. Devices that monitor patients continuously, outside the hospital, without anyone in the room. Wearables that collect clinical-grade data around the clock. Software that analyzes that data and flags problems before a patient even feels them. AI systems that help physicians make decisions in real time.

Digital health is not a trend. It is a category. And it is generating a commercial infrastructure that looks and feels different from traditional device sales in a lot of ways, but rewards the same fundamental skills: clinical credibility, relationship building, and the ability to explain complex technology to people who are busy and skeptical.

Issue #010. Ten weeks in. This week we go deep on where digital health is heading, what it means for the industry, and what it means for anyone building a career in this space.

Glad you're here. Let's get into it.

Andy Knapik, Founder

The Modern Med Rep

Digital health is a broad term that covers a lot of ground. At its core, it refers to the use of technology, specifically software, connectivity, and data, to deliver, support, or improve healthcare outside the traditional clinical setting. In the medical device context, that means wearables, remote patient monitoring platforms, Software as a Medical Device (SaMD), connected implants, AI-powered diagnostic tools, and the infrastructure that ties all of it together.

Here is how the major sub-segments break down commercially.

Wearables and remote patient monitoring.  This is the most visible category in digital health right now. Devices like the iRhythm Zio patch, the Abbott FreeStyle Libre continuous glucose monitor, the Dexcom G7, and the Empatica EmbraceMini collect clinical-grade physiological data continuously from patients living their normal lives. The commercial model is different from traditional device sales: instead of a one-time implant or a disposable used in a procedure, these are often subscription-based or per-patient-per-month models. The customer conversation involves physicians, hospital systems, health plans, and increasingly, employers. Clinical credibility still matters, but so does the ability to navigate software contracts, data security conversations, and reimbursement models that are still evolving.

Software as a Medical Device (SaMD).  SaMD refers to software that performs a medical function on its own, without being part of a hardware device. AI-powered diagnostic imaging tools, clinical decision support platforms, and mental health apps that have received FDA clearance all fall into this category. The FDA's new GenAI framework discussion reflects just how seriously the agency is taking this segment. For commercial professionals, SaMD represents an entirely new kind of sale: the customer is often a health system CIO or clinical informatics team rather than a surgeon, the sales cycle involves IT security review and EHR integration requirements, and the value proposition is built around data, workflow efficiency, and outcomes rather than the physical properties of a product.

Connected devices and the Internet of Medical Things.  Traditional medical devices are increasingly being built with connectivity built in. Pacemakers that transmit data to physicians remotely. Insulin pumps that communicate with continuous glucose monitors. Orthopedic implants with embedded sensors that track patient recovery. This convergence of traditional device hardware with digital infrastructure is creating a new category of commercial complexity, and a new category of expertise that device companies are actively recruiting for.

Digital therapeutics.  A smaller but fast-developing area involves software that delivers a therapeutic intervention directly, without a physical device. FDA-cleared apps for treating conditions including insomnia, substance use disorders, and diabetes management already exist. The commercial model for digital therapeutics is still being established, but it is generating interest from both device companies looking to expand their portfolios and pharmaceutical companies looking for non-drug treatment options.

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Digital health is one of the most active hiring areas in the device industry right now. Here is where the opportunity is concentrated.

Remote patient monitoring.  Companies like iRhythm, Dexcom, Abbott, Philips, and a growing number of startups are building commercial teams to sell and support RPM platforms. These roles typically involve hospital systems and physician practices as customers and require both clinical credibility and comfort with subscription-based commercial conversations. Clinical backgrounds in cardiology, endocrinology, and pulmonology are particularly valued.

Health system and enterprise digital health sales.  Larger digital health platforms that sell to health systems and payers need enterprise account executives who can navigate complex, multi-stakeholder sales processes involving clinical, IT, and administrative decision-makers. This is one of the more senior and better-compensated roles in the digital health commercial landscape, with OTEs ranging from $150,000 to $300,000 or more at established companies.

Clinical implementation and customer success.  Digital health products require significant implementation support and ongoing customer success management to drive adoption among physicians and clinical staff. These roles are excellent entry points for people with clinical backgrounds who want to move into the device industry without going straight into sales. They are also a common pathway into a full commercial role once you have built product and market knowledge.

Emerging roles worth tracking.  The Marquee Staffing 2026 emerging roles report specifically flags Digital Therapeutics Specialist, Remote Monitoring Analyst, and Biomedical Device Cybersecurity Expert as roles that did not exist at meaningful scale three years ago and are now actively being recruited for. These are not the most visible roles in the job market yet, but they are where the growth is heading.

The FDA is currently asking the public to weigh in on how generative AI-enabled medical devices should be regulated. The comment period is open until October 19. For most device professionals, this sounds like a regulatory policy story. It is actually a preview of what the next generation of clinical decision support tools is going to look like and what will be required to sell them.

Here is what the FDA is grappling with. Traditional AI in medical devices, like an algorithm that flags abnormal patterns in a cardiac monitor, is relatively well understood from a regulatory standpoint. It does a defined thing based on a defined input and produces a defined output. The FDA can evaluate it, clear it, and monitor its performance in the market.

Generative AI is different. A GenAI system can produce a response it has never seen before, which means its outputs are harder to predict, test, and bound in advance. The FDA specifically called out hallucinations, where the system produces output that sounds authoritative but is incorrect, as a unique risk in medical applications. A diagnostic suggestion that is wrong but presented confidently could cause a physician to miss something or pursue the wrong treatment.

What this means for the commercial landscape is that GenAI-enabled devices are going to face a more complex regulatory pathway than traditional devices, which means longer timelines and more documentation. It also means that clinical validation, transparency about model limitations, and ongoing post-market surveillance are going to be critical selling points in conversations with sophisticated hospital buyers. The rep who can explain what their company's AI does, how it was validated, and what guardrails are in place to prevent errors will have a significant advantage over one who cannot.

This week's question fits the digital health theme directly:

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QUOTE OF THE WEEK

“The future belongs to those who prepare for it today.”

- Malcolm X