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Smaller medical device companies keep losing a game the U.S. market rigged against them from the start. The traditional path asks a small company to sell a product, which means fronting an expensive sales force, building a distributor network, and competing for the physician’s attention and workflow.

Paul Mastoridis, who brings more than 20 years in medical affairs and chief executive officer experience building and scaling medical device and digital health companies, has watched this wall stop good companies with good products. The way through is not a smarter way to sell the device – it is to stop selling altogether. “Stop thinking about how to sell more devices,” Mastoridis urges. “Start thinking about how to deliver outcomes.”

The Cost Barrier Was a Product-Model Problem

Traditional U.S. market entry is expensive because selling a product is expensive. It demands large sales teams, distributor networks, and the slow work of persuading one clinic at a time to adopt something new. A smaller company has to carry all of that overhead upfront, betting scarce capital on a sales motion that may take years to return anything. Remote patient monitoring (RPM) changes that. The company ships devices directly to patients, handles onboarding and education itself, and bypasses selling into busy clinics altogether.

“You enter the market with a service, not a product sitting in a warehouse waiting for orders,” Mastoridis explains. Since there is no distributor network to build and no clinic sales cycle to survive, the company is delivering a service to patients rather than pushing a product. 

Reimbursement Turns One-Time Sales Into Recurring Revenue

A device sale is a one-time event, which forces a small company to keep selling continuously just to hold revenue steady. RPM replaces that, since it is reimbursable under existing U.S. billing codes; the economics work for everyone at once. The physician gets paid, the device company gets paid, and the patient benefits, which produces recurring monthly revenue from day one. “For a smaller company entering the U.S., predictable revenue changes everything about how you scale,” Mastoridis notes.

This is the difference between a business that has to re-earn its revenue every quarter and one that builds a base of monthly income. Predictable recurring revenue is not a minor advantage. For a small company deciding whether it can afford to scale at all, it is the difference between a viable business and a fragile one.

Adoption Follows When the Clinic Does Not Work

Physicians are overwhelmed, and a product sale asks them to take on new inventory, workflow, and burden, all in exchange for uncertain value. A small company competing for that attention against larger, better-resourced rivals rarely ever wins. RPM removes the requirement entirely. It takes 100% of the workload off the clinic while delivering measurable patient outcomes, fewer emergency room visits, fewer hospitalizations, and better adherence in patients with asthma and chronic obstructive pulmonary disease (COPD).

“When you give physicians results without burden, adoption follows naturally,” Mastoridis observes. The wall hit by smaller companies was never a sales problem to be out-hustled. It was a business-model problem, and the real opportunity lies in delivering outcomes as a service rather than selling devices as a product.

To learn more about entering and scaling in the U.S. market through remote patient monitoring, including the operations, clinical workflows, and billing model, connect with Paul Mastoridis on LinkedIn.

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