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The Difference Between a Distributor and a Distribution Strategy
Why Most MedTech Companies Get This Wrong Before They Ever Ship a Product There is a conversation that happens far too often in MedTech boardrooms. A company has a strong device, solid clinical data, and a genuine shot at international revenue. Leadership asks who can move product in Germany, in Brazil, in Singapore. Someone finds a name, a contract gets signed, and two years later the company has a distributor relationship on paper and almost nothing to show for it in the ma
May 206 min read
Why Regulatory and Commercial Strategy Must Be Built Together
Here is something no one in MedTech says out loud: most companies do not fail at the regulatory agency. They fail at the revenue line, long after the clearance or approval letter arrives. The device works. The clinical data is solid. The 510(k) clears, the PMA gets approved, or the CE Mark is issued. Then the product sits on a shelf. It waits in a distributor's warehouse. It stalls inside a hospital value analysis committee in Frankfurt, São Paulo, or Singapore. Not because t
May 136 min read
Why Warm Introductions Create Cold Performance
Why Warm Introductions Create Cold Performance The studio executive leaned back in his leather chair, tapping a script against the mahogany desk. “I know the writer personally,” he said. “We went to film school together. He’s brilliant.” I’d heard this before. Too many times. Three months and $2 million later, that “brilliant” writer delivered a screenplay that couldn’t get past page 30 without losing the audience. The project died in development. The executive’s relationship
May 68 min read
Why Launch is Not Shipment
I thought we had a successful launch. We had regulatory clearance, product was shipping, and revenue had started to come in. On the surface, everything looked like it was working exactly as planned. Six months later, we had inventory sitting in distributor warehouses and no real adoption. Clinicians weren’t using the product, and the early momentum we thought we had built wasn’t translating into anything that would last. We had confused shipment with launch. That mistake cost
Apr 294 min read
The Hidden Cost of "Easy Entry" Markets
Last year, I watched a competitor burn through $4.7 million entering a market that looked perfect on paper. No reimbursement barriers. Minimal regulatory friction. A clear clinical need. Their device worked beautifully in trials. They exited eighteen months later with nothing to show for it. The market wasn't wrong. Their strategy was. This plays out constantly in MedTech. We chase markets where regulatory timelines are short, barriers feel manageable, and revenue comes
Apr 227 min read
Why Global MedTech Expansion Fails Quietly and How to Stop the Leak
I’ve watched strong technologies fail overseas for one reason: companies treat expansion like a checklist instead of a system. Not bad science. Not lack of demand. Execution. The failure isn’t loud. No recalls or headlines. Just two years of burn, optimistic updates, then a quiet retreat. The P&L shows it. The post-mortem rarely explains it. I’ve also seen international become the most profitable part of the business. Same industry. Similar resources. Different approach. Most
Apr 154 min read
Portfolio Investor Building a Cross-Regional Platform
A healthcare-focused investor held several medtech assets across Europe and Asia, each operating in silos. The firms lacked a unified strategy to enter the US or other stringent regulated markets. As due diligence teams began focusing more heavily on global scale potential and regulatory robustness, the investor needed a partner to turn fragmented expansion attempts into a coherent, value-creating plan. Without coordination, portfolio companies were duplicating regulatory eff
Mar 31 min read
US Innovator Expanding into Regulated & Emerging Markets
A VC-backed US company with a breakthrough Class II device had saturated its initial US niche and needed international growth to support its next funding round. Leadership was enthusiastic about “going global,” but had no in-house expertise in EU MDR, MHRA guidance, or reimbursement approaches in emerging markets. Attempts to explore multiple countries simultaneously led to scattered conversations, inconsistent distributor quality, and growing concern from the board about reg
Mar 31 min read
European Manufacturer Entering the US
A mid-sized European device manufacturer with strong CE Mark credentials had repeatedly failed to crack the US market. They had trialed two US distributors, both selected through existing relationships. Launches stalled, regulatory expectations were misunderstood, and leadership viewed the US as “too hard and too expensive.” Meanwhile, investors were pressuring management to access the US reimbursement upside and justify prior R&D and clinical investments. Each delay increase
Mar 31 min read
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