What happens when an ortho startup catches their first FDA clearance ?
For ortho startups, FDA clearance feels like the holy grail. It’s the “yes” they’ve been chasing, the green light after all those nights in the lab.
But here’s the reality: your FDA clearance is just a “fishing license.” It’s permission to play, not a business yet.
Think of it like a dog finally catching the car it’s chased for months. It’s thrilling — but then what?
FDA approval is just the beginning. Now comes the hard part: building a real business.
- Product-Market Fit: Clearance is just step one; you still need proof that the market truly wants what you’re selling. Are you solving a real pain point, and is there real demand? Without product-market fit, no amount of clearance or funding will turn your idea into a sustainable business.
- Business Model: Clearance doesn’t pay the bills. You need a model that scales — will you sell the product once, or is there a recurring revenue opportunity?
- Funding: Investors now want to see growth, not just the product. Without a clear path, you’re back to chasing cash.
- Sales & Distribution: Great products don’t sell themselves. You need relationships, logistics, and a plan to get into the OR.
- Value Analysis Approvals: Hospitals have Value Analysis Committees to ensure new products add measurable value without unnecessary costs. Getting through this gate is no small feat — you’ll need data to prove cost-effectiveness, clinical benefit, and strategic value. Without this, your product stays on the sidelines.
- Marketing & Education: Surgeons need convincing. That means educational outreach and clinical studies.
- Customer Support: Once in use, you’re on the hook for support, troubleshooting, and proving long-term value.
Many startups stumble post-clearance, stuck in “product-focused” mode. The real game is turning FDA clearance into a business — the marathon after the sprint. So, don’t just chase the car; plan for the road ahead. That’s where the true journey begins.
Most ortho startup have their eyes set on the first big prize: the FDA clearance. It’s the golden ticket, the moment when all the late nights, the research, and the endless iterations finally pay off.
But the FDA clearance is just a “fishing license”. The company doesn’t have a business yet.
You see, getting FDA clearance is akin to a dog catching the car it’s been chasing for months. It’s exhilarating, it’s the culmination of dreams, but then what? That’s where many in our industry, including myself in my earlier days, stumble.
Here’s the raw truth: FDA clearance is the beginning, not the end. It’s the starting line for the real marathon of business.
Let’s paint the scene: You’ve got your sexy new ortho implant, cleared by the FDA. A few surgeons, maybe even some investors, start using it. There’s buzz, there’s excitement, there’s… not enough sales to keep the lights on.
So, what’s next?
- The Business Model: Many startups focus so much on the product that they forget the business needs a model that can scale. How are you going to make money? Is it a one-time sale, or is there a service component? Recurring revenue?
- Financing: With clearance in hand, you might think the money would come flooding in. But here’s the kicker: investors now want to see how you’ll grow. They’re looking for a proven business model, not just a great product. Without a clear path forward, you might find yourself in the same spot, chasing the next funding round just as desperately.
- Sales and Distribution: Getting into surgeons’ hands isn’t just about having a good product. It’s about relationships, logistics, training, and support. You need a distribution strategy that can actually get your product into the operating room.
- Marketing and Education: You’ve got to convince not just the market but the medical community that your product is superior. This means educational campaigns, clinical studies, and a lot of handshakes at conferences.
- Customer Support: Once those implants are in, the real work begins. What about follow-ups, troubleshooting, and evolving care? This isn’t just about selling; it’s about standing behind your product.
Here’s where I’ve seen startups falter: they become product-focused rather than market-focused post-clearance. The product is just the tip of the iceberg; the bulk of the success lies beneath in strategy, operations, and service.
The Moral of the Story? Don’t just chase the FDA car. Think about what you’ll do once you catch it. Plan for the journey after clearance. Build a business that can run with the car, not just catch it.
In the world of ortho startups, the real innovation often begins after the FDA nod. It’s about turning that clearance into a flourishing business. And trust me, that’s where the true adventure lies.