What Should You Do Right After FDA Clearance?

Right after FDA clearance, start selling and start the hospital process at the same time. Clearance does not mean the hard part is over. In my experience it is where the real work begins: getting on the shelf, getting the first cases, getting adoption and then keeping it.

Why isn't clearance the finish line anymore?

For a long time the valley of death in medical devices was the FDA. That has changed. I think the FDA has made the process fairly straightforward. They give you the answers to the test up front, and it is up to you whether you can answer those questions. The new valley of death is what comes after approval: access and adoption.

When I started in this business, I could walk into a hospital with a bag, go straight to the OR, get an authorization and walk down to procurement for a PO number. That world is gone. Today the hospital system decides what goes on the shelf. Even physicians who bring a lot of business into a hospital are often not invited to sit on the value analysis committee anymore.

The other problem is money. Many companies I talk to have a hard time raising commercial money after they get their approvals. They spent their capital on research, the clinical trial and the regulatory work. Then they need to stand up a whole sales organization, and the few million dollars they can raise just isn't going to cover it.

What should happen in the first 30 days?

I start with a go-to-market assessment. What does the total opportunity look like? What does the technology really offer? Which items matter most to the market? Then we test those answers in the market before money goes into a full launch.

This is also when you decide how you will go to market. There are a few options. You can stand up your own sales and marketing organization. You can build a distributor network. You can bring in a consultant to give you a game plan and run with it yourself. Or you can put the product in the bags of independent 1099 reps. Each option trades cost against control. With distributors and 1099 reps, you have very little influence over what they do every day.

What happens between day 31 and day 90?

From day 31, I move into a soft launch. We roll through what the sales cycle looks like, test the messaging and actually create some revenue. We also build a clinical advisory group, starting with the physicians the founders already know will make a difference.

In the same window, I start applying to hospital value analysis committees. This is the step most founders leave too late. Even if a hospital loves the device, the process takes months, so you need a funnel of hospitals working through it while you sell. You want several hospitals in the process early, not one at a time.

By day 90 you should have a full launch package, from A to Z. A new device launch has hundreds of activities to complete. I count around 800. Then you decide who runs it: your own team, or an outside commercial team.

What if we were cleared a while ago and still haven't launched?

Then you are behind, and every month costs you runway. I spoke with one company that had held a 510(k) for two years and was still asking what to do next. That is a desperate situation. The fix is the same plan, only faster: pick one go-to-market model, start the hospital applications now and get your first cases booked.

Where to start

Write down three things this week. First, which go-to-market model fits the cash you actually have. Second, which physicians you want as your first clinical advisors. Third, which hospitals you will apply to first. If you cannot answer all three, that is your first 30 days.