Getting a diagnostic test approved by the FDA is hard. Delivering it to market reliably and at scale is an entirely different challenge, and one that doesn't get nearly enough attention.
The diagnostics industry spends a lot of time talking about clinical validation, regulatory milestones, and pipeline development, but there's a mountain of operational work required to build the infrastructure to support a successful commercial launch.
Here's what that looks like in practice, and it all starts with the customer.
Commercial readiness is customer readiness
When a diagnostic test receives FDA approval, a new set of questions immediately follows, and most of them are about the customer. Are the labs running this test set up to do so? Do they have the right equipment? Are staff trained? Are the IT connections in place so ordering and reporting are easy for clinicians?
An FDA approval can be a catalyst for a lot of these pieces to fall into place, but the most prepared companies don't wait for approval to start building their operational foundation. Protocols for assay implementation must be in place before the first customer places their order. The systems clinicians use to order tests need to be configured. Reimbursement pathways need to be established so that the labs and clinicians doing this work are getting paid for it.
Companies must be prepared to learn alongside customers and solve problems together rather than tossing it back over the fence to them. The clinical case for a test can be strong, but at launch, if the customer experience is rocky, that's what people will remember. Getting this right early on is what turns a first-time customer into a long-term one.
Building the infrastructure behind the launch
The customer-facing side of commercialization is only half the equation. The real operational work lives in ensuring you can consistently provide the test to the clinical laboratory when they need it. That requires robust internal infrastructure, supply chain, quality systems, and manufacturing capacity.
High demand is a good thing but requires the infrastructure to support it. If demand increases and supply can't keep up, customers get frustrated and their trust can erode quickly. The key is ensuring the front of the house is connected to the back of the house, meaning the sales pipeline and customer funnel must be in active communication with manufacturing, supply, clinical, and quality teams so all functions are ready to deliver.
That's why quality management infrastructure, validated through standards like ISO 13485, is important. It creates documented, repeatable processes that allow a company to scale without introducing inconsistency. A controlled launch with a tight feedback loop via early customers will surface issues that weren't visible beforehand. Solving those problems on a smaller scale is far less costly than discovering them after a full rollout.
A framework for scaling with intention
For companies earlier in the commercialization journey, the window to get the operational foundation right is narrower than most expect. Below are three guiding questions every growing diagnostics company should answer to achieve a successful commercial launch.
Are you clear on the value you bring to the market?
Your test must provide value at the clinical, operational, and financial levels. In addition to clear clinical utility, a test must be operationally easy to adopt and financially viable for the labs offering it. If something is valuable but hard to use, or if the economics don't work for the people implementing it, it won't gain traction. Companies need to have a clear understanding of clinical, operational, and financial value before they go to market.
Where in the market do you best fit?
Most companies start with the belief that they can do everything for everybody. That may be true over time, but the key to commercialization is figuring out where your diagnostic best fits today, and building from there. The tighter your market focus, the more targeted and effective the operational build behind it can be.
Are you ready to deliver on your promise?
If a company tells customers a test will perform a certain way, it should perform that way in a real-world lab environment. If a customer is told that an order placed Tuesday will arrive Friday, that must happen. Operational readiness isn't just a back-office concern, it’s the commercial promise, and every failure can chip away at the customer’s trust that took years to build.
The path from FDA approval to commercial scale is often longer and more challenging than it looks. The companies that navigate it well treat the operational build with the same seriousness as the science.
