There’s a lot of uncertainty in laboratory developed test (LDT) development right now. What rules apply, what pathway to follow, and what the FDA might do next are all fair questions, but none of them should slow you down. If you are building from scratch, you have a clean slate and an opportunity to set yourself up for competitive advantage to do things right. With the right partner, you can build a test that works, a lab that scales, and a business with a strong foundation.
Common Concerns for Startups
For a diagnostic startup, the science is only half the battle. The bigger challenge is often figuring out what path makes sense for your test, your timeline, and your business.
Common questions include:
- “What is the best regulatory pathway?” Many early teams are not sure whether they qualify as an LDT, need to pursue a 510(k) or De Novo, or should be thinking about both; the answer depends on your intended use, your technology, and how you plan to reach the market
- “Do I need my own lab?” If your workflow is complex or you need to move quickly, having access to a CLIA lab can be a major advantage
- “What resources do I actually need?” From quality systems to clinical validation, it is easy to overbuild or underprepare; a rightsized plan can help you avoid wasting time or money
- “How do I make sure this supports a real business need?” A lot of teams can build a test. Fewer can show exactly who it is for, when it will be ordered, and what the patient benefit will be. That clarity early on can shape everything from your design inputs to your funding strategy
The key to addressing these questions is knowing where you stand now, what your goals are, and what course of action makes the most sense from a business and regulatory perspective.
Building for Competitive Advantage
Startups often think of regulatory requirements as a barrier. In reality, they can be a blueprint for building a stronger business, especially with the right partner to help you apply them.
Regardless of your regulatory pathway, you can incorporate quality management best practices where they make sense, including investigations of unexpected results, supplier management, and robust procedures. For example, design controls, a requirement under the FDA’s quality system, aren’t part of most lab regulations. But they force you to consider the actual user needs and build a test with performance characteristics that meet the user needs and serves the patient..
Discipline now can protect you from costly failures later. Even a seemingly simple oversight could result in losing the trust of your customers overnight. For example, switching a reagent to a new supplier could mean your assay won’t work correctly. By planning early, you can define your requirements and build internal processes to prevent scenarios like this.
Getting your regulatory and quality strategy in place early also signals to investors and partners that you’re building something sustainable. It shows you have a defined use case, know your market, and aren’t just throwing a test into the world to see what sticks.
Practical Starting Points for Diagnostic Teams
You don’t need to tackle everything at once, and you definitely don’t need to handle it alone, but you do need a plan.
Here are a few key actions that can set you up for success:
- Define your intended use statement early. This helps clarify what your test is for, who it serves, and how it fits into the clinical workflow; that focus will shape your development plan, your regulatory pathway, and your pitch to investors
- Identify key performance characteristics that support the intended use
- Conduct a regulatory gap analysis. Understanding where your assay stands today helps you avoid surprises later; a good partner can spot the gaps early and help you close them in a way that matches your business goals
- Engage with regulatory experts who know the current state of play. Whether your test qualifies as an LDT, would benefit from a 510(k), or needs a different approach entirely, expert input now can save months of delays down the road
- Build a scalable quality management system (QMS). You do not need to overengineer it, but you do need one; a rightsized QMS that is build to support the processes needed to manage the risks of your specific test will give you the structure to grow without slowing you down
- Look for a partner that brings more than a lab. You can benefit from access to CLIA infrastructure, hands-on testing support, and the regulatory and quality expertise to help you move from idea to execution, without having to build everything from scratch
Your Dedicated Development Partner
Whether you’re still shaping your first use case or planning your path to market, the right partner can make the difference between moving forward and getting stuck.
RDI builds smarter from day one, withthe regulatory expertise, lab infrastructure, and practical experience. We’ve worked through LDT development challenges in real labs, with real assays, and we’re ready to help you do the same.