Bridging the Gap Between R&D and Commercial Production with Pilot Runs

Moving from R&D to full-scale manufacturing isn’t just about turning on bigger machines, it’s a critical phase that determines whether your product launches smoothly or stalls in costly delays. Many companies underestimate this step, but pilot runs exist to bridge the gap.

At ReCurve Medical, we see pilot runs as more than a box to check. They are the proving ground where design intent meets manufacturing reality.

Why Pilot Runs Matter

Pilot runs are not small-scale production for its own sake, but the first true validation of how your product performs in a controlled, manufacturing-like environment. This stage helps you:

• Validate Design for Manufacturability (DFM): Confirm that the design you approved in R&D actually works in real-world production.

• Identify Hidden Risks Early: Spot issues with tooling, process flow, or material behavior before they derail a validation timeline.

• Generate Data for Decision-Making: Provide yield, cycle time, and cost-per-unit data to support commercial planning.

Skipping pilot runs often means unexpected failures during validation, which can result in months of delay and millions in lost revenue.

Validation & Pre-Validation

Validation is the guarantee that your process can repeatedly produce a device that meets every specification. But going straight into full validation without preparation is a recipe for failure. That’s where pre-validation work through pilot runs changes everything.

Pilot runs provide the data and discipline needed for success. They prove process capability by capturing real-world data on tolerances, cycle times, and yields. They also help lock down documentation, refining SOPs and building workflows that align with formal IQ/OQ/PQ requirements and they de-risk scale-up by simulating full-scale manufacturing conditions and identifying gaps before the stakes are high.

Skipping this step often leads to failed validations, delayed submissions, and runaway costs. Structured pre-validation ensures you enter IQ/OQ/PQ with confidence and evidence. This is standard practice at ReCurve. Our pre-validation processes save valuable time for our customers when we scale up a project.

Why Tightening Specs Matters (and Why We Embrace It)

A common mistake during scale-up is loosening tolerances to make production easier. At ReCurve Medical, we take the opposite approach. We believe maintaining and tightening production specs isn’t just a regulatory necessity. We consider it a competitive advantage because tight specs mean predictable performance, fewer downstream complaints, and lower total cost of ownership. While other manufacturers see this as a burden, we see it as the standard for building trust with regulators, clinicians, and patients.

Our pilot runs are designed to lock in that rigor so when you go to market, you’re not crossing your fingers. You’re confident.

Bridging the Gap Without Breaking Your Timeline

The handoff from R&D to production is where many programs stall. Pilot runs done right accelerate that transition by:

• Validating critical processes early

• Aligning documentation with regulatory expectations

• Eliminating surprises before high-stakes validation

At ReCurve Medical, we make that transition seamless. Our approach is structured, data-driven, and focused on maintaining quality without sacrificing speed. Contact us today to discuss your project and discover how our validation process can help you go-to-market with confidence.