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© 2026 Boyd Biomedical, Inc.
Commercial Launch
We produce your device for the market. Validated processes move into routine commercial manufacturing, with the quality systems and supply chain in place to meet real demand from the first order forward.
Please feel out the form below and someone from our team will contact you shortly.
Phase Overview
Commercial Launch is where a validated process becomes a production operation. Manufacturing moves from qualification lots to routine commercial builds, running under change control with release testing, batch records, and lot traceability for every unit shipped. Supply is aligned to forecast, production is scheduled against real orders, and performance is monitored against the assumptions the process was validated on. The output is a device in the market, supplied reliably, with the data to show the process is performing as intended.
What Happens in This Phase
Each phase draws on a different combination of our disciplines and sub-disciplines. These are the ones that turn a validated process into reliable commercial supply.
Commercial Production
Routine manufacturing executed to released documentation, under change control, with capacity aligned to committed volumes.
Quality Release
Batch records reviewed, release testing completed, and product released to specification before it ships.
Lot Traceability
Materials, processes, and finished units traced through the build so any lot can be reconstructed on demand.
Supply Chain Management
Supplier performance managed and inventory positioned against forecast so material availability doesn't constrain supply.
Production Planning
Production scheduled against orders and forecast, with lead times and capacity commitments you can plan around.
Process Monitoring
Yield, capability, and cost tracked against validated baselines to confirm the process is performing as expected.
Nonconformance & CAPA
Deviations investigated, root causes identified, and corrective actions implemented under the quality system.
Regulatory Maintenance
Registrations, records, and change documentation maintained so commercial supply stays in compliance.
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What You Walk Away With
A device in commercial supply and the evidence that it's under control: released product with complete batch records and lot traceability, a managed supply chain aligned to forecast, production schedules against committed lead times, monitored yield and capability data against validated baselines, a functioning nonconformance and CAPA process, and maintained regulatory documentation.
Why This Phase Matters
Commercial Launch is when manufacturing stops being a project and becomes an obligation. Clinicians schedule around availability, distributors hold inventory against your lead times, and a stockout costs more than a delayed launch. Producing reliably from the first commercial order is what turns a cleared device into an adopted one.
Scale-Up
With the device in commercial supply and the process performing to plan, your program moves into Scale-Up, where capacity is expanded to meet growing demand without compromising existing supply.
Please feel out the form below and someone from our team will contact you shortly.
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