Medical Device Sampling: From Prototype to Pilot Run to Mass Production

In medical device OEM, "sampling" should not mean random trial builds. A strong sampling service is a structured workflow designed to reach a stable specification quickly—then scale with controlled processes.

1Feasibility review

Before building anything, the OEM should confirm:

- Critical requirements and target market assumptions - Packaging constraints (label sizes, languages, compliance considerations) - Risk items and open questions that could block scaling

2A sampling plan (deliverable-based)

A sampling plan should clearly state:

- What will be built (BOM-level clarity) - What will be tested/inspected (acceptance criteria) - What decisions will be made after sampling (go/no-go gates)

3Pilot run definition

A pilot run is not "a bigger sample." It is where you:

- Lock process steps that affect quality - Confirm packaging and labeling controls - Confirm stable yields and predictable lead time

ISO 13485 is useful even at sampling stage because it enforces:

- Document control (revision history) - Nonconformance handling (what happens when sample fails) - Traceability (what material lot created which sample)

This structure reduces hidden risk later when you scale.

- Provide clear target market and labeling expectations early - Share reference samples or competitor benchmark constraints - Agree acceptance criteria before the OEM builds - Keep a single source of truth for spec revisions

Stage 1: Prototype/Sample Build

Goal: Prove feasibility and lock basic specs

Deliverables: - Physical samples (typically 10-50 units) - Initial BOM and process notes - Packaging mockup or prototype

Timeline: 2-4 weeks (depending on complexity)

Stage 2: Pilot Run

Goal: Validate process stability and packaging controls

Deliverables: - Pilot batch (typically 500-2000 units) - Locked process documentation - Final packaging and labeling approval - Quality inspection records

Timeline: 4-6 weeks

Stage 3: Mass Production

Goal: Scale with controlled quality and predictable lead time

Requirements: - Approved master batch record - Change control process in place - Supplier qualification complete - Packaging artwork locked and versioned

1Unclear acceptance criteria

If you don't define "pass/fail" upfront, every sample becomes a negotiation.

2Changing specs during pilot run

Pilot run is for validation, not redesign. Lock specs before pilot.

3No packaging plan

Packaging and labeling often take longer than the product itself. Plan early.

4Skipping traceability setup

If you can't trace material lots in pilot run, you'll have chaos in mass production.

- What information do you need to prepare a sampling plan? - What is your typical sampling timeline and deliverables? - How do you handle spec changes during sampling? - What defines a successful pilot run? - What documentation do you provide at each stage?

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If you want a fast sampling → pilot run path, send a brief requirements pack (market, product type, packaging, volume, timeline). A certified OEM can reply with feasibility, sampling milestones, and production readiness steps.