Medical Device Product Label Customization Case
Project Metrics
[Project Overview]
Case Type: Anonymous Real Project (Client Information Desensitized)
Industry: Healthcare
Product: Medical Device Product Adhesive Labels
Material: 70μ Synthetic Paper + Acrylic High-Tack Adhesive + 25μ Matte Film
Process: Digital Printing + Matte Lamination + Die Cutting + Roll Separation
[Client Background and Application Scenario]
This case is desensitized based on similar project experience, specific enterprise names and product models are not disclosed. A medical device enterprise needs to produce outer packaging identification labels for multi-specification products. Labels are affixed to color boxes or turnover outer packaging surfaces, not as sterile barriers, nor in direct contact with devices. They go through storage, distribution and hospital circulation with the product, needing to carry product names, model specifications, batch fields and QR codes. When multiple SKUs run in parallel, material durability is only the foundation. Document versions, code area readability and roll marking also affect receiving verification.
💬 Customer Needs
[Client Requirements and Original Solution Issues]
The original solution for this type of project typically uses 80g coated paper adhesive, with fixed information and batch fields arranged on the same layout. While cost-effective in dry environments, when exposed to moisture or handling friction, the graphic area of paper face materials is generally more prone to damage. Without version management, older files, batch data, and new drafts are typically more prone to confusion. The client did not require the label to serve as a sterile barrier; the focus was on outer packaging identification and traceability information management.
The client's core requirements include three points: First, output according to the client's finalized files. Second, support multi-SKU and variable data. Third, no need for repeated plate making for small batch revisions. Label text and code types are confirmed by the client based on registration materials. Lexiang is responsible for pre-press verification, sample confirmation, printing consistency, and roll separation, and does not substitute for the registrant in determining regulatory applicability.
Project Challenges:
✓ Multi-SKU shared layout, fixed fields and variable fields need clear partitioning
✓ Model specifications, batch fields and QR codes need item-by-item correspondence
✓ Labels need to adapt to warehouse humidity and general handling friction
✓ Frequent revisions, traditional plate making increases switching costs
💡 Solution
[Solution Overview]
Lexiang produces multi-SKU adhesive labels for this type of medical device project. The solution uses 70μ synthetic paper, acrylic high-tack adhesive and 25μ matte film, combined with digital printing and roll management. Fixed layout and variable fields are processed separately, with production focus on file lock, sampling scan and batch isolation.
[Selection Analysis]
Why 70μ synthetic paper?
According to material technical data, synthetic paper has waterproof and tear-resistant properties. When used for outer packaging identification labels, it can typically handle warehouse moisture and general handling friction. The 70μ specification comes from the case standard parameter library, facilitating uniformity for similar medical labels.
Why not continue using 80g coated paper?
80g coated paper is suitable for dry, short-cycle and cost-priority labels. Its paper face material is not primarily water-resistant, and is typically more prone to damage when exposed to moisture or repeated friction. This project places greater emphasis on graphic protection during circulation, so paper face materials are not continued.
Why not use 50μ PET?
PET is typically more suitable for device shells, outdoor or frequently cleaned scenarios. Labels in this project are mainly affixed to color boxes and turnover outer packaging, and do not bear chemical cleaning requirements. If subsequently changed to equipment surface labeling, it is recommended to use 50μ PET to re-conduct adhesive and cleaner compatibility tests.
Why acrylic high-tack adhesive?
Labels need to go through product storage and circulation cycles, and are not designed as temporary identifiers. Acrylic high-tack adhesive is suitable for long-term attachment. Rubber-based removable adhesive is more suitable for temporary identifiers that need to be replaced, so it was not selected as the first choice for this project.
Why 25μ matte film?
Lamination covers the printing surface with a protective film. 25μ matte film can protect the graphic area, reducing direct contact between general scratches and stains with the printing layer. Without lamination, the synthetic paper face material remains, but the ink layer lacks additional protection. Glossy film has stronger surface reflection and may be affected by incident angles during scanning, so matte film is used in this project.
Why digital printing?
Digital printing outputs directly from electronic files without plate making. It is suitable for multi-SKU, small batch and piece-by-piece varying data. Flexographic or offset printing is more suitable for larger batches with stable versions. The current project has many revisions and variable fields, so digital printing is selected.
[Production Implementation and Quality Control]
① Receive client confirmation drafts and variable data, establish SKU, version and filename correspondence table.
② Pre-press check fonts, sizes, bleed, code area margins and data fields.
③ Output samples, client confirms text, specifications, colors and scan content.
④ Calibrate colors according to confirmed samples, pre-scan QR codes or barcodes.
⑤ After digital printing, apply 25μ matte film, then die-cut, waste removal and roll separation.
⑥ During production, check first piece, roll change points and data start-end intervals to avoid version mixing.
⑦ Ship inspection for size, appearance and code area readability, record inspection batches.
⑧ Pack by SKU and version, mark roll numbers on outer boxes before delivery.
✅ Project Results
[Project Results]
[Delivery Data]
✓ Delivered Products: Medical Device Product Adhesive Labels
✓ Material Specifications: 70μ Synthetic Paper + Acrylic High-Tack Adhesive + 25μ Matte Film
✓ Printing Method: Digital Printing, Fixed Layout and Variable Fields Output Separately
✓ Delivery Organization: Packed by SKU, Version and Roll Number
[Usage Effects]
✓ Document Consistency: Correspondence established between confirmation drafts, variable data and output samples
✓ Code Area Inspection: Random scan by roll before shipment, confirmed readable before packaging
✓ Graphic Protection: 25μ matte film can typically reduce direct contact between handling friction and printing layer
✓ Batch Management: Roll labels indicate SKU and version, helping on-site material verification
[Case Summary]
Medical device product labels need to control material compatibility, version files, code area readability and batch isolation. Lexiang uses 70μ synthetic paper, acrylic high-tack adhesive and 25μ matte film. This solution, combined with digital printing, produces multi-SKU outer packaging adhesive labels. Synthetic paper is suitable for general warehouse moisture and handling friction. Digital printing facilitates switching specifications, batches and QR code data. Checking by version and random scanning before shipment helps reduce risks of wrong version and mixed materials.
[Lexiang Experience]
Applicable Scenarios: Medical device outer packaging labels, multi-SKU model labels, batch or QR code variable data labels
Material Recommendations: Evaluate 80g coated paper for dry short-cycle use. Select 70μ synthetic paper when moisture and friction exist. For device shells or frequent cleaning, recommend evaluating 50μ PET.
Inapplicable Scenarios: This solution is not directly used for sterile barrier, device direct contact surface, high-temperature sterilization or strong solvent environment
Notes: Label text should be based on client-confirmed registration materials. When thermal transfer is needed later, reserve uncoated printing area. Ribbon and face material also need to confirm compatibility first.
[Professional Knowledge]
What is the difference between medical device product labels and sterile barriers?
Outer packaging identification labels mainly carry product and traceability information. Sterile barrier systems are used to maintain sterility after sterilization, with different application requirements. If labels are directly affixed to sterile barriers, it is recommended to evaluate the material system in accordance with ISO 11607-1. The packaging process should be verified in accordance with ISO 11607-2. This case solution does not represent completion of such verification.
How to choose between synthetic paper, coated paper and PET?
80g coated paper is suitable for dry and short-cycle use. 70μ synthetic paper typically balances moisture resistance, tear resistance and outer packaging attachment. 50μ PET is more suitable for frequent cleaning or stronger durability requirements, but needs to re-sample with the attachment surface.
Why partition fixed and variable information?
Product names, enterprise information and graphics usually belong to fixed layout. Batches, serial numbers and QR codes can be managed separately as variable fields. Partitioning facilitates data source verification and helps reduce misalignment risks during revisions.
[Why Choose Lexiang]
✓ Labels start from 1 roll, suitable for multi-SKU batch arrangement
✓ Digital printing eliminates plate making, specifications and variable data can switch by file
✓ Pre-press verification, sample confirmation, random scanning and roll marking integrated into one process
✓ Packaging boxes and labels can share version list, reducing cross-supplier document round-trips
✓ Each SKU packed by roll number, facilitating procurement and warehouse verification
❓ FAQ
What is the minimum order quantity for medical device adhesive labels?
Labels support 1 roll minimum order. The number of labels per roll depends on finished size, die-cut shape and version quantity. Simply provide dimensions, SKU count, quantity per version and core requirements when requesting a quote.
How long does medical label sampling usually take?
Label sampling is typically 1-3 days, calculated from file and material confirmation. Special face materials or additional post-processing require separate cycle assessment.
How to choose materials for medical device outer packaging labels?
Evaluate 80g coated paper for dry outer boxes. Select 70μ synthetic paper when moisture and handling friction exist. For device shells requiring frequent cleaning, recommend evaluating 50μ PET and conducting attachment tests.
What is the difference between synthetic paper labels and PET labels?
Synthetic paper labels are typically suitable for moisture-resistant and tear-resistant outer packaging scenarios. PET labels are more suitable for chemical-resistant or higher durability requirements. Confirm the labeling surface, cleaning method and usage environment before selection.
Can medical device QR code labels do variable data?
Yes. Digital printing can output piece-by-piece different QR codes, batch numbers or serial numbers. Clients need to provide finalized data and coding rules, then verify samples before production.
Can medical device UDI labels be directly generated?
Printing can be performed according to UDI carrier files and data provided by clients. Code type selection, data content and declaration responsibility are confirmed by the registrant. Lexiang is responsible for variable output, layout verification and sample scanning.
Will 25μ matte film lamination affect barcode or QR code reading?
Matte film typically has weaker reflection than glossy film, but reading results are still affected by code size, contrast and scanning angle. It is recommended to confirm samples with actual scanning devices before mass production.
Can such medical device traceability labels be affixed to sterile barriers?
This case cannot be directly used as an applicable conclusion. If labels are affixed to sterile barriers, it is recommended to evaluate the material system in accordance with ISO 11607-1 and verify the packaging process in accordance with ISO 11607-2.
Can labels be sterilized together with medical devices?
Evaluation is required according to specific methods such as ethylene oxide, irradiation or moist heat. Clients should provide sterilization methods and process parameters, then conduct compatibility verification of face materials, adhesives and printing layers. This case solution is not used for sterilization scenarios.
What if batch numbers need subsequent thermal transfer?
Reserve uncoated printing area, or switch to thermal transfer-compatible face materials. Provide printer model, ribbon type, printing width and content position before sampling.
How to avoid version mixing for multi-SKU labels?
Set version for each confirmation draft, archive variable data separately. Roll labels indicate SKU, version and roll number. Re-confirm samples after file changes before production.
How to determine batch delivery time for medical device label customization?
Label sampling is typically 1-3 days. Batch delivery time needs to be determined after sample confirmation, considering quantity, SKU count, material inventory and post-processing.
How to choose between digital printing labels and flexographic labels?
Multi-SKU, small batch or variable data typically choose digital printing without plate making. For stable versions with larger quantities, flexographic printing can be evaluated. Total quantity and distribution per version should be provided before quotation.
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