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How to Spec a Wearable Skin-Interface Part: What to Send H-O for a Quote
A wearable or on-body skin-interface part quotes fastest when the request separates the layers and states the job, the wear window, the environment and the documentation up front. A converter cannot select a skin-contact adhesive, a comfort cushion or a perimeter seal from a part name alone, because each layer is a different material family with different driving properties. This guide is the eight-item checklist that turns a wearable RFQ into a same-direction quote and a sample on your geometry, with everything kept at the material level.
What does H-O need to quote a wearable skin-interface part?
A wearable or on-body part quotes fastest when the request separates the layers and states the job, the environment and the documentation up front. A converter cannot select a skin-contact adhesive, a comfort cushion or a perimeter seal from a part name alone, because each layer is a different family with different driving properties. The checklist below is what turns a wearable RFQ into a same-direction quote and a sample on your geometry.
The eight things to send
- The layer and its job. Name the layer you need quoted: skin-side attachment, comfort cushion, perimeter or device seal, or interior electronics pad. If it is a kit of layers, list them; each is a separate selection.
- The drawing or outline. A die line, a DXF, a PDF with dimensions, or a marked-up sketch. Include the outline, any windows or islands, corner radii, and where the adhesive is and is not.
- Gauge and stack height. The thickness you need, or the gap the part fills. For an interior pad, the available stack height between the board and the housing.
- The wear window (for a skin layer). The target wear time, the body site, and the moisture load. This drives the chemistry-and-backing pair and the MVTR you read on the data sheet.
- The environment. Sweat, wash, wipe-down, temperature span, and any ingress class the housing must reach under IEC 60529.
- Material-level documentation needed. State whether you need an ISO 10993-10 sensitization designation, USP Class VI or an ISO 10993 designation, or an FDA-grade composition basis, all at the material level. The device file stays with you.
- Adhesive and liner needs. Which side carries adhesive, the liner and any application tab, and whether the device-bonding side is separate from the skin side.
- Quantities and dates. Prototype count plus annual volume, and your sample and production dates. This sets the cut method and tooling path.
What you get back
With the checklist in hand, H-O returns a cautiously framed material direction for each layer, a converting plan (die-cut, kiss-cut, laser or rotary, laminated, kitted on liners), and samples on your geometry for common configurations. Grade-specific values and any material-level documentation are confirmed against the manufacturer's current technical data sheet; the finished-device biocompatibility assessment and regulatory file remain with you.
We name a family only where it is catalog-verified, and we make no clinical, therapeutic or skin-safety claim. For example, a comfort layer commonly maps to PORON® Medical microcellular polyurethane, confirmed to your grade on the data sheet.
What H-O does not decide for you
- The finished-device biocompatibility. The material-level ISO 10993-10 or USP Class VI designation is the material maker's; the finished-device biological evaluation is yours.
- The wear protocol. A peel number is a proxy; the actual wear time and removal protocol are confirmed on your device.
- The ingress rating. The class belongs to the tested housing; the gasket is one element of it.
- Grade-level numbers. Force-deflection, peel, MVTR and any designation are read on the maker's current data sheet, not invented in the quote.
A model RFQ
"We need a two-layer skin-interface part for an on-body monitor: a skin-side adhesive border for a 3-to-5-day wear window at a moderate-moisture site, and a soft microcellular polyurethane comfort cushion behind it. Outline attached as DXF, 42 mm by 30 mm with a 6 mm center window, 3 mm corner radius. Cushion gauge about 1.5 mm; skin border about 0.2 mm on a release liner with a pull tab.
We need the skin adhesive to carry an ISO 10993-10 material-level designation on its data sheet; our device file is in house. Quantities 50 prototype plus 20,000 per year; samples in three weeks." That request can be directioned and sampled without a clarifying round.
Ready to spec a wearable skin-interface part?
Send the layer list, the outline, the wear window and any material-level documentation you need. We will return a family direction for each layer and convert samples on your geometry.
Samples typically ship in 3 to 5 business days for common die-cut configurations; standard production runs about two weeks; special orders are quoted to the job.
Family-owned in Winsted, Connecticut since 1971 · ISO 9001:2015 certified · OEMs worldwide send us a drawing — and get back their part.
Related reading
Frequently asked questions
What do I need to send H-O to quote a wearable patch part?
Send the layer and its job (skin attachment, comfort cushion, perimeter seal or interior pad), a drawing or outline with windows and corner radii, the gauge or stack height, the wear window and body site for any skin layer, the environment and ingress class, the material-level documentation you need (ISO 10993-10, USP Class VI by designation), the adhesive and liner details, and your quantities and dates. With that, H-O returns a material direction per layer and samples on your geometry.
Do I have to choose the material before I ask for a quote?
No. Describe the job, the wear window and the environment, and H-O recommends a cautiously framed material family direction for each layer. We name a family only where it is catalog-verified, and we confirm grade-specific values and any material-level documentation against the manufacturer's current technical data sheet. The finished-device biocompatibility assessment stays with you.
Can H-O provide biocompatibility documentation for my wearable?
H-O can request and pass through the material maker's material-level documentation, such as an ISO 10993-10 sensitization designation or a USP Class VI designation, where the named grade carries it on its data sheet. That documentation describes the material. The finished-device biological evaluation and regulatory file are owned by you as the device maker. H-O is a converter and an ISO 9001:2015 certified organization; it is not an ISO 13485, FDA or cleanroom certified provider.
Request a quote for your wearable skin-interface part
Send H-O your layer list and outline—engineering reviews every RFQ, recommends a family per layer, and converts samples on your geometry.
Last updated · Reviewed by H-O Products engineering (ISO 9001:2015 certified converter, Winsted, CT).
References
- ISO 10993-10, Biological Evaluation of Medical Devices, Part 10: Tests for Skin Sensitization. International Organization for Standardization (material-level designation).
- USP Class VI, United States Pharmacopeia, Biological Reactivity Tests, In Vivo (material-level designation).
- IEC 60529, Degrees of Protection Provided by Enclosures (IP Code). International Electrotechnical Commission.
- ASTM D3330, Standard Test Method for Peel Adhesion of Pressure-Sensitive Tape. ASTM International.
- Manufacturer technical data sheets for the named material families; grade-specific values and material-level documentation are confirmed on the maker's current TDS.
This article describes material families H-O Products converts and cites published standards by designation (ISO 10993-10 for sensitization and irritation evaluation, USP Class VI and ISO 10993 as material-level designations, ASTM D3574 and ASTM D395 for urethane force-deflection and compression set, ASTM E96 for water-vapor transmission, ASTM D3330 for peel adhesion). It makes no patient, clinical, therapeutic, healing or efficacy claim of any kind.
The material maker evaluates and documents a grade against these standards on its current technical data sheet; the device maker owns the finished-device biocompatibility assessment and regulatory file. H-O Products is a precision die-cut converter, not a raw-material producer and not a medical-device manufacturer; this is not, and does not imply, an ISO 13485 certification, an FDA device registration, a cleanroom certification or a biocompatibility certification.
The only certification claimed is ISO 9001:2015, which governs the converting process. Grade-specific values are confirmed against the manufacturer's current technical data sheet and an engineering drawing review. All parts are custom manufactured to order and minimum production run quantities apply.