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How to Spec a Custom Die-Cut Medical Part: What to Send H-O for a Quote
A fast, accurate quote on a custom die-cut medical part comes down to a handful of inputs: the contact type and duration, the mechanical job the part does, the cleaning or sterilization method and how many cycles, whether it touches skin or a fluid, the biocompatibility basis you need documented, the adhesive and packaging, your prototype and annual volumes, and a drawing.
This guide walks each input, explains why it matters, and ends with a spec builder that assembles your answers into a request you can paste straight into the quote form. One framing carries through all of it: H-O cuts a grade the material maker reports as evaluated for the contact, and the device maker owns the finished-device file.
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The application problem: an incomplete medical spec stalls the quote
H-O Products is a precision die-cut converter, and every medical and biocompatible part is made to order from sheet, slab, or roll stock cut to your drawing. The concrete problem a buyer runs into is the stalled quote: a request that says "I need a biocompatible foam gasket" without the contact type, the sterilization method, or the documentation basis cannot be turned into a grade and a price without a round of follow-up questions.
The inputs below are the same ones an applications engineer would ask for, so sending them up front turns a back-and-forth into a single response.
The first two inputs do the most work. As covered in the companion guide on choosing a biocompatible material, the part's contact type (intact skin, breached surface, fluid path, or instrument surface) and its contact duration set which biological endpoints apply under ISO 10993-1, which narrows the material family before any geometry is discussed. The rest of the spec branches from those answers.
Why it is challenging: the requirement and the documentation are separate inputs
Specifying a medical part is harder than listing dimensions because two of the most important inputs are not geometry at all, and because the documentation you can receive is set by what the material maker has evaluated, not by what the converter can assert. The contact type and duration travel together as a pair, because a short skin contact and a prolonged one invoke different ISO 10993 endpoints.
The mechanical job and the sterilization method travel together too, because a cushion that is sterilized once is a different material problem than a seal autoclaved fifty times. And the compliance line on a quote reflects the material maker's biological-evaluation basis for the grade, assembled into a documentation package, rather than a device clearance that the converter cannot own. The checklist below is organized around those realities.
What to send, input by input
1. Contact type and duration
State what the part touches and for how long. ISO 10993-1 classifies contact as a surface device (for example on intact skin), an external-communicating device, or an implant, and duration as limited (under 24 hours), prolonged (24 hours to 30 days), or permanent (over 30 days). For a wearable that means "intact skin, prolonged"; for a wound dressing it means a breached surface, which is evaluated more stringently. These two answers set the biological endpoints and narrow the family.
2. The mechanical job
Tell us what the part does physically: cushion or pad, seal or gasket or bumper, absorb or wick or distribute fluid, or barrier or spacer. The job selects the structure. A cushion wants a soft, low-set foam; a moisture seal wants a closed-cell silicone; a fluid-management layer wants an open-cell reticulated foam.
3. Cleaning or sterilization method and cycle count
Name the method (steam autoclave, ethylene oxide, gamma, or e-beam) and how many cycles the part must survive. Solid and medical cellular silicone (BISCO MS-80 / MS-96)s tolerate repeated sterilization, which is why they lead for reusable instrument parts. Microcellular and reticulated polyurethane foams are often single-use. Gamma crosslinks silicone and can change its elasticity at high dose, so the cycle count and dose are part of the spec, not an afterthought.
4. Skin contact and fluid contact
State plainly whether the part contacts skin, a fluid or reagent, or both. Skin contact pulls in sensitization (ISO 10993-10) and irritation (ISO 10993-23) for both the base material and any adhesive. A fluid path pulls in extractables, which is why a platinum-cured silicone is preferred over a peroxide-cured one, and an FDA composition basis where the contact requires it.
5. Biocompatibility basis to document
Tell us which documentation basis your design needs: ISO 10993 endpoints for the contact, a USP Class VI evaluation, an FDA composition citation (for example 21 CFR 177.2600), or a combination. H-O cuts a grade the material maker reports as evaluated against those frameworks and assembles the supporting documentation into a customer-specified compliance package. The package documents the material; it is not a finished-device clearance.
6. Adhesive and stack-up
Tell us whether the part needs a skin-side or device-side pressure-sensitive adhesive, a release liner, a pull-tab for clean placement on a line, or a laminated stack. A skin-interface part is usually a stack: a skin-side adhesive, a die-cut cushion foam, and a face film or carrier on a liner. H-O converts the die-cut cushion and the adhesive layers and can kit the stack for your line.
7. Packaging and handling
If the part needs clean or controlled handling, bagging, or a specific kit format, say so. This affects how the part is converted, packaged, and shipped, and it is better stated up front than discovered at first article.
8. Geometry, gauge, and the drawing
Send the footprint, the thickness or gauge, the hole or slot pattern, tolerances, and any adhesive callouts. A dimensioned drawing in DXF, STEP, or PDF closes the loop. If you do not have a formal drawing yet, a marked-up sketch with dimensions is enough to start a prototype.
9. Prototype and annual volume
Share both the prototype quantity and the expected annual volume. All parts are custom manufactured to order, and minimum production run quantities apply, so the volume shapes the converting approach and the tooling decision. Prototype quantities through full production are welcome.
The spec at a glance
| Input | What to send | Why it matters |
|---|---|---|
| Contact type and duration | Skin / breached / fluid / instrument; limited / prolonged / permanent | Sets the ISO 10993 endpoints and narrows the family |
| Mechanical job | Cushion, seal, fluid management, barrier | Selects open-cell vs closed-cell vs solid |
| Sterilization | Method (steam / EtO / gamma / e-beam) and cycle count | Silicone for repeated cycles; foam often single-use |
| Contact details | Skin contact y/n; fluid contact y/n | Pulls in -10 / -23 and extractables / FDA basis |
| Documentation basis | ISO 10993 endpoints / USP Class VI / FDA citation (material level) | Defines the material-level compliance package |
| Build | Adhesive, liner, pull-tab, lamination, kit, packaging | Sets the converting and assembly approach |
| Commercial | Prototype quantity + annual volume; drawing (DXF / STEP / PDF) | Shapes tooling and confirms geometry |
Medical Part RFQ Spec Builder
Contact: Intact skin (confirm duration: limited / prolonged / permanent) Mechanical job: to be provided (cushion / seal / fluid management / barrier) Sterilization: method to be provided; cycles to be provided Geometry: footprint to be provided; thickness/gauge to be provided Documentation basis: ISO 10993 endpoints for the stated contact (material level) Build: standard die-cut Packaging: standard Commercial: prototype quantity to be provided; annual volume to be provided Drawing: to follow Note: H-O cuts a grade the material maker reports as evaluated for this contact; the finished-device file is owned by the device maker.
Illustrative only; confirm against current material data and a drawing review. This builder formats your inputs into a request; it does not select a grade, evaluate biocompatibility, or assign a device clearance. The material grade, its biological-evaluation basis (ISO 10993 / USP Class VI / FDA composition, at the material level), and its sterilization tolerance are confirmed on the manufacturer's current technical data sheet, and the finished-device biocompatibility and regulatory file is owned by the device maker.
Common failure modes in the spec itself
| Spec gap | Why it stalls the quote | The fix |
|---|---|---|
| "A biocompatible foam," no contact | The family cannot be set without the contact type and duration | State the contact type and duration so the ISO 10993 endpoints are clear |
| No sterilization method | Silicone-versus-foam and single-use-versus-reusable are undecided | Name the method and the cycle count |
| "USP Class VI certified part" | USP Class VI is a material-level evaluation, not a part or device clearance | Ask for a grade evaluated to USP Class VI and document the basis |
| Asking the converter for a device clearance | FDA-grade describes material composition; a finished-device clearance is the device maker's, not the converter's | State the FDA composition basis needed (for example 21 CFR 177.2600) |
| No volumes | The converting and tooling approach depends on prototype versus production scale | Send both prototype quantity and annual volume |
How H-O Products helps
H-O Products is a precision die-cut converter.
Once your spec is complete, we recommend a material family and grade direction across microcellular polyurethane (PORON® Medical), medical silicone (BISCO® MS-1600 solid, BISCO® MS-80 / MS-96 medical cellular, and SSP-2390 platinum-cured), reticulated polyurethane, crosslinked polyethylene and EVA foams, and FDA-grade foams and films, then convert the maker's stock to your drawing: die-cut, kiss-cut, laser or waterjet cut, laminated, slit to width, and kitted.
Documentation available on request includes the material technical data sheet, a certificate of conformance, lot traceability, first-article inspection, and the material maker's biological-evaluation basis for the grade, assembled into a customer-specified compliance package, all under our ISO 9001:2015 certified quality management system.
We do not produce the raw stock, we do not certify the finished device, and we are an ISO 9001:2015 certified organization, not an ISO 13485 or FDA-registered facility. Grade properties and biological-evaluation results are confirmed against the manufacturer's current technical data sheet, and the finished-device file belongs to the device maker.
Frequently asked questions
What information does H-O need to quote a custom medical part?
Send the contact type and duration; the mechanical job (cushion, seal, fluid management, or barrier); the sterilization method and cycle count; whether the part contacts skin or a fluid; the biocompatibility basis to document (ISO 10993 endpoints, USP Class VI, or an FDA composition citation, all at the material level); the adhesive and packaging needs; the footprint, thickness, and a drawing in DXF, STEP, or PDF; and the prototype quantity and annual volume.
Can H-O make my part ISO 13485 or FDA certified?
No. H-O is a die-cut converter and an ISO 9001:2015 certified organization, not an ISO 13485 or FDA-registered facility. H-O cuts a grade the material maker reports as evaluated for the relevant contact and provides the supporting documentation on request. The finished-device biocompatibility and regulatory file is owned by the device maker.
What documentation can H-O provide with a medical part?
Available on request: the material technical data sheet, a certificate of conformance, lot traceability, first-article inspection, and the material maker's biological-evaluation basis for the grade (ISO 10993 / USP Class VI / FDA composition), assembled into a customer-specified compliance package under the ISO 9001:2015 quality management system. The package documents the material; it is not a finished-device clearance.
Do I need a finished drawing to get a quote?
No. A dimensioned drawing in DXF, STEP, or PDF is ideal, but a marked-up sketch with the footprint, thickness, and tolerances is enough to start a prototype. All parts are custom manufactured to order and minimum production run quantities apply, so sending the prototype quantity and annual volume with the geometry speeds the quote.
Send the spec, get a quote
Use the builder above to assemble your request, then paste it into the quote form with your drawing attached. We will recommend a material direction and convert samples on your footprint.
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
Request a quote for your medical & clean components part
Send H-O your drawing or describe the part—engineering reviews every RFQ and converts samples on your geometry.
Last updated · Reviewed by H-O Products engineering (ISO 9001:2015 certified converter, Winsted, CT).
References
- ISO 10993 (biological evaluation of medical devices). ISO.
- USP <88> (in-vivo biological reactivity, USP Class VI). U.S. Pharmacopeia.
- 21 CFR (fluid-contact composition basis). U.S. FDA.
- ASTM D3574 (flexible cellular foam) and ASTM D3330 (pressure-sensitive adhesive peel). ASTM International.
- Manufacturer technical data sheets: BISCO medical silicones, PORON Medical microcellular polyurethane, and the skin-contact adhesive grades named in this article.
This article cites general engineering principles and published standards (ISO 10993 for biological evaluation, USP <88> for in-vivo biological reactivity / USP Class VI, 21 CFR for fluid-contact composition basis, ASTM D3574 for flexible cellular foam, ASTM D3330 for pressure-sensitive adhesive peel). Material names refer to material families H-O Products converts. Biological-evaluation results and material properties are grade-specific; confirm all values against the manufacturer's current technical data sheet.
The material maker evaluates the grade against the relevant frameworks at the material level; the finished-device biocompatibility and regulatory file is owned by the device maker. All parts are custom manufactured to order and minimum production run quantities apply. H-O is a die-cut converter and an ISO 9001:2015 certified organization, not an ISO 13485 or FDA-registered facility, and does not certify finished devices.