Medical Devices

Human ex vivo NAMs for device
development and local tolerance assessment

Find the right starting point for device testing

Medical devices that interact with the skin require careful evaluation of local tissue response, irritation risk, inflammation, wound compatibility, and device–tissue interactions. Genoskin’s ex vivo human skin models preserve native tissue architecture, resident immune cells, donor variability, and route-specific responses, helping medical device teams generate human-relevant data earlier in development.

From injectable devices to wound dressings, adhesives, microneedles, and skin-contact materials, Genoskin supports exploratory, mechanistic, and translational studies before resource-intensive regulatory testing.

Early response screening

Evaluate local effects on tissue, inflammatory signals, and early tolerance indicators for devices, materials, and formulations that interact with human skin.

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Injection-site response assessment

Assess local immune activation and tissue response after intradermal or subcutaneous administration of injectable devices, delivery systems, or combination products.

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Local tissue compatibility studies

Generate human-relevant data on tissue viability, histological changes, inflammatory mediators, and donor-dependent responses before downstream testing.

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Skin-contact & transdermal device testing

Study adhesives, patches, microneedles, skin-contact materials, and transdermal delivery systems using native human skin models.

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Inflammation & tissue remodeling models

Investigate how devices, biomaterials, or locally acting products influence inflammatory pathways, immune activation, and tissue remodeling in human skin.

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Human skin models for medical device development

Order ready-to-use models for in-house studies, or work with our CRO team for custom medical device study designs.

HypoSkin®

The only ex vivo model including the hypodermis, where subcutaneous injections and deeper tissue interactions occur. Native immune cells are fully preserved. Best for:

  • Injectable devices
  • Combination products
  • Fillers and implantable materials
  • Local tolerance and ISR assessment

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NativeSkin®

Full-thickness human skin, including the epidermis and dermis, suited for topical, transdermal, and direct skin-contact studies across a range of product formats. Best for:

  • Wearables and adhesives
  • Skin-contact materials
  • Barrier and irritation-related studies

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WoundSkin®

A wounded human skin model designed to evaluate healing, inflammation, tissue repair, and infection-relevant endpoints. Best for:

  • Wound dressings
  • Advanced wound care products
  • Antimicrobial materials
  • Tissue repair and healing studies

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Frequently asked questions

Can Genoskin replace ISO 10993 testing?

Genoskin models are designed to support early, human-relevant evaluation of local tissue response before formal regulatory testing. They can help de-risk material selection, formulation strategy, device design, and study planning, but should be positioned as complementary to required ISO 10993 biocompatibility testing unless a specific validation strategy has been established.

What types of medical devices can be tested?

Genoskin can support studies for skin-contact, injectable, transdermal, wound care, aesthetic, and locally acting devices. Examples include microneedles, wearable adhesives, wound dressings, dermal fillers, drug-device combinations, local delivery systems, and materials intended to interact with human skin.

What endpoints can be measured?

Endpoints can include histology, tissue viability, cytokine and chemokine profiling, inflammatory markers, gene expression, spatial biology, barrier-related readouts, wound closure, immune-cell dynamics, and donor-to-donor variability depending on the model and study design.

Can devices be applied directly to the tissue?

Yes, depending on the device format and study objective. Genoskin models can support direct topical application, intradermal or subcutaneous administration, material exposure, formulation testing, and customized workflows designed around the device’s intended route of use.

Why use ex vivo human skin instead of reconstructed skin models?

Reconstructed skin models are useful for standardized irritation testing, but they do not fully capture native tissue architecture, resident immune cells, dermal and hypodermal compartments, or donor variability. Genoskin’s ex vivo models help bridge the gap between simplified in vitro assays and later-stage preclinical or clinical studies.