Ex vivo skin models for medical devices: from proof of concept to performance evaluation
When developing a medical device intended for use on or within the skin, demonstrating performance early in the development process is essential. Ex vivo human skin models offer a valuable medium for the pre-clinical evaluation of medical devices, supporting R&D, applicability testing and proof-of-concept studies before moving towards clinical evaluation.
A versatile approach for medical device development
At Eurofins Cosmetics & Personal Care, ex vivo models can be used to assess a broad range of skin-related medical devices and technologies, including:
- Wound-healing solutions: topical formulations, dressings and healing-support devices
- Specialised skin decontamination solutions: medical devices designed to cleanse the skin following contact with hazardous substances or chemical agents
- Penetration and delivery devices: microneedles, needle-free systems and iontophoresis
- Injectables: including hyaluronic-acid-based products
- Dermabrasion and chemical peeling technologies
- Body-contouring devices: including ultrasound and cryolipolysis
- Energy-based technologies: laser and light devices
- Microneedling and tattooing devices
From tissue response to measurable performance
Depending on the medical device and study objective, different experimental approaches can be designed using whole skin tissue or maintained skin explants. Assessments may combine photography, physical measurements, Raman analysis, histology, biochemistry, ,and topography.
This versatility enables the evaluation of specific performance endpoints.
For wound-healing applications, models can assess tissue and cellular morphology, wound closure and retraction, as well as biomarkers using immunostaining.
For penetration devices, ex vivo testing can visualise the delivery of an active ingredient into the skin, while injectable products can be assessed by monitoring the injected bolus and cutaneous response. Topography, TEWL, corneometry and cutometry can also provide complementary measurements.
Supporting medical device development with ex vivo evidence
From early R&D and proof of concept to applicability and performance testing, Eurofins Cosmetics & Personal Care can develop ex vivo approaches adapted to the medical device, its technology, and the endpoints to be investigated.
Developing a skin-related medical device? Contact Eurofins Cosmetics & Personal Care to explore how ex vivo models can support your development programme.