Medical Device Specialized Histology

Specialized Histology

At Inotiv, our GLP-compliant histology laboratory has vast expertise in both plastic and paraffin processing, offering a wide range of specialty stains to deliver optimal and visually striking results.

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Specialized Histology Expertise

Whether you have samples explanted from a pre-clinical model or a research based clinical trial, our team is here to support your product from histology processing through pathology evaluation and reporting. With a full understanding of how your test article will interact with our various embedding mediums, our team will guide you to select the optimal approach for sample preparation.

Paraffin Histology

Utilized for soft tissue, decalcified bone, and non-target tissues, paraffin histology is widely used and accepted in the field of medical device and drug development. Samples are processed to block, then taken to slide via microtome – creating slides to then be stained with the standard Hematoxylin & Eosin (H&E) in addition to a variety of special stains and/or immunohistochemical (IHC) labels.

Plastics Histology

Test article in need of a plastic embedding medium? Inotiv, has you covered with extensive experience in Spurr resin and Methyl Methacrylate (MMA) embedding techniques, paired with special stains modified for use in a plastic medium. Plastics histology is commonly used for undecalcified bone samples, various hard plastic or metal implants, and cardiovascular devices.

Immunohistochemistry

Inotiv has an extensive list of developed immunohistochemistry (IHC) labels for use on both paraffin and some plastic-embedded sections. Please reach out for a comprehensive list of targets, or to submit a specific inquiry.

Histomorphometry

As a quantitative analysis method, histomorphometry can be used for both soft and hard tissue. Our validated systems and techniques help to accurately measure your product performance.

Some typical measurements include:

Percent bone ingrowth as a function of an area (a defined region of interest; ROI)
Percent residual implant material as a function of a defined ROI (e.g., defect or fusion mass)
Percent of a target tissue type (e.g., fibrosis) as a function of a defined ROI
Percent of a target tissue type as a function of tissue or implant length (e.g., percent osteoid on a bone surface)

Frequently Asked Medical Device Specialized Histology Questions

What special stains do you have developed in-house?

Trichrome stains (Elastin Trichrome, Gomori’s Elastin Trichrome, Masson’s Trichrome), Stevenel’s Blue/van Gieson, Picrosirius Red, Alcian Blue, and more! Please reach out for specific inquiries.

What is a whole slide scanner?

A slide scanning machine that allows scanning of the entire slide, both standard sized and oversized, and paraffin or plastic – not just pictographs of a region of interest.

What types of devices can you process?

Orthopedic, Cardiovascular, Dental, Neurology, Wound Healing, and more! Please reach out for specific inquires.

What is Histomorphometry?

A quantitative analysis technique used to measure specific tissue areas and/or object counts within a defined region of interest.

What embedding media do you have?

Paraffin wax, Methyl Methacrylate (MMA), and Spurr Resin.

What are your other capabilities for medical device?

Please see our Medical Device Home Page for more information. Or, reach out to a Medical Device Expert to learn more.