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Inotiv’s Pathology Evaluation of Medical Devices

Inotiv

At Inotiv, we understand that the success of your medical device hinges on their safety and/or efficacy testing for regulatory approval. Our on-site and specialized Pathology services are designed to provide comprehensive assessments of medical device performance, ensuring that the in-life and histopathology testing for each device meets current regulatory standards. We offer guidance on study design and can provide necessary documentation to sponsors for their early pre-sub/Q-sub meetings with FDA prior to starting a full GLP study.

Our team of board-certified medical device pathologists utilizes advanced techniques and methodologies to evaluate the biocompatibility, safety, and/or efficacy of medical devices throughout their development and clinical trial stages. We offer a wide range of services, including:

Boneimplant

Necropsy oversight

Our board-certified veterinary pathologists will oversee your necropsy at Inotiv or at an external location.

Therapeutic Expertise

Our ACVP board-certified Pathologists have a breadth of experience in a variety of therapeutic areas.

  • Orthopedic Devices and Models
    • Dental Implants
    • Bioabsorbable and biostable implants
    • Critical sized defects
    • Bone filler materials
    • Fracture models
    • Cranial defects
    • Femoral epicondylar and articular cartilage defects
    • Osteoarthritis (OA) models
    • Posterolateral Lumbar Fusion (PLF)
  • Wound Healing Devices and Models
    • Adherent and Non-Adherent Dressings
    • Biological Wound Healing Products
    • Anti-adhesion products
    • Dermal Matrices
    • Films, foams, and gels
    • Hydrocolloids and Hydrogels
    • Full thickness wounds
  • Gastrointestinal Devices
    • Staplers
    • Electrosurgical Closure / Ligation Devices
  • Sutures
  • Ocular Implants
  • Subcutaneous and Intramuscular Implants
    • Cardiovascular Devices
    • Intravascular Peripheral and Coronary Stents
    • Drug Coated Balloons
    • Vascular Access Catheters
    • Grafts
    • Vascular / Vessel Sealers
    • Prosthetic Heart Valves
    • Left Ventricular Assist Devices (LVAD)
  • Ablation Devices
    • Dermal Ablative Therapies
    • Cryoablation Therapies
    • Radiofrequency (RF) Ablative Therapies
    • Electroporation Ablation

Histopathology Reports

At Inotiv, we understand your unique needs. Whether you need data to make quick design changes, to hit an internal deadline, or to submit to a regulatory body such as the FDA, we offer a variety of flexible and sometimes expedited reporting options from tabulated data summaries to fully signed pathology reports. Our reports are often supplemented with high-quality annotated images, and provide clear methods, results, and conclusions written to satisfy decision makers during every step of the development journey.

Safety and Efficacy Assessment

Histopathology evaluation is crucial to gain a comprehensive assessment of device performance in pre-clinical and clinical trial studies. The FDA and other agencies will require this type of evaluation to ensure safety and efficacy for human use. Inotiv can assist you with navigating these studies and conversations.

Regulatory Compliance and Support

Our pathology team has a proven track record of navigating conversations and supporting study submissions to FDA and international agencies. If the agency comes back with questions, our team will support yours in responding. Our team can evaluate devices in accordance to ISO 10993 Parts 4, 6, and 11.

fda regulatory pathways

Speak to a Surgical/Medical Device Expert

Frequently Asked Pathology Evaluation Questions

What is the difference between pre-clinical and clinical trial pathology in the context of medical devices?

  • Pre-clinical / Nonclinical pathology focuses on the evaluation of medical devices in animal models before they are tested in humans. It involves assessing the biocompatibility, safety, and/or efficacy of the device in a controlled laboratory setting.
  • Clinical trial pathology examines medical devices on a research and development basis after they have been used in human clinical trials. It involves analyzing tissues and materials associated with the device to identify any adverse events, assess performance, and to support regulatory submissions.

What types of medical devices do you specialize in?

Inotiv specializes in a wide range of medical devices, including:

  • Implants (e.g., stents, pacemakers, joint replacements)
  • Surgical Instruments
  • Diagnostic Devices (e.g., catheters, endoscopes)
  • Biomaterials (e.g., scaffolds, sutures, bone fillers)

What techniques do you use for histological and immunohistochemical analysis?

We employ advanced techniques such as:

  • Hematoxylin and eosin (H&E) staining for general tissue morphology
  • Special stains for identifying specific cell types or structures
  • Immunohistochemistry (IHC) utilizing antibodies to identify specific antigens related to device-tissue interactions

How do you ensure the accuracy and reliability of your results?

Inotiv maintains strict quality control standards and follows Good Laboratory Practices (GLP) guidelines. Our team of experienced pathologists and scientists uses validated methodologies and equipment to ensure the accuracy and reliability of our results.

Can you provide examples of how your services have helped clients?

Inotiv successfully supports more than 50 clients a year in the medical device industry by:

  • Assessing the biocompatibility of novel materials
  • Supporting regulatory submissions
  • Optimizing device design and manufacturing processes
  • Identifying potential safety issues with devices before they reach clinical trials

How long does a typical project take?

The timeline for a project can vary depending on the complexity of the device and the specific services required. Our team will provide you with a detailed project timeline at the beginning of the engagement.

What are the costs associated with your services?

Our pricing is based on the scope of the project, the specific services required, and the complexity of the device. We will provide you with a detailed quote after discussing your specific needs

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