Surgical Support and Medical Device Testing

Your Trusted Partner for Novel Surgical Procedures and Streamlined Medical Device Development

At Inotiv, we understand the complexities involved in bringing innovative medical devices to market. That is why we offer a comprehensive and integrated portfolio of services to provide GLP and non-GLP testing for medical device development and novel surgical procedures to support you throughout your entire development journey.

Our advantage lies in our comprehensive, on-site services. Our highly skilled team of surgical veterinarians and histopathologists collaborate closely with you throughout the entire study. This fosters clear communication and streamlines execution, from the initial stages to final analysis.

Speak to a Surgical/Medical Device Expert

Established Expertise, Streamlined Approach

Since 2005, our dedicated team in Fort Collins, Colorado, has served as a preclinical research site specialized in large animal surgical procedures. We foster a collaborative environment, partnering with you from initial inquiry all the way to regulatory submission. This includes expert guidance on study design, model selection, protocol development, in-life phases, and post-mortem evaluation.

By partnering with Inotiv, you gain a trusted collaborator dedicated to accelerating your program with efficiency and scientific attention. Explore the following to unlock the potential of your surgical or medical device program.

Tailored Solutions to Accelerate Your Development Journey

We understand that your needs may vary. Whether you require a complete solution encompassing the entire development process or specific standalone services, Inotiv is here to support you in the areas of:

Medical Device Testing and Model Development: Our surgical team creates novel models designed to support your device’s unique requirements and conducts comprehensive testing to assess its safety and efficacy.
Specialty Surgical Support and Training: Benefit from our team’s ability to utilize advanced surgical techniques and to provide training opportunities to help you refine your device’s application and testing protocol.
Special Drug Delivery System Testing: Our experts create innovative models tailored to your specific device application and delivery specifications.
Comprehensive Safety and Efficacy Assessments: Our team provides the guidance needed to help you navigate your program through the non-regulated and regulated preclinical stages of development, ensuring your device meets the highest standards.
Specialized Histology: Gain valuable insights through our advanced histology services, including plastics/resin analysis, immunohistochemistry, and histomorphometry.
Medical Device Pathology: Our dedicated pathologists are committed to providing a customized approach for your in vivo medical device programs. We partner with you from the outset, offering expert guidance during initial planning stages and continuing all the way through to the final study report. Our comprehensive reports clearly communicate the methods, results, and conclusions, ensuring a clear and concise understanding of your device’s impact.
Clinical Pathology: We offer a comprehensive array of clinical pathology and biomarker services to support your development project in discovery and regulated preclinical studies.
Bioanalysis: Access advanced bioanalytical support to gain a deeper understanding of your device’s toxicokinetic and pharmacokinetic profile.
Expert Consulting: Our team of consultants is available to provide strategic and regulatory direction throughout your development process.

Unleash the Potential of Your Medical Device with Inotiv’s Advanced Surgical Support Team

At Inotiv, we understand the critical role surgical expertise plays in successful medical device development. That is why we have assembled a team of eight exceptional veterinarians and boarded specialists, bringing over 100 years of combined experience.

Unmatched Surgical Skill and Experience:

Each team member brings a deep understanding of animal care, surgical techniques, anesthesia management, and histopathological procedures.
Our team specializes in a wide range of surgical procedures, including minimally invasive surgery, soft tissue and orthopedic surgery, wound healing studies and more.
Whether you are in the initial stages of discovery or navigating regulatory hurdles, our team is equipped to support your project at every step.

Facilities and Technology:

Our commitment extends beyond exceptional personnel. We offer two surgical suites equipped with:
- Portable C-arm for real-time fluoroscopic imaging during surgery.
- Laparoscopic tower for minimally invasive procedures.
- Advanced radiograph and ultrasound imaging systems for precise pre- and post-operative assessments.

Unique Training Opportunities:

Inotiv offers a unique advantage—the ability to host surgical training labs.
You can leverage our facilities and expertise to train your staff on specific procedures using either lab animals or cadavers.

Exceptional Animal Care and Facility:

Our dedication to animal welfare is unwavering. Our facility is fully accredited by AAALAC and adheres to the highest ethical standards.
With a recent expansion of our housing facilities and a beautiful ranch setting in Northern Colorado, we ensure the well-being of animals entrusted to our care while providing ample space for large and small animal studies, both chronic and recovery focused.

By partnering with Inotiv, you gain a team of highly skilled veterinary surgeons, advanced surgical suites, and a commitment to animal welfare, on-site histology, and board-certified pathologists. We empower you to navigate the complexities of medical device development with confidence and efficiency.

Where Expertise Meets Ethical Research Practices

At Inotiv, animal welfare is paramount. We highly value and embrace the use of ethical research practices, with full AAALAC accreditation and an OLAW assurance. This commitment ensures the well-being of animals entrusted to our care.

We provide meticulous oversight at necropsy, ensuring accurate data collection. Additionally, our services are fully compliant with ISO 10993 biological evaluation, including Part 6 (tests for local effects after implantation) and Part 11 (systemic toxicity). We also offer semi-quantitative evaluation, providing valuable insights into your medical device’s performance.

By partnering with Inotiv, you gain a trusted collaborator dedicated to both scientific excellence and animal welfare. Let us help you navigate the complexities of medical device development with confidence.

FDA Inspection FDA Inspection The FDA conducts inspections of facilities that manufacture or process FDA-regulated products like food, drugs, and medical devices.

AAALAC Accreditation AAALAC Accreditation AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care International) is a private, non-profit organization that promotes the humane treatment of animals involved in research, testing, or teaching.

OLAW Assurance OLAW Assurance OLAW Assurance (Office of Laboratory Animal Welfare Assurance) is a program overseen by the National Institutes of Health (NIH) in the United States [National Institutes of Health (NIH), Obtaining an Assurance].

IACUC IACUC IACUC (Institutional Animal Care and Use Committee) is a critical committee responsible for overseeing the ethical and humane treatment of animals used in research, testing, or teaching at an institution.

Frequently Asked Questions (FAQs) for Surgical Models and Medical Device

Do you provide protocol development for pre-submission to the FDA?

Yes, every quote includes a protocol development fee as part of the full study price. As needed, and if requested, we can pull this fee into a standalone quote. Once signed, a study director will be assigned to your study. They will collaborate with you and our internal team of veterinarians and pathologists to help develop a protocol suited to submit during a pre-sub or Q-sub meeting with the FDA.
We are always happy to discuss study details and results directly with the FDA, as well.

What is the difference between ISO 10993 evaluation and semi-quantitative evaluation?

ISO 10993-6 and -11 are provided scoring systems that fall under semiquantitative evaluation. At Inotiv, we include the ISO in our scoring system and add additional parameters to ensure a thorough evaluation. The additional parameters are dependent on the type of study, the type of device or surgical technique, target tissue, etc.

Do you provide responses to FDA feedback?

Yes, we are more than happy to speak to the “why” of any part of a design. We are often involved in providing scientific responses and justification to the FDA.

How does your internal Institutional Animal Care and Use Committee (IACUC) review and approval work?

Our Institutional Animal Care and Use Committee (IACUC) oversees the care and use of animals on site, reviewing all proposed studies as well as the program. Our study directors develop protocols for IACUC submission.
The IACUC review is performed within three days of submission, approving the study to commence in a timely manner.

What species do you work with?

Large animal and limited rodent models (e.g., rat, rabbit, canine, swine, and ovine). Beyond the standard models, our expertise extends to unique species like ferret, bovine, caprine, and more.

What are some unique features of the Fort Collins Site?

Three on-site board-certified pathologists for oversight of surgical procedure, necropsy, and histological processing. This is hugely beneficial for most studies to adequately capture the implant/surgical sites for evaluation.
We have a large animal ranch facility which allows the animals to roam freely pre-study and, if acceptable, for long-term recovery studies.
Our on-site histology lab has SPURR resin and methyl methacrylate (MMA) capabilities to support special processing needs for cardiovascular and orthopedic devices.

Which regulatory organizations provide oversight?

AAALAC International, USDA, FDA, OLAW. We also welcome sponsor visits and QA audits.

What are Inotiv’s Values?

Our Core Values

Deliver Excellent Client Experiences
Provide Insightful Problem Solving
Always Do the Right Thing
Be Humbly Confident
Get It Done

Which conferences/events do you attend?

We are active in the local Colorado BioScience Association (CBSA), and attend/exhibit at many of their community events. We also attend the following larger conferences:
- Orthopedic Research Society
- American Academy of Orthopedic Surgeons
- Cardiovascular Research Technologies
- Wound Healing Society
- Society of Robotic Surgery
- Transcatheter Cardiovascular Therapeutics
- Society of Toxicology
- BIOMEDevice Silicon Valley
- See all our upcoming events!