Solutions for Medical Device Development
Transforming Innovative Ideas Into Successful Medical Devices Requires a Strategic Approach
Inotiv’s Novel Model Development service provides a comprehensive solution to streamline this process. Our program leverages the expertise of our veterinary surgeons, pathologists, and regulatory specialists to guide you through every stage of development.
Novel Model Development
- Literature Search
- Our surgeons and pathologists are experts at finding and understanding relevant research. They efficiently sift through complex medical and regulatory-focused literature to gather the knowledge needed for optimal model development.
- Pilot Study Work
- Pilot study work is important proof-of-concept testing for both medical device and surgical model development. Plus, it helps save on cost. Our team will collaborate with you to design pilot work as needed, prior to committing to a full GLP compliant study.
- Examples of Developed Models:
- Extratracheal Splinting
- Atrial Fibrillation
- Joint Immobilization
- Barbed Suture Closure and Mechanical Testing
- Intratracheal Coil
- Cartilage Defect and Osteoarthritis (OA)
- Vas Deferens Injection
Protocol Design
- Timely IACUC Approved
- Our on-site Institutional Animal Care and Use Committee (IACUC) reviews and approves every project within days of submission.
- Pre-submissions to Regulatory Bodies
- If requested, our team offers protocol development up front for pre-submission to regulatory bodies. A study director, surgeon, and pathologist will be assigned to your team, and collaborate to deliver a high-quality draft protocol for regulatory reviews.
- Collaboration with Veterinarian Experts and Boarded Specialists
- From initial inquiry to FDA response, our team of experts is with you every step of the way. Through study design, protocol development, study execution, submittal, and response—we are there as an extension of your home lab and team.
Class II and III Devices
- Implants
- Screws / Fasteners
- Biologics
- Wound Dressings
- Catheters / Guidewires
- Pacemakers
- Ventilators
- Stents
- Electrodes
Regulatory Responses and Feedback
- Pre-submission Support (510k, PMA, IDE, De Novo)
- If requested, protocol development is available as a standalone service to aid in the pre-submittal process.
- Reporting (Non-GLP or GLP)
- With our on-site quality assurance unit, we provide timely audited reports for any objective.
- Pathologist Consultation with Regulatory Body
- Post-study, our team of experts is routinely involved in responding to FDA questions and feedback. Our pathologists will provide sound, scientific reasoning for sample size and data acquisition/analysis.
Histology
Pathology
Bioanalytical
Consulting
