Frequently Asked Questions
Preclinical Research
How quickly can a MedTech company start a preclinical study with IBEX?
A common concern among startups and device developers is the length of time it will take to start testing. Teams may expedite schedules, produce early safety and performance data, and get closer to regulatory submissions without needless delays at IBEX because studies can begin as soon as two to three weeks following initial contact.
What is the significance of GLP-compliant research for FDA submissions?
GLP compliance guarantees that the data gathered satisfies firm documentation and quality requirements accepted by the FDA and other international regulatory agencies. This gives MedTech inventors assurance that their preclinical results will withstand regulatory assessment because the study is reliable, repeatable, and audit-ready.
What kinds of medical devices gain the most from preclinical research conducted by IBEX?
Orthopedic implants, spinal fixation systems, corrective tools, drain, imaging-guided devices, surgical sealants, and tailored biotech solutions are just a few of the many products that IBEX supports. Device teams at MedTech companies, whether they are new or well-established, depend on IBEX to provide clinically relevant models that accurately represent real-world use.
Can physicians be trained on devices during preclinical studies?
Yes. IBEX provides live large-animal models for physician training in a cadaver-free, realistic setting. In the same location as preclinical testing, surgeons can test placement, assess usability, and give feedback as device teams perfect performance in real time.
How are the 3Rs (Replacement, Reduction, Refinement) and social issues in animal research handled by IBEX?
IBEX’s process is centered on ethics and responsible research. The team applies the 3Rs principle by:
- Replacing animal use when alternative methods are valid.
- Lowering the animal population by the use of data-rich models and sophisticated imagery.
- Enhancing procedures to reduce suffering and improve animal welfare.
This strategy strikes a balance between compassionate research methods that meet international standards and creativity.
Orthopedic Preclinical Research
How can IBEX guarantee the precision and dependability of the results of orthopedic preclinical research?
IBEX uses state-of-the-art imaging technologies, such as X-ray, CT, and MRI, and meticulously replicates clinical situations to provide precise, scalable, and meeting requirements results for orthopedic devices. For all procedures, IBEX uses veterinarians with preclinical research expertise.
What kinds of orthopaedic devices are fitting for IBEX testing?
IBEX evaluates biomaterials, joint replacements, implants, and other musculoskeletal procedures.
Does IBEX allow orthopedic device regulatory submissions?
From preliminary feasibility testing to follow-ups after approval, IBEX offers comprehensive regulatory positing help.
Preclinical Research Facility & Equipment Services
What preclinical testing capabilities does the IBEX facility offer?
Orthopedics, dentistry, neurology, cardiology, ophthalmology, wound care, gastrointestinal, and toxicology are just a few of the therapeutic areas in which IBEX provides vast preclinical research capabilities, including in-vivo medical device implantation and safety studies. Their state-of-the-art vivarium, surgical suite, and imaging systems enable accurate, notable research.
What kinds of preclinical animal models does IBEX employ?
To guarantee accuracy, IBEX employs a range of animals, such as rats, rabbits, lambs, and dogs, simulation of clinical conditions.
Does the IBEX facility have accreditation and adhere to rules?
The faculty does adhere to FDA, USDA, and OLAW direction for ethical research and animal care, and they are AAALAC-accredited.
How is refined surgical and interventional research supported by IBEX's facility?
The IBEX facility has a 500-square-foot operating room, a 10-room vivarium with an outside barn, and original imaging equipment like CT, digital X-ray, MRI, fluoroscopy, and ultrasound. Observer can carry out multiple surgeries at once with this configuration, track in vivo development in real time, and produce high-quality data for device and treatment pricing.
Soft Tissue Surgery Preclinical Research
Why is research on preclinical soft tissue surgery crucial to the creation of medical devices?
Because it assesses the recital, safety, and effectiveness of surgical instruments and methods prior to human usage, preclinical soft tissue surgery research is essential. It improves clinical results and patient safety by assisting in the identification of possible dangers including rawness, infection, or tissue responses, honing surgical techniques, and supplying reliable data to back up regulatory applications.
Which soft tissue surgery procedures are being tested?
A variety of procedures are tested by IBEX, such as organ repair, wound healing, circulatory grafts, and catheter implantations.
Is regulatory submission supported by IBEX?
Every study complies with GLP and is intended to produce data appropriate for submission to the FDA and other regulatory bodies.