Preclinical and Experimental Surgery Solutions
Verify the safety and performance of your prototype
Embarking on a journey to design the next medical device breakthrough brings new considerations in the preclinical stage of development, such as:
- Are the materials being considered safe and biologically compatible?
- Does an implantable device prototype fit and work the way we intended?
- How can I best train my commercial team and physicians?
Craft the optimal preclinical strategy by collaborating with our medical device development specialists. Then access the preclinical resources necessary to make your initial development stage easier. Whether you are exploring a promising device concept, initiating a comprehensive testing plan or conducting a single study, Covance Medical Device and Diagnostic Solutions can help you prove out your device in its earliest stage of development:
Ensure the materials in your medical device are safe for use.
Explore design options and optimize proof-of-concept for your novel product.
Advance sales/physician skills by providing hands-on education.
Proving your device is made of biologically compatible materials is a regulatory requirement of every device. Start with a solid plan that identifies the right biocompatibility studies for your specific device, and then move forward conducting your studies at one of our EN 45011, ISO 17025, GLP or GMP certified global laboratories that deliver high-quality scientific data and analytical support. Your customized testing roadmap ensures you get the data required to progress your device to the next stage of development, quickly and efficiently.
Access a full range of biocompatibility testing in the following critical categories:
- Acute systemic toxicity
- Biocompatibility/risk assessment reporting
- Chemical assays (fingerprint assays and extractable & leachable testing)
- Developmental and reproductive toxicity
- Implantation (local effects and toxicity studies)
- in vitro irritation
- in vivo irritation
- Material mediated pyrogenicity
- Sub-acute, sub-chronic and chronic toxicity
Sometimes you need more information to optimize your product concept to get to your final prototype. Gain valuable insight with an early surgical test using a built-for-purpose operating room (OR). An experimental study will provide you with a better understanding of how you can enhance your design or develop your concept further.
Access four surgical OR suites that are fully equipped for your experimental surgery requirements. Start with guidance on selecting the right high-quality surgical models that meet exacting scientific and regulatory standards. Plus, enjoy full support, including model and OR preparation, necropsy and pathology support, surgery scrub, instrument preparation and laboratory tests, and even an engineering lab should your device require minor adjustments during testing.
Determining the appropriate model best suited to your study needs doesn’t have to be a challenge. Collaborate with our team to evaluate and develop animal model systems or select appropriate human anatomic models for various device types, including:
- Drug delivery
- Tissue engineering
- Wound healing
Partner with our highly skilled veterinary team to choose the appropriate model and implement your study design under GLP or non-GLP standards, ensuring you get the information you need to progress your proof of concept.
- GLP: Conduct your GLP study under acute or chronic research protocols. Work closely with a program manager throughout the testing process, including protocol development and model selection, in-life phase, and authoring the final study report for regulatory submission.
- Non-GLP: Not every study requires the rigor of a GLP study. For exploratory research, non-GLP testing is an affordable approach to get quick decision-making insight to inform your early design. Your study is still performed under conditions similar to GLP and optional report and pathology are available upon request.
Cadaver studies make it easier to assess the function of your device within the human body, potentially with more accuracy. Gain valuable experience visualizing your device in conjunction with the bones, muscles and organs that it ultimately will come into contact with in the living body. Full cadavers, partial cadavers and/or relevant tissues are available to support your study to exacting specifications, via approved vendors, while reducing the number of non-human models required for research.
You have access to imaging equipment for documenting the placement and performance of your implanted device.
- Cardiac catheterization lab
- General ultrasound
- ICE (intracardiac echocardiography)
- IVUS (intravascular ultrasound)
- Laparoscopic towers
- TEE (transesophageal ultrasound)
- Transthoracic ultrasound
Advance your sales team’s marketing efforts and investigator skills with hands-on clinical education to build knowledge or skills related to your medical device - using non-human and human anatomical models (tissue or cadavers).
With access to our 22,000 square foot facility, four spacious surgical suites and a synergy of tools, providing your team with the best learning environment to achieve your training objectives is a whole lot easier. Your trainers can share techniques that provide your medical professionals with the level of expertise needed to ensure success.
The Covance Medical Device and Diagnostic Solutions education site gives you access to an integrated training space that flexes to your curriculum. Start with an engaging didactic session, move into the OR for hands-on surgical training and end with a feedback or Q&A session. It’s all possible at one site for a full range of training programs:
- Bioskills labs
- Cadaver-based training
- Clinical trainings
- Clinical trial investigator training
- Didactic training
- Educational programs
- Hands-on workshops
- Nonclinical model-based training
- Product launches
- R&D market surveys and product evaluations
- Sponsor-designed, product-specific instructional courses
- Surgeon-to-surgeon training
Train larger groups using state-of-the-art audio/visual equipment that provides multiple camera views and display options from each of the OR suites into onsite adjacent viewing rooms.
- Located 15 minutes from the San Francisco International (SFO) airport
- Four state-of-the-art surgical OR suites
- Access to imaging equipment for viewing surgical results
- Audio/visual capabilities for onsite viewing by larger groups
- General surgical support team
- Adjacent space for group learning sessions, networking and meal breaks
- Catering support coordination
Each medical device and diagnostic product is different. Whether you need a partner for every phase of development or just one study, Covance Medical Device and Diagnostic Solutions can meet the goals for your next breakthrough.