MPI Research has been conducting preclinical medical device evaluations for many years. The types of studies performed range from proof of concept / efficacy to large-scale multi-specie safety evaluations for vascular stents and orthopaedic implants such as spinal products for fusion and artificial inter-vertebral disks. MPI Research has also been a leading CRO in the study of many types of drug-device combination products and continues to be a resource for companies needing innovative scientific insight and flexible scheduling to help gain speedy regulatory approval for their products.

A key process in the evaluation of many medical devices, in particular orthopaedic and vascular devices, is the ability to embed tissues such as bone and blood vessels in plastics for histological and histomorphometric evaluation. Few laboratories exist in the US that can conduct these key evaluations under GLP conditions, and none of these labs exist in combination with an in vivo animal facility performing the in-life portion of these studies. MPI Research will be the first and only CRO, with the ability to perform all of the key preclinical components of a medical device program at one location. The addition of the new laboratory will have a significant impact on the overall time it takes to complete these critical studies for Sponsors. Construction of the new facility will begin in September and should be finished, with all validations completed by January of 2005.

Dr. James Laveglia, Executive Vice President and Director of Research of MPI Research commented, “We have been providing premium services for our medical device sponsors for many years but a key component was missing, the ability to embed tissues in plastic for the final histological evaluation. This is a critical step that all CRO’s have had to outsource. Losing control of this key component of device evaluations has made it difficult for CRO’s to meet reporting deadlines. Meeting report deadlines has been a hallmark of the service MPI Research provides, and so we have made the commitment to add this capability for our customers. We will have the ability to perform thick sectioning, which is needed for some stent and bone evaluations, and also thin sectioning which is needed for many types of stents and neural evaluations. The addition of this service is just another example of how MPI Research meets the needs of our Sponsors.”

MPI Research exists to provide comprehensive preclinical research that meets the requirements of pharmaceutical, medical device, animal health and chemical companies as well as governmental agencies as we partner together to bring safer, healthier products to the world. MPI Research employees specialize in a wide variety of scientific disciplines including toxicology, pharmacology, metabolism, pathology, clinical pathology, reproductive and developmental biology, veterinary science, neuroscience, experimental therapeutics, immunotoxicology, analytical chemistry, computer science, regulatory science, and statistics.

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