- Engineering Support »
- Design review to help conceive elegant, cost-effective and robust solutions for new medical devices
- Materials Selection »
- The critical task of selecting metals, plastics, adhesives, colorants, inks, radio-density markers, polymers, etc. for medical devices can be a daunting one. Bio-Logistics Preclinical maintains a sample inventory of medical device materials shown to be biocompatible in both animals and humans. Please contact us with questions regarding materials choices.
- We also offer materials testing and computational modeling expertise so that failure criteria can be specified and confirmed.
- Pilot Studies »
- Pilot studies to evaluate the safety, functionality or efficacy of your medical device. Capable of supporting species from nude mice to small ruminants.
- Feasibility Analysis »
- Cogent analysis of the market for the product, competitive advantages of your device over competitors, including strengths and weaknesses of both, preliminary pro forma data models.
- Surgical Modeling »
- Bio-Logistics Preclinical employs skilled veterinary surgeons to assist in your surgical modeling or protocol development needs. Basic surgical competency areas include soft tissue, orthopedic, and vascular intervention. We utilize surgical suites with advanced support services including onsite hematology, clinical chemistry, and blood gas analysis, and imaging modalities including plain and digital radiography and fluoroscopy.
- Human Factors »
- Human factors engineering (HFE), is the interaction of human expectations, physical abilities and limitations, is an integral part of medical device design. This consideration of man-machine interface takes into account field-use conditions, personnel training, labeling, controls, maintenance issues and logic of operation. The overriding goal of incorporating HFE is to reduce errors and injuries associated with the use of the device.
Bio-Logistics Preclinical offers human factors analysis feedback and reports to product engineers as discrete assessment, or part of a comprehensive medical device development program.
 
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- Model Development »
- Medical device development frequently utilizes in vitro, in vivo and in silico models. Selection of the correct model is vital to the effective evaluation of the product. Too lenient and the device is not adequately evaluated. Too rigid or critical a model and the device may be deemed unfeasible.
Bio-Logistics Preclinical specializes in the design and application of in vivo models that accurately evaluate the product in its intended application. These models yield realistic, predictable data that companies can use to support movement of the device into clinical trials and/or regulatory submissions.
- Efficacy Studies »
- The scope of "efficacy" varies tremendously across medical devices. Whether a single-day evaluation of a prototype or a multi-month evaluation utilizing dozens of subjects is required, Bio-Logistics Preclinical is prepared support your needs.
- GLP Safety Studies
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- FDA Filing Strategies »
- A comprehensive regulatory filing strategy is an imperative element of any medical device company's business plan. This strategy plays a tremendously important role in strategic, operational and budgetary planning. Identification of a predicate device, FDA issues such as device classification, 510k versus PMA, proactive discussions with the appropriate FDA device branch, Investigational Device Exemption issues, etc. are all pieces of the puzzle. With a well-crafted regulatory filing strategy puzzle pieces become waypoints on a map, bringing clarity to the device development process.
- QSR Implementation »
- Often with start-up companies, Quality Systems Regulations are something to be grappled with and implemented at some time in the future. In reality, early migration to the QSR philosophy improves all aspects of product design, evaluation and production; resulting in a more coherent, efficient use of human, physical and financial resources. Bio-Logistics Preclinical can access your current level of adherence to the QSRs, and based on the stage of growth or product development, provide training and implementation of this required set of regulations.
- Technical Writing »
- Bio-Logistics Staff are experts at writing scientific manuscripts, research proposals and technical reports, having had successful careers in academic research.
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