(585) 270-8354
1667 Lake Avenue, Suite 354
Rochester, NY  14615


 

               Polymer Engineering

              Technology Development
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MEDICAL DEVICES
present a number of challenges in the development process. Careful specification definition in both raw material / component  and product performance are extremely important when following design control. Early interaction with regulatory bodies (e.g. FDA) and development of a strategic decision package limits subsequent pitfalls. Also, consideration of manufacturing under either GMP or cGMP guidelines must be considered in the development process as well as the production of clinical trial materials. Rapid development of the final process is advantageous in producing product for clinical trials that closely mimics that of the final commercial product. 

We provide technology consulting services including contract research to small and medium sized companies as well as start-ups involved in the research, development and transfer of technology. A comprehensive technical assessment and proposal is developed based on the client’s area of interest.

INNOVATION is the process of producing a novel or improved idea or product. This process provides the basis for intellectual property and competitive advantage. Development of broad based technology platforms allows for the design of multiple products off one technology. This  allows for efficient use of resources as opposed to developing a technology for each product. Therefore, early consideration of how certain technologies can be translated into products is essential in evaluation of resource deployment. An integral part of innovation is the anticipation of future needs that are not present in the minds of customers today. Technology and societal trends can provide information used to evaluate ideas that may prove successful.

TESTING STRATEGIES can be incorporated into  the research, development or manufacturing phases of a project and will be the foundation of your quality plan and future regulatory submissions.