Development of a Medical Product

We are also experts in the use of 3D CAD platforms (ProEngineer, Solidworks and Autocad) to develop and layout complex mechanical and electromechanical mechanisms and systems for the development of a medical product. These tools allow us to rapidly visualize and develop designs that are ergonomic, pleasing to the eye and work well. Virtual simulation is carried out through a wide variety of tools, including CosmosWorks and ProMechanica for finite element analysis, for the evaluation of stress, strain and deflection, as well as thermal analysis. Kinematic analysis of linkages, cams, springs and simulation of vibration are often integrated into our development of a medical product process for more complex medical devices. Virtual simulation helps us to predict mechanical behavior early in the design process, allowing for a shorter development cycle with fewer prototypes.

Hands on experience in cooperation with surgeons, engineers and marketing personnel allowed the development of a medical product with a distinctive line of surgical tools for spinal surgery, see the image on the left, offering improved ease of use, comfort for long procedures and a uniquely identifiable branded appearance.

Development of hardware, firmware and software, including user interface design, for electronic and electromechanical devices and systems is developed in house and through the use of our strategic partnerships.

No medical design is complete unless it can be effectively communicated to prospective buyers, clients or manufacturers. By creation of control, assembly and full documentation packages utilizing GD&T techniques we turn exceptional design and engineering for the development of exceptional medical products. Complete documentation and tolerance analysis, as required for most medical devices and systems, provide the tools required to assure quality control and critical performance goals are met by the end product.

To that end, Bresslergroup has an engineering laboratory with capabilities for product testing and data acquisition, for evaluation of critical performance parameters including parts inspection, stress, strain, thermal, fluid flow, vibration and noise during the development of a medical product process. We also use our advanced CAD tools and skills for analysis and evaluation of design performance through systems analysis and failure mode and effects analysis (FMEA). This rigor assures that products we design are safe to use and meet all the regulatory requirements for the development of a medical product, from FDA, CSA, CE, UL and other agencies.

Significant research led to the creation of a truly novel and important medical product for BD. The purpose of the SafetyGlide shielding hypodermic needle is to provide nurses, doctors, phlebotomists and medical technicians, a hypodermic needle that can be attached to any standard “Luer” syringe and which can be made intrinsically safe immediately after injection. Upon completion of an injection using the “SafetyGlide” the user can, with one hand (right or left), activate a self deploying shield which covers the needle and protects the user and others from accidental needle sticks and the resulting risk of infection.

About 1 million needlestick injuries occur each year and if available surveillance data are correct, between 50 and 80 medical workers become infected by HIV each year, not to mention other infectious diseases like Hepatitis and the simple mental and physical discomfort associated with such injuries. Costs associated with treatment of medical workers who have experienced needlestick injuries is estimated to be $405 per treatment, which suggests the total cost of needlestick injuries could exceed $400 million per year.

Additionally, there are over 100 US and foreign patents for safety needles. The design challenge required the delivery of a unique solution, better fulfilling user needs than any existing product without infringing upon existing patents. This concept had to be applicable to all common needle sizes from 1/2” to 1 1/2”, not require significantly more needle length than current units and employ the same or similar high quantity production tooling and assembly methods. With so many safety needles on the market, the product design team knew that a unique approach, which best addressed the needs and concerns of medical customers would be critical to the immediate and long-term success of the product design.

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