Development of a Medical Product

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.

The electrical block diagram for the portable oxygen concentrator, see the image on the left, represents the control architecture of a sophisticated development of a medical product, for control of everything from internal motors, pumps, solenoids and sensors, to power management of the onboard battery recharging system and user interface in the form of a membrane keypad, LCD and LED displays.