In the highly regulated world of the medical device manufacturer, risk management is a fundamental aspect of the product development process, and it is vitally important that “ risk thinking” is included as early in the design process as possible.
This is especially the case as today more and more complex and inter-connected devices are being produced. Increased complexity means risk mitigation becomes more onerous, and this can ultimately stifle product innovation if OEMs do not have the bandwidth or knowledge to manage risk effectively.
In the area of micro-manufacturing, where tolerances are measured in microns, risk mitigation is vital and complicated, and requires an intelligent and concerted focus.
Micro Engineering Solutions believes that risk mitigation is driven by a complete understanding of all phases of the process used to manufacture a micro medical device or drug delivery system. We help our customers get to market with optimal products in a timely fashion using a proven process that focuses on the potential micron tolerance variation at each stage of the product development process, including for example precision tooling, metrology, material drying, material lot-to-lot variation, and microfabrication.
Working with Micro Engineering Solutions is an exercise in partner selection, not job-shop selection. The micro medical device development process is intricate, and to ensure optimal design to manufacturing decisions are taken, medical OEMs — especially when looking at risk management — need to link arms with their chosen expert agency as early in the design process as possible.
In this way, partnering with Micro Engineering Solutions, customers will ensure that the most efficient, speedy, and cost-effective manufacturing process can be achieved without the need for fundamental revisions and restarts in the process.