Speaker: Becky Kelderman
The primary challenge facing medical device manufacturers today is, first and foremost, government regulation. The government has initiated many more traceability requirements, documentation requirements, and quality requirements that medical device manufacturers need to consider through the manufacturing processes.
A second challenge is traceability. The moment a product is delivered to manufacturing shops or to a customer, the ability to trace back all the way through the raw material supply is becoming very important.
The final challenge is cost. We all want to reduce our manufacturing costs, so being able to lean out processes, understand the documentation and traceability requirements, and implement them in an efficient, lean manner is very important in the medical device industry.
Solumina will help the medical device manufacturing industry because we offer a totally integrated package to our customers from the supplier-quality aspects where we are gathering statistical process control (SPC) and end-process quality data all the way through the traceable requirements delivered on the shop floor and ultimately to the customer for maintenance and warranty work. Solumina will give that fully traceable package not only to the customer, but to the government as well.