Some of our consultants come out of the medical device industry in the US, Taiwan, and China. The most common issues we work on are listed below:
Quality issues stemming from poor management or lack of understand of standards & regulations. Lack of detailed test plan and/or statistical process control, ineffective corrective actions.
Rising costs due to poor organization of production, excessive office costs (while competition from local suppliers is increasing).
Here are typical ways we work with medical device manufacturers.
Respect of specifications is extremely important for medical device manufacturers. You want to avoid Inconsistent quality as well as early field failures. We can help you put in place statistical process control and a strong quality system.
You have probably purchased expensive equipment. A common problem in China is poor maintenance (waiting until it is broken to work on repairs), and it impacts costs as well as quality and delivery times. Our engineers can put a strong preventive maintenance program in place that keeps your equipment up and running.
Are you suffering from increasing price competition from local manufacturers? You need to increase efficiency. We can achieve that goal by re-arranging production lines and applying industrial engineering tools, as part of a wide lean manufacturing program.
In case your NPI process is insufficiently structured and causes issues, our engineers can come and help set up an NPI process that makes sense in your company. This way you will develop products faster and more efficiently.
Are your suppliers the source of certain quality issues? You can hire CMC to implement a strong quality system in their operations. This way you don’t need to spend a lot of time checking, reworking, or sending back their components. You can receive better quality, nearly often on time, and avoid disrupting your operations.
Overall, CMC helps medical device manufacturers improve their product quality while reducing costs (or increasing capacity without any further investment).
2 most relevant practice areas: