According to the latest research, analysts estimated that the direct cost of quality in the medical devices industry is between 6.8% and 9.4% of sales. Global sales of medical devices reached $380 billion in 2018, which means that the direct annual cost of quality is around $30 billion!
Analysts estimated that one-third of that amount is dedicated to ensuring good quality, while the remaining two-thirds is the direct cost of poor quality.
The stakes in the medical devices market are high: a single error could have severe consequences not just for patients, but also for the companies.
Globalization brings more challenges. In order to remain competitive and stay ahead of the game, manufacturers strive to reduce costs, boost quality and customer satisfaction, and improve time-to-market.
Kitov-CorePlus offers the medical device industry a comprehensive solution for all of these challenges. Kitov-CorePlus effectively finds all defects and sets a worldwide standard for quality. Kitov-CorePlus is flexible and can be easily customized for a variety of products and assemblies by customer personnel.
Kitov-CorePlus brings Industry 4.0 abilities to the world of global manufacturing. All product and test information is recorded in a database, enabling product traceability. Data analytics tools can be applied to get statistics of defects, as well as enabling manufacturers to find the defect contributors, improve production processes and even product designs. This database can also be used for future tests to verify the quality of products that were already delivered.
OrSense is a medical devices company that develops and commercializes innovative non-invasive monitoring technologies for continuous and spot measurements of blood parameters.
The NBM 200 is a non‐invasive blood analyte monitor. It measures and displays blood hemoglobin, oxygen saturation levels and pulse rate values.
The device is manufactured by OrSense in their facility in Israel. The product is assembled, and packed after a thorough functional test and visual inspection and shipped to the end customers: clinics and hospitals
Like any medical device, quality tests are critical and OrSense has a zero tolerance policy for human errors.
Smart visual inspection has very clear advantages for such application. Not only can smart visual inspection effectively detect all possible quality issues, find the relevant defects and their root causes, it also ensures that every product complies with the highest standards.
OrSense has successfully evaluated Kitov-CorePlus. During visual inspection, the barcode of each product was read and used for product traceability. Data collected by Kitov-CorePlus can be analyzed to recognize trends related to quality issues and allow a more proactive approach towards quality. This information helps to improve the production process and product design