Image to implant solution for personalised medical devices

PLM (product lifecycle management) software enables a regulatory-compliant, cost-effective and streamlined process chain for planning, design and manufacture of patient-matched medical devices.

The demand for more “personalized” orthopedic treatments and therapies is growing rapidly. With the help of today’s integrated design, manufacturing and data management software technology, medical device manufacturers are now able to design and produce personalized orthopedic therapies optimized for an individual patient, making “personal” orthopedic medicine more widely accessible.

Early-stage identification and resolution of quality issues via an integrated PLM platform

The medical device industry is facing many challenges as global competition is increasing and healthcare systems worldwide are demanding proven efficacy and the highest possible quality in production outputs. In addition, research and development (R&D), manufacturing and supply chains are becoming increasingly global, which makes managing quality controls much more difficult.

In order to meet these demands, medical device companies must manage quality throughout all phases in the product lifecycle and adhere to rigorous system regulations, all while remaining inherently focused on innovation.

Across the industry, investments in medical device quality management have typically focused on late-stage quality documentation and inspection processes, as mandated by regulations. However, this practice of late-stage identification and resolution leads to delayed product launches, reduction in speed to market and, in some cases, product recalls.

Proactive, as opposed to reactive, medical device quality control systems must become the new norm. Companies in today’s marketplace must do more than merely comply with regulations – they must develop an integrated approach based on “Quality by Design” philosophy. Through the integration of quality management processes into product lifecycle management (PLM), product issues can be identified and resolved during early-stages, when correction can be handled in a much more cost-effective and efficient manner.

Integrated Systems in Medical Device Quality Management

Medical device companies must view quality management in a new light, by designing quality into medical devices during the initial stages of product development, as opposed to ensuring quality during later phases. By eliminating the dependency on re-work cycles which occur when system controls detect an issue later in the product lifecycle, innovation and speed can a become more central element in the overall design and manufacturing process.

Our Integrated Quality solution unites all the phases in medical device quality management processes. By enacting early-stage quality control processes which isolate and correct quality issues as quickly as possible, worst-case scenarios can be avoided, benefiting both the device manufacturer and the consumer alike. Furthermore, Integrated Quality recognizes the need for key elements in a closed cycle quality system that support processes such as corrective and preventative actions (CAPA) and change control within R&D processes.