Medtech companies are increasing expectations on medical device manufacturers post-Covid, necessitating quicker device market entry. This shift has accelerated the need for digital commissioning in advanced manufacturing to meet tighter production timelines using virtual models and automated validation systems.

The FDA’s Case for Quality programme launched in 2011, focusing on device manufacturers improving product and process performance. The Medical Device Innovation Consortium (MDIC) joined the initiative, leading to the voluntary improvement programme (VIP) to assess manufacturing sites and encourage process advancements using digital tools like automation and process monitoring.

Andy Glaser from ATS Life Sciences Systems discusses the impact of Covid on medical equipment demand and production challenges. The convergence of priorities like time-to-market and device design overlap, creating conflicts in manufacturing. Skill availability, device complexity, and reliability concerns further complicate production processes.

In response to challenging production scenarios, digital commissioning proves beneficial in reducing risk, enhancing training, and expediting validation processes. By implementing digital tools early in manufacturing cycles, time to revenue is compressed, operational risk is reduced, and regulatory compliance is improved.

Glaser emphasizes the need for advanced digital twin models to predict device performance and design changes’ impact. By incorporating device performance simulations with machine design, manufacturers can quickly assess design changes’ impact on product quality and performance, streamlining production processes and ensuring immediate responsiveness to market demands.

Read more at Yahoo Finance: The medical device manufacturing crunch