Automation, artificial intelligence, and the changing medical manufacturing landscape

One of the most significant challenges medical device manufacturers face is managing the balance between innovation and user confidence. While manufacturers are expected to deliver cutting-edge technology and leverage artificial intelligence (AI) and automation, they must also remain sensitive to the uncertainty of users. Balancing the two is crucial, as pushing innovation too aggressively without considering user concerns can drive customers away and toward competitors, while failing to innovate poses the risk of losing customers due to potentially missing features.

Another major challenge is navigating the regulatory landscape. Manufacturers must balance the need for rapid innovation in technology without compromising on safety, data security, or quality. This means relying not only on anticipated or simulated data but also on verified and validated data meeting strict regulatory standards. For example, complying with new FDA rules and regulations is crucial, and new requirements for AI and automated systems highlight the need for a proactive and well-informed approach from manufacturers.

To stay competitive, manufacturers need to invest carefully in automation, as another one of their biggest challenges is developing flexible systems that can quickly handle low-volume validation processes and smoothly scale up to mass production. It requires a strategic balance between meeting market demands and complying with regulatory requirements.

The benefits of AI and automation balance the challenges. They enable faster product development, making it feasible to create customized solutions for individual applications. Access to more comprehensive and real-time data allows manufacturers to anticipate issues and improve product design, comfort, and life cycles while supporting continuous growth and innovation.

Automation ensures consistent high quality throughout all product phases. Whether beginning with low-volume, manual workstations or scaling to high-volume mass production, a well-implemented automation strategy ensures each stage meets strict standards without requiring questioning of the production processes and quality.

Automation even facilitates complete documentation and transparency across all major production processes. This helps with regulatory compliance and enhances internal quality assurance and customer trust.

Technology, standards, and regulation

ISO standards play an important role in defining different levels of safety and cleanliness, as well as in measuring and verifying compliance. Manufacturers are required to offer verifiable proof, usually through third-party certification, that they are complying with the necessary methods and circumstances. Automation ensures the repeatability and testing of products, documenting the full production system to maintain cleanliness and prevent pollution. Platforms such as PIA’s PIA App Suite support the validation process by providing real-time monitoring and full traceability of machine performance, process parameters, and batch controls. These systems ensure critical data is collected and stored from day one, creating a positive digital footprint for each product.

While considering regulatory specifications and requirements, AI can help manufacturers generate the data needed to identify patterns in various diseases or DNA, leading to significantly faster development and generation of antidotes. Patient and user feedback can also be analyzed more efficiently using AI.

Automation can reduce investment costs and improve process and product quality during low-volume and high-flexibility phases of product development. This can then be transferred to high-volume production without the need for additional revisions, resulting in faster assembly and testing.

From the consumer’s perspective, the increasing role of automation and AI can lead to a more personalized, efficient, and accessible healthcare process. However, manufacturers must ensure these technologies are implemented within a secure and clearly regulated framework to help combat growing concerns regarding data security and transparency.

On the positive side, AI enables more precise matching of treatments to patient needs, facilitates quicker diagnosis through image analysis, and even supports simulation for surgery planning or implant design. This requires medical devices to evolve, becoming smarter, smaller, and capable of delivering real-time feedback, while still meeting high standards for hygiene and safety.

Automation also allows global availability of consistently manufactured medical products, ensuring the same high quality regardless of location. This helps reduce time-to-market and lower production costs, making advanced medical tech more affordable and accessible to consumers.

Medical technology solutions from PIA

PIA offers several solutions for medical manufacturing. Its meditec platform is a standardized and highly adaptable solution made specifically for the production of medical devices. It offers a comprehensive range from preconfigured base cells and various process modules to full validation support, all while being integrated within a single, good manufacturing practice (GMP)-compliant platform.

Built on best practices from real-world projects, meditec combines proven solutions with customization where it’s needed. It supports all production scales, from low-volume manual workstations and semi-automated cells to fully automated high-volume.

Each aspect is optimized for GMP cleanroom environments, focusing on easy cleaning, organized supply handling, and minimizing unnecessary movement to reduce contamination risks.

The meditec platform is designed to address several key challenges in medical manufacturing, including:

• Ensuring compliance with GMP and other product-specific requirements
• Reducing time to market while ensuring safety and quality
• Providing a flexible yet standardized base that allows for innovation by complying with requirements

Several specific examples highlight the versatility and effectiveness of the meditec platform, including:

1. Autoinjector testing and inspection in Ireland, where meditec was used to build a robust system capable of reliably testing devices under strict quality control requirements.
2. An inhaler assembly line, where a semi-high-volume system was developed to produce 18 parts per minute, demonstrating meditec’s scalability and performance in respiratory product manufacturing.
3. Manual workstations for pen assembly in Germany, where meditec supported low-volume production that was later scalable for larger volumes.

Technology evolves quickly, but PIA stays ahead by using dedicated teams, each focused on different core areas such as AI, machine learning, automation, and digital engineering. By collaborating across projects, the teams build on each other’s developments and contribute to increased customer satisfaction by delivering solutions that are easy to use and fully documented.

For example, the meditec platform is continuously evolving. With every project and proof of concept, it incorporates new learnings, features, and technologies. PIA also supports customers early in the design for manufacturing (DFM) phase, ensuring even hand samples or initial concepts can be developed with scalability in mind.

PIA dives deep into each project’s execution by continually reviewing and refining its internal processes. By integrating the latest technology, including AI, PIA is able to create digital twins of its machines. This enables the programming, testing, and optimization of equipment before it’s even physically built, so what previously had to happen after assembly and part delivery can now begin as soon as the machine’s design is finalized. While final alignment is still completed on-site, the overall maturity of the machine at deployment is significantly higher than it previously was, allowing for faster commissioning, reduced downtime, and a smoother validation process, decreasing time to market.

PIA Automation
https://www.piagroup.com

About the author: Falc Borchard is VP Sales & Marketing for PIA North America.