ALM-PLM Integration in Medical Technology How Hardware and Software Grow Together Over the Entire Product Life Cycle

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An ageing society and AI are creating new opportunities in medical technology. But only companies with integrated development processes will benefit. Why ALM-PLM integration is becoming a success factor.

An ageing society and the increase in chronic diseases such as diabetes are increasing the need for innovative treatment and therapy options. Artificial intelligence (AI) is driving this development forward and opening up additional possibilities.

At the same time, medical technology companies are faced with an increasing flood of regulations, which are also changing ever faster. Developers have to spend valuable time on documentation tasks, which is already reflected in a declining number of registered patents/innovations. In addition, there is growing product complexity, increasing pressure on margins and a volatile market in which tech giants such as Google are also establishing themselves as new competitors.

These challenges can no longer be overcome by gradually optimizing processes. What medtech companies need are efficient processes to ensure compliance and quality, more resources for innovation as well as traceability, transparency and agility. The key to this lies in an integrated product development solution that combines hardware and software, quality, manufacturing and service. The core of this solution is ALM-PLM integration.

What is an ALM-PLM Integration?

In modern medical devices, hardware and software are closely linked. However, they are usually developed, manufactured and maintained in different, separate processes and tools: Product Lifecycle Management (PLM) supports the design, configuration and lifecycle of physical components (CAD models or parts lists), while Application Lifecycle Management (ALM) manages the creation and further development of software components (requirements, code, tests and releases).

If these systems work in isolation from each other, this leads to gaps in traceability, uncoordinated releases, compliance risks and inefficient processes with longer development cycles. An ALM-PLM integration eliminates silos and enables seamless collaboration between mechanical, electrical and software systems, resulting in consistent, efficient product development and lifecycle control.

Requirements, components, code and test cases are linked across hardware and software. The result is a holistic view and transparency that enables improved collaboration, data-based insights and effective governance.

Digital Consistency Using the Example of Fresenius Medical Care

Medical technology companies that integrate their quality management systems (QMS), ERP, manufacturing execution systems (MES) and service lifecycle management (SLM) alongside ALM and PLM have also created the technological basis for a digital thread. This is particularly crucial in medical technology, where companies need to demonstrate how they make decisions and how changes affect the safety and performance of devices. They also need to ensure compliance from design to after-sales service.

Fresenius Medical Care has created its digital consistency based on the PLM software Windchill from PTC. This connects research and development with production, products and services. This breaks down data silos and enables Fresenius Medical Care to utilize the full value of its data to automate processes and achieve greater flexibility and speed with a high number of variants and quality.

"The Digital Thread gives us transparency along the entire value chain," says Christian Vogelei, Principal Capability Architect at Fresenius Medical Care. "We gain insights into how our products are manufactured and used throughout their life cycle. This in turn has an impact on product development. We can identify changes much earlier and our change management is faster and more transparent."

The main aim of the Digital Thread is to give everyone involved in the product life cycle access to precise, up-to-date and contextualized product data. This democratization of data and transparent flow of information increases product quality and efficiency while shortening time-to-market.

The relationship between research and development and production has changed fundamentally as a result of the digital thread: "There is a much better understanding of each other. Our traceability has also improved," confirms Vogelei. "In terms of regulation, reliable configuration management is crucial for me. If this is set up properly, you can easily adapt to regulatory or other changes. And once you have created a DHF (Design History File) or a DMR (Device Master Record) in Windchill at the click of a mouse, you will never want to go back to another system."

Agile and Continuous Development

PLM systems traditionally use a more structured, milestone-oriented approach, while ALM systems support Agile, CI/CD and DevOps. The integration of the systems enables agile software delivery without losing the connection to regulated hardware development.

ALM is becoming increasingly relevant with regard to software-defined products - especially in medical technology, where embedded software is subject to the same strict regulations and safety standards as hardware. Prefabricated cybersecurity solutions support compliance, while automated validation ensures consistent, verifiable tests that meet regulatory requirements.

ALM systems also enable the reuse of validated components, designs and processes. This allows companies to avoid redundant work and save time for re-validation. The result: faster development cycles as well as greater consistency and reliability.

Mastering Regulatory Complexity

The basis for compliance with legal regulations is first and foremost complete traceability throughout the entire product life cycle. With requirements and test management tools integrated into ALM and PLM systems, manufacturers create a platform to track product data, manage documentation and meet compliance requirements. This ensures complete traceability and makes documentation from concept to delivery available for audits at any time.

In addition, ALM and PLM solutions support automated conformity checks and the identification, assessment and reduction of risks throughout the entire product life cycle. This speeds up the approval process and therefore also the market launch.

A Look at Production Planning

An integrated solution comprising PLM and ALM as well as ERP and MES links design, planning and production and ensures that designs are production-ready, cost-efficient and compliant. It enables early production planning and forms the basis for the design-anywhere-and-build-anywhere approach.

"One of our biggest achievements over the past year has been that the designs are no longer tied to specific locations," says Christian Vogelei. "We can now transfer them quickly and transparently to other sites, allowing us to adapt the production location according to capacity and demand." Faster DFM (Design for Manufacturing) feedback supports efficient design transfer and ensures that process plans, work plans and parts lists are aligned with the technical changes.

A closed change cycle ensures traceability and synchronization of the teams in the further development of designs. The connection of product data with MES and ERP improves transparency, avoids duplication of work and optimizes execution.

Service as a Source of Income

Services can be a good source of income and a competitive advantage for medical technology manufacturers. However, they are often also a regulatory requirement. In both cases, coordinated and efficient processes are a must.

Service Lifecycle Management (SLM) supports this with the strategy, processes and tools to manage service, maintenance, asset tracking and post-market monitoring. Integrated SLM also connects field service teams with up-to-date product data, enabling faster and more accurate service and traceability. This helps service teams with work preparation, service documentation and spare parts planning. Closed-loop feedback feeds findings from service back to engineering and quality, speeding up product updates.

Technical Integrations Along the Digital Thread

Today, ALM solutions are often integrated with PLM solutions via common standards such as OSLC or REST-based interfaces. It is important to ensure a bidirectional interface here. This ensures that employees in development have access to information from the design.

Modern PLM solutions, on the other hand, use REST-based integration options such as OData to exchange data with MES or ERP solutions. Here too, bidirectional integration must be established in order to optimize the data flow. Ideally, the corresponding data points in PLM can be easily mapped with the data points in the ERP or MES system. Integrated functions for monitoring the data exchange enable monitoring and a quick response in the event of an error.

In order to remain competitive, it is less and less enough to offer good products. Manufacturers must also be agile, resilient and efficient enough in their core processes in order to successfully meet current and future market requirements. This requires a fundamental shift away from fragmented systems and manual processes towards integrated solutions. (heh)

*René Zölfl is Global Industry Advisor MedTech at PTC.