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ASK THE EXPERT

René Zöelfl is the Global MedTech Industry Advisor at PTC. With deep expertise in guiding MedTech companies through digital transformation and regulatory complexity, he serves as chair of PTC’s Healthcare Executive Advisory Council. Rene is an active member of ISPE and contributed to the Pharma 4.0 Special Interest Group and the acatech Industrie 4.0 Maturity Index. He brings extensive experience in digital thread, digital twins, and AI, helping organizations enhance innovation, streamline operations, and ensure compliance across the product lifecycle.

The MedTech industry is under growing pressure to innovate faster, ensure compliance, and deliver exceptional patient outcomes – while navigating increasingly complex global regulations and rising market expectations. To meet these demands, leading organizations are embracing the Intelligent MedTech Lifecycle: a unified, data-driven approach that breaks down silos and drives agility across the entire product journey.

So, how can MedTech companies evolve from disconnected systems and processes to an integrated, insight-rich lifecycle? According to Rene Zöelfl, Global Industry Advisor Life Science at PTC, eliminating functional silos accelerates time to market and fosters cross-disciplinary innovation. MedTech product teams and organizations must build a model-based enterprise that serves as the foundation for advanced analytics, automation, and AI-driven insights. By integrating service and post-market feedback into the product lifecycle enables continuous improvement, regulatory traceability, and enhanced user satisfaction.

We asked Mr. Zöelfl about the current market conditions and how data-supported technology can help reduce cost, speed innovation, and improve quality and compliance processes.

MTI:  What are the key drivers behind rising operational costs for MedTech manufacturers today?

Zöelfl: Rising operational costs for MedTech manufacturers are being driven by a combination of global supply chain disruptions, regulatory pressures, and increasing complexity in both product design and workforce needs. The cost of raw materials and components—such as biocompatible plastics, surgical-grade metals, and semiconductors—has surged due to shortages and global volatility.

At the same time, compliance with evolving regulatory standards like the EU MDR and FDA’s harmonization with ISO 13485 demands extensive documentation, testing, and re-certification, all of which add significant overhead. Labor costs are climbing, particularly for specialized roles in engineering, quality assurance, and regulatory affairs and in general driven inflation and higher costs of living. Additionally, intricate device designs often require custom tooling and longer production cycles, which reduce efficiency and increase costs.

Logistics and freight expenses have risen due to global transportation challenges, while energy and utility costs continue to escalate. Low production volumes and inefficiencies, such as scrap and rework, further inflate per-unit costs.

Finally, post-market support, including servicing, repairs, and warranty management, adds ongoing operational burdens that are often underestimated. Together, these factors are putting sustained pressure on margins across the MedTech manufacturing landscape.

MTI: How can digital transformation help MedTech companies manage or reduce costs without sacrificing quality or compliance?

Zöelfl: Digital transformation enables MedTech companies to manage and reduce operational costs without compromising quality or compliance by streamlining processes across engineering, production, operations, service, and the supply chain. By automating workflows and leveraging digital data throughout the product lifecycle—through tools like Application Lifecycle Management (ALM), Product Lifecycle Management (PLM), and Service Lifecycle Management (SLM)—organizations can optimize efficiency and reduce manual errors. Comprehensive quality management systems allow all stakeholders to collaborate on the same data in real time, ensuring alignment, reducing rework, and maintaining compliance.

Additionally, IoT-connected devices and cloud infrastructure enable predictive analytics that forecast equipment failures, allowing for proactive maintenance and minimizing costly disruptions. Remote service capabilities further reduce the need for on-site interventions. These digital strategies also enhance service delivery, improve after-sales visibility, and increase service contract attachment rates, ultimately lowering costs while safeguarding product performance and brand reputation.

Finally, software solutions deployed as SaaS enable MedTech companies to reduce infrastructure and maintenance costs while ensuring scalability, continuous compliance updates, and high-quality performance across global operations. Additionally, AI and generative AI technologies can automate routine tasks, optimize supply chain decisions, and support regulatory documentation, helping companies maintain compliance and quality while significantly lowering operational overhead.

MTI: What role do connected product data and an Intelligent Product Lifecycle play in improving cost efficiency across the product lifecycle?

Zöelfl: Connected product data and the digital thread—central to an Intelligent Product Lifecycle—play a critical role in improving cost efficiency across the MedTech value chain. By enabling a seamless flow of data across all stages of the product lifecycle, from design and development to manufacturing, service, and end-of-life, companies can ensure traceability, maintain a continuous chain of custody, and push changes downstream effortlessly.

A unified digital thread, supported by a strong internal ecosystem and deeply integrated portfolio, empowers MedTech organizations to reduce manual overhead, boost team productivity, and accelerate standardized product development processes. This approach breaks down silos, enhances cross-functional collaboration, and drives operational excellence at scale. Ultimately, it allows companies to innovate more efficiently while maintaining compliance and controlling costs. The digital core empowered by the digital thread sets the foundation for the use of (generative)AI. AI and generative AI further amplify the benefits by unlocking predictive insights from product and operational data, automating documentation and reporting tasks, and enabling intelligent decision-making across the lifecycle—from R&D to post-market surveillance—helping MedTech companies stay agile, compliant, and cost-effective.

MTI: Where should MedTech leaders prioritize investment to have the biggest impact on cost control and margin protection?

Zöelfl: To drive cost control and protect margins, MedTech leaders should prioritize investment in two critical areas: Supply Chain and Manufacturing Excellence and Digital Transformation with AI Adoption. On the supply chain front, automating and outsourcing warehousing and logistics can significantly reduce overhead, while building end-to-end visibility through digital tools and control tower solutions enhances agility and responsiveness. Additionally, bringing critical processes like sterilization in-house can improve resilience and reduce dependency on external partners. On the digital front, deploying digital twins and agile quality management systems uniting all stakeholders along a product lifecycle helps cut development time and costs. Leveraging AI and machine learning for automating tasks and workflows, predictive modeling in procurement, supply chain management, and Service Parts Inventory can enable smarter, faster decisions.

MTI: Are there any examples or success stories of MedTech organizations effectively navigating cost pressures through technology?

Zöelfl: Fresenius is a great example. A fragmented setup of siloed systems, independent sites, and manual, paper-based processes  was causing delays, compliance risks, and made collaboration and design transfer difficult across R&D and manufacturing. Fresenius Medical Care traded in paper-based silos for Digital Product Development.

Join Rene Zöelfl and MTI Webinars on November 12, 2025 to hear how moving from silos to synergy can help build your MedTech Lifecycle Intelligence.

The post Managing MedTech Cost Pressures With Data-Driven Lifecycle Intelligence appeared first on MedTech Intelligence.