The global electronics supply chain has always run in cycles — tight supply followed by sudden gluts — but in recent years, the pace and scale of disruption have accelerated. From semiconductor shortages to shifting trade policies and pandemic-driven bottlenecks, OEMs across every sector have been forced to rethink how they source and secure critical components.
For medical device manufacturers, the stakes are even higher: design timelines are long, regulatory pathways rigid, and the margin for error slim when patient safety depends on continuity of supply. To better understand both the historical ebb and flow of electronics availability and the outlook for the years ahead, Medical Design Briefs spoke with Ross Valentine, Anal Dharamshi, and Srinivasan Kandaswamy, experts in supply chain and design engineering at Arrow Electronics and its subsidiary eInfochips. These insights highlight strategies medical OEMs can adopt to balance cost, resilience, and innovation in an increasingly complex supply environment.
MDB: Supply chain cycles have long affected consumer and industrial electronics. What lessons from those historical ebbs and flows are most relevant for medical device manufacturers today — especially those designing life-sustaining products with strict regulatory requirements?
Ross Valentine: While cost optimization should always be a function of supply chain, the ultimate criterion of success is the ability to ensure uninterrupted supply of essential products, even during global disruption. As we’ve seen through a pandemic, geopolitical instability, natural disasters, and unforeseen demand surges, strategic supplier partnerships that can be relied upon during crises are one of your most important assets. Furthermore, the lifecycle of healthcare products is often long, requiring companies to continuously adapt supply chain models well after product launch. A “one and done” approach is insufficient.
Today, medical device manufacturers find themselves revisiting and refining their supply chain models for any given component throughout the product lifecycle. To do this effectively, they must shift their perspective on supplier relationships, treating suppliers as strategic partners rather than just companies at the other end of a purchase order. In an industry that helps save lives, it's imperative to prioritize reliability and resilience over cost considerations, even when facing margin pressure.
Anal Dharamshi/Srinivasan Kandaswamy: Medical device manufacturers can draw critical lessons from past electronics supply chain cycles:
- Supply resilience must be embedded in the early design phase, selecting components not just for performance, but also long-term availability, multi-source options, and cross-qualification potential. Alternate BOMs, verified early through risk-based testing, prevent downstream redesigns that can delay regulatory filings or service continuity for life-sustaining devices.
- Component lifecycle intelligence — tracking obsolescence forecasts and using lifecycle management tools — can help anticipate supply disruptions early and support proactive redesign within regulatory constraints.
- Close collaboration with supply-chain partners provides visibility into upstream inventories, raw-material availability, and lead-time trends, allowing for better forecasting and allocation planning.
- Robust change control and traceability systems ensure that component substitutions or redesign can be validated, documented, and approved efficiently, which is critical for Class II/III devices where regulatory compliance and patient safety are non-negotiable.
MDB: The pandemic placed extraordinary pressure on healthcare supply chains. How did electronics suppliers help medical device companies secure critical components at that time, and what structural changes in sourcing or inventory strategy remain in place as a result?
Valentine: From my view, perhaps the most important learning was the agreed importance of supply chain as a competitive advantage rather than a back-office function or cost center. What we saw firsthand at the beginning of the pandemic was companies, suppliers, distributors, and manufacturers coming together with a shared purpose to address shortages of life-saving equipment such as ventilators. This demonstrated that a more collaborative supply ecosystem could achieve remarkable outcomes at unprecedented speed. This has carried over today through closer partnerships and more open communication. End-customers now provide suppliers with greater visibility into demand through long-term forecasts (often spanning 24 months), which then enables suppliers to reserve capacity, pipeline materials, and align their operations to the needs of the industries they serve. All these practices are helping create more transparent, resilient supply chains that are better equipped to combat the unknown.
MDB: Semiconductor shortages made headlines, but many medical device delays were tied to less visible components such as sensors, passives, and power modules. Which categories do you see as the most fragile today, and how should medical OEMs prepare?
Valentine: While high-end semiconductors are the backbone of modern electronics and often dominate headlines, it’s a very valid point that lesser known, seemingly insignificant components can become critical bottlenecks. Rather than talk about specific commodity risks, more fundamentally, the bigger challenge is the lack of visibility some device manufacturers have into the third-party modules and subassemblies that go into their products, and the smaller, discreet components that comprise those modules and subassemblies. Companies can easily lose sight of the granular details, and that’s where supply chains can become compromised.
These granular components, often overlooked due to their low value, can have a disproportionate impact on production timelines and product delivery when supply chain disruptions occur. Derisking the supply chain doesn’t need to be costly — as we often see, having a buffer for a $1 part can mitigate revenue impact of $1 million. Rather than focusing solely on high-cost commodities that are often already well-managed, device manufacturers must also analyze the long tail of less expensive parts, prioritizing transparency and traceability to ensure every component, no matter how small, is accounted for.
MDB: Medical device developers often face long design and regulatory cycles. How should they think about dual sourcing, alternate part approval, or inventory strategies — given that design changes can trigger requalification and regulatory hurdles?
Valentine: In a highly regulated industry such as medical device manufacturing, the foundation is reliable, up-to-date part data to give design engineers and procurement managers a 360-degree view of every component, including important details like years to end of life, country of origin/diffusion, and tariff impacts. This data helps companies make informed decisions early in the product design and NPI process, ensuring that parts selected not only satisfy regulation, form, fit, and function, but also mitigate risks like sole sources, long lead times, and material allocations.
By maintaining a data-enriched approved vendor list (AVL) and approved component list (ACL), companies also can get ahead of lengthy supplier and part qualifications, enabling them to adapt quickly to change. For example, knowing which parts are pin-to-pin matches versus those requiring rework allows for seamless substitutions, reducing risk of delays. Together, these strategies ensure medical device manufacturers are not only prepared for today’s challenges but also positioned for the future.
Dharamshi/Kandaswamy: Medical OEMs can avoid costly redesigns and regulatory delays by embedding supply assurance into design and quality systems. A risk-based, modular, and data-driven approach to dual sourcing, alternate qualification, and inventory planning ensures that long-lifecycle, life-sustaining devices remain compliant, manufacturable, and uninterrupted even under volatile supply conditions:
- Integrating Supply Resilience into Design Control. Dual sourcing and alternate-part planning must begin during the design phase, not after release. Identifying high-risk components early on, such as sensors and microcontrollers, will enable qualification of at least one alternate part that meets identical form, fit, and function criteria. Including this data in the design history file (DHF) and device master record (DMR) will ensure regulatory traceability and provide flexibility when disruptions occur.
- Minimizing Requalification Through Robust Design Architecture. Medical devices benefit from modular and standardized design architectures that isolate the impact of component changes. Using common footprints, standardized communication interfaces, and interchangeable module designs is conducive to substitution within a confined subsystem rather than the entire device. This approach reduces the scope of verification and validation testing when alternate components are introduced. A risk-based evaluation aligned with ISO 14971 can further ensure that substitutions maintain the device’s safety and performance without triggering extensive regulatory reapproval.
- Strategic Inventory and Lifecycle Management. Maintaining safety stock for high-risk components and executing lifetime buys for parts nearing obsolescence can secure long-term supply continuity. Vendor-managed or consignment inventory models help balance availability with cost, especially for long-lead-time items or high-value components. Continuous lifecycle monitoring — tracking lead times, EOL notices, and supplier reliability — enables medical OEMs to align inventory planning with regulatory and manufacturing schedules.
MDB: Arrow has been advancing predictive analytics, digital twins, and visibility platforms. How can these digital tools help medical OEMs better forecast demand, prevent obsolescence issues, and secure continuity of supply in mission-critical products?
Valentine: Leveraging systems and processes that lean heavily into data analytics, Arrow and other companies are moving beyond table stakes operational insights, such as forecast accuracy and on-time delivery, to incorporate macroeconomic factors like geographic exposures, provenance, and risk mitigation. This expanded visibility allows companies like Arrow to anticipate disruption and proactively eliminate vulnerabilities. Being able to simulate scenarios and establish contingency plans, both speculatively and in response to real events, can mean the difference between revenue-generating production and costly shutdowns. Companies need to embrace such technology and partners to optimize their supply chains, designing supply chain networks that are not only efficient but also built with contingencies and optionality.
Dharamshi/Kandaswamy: Digital tools like predictive analytics, digital twins, and visibility platforms enable medical OEMs to predict problems, plan ahead, and stay compliant. Machine learning algorithms can predict the probability of a component shortage or obsolescence event months in advance for early risk mitigation, alternate qualification, lifetime buys, or supplier diversification. When combined with digital twins of product architectures, OEMs gain a closed-loop system that links design, sourcing, and operations — allowing for precise scenario modeling and faster regulatory assessment of component substitutions:
- Predictive Analytics for Better Forecasting. Predictive analytics help medical device companies understand future demand and supply risks. By analyzing data including past orders, supplier performance, and lead times, these tools can model early signs of part shortages or delivery delays.
- Using Digital Twins for Lifecycle and Obsolescence Management. For medical OEMs, digital twins offer real-time visibility into each component’s availability, lifecycle stage, and risk of obsolescence. When a supplier discontinues a part or a new regulation affects compliance, the digital twin can simulate the impact and help engineers plan design updates or alternate sourcing before production is affected.
- Enhancing Supply Chain Visibility Across Tiers. Visibility platforms merge data from different suppliers and logistics partners, helping manufacturers track where parts come from, how long deliveries take, and what risks exist in different regions. For regulated products, this transparency also supports traceability and compliance with standards such as FDA or EU MDR, helping teams respond faster to supply chain issues.
MDB: Medical device companies operate under cost pressure but cannot risk disruptions in critical components. How do you counsel them to strike the balance between cost efficiency and supply chain resilience, and has the industry’s willingness to pay for resilience shifted?
Valentine: The industry has begun to recognize resilience as a necessity, and willingness to invest is growing. Recent disruptions have shed light on models such as just-in-time production, revealing vulnerabilities during periods of constraint. Striking a balance between cost and resilience requires a shift in mindset away from short-term savings and toward long-term differentiation. By deploying a “plan for every part” process, companies can assign an appropriate supply chain model to each component based on characteristics and risk factors, ensuring higher-risk components are safeguarded while optimizing cost for other components.
Whether triggered by disruption or tariffs, panic buying has ultimately led to surplus and obsolete inventory for many companies. Such inefficient and costly situations can be avoided by using data to better forecast what high-risk components to buffer and to ensure that production is never held up by low-value components. Additionally, maintaining regional squared sets of parts for bill of materials allows companies to build a predetermined number of products even if global supply chains come to a halt for a period. This proactive approach not only minimizes working capital investment but also helps hedge supply chains against future disruption.
MDB: With healthcare increasingly dependent on advanced sensors, wireless modules, AI-enabled processors and miniaturized power solutions, what emerging technologies could become future pinch points? Which innovations might strain supply chains the way semiconductors did in recent years?
Valentine: As one example, a macro concern is the growing demand for advanced silicon, driven by hyperscalers that build and manage data centers to support AI models. Broadly, technology is becoming more ubiquitous across industries. As the need for advanced technology grows, the healthcare industry must prepare for a future where competition for electronic components will only intensify. This calls for a collaborative approach, working closely with suppliers to forecast demand, secure capacity, and prioritize critical applications — and the time to act is now. By anticipating challenges and building robust strategies, the industry can turn potential constraints into opportunities for growth and leadership in a rapidly evolving technological landscape.
Dharamshi/Kandaswamy: Future pinch points for medical device OEMs will likely arise from AI silicon, MEMS sensors, miniaturized power electronics, and wireless connectivity modules — each requiring specialized manufacturing ecosystems and extended regulatory validation. Proactive lifecycle management, supplier diversification, and digital supply-chain intelligence will be essential to prevent the next semiconductor-style disruption in the medical technology sector:
- AI-Enabled and Edge Processing Chipsets. The rapid adoption of AI/ML processors and edge inference SoCs in next-generation medical devices (patient monitors, diagnostic imaging, and wearables) is creating new dependency clusters. These chips require advanced nodes (5-10 nm), specialized packaging, and high compute density similar to automotive and consumer AI markets. Limited fabrication capacity and long lead times could mirror the semiconductor crunch, especially for FDA-cleared platforms where alternate silicon cannot be easily requalified.
- Advanced Sensor Ecosystem. Medical devices increasingly rely on MEMS-based sensors, bio-signal transducers, and multi-parameter sensing modules (temperature, SpO₂, pressure, accelerometers). As these become more application-specific and integrated with embedded AI, sourcing challenges will emerge due to custom calibration, sterilization compatibility, and traceability requirements. Supply tightness in sensor-grade silicon wafers and ASIC interfaces could represent the next high-risk pinch point.
- Miniaturized and High-Efficiency Power Solutions. Emerging GaN and SiC power devices, high-density batteries, and precision power management ICs are essential for portable and implantable medical systems. However, limited global capacity for substrates and epitaxy wafers — along with stringent reliability validation — can lead to long qualification cycles. OEMs depending on niche power technologies may face bottlenecks in sustaining IEC 60601-compliant designs if vendors reprioritize production for automotive or EV markets.
- Wireless Connectivity and RF Modules. The shift toward IoMT (Internet of Medical Things) has increased reliance on Bluetooth Low Energy, Wi-Fi 6, and 5G medical-grade modules. These modules integrate high-performance RF components that are subject to export controls, spectrum regulation, and material shortages (e.g., rare-earth elements for filters and antennas). Any change in these modules can trigger full requalification under EMC and wireless standards (ETSI/FCC), making them a critical supply-chain risk area.
- Specialized Materials and Packaging Technologies. Miniaturization drives demand for biocompatible polymers, advanced ceramics, and hermetic packaging materials. Constraints in material purity, sterilization tolerance, and long supplier validation cycles may strain production. Furthermore, geopolitical pressures on rare metals used in sensor electrodes and capacitors could mirror semiconductor-style disruptions.
MDB: What leading indicators or market signals should medical device companies be monitoring to anticipate supply chain issues before they become crises?
Valentine: Geopolitical factors, such as trade agreements and restrictions on rare earth minerals, can have a profound impact on the availability of critical components. By staying informed about these developments, companies can proactively adjust sourcing strategies and diversify their supply chains. Factors like tracking outbreaks and pandemics serve as vital demand indicators, enabling businesses to anticipate surges in medical device needs and prepare accordingly. Technological advancements also play a crucial role in shaping supply chain dynamics. Monitoring capacity constraints and understanding the verticals competing for the same resources, such as hyperscalers, can help medical device companies strategize and secure their share of critical components. By leveraging data and analytics to track these signals, businesses can build resilient supply chains that are prepared for both immediate challenges and long-term shifts.
Arrow Electronics (NYSE:ARW) sources and engineers technology solutions for thousands of leading manufacturers and service providers. For more information, visit here . eInfochips, an Arrow Electronics company, is offers digital transformation and product engineering services. For more information, visit here .
