Medtech leaders warn of cyber risks
The medical technology sector is entering a year marked by intense pressures—cybersecurity threats, trade barriers, inflationary costs, and a rapid expansion of wearable devices—all while handling regulatory obstacles and persistent supply chain disruptions. At the forefront of these challenges stands Mick Farrell, who serves as chairman of AdvaMed and CEO of ResMed. Following the group’s recent MedTech Conference, Farrell outlined his strategic priorities in an interview.
His immediate focus at ResMed centers on expanding respiratory care access. The company has forged a partnership with Oura, a consumer health technology firm, to merge wearable technology with medical diagnostics. This collaboration reflects a broader industry trend: as consumer wearables proliferate, medtech companies are increasingly teaming with tech firms to embed screening and monitoring capabilities into everyday devices.
As AdvaMed chairman, Farrell’s responsibilities extend across the entire sector. The industry’s relationship with regulators, particularly the FDA and CMS, remains a defining challenge. In a private meeting with FDA leadership, including Dr. Michelle Tarver, chief of the Center for Devices and Radiological Health, Farrell and other executives urged solutions to persistent approval bottlenecks. Staffing shortages at the FDA continue to delay device reviews, while 510(k) and PMA processing times remain unpredictable. The RAPID initiative, which aims to synchronize FDA and CMS decisions on breakthrough devices, is still in development but offers potential for faster patient access.
Trade Policies Risk MedTech Supply Chain Stability
Trade policy poses another critical threat. While the White House promotes friend-shoring to relocate supply chains from adversarial nations, medtech manufacturers fear missteps could destabilize operations. Hundreds of billions in production already operate within the U.S., Mexico, and the Dominican Republic. Any tariff miscalculations could force companies to absorb costs or pass them to consumers and payers. Farrell’s team is engaging directly with the administration to advocate for medtech exemptions, arguing that the sector’s U.S.-focused production makes it a national priority.
The semiconductor shortage that strained medtech in 2021 has eased but persists. The AI boom has redirected manufacturing capacity toward GPUs and high-end chips, leaving medtech firms competing for limited supplies. While access remains possible, inflation and geopolitical disruptions, such as the Strait of Hormuz closure, have increased shipping and air freight costs. The result is higher device prices, with some cost increases filtering down to patients and insurers.
Farrell draws lessons from the COVID-19 pandemic, when ResMed chartered a plane through Air Canada to transport ventilators after commercial freight collapsed. The crisis exposed a critical vulnerability: despite the U.S. being the primary market, too few devices are manufactured domestically. The question now is whether the industry can reshore production without triggering further cost escalation.
Cybersecurity Standards Become Critical for Patient Safety
Beyond supply chains and regulations, Farrell is advancing industry-wide standards for cybersecurity, privacy, and interoperability through AdvaMed’s Digital Health Division. The effort models best practices from the fintech sector, where strict rules govern data security, ownership, and seamless system transfers. The goal is to treat patient data with the same protections as financial transactions, secure, private, and accessible only with consent.
Cybersecurity has become a boardroom priority after recent high-profile attacks on medtech firms, some linked to state actors. Farrell acknowledges that breaches are inevitable but emphasizes preparation: rapid system shutdowns, threat isolation, and uninterrupted patient care. The AdvaMed initiative aims to standardize these responses, preventing localized breaches from becoming systemic risks.
Government cybersecurity experts warned earlier this year that geopolitical tensions, particularly with Iran, would escalate threats. Those concerns have materialized, forcing medtech executives to justify cybersecurity investments not by necessity but by resource allocation. Farrell’s focus is on interoperability: devices must communicate securely, or they fail patients. The stakes have never been higher.
