Cybersecurity pressures intensify for medtech innovators

As cybersecurity threats continue to evolve, medical technology companies face a distinct risk profile shaped by connected devices, sensitive patient data and growing regulatory scrutiny. For medtech businesses, cybersecurity is no longer a downstream IT issue; it is increasingly embedded across product development, operations and long‑term strategy.

According to Amanda Laskey, a life sciences senior analyst at RSM US LLP, cybersecurity expectations in the medtech sector have shifted significantly in recent years, mirroring broader themes identified in the RSM US Middle Market Business Index Special Report: Cybersecurity 2026.

“The biggest trend we’ve been seeing in medtech is that cybersecurity is no longer something you think about after the product is launched,” she says. “It now starts at ideation and carries through development, approval and launch.”

Regulators now expect companies to demonstrate how cybersecurity risks are addressed throughout the product lifecycle, including how vulnerabilities will be patched over time.

This shift reflects the unique cyber exposure medtech companies face. Unlike other life sciences segments, medtech organizations must secure not only internal systems, but also connected devices, data transmission pathways and integrations with hospital and third‑party systems.

“There are just more opportunities to tap into risk,” Laskey notes, pointing to device access points, data storage environments and operational supply chains as key vulnerability areas.

Dealing with data

Patient data protection remains a central concern, too. While operational disruptions can be costly, safeguarding patient information continues to drive regulatory focus as well as threat actor interest. Medtech companies often collect large volumes of data, some of which may not yet have a defined business or clinical use.

“That data still creates a vulnerability,” Laskey says, adding that organizations must carefully assess what data they collect, retain and secure, even if its future value is uncertain.

Third‑party relationships further complicate the risk landscape. Outsourced manufacturing, distribution partners and software integrations expand the attack surface and increase dependency on vendor cybersecurity maturity. Close coordination and governance across these relationships are essential to maintaining security and compliance.

Emerging technologies such as artificial intelligence introduce both opportunity and risk as well. While AI can help analyze complex datasets and uncover insights, it also raises governance, accuracy and data‑control challenges.

“One of the most important things is working with a trusted AI provider and ensuring your data isn’t going outside your control systems,” Laskey says.

Looking ahead, product lifecycle management is becoming a critical cybersecurity theme. Regulators increasingly expect companies to plan for long‑term device support, including how vulnerabilities will be addressed as technologies age. Legacy systems that can no longer be updated pose significant risk, potentially threatening market access if patches are unavailable.