Best Cyber Insurance Programs for Medical Device Manufacturers 2026.

01

Connected device default

FDA Class II/III medical device manufacturers with networked or Bluetooth-enabled devices, including implantables, infusion pumps, and remote monitoring devices.

• - First-party cyber at $5M to $25M sized to the post-market device fleet (not headcount).
• - Third-party cyber liability for breach of patient data, including downstream HIPAA exposure through hospital systems.
• - Product cyber endorsement on the products liability policy - responds to bodily injury or property damage from cyber-induced device failure.
• - Pre-market cyber documentation per FDA Cybersecurity in Medical Devices Guidance; coverage for post-market vulnerability disclosure and patch deployment.
• - Contingent business interruption for software supply chain failures (e.g., compromise of OS or cloud platform vendor).

Premium range: $40K-$120K annually for a Texas medtech manufacturer at $5M-$50M revenue, with active connected-device fleet.

02

Legacy device manufacturer (no connected fleet)

Class I/II manufacturers with mechanical, non-networked devices: surgical instruments, single-use kits, mechanical implantables.

• - Lighter cyber program at $2M to $10M, sized primarily to internal operational exposure (HR systems, ERP, design IP).
• - No product cyber endorsement needed; products liability stays clean of cyber-driven claims.
• - Standard HIPAA business associate framework if the manufacturer handles any patient data through customer service or sales operations.
• - Lower premium but with the structural question: when does the manufacturer move to a connected device platform, and what triggers the program upgrade.

Premium range: $15K-$40K annually for legacy device manufacturers at similar revenue range.

03

Software-as-medical-device (SaMD) manufacturer

FDA-cleared software-only medical devices, including diagnostic imaging AI, clinical decision support, and digital therapeutics.

• - Heaviest cyber program in the medtech segment; $10M to $50M first-party and third-party.
• - Errors and omissions / professional liability for software defects, separate from products liability.
• - Cloud platform contingent coverage critical because SaMD usually runs on third-party cloud infrastructure (AWS, Azure, GCP).
• - Cyber product liability endorsement for clinical decision errors driven by AI/ML model behavior; underwriting now actively asks for model governance documentation.

Premium range: $80K-$250K annually depending on SaMD risk class and clinical use category.

04

Contract manufacturer (CM) for medical device

Contract manufacturers producing medical devices for OEMs, with limited direct PHI exposure but high IP/trade secret exposure on customer design files.

• - Cyber sized to the customer IP exposure on systems - design file confidentiality, manufacturing process IP, and customer regulatory submission data.
• - Standard third-party limits at $5M to $10M; first-party heavy on ransomware and operational interruption (a CM ransomware event halts production for every customer simultaneously).
• - Contractual cyber required by OEM customer agreements - most OEMs now require named cyber coverage in the CM contract.
• - Specific endorsements for design file confidentiality breach and customer DFAR/ITAR data exposure where applicable.

Premium range: $25K-$80K annually for a CM at $10M-$50M revenue.

05

PHI-handling device manufacturer

Manufacturers whose devices generate or store identifiable patient data the manufacturer can access - cloud-connected monitoring, telehealth devices, in-clinic AI platforms.

• - Highest exposure category by dataset size. Manufacturer is a HIPAA covered entity or business associate depending on data flow.
• - Cyber at $25M to $100M; sized by patient count under management.
• - OCR breach response coverage including dedicated OCR investigation defense.
• - Contingent business interruption for cloud platform failures; specific endorsements for ransomware affecting device fleet operability.
• - Required by most hospital customer agreements as named coverage with hospital as additional insured for breach notification.

Premium range: $100K-$400K annually depending on patient count and cloud platform stack.