INDUSTRY FACT FILE · MEDICAL DEVICES & MEDTECH

Five New Case Studies in Medical Device Security

Original 2026 case studies, each written as a blog post, showing how current threats play out for medtech companies and how Codec Networks services break the attack chain.

In this document 1.  About these case studies 2.  Case Study 1: The Monitor That Phoned Home 3.  Case Study 2: The Update Server That Shipped Malware 4.  Case Study 3: The Debug Port on the Production Board 5.  Case Study 4: The Remote Monitoring Cloud With One Key 6.  Case Study 5: The Export Submission That Came Back

These five case studies were written for this document set and have not been published elsewhere. Each is a composite scenario combining weaknesses and control failures widely observed in medical devices with the regulatory expectations that apply as of October 2026—in particular the Medical Devices Rules, CDSCO's software guidance, US FDA section 524B, the EU MDR and CERT-In's Directions.

Important disclosure The organisations described are fictional and the scenarios are illustrative. They are not accounts of real incidents, and they are not Codec Networks client engagements or claims of achieved outcomes. Their value lies in showing how connected weaknesses form an attack chain, which controls break it, and which services test those controls.

Case study	Company type	Core threat	Regulatory lens	Primary bundles
1. The Monitor That Phoned Home	Patient monitor manufacturer	Hidden function in a third-party module	Medical Devices Rules; FDA; EU MDR	B1, B9, B4
2. The Update Server That Shipped Malware	Connected device manufacturer	Compromised update infrastructure	FDA 524B; EU MDR; CERT-In	B2, B3, B8
3. The Debug Port on the Production Board	Wearable device start-up	Debug interface and shared keys	Medical Devices Rules; DPDP	B1, B2, B5
4. The Remote Monitoring Cloud With One Key	Remote monitoring platform	Shared API key and broken authorisation	DPDP; CERT-In	B2, B3, B6
5. The Export Submission That Came Back	Diagnostic equipment manufacturer	Insufficient cybersecurity evidence	FDA 524B; EU MDR; CDSCO	B4, B2, B5

The manufacturer didn't write the code. Customers still held it responsible.

At a glance
Organisation	A patient monitor maker (“OEM A”) using a third-party communications module
Threat	An undocumented remote connection in a supplier's module
Why it is new	Third-party components can hide functions the OEM never sees
Codec Networks services	Firmware analysis, supplier assessment, regulatory evidence (Bundles B1, B9, B4)

The scenario

OEM A integrated a communications module from a supplier to speed up development.

A hospital customer's security team noticed the monitors attempting connections to an unknown external address.

Analysis found an undocumented remote-access function in the module. OEM A had to inform customers and regulators and plan a field action.

Figure 8: Illustrative attack path for Case Study 1 and the controls that break it.

What went wrong

• No SBOM covering the module's software.
• Firmware was not analysed before release.
• Network behaviour was not tested.
• Supplier contracts lacked security requirements.

The impact

OEM A faced a field action, customer distrust and regulatory scrutiny in several markets.

The regulatory lens

• Medical Devices Rules: manufacturer responsibility for device safety and performance.
• US FDA and EU MDR: cybersecurity and component transparency expectations for marketed devices.
• CERT-In Directions: reporting of related incidents within six hours where applicable.

How Codec Networks would help

Need	Codec Networks response	Bundle
Analyse firmware	Firmware and network behaviour analysis	B1
Assure suppliers	Supplier security assessment and requirements	B9
Support regulators	Regulatory communication and evidence	B4

Key lessons Know every component (SBOM). Analyse firmware before release. Test what devices connect to. Put security in supplier contracts.

The devices trusted anything that came from the update server.

At a glance
Organisation	A maker of connected home-care devices (“OEM B”)
Threat	A tampered firmware image uploaded to a poorly protected update server
Why it is new	Whoever controls updates controls the fleet
Codec Networks services	Secure update review, infrastructure hardening, incident response (Bundles B2, B3, B8)

The scenario

OEM B's update server used a weak admin password and had no monitoring.

An attacker uploaded a modified firmware image. Devices accepted it because firmware signatures were not verified.

Field units began malfunctioning. OEM B had to stop updates, investigate and notify regulators and customers.

Figure 9: Illustrative attack path for Case Study 2 and the controls that break it.

What went wrong

• Firmware was not signed or verified at boot.
• The update server was weakly protected.
• No staged rollout or rollback.
• No product incident plan.

The impact

OEM B faced a recall-scale response, regulatory notifications and reputational harm.

The regulatory lens

• US FDA 524B: design controls and processes to provide updates and patches.
• EU MDR: IT security within safety requirements.
• CERT-In Directions: incidents reported within six hours.

How Codec Networks would help

Need	Codec Networks response	Bundle
Secure updates	Signing, verified boot and update design review	B2
Harden servers	Update infrastructure review	B3
Respond	Product incident response	B8

Key lessons Sign firmware and verify at boot. Harden and monitor update servers. Stage rollouts with rollback. Plan for product incidents.

The researcher needed a few wires and an afternoon.

At a glance
Organisation	A wearable device start-up (“Start-up C”)
Threat	An enabled debug port allowing extraction of firmware and a fleet-wide key
Why it is new	Development shortcuts often survive into production
Codec Networks services	Hardware testing, identity review, secure lifecycle (Bundles B1, B2, B5)

The scenario

Start-up C's production boards still had debug interfaces enabled to simplify manufacturing tests.

A security researcher connected to the port, extracted firmware and found a single key used by every device.

With the key, cloned devices could impersonate genuine ones to the cloud. The researcher disclosed the issue.

Figure 10: Illustrative attack path for Case Study 3 and the controls that break it.

What went wrong

• Debug interfaces were enabled in production.
• One key was shared across all devices.
• No hardware security testing before launch.
• No disclosure process was in place.

The impact

Start-up C had to redesign provisioning, rotate keys and reassure customers and investors.

The regulatory lens

• Medical Devices Rules: device safety and performance obligations.
• DPDP Act and Rules: safeguards for user data once provisions commence.
• Export markets: design controls and identity expectations.

How Codec Networks would help

Need	Codec Networks response	Bundle
Test the hardware	Hardware and debug interface testing	B1
Fix identity	Unique keys and provisioning review	B2
Formalise the lifecycle	Secure lifecycle and disclosure process	B5

Key lessons Lock debug ports in production. Give every device a unique key. Test hardware before launch. Set up disclosure early.

The key was meant to be secret. It was inside every copy of the app.

At a glance
Organisation	A home-monitoring platform (“Platform D”) collecting readings from thousands of patients
Threat	A shared API key extracted from the companion app and used to query patient readings
Why it is new	Platforms aggregate patient data at scale
Codec Networks services	Mobile app and API testing, cloud review, data protection (Bundles B2, B3, B6)

The scenario

Platform D's devices and app authenticated to the cloud with one shared API key.

An attacker extracted the key from the mobile app and found the API did not check which patient's data was requested.

Readings for many patients were downloaded before the issue was reported.

Figure 11: Illustrative attack path for Case Study 4 and the controls that break it.

What went wrong

• A shared API key instead of per-device identity.
• No object-level authorisation.
• Secrets embedded in the app.
• No monitoring of unusual API usage.

The impact

Platform D faced breach reporting, regulatory scrutiny and a platform redesign.

The regulatory lens

• CERT-In Directions: incidents reported within six hours.
• DPDP Act and Rules: safeguards and breach intimation once provisions commence.
• Device regulations: where the platform is part of a regulated device system.

How Codec Networks would help

Need	Codec Networks response	Bundle
Test the app and API	Mobile app and API testing	B2
Fix the cloud	Device identity and cloud review	B3
Protect patients	Patient data protection programme	B6

Key lessons Use per-device identities. Authorise every request by patient. Keep secrets out of apps. Monitor API usage.

The device was ready. The paperwork was not.

At a glance
Organisation	An Indian diagnostic equipment maker (“OEM E”) entering the US market
Threat	A premarket submission lacking a threat model, SBOM and test evidence
Why it is new	Cybersecurity evidence is now part of market access
Codec Networks services	Threat modelling, SBOM, secure lifecycle (Bundles B4, B2, B5)

The scenario

OEM E prepared a US premarket submission for a connected analyser, focusing on clinical performance.

The cybersecurity section had no threat model, no SBOM and limited test evidence.

The submission was not accepted for review, delaying launch by months while OEM E built a product security programme.

Figure 12: Illustrative attack path for Case Study 5 and the controls that break it.

What went wrong

• No threat model traceable to risk files.
• No SBOM.
• Limited penetration testing evidence.
• No vulnerability management plan.

The impact

OEM E lost months of market access and had to invest urgently in product security.

The regulatory lens

• US FDA 524B: cybersecurity plan, SBOM and design controls required for cyber devices.
• EU MDR: IT security documentation for CE marking.
• CDSCO software guidance: cybersecurity expectations for device software in India.

How Codec Networks would help

Need	Codec Networks response	Bundle
Model the threats	Product threat modelling and risk assessment	B4
Build the SBOM	SBOM and testing evidence	B2
Formalise the process	Secure lifecycle aligned to IEC 81001-5-1	B5

Key lessons Start security evidence at design. Maintain an SBOM. Test before submission. Document vulnerability management.

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