Preparing for the Post-Quantum Era: What Medical Device Manufacturers Need to Know

Quantum computing may not be widely deployed yet - but the security risks it introduces are already influencing cryptographic planning. With NIST‘s release of the first set of FIPS-approved Post Quantum Cryptography (PQC) algorithms in August 2024, medical device manufacturers (MDMs) can no longer afford to wait.

For manufacturers building connected devices with long lifespans, cryptographic agility must be a design priority. Devices entering the market today could still be in the field when post-quantum requirements take full effect. In fact, NIST has outlined a phased transition plan for the deprecation of legacy cryptographic algorithms - such as RSA and ECC - beginning by 2030, with full disallowance expected by 2035. These timelines make it imperative for manufacturers to start planning now, regardless of how soon large-scale quantum computers become practical.

Importantly, regulators are following suit: the FDA’s guidance states that cryptographic algorithms used in medical devices should be “consistent with standards and norms set by recognized standards organizations such as NIST.” Translation? If it’s not NIST-approved, it won’t meet regulatory expectations in the future.

Threat Spotlight: Capture Now, Decrypt Later

Nation-states and other sophisticated adversaries are already intercepting encrypted data with the intent to decrypt it in the future. This is not just theoretical: healthcare-specific intelligence sources report that cybercriminals are already executing 'harvest now, decrypt later' (HNDL) strategies - anticipating the day quantum computing will make decryption feasible.

Healthcare Spotlight: According to Medical Economics, bad actors are targeting encrypted healthcare data today - mining it from apps, collaboration tools, and other systems - with plans to decrypt it in the quantum future. This makes medical device ecosystems a prime target for long-term exploitation. This is not just theoretical: healthcare-specific threat intelligence reports, including those from the HHS Health Sector Cybersecurity Coordination Center (HC3), have warned that data exfiltration from hospitals and device ecosystems could be stockpiled by nation-state actors for future decryption when quantum capabilities emerge.

This strategy, known as “capture now, decrypt later”, turns today’s encrypted patient data, intellectual property, and communication logs into tomorrow’s breach headlines. For manufacturers of long-lived connected devices, this means:

• Even secure communications today could be compromised years from now.
• Regulatory and customer trust will hinge on crypto agility and long-term resilience.
• The risk isn’t theoretical - the window of exposure is already open.

Future-proofing starts with crypto agility.

The most important step manufacturers can take is to design for cryptographic flexibility - ensuring devices can adapt as cryptography standards evolve. Instead of locking into a single algorithm or key type, systems should be built to support multiple algorithms, including post-quantum and hybrid models. 

This is where Medcrypt’s Guardian platform delivers value: by abstracting cryptographic operations and tracking algorithm usage across devices, Guardian enables manufacturers to transition from RSA or ECC to PQC - without needing to re-architect every component.

Six Key Considerations for PQC Readiness

1. Start with the Right Algorithms: FIPS-Approved Standards

NIST has finalized three PQC algorithms as FIPS standards:

• FIPS 203 (ML-KEM): A key encapsulation mechanism designed for post-quantum secure key exchange, ideal for TLS and other secure communications.
• FIPS 204 (ML-DSA): A digital signature scheme for code signing, firmware authentication, and secure boot.
• FIPS 205 (SLH-DSA): A hash-based signature scheme, more specialized and generally used for long-term archival or limited-use cases.

Most medical device applications will start with ML-KEM and ML-DSA, as they cover the most critical use cases for encrypted communications and code signing. 

Because these algorithms are still relatively new and unproven at scale, hybrid cryptography - combining post quantum schemes with ECC - is the most pragmatic approach. This ensures you’re protected if one algorithm is broken while maintaining compatibility with existing systems.

Guardian helps manufacturers track where ECC, hybrid, or PQC only schemes are used across devices, ensuring compliance while maintaining cryptographic agility.

2. Evaluate Hardware Constraints: CPU, Memory, and Battery Life

PQC algorithms are generally more resource-intensive than their classical counterparts, requiring thoughtful hardware planning - especially for power- or space-constrained devices.

• Processor and memory: Devices must be capable of handling larger key sizes and more complex mathematical operations. In constrained environments (think battery-powered wearables or implantables), this can create real performance bottlenecks.
• Battery life: Post-quantum operations often increase power draw, potentially reducing battery life and impacting device longevity. This may require firmware optimizations, more efficient crypto libraries, or hardware accelerators.

To reduce software disruption, many manufacturers are now exploring PQC acceleration in hardware - through dedicated cryptographic co-processors, secure elements, or TPMs. These allow post-quantum functions to run more efficiently and with minimal change to application-layer code.

Guardian helps MDMs identify which devices are PQC-ready -  or can be upgraded with minimal friction - by abstracting cryptographic functions and enabling crypto agility across the device fleet. 

3. Design for Seamless: Crypto-Agile Architecture 

PQC isn’t a plug-and-play swap. You’ll need to:

• Upgrade TLS libraries to support hybrid key exchange (e.g.., ML-KEM + ECC).
• Adapt secure boot and firmware signing pipelines (e.g., ML-DSA).
• Update provisioning systems to handle new key types and longer certificate chains.

That’s why building on a crypto-agile foundation is essential. If you’ve already abstracted your crypto architecture, these changes become significantly easier to implement. 

Guardian helps operationalize crypto agility by tracking what algorithms are used across devices, identifying components eligible for upgrade, and reducing the burden of system-wide cryptographic transitions.

4. Plan Now for Lifecycle Flexibility

Devices that last 10+ years will need cryptography that can evolve. Planning for PQC means making investment decisions today that will support secure operation long into the future:

• Hardware that can support crypto updates, including the option to add PQC hardware acceleration (e.g., secure elements, co-processors, or crypto modules) where performance or power constraints demand it.
• Firmware that includes algorithm negotiation capabilities, enabling hybrid or PQC algorithms to be activated later without requiring a full firmware rewrite.
• Provisioning systems that anticipate future updates, even if PQC isn’t fully enabled at launch. That includes managing key lifecycles, certificate chain length, and algorithm support from the beginning.

Guardian provides visibility across the entire device lifecycle, from design and provisioning to field upgrades and decommissioning. Making it easier to prioritize which devices are ready for PQC, which ones need investment, and how to justify those decisions internally.

5. Demonstrate Regulatory and FIPS Alignment

The first wave of PQC algorithms now carry FIPS 203/204/205 designations - meaning MDMs can begin demonstrating cryptographic compliance under these new standards.

Medcrypt’s approach ensures that:

• You’re selecting algorithms aligned with NIST guidance, starting with FIPS compliant algorithms like ML-KEM and ML-DSA for key exchange and digital signatures.
• You’re implementing hybrid cryptography strategically, balancing the risk of immature PQC algorithms with the known vulnerabilities of classical schemes like ECC and RSA.
• You can produce FDA-ready security reports and SBOM data that document cryptography usage and system posture - supporting regulatory submissions and third-party audits.
  
  

Guardian surfaces the cryptography state of every device, enabling regulatory teams to easily demonstrate readiness during FDA reviews. Today, these FDA-ready reports can be delivered through Medcrypt’s Helm SBOM and Vulnerability Management tool - and Guardian’s security documentation aligns with the FDA Cybersecurity Guidance.

6. Communicate Your Readiness to Customers and Auditors

The shift to PQC can feel overwhelming, especially for customers and regulators who may not be deeply technical. That’s why clear, confident communication is critical to building trust and demonstrating leadership:

• Help customers understand the value of hybrid cryptography - it's not just a hedge, it's the best practice recommended by NIST for transitioning to PQC securely while maintaining backward compatibility.
• Be transparent about your roadmap for cryptographic updates - which devices support PQC today, which are crypto-agile and ready for upgrade, and which will require investment.
• Use Guardian to provide a real-time snapshot of your fleet’s cryptographic posture - what algorithms are in use, which devices are update-ready, and where the risks are concentrated. 

This level of transparency not only builds confidence - it prepares your organization to respond effectively to audits, customer security reviews, and emerging regulatory requirements

Bridging Strategy with Execution: The Role of Product Security Intelligence Platform

While Guardian provides the tooling and infrastructure visibility to manage post-quantum readiness, effective execution also depends on organizational maturity, cross-functional alignment, and the ability to measure progress across security programs. That’s where Medcrypt’ Product Security Intelligence Platform (PSIP) comes in. 

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PSIP helps MDMs: 

• Access product and organizational security maturity
• Prioritize investments that strengthen both technical and regulatory posture
• Connect engineering decisions (like PQC readiness) to broader business goals like faster approvals, reduced cost of ownership, and market trust

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In short, PQC isn’t just a cryptographic decision - it’s a product strategy division. And PSIP ensures you can treat security not as a sunk cost, but as a growth lever. 

Final Thoughts

PQC isn’t just about preparing for future threats - it’s about building resilience into your products and infrastructure today. For connected medical devices, the risk window is already open, and the consequences of cryptographic failure  - whether during device operation or in the manufacturing supply chain - are increasingly severe. 

That’s why crypto agility and strong cryptographic hygiene must extend beyond the device itself. Medcrypt’s Guardian not only helps manage cryptographic posture in deployed products, but also supports the security of the manufacturing infrastructure that surrounds them. From symmetric secure boot keys to provisioning and certificate management, Guardian helps manufacturers reduce the risk of key leakage, avoid costly recalls, and build secure systems from the ground up. 

Companies that start now will be best positioned to meet NIST’s PQC implementation timelines and lead the path forward in device security - earning trust with regulators, customers, and patients.

Guardian is purpose-built to support this transition - not as a static dashboard, but as an evolving platform that helps you track, manage, and upgrade cryptographic protections across your entire device lifecycle and development ecosystem. 

Have questions about where to start? Let’s talk.

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