Bridging the Gap: Decrypting Cryptography

Modern medical devices must balance safety, functionality, and cybersecurity amid increasingly connected healthcare environments. This whitepaper unpacks the complexity of implementing cryptography — the foundation of digital trust — in medical devices. It explores the technical, regulatory, and operational factors that determine whether encryption and authentication mechanisms actually make devices more secure or inadvertently create vulnerabilities. Readers will learn how to align cryptographic design with FDA expectations, NIST recommendations, and real-world device constraints.

Cryptography is often misunderstood or inconsistently applied in the medical device industry. Getting it wrong can undermine patient safety, delay regulatory approval, and damage brand reputation. As regulators tighten expectations around secure design, key management, and root of trust, medical device manufacturers must take a proactive approach. This whitepaper helps bridge the gap between theoretical cryptography and practical, compliant implementation across the device lifecycle.