The software is intended to help manufacturers demonstrate cybersecurity maturity as expectations from regulators and hospital purchasers continue to rise.
Medcrypt Inc, specializing in medical device cybersecurity, has launched Medcrypt Security Intelligence, a software solution for assessing, benchmarking, and advancing cybersecurity program maturity across the medical device lifecycle.
Medcrypt reports that it has supported more than 250 projects for over 80 clients and has a 100% US Food and Drug Administration (FDA) submission approval rate for cybersecurity elements. Medcrypt’s team includes experts who participated in developing the FDA’s Cybersecurity Guidance and the Health Sector Coordinating Council’s Joint Security Plan, documents that have influenced current medical device cybersecurity practices.
With Section 524B of the FD&C Act changing the FDA mandate on cybersecurity and the global push for standards harmonization, medical device manufacturers must now demonstrate measurable cybersecurity maturity across the product lifecycle to achieve and maintain compliance and market access. At the same time, hospital systems are raising expectations by increasingly including cybersecurity in their procurement processes, requiring proof of security readiness before purchase. Medcrypt’s recent whitepaper highlights how this dual pressure from regulators and buyers is reshaping the market.
The Security Intelligence solution is designed to turn fragmented security program data into actionable insights, with the goal of helping medical device manufacturers shift from reactive compliance to more proactive cybersecurity management.
Key capabilities include:
- Security Insights Dashboard: Central command view of security program maturity, assessing key activities such as threat modeling, vulnerability management, cryptography gaps, and general regulatory readiness.
- Benchmarking and Maturity Assessment Tools: Proprietary model that evaluates medical device manufacturers’ security program posture based on 12 representative industry frameworks, guidances, and standards (such as FDA Cybersecurity Premarket Guidance, IEC 81001-5-1, ISO 14971, and HSCC Joint Security Plan v2).
- Regulatory Evidence Engine: Collects and maps artifacts needed for submission (eg, Software Bill of Materials, threat models, cryptographic controls documentation) to aid FDA and global regulatory reviews.
- Expert Guidance Overlay: Direct access to Medcrypt’s regulatory and product security experts for interpretation, prioritization, and multi-year roadmap planning.
- Quantify Financial Risk: Understand the potential business impact of security gaps and justify appropriate investments to mitigate risks.
“Medical device manufacturers are being asked to prove that their security lifecycle processes are mature and hold up against regulatory scrutiny, by both regulators and customers,” says Mike Kijewski, CEO of Medcrypt, in a release. “Our people are what make Medcrypt different. Our team includes former FDA reviewers who helped write the current regulations. Medcrypt Security Intelligence turns that expertise into actionable intelligence, giving security, quality, and regulatory teams a common source of truth to demonstrate compliance, reduce risk, and ultimately deliver safer, more resilient products to patients.”
The launch follows a year in which Medcrypt reported 50% year-over-year customer growth and said it expanded its work with 15 of the top 25 global medical device manufacturers.
Since the FDA’s eSTAR and 524B enforcement took effect, all of Medcrypt’s inbound leads have been driven by these new mandates, “a clear sign that enforcement is accelerating manufacturers’ adoption of robust cybersecurity programs and turning compliance readiness into a competitive differentiator,” according to a release from the company.
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