Where Product Security Lives: The Business Case
Product cybersecurity is now a material business risk. Yet most product security programs are still operated through fragmented tools, spreadsheets, and manual workflows. This creates unnecessary operating cost, slows product launches, and increases regulatory exposure. Here's why leading medical device companies are consolidating product security into one living platform.
Product Security Is Now a Business Function
For large medical device manufacturers, product cybersecurity has become a material business risk. Regulatory scrutiny is increasing, post-market vulnerability activity is accelerating, and cybersecurity findings now directly affect time-to-market and corporate liability.
Yet most product security programs are still operated through fragmented tools, spreadsheets, and manual documentation workflows. This creates unnecessary operating cost, slows product launches, and increases exposure to high-impact cybersecurity events.
1. Reduce the Cost of Running Product Security
Today, product security teams spend a large portion of their time manually:
- • Rebuilding documentation for each product
- • Maintaining traceability between architecture, threats, vulnerabilities, and compliance evidence
- • Reconciling data across disconnected tools and spreadsheets
This is expensive and does not scale. Product Security Hub replaces these fragmented workflows with a unified operational workspace that keeps all product security artifacts continuously synchronized. This eliminates duplicated manual work and redirects team effort toward actual security analysis and risk management.
The outcome:
- • Significant reduction in manual documentation and reconciliation work
- • Operating cost savings that scale with portfolio size
2. Accelerate Regulatory Submissions and Revenue Recognition
Cybersecurity evidence is now a required component of regulatory submissions. Delays in preparing defensible cybersecurity documentation routinely slow product approvals—deferring revenue and increasing development costs.
When product security lives in documents and disconnected tools, evidence reconstruction happens late in the approval cycle. This creates friction with regulators and extends approval timelines.
Product Security Hub maintains continuously up-to-date cybersecurity evidence across the product lifecycle. Architecture changes, threat updates, vulnerability assessments, and compliance mappings are always current. When regulators ask for evidence, it's ready—not assembled at the last minute.
The outcome:
- • Shorter regulatory approval cycles
- • Reduced friction with regulatory bodies
- • Faster revenue recognition on new products
3. Reduce Exposure to High-Impact Cybersecurity Events
Cybersecurity-driven recalls and field actions increasingly cost medical device manufacturers tens of millions of dollars per event. These failures are often driven by:
- • Incomplete SBOM visibility – vulnerabilities in components you didn't know were used
- • Weak post-market vulnerability tracking – vulnerabilities arriving faster than you can track them across releases
- • Poor cross-product traceability – can't quickly determine which products are affected by a vulnerability
Product Security Hub provides continuous, portfolio-wide visibility across architecture, vulnerabilities, and risk. Every vulnerability connects to components and affected products. Every component links back to architecture and threat model. When a new vulnerability emerges, you know instantly which products are affected and what the actual risk is.
The outcome:
- • Early detection of threats and vulnerabilities
- • Defensible evidence of risk assessment and mitigation
- • Reduced probability of costly incidents and recalls
4. Build a Scalable Product Security Operating Model
As product portfolios grow, manual product security processes become unsustainable. Tribal knowledge becomes a liability. Executive-level risk visibility disappears. Regulatory posture weakens.
Product Security Hub establishes a scalable operating foundation that:
- • Reduces dependence on individual experts and tribal knowledge
- • Improves executive-level risk visibility
- • Strengthens regulatory posture across the organization
This transforms product security into a mature, well-governed business function.
The outcome:
- • Product security scales with portfolio growth
- • Consistent processes and governance across products
- • Reduced operational risk from knowledge loss or transition
A Living Platform, Not a Point Tool
Product Security Hub is not simply a threat modeling tool, an SBOM scanner, or a compliance documentation system. It is where product security lives across development and post-market—a single operational platform for managing product cybersecurity at scale, where all security artifacts are continuously synchronized and accessible.
Unlike point tools that solve individual problems, Product Security Hub unifies the entire product security lifecycle into one connected workspace:
- ✓ Architecture Views – visual diagrams that stay connected to threat models, vulnerabilities, and requirements
- ✓ Threat Modeling – identify threats mapped to architecture, linked to requirements and post-market data
- ✓ Security Requirements – curated requirements catalog with AI-assisted mappings to your architecture
- ✓ Risk Assessment with CVSS – quantify vulnerability impact using CVSS v3/v4 scoring
- ✓ SBOM & SCA – import SBOMs and scan against vulnerability databases, auto-linking to architecture
- ✓ Vulnerability Management – triage, prioritize, and track remediation across pre-market and post-market
- ✓ Compliance Evidence – automatically generated from security work, not assembled last-minute
- ✓ Post-Market Surveillance – continuous vulnerability tracking and risk updates integrated with pre-market decisions
For medical device manufacturers, this unified approach delivers:
Lower operating cost
Eliminate manual reconciliation and documentation work
Faster time-to-market
Continuous evidence readiness, no approval delays
Reduced enterprise risk
Portfolio-wide visibility and continuous defensibility
Why Now
The regulatory and threat landscape has fundamentally shifted. Cybersecurity is no longer a feature of medical devices—it's a foundational requirement. FDA expectations for SBOM visibility, post-market surveillance, and threat modeling are clear. The market for vulnerabilities is accelerating.
At the same time, the cost of operating product security through fragmented tools has become unsustainable. Teams are spending significant time on manual work. Approvals are delayed by evidence preparation. Risk visibility is poor.
Organizations that consolidate product security into a living platform—where all security work is continuously synchronized and accessible—gain competitive advantage: faster approvals, lower operating cost, stronger regulatory posture, and measurably reduced risk.
Product Security Hub is built for organizations that treat product security as a core business capability.
Ready to understand how Product Security Hub applies to your organization?