Every month of FDA clearance delay costs between $500K and $2M in deferred revenue.
A Technical Screening hold from a missing SBOM is entirely preventable. So is its cost.
and
The hidden cost is not the compliance program. It is the deferred revenue from a preventable hold.
X-DLM™ entry pricing via Polarion Startup Program. Scales with device programs and users. Black Duck MSSP pay-per-scan available.
Reduction in submission preparation time when evidence is generated continuously rather than assembled in the weeks before filing. Source: X-DLM™ customer benchmarks.
Estimated monthly cost of FDA clearance delay in deferred product revenue per device program. Source: Medical device industry benchmark estimates.
Of hospital procurement organizations will not consider a device without an SBOM — an effective disqualifier in more than a third of the procurement market. Source: RunSafe 2026.
Convert an unquantified submission risk into a defined, budgetable compliance program.
- 01
Put a number on the clearance delay risk
A Technical Screening hold from a non-compliant SBOM adds a minimum 90-day reset to your 510(k) review cycle. X-DLM™ starts at ~$5K/year. The ROI of a single avoided hold covers the program cost by orders of magnitude.
- 02
Protect deal value in hospital procurement and M&A
35% of hospital procurement teams disqualify devices without SBOM. M&A diligence in medical devices increasingly requires SOUP documentation, vulnerability response records, and IEC 62304 traceability evidence. Black Duck and X-DLM™ make that evidence package available on demand.
- 03
Eliminate the pre-submission evidence sprint cost
Medical device regulatory teams spend 6–12 weeks assembling submission evidence manually before each FDA filing. Polarion LiveDocs and X-DLM™ eliminate that sprint — evidence is continuous. The compliance team's time is redirected to product development, not document assembly.
See how Siemens Polarion and Black Duck become one governed software risk workflow.
X-DLM™ turns Black Duck software supply chain intelligence into Siemens Polarion work items, requirements links, approvals, escalation paths, and continuously maintained evidence.
Brand authority buyers recognize
Backed by Siemens lifecycle governance and Black Duck AppSec intelligence.
Siemens Polarion ALM
Polarion provides the lifecycle system of record for requirements, tests, approvals, traceability, workflow automation, audit evidence, and regulated software delivery.
Black Duck Software Composition Analysis
Black Duck identifies open source and third-party components across source, binaries, containers, firmware, snippets, AI-generated code, and C/C++ environments without package managers.
Medical device companies answer to more than one framework — simultaneously.
FDA Section 524B is the floor, not the ceiling. IEC 62304, EU MDR, ISO 14971, HIPAA, and NIST SSDF run in parallel — each with its own evidence requirements, its own submission deadline, and its own consequence for missing components.
View FDA 524B, IEC 62304 & All Regulations →Remove submission delay risk from the board risk register.
Budget X-DLM™ before the Technical Screening hold arrives.
See how X-DLM™ converts FDA submission delay risk, SOUP liability, and HIPAA exposure into a defined, budgetable compliance program — starting at approximately $5K/year.