MedCrypt GTM brain

Medcrypt provides cybersecurity compliance software and advisory services to medical device manufacturers preparing and maintaining FDA submissions.

category

Medical device cybersecurity compliance

market profile

  • text: Medical device manufacturers must assemble security evidence for premarket submissions and manage vulnerabilities after release.
  • text: The product combines submission readiness, threat modeling, SBOM and vulnerability management with expert advice.

personas

  • title: VP regulatory affairs at a medical device manufacturer
    pains:
    • Cybersecurity evidence gaps may delay an FDA submission.
    • Threat models, SBOMs and postmarket plans must be consistent and traceable.
  • title: Product security lead
    pains:
    • Maintaining software inventories and monitoring vulnerabilities across device lifecycles.
    • Coordinating risk assessment and remediation with engineers and regulatory teams.
  • title: Medical device engineering leader
    pains:
    • Security documentation and testing compete with product delivery.
    • Small teams may lack specialist FDA cybersecurity expertise.

icp

  • text: Medical device OEMs building connected or software-enabled devices for FDA review, from emerging manufacturers to large multi-product enterprises.
  • text: Manufacturers with a product security, quality or regulatory function and ongoing postmarket obligations.

message pillars

  • text: Identify gaps ahead of review.
  • text: Combine tools with healthcare-specific expertise.
  • text: Manage compliance throughout the device lifecycle.

objections

  • objection: We have internal security and regulatory staff.
    response: Use the readiness check to identify specific documentation gaps and assess where reviewer expertise helps.
  • objection: We need SBOM monitoring but not a full platform.
    response: The pricing page offers standalone Helm by discussion; confirm scope and pricing.
  • objection: The subscription is expensive for one submission.
    response: Assess the annual per-product-line package against ongoing monitoring and included advisory hours, not just initial filing.

competitors

  • name: Cybellum
    website: https://cybellum.com
    why: Product security and SBOM tools for device manufacturers.
  • name: MedSec
    why: Medical device cybersecurity consulting and testing across the lifecycle.
  • name: Cybeats
    why: SBOM and software supply chain security for device makers.

keywords

  • FDA medical device cybersecurity
  • medical device SBOM software
  • FDA cybersecurity submission readiness
  • medical device threat modeling
  • medical device vulnerability management
  • FDA eSTAR cybersecurity

voice

  • regulatory-specific and direct
  • confident and pragmatic

signals

  • text: A connected device manufacturer is preparing an FDA submission or addressing a cybersecurity deficiency letter.
  • text: A device business is building its first SBOM and postmarket vulnerability program.

pricing

model: flat
starting price: $35,000 per product line per year

motion

hybrid

channels

  • LinkedIn
  • webinars
  • search
  • industry partnerships
  • sales

confidence

high

Founders

  • name: Mike Kijewski
    title: Founder
    role: Founder
  • name: Eric Pancoast
    title: Founder
    role: Founder

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