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Case study · October 3, 2025

CryptographyDevice AuthenticationFDA Cybersecurity ReadinessPlan & Benchmark Product Security

Building the Business Case for Secure Connectivity: Medcrypt's Risk Analysis Drives $1M+ Investment

From Uncertain ROI to Executive Buy-In

AJ Reiter, Naomi Schwartz, Nick Atwell

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The Challenge

Justifying Proactive Cybersecurity Investment to Executives

At a Glance:

  • Client: Global medical device manufacturer
  • Challenge: Securing executive buy-in for proactive cybersecurity investment
  • Solution: Risk Return Analysis (RRA) & strategic connectivity roadmap
  • Impact: $1M+ investment secured, 5-year secure-by-design roadmap

Challenge:

  • Secure executive buy-in for proactive cybersecurity investment
  • Leadership viewed security as a cost center
  • No quantifiable data demonstrating risk and ROI
  • Struggled to compete for budget against revenue-generating initiatives
  • Needed compelling business case translating technical vulnerabilities to financial impact

Details:

A global medical device manufacturer's security lead faced a critical challenge: how to secure executive buy-in for proactive cybersecurity investment when leadership viewed security as a cost center rather than strategic imperative. Without quantifiable data demonstrating risk exposure and return on investment, the security team struggled to compete for budget against revenue-generating initiatives. The organization needed a compelling business case that translated technical vulnerabilities into financial impact and demonstrated clear ROI for secure-by-design principles across their device portfolio.

The Solution

Risk Return Analysis and Strategic Connectivity Roadmap

At a Glance:

  • Risk Return Analysis (RRA) model quantifying current risk exposure
  • Specific dollar values for FDA enforcement, recall costs, market share loss
  • Connectivity roadmap showing incremental security investments
  • Prioritized initiatives by ROI, timeline, and regulatory alignment

Risk Return Analysis Model:

Medcrypt deployed its Risk Return Analysis (RRA) model to quantify the manufacturer's current risk exposure across regulatory, reputational, and financial dimensions. The analysis revealed specific dollar values associated with potential FDA enforcement actions, recall costs, and market share loss from security incidents.

Strategic Connectivity Roadmap:

Beyond quantifying risk, Medcrypt developed a practical connectivity roadmap showing how incremental security investments would reduce exposure while enabling new revenue opportunities through connected device capabilities. The roadmap prioritized initiatives by ROI, timeline, and regulatory alignment, providing executives with clear decision criteria for both existing device hardening and next-generation secure-by-design development.

The Impact

Executive Alignment and Major Security Investment

Medcrypt's Risk Return Analysis transformed the security conversation from technical concerns to executive-level business strategy, delivering measurable outcomes that secured leadership commitment.

  • Demonstrated quantifiable risk exposure across regulatory compliance, brand reputation, and financial liability, translating technical vulnerabilities into executive-level business metrics
  • Informed strategic 5-year roadmap for next-generation device development with secure-by-design principles embedded from concept through commercialization
  • Secured immediate $1M+ cybersecurity investment by proving ROI and regulatory necessity, transforming security from cost center to strategic business enabler

Need Help Building Your Security Business Case?

Medcrypt's Risk Return Analysis quantifies your cybersecurity exposure and demonstrates clear ROI to secure executive investment.

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