Medtech’s Custom-Build Default has Outlived its Rationale

Overview

Many medtech and diagnostics organizations still believe their operating model is too specialized for standard commercial software, so they build. That belief made sense once, but years of CRM, ERP, and order system extensions have left teams carrying technical debt, manual reconciliation, and validation burden that the platform market and FDA’s updated Computer Software Assurance guidance no longer require. Our analysis of public filings from 70 US companies shows device manufacturers spend 40% of revenue on SG&A, compared with 23% in pharma, and hold more than twice as much inventory relative to revenue. This whitepaper explains how to price the cost of customization, decide what to standardize, configure, or build, and make the case for change in measurable increments.