# Research & Guides

Data-backed frameworks for medical device commercial teams. Built from conversations with hundreds of device companies, backed by research from McKinsey, EY, Deloitte, and more.

## Regulatory Guide  April 2026
**When Your Ops System Became a Validated System**
Three regulatory shifts in the last ten months — the July 2025 GAMP AI Guide, the September 2025 finalization of CSA, and the February 2026 QMSR transition — pulled operations software into validated-system scope. Covers GAMP Category 5 classification for custom-built ops systems, the QMSR expansions that widened the audit surface (enterprise-wide QMS, management review, outsourcing, PLM/QMS traceability, access provisions), and what validation actually requires.
[Link](/content/resources/validation-burden-custom-ops/index.html)

## Playbook  April 2026
**The Four-Week Audit Playbook**
How a Southeast ortho distributor closed a physical inventory audit in four weeks instead of five months, and recovered $1.46M that had been written off the year before. Includes the five-step field sequence, a pre-audit readiness diagnostic, and the Medical Ventures case study.
[Link](/content/resources/four-week-audit/index.html)

## Evaluation Guide  April 2026
**Medical Device Field Inventory & Operations Software Buyer’s Guide**
A practitioner’s guide to evaluating field inventory and operations software. Names the players (Movemedical, ImplantBase, WebOps, ERP modules), walks through validation and audit readiness under QMSR, and includes printable vendor evaluation questions.
[Link](/content/resources/inventory-software-guide/index.html)

## Operations Guide  April 2026
**The Field Inventory Problem**
Why medical device companies lose money, time, and visibility once inventory leaves the warehouse. A practical breakdown of consignment, trunk stock, loaner kits, and field transfers — where each one breaks and how to fix them.
[Link](/content/resources/field-inventory/index.html)

## Operations Guide  March 2026
**The Complete Guide to Order-to-Cash Automation**
How medical device commercial teams are eliminating manual order entry, accelerating revenue recognition, and gaining real-time visibility across stock, consignment, and bill-only orders.
[Link](/content/resources/order-to-cash/index.html)

## Research  Framework  March 2026
**The Hidden Coordination Tax**
Every manual handoff between a surgical case and a collected payment costs more than you think. This guide breaks down the 10 hidden costs nobody budgets for — with formulas, worked examples, and research from McKinsey, EY, and Deloitte.
[Link](/content/resources/coordination-tax/index.html)