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

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

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

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

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

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