MedTech Project Execution
From idea to launch and post-market surveillance, a playbook for start-ups and scale-ups
MedTech Project Execution is a practical playbook for start-ups and scale-ups building medical devices, connected wearables, SaMD, surgical equipment and combination products in a regulated environment. It is designed for teams who must move quickly while producing evidence that can withstand scrutiny from regulators, notified bodies, auditors, partners and customers.
This book provides an end-to-end, stage-by-stage approach to execution across the full product lifecycle, from early opportunity and concept through development, verification and validation, transfer, launch readiness and post-market operations.
It focuses on the predictable failure modes that delay submissions, drive rework and undermine credibility, and it translates them into clear actions, decision points and governance that enable pace without sacrificing control.
This book is for
- MedTech founders and executives seeking clear direction, funding discipline and governance that supports fast, provable delivery
- MedTech project, programme and portfolio leaders responsible for integrated planning, evidence sequencing and decision hygiene
- Functional leaders across engineering, regulatory, quality, clinical, human factors, manufacturing and supply chain who need shared readiness criteria and reliable interfaces
Inside you will find:
- A stage-by-stage lifecycle playbook (Stages 0–6) with gate criteria and readiness expectations
- Evidence planning guidance to keep proof aligned to intended use, claims and risk
- Over 50 templates, checklists and trackers for governance, traceability, V&V closure, transfer readiness and post-market control
- Practical patterns for managing change, suppliers and multidisciplinary execution at speed
- Methods for identifying common failure modes and preventing them
