The Medical Device Development Process at DeviceLab | Part 1

In this nine-part series of blog posts, we’ll be talking about the process of medical device development practiced at DeviceLab. 

Some of the information discussed will be the implementation of internationally recognized standards for quality systems, and the distillation of 20 years’ experience in project management, design, and engineering. You’ll learn how we organize our efforts and resources, and how we manage activities, timelines, and budgets. We also describe our commitment to producing optimal designs through iterative development practices and building prototypes.

A Medical Device Development Model

DeviceLab has refined a model of medical device development that captures both regulatory imperatives and best practices in business and engineering. This blog series presents that model and explores how it accomplishes the goals we set for it. While some products are too simple or too complex for this model, most projects benefit from iterating the product through four design embodiments that we’ll call Proof-of-Concept, including;

    • • AlphaBeta
    • • Pilot Production
    • • Manufacturing

Each of these embodiments is associated with a set of goals and requirements that become more complex and stringent over time. This “multi-pass” approach facilitates thorough debugging, selection of best options, and design for manufacturing and testing. Most projects also incorporate a Research Phase where conceptual design is performed prior to invoking Design Controls.

The Model: Tracks, Phases, and Tasks

The DeviceLab RoadMap below diagrams how we organize our projects. Time flows left-to-right, and the six tracks (rows) shown represent different functional areas of the effort, with tasks generally being performed by the same specialists over the course of the program. In each track, individual tasks are shown, but they really represent just a summary of the actual tasks in the plan. Some projects won’t need all these tasks, and tasks can slide forward or backward when opportunities or problems present themselves. In that way, we adapt our RoadMap to the needs of the individual client.

Medical Device Development Process at DeviceLab Chart

We’ll dig deeper into the process depicted in our RoadMap in this series. Below is a list of upcoming titles:

    • • The Six Phases of a Medical Device Development Project
    • • The FDA “Waterfall” and DeviceLab’s 6 Phases
    • • 6 Development Tracks: Design in Parallel
    • • Agile Hardware Development: Why It’s important to Iterate a Design
    • • The Project Management Process at DeviceLab
    • • Leveraging Prototypes in Medical Device Development
    • • Tips for Outsourcing Medical Device Development
    • • When to Invoke Design Controls in a Medical Device Project

Please stay tuned for each of these posts. Together they’ll give you a good view of how medical devices are designed – all the way from ideas to products that make patients’ lives better every day In our next post, we’ll talk about how DeviceLab organizes projects into six distinct phases, and what gets done in each. See the Process and Compliance pages on our website for more information on how we do things.