NOVO has a product development process (PDP) that we follow for any project we take on. While the process is the same for medical devices as for other products, special considerations are warranted for the level of rigor required in developing a medical device.

Product Development Process Overview

Our product development process uses a phase-gate approach to ensure that we develop high-quality products in an efficient, predictable, and orderly manner. Within each phase of development, we use our prior experience, technical expertise, and our understanding of the needs of our clients to develop a detailed plan for rapid design iterations. Our PDP has been integrated into our quality management system (QMS), which is certified to the ISO 13485:2016 standard.

Our PDP represents our commitment to continuous improvement, as we refine it based on lessons learned from each project. It was originally created based on our in-house knowledge of industry best practices, which we gleaned from intensive research and years of experience working with some of the top product development companies in the world. Today, it includes phases, activities, and deliverables that we have added and revised over more than 15 years in business.

The phases of our product development process are:

  1. Concept Development
  2. Estimating and Planning
  3. Detailed Design
  4. Verification and Refinement
  5. Validation and Transfer

Design Controls

Because the medical device industry is regulated, our clients in that field require strict adherence to a methodology commonly known as “design controls.” This methodology results in an auditable record of the PDP, showing that the PDP has been followed at every step.

Our design controls are cyclical within each phase of the PDP, using a series of inputs and outputs to create, review, and iterate at every step. While the controls can be scaled up or down depending on client needs and the level of concern of the device being developed (Class I, II, or III), the design process is the same. At the conclusion of the development process design controls ensure the appropriate device development documentation is available for audits or submissions for regulatory review (e.g., IDE, PMA, 510(k), CE).

For more information on our PDP, visit our process development page.

For more information on our medical device development services, visit our medical device page.