At NOVO, we have divided the medical device development process into five phases and identified the critical activities to complete in each phase. Adhering to this process, which we outline in greater detail in our quality manual, ensures greater efficiency and best enables you to develop a safe, effective, commercially viable device. Once you have identified the market opportunity and have a clear sense of your business imperatives, you are ready to begin development.

Phase 1: Product Definition

In Phase 1, we work with our clients to create a roadmap for the ensuing development work. The purpose of this phase is to ensure that our engineers will be able to develop a product that not only meets the needs of your users but achieves your business objectives. This starts with a thorough feasibility analysis of potential solutions, a comprehensive concept study that balances user needs and engineering solutions, and ends with a robust product architecture definition.

Key activities:

  • Product requirements development
  • Technology assessments
  • Risk analysis
  • Concept development
  • Product architecture

Phase 2: Planning

In this phase, program management does its most influential and important work, which is critical to the success of a development effort. Program management needs to understand how different teams work together to develop a project plan that both considers the needs of all stakeholders and mitigates risks in the development of your product. Ultimately, the goal is to have a realistic project plan that sets the project for success.

Key deliverables:

  • Development plan
  • Quality plan
  • Manufacturing plan
  • Clinical plan
  • Risk management plan

Phase 3: Detail Design

This is the phase in which we develop your product, working in a design-build-test cycle of design iterations intended to demonstrate incremental progress, reduce costs, and mitigate risks. Our engineering team creates detailed specifications for manufacturing and testing your medical device. In parallel, the engineering team develops verification plans, protocols, and tools. At the end of this phase, we expect to have the full set of design outputs for your product and a detailed plan for verifying the design.

Key activities:

  • Design development
  • Manufacturing development
  • Test development
  • Verification development

Phase 4: Verification

The purpose of this phase is to prove that the device meets the product requirements. This consists primarily of executing the verification plan developed in the previous phase. After this phase, you should have all the required design verification evidence with traceability back to user needs.

Key deliverables:

  • Execute verification plan
  • Verification report
  • Risk management report
  • Requirements traceability matrix

Phase 5: Validation and Transfer

In Phase 5, you will demonstrate that your device is ready for market introduction. Validation confirms that the device meets user needs to support the submission required to secure regulatory approval for marketing the device. Transfer to manufacturing validates the manufacturing process to support product launch.

Key activities:

  • Product validation
  • Manufacturing tool validation and process qualification

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.

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.