NOVO follows a product development process (PDP) that improves the efficiency of project execution and produces higher-quality products. The process features five phases and identifies the critical activities to complete in each phase. These phases are:

  1. Product Definition
  2. Estimate and Planning
  3. Detail Design
  4. Verification
  5. Validation and Transfer

While the process is the same for medical devices as for other products, special considerations are warranted for the level of rigor that is required for developing a medical device. We ensure these special considerations are implemented into the process, assuring greater efficiency and enabling you to develop a safe, effective, commercially viable device. 

When is it time to begin your medical device development? Once you have identified the market opportunity and have a clear sense of your business imperatives. If you’ve completed those steps, 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 also achieves your business objectives. This begins with a thorough feasibility analysis of potential solutions, continues with a comprehensive concept study that balances user needs and engineering solutions, and ends with a robust product architecture definition.

Key activities and deliverables from this phase:

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

PHASE 2: ESTIMATE AND 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 medical device. Ultimately, the goal is to have a realistic project plan that sets the project for success.

Key activities and deliverables from this phase:

  • 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 and deliverables from this phase:

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

PHASE 4: VERIFICATION

The purpose of this phase is to prove that the medical 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 activities and deliverables from this phase:

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

PHASE 5: VALIDATION AND TRANSFER

In Phase 5, you will demonstrate that your medical 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 product manufacturing process to support product launch.

Key activities and deliverables from this phase:

  • Product/device validation
  • Manufacturing equipment qualification and process validation

To learn more about the work that we’ve done with medical devices, as well as more information on our medical device development services, visit our medical device page.

If you are ready to begin the product development process for your medical device, contact the team at NOVO and we can explore the possibilities of a partnership.