Full citation

Schnoll, L. (2009). To Launch or Not to Launch. Quality Progress, 42(2), 64-68.

Format: Peer-reviewed article

Type: Experience

Experience level of reader: Fundamental

Annotation: Summary of the U.S. Food and Drug Administration's regulations for the research and development process underlying Medical Device manufacturing. Includes a review of Stages (phases), a Table of Steps, and a process flowchart.

Setting(s) to which the reported activities/findings are relevant: Large business, Small business (less than 500 employees), University

Knowledge user(s) to whom the piece of literature may be relevant: Manufacturers, Researchers

Knowledge user level addressed by the literature: Organization

This article uses the Commercial Devices and Services version of the NtK Model

Primary Findings

Model: Quality System Regulations for medical devices require manufacturers to use a standard process for new product research and development. This process follows a series of Stages (phases), each including a set of steps and activities. A standard process imposes quality controls over each element of design, which is expected to generate higher quality devices.
Summary of U.S. Food and Drug Administration regulations regarding standard design guidelines for medical device research and development.

Methods:

  • To ensure compliance with the FDA's Quality System Regulation, medical device manufacturers should use a structured product development process to instill discipline in the product life cycle. A hierarchical approach arranges activity from Stages (phases) to Steps to Activities and finally to Tasks. Each Stage has a unique theme and set of deliverables. For example: Stage 0 — Concept Research. This stage identifies new market opportunities, determines customer needs and conducts high-level evaluations of the opportunity and its strategic fit. This activity concludes with the management approval of an integrated business plan for the project, which is then updated at the conclusion of each subsequent stage.
    Summary of the U.S. Food and Drug Administration's regulations for the research and development process underlying Medical Device manufacturing.
    Occurrence of finding within the model: Stage 1, Stage 2, Stage 3, Stage 4, Gate 1, Gate 2, Gate 3, Gate 4
  • To ensure compliance with the FDA's Quality System Regulation, medical device manufacturers should use a structured product development process to instill discipline in the product life cycle. A hierarchical approach arranges activity from Stages (phases) to Steps to Activities and finally to Tasks. Each Stage has a unique theme and set of deliverables. For example: Stage 2 — Design & Development. This stage continues the design and development of the product offering and the supporting processes. The key deliverables is a prototype product that is ready for verification and validation testing.
    Summary of the U.S. Food and Drug Administration's regulations for the research and development process underlying Medical Device manufacturing.
    Occurrence of finding within the model: Stage 5, Gate 5
  • To ensure compliance with the FDA's Quality System Regulation, medical device manufacturers should use a structured product development process to instill discipline in the product life cycle. A hierarchical approach arranges activity from Stages (phases) to Steps to Activities and finally to Tasks. Each Stage has a unique theme and set of deliverables. For example: Stage 3 — Verification & Validation. Demonstrate that the entire product offering and its supporting processes are robust and comply with the design requirement specifications and the customer's specifications prior to market introduction. All regulation, code, standards and product safety approvals must be obtained by the end of this stage. Demand building activities may be initiated in anticipation of commercial release.
    Summary of the U.S. Food and Drug Administration's regulations for the research and development process underlying Medical Device manufacturing.
    Occurrence of finding within the model: Stage 6, Stage 7, Gate 6, Gate 7
  • To ensure compliance with the FDA's Quality System Regulation, medical device manufacturers should use a structured product development process to instill discipline in the product life cycle. A hierarchical approach arranges activity from Stages (phases) to Steps to Activities and finally to Tasks. Each Stage has a unique theme and set of deliverables. For example: Stage 1 — Definition & Planning. This stage initiates design and quality control activities, where the whole product is defined and the remaining process is planned. Key deliverables include the formalization of the customer requirements and the product requirement specifications.
    Summary of the U.S. Food and Drug Administration's regulations for the research and development process underlying Medical Device manufacturing.
    Occurrence of finding within the model: Stage 4, Stage 5, Gate 4, Gate 5
  • To ensure compliance with the FDA's Quality System Regulation, medical device manufacturers should use a structured product development process to instill discipline in the product life cycle. A hierarchical approach arranges activity from Stages (phases) to Steps to Activities and finally to Tasks. Each Stage has a unique theme and set of deliverables. For example: Stage 4 — Commercialization. Delivering the product to customers in a controlled manner and gathering feedback on the product's performance. Includes full-scale product launch, release of evaluation tools and mass communication with customers. Manufacturing operations are ramped up to full-scale production. In addition, a post-launch evaluation is conducted to assess the actual results in comparison to projected performance and sales. The NPD team hands the product ownership and control over to the supporting organization for the duration of the product's life cycle.
    Summary of the U.S. Food and Drug Administration's regulations for the research and development process underlying Medical Device manufacturing.
    Occurrence of finding within the model: Stage 7, Stage 8, Stage 9, Gate 7, Gate 8, Gate 9