Question

What is the product life cycle for AAMI?

Answer 1

The concept of a life cycle for medical devices is adopted from the broader idea of a product life cycle (PLC). Like all products, medical devices begin their lives in a manufacturing plant, then sold to the end user and may be used until the natural end of their life cycle.

Picking the right medical device product life cycle management (PLM) tool is a huge deal. Selecting the wrong PLM could lead to headaches and legal trouble. If you fail to manage compliance and quality throughout the entire device life cycle, you could face safety issues, recalls, and lawsuits.

Adopting the best device PLM tool from the earliest stages of device design can help you avoid unforeseen quality issues and regulatory headaches.

1. Conception

This phase contains several steps from idea conception, the use context of the medical device, initial concept development, up to proof of concept. These ideation processes generate abstract concepts in need of further development, refinement, and adaptation, to result in a workable base for developing a medical device that is effective to use, feasible to produce, and can achieve regulatory compliance.

2. Design & Development

New Process Development (NPD)
Medical device product design should be carried out with manufacturing in mind. From the early stages of device components design, factors such as practical manufacturing limitations, ease of components assembly, and cost-efficient processing, should be taken into account. An experienced contract manufacturer utilizes New Process Development (NPD) principles, that include several techniques necessary to achieve seamless transitioning from design to manufacturing phase.

Process Flow Diagram (PFD)
Following the initial design phase, a PFD is developed to layout and describe in detail all of the medical -device’s assembly steps. This helps identify critical processes and preemptively avoid issues down the line, saving you money.

Design for Manufacturing (DFM)
Design for Manufacturing (DFM) focuses on adapting, from an engineering perspective, the product, its components, and/or any elements associated with its assembly, to mass production capabilities and parameters. This enables an effective, fast and smooth production process.

Pre-Process Failure Mode Effect Analysis (Pre-PFMEA)
The PFMEA is an analytical tool used to identify and evaluate the potential failures of a process. Through a PFMEA analysis, it is possible to identify and prioritize risk factors throughout the medical device product development lifecycle. The identified risk factors are then addressed from the design phase, removing major barriers for proceeding to production.