Effectively Managing the Lifecycle of Medical Devices

Having a consistent, reproducible, and reliable product lifecycle process is critical to a medical device or component’s effectiveness. An effective lifecycle for medical devices will ensure that, at each stage, every requirement is met, and potential risks are anticipated and resolved. Managing this process helps ensure the device will be ready to meet regulatory requirements and get to the market, where it will provide the most benefit.

A primary component of this process is that a medical device product lifecycle should be consistent and reproducible. Yet, the product lifecycle should be flexible enough to include new types of or updated processes and more effective testing as necessary. Finally, there must be a mechanism to quickly respond to changes in government regulations.

To support Medical Device Manufacturers in their management of device lifecycle management, Flexan utilizes a unique proprietary operating model called Flexacution. This model was created to ensure that quality and engineering come together to promote innovative solutions that support best practices in product development and manufacturing productivity.

Flexacution reflects the benefits of true collaboration that can occur between a supplier and a customer when traditional boundaries are redefined to enable world-class solutions for custom manufactured components and devices. This unique process includes three primary Phases: Design, Develop and Deliver.

Since Flexan produces more than 2,000 custom manufactured products annually, we use that experience to engage at the earliest stages of product development to help our customers explore the limits of manufacturing possibilities in their efforts to design market leading products. Our capabilities extend from simply molding components to fully finished production and packaging. We help our customers accelerate their time-to-market with critical input from concept to design for manufacturability.

We know that truly great ideas require more than just proof of concept. They require real manufacturing solutions. In the develop phase, our project engineers lead cross-functional teams through a disciplined project plan, ensuring accountability and results. Each product we produce follows strict requirements as outlined in the master validation plans, ensuring that we achieve your quality requirements through proven manufacturing controls before we transfer products to production status.

With evidence that we can repeatably achieve the rigorous quality requirements through tight manufacturing controls, we deploy lean manufacturing principles to balance the fluctuating demand requirements in your market with an emphasis on OTIF (on-time, in full) to maintain an efficient and sustainable pipeline of product within your supply chain. We also continue to explore opportunities for improvement through our sustaining engineering teams, supporting your goals in the full product life-cycle management with our commitment to continuous improvement.

Flexan is a medical device contract manufacturing organization that delivers powerful custom manufacturing solutions for companies developing medical devices. Flexan offers our unique Flexacution method of designing, developing, and delivering top-quality components for medical devices. We approach the entire process holistically, which enables us to quickly identify and fix potential problems to increase speed-to-market. We are FDA Registered and ISO 13485 Certified to ensure regulatory compliance globally.

If your medical device company could benefit from Flexan’s experience bringing medical devices to market, contact our sales team today.