2 min read

Beginning Design Phase: What You Need to Know

Beginning Design Phase: What You Need to Know

The design phase of engineering is a critical stage in the product development lifecycle. This phase is where conceptual ideas transform into tangible solutions, ultimately leading to the creation of devices that improve patient care and healthcare outcomes. Understanding the key components of the design phase is essential to ensure a successful outcome.

Below is a breakdown of what you need to know when entering the design phase of engineering and how Fluid Metering can help.

1. Understand the Regulatory Requirements
The medical device industry is highly regulated, and the design phase is where regulatory compliance becomes a top priority. These regulations mandate that every device must go through a series of design controls to ensure safety, efficacy, and performance.

Fluid Metering is familiar with regulatory requirements including FDA guidelines and international standards. Our engineers collaborate closely with design teams to meet all quality requirements, while our regulatory affairs department ensures compliance with all relevant standards.

2. Define Fluidic Design Requirements
It is critical to define the fluidic requirements of the device. This involves understanding how the device will handle fluids, ensuring optimal performance and safety. Defining these needs helps to shape the design, including fluid flow, pressure management, and compatibility with medical applications.

Fluid Metering engineers help perform a detailed analysis of the intended fluidic functions, such as flow rates, viscosity, and pressure requirements. Our decades of experience helps our understanding of fluid handling challenges, such as risk of contamination, leakage, or clogging, and allows our engineers to develop solutions to address these issues, tailored to your needs.

3. Prototyping and Iteration
Prototyping is a vital part of the design phase. The first prototypes may not be perfect, but they are crucial for identifying design flaws, verifying functionality, and validating user needs. The iterative nature of prototyping allows teams to refine the device before final production.

Fluids Metering’s rapid prototyping program offers fast lead times that help move projects along quicky. With many off-the-shelf components, as well as customized solutions, our expert team of engineers quickly optimizes the best solutions, with most prototypes being delivered in 10 business days*.

Fluid Metering’s dedicated and proactive support team helps minimize roadblocks and delays with experts guiding you through every step.

4. Planning for Manufacturing and Scalability
During the design phase, it's crucial to keep the manufacturing process in mind. Early consideration of how the device will be manufactured ensures that scalability, cost, and quality control are accounted for.

Fluid Metering takes all of this into consideration when developing a customized solution for an OEM. Once the prototype is approved, Fluid Metering will create a production order for the specific pump and train their associates to calibrate and build to the exact specifications laid out by the customer's design.

Conclusion
The beginning of the design phase is a complex and collaborative journey that sets the foundation for a product’s success in the market. By understanding the regulatory landscape, defining specifications and needs, collaborating across disciplines, and prioritizing safety and usability, Fluid Metering can help you navigate the design phase for your next project.

 


*Prototype requests are subject to availability of parts and materials. Fluid Metering will contact you within 2 business days of receiving your request to confirm availability and provide an estimated shipping date. If there is a delay in shipment, a new estimated shipping date will be provided as soon as possible.

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