Center of Excellence

Offering Next-Generation Fluid Management Solutions

Advancements in medical treatments, a rise in chronic diseases, and the need for faster diagnoses, cost efficiency, and more personalized and direct care are all driving increased global demand for fluid management systems. In many cases, a reduced product footprint is a high priority, such as microfluidic systems for in-vitro diagnostics, lab-on-chip (LOC) technologies, and other emerging applications. As a result, a growing number of medical device manufacturers are turning to Benchmark Almelo, a Center of Excellence for Fluid Management. As a trusted design, engineering, and manufacturing partner with next-generation technology solutions and a collaborative team, Benchmark Almelo ensures both consistency and precision for your fluid management product—every time.

As a Center of Excellence for Fluid Management, Benchmark Almelo stays ahead of industry trends. We understand the challenges you face in this highly regulated industry and have the experience and expertise to help enhance your products while shortening your time to market. By specializing in end-to-end product realization services, our team helps you create customized, cost-effective, manufacturable fluid management products to meet your customers’ unique needs. In short, we help you develop and expedite to market advanced fluid management solutions.

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Capabilities at a glance

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Concept & Design

Design & Engineering Excellence

Concept & Design

Foundational Microfluidic Cartridge Testing Platform

Design Verification & Pre-Production

Test Readiness & Development

Design Verification & Pre-Production

Failure Mode & Effect Analyses (FMEA)

Qualification & Production

Manufacturing & Sustaining Services

Concept & Design

Design & Engineering Excellence

Concept & Design

Foundational Microfluidic Cartridge Testing Platform

Design Verification & Pre-Production

Test Readiness & Development

Design Verification & Pre-Production

Failure Mode & Effect Analyses (FMEA)

Qualification & Production

Manufacturing & Sustaining Services

Concept & Design

Design & Engineering Excellence

In the concept and design phase, a combination of design, manufacturing, and supply chain expertise is applied specifically to fluid management. This is critical to our product realization solutions since this combination ensures that these interconnected parts of the fluid management system work together. Our design engineering group is experienced in executing complex and innovative projects from initial concept phase through development, new product introduction (NPI), manufacturing collaboration, fulfillment, and after-market support. Our team also offers customers localized research and development (R&D) services, including industrial design, design for usability, usability testing, mechanical, electronics, embedded software engineering, and fast prototyping. Key capabilities include:

Architectural Design Feasibility Studies
Regulatory Compliance Simulations
Requirement Specifications Verification
Detailed Design/ Design for Excellence Proof of Concept
Biochemistry Informative Testing
Cartridge Design Macro/Meso/Micro Interfacing
Design for Usability/Usability Testing Mechatronics
Flow Control Optics
Gas Control Pneumatic Control
Human Factors Precision Positioning
Industrial Design Thermal Control
Concept & Design

Foundational Microfluidic Cartridge Testing Platform

Benchmark Almelo offers a microfluidic testing platform that customers can incorporate into their design to save on development costs while also reducing time to market.

Since microfluidics technologies used in LOC diagnostics applications only require small samples of blood, they are becoming highly desirable within the medical industry. And while the initial investment can be both expensive and time intensive, many applications require the microfluidic’s core elements to remain consistent (e.g., avoid airborne contamination and hold a tight seal to the test device). For this reason, Benchmark Almelo is developing a foundational microfluidic cartridge testing platform to support several microfluidics applications. Our work is helping to make analysis tools simpler, faster, and less expensive to operate for end users, leading to several benefits, including:

Adaptable machine interface Greater risk mitigation
Automated connections Increased product flexibility
Faster proof of concept Reduction in development costs
Faster time to market Significant decrease in dead volume
Design Verification & Pre-Production

Test Readiness & Development

Test development provides direct in-line support for the setup and maintenance of testers in manufacturing use due to having all departments at the same site and/or location as opposed to having testers from another site or company. Benchmark Almelo works closely with our customers and will offer professional advice regarding the most appropriate test strategy to help ensure future yields for a sound business case. At Benchmark Almelo, our design for testing sessions involve design discussions from a test engineering point of view. We will always take the necessary time to review the product’s testability to determine if it will need further improvements.

Design Verification & Pre-Production

Failure Mode & Effect Analyses (FMEA)

These analyses can be done on design, production, or testing level, and are performed to find and mitigate risks in the process. Such analyses often result in mitigations that require effort from other disciplines (e.g., production risks can be mitigated by the design or vice versa). Therefore, we not only need to discuss the results with the relevant stakeholders, but we often include other disciplines as well in the analysis itself. These reviews and analyses will be repeated where necessary after prototyping runs to further improve the design and mitigate risks in the process. For this reason, we have reports and reviews such as the Proto Evaluation Report and the Technical Product Design Acceptance Sheet (TAS).

The Proto Evaluation Report provides feedback based on the results of a prototype production run. These results are also discussed with specialists in the relevant disciplines to determine if any additional steps should be taken to further improve the product. We also make sure that, where applicable, reviews of important documentation are performed by one or more representative in another discipline. For example, the TAS is a deliverable in which the TPD (Technical Product Documentation) created by Design Engineering is reviewed by Manufacturing Engineering on set criteria to suggest minor (and sometimes major) DFX improvements or to enhance production readiness. 

Qualification & Production

Manufacturing & Sustaining Services

With a proven track record serving high technology medical device manufacturing companies, Benchmark Almelo manufactures complex products for high reliability applications. By partnering with the Almelo Center of Excellence for Fluid Management, you’ll enjoy a long list of benefits, from a reduction in sample processing time and increased accuracy to improvement in your product’s overall quality and usability, all while keeping costs low. With a modern, controlled, automated, and aseptic cleanroom environment, Benchmark Almelo meets stringent ISO Class 6&7 industry standards.

As an integral part of our global network of sites, Benchmark Almelo also provides aftermarket support for the industry’s leading drug delivery, sterile fluid control, dialysis, and blood management products.

Let’s innovate together.

 

When Fluid Management Matters

Benchmark Almelo’s Center of Excellence for Fluid Management partners with some of the most disruptive and high-growth medical device companies worldwide, offering a full suite of market-leading solutions and platforms customized to your unique needs. With our global footprint, we can seamlessly keep your engineering and manufacturing close to home (or close to your customers) then gradually push offshore as volumes increase with a seamless and standardized site transition.

Certifications and Registrations

*Medical FDA/QSR capable in first half of 2023.