Diagnostics

Contract Manufacturing for Disposable and Point-of-Care Diagnostic Equipment and Instruments

At SMC, we specialize in flexible manufacturing services for the development, launch, and volume-production of disposable and point-of-care (POC) medical diagnostic kits and devices. These diagnostic consumables can be anything from a self-DNA test kit, to a clinical sepsis test, to an on-the-battlefield blood test kit.

Experienced in meeting custom requirements for diagnostic equipment, instruments and devices

SMC focuses exclusively on custom contract manufacturing for the medical market. All manufacturing facilities are FDA registered and ISO 13485 certified. Our services include design, molding, assembly, high-speed automation and final packaging for your diagnostic applications.

SMC serves as a partner to many of the top diagnostics companies in the world. Our diagnostic equipment manufacturing experience includes:

Point of care
Laboratory disposables
Home sample kits
In vitro diagnostics kits
POC in vitro diagnostics kits
Microfluidic cartridges

Engineering-driven manufacturing solutions for diagnostic devices

Experienced staff, robust in-house services, and a global supply chain are pillars of our comprehensive medical manufacturing capabilities. Our background in both high-volume and low-volume manufacturing methods informs a nuanced understanding of commercialization scale-up. Best-in-class facilities and state-of-the-art equipment around the world deliver precise execution of every step in the diagnostics manufacturing process:

Design and development, including prototyping
Program management, from design through packaging, labeling and distribution
Microfluidics expertise for POC diagnostic devices that use increasingly smaller patient samples and reagent volumes
Integrating formulation and handling of the chemistry directly into the manufacturing process of the consumable
Injection molding, including in-house tooling
In-house automation and assembly, including ISO Class 7 and 8 clean rooms
Quality and regulatory capabilities
Sustainable manufacturing and procurement processes

Manufacturing methods that de-risk diagnostic device production

The need for medical manufacturing methods that support adaptable, scalable solutions has become more crucial than ever in the diagnostic space. As the technologies associated with creating a lab-on-a-chip become more complex, so does the process of bringing the assay to a fully commercialized product. Our customers rely on us for speed to market with high-quality results.

A Dedicated Program Manager

Our program manufacturing team works to minimize risk, lower costs and establish a robust process. A dedicated Program Manager, responsible for all communication and overall performance, including volume expectations, cost parameters and regulatory requirements, will be assigned to you for the duration of your project.

Microfluidic Design Specialists

To ensure precision in manufacturing increasingly complex and compact POC consumables, we employ design specialists with specific experience in microfluidic cartridges and cassettes. This expertise helps our partners improve the value stream of microfluidic POC devices, from development through commercialization.

In-house Automation Expertise

In-house automation expertise sets our manufacturing methods apart, saving time and streamlining the supply chain. Depending on volume, we design and build automation tools and work cells in-house, or we work closely with established suppliers of high-speed automation systems to plan the best method of assembly for each component. Every program is customized, given the technical requirements, volume, cost and timeframe.

More than 35 years of manufacturing medtech devices

Since 1988, SMC has been a reliable manufacturing partner for medical device companies. Our capabilities have grown to encompass drug delivery and diagnostic devices, and our manufacturing footprint has grown from Wisconsin to locations around the globe. As a privately held company, we serve our customers with agile decision making, access to leadership, best-in-class facilities and technology, and subject matter experts. Our global quality teams operate in accordance with an ISO 13485-certified Quality Management System (QMS).

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