Medical Device Manufacturing

INDUSTRY PERSPECTIVES

Hormuz Deal Brings Cautious Relief To Pharma Packaging Supply Chains

Restrictions and fear on the Hormuz Strait have fractured supply chains, especially for primary materials used in pharmaceutical packaging.

The Need For Speed: Is Your Medtech Supply Chain Ready For The Next Disruption?

In a recent Deloitte Center for Health Solutions survey, 68% of medtech leaders said they lack confidence in their companies’ ability to restore disrupted supply chains quickly. Here are key practical action items to take.

Closing The MES Value Gap: Why Technology Isn't The Problem

Manufacturing execution system (MES) technical maturity is rising, but adoption across manufacturing sites is uneven. Organizational readiness may hold the key.

Why Your MES RFP Is Failing Before It Starts

Many manufacturing execution system requests for proposals fail. Not because vendors cannot deliver or the tech is immature, but because the requirements are written backward.

More Perspectives On Medical Device Manufacturing

WHITE PAPERS & CASE STUDIES

Reagent Storage On Microfluidic Cartridges

Learn how scalable reagent storage solutions simplify microfluidic cartridge manufacturing, improve assay reliability, and accelerate commercialization for point-of-care diagnostic applications.

Pattern Bioscience Single Cell Microbiology To Decode Bacterial Infection

Discover how thinXXS helped Pattern Bioscience accelerate digital droplet chip development through precision manufacturing, rapid design iteration, and scalable reagent storage solutions.

The Mold Is Only Half The Story

In micro molding, automation isn’t an add-on. Learn how integrated handling, inspection, and packaging enable scalable, high-quality production.

How To Validate And Hold Tolerances When Clinical Risk Lives In The Fit

In micro medical manufacturing, prototype success doesn’t guarantee production success. Learn how tolerance strategy, tooling, and metrology ensure reliable assembly at scale.

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MANUFACTURING PRODUCTS & SERVICES

KittingandPackaging
Medical Device Assembly, Kitting and Packaging Services

SMC provides manufacturing and assembly services for full devices or subassemblies for finished devices. Our global facilities offer ISO 13485 systems for assembly as well as kitting and packaging services. SMC’s assembly services range from skilled human touch to fully automated assembly and testing equipment. Whether your program requires simple table-top fixtures or fully automated cells, our in-house automation team will assess your program and work with you to build a cost effective solution to meet your stringent requirements.

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Assembly Services

Complete outsourcing solution

B. Braun exclusively designs and manufactures products for the medical market. This single-minded focus on medical devices established our reputation for unrivaled quality. We’ve built advanced manufacturing facilities around the world, and our primary North American facility is no exception. It features state-of-the-art quality systems and ISO Class 8 clean rooms. With the flexibility to change from manual to semi-automated to fully automated assembly, they can produce both small- and large-scale volumes.

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ABOUT MEDICAL DEVICE MANUFACTURING

Medical device manufacturing includes all aspects of the fabrication of a medical device, from designing a manufacturing process to scale-up to ongoing process improvements. It also includes the sterilization and packaging of a device for shipment.

Throughout the manufacturing process, medical device makers strive to be faster and more efficient, but they also wish to be responsible corporate citizens. Thus, manufacturing demands constant insight into renewable resources, sustainable materials, equipment that is more energy efficient, and methods to reduce waste creation. Solutions to these issues can come in the form of improved processes, technological advances in machines or equipment components, or safer/more reliable materials. The same principles apply to the packaging process.

Such "LEAN" manufacturing is considered an industry best practice: eliminating any activity, process, or material that does not add value for which a customer will pay.

Still, while speed and cost-savings are vital to successful manufacturing, quality control is of the utmost importance — particularly as medical device market demands shift toward a more value-driven landscape. Packaging validation, proving to the FDA that a product is sterile when it ships, is the final step.

Many medical device manufacturers excel in the ideation, concept, and prototyping phases of product development and outsource the production of components or entire devices to contract manufacturers. This is as true of established original equipment manufacturers (OEMs) as it is for mid-sized companies and startups. Contract manufacturers vary in size and expertise, as well — some comprise small, precise operations specializing in particular materials or components, while others are massive cleanroom facilities equipped for large-scale production.

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