Medical Device Manufacturing

INDUSTRY PERSPECTIVES

New ISPE Framework Targets Uncertainty In Pharma's AI Deployment

International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.

The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing

The promise of AI is colliding with the harsh reality of data chaos in pharma manufacturing. This article explores why most AI investments fail, and a 5-layer solution.

Why Use Total Organic Carbon Analysis For Cleaning Validation?

Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.

Risk-Based Analytical Method Selection In Cleaning Validation Using ASTM International Standards

This in-depth article describes risk in cleaning and provides a science- and risk-based framework for selecting analytical methods using ASTM International standards.

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WHITE PAPERS & CASE STUDIES

Cryogenic Storage Of IV Bags For Cell And Gene Therapies

Cryogenic storage can compromise packaging integrity for cell and gene therapies. Learn how vacuum decay technology detects micro leaks and ensures product safety under extreme conditions.

PolyPeel™ Peelable Polyester Heat Shrink Tubing

PET heat shrink is a strong barrier for medical devices, but difficult to remove. Peelable polyester heat shrink tubing is designed to overcome PET’s shortcomings.

Enabling Simpler, Quieter, And More Precise Wearables Utilizing Disruptive Pump Technology

Disc pumps enable quieter, smaller, and more precise wearable medical devices, improving patient comfort, measurement accuracy, and system reliability for innovative healthcare solutions.

When Clean Is The Key To Precision

Cleanroom micro molding ensures ultra-small components meet strict contamination and performance standards. As devices shrink and precision rises, controlled environments are essential for quality, reliability, and regulatory success.

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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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