Medical Device Manufacturing

INDUSTRY PERSPECTIVES

Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification

A cleaning validation professional must know how many process performance qualification runs are necessary. Here's how to go about demonstrating this with a high degree of assurance while minimizing the number of qualification runs.

What To Expect When You Move Into Production For The First Time

In medical device development, things don’t go quite as you planned the first time around. This article shares what to really expect when you take your device into manufacturing.

Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements

This article examines the role of sample sizes in the determination of cleaning process capability or process performance in the manufacture of drugs/therapies and medical devices.

3 Lesser Known Keys To Effective Biopharma Supplier Engagement

In this article, Fran DeGrazio lays out ways for biopharma companies developing and commercializing combination products and other drug delivery devices to ensure that their product requirements and related documentation needs are well met by suppliers of materials, devices, components, and services. 

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WHITE PAPERS & CASE STUDIES

Navigating Regulatory Compliance In Medical Device Development For Prefilled Syringes And Auto-Injectors

Developing prefilled syringes and auto-injectors requires rigorous mechanical, user-focused, and compliance testing to ensure device safety, effectiveness, and seamless regulatory approval for patient use.

Adapting To USP 382: Enhanced Testing Protocols For Parenteral Packaging Systems

USP 382 introduces system-level, function-specific testing for elastomeric components in parenteral packaging, improving container integrity, sterility, and patient safety through enhanced protocols.

Best Practices For Sterilization Validation In Medical Device Manufacturing

Sterilization validation ensures medical device safety by confirming sterility through rigorous testing, method selection, and regulatory compliance, using both established and emerging sterilization technologies.

Vial Adapter Transfer Device Compatibility With Cell Therapies

Needles and syringes are commonly used to retrieve cell therapies from vials, posing the risk of needle stick injury. Explore the suitability of needle-free polycarbonate transfer devices.

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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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