Medical Device Manufacturing

INDUSTRY PERSPECTIVES

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.

Lilly's Unified Mindset For A Global Parenteral and Device Manufacturing Network

Eli Lilly and Company's one-team mindset aims to templatize facility design while remaining nimble enough to react to new manufacturing breakthroughs.

MES Is Still In The CD ROM Era But The Data Architecture Has Moved On

Many manufacturing execution system (MES) deployments still operate like it is 2005: a big install, disruptive upgrades, etc. Here's a clearer path forward.

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.

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WHITE PAPERS & CASE STUDIES

Package With A Purpose

Packaging shapes how devices are understood, handled, and used. A human-centered approach surfaces critical info sooner, reduces errors, and strengthens safety and usability.

Deterministic Nondestructive Seal Integrity Testing

Deterministic, non-destructive seal integrity testing delivers validated, quantitative results. Learn why this method outperforms traditional approaches in ensuring patient safety and product quality.

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.

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MANUFACTURING PRODUCTS & SERVICES

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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.

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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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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