Medical Device Manufacturing
INDUSTRY PERSPECTIVES
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![Biological safety cabinet and scientist-GettyImages-1173376974]( "Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements")
Cleaning Process Capability: Understanding Populations, Samples, And Sample Size RequirementsThis 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.
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.
Surrogate surfaces, or “coupons”, are used to simulate pharmaceutical manufacturing surfaces or medical devices for the performance of swab and rinse recovery studies. Experts from The Center for Pharmaceutical Cleaning Innovation provide insights for proper care and handling.
In the life sciences, audits have long been bogged down by repetitive tasks. AI is changing the way auditors operate, making compliance more seamless than ever.
A typical life sciences enterprise now has 500+ software applications. A digital adoption platform (DAP) is an overlay to help with user adoption, like an advanced version of the MS Word "paperclip" assistant.
WHITE PAPERS & CASE STUDIES
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![Accumold - micro optics]( "The Non-Negotiable Need For Quality In Micro Molding")
The Non-Negotiable Need For Quality In Micro MoldingQuality in micro molding is essential. Accumold ensures precision through advanced metrology, process validation, and continuous improvement, meeting tight tolerances for complex, miniaturized components.
Medbio ensures seamless tool transfers for medical device manufacturing by assessing tools, implementing improvements, and minimizing downtime to maintain quality, efficiency, and regulatory compliance.
It was imperative for a large European CMO that produces multiple biologic drugs to select the right product quality and value for each customer to comply with the August 2023 revision to the EU GMP Annex 1.
Micro molding is essential for high-precision industries. Choosing the right partner ensures scalability, reliability, and innovation, minimizing risks and disruptions while future-proofing supply chains for sustained success.
A virtual start-up partnered with Nordson MEDICAL for complete design, development, and manufacturing of a catheter-based device for TAVR patients, leading to CE mark and acquisition.
MANUFACTURING PRODUCTS & 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.
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.
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.
LATEST HEADLINES
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Discover Medbio's Medical Molding Expertise At MD&M East5/8/2025
Visit Medbio at Booth #837 to explore full-service medical manufacturing backed by 100+ years of expertise, trusted by top global device makers.
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Knowles Extends Custom Miniaturization Capabilities To MedTech OEMs5/7/2025
Knowles expands into MedTech, offering precision miniaturization services to OEMs for scalable, cost-effective manufacturing of implantables, diagnostics, surgical tools, and drug delivery devices.
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Visit Medbio At MD&M West In Anaheim, CA1/28/2025
Medbio and Caplugs bring 100+ years of expertise, offering innovative solutions and seamless support for medical manufacturers. Visit us at Booth #2113 from February 4 - 6 at the Anaheim Convention Center.
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Accumold Brings Micro-Optics Expertise To Photonics West 20251/22/2025
Accumold, a global leader in precision micro injection molding, is excited to kick off the new year with its annual attendance at industry-leading trade shows, starting with SPIE Photonics West in San Francisco, CA, from January 28-30, 2025. The company will be at booth 1853, showcasing cutting-edge micro-molded plastic components that range from 5 cm down to under 1 mm in size, all exhibiting micron-level features.
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Nordson MEDICAL, Boyle Receives MedAccred Accreditation1/15/2025
Nordson MEDICAL’s Boyle, Ireland facility has earned MedAccred accreditation, joining PRI's Qualified Manufacturers List, highlighting its high-performance manufacturing for medical device applications.
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Accumold To Showcase Micro Molding Expertise At MEDevice Silicon Valley 202410/28/2024
Accumold, a leader in precision micro molding, will showcase innovative solutions for medical device OEMs at Booth 1034 during MEDevice Silicon Valley, November 20-21, 2024.
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Accumold Showcases Micro Molding Innovation At Compamed10/22/2024
Accumold is set to participate at Compamed in Düsseldorf, Germany, from November 11-14 where they will highlight their small and complex parts for medical device OEMs.
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New US-Made Precision Motion Stages For Semiconductor, Photonics, Life Science, Scanning, Measuring, Imaging, Alignment Applications10/22/2024
PI Americas has introduced several new families of motorized linear and rotary stages tailored for precision automation, motion control, and positioning applications in the photonics, semiconductor, imaging, and metrology industry.