Medical Device Manufacturing
INDUSTRY PERSPECTIVES
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![AI-GettyImages-2161301983]( "How AI Is A Game-Changer For Auditing Compliance And Efficiency")
How AI Is A Game-Changer For Auditing Compliance And EfficiencyIn 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.
Few life sciences companies are ready for a disaster, particularly a cyber one. Key factors include an integrated approach to cyber preparedness and risk planning, a dedicated team, and more.
Medical device labels that lack information or contain inaccurate information may lead to product recalls or delays in product release. Generative AI offers a solution to streamline the labeling development process.
Article 16 of the European Union’s Medical Device Regulation and In Vitro Diagnostic Regulation specifically address the obligations of importers and distributors who engage in relabeling and repackaging activities.
WHITE PAPERS & CASE STUDIES
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![GettyImages-1938951579-automation-filling-bottles-modern-robot-manufacturing]( "Success In Times Of Crisis: A Journey From Concept To Market In 8 Months")
Success In Times Of Crisis: A Journey From Concept To Market In 8 MonthsMedbio 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.
Explore how medical device companies aim to balance patient safety with environmental stability by offering bio-based UHMWPE, reducing carbon footprints by up to 70%.
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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SMC Ltd. Announces Expansion For Costa Rica Facility4/7/2021
SMC Ltd. announced the expansion of its Facility in Costa Rica. With continued growth, SMC’s Costa Rica newest expansion allows for additional clean room molding and contract manufacturing capacity. The expansion will double its current facility bringing it to 120,000 square feet in the Coyol Free Zone Park in Alajuela, Costa Rica.
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Rapid 3D Printing In Water Using Novel Hybrid Nanoparticles Holds Promise For Old And New Industries8/1/2017
Researchers at the Hebrew University of Jerusalem’s Center for Nanoscience and Nanotechnology have developed a new type of photoinitiator for three-dimensional (3D) printing in water.
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Obamacare Replacement Will Permanently Remove Medical Device Tax3/9/2017
Republican leaders in the U.S. House of Representatives have unveiled proposed legislation to repeal and replace the Affordable Care Act, which, among several tax cuts, will eliminate permanently the 2.3 percent excise tax on medical devices and products.
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India To Split Med Device Industry From Pharma, Revisit Free Trade Agreements2/14/2017
Moves under consideration include separation of medtech from its pharmaceutical industry, increased government funding for the medtech industry, and the renegotiation of existing free trade agreements (FTAs) with other countries. The device industry also is asking the government to recognize local regulatory certifications, in addition to the currently accepted FDA approval from the U.S.
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Wearable THz Scanning Device For Inspection Of Medical Equipment, Human Body11/17/2016
Scientists at Tokyo Institute of Technology have developed a portable and wearable terahertz scanning device made using arrays of carbon nanotubes, for applications including non-invasive inspection of equipment such as syringes, and imaging of cancer cells, blood clots, and teeth. The findings are published in Nature Photonics, November 2016.
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Thinfilm Launches Medical Device Communication Platform7/8/2016
Norwegian printed electronics maker Thinfilm has partnered with an unidentified Fortune 500 pharmaceutical firm to build a near-field communication (NFC) platform for medical devices to help patients adhere to treatment regimens and connect with healthcare providers.
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3D-Printed Camera Small Enough To Be Injected Through a Syringe7/1/2016
German scientists have produced a camera, using additive manufacturing with a femtosecond laser printer, capable of building free-form optics. Researchers claim that technology opens possibilities for micro- or nano-optical devices, such as endoscopes and mini-robots with autonomous vision, and paves the way for a “paradigm shift” in medical imaging that could be injected into the body through a syringe.
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Cancer Moonshot Initiative To Speed Cancer Research, Treatment6/30/2016
United States Vice President Joe Biden led the National Cancer Moonshot Summit in Washington, D.C. to call on patients, families, advocacy groups, researchers, scientists, physicians, organizations, and companies to work together in accelerating the diagnosis, treatment, and research toward cures for cancer.