Medical Device Manufacturing

INDUSTRY PERSPECTIVES

  • Diners, Devices, And Dives
    Diners, Devices, And Dives

    We are often drawn to bright, shiny objects of some sort. This holds true for the medical device industry as well. The top four economic areas in the U.S. for medical device employment in 2015 were Los Angeles, New York City, Boston, and Minneapolis. As I look at my home state of Pennsylvania, I see a microcosm of the national paradigm.

  • Hammering Home A Solution For The Opioid Crisis

    Have you ever accidently struck your thumb or finger with a hammer? What was your immediate reaction? I mean after the few choice expletives! Most, if not all of us, will grab and rub the impacted appendage. Why do we do this, and what does this have to do with a potential solution for the opioid crisis?

  • The Taiwanese Bone Graft Substitute Market: A Small, But Profitable Target

    With less than 25 million residents, Taiwan flies under the radar of many medical device manufacturers. However, the low penetration rate of bone graft substitutes and a rapidly aging population, make Taiwan a potentially lucrative target for orthopedic biomaterial manufacturers considering expansion in the Asia Pacific region.

  • When Regulatory Goes Wrong

    In spite of my preference for “happily ever-after” as detailed in a previous article, sometimes things do not go well for medical device companies as it pertains to regulatory affairs.

  • Incorporating Accessibility Into Medical Device Design

    When incorporating human factors into medical device development, conducting user testing and gathering feedback from the device’s target end users is critical. To do this properly, the end user groups must be appropriately defined.

More Perspectives On Medical Device Manufacturing

WHITE PAPERS & CASE STUDIES

OEMs: Do You Trust Your Medical Device Supplier’s Quality?

As an OEM, it is your responsibility to ensure the parts supplied to you are compliant with ISO regulations. That is no easy task. Ideally, your supplier’s quality systems are strong enough to identify risks, prevent defects, and to catch defects quickly if they do occur. This requires a robust quality management system. When it comes to evaluating the quality systems of your medical device supplier, where do you begin?

The Coming Wave Of Dual-Chamber Systems For Drug Delivery

Selecting and validating the best dual-chamber design option for the delivery of a given pharmaceutical.

Managing The Unpredictability Of The Product Development Process

How development teams need to engage in the holistic, programmatic risk management necessary for a predictable development program.

Manufacturing Under Pressure: Is Lean Your Solution For Cost Savings?

Changes in today’s medical device market and political atmosphere are causing manufacturers to re-evaluate how they do business in order to reduce costs. Can the Lean manufacturing approach to productivity and efficiency be the solution your company needs?

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MANUFACTURING PRODUCTS & SERVICES

Medical Device Contract Manufacturing Medical Device Contract Manufacturing

Contract manufacturing for single-use medical devices is how Phase 2 got their start. They provide ultrasonic cleaning, injection molding, solvent and UV bonding, soldering, annealing, and more manufacturing services to both startup single-use medical device companies and larger-sized OEMs.

Plastic Injection Molding Plastic Injection Molding

PTI’s plastic injection molding services include prototype, short-run, high-volume, and multi-cavity molding for a wide variety of applications. These monitored and controlled processes are completed in-house and contribute to providing competitive advantages in cost, quality, and lead times.

Medical Device Assembly, Kitting and Packaging Services 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.

Medical Device Contract Manufacturing Services Medical Device Contract Manufacturing Services

Carclo offers medical device contract manufacturing services that streamline taking your medical device to market. Services include project management of all capital equipment builds, process and product validation, and serial production.

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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.

Many companies call these ideals “lean” manufacturing, which 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

  • Rapid 3D Printing In Water Using Novel Hybrid Nanoparticles Holds Promise For Old And New Industries

    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.

  • Obamacare Replacement Will Permanently Remove Medical Device Tax

    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.

  • India To Split Med Device Industry From Pharma, Revisit Free Trade Agreements

    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.

  • Wearable THz Scanning Device For Inspection Of Medical Equipment, Human Body

    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.

  • Thinfilm Launches Medical Device Communication Platform

    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.

  • 3D-Printed Camera Small Enough To Be Injected Through a Syringe

    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.

  • Cancer Moonshot Initiative To Speed Cancer Research, Treatment

    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.

  • 3D-Printing Method Uses Multiple Materials At Once, Expands Personalized Medicine Options

    Researchers from Dresden have introduced additive manufacturing (AM) technology that can work with multiple materials at the same time, giving greater design flexibility to the 3D printing process. Their technique — which can work with any combination of plastic, glass, ceramics, or metal — would allow for the quicker production of more complex and personalized bone implants, dentures, or surgical tools.

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