Medical Device Manufacturing

INDUSTRY PERSPECTIVES

  • “We Are Only Diabetes”
    “We Are Only Diabetes”

    Medical device companies often face difficult choices regarding their products, from design tweaks and regulatory red tape to determining whether to solve needs in-house or outsource.One uniquely difficult decision, though, is whether to diversify — and how much — or to specialize.

  • 2018 – Good For The Device Industry, Good For Patients, Good For FDA

    I recently assembled a forward-looking article for Life Science Leader magazine, blending feedback from seven medical device industry leaders, who discussed industry trends for 2018. Here, I share the full set of responses from Maureen L. Mulvihill, co-founder, owner, and CEO at Actuated Medical, Inc.

  • 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.

  • 5 Things Medical Device Engineers Should Know About User Research

    When designing a medical device, nothing beats direct observation of, and feedback from, the people who will be using it. Ideally, this research is performed as a close partnership between the human factors (HF) researchers and the engineers who will be working on the device.

  • India Looking To Local Solutions For Domestic Medtech Needs

    For most of the last century, innovation in the medical device ecosystem has emerged from rich countries: the United States, Japan, Europe, and Australia. But today, a thriving ecosystem has developed across India, driven in part by unique needs in India and in part by the cross-fertilization of ideas, education, and capital from American sources. In this article, we look at three startups that are addressing India’s unique problems today, but may eventually bring their solutions to a global audience.

More Perspectives On Medical Device Manufacturing

WHITE PAPERS & CASE STUDIES

Assuring Reliability In Medical Device Manufacturing Using Automation And A Digital Factory

.A fail-safe, fast response strategy for manufacturing reliable medical electronics in a controlled, data-rich, and cost-efficient environment.

Why Predictability Matters In High-End PCB Manufacturing

Predictability is essential for PCB manufacturing. Without it, a product’s reliability cannot be assured. Conventional approaches to predictability often fall short. Inspection, for example, only reveals superficial flaws. Micro sectioning is destructive in nature and inadequate for complex PCBs with thousands of vias. 

How To Avoid Compliance & Timeline Risks When Selecting A Medical Device Supplier

Discover the 9 elements of a predictable quality system when evaluating CMO partners. Predictable quality shortens your time to market, reduces your compliance risk, and reduces risk to the patient.

Giant Step Forward For Neural Bypass Technology

How recent accomplishments are taking science a step closer to realistically fixing paralysis.

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MANUFACTURING PRODUCTS & SERVICES

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 Injection Molding Medical Device Injection Molding

Carclo is a specialist in the development and manufacture of injection molded components and assembled devices for the medical, pharmaceutical, diagnostics, and ophthalmic industries. Our engineering depth and leading-edge technology ensure superior results for our medical products.

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.

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.

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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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