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.
I had given a good manufacturing practice (GMP) refresher session in a company whose mantra was efficiency and speed. After the session, a manufacturing operator talked to me about employees’ frustration with the situation, saying, "Why don't people understand that if we focus on doing things right, efficiency will come?"
What are contract manufacturers (CMs) really looking for when they size up a medical device OEM or other medtech firm? Finding out could lead to the right match, and even a trip down “the aisle” — to regulatory approval (if necessary), to market, and to revenue.
Innovation in Class III medical devices — such as pacemakers, defibrillators, and implantable nerve stimulators — continues to accelerate at a rapid rate. Medical OEMs are designing more innovative and technically complex products in smaller form factors. Manufacturing is creating the tools to keep up, though.
When a medical device fits into the user’s life, he or she is more likely to use it as intended. Patients are much more than the disease being treated. They are human beings with full lives, and they don’t always want to be reminded that they are “sick.”
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?
Selecting and validating the best dual-chamber design option for the delivery of a given pharmaceutical.
How development teams need to engage in the holistic, programmatic risk management necessary for a predictable development program.
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?
Liquid polymer crystals are important in day to day use, especially in medical device fields and applications. This article introduces liquid crystal polymers and discusses their origin, structures, behaviors, and uses in thermoplastics and fibers with potentially broad applications.
Drug Delivery Device Design and Development, from Concept Forward
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.
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.
Phase 2 Medical’s Rochester, NH location was recently outfitted with 2,500 sq. ft. ISO Class 8 (100,000) cleanroom facility with an injection molding press. This was done in an effort to integrate quality plastic components in their customers’ disposable medical devices.
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.
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.
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.
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.
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.
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.
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.
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.
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.
