Because FDA requirements focus heavily on usability issues related to safety, device developers can fall into the trap of assigning less meaning to usability problems that won’t cause harm. But, it is not always possible to catch all unanticipated use errors during validation, and usability problems not directly related to safety risks can still affect purchasing decisions and device acceptance.
If you’re trying to decide whether to hire a product development firm, or determine which one is best for your needs, the key questions you should ask establish a checklist to make sure the firm follows best practices, and reveals more nuanced aspects of how the firm performs its work.
A product's entire evolution, from thoughtful design through prototypes and iteration, inherently becomes the footing for an efficient transition to manufacture. The steps discussed here identify what to expect, and how to respond as a team to move a well-designed device to volume production.
Companies seek to manage production, shorten lead times, and lower costs, as well as improve their competitive edge through collaborative partnerships and outsourcing, but this is no longer sufficient to meet increasing market demands.
When implementing a recall, medical device manufacturers may study the event, risk management files, and product evaluations, using their findings to implement quality and reliability improvements - turning a negative occurrence into a positive force for improvement.
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.
The use of silicone rubber in medical implant devices continues to grow exponentially in many types of applications. As a highly biocompatible material, medical-grade silicone is utilized in many critical devices such as defibrillators, heart pumps, and surgical reconstructive components. This article offers a brief overview of the history of biocompatible silicone, new testing and standards, and the issues regarding biocompatibility and patient safety.
As the FDA’s next deadline for the unique device identification (UDI) of Class II devices draws closer, medical device manufacturing companies are looking to further their UDI implementation, whether they are well on their way to success or they haven’t even started. Barcoding, or identifying products via GS1 regulatory standards, is essential for companies wishing to be up to date on UDI implementation. Unfortunately, companies may be delaying UDI implementation because they view the new regulations as something an organization can address quickly. This is not the case. This article discusses the importance of viewing UDI implementation as process that encompasses the entire company rather than just as a “quick fix.”
Radio frequency (RF) ablation uses RF energy to ablate or destroy unwanted tissues. When delivered via a catheter, it offers a minimally invasive treatment for a wide variety of conditions, including atrial fibrillation (AF). These systems typically include a peristaltic pump to provide cooling or temperature control, and this pump must be able to produce and control the high pressures (up to 130 psi) required in this application.
Manufacturing Execution System (MES) solutions have the potential to generate efficiencies, improve productivity, and simplify compliance within the medical device manufacturing industry. Used to manage production activities, this class of software typically provides the ability to schedule activity, deliver instructions to operators, synchronize manual activities with automated processes, and integrate with manufacturing computer systems to enable quality control, deviation management and effective enterprise resource planning (ERP), equipment management, and the documenting of floor activities for monitoring and reporting purposes.
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.
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.
Nanoelectronics research center imec and Holst Centre, an open-innovation initiative set-up by imec and TNO, today presented a 0.6V ECG readout chip in 40nm technology based on time-domain circuit techniques. The chip maintains consistent beat detection capabilities, even under movement (~40mVpp), paving the way to a low cost, low power multi-sensor Systems-on-Chip (SoCs) solution for wearable medical applications.
Amada Miyachi America, Inc., a leading manufacturer of welding equipment and laser processing systems, announces the introduction of its LF Series fiber lasers specifically designed for precision micro welding.