3D printing of medical devices will revolutionize and disrupt healthcare as we know it. The U.S. Food and Drug Administration (FDA) has already cleared more than 80 medical devices and one prescription drug that are produced by 3D printing techniques.
Year after year, design control deficiencies rank as the top reason medical device companies receive 483 observations; such deficiencies also rank in the top three reasons for warning letters. Most, if not all, of these FDA actions are avoidable. Let’s dive deeper into why your design control and risk management processes may be failing, and discuss what you can do about it.
Innovation can often upset the apple cart, especially in cases where new and unfamiliar technologies are utilized to enable new functionality. This less-than-optimal user experience can hurt the product’s adoption and lead to high rates of abandonment. Here are five suggestions to ensure that new designs lead to safe, effective, and desirable outcomes.
The first part of this article examined how China’s healthcare reform, within the context of the 13th Five-Year Plan, affected Chinese diagnostic imaging vendors. Here, we examine the role of foreign manufacturers, as well as the challenges and opportunities they face.
The orthopedic implant industry is in a continual state of development, witnessing an explosion of novel materials, designs, and applications. This process is, however, often laced with challenges and articulating joints can present the greatest number of these. By Aia Malik, Lucideon, and Chris Pickles, Ph.D.
Fused Deposition Modeling™ (FDM® ) can be used to produce an array of medical devices; however, for such devices to be practical, they must be manufactured using sterilizable materials. By David Espalin, Francisco Medina, Mireya Perez, and Ryan Wicker, The University of Texas at El Paso; and Terry Hoppe and Rob Winker, Stratasys
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.
The complexities of implantable medical devices such as stents, intraocular lenses, prosthetics, and catheters have increased dramatically to meet new usage demands and improve patient outcomes. The advanced features and materials used for the fabrication of these devices has proven to be a challenge. As stent-strut sizes continue to shrink and the quality of cut edges becomes more critical, the degree of precision needed is more difficult to achieve. Ultrashort-pulse lasers are on their way to becoming the tool of choice for creating these medical devices with high precision. This article discusses the technology behind ultrashort-pulse lasers and how they are used in the process of micromachining ultrafine stents, bioabsorbable stents, and many other devices.
There’s a need for better access to medical technology in the region — a forward-looking approach will help companies reach more patients.
Medtronic and Qualcomm will collaborate on the development of future-generation continuous glucose monitoring (CGM) systems for diabetics, starting with a single-use CGM device that will utilize a new, smaller sensor that monitors blood glucose levels in real-time, helping general practitioners caring for patients with type 2 diabetes.
An FDA panel has issued the green light for St. Jude’s Aplatzer PFO Occluder device, saying studies of the device showed “reasonable assurance” that the device was safe for use. The implant, which is intended to prevent recurrent ischemic strokes in patients with patent foramen ovale (PFO), has been the subject of controversy for decades, and the panel’s decision represents a major milestone for the technology, said St. Jude executives.
Toyota announced a strategic partnership with Segway inventor Dean Kamen and his company Deka Research and Development to develop the next-generation iBot, a motorized wheelchair capable of self-balancing and climbing stairs. The deal will give Toyota access to Deka’s proprietary balancing technology while providing Deka with the necessary funds to launch iBot and other potential collaborative projects.
Varian Medical Systems plans to spin off its imaging components business into a new independent, publicly traded company with projected annual revenues of $574 million and 1,300 employees worldwide. The move will allow Varian to concentrate on its radiation oncology business.
Royal Philips recently announced the launch of a new handheld blood test, the Minicare I-20 system, for rapid diagnosis of a heart attack at the point of care.
The US Food and Drug Administration (FDA) has issued final guidance for manufacturers subject to postmarket surveillance requirements of certain Class II and Class III medical devices under Section 522 of the US Federal Food, Drug and Cosmetic Act (the Act), as amended by Section 212 of the Food and Drug Modernization Act (FDAMA) of 1997, and Section 212 of the Food and Drug Modernization Act (FDAMA) of 1997.
The National Institute on Alcohol Abuse and Alcoholism (NIAAA), an arm of the National Institute of Health (NIH), has awarded a $200,000 prize to San Francisco-based startup BACtrack for its wristband that monitors blood alcohol concentration (BAC) in sweat. The developers say the device could aid alcoholism research and treatment.
Vectura Group plc (LSE: VEC) and Propeller Health, the leading digital health solution for respiratory medicine, today announced a collaboration to develop inhalers that combine Vectura's proven dry powder inhaler ("DPI") technology with Propeller's FDA-cleared digital health platform.