It may not surprise you to learn that cancer is now the leading cause of early death worldwide, and cancer rates are expected to continue to rise dramatically. Studies project that cancer cases will increase from 14.1 million in 2012 to 24.6 million by 2030. In addition to the lives impacted by cancer, its global economic burden is also staggering — $2 trillion in 2010 alone.
Next-generation stent technology is and will be bio-absorbable or bioresorbable. To gain a richer understanding of the current trends, I sat down with Craig Thompson, MD, who is SVP/CMO of Boston Scientific’s Interventional Cardiology. Dr. Thompson also provided insight behind the SYNERGY Coronary Stent's development.
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 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.
The World Health Organization (WHO) has released a draft proposal for its global regulatory framework for medical devices and in vitro diagnostics (IVDs).
The Council of the European Union (EU) and representatives of the European Parliament have agreed on two long-awaited draft regulations on medical devices and in vitro diagnostics (IVDs). The text documents were not made available, but the Council says the drafts were deliberated upon to make sure that medical devices and IVDs in Europe are safe while allowing patients to benefit from innovative health care solutions in a timely manner.
Recognizing the strategic advantages of conducting Early Feasibility Studies in the US, the Medical Device Innovation Consortium (MDIC) sought to develop a Blueprint for Early Feasibility Study Success, a best practices guidelines for planning and executing US-based Early Feasibility Studies.
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.
Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement after introduction of legislation in the U.S. Senate, S. 2998, to expedite CMS decision-making for innovative medical technologies:
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.