FEATURED EDITORIAL

Confronting A Global Radiotherapy Shortfall
Confronting A Global Radiotherapy Shortfall

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.

  • Bioresorbable Polymers: The Next Generation In Stent Technology
    Bioresorbable Polymers: The Next Generation In Stent Technology

    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.

  • 8 Reasons Design Controls And Risk Management Processes Fail
    8 Reasons Design Controls And Risk Management Processes Fail

    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.

  •  Innovative vs. Intuitive: 5 Ways To Ensure Novelty Doesn’t Compromise Usability
    Innovative vs. Intuitive: 5 Ways To Ensure Novelty Doesn’t Compromise Usability

    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.

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INDUSTRY INSIGHTS

  • Tribology And Testing Of Orthopedic Implants

    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.

Sterilization Of 3D Printed Medical Devices

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

An Introduction To Manufacturing Execution Systems For The Medical Device Industry

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.

Ultrashort-Pulse Laser Micromachining Advances Implantable Medical Devices

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. 

Meeting Growing Asia-Pacific Demand For Medical Technology

There’s a need for better access to medical technology in the region — a forward-looking approach will help companies reach more patients.

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SOLUTIONS

Liquinox: Critical-Cleaning Liquid Detergent Liquinox: Critical-Cleaning Liquid Detergent

Concentrated to save you money, this detergent replaces corrosive acids and hazardous solvents. It’s phosphate-free, biodegradable, readily disposable, and is free-rinsing to give you reliable results and no interfering residues.

Secondary Operations Saving Time And Money Secondary Operations Saving Time And Money

PTI has exceptional plastic joining experience, technical expertise, and responsive services in place to meet secondary assembly challenges. This experience alongside their designs for manufacturability enables PTI to provide the best methods for matching important assembly requirements and other add value services.

3M™Comply™Chemical Indicators 3M™Comply™Chemical Indicators

3M presents a wide series of Class 1, Class 2, Class 4, and Class 5 chemical indicators that are internal pack monitors for steam, ethylene oxide, or vaporized hydrogen peroxide sterilization cycles. These indicators are designed to provide clear visual pass/fail results showing if sterilization conditions have been met.

Solenoid Valves: IEP Series Solenoid Valves: IEP Series

The IEP Series is made up of 2-way, extended performance, axial-flow solenoid operated valves. Each of these valves are supplied with a 1/16” inlet and outlet stainless steel tubing, allowing the valves to be connected through the use of standard high-pressure chromatography fittings, or welded directly in place.

Digital Encoder Galvano Scanner: GM-1000 Series Digital Encoder Galvano Scanner: GM-1000 Series

The GM-1000 series of digital encoder galvano scanners is comprised of four different models with variations in beam diameter, scan angles, small step response, and resolution. Each model has a compact physical profile, super low thermal drift, and extreme high resolution, precision, and accuracy.

Infrared Camera for Non-Contact Temperature Measurement: A6700sc Infrared Camera for Non-Contact Temperature Measurement: A6700sc

FLIR’s A6700sc is a mid-wave infrared camera ideal for use as a non-contact temperature measurement device in the R&D and quality assurance testing phases of medical device development.

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FEATURED SUPPLIERS

Ophir Photonics Ophir Photonics

Ophir Photonics, a Newport Corporation, began making laser power meters, energy meters, and beam profilers in 1979, and we’ve never looked back. We have headquarters in the United States, Israel, Japan, and Germany, as well as distributors in over 50 countries worldwide.

MTD Micro Molding MTD Micro Molding

MTD is a focused micro medical device manufacturer that’s built for high performance in one area: the micro molding of advanced medical products. Our experienced team will consult with you to help you refine and develop your design, using the most advanced materials and micro molding technology. We’re here to help our customers it right – from design through production – so companies can produce a high quality device, and get it to market quickly.

DOUG'S LATEST COLUMNS

Doug's Latest Columns

LATEST HEADLINES

  • World Health Organization (WHO) Unveils Global Regulatory Framework For Medical Devices
    World Health Organization (WHO) Unveils Global Regulatory Framework For Medical Devices

    The World Health Organization (WHO) has released a draft proposal for its global regulatory framework for medical devices and in vitro diagnostics (IVDs).

  • EU Reaches Accord On New Medical Device, In Vitro Diagnostics Regulations
    EU Reaches Accord On New Medical Device, In Vitro Diagnostics Regulations

    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.

  • Medical Device Innovation Consortium Releases Draft Blueprint For Early Feasibility Study Success

    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, Qualcomm Join Forces To Develop Continuous Glucose Monitors
    Medtronic, Qualcomm Join Forces To Develop Continuous Glucose Monitors

    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.

  • FDA Panel Votes 15-1 To Approve St. Jude’s Stroke Prevention Device
    FDA Panel Votes 15-1 To Approve St. Jude’s Stroke Prevention Device

    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.

  • Senate Bill Would Streamline CMS’s Process For Breakthrough Technologies

    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 Partners With Segway Inventor Kamen To Develop Stair-Climbing Wheelchairs
    Toyota Partners With Segway Inventor Kamen To Develop Stair-Climbing Wheelchairs

    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 Spins Off Imaging Components Business
    Varian Medical Spins Off Imaging Components Business

    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.

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UPCOMING TRAINING COURSES

FDA's New Guidance on Comparability Protocols: What You Need to Know June 7, 2016
1pm-2:30pm EDT, Online Training
Best Practices in CMC Dossier Preparation – Facing Tough Challenges June 9, 2016
Special Time for EU and US Participants - 10:30am-12pm EDT, Online Training
NEW FDA Data Integrity Draft Guidance – Key Points to Understand June 14, 2016
1pm-2:30pm EDT, Online Training
Monitoring Electronic Health Records (EHRs): Frequently Asked Questions June 16, 2016
1pm-2:30pm EDT, Online Training
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