FEATURED EDITORIAL

FDA’S 3D Printing Draft Guidance Leaves Much Unresolved, Even More Unknown
FDA’S 3D Printing Draft Guidance Leaves Much Unresolved, Even More Unknown

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.

  • 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.

  • China’s Diagnostic Imaging System Market: Foreign Vendor Opportunities & Challenges
    China’s Diagnostic Imaging System Market: Foreign Vendor Opportunities & Challenges

    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. 

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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

Medical Micromolding Medical Micromolding

MTD Micromolding is solely committed to providing the highest quality micromolding services of advanced medical products. MTD offers their innovative skills in exploring and producing very small, delicate, and intricate components required for advanced medical applications and products such as specialized surgeries, bioabsorbable devices, and implant devices. With a constant demand for newer, smaller, never-before-seen micro medical devices, MTD is also prepared to assist their strategic partners in the development of new solutions.

Medical Device Technical Support and Validation Services

Together, the STERIS Isomedix Services TechTeam® experts and Biotest Laboratories assist medical device manufacturers with sterilization validation and laboratory testing services, providing a single source for every stage of the sterilization design process, from product development through routine processing. The Biotest Laboratories team also provides consulting and testing services for reusable medical device cleaning, disinfection and sterilization.

Custom Packaging And Pouching Custom Packaging And Pouching

As demands in customer packaging and pouching grow in sophistication, ATL has kept pace by expanding our packaging capabilities. We have the engineering expertise to go beyond typical "cookie-cutter" type packaging modes in order to accommodate your one-stop supplier needs.

Device Security

Identify and resolve potential cyber security threats for regulatory compliance with BATTELLE DeviceSecure™ Services – a suite of cyber security services for medical devices. DeviceSecure Services combine expertise in cybersecurity, medical device design, hardware and software development, and user experience for a complete solution to your challenges in cybersecurity for medical devices.

Biologic and Pharmaceutical Sterilization Biologic and Pharmaceutical Sterilization

Peracetic Acid (PAA) vapor is a gentle, room temperature sterilization method available for fragile biologicals. Since large molecule biologics have a complex molecular structure, the Revox sterilization process is ideal for ensuring sterilization while leaving delicate proteins intact and not harming the efficacy of the biologic. 

Assembly And Packaging Assembly And Packaging

Assembly, packaging and sterilization for critical medical devices are vital processes that Donatelle performs with unparalleled rigor and skill. Options are available to choose from white room, ISO 7 (class 10,000) or ISO 8 (class 100,000) cleanroom assembly and packaging, in Donatelle’s vertically integrated facility.

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FEATURED SUPPLIERS

Micro Systems Technologies Micro Systems Technologies

Starting with the specifications phase, through design, prototypes up to volume production, the MST Group is your reliable partner for turning any of your ideas into a marketable product.

Medtronic Medtronic

As a global leader in medical technology, services and solutions, Medtronic improves the lives and health of millions of people each year. We use our deep clinical, therapeutic, and economic expertise to address the complex challenges faced by healthcare systems today.

DOUG'S LATEST COLUMNS

Doug's Latest Columns

LATEST HEADLINES

  • 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.

  • 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.

  • Philips Launches Handheld Blood Test For Rapid, Point-Of-Care Diagnosis Of Heart Attack
    Philips Launches Handheld Blood Test For Rapid, Point-Of-Care Diagnosis Of Heart Attack

    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.

  • FDA Releases Final Guidance On Postmarket Surveillance Of Medical Devices
    FDA Releases Final Guidance On Postmarket Surveillance Of Medical Devices

    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.

  • Wearable Biosensor That Measures Blood Alcohol In Sweat Wins NIH Prize
    Wearable Biosensor That Measures Blood Alcohol In Sweat Wins NIH Prize

    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, Propeller Health To Co-Develop Digitally Connected Inhalers

    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.

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