LEAD STORIES

FDA Clarifies Medical Device UDI Marking Process

The U.S. Food and Drug Administration (FDA) has released new draft guidance pertaining to the direct marking of unique device identifiers (UDI) on medical devices. The document contains compliance dates, exemptions, methods of direct marking, and interpretation of "reprocessing" for direct marking requirements. It is the latest in a series of guidance documents related to the FDA's UDI program, which tracks devices in order to assess adverse event reports more effectively.

  • Zimmer Closes Biomet Deal, Sells Knee Implant Biz To Smith & Nephew
    Zimmer Closes Biomet Deal, Sells Knee Implant Biz To Smith & Nephew

    Zimmer's acquisition of Biomet will result in a transaction worth about $14 billion and the new company will be known as Zimmer Biomet Holdings, Inc. The new entity’s headquarters will be in Warsaw, Ind., where both Zimmer and Biomet already were based. The merger is contingent upon Zimmer’s sale of the rights and assets to its U.S. ZUK unicondylar knee implant to London-based Smith & Nephew, as well as Biomet's sale of the rights and assets to its U.S. Discovery Total Elbow implant and Cobalt Bone Cement to Vista, Calif.-based DJO Global, Inc.

  • Google Developing Wristband For Clinical Applications
    Google Developing Wristband For Clinical Applications

    Google has unveiled a new wristband that would provide doctors with "minute-by-minute" clinical information from wearers of the device. Unlike similar wearables from rivals targeting the consumer market, Google's device is being designed to extend clinical and drug studies beyond trial sites. The experimental wristband can measure a wearer's vital signs, such as pulse, heart rhythm, and skin temperature, as well as monitor ambient information, like light exposure and noise levels. 

INDUSTRY PERSPECTIVES

  • European Market For Orthopedic Biomaterials Undergoing Rapid Change
    European Market For Orthopedic Biomaterials Undergoing Rapid Change

    The market for European orthopedic biomaterials (OB) has undergone dramatic changes over the last two years. Prices, quantities sold, and competitors have been in an almost constant state of flux. While quantities sold are marginally increasing, ASPs (average sales prices) are being driven down by an increase in competition. This analysis includes the markets for bone morphogenetic proteins (BMPs), hyaluronic acid viscosupplementation injections, bone graft substitutes, and autologous chondrocyte implantations (ACIs). 

  • That Medical Device Invention Can’t Be Patentable … Can It?
    That Medical Device Invention Can’t Be Patentable … Can It?

    Most medical device and diagnostics innovation is based largely on some understanding of the fundamental laws of nature with respect to biology. However, while most medical device patents describe tangible products or diagnostic methods, laws of nature, natural phenomena, and abstract ideas are not patentable.

  • Rethinking The Medtech Value Curve — Moving Beyond Feature- And Cost-Based Differentiation
    Rethinking The Medtech Value Curve — Moving Beyond Feature- And Cost-Based Differentiation

    All product development ventures face the essential question of whether the opportunity is worth pursuing. Sometime in the distant past, before the hijacking of healthcare by the insurance industry — perhaps 15 or 20 years ago — the path from technology concept to medical device was a straightforward one. If you had an idea with clinical merit, and you were self-possessed and persistent enough, you probably could find a way to get your product to market.

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FROM THE EDITOR

  • 3 Top Trends Driving Medical Device Design In 2015 — Experts Weigh In
    3 Top Trends Driving Medical Device Design In 2015 — Experts Weigh In

    What factors should you consider before designing your next medical device? What capabilities will end users request (or demand?) from new devices in the coming months? What design approaches are your peers taking? What types of designs will be successful in the future?

  • Developing A Surgical Robotics System That Doctors Really Want — And Hospitals Can Afford
    Developing A Surgical Robotics System That Doctors Really Want — And Hospitals Can Afford

    TransEnterix has taken a most unconventional approach to the design of its SurgiBot platform for laparoscopic surgery. While traditional systems are controlled via a console located outside the sterile field, TransEnterix decided to return the surgeon to the patient’s bedside. The result is a robotic surgery system that is quite literally just what the doctor ordered — and that costs a fraction of existing platforms. Med Device Online recently spoke to Todd Pope, the company's president and CEO, about the rigorous process TransEnterix used to incorporate stakeholder feedback from across the healthcare system in SurgiBot’s design.

  • Companies To Watch: Novian Health
    Companies To Watch: Novian Health

    With its novel, laser-based technology, this early-stage company hopes to displace lumpectomy as the standard of care for eliminating breast tumors after early detection.

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WHITE PAPERS & CASE STUDIES

  • Which Antimicrobial Is Right For Your Medical Device?

    Less than 40 percent of U.S. hospitals are in full compliance with HAI guidelines. Today, in order to significantly reduce HAIs and to combat the increased threat of antibiotic-resistant bacteria, many healthcare organizations are adopting broader, more vigilant infection-control strategies that include following guidelines more thoroughly, changing staff behavior, and adopting antimicrobial-treated medical devices and surfaces.    

The Multiplier Effect of Drug-Device Convergence

First-generation drug-device pioneers could not have envisioned today’s landscape. The growing convergence between medical devices, pharmaceuticals, and biologics is transforming these once-separate market sectors, not to mention the state of health care and our quality of life. The global market for drug-device combinations is on track to generate $115 billion in market value by 2019. Thus, opportunity — and demand — abounds for effective treatments combined with innovative drug delivery methods.

Prototyping and Low-Volume Production for the Medical Industry

This comprehensive white paper is about prototyping and low-volume production for the medical industry. It highlights the things that should be taken into consideration when in the midst of developing new medical devices.

Five Trends Transforming The Medical Device Industry In 2015

Brace yourself for another year of opportunities and challenges in the medical device industry. For 2014, we predicted that longer life expectancies, emerging markets, increased regulatory scrutiny and health care reform would drive industry change. As we move into 2015, we see many of those trends continuing to evolve, and some exciting new trends emerging.

Clinical Data For Medical Devices — Preparing For Increased Requirements In The EU

European regulation of medical devices is undergoing significant revision. A significant aspect of The Medical Devices Regulation Proposal is that it represents a bid to raise the regulatory bar on clinical evidence requirements, exposed as inadequate by the scandal of defective breast implants produced by the French Poly Implant Prothèse (PIP). This article focuses on the regulatory changes set to erode the traditional differences between medical device and pharmaceutical clinical studies.

More White Papers & Case Studies

PRODUCT SHOWCASE

Alconox: Powdered Precision Cleaner

Alconox: Powdered Precision Cleaner

Concentrated to save you money. Biodegradable and readily disposable. Penetrating wetting power to save you time. Replaces corrosive acids and hazardous solvents. Free rinsing to give you reliable results and no interfering residues. Use to pass your cleaning validation tests for lab accreditation and plant inspection approval.

High Speed NIR Photodiodes

High Speed NIR Photodiodes

First Sensor offers high-speed epitaxial photodiodes ideally suited for VIS and NIR applications with low operating voltages. These photodiodes are optimized for high speed and maximum sensitivity at 800nm. First sensor can customize the technical or performance parameters of these photodiodes to meet your requirements.

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.

Surface Treatment

Surface Treatment

Carclo Technical Plastics supplies a wide range of coatings and treatments to the surface of plastic components to impart special properties, decoration, improved wear, and increased performance.

Medical Device Contract Manufacturing

Medical Device Contract Manufacturing

Contract manufacturing for single-use medical devices is how Phase 2 got their start. They provide ultrasonic cleaning, injection molding, solvent and UV bonding, soldering, annealing, and more manufacturing services to both startup single-use medical device companies and larger-sized OEMs.

Air/Gas Micro Diaphragm Pumps: T2-05-IC Series

Air/Gas Micro Diaphragm Pumps: T2-05-IC Series

Parker Hannifin’s T2-05-IC Series micro diaphragm pump is designed to fit where other pumps cannot.  The T2-05-IC miniature diaphragm pump is ideal for applications in Negative Pressure Wound Therapy devices.  It offers consistent negative pressure (suction) over the wound site to help aid in the healing process.

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LATEST HEADLINES

  • FDA Clarifies Medical Device UDI Marking Process
    FDA Clarifies Medical Device UDI Marking Process

    The U.S. Food and Drug Administration (FDA) has released new draft guidance pertaining to the direct marking of unique device identifiers (UDI) on medical devices. The document contains compliance dates, exemptions, methods of direct marking, and interpretation of "reprocessing" for direct marking requirements. It is the latest in a series of guidance documents related to the FDA's UDI program, which tracks devices in order to assess adverse event reports more effectively.

  • Blackberry To Design Bacteria-Free Smartphone
    Blackberry To Design Bacteria-Free Smartphone

    Blackberry plans to give healthcare workers one less thing to worry about in the fight against hospital-acquired infections (HAIs) by designing a bacteria-free smartphone. In recent years, Blackberry has lost its foothold in the broader smartphone market, but many believe this move could re-establish the company in the healthcare sector.

  • Human Organ-Mimicking Chip Could Revolutionize Clinical Trials
    Human Organ-Mimicking Chip Could Revolutionize Clinical Trials

    The Organs-on-Chips technology, created at Harvard University’s Wyss Institute, is a piece of clear flexible polymer, roughly the size of a flash drive, that contains hollow microfluidic channels lined with human stem cells coaxed into mimicking a particular organ. So far, the research team has designed chips to mimic fifteen organs including the heart, lungs, liver, eyes, and intestines.

  • Zimmer Closes Biomet Deal, Sells Knee Implant Biz To Smith & Nephew
    Zimmer Closes Biomet Deal, Sells Knee Implant Biz To Smith & Nephew

    Zimmer's acquisition of Biomet will result in a transaction worth about $14 billion and the new company will be known as Zimmer Biomet Holdings, Inc. The new entity’s headquarters will be in Warsaw, Ind., where both Zimmer and Biomet already were based. The merger is contingent upon Zimmer’s sale of the rights and assets to its U.S. ZUK unicondylar knee implant to London-based Smith & Nephew, as well as Biomet's sale of the rights and assets to its U.S. Discovery Total Elbow implant and Cobalt Bone Cement to Vista, Calif.-based DJO Global, Inc.

  • Google Developing Wristband For Clinical Applications
    Google Developing Wristband For Clinical Applications

    Google has unveiled a new wristband that would provide doctors with "minute-by-minute" clinical information from wearers of the device. Unlike similar wearables from rivals targeting the consumer market, Google's device is being designed to extend clinical and drug studies beyond trial sites. The experimental wristband can measure a wearer's vital signs, such as pulse, heart rhythm, and skin temperature, as well as monitor ambient information, like light exposure and noise levels. 

  • FDA Clears Medtronic’s Recapturable, Repositionable TAVR
    FDA Clears Medtronic’s Recapturable, Repositionable TAVR

    Medtronic has announced that its Evolut R transcatheter aortic valve replacement (TAVR) system has been cleared by the U.S. Food and Drug Administration (FDA). This is the second big U.S. win for Medtronic TAVR systems — CoreValve was approved last year — and this newest innovation is the first recapturable and repositionable TAVR system offered in the U.S. TAVR technology was developed as a non-invasive valve replacement alternative for high-risk patients deemed too sick to undergo open heart surgery. 

  • Sorin And Cyberonics Unveil Name Of Combined Company: LivaNova™

    Sorin S.p.A., (MTA; Reuters Code: SORN.MI "Sorin"), a global medical device company and a leader in the treatment of cardiovascular diseases, and Cyberonics, Inc. (NASDAQ: CYBX, "Cyberonics"), a medical device company with core expertise in neuromodulation, today unveiled LivaNova as the name of their combined company, effective at the close of their proposed merger.

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