LEAD STORIES

Off–Label Promotion Or Scientific Exchange? A Multimillion Dollar Question

Medical device industry headlines have been dominated in recent months by the significant regulatory oversight applied to promotional claims made for medical products, as well as the penalties imposed when manufacturers run afoul of those regulations. In this article, we outline best practices for companies wishing to proactively install safeguards between scientific and promotional exchanges with physicians and other HCPs.

  • Stent Retrievers, Left Atrial Appendage Occlusion Devices Could Revolutionize Stroke Care
    Stent Retrievers, Left Atrial Appendage Occlusion Devices Could Revolutionize Stroke Care

    In light of new evidence from recent clinical trials, the American Heart Association (AHA) and the American Stroke Association (ASA) are, for the first time, recommending stent retriever devices as endovascular treatment for acute ischemic stroke in select patients. Additionally, the American College of Cardiology, Heart Rhythm Society, and the Society for Cardiovascular Angiography and Interventions recently released a joint overview on left atrial appendage occlusion devices and their ability to prevent stroke in patients suffering from atrial fibrillation.

  • J&J Subsidiary Invests $3.2M In Bariatric Surgery Studies
    J&J Subsidiary Invests $3.2M In Bariatric Surgery Studies

    Ethicon, a subsidiary of Johnson & Johnson, has invested $3.2 million into studying the effects of bariatric surgery on obesity and Type 2 diabetes. The funds will be allocated toward more than 20 clinical trials to be conducted in five countries. Data collected may lead to better access to bariatric and metabolic surgeries worldwide. According to the World Health Organization  (WHO), 1.9 billion people are overweight, and 600 million are obese, a figure that has nearly doubled since 1980. 

INDUSTRY PERSPECTIVES

  • Off–Label Promotion Or Scientific Exchange? A Multimillion Dollar Question
    Off–Label Promotion Or Scientific Exchange? A Multimillion Dollar Question

    Medical device industry headlines have been dominated in recent months by the significant regulatory oversight applied to promotional claims made for medical products, as well as the penalties imposed when manufacturers run afoul of those regulations. In this article, we outline best practices for companies wishing to proactively install safeguards between scientific and promotional exchanges with physicians and other HCPs.

  • 5 Things To Know Before Entering The Chinese Medical Device Market
    5 Things To Know Before Entering The Chinese Medical Device Market

    The Chinese medical device market, according to statistics and economic forecast, is an increasingly attractive place to invest because of many interrelated factors, described more extensively in the first article in this series, Chinese Medical Device Market: Opportunities And Challenges.

  • Achieving Realism In Human Factors Work: How To Stay Out Of Fantasy Land
    Achieving Realism In Human Factors Work: How To Stay Out Of Fantasy Land

    In our last article, we discussed the key ingredients in a summative usability study. Here, we would like to focus more in-depth on a central issue related to usability studies — “representativeness.” One of the terms the FDA repeatedly uses in describing the requirements regarding usability studies is “representative." We interpret this as a call to infuse every step of the device-development process with as much realism as possible.

     

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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.

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PRODUCT SHOWCASE

Micro Prisms

Micro Prisms

Micro prisms have a minimum of two plano surfaces that are separated by a wedge angle. Precision Optics Corporation manufactures prisms as small as 0.18 mm to rotate, deflect, and deviate beams of light and disperse their wavelengths.

Medical Device Engineering Services

Medical Device Engineering Services

Phase 2 Medical employs an engineering team with vast experience in the complexities of assembling, testing, and packaging single-use, disposable medical devices. Their engineers specialize in the LEAN manufacturing of medical devices.

New, Very Small PIN Module for Radiation Detection

New, Very Small PIN Module for Radiation Detection

This radiation detection module from First Sensor combines a 100 mm2 photodiode with an 8 mm CsI:Tl scintillator. The module measures only 17 by 16 by 19 mm and detects gamma radiation in the energy range of 150 to 1500 keV.

Thick Film Aluminum Heaters

Thick Film Aluminum Heaters

Heatron’s line of thick-film aluminum heaters are ideal for a wide variety of medical devices. This includes machines for dialysis, DNA analysis and blood testing, surgical devices, MRI equipment, and CPAP.

Ethylene Oxide (EO) Sterilization of Medical Devices

Ethylene Oxide (also known as EO or EtO) sterilization is a simple chemical compound that is commonly used for gaseous sterilization of disposable medical devices and healthcare products. A wide variety of materials and components commonly used in the manufacture of these products may undergo ethylene oxide sterilization in their final breathable packaging configuration.

High-Temperature Injection Molding

High-Temperature Injection Molding

High temperature plastic resins provide physical and dimensional stability and excellent elasticity. They’re resistant to harsh chemicals and hydrolysis and feature exceptional electrical properties and low flame and smoke toxicity.

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LATEST HEADLINES

  • Device and Drug Manufacturers Paid $6.49B To Doctors, Hospitals in 2014
    Device and Drug Manufacturers Paid $6.49B To Doctors, Hospitals in 2014

    According to a federal government report, medical device and drug manufacturers paid out $6.49 billion to doctors and teaching hospitals in 2014 to promote their products. While many support the Physician Payments Sunshine Act’s (PPSA) effort to create more financial transparency, some feel it is damaging U.S.-led innovation and industry investment.

  • FDA Exempts 120 Medical Devices From PMA Requirements
    FDA Exempts 120 Medical Devices From PMA Requirements

    The U.S. Food and Drug Administration (FDA) has released a list of 120 medical devices it intends to exempt from premarket notification requirements. The FDA has deemed these devices sufficiently well understood that further regulatory review is unnecessary to ensure their safety and effectiveness before they hit market. Among the products slated for exemption are dentures, hearing aids, and surgical lights/lamps.

  • FDA Approves Alternate Confirmation Test for Bayer's Permanent Birth Control Device

    Bayer HealthCare has announced that the U.S. Food and Drug Administration (FDA) has approved the use of transvaginal ultrasound (TVU) as an alternate confirmation test for Essure permanent birth control. A confirmation test must be given three months following the Essure procedure to confirm that the device is properly placed and the woman can rely on Essure for birth control. 

  • B. Braun Acquires Lauer Membran Wassertechnik GmbH

    B. Braun Medical Inc. has announced that B. Braun Avitum AG has acquired Lauer Membran Wassertechnik GmbH to round out its extensive portfolio of water treatment systems for dialysis. The Aquaboss system, which is manufactured by family-owned Lauer, is one of the world's leading premium water treatment systems for dialysis. 

  • Fischer Connectors Introduces New Ultra-Sterile Connector: Fischer Core Series Stainless Steel
    Fischer Connectors Introduces New Ultra-Sterile Connector: Fischer Core Series Stainless Steel

    Fischer Connectors introduces the new line of stainless steel connectors and cable assembly solutions – the Core Series Stainless Steel. These new circular connectors offer excellent chemical, temperature, and radiation resistance in severe environments found in nuclear or medical applications.

  • Novartis' Alcon Gets CE Mark For IOL

    Alcon, a division of Novartis, has received European CE Mark for its AcrySof® IQ Aspheric IOL with the UltraSert™ Pre-loaded Delivery System for patients undergoing cataract surgery. The new delivery system combines the control of a manually loaded device with the safety and convenience of a disposable, pre-loaded injector to optimize implantation of the AcrySof IQ Aspheric IOL. 

  • Patterson Companies Announces Definitive Agreement To Sell Its Medical Business To Madison Dearborn Partners

    Patterson Companies, Inc. has announced a definitive agreement to sell its medical business (Patterson Medical) to Madison Dearborn Partners (MDP), a leading private equity firm based in Chicago, for gross proceeds of approximately $715 million in cash. The sale is expected to close in the fiscal second quarter, following the satisfaction of regulatory requirements and other customary closing conditions.

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FEATURED SUPPLIERS

Alconox, Inc.

Alconox, Inc.

With more than 60 years of experience in formulation of quality aqueous cleaners, Alconox Inc. understands the cleaning needs of the medical device manufacturing industry including stringent FDA regulations and GMP compliance.