LEAD STORIES

Report: BD To Sell Respiratory Device Business After CareFusion Merger

Medical device and supplies manufacturer Becton Dickinson (BD) is reportedly preparing to sell its respiratory device unit in the wake of its deal to acquire CareFusion. An unnamed sources with knowledge of BD’s plans said that the company is disposing unwanted assets, the largest of them being the respiratory device business.

  • First Working Tricorder Prototype Revealed
    First Working Tricorder Prototype Revealed

    Canadian startup Cloud DX unveiled a working prototype of its all-in-one diagnostic device at the recent South by Southwest (SXSW) Festival in Austin, TX. Cloud DX is one of 10 finalists in the Qualcomm Tricorder XPRIZE competition, which will award $10 million to a team that develops a mobile, consumer-friendly device capable of diagnosing 15 diseases and monitor vital signs for 72 hours.

  • Experts Divided On FDA’s Approach To Medical Device Regulation
    Experts Divided On FDA’s Approach To Medical Device Regulation

    The U.S. Food and Drug Administration (FDA) attempts to walk the fine line between protecting public health safety and encouraging the development of innovative medical devices. There is no shortage of differing opinions on whether or not the FDA’s current regulatory approach towards medical devices should be overhauled, slightly tweaked, or stay the course.

INDUSTRY PERSPECTIVES

  • Cybersecurity As A Competitive Differentiator For Medical Devices
    Cybersecurity As A Competitive Differentiator For Medical Devices

    In 2013, the Food and Drug Administration (FDA) issued its first cybersecurity safety communication, followed in 2014 by final guidance. While it took the agency much longer to focus on cybersecurity than many of us would have liked, I think it struck a reasonable balance between new regulations (almost none) and guidance (in the form of nonbinding recommendations).

  • Are You Sure You Know The Best Regulatory Pathway For Your New Medical Device?
    Are You Sure You Know The Best Regulatory Pathway For Your New Medical Device?

    So, you’ve determined the appropriate FDA classification for your medical device or diagnostic product, and now it’s time to select a premarket submission pathway. Pretty straightforward decision, right? If your technology is substantially equivalent to a currently marketed device (or predicate) then you file a 510(k). If not, or if your device falls into Class III, then the premarket approval (or PMA) is the route for you. Well... not necessarily.

  • Supporting Medtech Innovation Requires Changes To New Payment Paradigms
    Supporting Medtech Innovation Requires Changes To New Payment Paradigms

    The unintended consequences of accountable care organizations (ACOs) and bundled payment initiatives.

More Industry Perspectives

FROM THE EDITOR

  • 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.

  • 3D-Printed Injection Molding: The Future Of Rapid Prototyping?
    3D-Printed Injection Molding: The Future Of Rapid Prototyping?

    3D printing has fundamentally changed the way medical devices are prototyped and tested; however, the technology can carry a product only so far into the development process, primarily due to material constraints. Injection molding (IM) can generate highly accurate prototypes in final production materials, but the process is not without its own drawbacks. Now, a hybrid prototyping process has emerged, offering medical device developers the best of both worlds — the speed and economy of 3D printing combined with the material and accuracy advantages of IM.

  • Development Of A Pathogen Inactivation System To Stop Ebola And Other Deadly Outbreaks
    Development Of A Pathogen Inactivation System To Stop Ebola And Other Deadly Outbreaks

    It wasn’t so long ago that the world was in an absolute panic over Ebola. One company that found itself smack in the middle of the global healthcare industry's response to Ebola was Cerus Corporation, maker of a technology that inactivates pathogens in transfused blood components. I recently had the pleasure of speaking with William “Obi” Greenman, the company's president and CEO. We discussed the Intercept system, the factors behind Cerus’ recent public stock offering, the modular premarket approval (PMA) pathway it used for Intercept, the story behind its Ebola involvement, and why it is uniquely positioned to help stop future infectious disease outbreaks.

More From The Editor

WHITE PAPERS & CASE STUDIES

  • Does Your CAPA System Need A CAPA? Automating Corrective And Preventative Actions In The FDA Environment

    FDA requires manufacturers to have a corrective action and preventive action (CAPA) process to address and mitigate the impact of deviations and nonconformances. A review of FDA warning letters indicates that some companies think of CAPA only after quality issues have emerged; others have CAPA systems, but they are inadequate. How does your organization handle CAPA? This white paper will discuss why medical device manufactures need CAPA and how to choose the right tools when you are establishing a new CAPA process or improving an existing one.

Cleaning Validation For Medical Device Manufacturing

This white paper outlines the basics of cleaning validation and the role that the cleaner manufacturer can play in simplifying, speeding up, and supporting the maintenance of cleaning validation. By Alconox, Inc.

Beginning With The End In Mind: Using A Target Product Profile (TPP) To Guide Strategic Medical Device And Diagnostic Development

Medical device and diagnostic makers face myriad challenges when developing a new product, including working within resource and financial constraints, deciding which opportunities have the highest return on investment (ROI), determining differentiating claims and positioning within the market and, in some cases, aspiring to the possibility of attaining multiple indications across multiple therapeutic areas.

Top Ten Tips For Medical Micro Molding

Micro molding processes allow medical device manufacturers to reduce the overall size of the products they develop. This document includes information on the differences between micro, miniature, and small parts, the impacts material selection can make,   maintaining manufacturability as sizes become smaller, and much more. Download it to better understand the micro molding process.

Advantages Of Additive Manufacturing Over Subtractive Manufacturing For Injection Molds

This white paper explains the differences between additive manufacturing and subtractive manufacturing and how the LUMEX Advance-25 additive manufacturing machine can help reduce delivery times, achieve more environmentally-friendly standards, reduce gas traps to improve part quality, and perform heat treatments without losing tolerance.

More White Papers & Case Studies

MED DEVICE INSIGHTS

Success in today’s medical device industry requires innovative ways of thinking about traditional and evolving problems. To this end, Med Device Online is pleased to bring you Med Device Insights, a new digital publication that imparts fresh perspectives and strategies from your peers and other thought leaders in the space. Our first issue includes original articles about:

  • A revolutionary new approach to rapid prototyping
  • The unintended consequences of new payment paradigms
  • Factors to consider when developing your India strategy
  • Using Internet-of-Things-style protocols for connected devices
  • Steps to identify the right clinical outsourcing partner
  • A company developing laser-based tumor ablation systems
  • And more...

Check out Med Device Insights today!

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.

Optical Thickness Gauge: 157 Series

Optical Thickness Gauge: 157 Series

The Model 157 optical thickness gauge uses proven optical interferometer technology to measure the absolute thickness of specialty plastic films, medical membranes, and ophthalmic products.

Medical Device Product Development

Medical Device Product Development

ProMed has been a contract manufacturer of custom implantable medical device components for over twenty years now. They offer materials selection analysis, cost analysis, prototypes in their specified material in five business days or less, reduced tooling costs, reduced qualification times, IQ, OQ, and PQ validations, and process failure mode and effects analysis (PFMEA).

High-Performance Batteries for Active Implants

High-Performance Batteries for Active Implants

These high-performance batteries are based on lithium-iodine or lithium-manganese dioxide. They feature high volumetric energy densities and low self-discharge. They’ve been specifically designed for use in medical implants.

Connectors And Cable Assemblies For Medical Devices

Connectors And Cable Assemblies For Medical Devices

Fischer Connectors® offers a line of connectors and cable assemblies that feature unparalleled signal integrity, fully secured connections, medical standard compliance, durability, 360° EMC shielding, and advanced ergonomics.

Step-Down DC-DC Converter: SKY87608

Step-Down DC-DC Converter: SKY87608

This non-synchronous step-down DC-DC converter is competitively priced and comes in a SOP-8L, EP, 5 x 6 x 1.55mm package. It’s ideal for distributed power systems, medical and industrial applications, set-top boxes, and automotive applications.

More Featured Products
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UPCOMING TRAINING COURSES

Coping With Change – A Primer for Staff and Managers

March 31, 2015
1pm-2:30pm EDT, Online Training

Got a Date with the FDA? Conducting Successful Meetings

April 7, 2015
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Cleaning Validation – Lessons Learned in the Trenches

April 16, 2015
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Communication With FDA: What Do We Say And How Do We Say It?

April 28, 2015
1pm-2:30pm EDT, Online Training
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FEATURED SUPPLIERS

Promed Molded Products Inc.

Promed Molded Products Inc.

ProMed was founded in 1989 to address an industry need for cleanroom molding of silicone components, primarily those having a medical application. The company has expanded its capabilities over the years and now offers silicone molding along with micro-molding of highly engineered plastics and drug eluting / combination products. From a single component to complete devices, ProMed has the resources, quality systems and facilities to meet most dimensional and cosmetic print specifications and comply with rigorous industry standards.