LEAD STORIES

An Antibacterial Plastic Made From Egg Whites

Scientists investigating alternatives to petroleum-based plastics have found that a bioplastic made from proteins found in egg whites demonstrate superior antibacterial properties and are fully biodegradable. The new bioplastic shows promise for use in medical devices, as it could reduce the spread of healthcare-associated infections and hospital waste.

  • Researchers Develop First Fully Implantable Fetal Pacemaker
    Researchers Develop First Fully Implantable Fetal Pacemaker

    Scientists have developed the first pacemaker designed specifically to be implanted in fetuses with complete heart block. The device was recently granted a humanitarian use device designation by the FDA, and its developers expect the first human implant to take place in the near future.

  • Could Carbon Nanotube Fibers Replace Metal Electrodes In Deep Brain Stimulation?
    Could Carbon Nanotube Fibers Replace Metal Electrodes In Deep Brain Stimulation?

    Engineers have constructed fibers from carbon nanotubes that can provide two-way communication with the brain. Researchers believe that the fibers could eventually replace metal electrodes traditionally used in deep brain stimulation (DBS), a treatment for Parkinson’s disease symptoms and other neurological disorders.

INDUSTRY PERSPECTIVES

  • Case Of Mistaken Identity: A Medical Device Company’s 22-Year Classification War With FDA
    Case Of Mistaken Identity: A Medical Device Company’s 22-Year Classification War With FDA

    When dealing with a government agency like the Food and Drug Administration (FDA), the most cynical among us anticipate lag times between communications, hearing delays, back-and-forth between legal teams, and lost, missing, and just plain misunderstood information. But in the confrontation between the FDA and makers of cranial electrotherapy stimulation devices (CES), no one expected a legal battle that would drag on for 22 years, nearly crippling a company and giving an entire industry a black eye.

  • 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.

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

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.

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.

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.

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.

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).

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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LATEST HEADLINES

  • An Antibacterial Plastic Made From Egg Whites
    An Antibacterial Plastic Made From Egg Whites

    Scientists investigating alternatives to petroleum-based plastics have found that a bioplastic made from proteins found in egg whites demonstrate superior antibacterial properties and are fully biodegradable. The new bioplastic shows promise for use in medical devices, as it could reduce the spread of healthcare-associated infections and hospital waste.

  • White House Unveils Anti-Superbug Strategy
    White House Unveils Anti-Superbug Strategy

    The White House recently unveiled a five-year roadmap for federal agencies to combat the growing problem of drug-resistant bacteria. The announcement comes in the wake of several high-profile superbug outbreaks that have sickened and killed patients, including two incidents in Los Angeles linked to contaminated duodenoscopes.

  • Medtronic’s CoreValve Receives FDA Approval For Transcatheter Valve-In-Valve Procedures

    Medtronic plc recently announced the U.S. Food and Drug Administration (FDA) approval of the CoreValve System for valve-in-valve (VIV) procedures in patients whose surgical aortic heart valves have failed.

  • 3D Printed Heart Model Aids In Treatment Of Teen’s Life-Threatening Aneurysm
    3D Printed Heart Model Aids In Treatment Of Teen’s Life-Threatening Aneurysm

    Ariana Smith, a 17-year-old Taylor teen, became the first patient at the Children's Hospital of Michigan, a part of the Detroit Medical Center (DMC), and the first in Michigan, to benefit from a revolutionary 3D printed heart model to aid heart specialists in treating a very large, complex aortic aneurysm.

  • J&J, Google Join Forces To Develop Surgical Robots
    J&J, Google Join Forces To Develop Surgical Robots

    Johnson and Johnson recently announced an agreement between its Ethicon subsidiary and Google’s life sciences division to build surgical robots. The move comes as medtech companies look for nontraditional partners to take advantage of growth in the robotic surgery market. Terms of the deal — which is expected to close during the second quarter — were not disclosed.

  • Researchers Develop First Fully Implantable Fetal Pacemaker
    Researchers Develop First Fully Implantable Fetal Pacemaker

    Scientists have developed the first pacemaker designed specifically to be implanted in fetuses with complete heart block. The device was recently granted a humanitarian use device designation by the FDA, and its developers expect the first human implant to take place in the near future.

  • Teleflex Medical OEM Adds Balloon Catheter Capabilities

    Teleflex Medical OEM, a global leader in custom-engineered catheters, announces the addition of balloon catheter manufacturing technologies to its extensive portfolio of in-house capabilities.

More News

UPCOMING TRAINING COURSES

Got a Date with the FDA? Conducting Successful Meetings

April 7, 2015
1pm-2:30pm EDT, Online Training

Cleaning Validation – Lessons Learned in the Trenches

April 16, 2015
1pm-2:30pm EDT, Online Training

Communication With FDA: What Do We Say And How Do We Say It?

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

Process Validation: Ensuring Compliance With Multiple Standards

May 6, 2015
1pm-2:30pm EDT, Online Training
More Upcoming Courses

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.