LEAD STORIES

New Devices Test Efficacy Of Multiple Cancer Drugs Simultaneously

Two new devices may offer oncologists a way to quickly “test drive” a variety of cancer drugs before committing a patient to a course of treatment. By further developing the technology, scientists hope to eliminate the trial-and-error methods currently used and potentially accelerate drug development with safer and faster clinical trials.

  • A Regulatory And Competitive Analysis Of The Asia-Pacific Dental Bone Graft Market
    A Regulatory And Competitive Analysis Of The Asia-Pacific Dental Bone Graft Market

    Development of the dental bone graft substitute (DBGS) market in Asia-Pacific has greatly lagged behind the progress made in the U.S. Allografts are widely used in the U.S. and have grown to become the DBGS material of choice by the majority of dental professionals, but allograft DBGS materials remain a small market in Asia-Pacific. The region remains highly reliant on synthetic and autogenous bone for dental bone graft procedures. However, recent medical device approvals and domestic R&D efforts are set to alter market trends and generate significant DBGS market growth for the Asia-Pacific market.

  • FDA Releases Guidance On Use Of Foreign Trial Data In Device Approvals
    FDA Releases Guidance On Use Of Foreign Trial Data In Device Approvals

    The U.S. Food and Drug Administration (FDA) recently released draft guidance on accepting foreign clinical trials in support of premarket submissions for medical devices. The guidance communicates considerations that sponsors of device submissions should take into account when initiating, or relying on previously collected data from, an outside the United States (OUS) clinical study to support an investigational device exemption (IDE), premarket notification [510(k)], de novo petition, humanitarian device exemption (HDE), or premarket approval (PMA) application.

INDUSTRY PERSPECTIVES

  • A Regulatory And Competitive Analysis Of The Asia-Pacific Dental Bone Graft Market
    A Regulatory And Competitive Analysis Of The Asia-Pacific Dental Bone Graft Market

    Development of the dental bone graft substitute (DBGS) market in Asia-Pacific has greatly lagged behind the progress made in the U.S. Allografts are widely used in the U.S. and have grown to become the DBGS material of choice by the majority of dental professionals, but allograft DBGS materials remain a small market in Asia-Pacific. The region remains highly reliant on synthetic and autogenous bone for dental bone graft procedures. However, recent medical device approvals and domestic R&D efforts are set to alter market trends and generate significant DBGS market growth for the Asia-Pacific market.

  • Tips For Developing Medical Device User Needs, Intended Uses, And Design Inputs
    Tips For Developing Medical Device User Needs, Intended Uses, And Design Inputs

    The FDA’s Design Control Guidance for Medical Device Manufacturers states, “Development of a solid foundation of requirements is the single most important design control activity.” This concept is likely to be self-evident to experienced medical device practitioners. However, what exactly is meant by the term “requirements”?

  • An Introduction To Lean For Medical Device Manufacturers
    An Introduction To Lean For Medical Device Manufacturers

    This is the first in a series of articles on the ways that medical device manufacturers can transform their operations — and gain a competitive advantage in the market — by implementing lean strategies. In this installment, Darren Dolcemascolo, senior partner and co-founder of EMS Consulting Group, discusses the framework for lean manufacturing and why it is particularly useful to those in the medical device industry.

More Industry Perspectives

FROM THE EDITOR

  • 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.

  • 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.

More From The Editor

WHITE PAPERS & CASE STUDIES

The Unique Requirements For Wireless Medical Devices

Medical device designers and manufacturers who don’t understand the unique requirements for ensuring success in a WLAN (wireless local area network) deployed solution run the risk of their device having adverse performance, potential regulatory recalls, the need for a product re-design, revenue loss, and competitive market positioning.  

Which Screw Is Best For You?

This white paper was written to provide a thorough understanding of screw drive trains and the many options available.

Understanding Connector Operating Voltage

It can be difficult to determine exactly how much voltage a connector can safely carry as the effects of humidity, air pressure, or safety requirements need to be considered. This paper discusses the different conditions engineers may encounter that can impact operating voltage in the connectors they specify so that they’ll perform as expected, even in challenging environments.

Medical Device Metal-To-Plastic Conversion In 6 Steps

With quickly increasing healthcare costs and improving technology, designers across the medical device industry are being tasked to increase performance and decrease costs associated with their products. One of the most effective methods for performance enhancement and cost cutting is metal-to-plastic conversion. Plastics can be used to replace even the strongest and stiffest steel devices by incorporating simple design modifications.

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

CMOS Sensor Endoscopes

CMOS Sensor Endoscopes

In the construction of endoscopes with distal end complimentary metal oxide semiconductor (CMOS) sensors, Precision Optics Corporation (POC) has utilized our proprietary micro lens design and manufacturing capabilities to build camera assemblies using a variety of different CMOS sensors including the OmniVision OV6930 (1.8 x 1.8mm, 160,000 pixels) and the Fujikura 29k (0.74 x 0.79mm, 29,000 pixels). POC has the in-house ability to custom manufacture to your specific needs and specifications.

Fineline Additive Manufacturing and Prototyping

Fineline Additive Manufacturing and Prototyping

Proto Labs, Inc. offers additive manufacturing services through three rapid prototyping processes: stereolithography (SL), selective laser sintering (SLS), and direct metal laser sintering (DMLS).

Automated Manufacturing Services for Medical Devices

Automated Manufacturing Services for Medical Devices

Automated cells can improve quality, reduce labor, lower cycle times and increase production. At SMC, we take pride in offering industry-differentiating automation expertise. We are committed to meeting or exceeding our customers’ requirements by designing and building work cells that gain a competitive edge. Our in-house automation team will design cutting-edge automation customized to your specific program, ensuring that your requirements for quality and reliability are met time and time again.

Quality Management Systems for Medical Devices

Quality Management Systems for Medical Devices

With their sole focus on being a contract manufacturer of medical devices, Phase 2’s Quality Management System (QMS) has helped to establish the company as a provider of quality medical devices manufactured in a lean production environment.

Class A Solid State Amplifier: 150W1000

Class A Solid State Amplifier: 150W1000

AR’s 150W1000 is a class A solid state amplifier that provides 1500 watts of output power from 80 to 1000 MHz. It has superior gain flatness, an exceptional noise figure, and better efficiency and harmonics than competitive products.

Linear Servo-Motor Driven Positioner: MX80L Miniature Stage Series

Linear Servo-Motor Driven Positioner: MX80L Miniature Stage Series

This low-profile/miniature stage measures in at 25mm high x 80mm wide, making it the smallest linear servo-meter driven positioner currently available. It’s been designed to meet rapid-fire positioning of light loads within a small work envelope.

More Featured Products
Newsletter Signup
Newsletter Signup
Get the latest medical device industry news, insights, and analysis delivered to your inbox.
By clicking Sign Me Up, you agree to our Terms and that you have read our Privacy Policy.

LATEST HEADLINES

  • New Devices Test Efficacy Of Multiple Cancer Drugs Simultaneously
    New Devices Test Efficacy Of Multiple Cancer Drugs Simultaneously

    Two new devices may offer oncologists a way to quickly “test drive” a variety of cancer drugs before committing a patient to a course of treatment. By further developing the technology, scientists hope to eliminate the trial-and-error methods currently used and potentially accelerate drug development with safer and faster clinical trials.

  • Medtronic DBS Stimulators Cleared In Europe For Full-Body MRI
    Medtronic DBS Stimulators Cleared In Europe For Full-Body MRI

    European regulators recently cleared Medtronic’s Activa deep brain stimulation (DBS) implants for use before and during full-body magnetic resonance imaging (MRI) procedures.

  • Cadence, Inc. Announces New LaserSwiss Capability

    Cadence has built its business on creating new-to-the-world manufacturing technologies to make complex products the world has never seen. The latest addition of innovative technologies includes a new LaserSwiss machining capability.

  • Stryker Betting On MAKO And Anti-Stroke Devices, Planning More Acquisitions To Drive Growth
    Stryker Betting On MAKO And Anti-Stroke Devices, Planning More Acquisitions To Drive Growth

    Stryker considers its MAKO robotic surgery system and its clot removal devices as growth accelerators for the company through 2016. The artificial knee and hip implants maker is also cautiously eyeing more M&A targets after it recently acquired a number of assets.

  • FDA Approves Breast Tomosynthesis Option For Siemens Mammography Platform

    The Food and Drug Administration (FDA) has approved the MAMMOMAT Inspiration with Tomosynthesis Option – the breast tomosynthesis add-on option for Siemens Healthcare’s MAMMOMAT Inspiration digital mammography platform. 

  • New Imaging System Could Predict Breast Cancer Risk, Reduce Need For Mammograms
    New Imaging System Could Predict Breast Cancer Risk, Reduce Need For Mammograms

    A new computer-aided detection system can accurately predict if and when a woman is likely to develop breast cancer. Researchers say the technology could reduce the number of mammograms performed each year and cut down on unnecessary risks that some experts say are caused by annual exams.

  • FDA Releases Guidance On Use Of Foreign Trial Data In Device Approvals
    FDA Releases Guidance On Use Of Foreign Trial Data In Device Approvals

    The U.S. Food and Drug Administration (FDA) recently released draft guidance on accepting foreign clinical trials in support of premarket submissions for medical devices. The guidance communicates considerations that sponsors of device submissions should take into account when initiating, or relying on previously collected data from, an outside the United States (OUS) clinical study to support an investigational device exemption (IDE), premarket notification [510(k)], de novo petition, humanitarian device exemption (HDE), or premarket approval (PMA) application.

More News

UPCOMING TRAINING COURSES

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

Remote Monitoring of Clinical Source Data – Why Not?

May 18, 2015
1pm-2:30pm EDT, Online Training

Introduction to Biostatistics: Collecting and Summarizing Data

May 28, 2015
1pm-3pm EDT, Online Training
More Upcoming Courses

FEATURED SUPPLIERS

Skyworks Solutions, Inc.

Skyworks Solutions, Inc.

Skyworks is the industry’s leading wireless semiconductor company focused on RF and complete semiconductor systems for mobile communications applications...