LEAD STORIES

FDA Finalizes 510(k) Substantial Equivalence Guidance

The FDA recently released final guidance addressing key issues in the agency’s 510(k) clearance program, describing in detail the critical decision points in the 510(k) review process.

  • Industry Leaders Address Revival Of U.S. Device Innovation
    Industry Leaders Address Revival Of U.S. Device Innovation

    Recently, an executive from industry giant Edwards Lifesciences addressed a congressional committee on the dwindling state of medical device innovation in the United States.

  • Google’s Newest Science Project: Defining Perfect Human Health
    Google’s Newest Science Project: Defining Perfect Human Health

    Google has launched a project focused on studying and analyzing the human body in greater detail than ever before by comprehensively cataloging genetic and molecular information. The ultimate goal of the project, which has been dubbed Baseline Study, is to map out a clear picture of what a perfectly healthy human body would look like.

  • St. Jude Medical To Cut 270 Jobs In California
    St. Jude Medical To Cut 270 Jobs In California

    St. Jude Medical is laying off up to 270 workers at its Sylmar, CA facility as part of a streamlining plan first announced by the company earlier this year.

INDUSTRY PERSPECTIVES

  • An Introduction To Human Factors Engineering For Medical Device Development
    An Introduction To Human Factors Engineering For Medical Device Development

    I hope by now the overwhelming majority of medical device manufacturers have at least heard of human factors. If you are reading this and are unfamiliar with human factors or usability, I fear that you may learn about it the hard way — a "wakeup call" from the FDA in response to your 510(k) submission requiring human factors and usability testing to be performed. But this type of testing, when executed correctly, will usually identify areas for design improvements to reduce use errors, leading to a better and more lucrative product.

  • Addressing Cybersecurity Vulnerabilities As Medicine Goes Mobile
    Addressing Cybersecurity Vulnerabilities As Medicine Goes Mobile

    Is your phone compromising the security of your heath data? The mobile health, or mHealth, field is exploding with a host of new Internet-connected apps and devices. With that growth comes new concerns around data security and device safety. By Scott Sheaf, senior software engineer, Battelle

  • Why Data Connectivity To Traditional IT Systems And EHRs Should Be A Priority In Your Device Designs
    Why Data Connectivity To Traditional IT Systems And EHRs Should Be A Priority In Your Device Designs

    According to a recent PriceWaterhouseCoopers report, a major area that’s lacking in medical devices is electronic health records (EHRs), health IT, and patient data connectivity. Only about 18% of device companies integrate data into clinical workflows and EHRs, which means there’s a very nice opportunity for upstarts and savvy incumbents. Any manufacturer that focuses on device integration and data connectivity from devices into traditional health IT systems like EHRs and billing systems will have a unique offering that customers will elevate during their product selection process.

More Guest Columns

ARTICLES

  • Robotic Rib Spreading Tool To Help Patients Hurt Less And Heal Faster
    Robotic Rib Spreading Tool To Help Patients Hurt Less And Heal Faster

    One advanced technology company is taking on the challenge of developing hand-held, robotic surgical instruments to help patients hurt less and heal faster. High torque maxon motors ensure jerk-free movement of the tool. By Deb Setters, maxon precision motors; By Anja Schütz, maxon motor ag

Critical Factors To Consider In Selecting Medical Grade Silicones

Applied Silicone explains the different levels of testing required for implantable silicones, and offers advice for device manufacturers on the lookout for a long-term-implantable silicone supplier.

Best Practices For Interventional Cardiovascular Medical Device Trials

Companies seeking to bring implantable cardiovascular products to market, whether they are stents, valves, pacemakers, ventricular assist devices, or other novel technologies, face several significant factors in designing and conducting clinical trials. This paper addresses the four aspects of implantable cardiovascular device clinical trials that Novella Clinical considers most critical: regulatory requirements, reimbursement strategy, clinical challenges, and vendor selection.

Design Verification Testing: The FDA Cares, You Should Too

Design Verification failures are costly, and these costs may be paid not just by development budget and schedule, but may result in rejection of submissions, warning letters, recalls, loss of market share, or in the worse cases, patient harm. Design Verification is one of the most commonly cited sections in recent warning letters issued by the FDA that include findings related to specific sections of the Design Control regulation (21 CFR 820.30).

Medical Device Development: Thinking Globally, Acting Locally

Incorporating international and emerging markets at an early stage of product development is critical for long-term success in getting to market, but also in bringing costs down by getting started smart. Understanding market opportunities from a regulatory, reimbursement, and healthcare delivery perspective, as well as understanding market fluctuations, is the first step in planning a global strategy.

More Articles

FROM THE EDITOR

  • Cutting Through The Remote Patient Monitoring Hype
    Cutting Through The Remote Patient Monitoring Hype

    There is so much hype surrounding remote patient monitoring (RPM) — and related buzzterms like wearables, mobile apps, big data, the Internet of Things (IoT), and mHealth — that sometimes it is difficult to separate hyperbole from reality. What opportunities does RPM really afford medical device makers? What should they do to take advantage? How do wearables fit into the equation? Should the medtech industry fear or embrace the involvement of tech titans like Google and Apple? Read on for answers to these and other important RPM-related questions.

  • Reverse Engineering A Human Heart Valve
    Reverse Engineering A Human Heart Valve

    The man who literally wrote the book (two books, in fact) on the aortic valve has devised a new artificial valve design that that he says will revolutionize transcatheter aortic valve implementation (TAVI). And if everything goes according to plan, his heart valve could reach European patients in 2015 and U.S. patients soon after. Find out how he and his startup company developed this technology — by using the natural aortic valve for their design output.

  • Do You Make These 5 Usability Mistakes In Your Medtech Development Process?
    Do You Make These 5 Usability Mistakes In Your Medtech Development Process?

    Major healthcare systems are starting to pay much closer attention to usability during the medical device procurement process. They are establishing internal human factors teams, having usability experts evaluate technologies prior to purchase, and sharing their learnings with other healthcare systems. If you fall prey to these five usability design pitfalls, your device won’t stand a chance in this new user-centric procurement environment.

More From The Editor

PRODUCT SHOWCASE

FitQuik® Connectors

FitQuik® Connectors

FitQuik® Connectors from Colder Products Company are high quality fittings for leak-free tubing connections. These precision molded fittings are designed to eliminate tubing leak points in medical devices, analytical instrumentation or air-driven equipment.

RF Power Amplifier for Medical EMC Compliance Testing: 75A250A

RF Power Amplifier for Medical EMC Compliance Testing: 75A250A

AR’s 75A250A is an RF power amplifier covering the 10 kHz to 250 MHz frequency range. It’s well suited for medical EMC compliance testing applications and offers up to 75 watts CW power when used with an RF sweep generator.

Color CMOS USB Camera: SPOT Idea

Color CMOS USB Camera: SPOT Idea

These digital microscope CMOS cameras come in 1.3, 3.0, and 5.0 megapixel resolution versions. They feature high speed readout, 12-bit image capture, Correct Color Technology for vivid color enhancement, an external trigger output, and more.

Alcotabs: Critical-Cleaning Detergent Tablets

Alcotabs: Critical-Cleaning Detergent Tablets

Special slow release tablet formulation for maximum cleaning performance from your syphon pipette washers. Concentrated to save you money. Biodegradable and readily disposable. 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.
Custom Manufactured Windows

Custom Manufactured Windows

LaCroix Optical Company produces window substrates in a wide variety of shapes and sizes using optical or filter glass, fused silica or other glass-like materials. All of our windows are produced and if necessary coated at our facility in Batesville, Arkansas.

 

Synthetic Fused Silica for High Optical Performance - DUV to UV/VIS Optics

Synthetic Fused Silica for High Optical Performance - DUV to UV/VIS Optics

Suprasil® 1 and Suprasil® 2 are high purity synthetic fused silica materials available in different grades for different applications.

Both grades are made from flame hydrolysis and are homogeneous in the primary functional direction. Both grades are made with low  impurities and therefore have low absorption in the DUV, UV and Visible range.

More Featured Products
Newsletter Signup
Newsletter Signup
Get the latest medical device industry news, insights, and analysis delivered to your inbox.

LATEST HEADLINES

More News

UPCOMING TRAINING COURSES

Introduction to Biostatistics: Hypothesis Testing

August 14, 2014
1pm-3pm EDT, Online Training

Root Cause Analysis for GCP – A Risk Action Plan Guide

August 19, 2014
1pm-3pm EDT, Online Training
More Upcoming Courses

FEATURED SUPPLIERS

AR

AR

Since 1969, AR has played a major role in the success of the automotive, medical, military, aerospace and telecom industries. The company’s products are used for a variety of critical applications including RF Test & measurement in a multitude of industries throughout the world. At AR, there’s no substitute for quality. It’s the foundation of our business and the AR value that’s recognized around the globe...