Skip to main content
  • Home
  • About Us
  • Advisory Board
  • Advertise
  • Editorial Submissions
  • Contact Us

  • Get The Newsletter!
  • View The Latest Newsletter
  • Follow me on Twitter
  • Friend me on Facebook
  • Connect with me on LinkedIn
  • Subscribe to me on YouTube
  • Subscribe to my RSS Feed

Menu

Skip to content
  • MedTech Economics
  • Manufacturing Execution
  • Product Design & Development
  • Quality/Regulatory
  • Resource Centers
    • Medical Device Audits, Certification & Verification
    • Medical Device Component
    • Medical Recall Resource Center
    • Quality & Regulatory Market Access Solutions Resource Center
  • Events & Webinars
  • Library

Product Design & Development

Featured Articles

January 15, 2021
Medtech, innovation

FDA: COVID-19 Put Spotlight on Digitization of Healthcare, and Importance of Data, Communication and Collaboration

By Maria Fontanazza

During this week’s Consumer Electronics Show, FDA Principal Deputy Commissioner Amy Abernathy talks about lessons learned from the pandemic and 2021 goals.

January 13, 2021
Abbott

Abbott’s Virus Hunters Saw COVID Coming, Developed Three Molecular Tests in 30 Days

By Maria Fontanazza

During a session at this week’s Consumer Electronics Show, Andrea Wainer, EVP of Rapid Molecular Diagnostics at Abbott, shares how the company scaled up to supply the global market with more than 300 million COVID-19 tests in 2020 and the path forward.

December 23, 2020
magnifying glass

In 2021 Predictions, Digital Health Reigns Supreme

By Maria Fontanazza

Leveraging the power of technology to create a more patient-centric approach and consolidate costs is expected to play a big role.

December 15, 2020
Medtech question

How Much Are You Involved in CM&S? Help Us in a Survey

By MedTech Intelligence Staff

Participate in our new survey and have a chance to win complimentary access to the Computer Modeling & Simulation Virtual Conference on January 27–28, 2021.

December 8, 2020
Wearable Cloud, Medical Device Connectivity

Medical Devices and the Cloud: What Does It Mean to Product Design?

By MedTech Intelligence Staff

Although the cloud offers great value for medtech manufacturers and device users, it also creates new challenges.

December 7, 2020
Combination product, drug, device and biologic

Quality Considerations for Drug-Device Combination Products

By Amy Scanlin

Understanding the GMP requirements of each component is critical to product and compliance success.

November 20, 2020
MedTech Intelligence

Six FDA Experts to Weigh in on Computational Modeling & Simulation in MedTech Product Development

By MedTech Intelligence Staff

No longer just “the big company advantage,” CM&S is an accepted and viable device industry path to market for large and small medical device makers alike.

November 16, 2020
MedTech Intelligence

COVID-19 Requires New Approach to Clinical Trials and Human Factors Studies

By MedTech Intelligence Staff

An upcoming webinar will discuss the new methods and protocols that have emerged as a result of conducting trials and HF studies during the pandemic.

View More Product Development Articles »

Columns

January 12, 2021
MEDdesign

The New Way of Healthcare with Additive Manufacturing

By Christopher Cho
Christopher Cho, nTopology

The adoption of this manufacturing process in healthcare saw a tremendous uptick in 2020.

January 4, 2021
MEDdesign

Compliance Is Compulsory, and Product Labeling Is No Exception

By Beth Peckover
Beth Peckover, Kallik

For pharmaceutical and medical device manufacturers, computerized systems validation is vital. The following are three areas businesses must fine tune to ensure computerized labeling systems meet the stipulations of the new GxP regulations.

December 22, 2020
Soapbox

Cloud-Based Informatics Enable Smarter Antibiotic Use and Infection Control

By Oliver Schacht, Ph.D.
Oliver Schacht, Ph.D., OpGen

Incorporating bioinformatics platforms can ease the burden of tracking, analyzing and managing the use of antibiotics.

December 21, 2020
MEDdesign

Does Your Class II Device Qualify for a 510(k) Premarket Notification Exemption?

By Tara Lysechko
Tara Lysechko, Starfish Medical

The exemption reduces the regulatory burden on the medical device industry—including the time and costs involved in preparing, submitting and responding to requests for additional information.

December 15, 2020
CAPA Corner

Why You Must Have a Single Source of Truth for CAPA

By Jon Speer
Jon Speer, Greenlight Guru

CAPA consistently remains a top reason for FDA’s 483 observations, usually due to inadequate processes or inconsistent adherence to regulatory requirements.

Upcoming Events & Webinars

January 27, 2021 – January 27, 2021
Computer Modeling & Simulation in MedTech Product Development & Submissions (Day One)
January 28, 2021 – January 28, 2021
Computer Modeling & Simulation in MedTech Product Development & Submissions (Day Two)
February 10, 2021 – 1:00 pm – 2:00 pm
Bringing Digital Transformation to Your Supply Chain: Connecting OEMs & Contract Manufacturers for Improved Performance


On Demand Events & Webinars

December 16, 2020 – 1:00 pm – 2:30 pm
Connected Medical Devices & the Cloud
August 20, 2020 – 1:00 pm – 2:00 pm
2021 – Preparing for Changes in the EU MDR Complaint Management and Vigilance Regulations
July 28, 2020
Defend Against MedTech Cyber Breach: A Fireside Chat with Critical Healthcare Stakeholders
May 21, 2020 – 1:00 pm – 2:00 pm
Emergency Use Authorization (EUA)
May 20, 2020 – 1:00 pm – 2:00 pm
Improving the safety, visibility & transparency of your supply chain during a crisis to sustain customer confidence

Product Development Archive





Topic Archives

  • MedTech Economics
  • Manufacturing Execution
  • Product Design & Development
  • Quality/Regulatory

Column Archives

  • Ameing for Asia
  • Ask the Engineer
  • CAPA Corner
  • Devine Guidance
  • From The Editor’s Desk
  • MEDdesign
  • Reimbursement Report
  • Soapbox

Contact Us

  • Advertising Opportunities
  • Editorial Submissions
  • General Inquiries
  • Privacy Policy
  • Cookie Policy
  • Sign Up for Newsletters

Innovative Publishing Company, Inc.

  • FoodSafetyTech
  • Food Safety Consortium Conference & Expo
  • MedTech Intelligence
  • Cannabis Industry Journal

© Copyright 2015 - 2021 Innovative Publishing Co. LLC, All Rights Reserved

Other Innovative Publishing Co. LLC Sites: Food Safety Tech  |  Cannabis Industry Journal

css.php
MedTechIntelligence.com

MedTech Intelligence is the leading online trade journal.
Join the MedTech Intelligence community
and stay engaged the way you want to!

  • Subscribe to MedTech Intelligence’s free weekly eNewsletter
  • Join the LinkedIn group
  • Follow MTI on Twitter
  • Follow MTI on Facebook
  • Subscribe to MedTech Intelligence’s RSS feeds

MedTechIntelligence


Wait! Wait! Don’t go yet!

Sign up for our FREE newsletters and get the top stories from MTI right in your email inbox.

    We are using cookies to give you the best experience on our website.

    You can find out more about which cookies we are using or switch them off in settings.

    MedTech Intelligence
    Powered by  GDPR Cookie Compliance
    Privacy Overview

    This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.

    Strictly Necessary Cookies

    Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings.

    We use tracking pixels that set your arrival time at our website, this is used as part of our anti-spam and security measures. Disabling this tracking pixel would disable some of our security measures, and is therefore considered necessary for the safe operation of the website. This tracking pixel is cleared from your system when you delete files in your history.

    We also use cookies to store your preferences regarding the setting of 3rd Party Cookies.

    If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.

    Cookie Policy

    A browser cookie is a small piece of data that is stored on your device to help websites and mobile apps remember things about you. Other technologies, including Web storage and identifiers associated with your device, may be used for similar purposes. In this policy, we say “cookies” to discuss all of these technologies.

    Our Privacy Policy explains how we collect and use information from and about you when you use This website and certain other Innovative Publishing Co LLC services. This policy explains more about how we use cookies and your related choices.

    How We Use Cookies

    Data generated from cookies and other behavioral tracking technology is not made available to any outside parties, and is only used in the aggregate to make editorial decisions for the websites. Most browsers are initially set up to accept cookies, but you can reset your browser to refuse all cookies or to indicate when a cookie is being sent by visiting this Cookies Policy page. If your cookies are disabled in the browser, neither the tracking cookie nor the preference cookie is set, and you are in effect opted-out.

    In other cases, our advertisers request to use third-party tracking to verify our ad delivery, or to remarket their products and/or services to you on other websites. You may opt-out of these tracking pixels by adjusting the Do Not Track settings in your browser, or by visiting the Network Advertising Initiative Opt Out page.

    You have control over whether, how, and when cookies and other tracking technologies are installed on your devices. Although each browser is different, most browsers enable their users to access and edit their cookie preferences in their browser settings. The rejection or disabling of some cookies may impact certain features of the site or to cause some of the website’s services not to function properly.

    Individuals may opt-out of 3rd Party Cookies used on IPC websites by adjusting your cookie preferences through this Cookie Preferences tool, or by setting web browser settings to refuse cookies and similar tracking mechanisms. Please note that web browsers operate using different identifiers. As such, you must adjust your settings in each web browser and for each computer or device on which you would like to opt-out on. Further, if you simply delete your cookies, you will need to remove cookies from your device after every visit to the websites. You may download a browser plugin that will help you maintain your opt-out choices by visiting www.aboutads.info/pmc. You may block cookies entirely by disabling cookie use in your browser or by setting your browser to ask for your permission before setting a cookie. Blocking cookies entirely may cause some websites to work incorrectly or less effectively.

    The use of online tracking mechanisms by third parties is subject to those third parties’ own privacy policies, and not this Policy. If you prefer to prevent third parties from setting and accessing cookies on your computer, you may set your browser to block all cookies. Additionally, you may remove yourself from the targeted advertising of companies within the Network Advertising Initiative by opting out here, or of companies participating in the Digital Advertising Alliance program by opting out here.