MedTech Intelligence Volume 9 Issue 11

Get Your FREE Subscription Here! About Us
	Volume 9 Issue No. 11

Business Analysis Combination Products Market Access Operations Product Development Quality/Regulatory

Featured Articles

Soapbox

Michael Lohan, IDA Ireland Ireland’s Medtech Industry Will Benefit from Brexit

By Michael Lohan, IDA Ireland

Uncertainty caused by Britain’s EU departure creates opportunity for its neighbor.

Devine Guidance

Christopher Devine, Ph.D., Devine Guidance International Training, Training, and More Training

By Christopher Devine, Ph.D.,
Devine Guidance International

Don’t overlook this critical practice.

Scott Gottlieb, M.D. President Trump to Pick
Scott Gottlieb as
FDA Commish

By MedTech Intelligence Staff

The president’s selection is drawing criticism due to reported ties with the pharmaceutical industry.

Hot Topics in Cybersecurity

Maria Fontanazza, Editor-in-Chief Protecting Products in the Face of Cybersecurity Vulnerabilities

By Maria Fontanazza, Editor-in-Chief

Taking a risk-based approach can help companies safeguard medical devices against exploitation and ensure an effective and secure network.

Featured Quote

Device manufacturers must consider cybersecurity, beginning with the design phase and throughout the product lifecycle, including the equipment and patients that will be connected to the device over a network.

— Eric Luyer, Axendia, Inc.

Top Trends of New Year Trump’s Impact, Pricing, R&D Funding and Cybersecurity Among Top Trends of New Year

By MedTech Intelligence Staff

It’s too early to tell how the new administration will affect the device industry, but user fees, the ACA and the FDA regulatory process are top of mind.

Cybersecurity FDA: Cybersecurity Is
a Shared Responsibility

By MedTech Intelligence Staff

FDA is encouraging medical device manufacturers to brush-up on their best practices and engage in good cyber hygiene.

Sponsored Content

5 Things Everyone Should Know
about Micro-Molding

With the pressure on design engineers to deliver smaller, lighter and more cost-effective components many are turning to micro injection molding for support. Challenges often arise when designing for micro molding that can present unforeseen road blocks. Questions like – What is micro molding? How is it different from standard molding? Or, what do I need to know to be successful at molding a micro plastic part? - are commonly asked by engineers. Download 5 Things Everyone Should Know about Micro-Molding to learn the answers to these and other questions.

Download the whitepaper now

Pacific Bridge Medical - Resource Center: a world of in-depth information about the Asian medical market at your fingertips.

Verse Solutions - Verse helps keep track of your Quality Story

Medical Device Software - March 21-22, 2017 - Washington, DC

Medical Device Cybersecurity - March 23-24, 2017 - Washington, DC

HHE, Benefit-Risk, and Recalls - May 17 – 18, 2017 - Washington, DC

Resource Centers

Resource Centers are single topic focused micro-sites within MedTechIntelligence.com that are portals of information on medical device components and quality systems offering news, articles, white papers, case histories and videos.

Medical Device Audits, Certification & Verification
sponsored by SGS
Quality & Regulatory Market Access Solutions
sponsored by UL
Medical Device Component
sponsored by 3M

Sponsored Resources

ISO 13485:2016 will be required in 2019 - Will you be ready?

The transition deadline for ISO 13485 is less than two years away and the survey results show that many companies are unprepared. Let UL ISO 13485 medical quality system experts help you. Our team has prepared webinars, white papers and FAQs to help you understand the key changes to the 2016 version so you can plan for resources needed to support the transition. In addition, our team can come to your site and walk you through the process unique to your existing quality system and products.

Click here for ISO 13485:2016 transition resources.

Verse Get a Complimentary Demo of Verse!

Maintaining a high level of compliance is paramount to success. With regulatory changes in oversight as well as the need to adhere to specific industry requirements, there is no better way to keep up with constant change of pace than automating your business processes. Automation is fundamental to quality today.

See how you can automate processes and save on resources with a Complimentary Verse demo.

Upcoming Events & Webinars

March 21-22, 2017 - Medical Device Software

Washington, DC

March 23-24, 2017 - Medical Device Cybersecurity

Washington, DC

May 2017 - HHE, Benefit-Risk, and Recalls

Washington, DC

June 5-6, 2017 - China: The MedTech Market

Washington, DC

June 2017 - Combination Products: A Conference for Drug, Devide, Diagnostics, & Biologics Manufacturers

Washington, DC

Q3 2017 - Medical Device Statistics for Non-Statisticians

Washington, DC