Top 10 Medical Device News Posts: April 8 to 15, 2014

medical device news logoEach week, KMC brings you the top 10 medical device news articles to keep you up-to-date on the latest medical device development, design and manufacturing industry information.

This week, look into the life of a chemist, discover what most companies are missing in their continuous improvement efforts, the latest FDA compliance updates and more.

1

Making Magic-like Contributions As A Chemist
By Tiberiu Siclovan 

I was born a curious kid. Since my hands became capable of coordinated movement, their role was to satisfy the question of “how are things made?”
Read more on the GE Global Research blog.

2

One Aspect Missing from Most Continuous Improvement Initiatives [DATA]
By Mike Roberts
With today’s global economy only becoming more competitive, it’s no surprise that everybody in the manufacturing environment is talking about continuous improvement.
Read more on the LNS Research blog.

3

Are MEDDEVs Required or Optional for CE Marking of Medical Devices?
By Rob Packard
MEDDEVs are guidance documents written by competent authorities—not law. As it states on the Europa website, “The guidelines are not legally binding.” However, the Competent Authorities take an active role in developing these guidance documents.
Read more on the Medical Device Academy blog.

4

Heartbleed Bug Endangers Medical Data, Internet as a Whole
By Chris Wiltz
A bug has been discovered by security solutions provider Codenomicon Defensics and Google Security that would allow hackers to access a variety of personal information without being detected. It's been dubbed “Heartbleed” and its medical-sounding name isn't the only reason that device makers and healthcare IT should be concerned.
Read more on MDDI.

5

Roche Acquires IQuum to Strengthen Offerings in Molecular Diagnostics.
By Roche
Roche has announced the acquisition of IQuum, Inc. based in Marlborough, Massachusetts, USA. IQuum is a privately held company focused on developing point of care offerings for the molecular diagnostics market.
Read more on MDT.

6

FDA Wants More Women Participating in Post-Approval Studies
By MPO
The U.S. Food and Drug Administration (FDA) is mandating the inclusion of women in post approval studies for medical devices. According to FDA officials, female participation is necessary to reduce any gender bias related to safety and effectiveness of devices.
Read more on MPO.

7

Emerging medtech margins: Don't think price, think COGS
By Tim Kofol
Fact: the prices of medical devices, whether innovative or commodity, are under significant pressure from all corners and in all parts of the globe, and will continue to be for the foreseeable future.
Read more on MassDevice.

8

Connected manufacturing – driving faster design to delivery
By Today's Medical Developments
PTC and GE announce availability of new solution to close the loop between product design and the factory floor.
Read more on Today's Medical Developments.

9

Understanding the FDA’s new guidance
By Today's Medical Developments
On February 18, the FDA issued an eagerly awaited, clarifying final guidance. This guidance helps speed the approval process at the FDA by giving you an early take on how the agency is viewing the submission work. That is, if the pre-submission is filed correctly. Done incorrectly, it can slow or even scuttle the development of a new medical device.
Read more on Today's Medical Developments.

10

Will This Huge New Find Electrify Med Tech's Growth?By Dan Carroll
Health care is one of the most innovative sectors on the market, and that's especially true in the medical device industry.
Read more on The Motley Fool.

Share your thoughts on any of these articles in the comments below.

Topics: KMC, medical device news, medical device industry news