User Rank
Look to other industries
naperlou   12/3/2012 9:54:43 AM
Beth, the compliance issue is an important one.  As many engineered products are used in life critical situations, compliance is important.  It is important not just for satisfying some external authority, but for serving customers. 

That said, this applies to many industries.  Avionics is one obvious one.  The standards for various industries are generally separate and generally very similar.  Thus, PLM vendors, who typically work across industries, can bring this knowledge to bear on new areas of opportunity.  Now, if the companies would be smart and look for people with a different, but similar, compliance problem, they might find it easier to comply. 

Nick Ranly
User Rank
Excellent article
Nick Ranly   12/3/2012 3:45:09 PM
Great article with good information. It really is surprising how much PLM is in its infancy in this highly regulated industry.

naperlou you are correct, aerospace companies have relied on PLM for decades to reduce risk and track their development/compliance. These tools are very much needed for the medical community and hopefully companies can adopt these solutions to keep innovation moving forward.

Nick Ranly - Life Sciences

Siemens PLM Software

Cabe Atwell
User Rank
Re: Excellent article
Cabe Atwell   12/3/2012 4:24:46 PM
Life safety give certain organizations clout to demand whatever they want. Since, they can pull that card at any moment, of course medical design companies are getting mad. Since new tech is being created every day in the industry, regulation is a must. Otherwise, we would still have x-ray machines at the shoe store. Those medical companies bought the ticket, they take the ride. (Hunter S. Thompson quote)

People are lazy, without these regulation woes we'd all get hurt.


Rob Spiegel
User Rank
Re: Excellent article
Rob Spiegel   12/3/2012 9:42:49 PM
Nice to see the quote from Hunter S. Thompson, Cabe. As for regulations, the medical industry was excused from RoHS, just as the military and aerospace industries were. Have those exclusions expired?

Charles Murray
User Rank
Re: Excellent article
Charles Murray   12/3/2012 6:51:07 PM
About 20 years ago, Design News did a story about a new implantable defibrillator from Medtronic. For the story, Medtronic photographed one of its employees standing next to a pile of compliance documentation. The pile was a couple of feet taller than the employee, and I'm sure it has gotten much worse over the past two decades.

William K.
User Rank
Compliance woes
William K.   12/4/2012 6:59:20 PM
My question is rather pointy, which is: what is the claimed value of having all of those records about every step pf the product design and development? Why should every design decision be placed where it can be second guessed? Most importantly, WHO will obtain the alleged value of all of this rather expensive and complicated to keep documentation? Is it being saved up as fuel for malpractice suits? Or as defense from them?

How about a truthful explanation of just why all these records are so very important.

Partner Zone
Latest Analysis
A database containing information on over 16,000 tests done on 500 composites and other materials for wind turbine blades is now available free from Sandia National Laboratories.
Imagine being able to illegally download a physical product the same way you can with music and videos. That’s basically what’s happening with 3D printing and digital manufacturing, with huge repercussions in the intellectual property domain.
Our latest Design News Quick Poll reveals that readers are facing serious cyber security challenges.
Ford will be the first automaker to commercially use Alcoa's tough & fast Micromill aluminum alloy process and materials, debuting on several 2016 F-150 truck components. Alcoa will also license its Micromill process and materials technology to Danieli Group.
Even as an increasing number of instrument manufacturers migrate toward modern touch screens, many engineers say they still prefer the tactile feel of knobs and buttons, a new survey says.
Design News Webinar Series
10/1/2015 11:00 a.m. California / 2:00 p.m. New York
9/10/2015 11:00 a.m. California / 2:00 p.m. New York
10/20/2015 8:00 a.m. California / 11:00 a.m. New York
11/10/2015 11:00 a.m. California / 2:00 p.m. New York
Quick Poll
The Continuing Education Center offers engineers an entirely new way to get the education they need to formulate next-generation solutions.
Oct 19 - 23, Embedded System Design Techniques™ - Driver Design Patterns and the Internet
SEMESTERS: 1  |  2  |  3  |  4  |  5  |  6 |  7

Focus on Fundamentals consists of 45-minute on-line classes that cover a host of technologies. You learn without leaving the comfort of your desk. All classes are taught by subject-matter experts and all are archived. So if you can't attend live, attend at your convenience.
Learn More   |   Login   |   Archived Classes
Twitter Feed
Design News Twitter Feed
Like Us on Facebook

Sponsored Content

Technology Marketplace

Copyright © 2015 UBM Canon, A UBM company, All rights reserved. Privacy Policy | Terms of Service