HOME  |  NEWS  |  BLOGS  |  MESSAGES  |  FEATURES  |  VIDEOS  |  WEBINARS  |  INDUSTRIES  |  FOCUS ON FUNDAMENTALS
  |  REGISTER  |  LOGIN  |  HELP
naperlou
User Rank
Blogger
Look to other industries
naperlou   12/3/2012 9:54:43 AM
NO RATINGS
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
Iron
Excellent article
Nick Ranly   12/3/2012 3:45:09 PM
NO RATINGS
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
Blogger
Re: Excellent article
Cabe Atwell   12/3/2012 4:24:46 PM
NO RATINGS
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.

C

Charles Murray
User Rank
Blogger
Re: Excellent article
Charles Murray   12/3/2012 6:51:07 PM
NO RATINGS
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.

Rob Spiegel
User Rank
Blogger
Re: Excellent article
Rob Spiegel   12/3/2012 9:42:49 PM
NO RATINGS
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?

William K.
User Rank
Platinum
Compliance woes
William K.   12/4/2012 6:59:20 PM
NO RATINGS
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
For city dwellers, finding a parking space can be a time-consuming and downright exasperating task. Now, however, engineers may have found a solution to that old urban problem.
Manufacturers have to manage a wide range of data, and unstructured data -- from PDFs to video files -- has become a big challenge as the new world of Big Data emerges.
Answer this question, and more, during Design News’ Focus on Fundamentals course -- From Rapid Prototyping to Quick-Turn Production: A User’s Guide -- June 2-4. Sponsored by Proto Labs.
In his keynote address at the RAPID 2015 conference last week, Made In Space CTO Jason Dunn gave an update on how far his company and co-development partner NASA have come in their quest to bring 3D printing to the space station -- and beyond.
On Memorial Day, Americans remember the sacrifices the US armed forces have made, and continue to make, in service to the country. All of us should also consider the developments in technological capabilities and equipment over the years that contribute to the success of our military operations.
More:Blogs|News
Design News Webinar Series
5/21/2015 11:00 a.m. California / 2:00 p.m. New York
5/7/2015 11:00 a.m. California / 2:00 p.m. New York
6/3/2015 8:00 a.m. California / 11:00 a.m. New York
6/11/2015 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.
Jun 8 - 12, Everything You Ever Wanted to Know about Filters
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.
Next Course June 2nd-4th:
Sponsored by Proto Labs
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