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Ron Sully, Director of Marketing


Welcome to OMNInews the electronic newsletter from Omnica Corporation. 
Here's our bi-monthly selection of relevant industry and science news, what's happening at Omnica and other generally interesting info. 
 Ron Sully - Director of Marketing 

September/October 2013
 
OMNInewsOriginal  If you are developing a medical device, your ISO registered outsourcing partner still needs to comply with the FDA's Quality Systems Regulations. As an individual involved in development of medical devices, you are likely aware of the terms "ISO Certified" and "13485 Compliant". What is the significance of these designations and should your design and engineering services contractor be certified? Probably not, unless they are also a manufacturer, but you will be in a better position to answer that question after reading:
 
Kathryn Small Costs attached to ISO Certification For companies with process standards documentation, a quality management system, and continuous improvement programs in place, maintaining a quality focused organization can be accomplished without ISO. For those who choose the certification route, yearly direct and indirect costs of auditing, additional record keeping, extra personnel, and maintaining certification can be significant - in the tens of thousands.     
Has investment in consumer electronics reached diminishing returns?
The fundamental technologies that power our consumer and commercial electronics have matured to the point of leveling off. Expanding electronics capabilities is extremely challenging, making minimal advances in technology too costly to pursue. The author expertly illustrates his point of view regarding semiconductor progress with an analogy to aerospace engineering.  
This is why electronic devices in 2053 will look and perform substantially like they do today.

Moore's Law to end in 2020 Moore's Law, going strong for almost 50 years, is based on semiconductor scaling and chip performance. He posited the number of transistors on integrated circuits would double every two years. According to Robert Colwell of DARPA, economics will be the roadblock to end Moore's Law, not physics. The chips can't be shrunk much more, and minimal performance improvements through microarchitecture and system design won't justify their cost of manufacturing if customers don't see the value.
 
                     OMNICA News and Announcements . . .   
 
Neo cup small
   We depend on advice from the experts, but there are occasions you have to confront a problem the old fashioned way. That's how we solved a plastics challenge when developing a consumable for the Neomatrix Halo breast cancer screening system.    
   The disposable component is a soft plastic cup (at left) used to collect nipple aspirate fluid for PAP-type cancer screening. There were some special requirements. We needed a biocompatible, low durometer plastic, which could be molded with thin walls in production quantities, and bondable to polypropylene (the primary plastic part in the consumable).  
  Our advisers and molding vendors believed Kraton was only polymer that could work but there wasn't any information to confirm the assertion. They had not seen the plastics co-molded and were not willing to build molds to give it a try. It was up to our team, so we involved Mark Mossberg, our CAD/CAM specialist and plastics expert, who has been with Omnica for 17 years. 
   We designed and built an aluminum mold prototype in our machine shop to learn more about the elastomer. It was an iterative process, and we quickly confirmed with our 28-ton Arburg that all-aluminum molds were best for molding this material. Typically, molders use steel for high-volume parts, but we knew aluminum's heat conductive properties would be the only substrate that would work in this case.  
   We ran the prototype co-molded parts and learned enough about their characteristics to define a process that could be used for the high-volume consumable. Our team transferred the information to a molder we sourced, who successfully accomplished the job for Neomatrix. 
  
Scotts 2013 Annual Pumpkin party October 30 and 31. Each year one of the delightful activities we enjoy is the Halloween Pumpkin Party. Our creations, ranging from fun to fantastic, will be on display for two to three days depending on the jack o' lantern decay factor. You may be amazed; some of the contrivances don't have much in common with traditional carved pumpkins. Last year, Scott Conway's entry was made of powder-coated aluminum (at left). 

OMNInews
September/October Calendar Quiz  
  It is Autumn, my favorite time of year, and for this issue we have an easy question to be rewarded with a Starbucks coffee card if answered correctly. Can you find the Omnica sphere hidden in the September calendar image? Email the correct answer and I'll send you a card. Also, we are working on the 2014 Omnica calendar now. If you want one, contact me and I'll add you to the mailing list.

New Omnica website coming soon  Omnica's re-imagined web site will be published shortly. When you see it, you will have a much better understanding of how we can solve your design and engineering challenges, and why Omnica is a unique medical device product development resource.

OMNInews Archives  
Did you miss issues from earlier this year?  You can read them here: 
July  - Mobile health apps and regulatory oversight  May - Time and Material vs Fixed Price Bids     March - Understanding Design Control  January - Why Medical Products are Getting Better October - Hiring a Full Service Manufacturer vs a Product Development Firm 
 
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               Please Call:  Ron Sully: 949-472-0275

 
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   Omnica is a full service high-tech design and engineering firm   in business for 29 years. We have 28 full-time employees, and perform all design and engineering services in house, at our Irvine facility. Our specialty is developing medical devices for both start-up companies, large firms like Terumo, Alcon, Instrumentation Laboratory, BD, Medtronic, Allergan, and others.