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Welcome to OMNInews from Omnica Corporation, a full-service product design and engineering firm located in Irvine, California.
Enjoy our selection of remarkable news, timely topics, and stay up-to-date with what's new at Omnica.                         

Ron Sully - Director of Marketing 


April 2017   
   
  A Modernized Search for Cures - Late last year a transformative $6.3B health care law was passed. The 21st Cures Act is a 1,000 page document that describes in detail how the FDA will speed the introduction of new medical treatments, and accelerate the approval process for new and promising drugs and medical devices. The Act goes further by acknowledging a need for a "least burdensome means" approval pathway for devices which are considered "breakthrough" technologies. Breakthrough devices are those that provide more effective treatment than existing standards, or are used in the diagnosis of life-threatening conditions.
 
Included in the law, among other provisions, are approvals for a boost in federal funding, research spending, and the push for better use of technology in medicine. Another section in the Cures Act describes a more lenient view of certain types of medical software (based on a low level risk to patients) to be separate from devices subject to FDA review. Industry is saying that the reforms will speed the development of lifesaving treatments, usher in a new golden age of medicine, and maintain the FDA's high standard of patient safety.

It sounds like real progress, but there are numerous critics, including some former  FDA officials and national consumer groups who disagree. Their position, is the FDA already moves faster than similar agencies in other countries. They have concerns, and don't want recently approved drugs, or those with newly approved indications to take a fast track to market by bypassing traditional randomized trials. It's their contention customers should be aware of these changes, and that drug safety has the potential to be compromised, especially for some new indications.
 
The 21st Cures Act is law, but this January the President signed an executive order that may seriously affect portions of the new legislation. It requires federal agencies, including the FDA, to eliminate two regulations for each new one the agency introduces. Much of the Cures Act directs the FDA to create new review pathways for drugs and devices, and the projected way to accomplish it is by creating new regulations.
 
  Treating Cancer Without Drugs - Since I work at a design and engineering firm, friends and acquaintances frequently ask, "What are you working on"? There are always
Nativis just raised another $10M to help develop their Nativis Voyager.
innovative projects in the pipeline, but because of non-disclosure agreements I usually have to dodge and deflect. Finally, one of our most interesting projects is in the news.
 
Nativis has been working with us for years to perfect a disruptive technology that uses ultra-low radio frequency energy in the form of electromagnetic fields to replicate the effect of chemotherapeutic agents to treat certain types of brain cancers without chemicals, radiation or drugs. The system detects changes in the electromagnetic fields that surround molecules. It can replicate that field, which alters the molecule profile, offering the same effect a drug would have on target cells when interacting with that molecule.

Nativis is conducting pre-clinical studies for drug-free treatment of other cancers like melanoma and lung. The technology can also be used for inflammatory disease and chronic pain. There have been no adverse effects or toxicities related to the device in human trials.

Networking and Trade Show Events

   MedTech Council - Last Monday in was the first meeting
We met friends and ate fine tacos at the MedTech Council Network event.
of a new national organization open to everyone in the Med Tech sector. Promenade Software in Irvine opened their offices to over 60 guests from service organizations, academia, venture capital, sales, marketing and medical device service providers.

The venue was intimate, but not too crowded or loud to get in the way of  meaningful conversation. There was plenty of food and drink to keep the visitors satisfied for more than two hours. The next meeting will be May 8 at Promenade Software in Irvine, CA. Everyone involved in the Med Tech field is welcome.  You can register here.
 
  Del Mar Electronics - We will display at the Del Mar Electronics and Manufacturing show on May 3 and 4 at the Del Mar Fairgrounds. Over the years, the show has grown considerably from a small, one tent show in the early 2000's to a well-attended and widely represented gathering of visitors and exhibitors in three large halls. The organizers also offer an extensive range of interesting seminars and discussions over the two days. We will be prepared to answer all your questions at Booth 411 in the West exhibit hall

OMNICA News and Announcements . . .  
 
  Diecast and Coffee - You probably know by now that everyone here has a hobby they are passionate about. It is uniquely inspiring when others share the same interests. Every fourth Friday, the industrial designers (Tim, Scott, Bob and Andy M) bring in five diecast automobile models and display them as a "Friday Five".  
   
The challenge is not who has the coolest models. The five cars they choose to display must represent a theme: cars that are blue, have overhead camshafts, or were featured in movies, for instance. They have been doing this for years,
Can you guess the theme of this "Friday Five"?
and surprisingly it's not a routine most Omnicans are aware of. You might say it is their private version of "Cars and  Coffee" that used to be held at Crystal Cove, and now in Aliso Viejo on Saturday mornings.                       
 
Here are five cars one of the designers displayed in last month's Friday Five. If you can guess the theme, contact me and I'll send you a Starbucks coffee card. Be sure to include your mailing address if you respond.

  The 2017 Omnica Calendar is Still Available.
 
 
2017 has barely started, and I have a few calendars left. If you want one for your desk, contact me and make sure to include your mailing address.
 
 
 
 
 

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               Please Call:   Ron Sully - 949-472-0275

 
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   We are different than other product developers. Omnica is a full service high-tech design and engineering firm in business for 33 years. We have 29 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.