Regulations For Everything Except : "I've Fallen & Can't Get Up "

Regulations For Everything Except : "I've Fallen & Can't Get Up "

In a world that regulates toxic waste disposal ,fuel emissions, food additives , communications signals and hundreds of other areas touching our daily lives , we don't regulate the quality of the medical devices we place in our bodies . Yes -- it's true , "I've Fallen & Can't Get Up  "  could very well apply to the fact that the entire medical implant community has no compelling reason to check or inspect the various bone screws and associated , hip ,knee ,elbow, shoulder ,or spinal devices that are placed inside thousands of patients yearly. It's hard to believe that the only FDA guidance on implant quality control comes under the guise of 510 (K) processes which only mandates device manufacturers adhere to "best practices". It's no wonder that there is a lengthy list of implant recalls and multiple lawsuits clogging our courts today.

http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/default.htm

We the people simply don't realize that when we go in for an implant procedure the devices being used have a high risk of never been inspected for flaws, material strength or overall compliance to design specifications. We see the results of our misguided assumptions daily as the recalls and lawsuits pile up. The device & implant companies’ solution is shockingly arrogant. They set up massive funds in advance to settle expected lawsuit settlements that range from $200,000 -$500,000 and employ larger legal teams then quality control specialists. We see story after story in newspapers, on TV and the internet covering the pain and suffering caused by implant malfunctions. Yet with all these exposures we fail to grasp that the crux of the issue is demanding the parts going into our bodies undergo the same quality control we expect in every other device that touches are daily lives.

Is There A Better Way?

Yes technology exists that is far superior and quantitative to what medical device manufacturers are using today- if anything to insure the parts that they are placing into the community are within tolerance to design specifications. If manufacturers are doing anything about quality control they are relaying on technology from 1906 optical comparators, slightly more modern coordinate measuring machines or microscopes to inspect thousands of parts. All these methods are very suspect in terms of actually providing modern quality metrics. Through the utilization of various types of robotic automated inspection technology the medical manufacturing industries could measure and ensure part tolerances to a very high degree. These 3-D approaches would be a winning play for all concerned. Manufacturers could pay out the money now earmarked for lawsuits to their shareholders and the public would be insured that the implant parts going into their bodies were within the design tolerances they were specified at. We all win under this scenario and pave the way for cost reductions to the concept of Affordable Care going forward.

Author Bio

Mr. James Falasco began his post graduate career at the University Of Illinois Medical Center where he focused on research and applying information science techniques to initial aspects of computer assisted learning. He gained exposure to numerous medical device applications involving CT, MRI, traditional X-Ray /PACS systems, Cardio Cine, & kinesiology .Mr. Falasco has held key business development and management positions with General Electric, Intel and Gould Electronics as well as other well known smaller high technology organizations with leading edge COTS products.

Mr. Falasco holds an M.S. from Western Michigan University and a B.S from B.G.S.U.

Seeking Navy SBIR Funding

http://www.navysbir.com/solicitations.htm

The above link will send you to Navy program offices for various key technologies and platforms that support the Fleet today and in the future. If one is seeking SBIR funding it is key to pursue the related PEO's in order to influence the wording of the SBIR announcement and increase your win
probability. I have had success in all aspects of Navy SBIR activity by following this approach in areas such as mine warfare , ASW , littoral conflict, C4ISR , airborne sensors to name a few.

Motion Control Survey For Surveillance and Security In An Asymmetrical Era

Many security and surveillance applications today have a requirement for Motion Control technology. Think about what it takes to move a camera , antenna or radar from side to side or up and down. Motion Control is playing an ever increasing role in situational awareness in today's asymmetrical era. Now is your big chance to not only get paid but also share your input in a key  survey. Please follow the below instructions.

L.E.K. Consulting is conducting a study on the motion control products market. We are testing a new product concept designed to help purchasers of motion control products dramatically improve sales and reduce costs. The survey will take approximately 20-25 minutes to complete and all responses will remain completely confidential.

All respondents who complete the survey will receive a $100 honorarium! If you are unable to accept an honorarium, we can donate this money to a charity of your choice. We will also provide you and your organization with high-level feedback from the survey!  My suggestion for donation is the Wounded Warrior Organization who do so much to help the true champions or the asymmetrical era.

We have recently changed our qualification criteria, so if you tried to take this survey in the past and could not, please try again!

http://www7.intellisurvey.com/run/motioncontrol?pan=99&c=1

If you experience any problems with this survey, please contact us at c.gonzalez@lek.com

Please make sure you note you were referred to this survey by answering in the second to last question  “How did you hear about our survey?  http://www.falascoj.blogspot.com

Stars In My Crown

http://m.youtube.com/index?desktop_uri=%2F&gl=US#/watch?v=SH_d13VL7sw

Stars In My Crown

 

A traditional old time movie shows what the world was like when asymmetrical activity only happened in the animal world. What has gone wrong?

The Real China

Several years ago while in China for business I took a weekend and went to the Great Wall with by local Beijing Sales team. The two associates that acted as my host had done so many times but never with anyone as knowledgeable in Chinese history as me. While leaving one of the museums we noticed dozens of military trucks pulling up. The local PLA base uses the Great Wall as the location of their weekly graduation ceremony. This would of course be akin to a USMC  recruit class at Quantico going to the Washington 
Monument to graduate. About 1,000 young Chinese got out of the trucks along with their drill instructors and marched in formation to the top of the Great Wall. Right  behind them were their parents,boyfriends & girlfriends, (the graduating class was COED ) , "Don't Ask /Don't Tell Hasn't Reached the a PLA yet .  The drill instructors lined the unit up and went into a typical pitch. Having only several months before watched my son graduate from his USAF basic training made me realize that drill instructors were the same all over the world. ( At least in organized provisional state oriented military groups vs.  Jihad central). When the ceremony was over ---it strangely paralleled what I had seen a few months before with the top squad , top recruit ,etc. mentioned , the graduates embraced their family members and left to celebrate. As I looked at the feet of the graduates I noticed almost every ones pants had holes in the bottom and their dress shoes were falling apart. As we followed them back to their trucks I noticed the trucks so resembled Tonka Toys from the 60's I couldn't help but smile and wondered what an air to ground missile from an F-16 would do to them. What's the point for bringing this up. Simple. China isn't our enemy. They may be pushing us economically which we need  . If anyone takes time to visit China they will find that it's becoming what we used to be. The biggest fights I saw were people trying to get onto the limited shuttle buses that were taking shoppers to the newly opened Walmart . At the Chinese McDonalds ,KFC,& Pizza Hut
while they speak Chinese vs. Spanish and  you are better understood and your order is correct vs. here. So stop trying to stir up anti Chinese sentiment by harping on defense cuts and preparing to fight China. Yes we need to fund our forces at the highest amount ; but for technology that makes sense and can be used for both the next 100 year asymmetrical era as well as classical conflict via the Jihadist wave hick jacking nation states ( Egypt,Libya,and the already hijacked Iran thanks to a weak presidents understanding of global dynamics ).

For details on what types of technology can be used to secure ourselves with a solution in surveillance and security in an asymmetrical era please see posts at :

http://www.surveillanceandsecurityinanasymmetricalera.com 

Constructive comments that can leverage anyone's product or position are welcome

Boeing's Private Space Taxi to Take Flight by 2016 | CST-100 Capsule : How Will Assets Like This Effect Surveillance and Security In An Asymmetrical Era?

With the end of shuttle operations the land rush or as it were space rush is on to be a supplier of transpiration systems to carry materials and people into space. The international space station will stay in operation and the stores and personal to man it will be transported by vehicles created and manufactured by private companies. The question then becomes how will this new paradigm effect the ability to conduct surveillance and security from space? The potential scenarios are endless with of course opportunities for any terror group or individual of that persuasion to have the ability to gain control of a platform and engage in activity that would emulate 9/11 space themed scenarios.

This publication serves as an extensive resource to review topics related to space and the associated areas potentially dealing with surveillance and security. 

http://www.space.com/15393-boeing-space-capsule-cst-100.html

Stop Bashing China

Several years ago while in China for business I took a weekend and went to the Great Wall with by local Beijing Sales team. The two associates that acted as my host had done so many times but never with anyone as knowledgeable in Chinese history as me. While leaving one of the museums we noticed dozens of military trucks pulling up. The local PLA base uses the Great Wall as the location of their weekly graduation ceremony. This would of course be akin to a USMC  recruit class at Quantico going to the Washington 
Monument to graduate. About 1,000 young Chinese got out of the trucks along with their drill instructors and marched in formation to the top of the Great Wall. Right  behind them were their parents,boyfriends & girlfriends, (the graduating class was COED ) , "Don't Ask /Don't Tell Hasn't Reached the a PLA yet .  The drill instructors lined the unit up and went into a typical pitch. Having only several months before watched my son graduate from his USAF basic training made me realize that drill instructors were the same all over the world. ( At least in organized provisional state oriented military groups vs. ? Jihad central). When the ceremony was over ---it strangely parallel what I had seen a few months before with the top squad , top recruit ,etc. mentioned , the graduates embraced their family members and left to celebrate. As I looked at the feet of the graduates I noticed almost every ones pants had holes in the bottom and their dress shoes were falling apart. As we followed them back to their trucks I noticed the trucks so resembled Tonka Toys from the 60's I couldn't help but smile and wondered what an air to ground missile from an F-16 would do to them. What's the point for bringing this up. Simple China isn't our enemy. They may be pushing us economically which we need that. If anyone takes time to visit China they will find that it's becoming what we used to be. The biggest fights I saw were people trying to get onto the limited shuttle buses that were taking shoppers to the newly opened Walmart . At the Chinese McDonalds ,KFC,& Pizza Hut .while they speak Chinese vs. Spanish you are better understood and your order is correct vs. here. So stop trying to stir up anti Chinese sentiment by harping on defense cuts and preparing to fight China. Yes we need to fund our forces at the highest amount ; but for technology that makes sense and can be used for both the next 100 year asymmetrical era as well as classical conflict via the Jihadist wave hick jacking nation states ( Egypt,Libya,and the already hijacked Iran thanks to a weak presidents understanding of global dynamics ).

For details on what types of technology can be used to secure ourselves with a solution in surveillance and security in an asymmetrical era please see posts at : http://www.falascoj.blogspot.com/  Constructive comments that can leverage anyone's product or position are welcome.