Designing products for regulatory compliance can eliminate surprises! How do you move through this maze? Today I had a great conference call with my old friend of many years, Bill Salzstein. Once we got caught up, we shared ironically same stories about how medical device companies tend to look at the 510(k) process. I can attest to this of what I went through this year,it is how you look at the whole risk mitigation piece in light of the reviewer that can have the ultimate impact on the timeliness of the approval process. Here is the excerpt article that Bill sent to me that is a good read.
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Archive for the ‘Syndicated’ Category
Medical Design for Regulatory Compliance
Friday, December 30th, 2011 by David HoglundThe Dream Phone – the Verizon I-Phone Coming Soon to a Store Near You
Friday, November 5th, 2010 by David HoglundPeople over the past couple of years have made fun of me because I carried a Blackberry, why not the I-Phone? OK, now I actually have the Motorola X, DROID, i.e. Android OS. The Motorola DROID is one major league data hog, but not one hiccup with the Verizon network. It is because of the network, stupid I say. ATT and Cingular smashing two companies together and not understanding the capacity requirements. When Apple I-Phone hit the ATT network, data usage shot up 5,000%!!. When that happened the macro cell foot print (sector) shrunk to ensure that the downlink and uplink for voice was preserved, however the smaller sector and data bounced voice calls when roaming…like driving down the road. CDMA of Verizon is better than GSM of ATT, but no doubt Verizon was waiting to up their capacity with LTE. LTE makes a lot of sense for the iPhone, as Verizon CDMA network does not allow consumers (and or healthcare physicians to make calls and surf the network (web simultaneously on the I-Phone). And here is the big kicker, 4G will not crumble to it’s knees like the 3G network of AT&T. It also will allow for world-wide use, versus having to have a combination CDMA/GSM phone. AT&T cannot build out more capacity on it’s macro network, so they are scrambling to put BTS and DAS into every venue that they can to add “capacity”. That is why the in-building DAS market is exploding and gone are the days in major metro areas of repeaters sucking bandwidth off the tower. (Well at least in Washington D.C., that is). This problem is not going away anytime soon, as data usage is only going up and up.
The most talked about cell phone in America is the one that does not exist (officially), the Verizon I-Phone. As Fortune magazine recently said, “consumers have yearned for the Verizon iPhone as if it were the second coming. The first hint of this was when Verizon started selling the I-Pad, most recently. The CEO Ivan Seidenberg of Verizon is a genius. For healthcare applications on a broadband model he has made a major coup. Early this year he persuaded Google to issue a joint policy framework supporting Verizon’s right to prioritize traffic on it’s wireless networks, altering Google’s long-held stance that all data should flow freely on wired and wireless systems. Thus, you could not have a kid’s 40MB video file overshadow a broadband wireless medical application.
802.11n 802.11a/g Multipath the Site Survey and Beamforming
Monday, November 1st, 2010 by David HoglundFrom a healthcare perspective (via any vertical market) the hospital is the worst multi-path environment available. This multipath environment is caused by all the reflective elements present such as steel carts, beds, fluids, and tile/reflective surfaces, plus everybody moving around 24/7/365. Add to this all the movement and mobility that is constantly going on as described. Not a good environment for a RF signal to play in..period. Example your smart phone in the depths of building. This is bad for the performance of 802.11a/b/g, but actually is an advantage for 802.11n. Understand that MIMO with 802.11n, takes advantage of multi-path. So then how has the site survey changed and what is the true throughput of 802.11n? The traditional site survey (for WLAN) plans for the performance of negating multi-path with 802.11a/b/g, but this will degrade the potential performance of 802.11n, thus decreasing available network throughput. This requires a careful thought process “and” site survey on how to balance both what is somewhat considered legacy WIFI (802.11a/b/g)with 802.11n. (Let me say that 802.11a/b/g is not legacy, but the IT mindset is focused on speed…more better) Just remember it is not always about speed, but for the application to perform in the correct defined business model. In this case a lot of medical device applications with 802.11a/b/g work extremely well. Add to this, not many if limited OEM embedded 802.11n modules are offered today. This will mature, just like 802.11b to 802.11a/b/g, and 802.11n, once power mangement issues are resolved regarding MIMO. (It takes a lot of power to transmit and receive). Sorry it is physics.
Beamforming is a great “marketing term”, sounds like something dreamed on a napkin over a few bottles of beer or glasses of wine, but in fact it is pretty simple and has been around the the wireless world for a long time. Beamforming is pretty straight forward. It is method of directing RF energy in order to improve the signal to noise ratio (SNR) at the receiver, thus improving the reliability of the signal. When you have more antenna elements (dynamic beamforming) to select a signal in an x/y/z axis you then can use software and algorithms to clean up the signal relative to the noise floor and then send back this signal in phase using the same antenna elements. So, what does this all mean? OK, Cisco uses ‘beamforming”, and also Ruckus Wireless. I go back to my old days of “digital radio receivers”. If you use 14 to 3 antenna elements you tend to receive a better S/N of which is based upon all the same output of the transmitter and received receiver. It also probably overcomes a lot of the noise floor issues, since you have more antenna elements to receive and thus transmit. Thus the algorithms can clean up the signal… in fact have a “cleaner signal”, to transmit back. Being able to look at the RF signal in a 3D axis, i.e. x/y/z, will in addition provide the value add of discerning the holistic environment from an actual multi-path and real life(demonstrated) RF performance venue provides major league value to ensure the ultimate network throughput. 802.11n is (each end point entity), wlll need to evaluate whether DAS can fit within a financial or technical within this broadband model..Enough said. Just look to those business models that tried a go at this! It is my opinion that RF performance not only needs to be looked at from the network valuation; but how the RF design will utimately impact the back end network “performance” model. While it is known that players like www.ruckuswireless.com have little footprint (at least in healthcare), their technology and performance just makes it seems some of a technical and financial sense against the yeah what network dudes consider. www.cisco.com. (I am not biased but just reading the performance RF models, of the leading network wireless performance modeling…leave it at that!) However RF is very complex and the more and more push to the RF envelope making it 100% 24/7/365 simply means better and confirmed absolute performance. Cisco Systems (while I got to digress they did not get where they are with not a lot of brilliant people), it just holds that a lot of smaller players with innovative technologies are nipping at their ankles). Heck, just think of Apple versus Microsoft! They the global leader in networking www.cisco.com tend to inovate by past experience via acquisition when competition threatens; so stayed tuned to the next venue of the next stage of wireless..it will be very interesing. They (Cisco Systems) will and have always kept their eye on the ball of technology innovation. Who is the next target for acquistion?
Next Generation DAS (Distributed Antenna System)
Tuesday, October 26th, 2010 by David HoglundTraditional in-building DAS systems can be either a combination of passive coaxial cable and/or a hybrid of single mode fiber and/or passive coaxial. Using ethernet to distribute broadband signals also has limitations. Oh yes, the decision on why a passive design to a fiber/based coaxial design has all to do with meeting the link budget requirements. Just like installing legacy WMTS coaxial antenna systems, it seems that using coaxial as a medium of choice for broadband signals (cellular and PCS), is very costly and most hospitals do not like to run multiples coaxial cable implementations into the ceiling. Advance in multi-mode and single mode fiber (better bending radius) and pre-determined lengths probably make this a better choice direct to the antenna element. These leads to the move to digital radio systems that are software controlled versus analog designs. Look to great advances in 2011 in this area and more to come on this blog.
