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ZDNet Resources
- The real end game in home automation
- We're getting older, the world's getting colder. There aren't going to be enough workers available to care for us when we get into our 70s and 80s. The answer is home automation. Not just to run our TVs, either. But to manage us in our old age. by Dana Blankenhorn
- Tags: Game, Marc Fleury, Automation, Home Automation, Medical Device Approval, Healthcare, Quality, Business Operations, Dana Blankenhorn
- Blog posts 2008-07-29
Additional Resources
- How a software engineer tried to save his sister and invented a breakthrough medical device
- I meet a lot of Silicon Valley companies but rarely do I come across a story as inspiring as this one. Robert Goldman is the founder of Vascular Designs, a company that just won FDA approval to sell a breakthrough medical device that could save the lives of countless terminally...
- Tags: Software, Medical Device, Robert Goldman, Federal Government, Healthcare, Government, Tom Foremski
- Blog posts 2009-09-02
- Certification the tip of the health reform spear
- Certification the tip of the health reform spearIt's difficult to move into new areasWhen the money controls the market entry.I'm in agreement with the need to displace the old approach as it certainly doesn't help us, as individuals or doctors or clinics/hospitals.One factor of interest to me is that the...
- Tags: CCHIT, certification, FDA, health care, ResMed
- Discussion threads 2009-05-06
- AGA Medical Corporation Consolidates Quality System Information Into One Master Source
- AGA Medical Corporation wanted to increase and accelerate access to design, manufacturing, compliance, and other information to accelerate time to market for the company's products that require regulatory approval and replace unsustainable, paper-based processes that were put in place when the company was one-tenth of its current size. The challenge...
- Tags: Product Lifecycle, Oracle Corp., Compliance, Product Lifecycle Management, Product Marketing, Manufacturing, Marketing
- Case studies 2009-02-01
- Time to overhaul grandfather's FDA approval process?
- Time to overhaul grandfather's FDA approval process?FDA Approval ProcessI believe that you are confusing the issue of grandfathering to devices before 1976 and the requirement to submit what the FDA calls a 510K in order to use device similarity to an already grandfathered device.Most new medical devices are 3 or...
- Tags: Federal government, HEALTHCARE, FDA-Approval Process, FDA-approval, FDA
- Discussion threads 2008-06-05
- Time to overhaul grandfather's FDA approval process?
- In February the U.S. Supreme Court ruled, in Riegel vs. Medtronic, that the FDA's authority to approve medical devices means states, and their courts, have no recourse when something goes wrong. At a stroke this pre-emption ruling eliminated medical device product liability. Once the FDA approves a...
- Tags: FDA, Medical Device, Recourse, Federal Government, Healthcare, Government, Dana Blankenhorn
- Blog posts 2008-06-05
- Designing Electronic Medical Diagnostic and Monitoring Devices for Extended Lifecycles Using Off-the-Shelf Single Board Computers
- Due to the high costs and long lead time of product development and regulatory approval, profitability in the medical device industry is dependent upon the manufacturer's ability to design and develop superior products that have a long lifespan in the marketplace. Since population demographics and the rapid pace of technological...
- Tags: Patient, Board, Monitoring, VersaLogic
- White papers 2008-06-01
- Medical companies celebrate death of patent reform
- Medical device makers and drug companies are celebrating the apparent death of the 2008 Patent Reform Act. (For the other side of this debate, visit my open source blog.) Why were AdvaMed, PHRMA, and the rest of the industry so dead-against an end to...
- Tags: Dana Blankenhorn, Drugs, Patent, Patent Approval
- Blog posts 2008-05-15
- Patent reform dead for 2008
- The death of the Patent Reform Act in the Senate spells hard times for open source. That's because one of the act's main aims was to end "forum shopping," the practice of filing lawsuits in, say, the Eastern District of Texas, which never saw a patent plaintiff...
- Tags: Patent, Dana Blankenhorn
- Blog posts 2008-05-15
- How this blog saved my life and saved me $100,000
- A few months back, I told you about how my neck had gone bad, really bad. At that time, I was in the middle of a six-month dive into pain, alleviated only by gobbling unwholesome quantities of Percoset. Three weeks ago last Friday, I had an amazing surgery that relieved...
- Tags: Blog, Doctor, Disc, Health Care, Surgery, Healthcare, Mitch Ratcliffe
- Blog posts 2008-04-20
- Medical lawsuits may soon be a thing of the past
- Whenever I discuss rising medical costs here, at least one commenter often several will chime in and blame the lawyers. If we just didn't have all those nasty lawsuits... Well you may get your wish. In a case called Riegel vs. Medtronic,...
- Tags: Wyeth, Lawsuit, FDA, Federal Government, Government, Dana Blankenhorn
- Blog posts 2008-03-09
- Should devices get the same scrutiny as drugs?
- Should medical devices get the same regulatory scrutiny as drugs? According to a controversial article in the Journal of General Internal Medicine, they should. Lead researcher Mitchell Feldman right of the University of California at San Francisco said this is just about getting good...
- Tags: Dana Blankenhorn, Device, Healthcare, Management, Strategy
- Blog posts 2008-02-01
- Becoming cyborg: Beware inequalities ahead
- For the past couple of months I have been exploring a different kind of technology, the biological ones. You see, I need a new neck. Most of the big news in medical technology seems these days to revolve around genetic discoveries. Nevertheless, the first kind of...
- Tags: Insurance Company, Disc, Fusion, Surgery, Mitch Ratcliffe
- Blog posts 2008-01-03
- Life-saving program BANNED by the Feds!
- Pardon me while I bang my head on my desk Less than 3 weeks ago I wrote about a simple storage device that saved 1500+ lives and over $175,000,000 in just a couple of hundred hospitals out of 3700 nationwide. Now the Feds have ordered...
- Tags: Checklist, Medicine, Patient, Procedure, Best Practice, OHRP, Robin Harris
- Blog posts 2007-12-30
- Google versus the telecoms
- Google versus the telecomsInfrastructure game will suck up all Google's cashThere is no better way to spend capital than investing in the infrastracture business. If Google gets into building a 700MHz network, it will be years before they can get their investment bank. There is also the handset side to...
- Tags: Telephony, Telecom & Utilities, Cellular phones, Wi-Fi, telecommunications, Google Inc.
- Discussion threads 2007-11-30
- Today's Debate: Is Medtronic recall good enough?
- Today's Debate: Is Medtronic recall good enough?reality show &/or 12 hr.,5 part maj. motion pic. much better!I didn't see this tv show which you reference as a basis for speculation about this Medtronic recall situation. However, from the few words with which you provide the substantive details of its synopsis,...
- Tags: HEALTHCARE, Gilligan, Medtronic Inc.
- Discussion threads 2007-10-18
- Establishing Regulatory Compliance in the Medical Device Industry
- The public health community and its providers are continually improving their ability to deliver new procedures, treatments, diagnostic methods and preventive practices. Breakthrough advances by medical device companies have facilitated both earlier disease detection and better long term healthcare. However, productivity within the medical device industry has been inhibited by...
- Tags: Medical Device, Regulatory Compliance, Healthcare
- White papers 2007-10-01
- How to tell if Frodo is getting better
- News reports on Silhouette Mobile, a new wound imaging system from ARANZ Medical of New Zealand, are all about how the technology is the same as that used to bring characters like Gollum to life in "Lord of the Rings."But this is better than a movie.The device, a finalist for...
- Tags: Document management, HEALTHCARE, Dana Blankenhorn, Silhouette Mobile
- Blog posts 2007-08-23
- Take a deep breath and check your health
- After several other newspapers, the Los Angeles Times is looking at the Heartsbreath test, which is a billion times more sensitive than police breathalyzers. These breath sensors can already check for asthma, ulcers or trouble with a heart transplant. But as says one of the researchers who worked on the...
- Tags: breath
- Blog posts 2005-12-24
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