John Oliver makes fun of 510k's and Medical devices

That ever awkward moment that someone asks you what you do for a living on a first date. Your heart sinks, because your job is nowhere as sexy as as “Silicone Valley Software Programmer”, “Digital Marketing Strategist”, “Influencer”, “Blogger”, or “Cybersecurity. Analyst” Well maybe not, sw programmer and cybersecurity anal, but you get my point. How the heck do you explain Quality and Regulatory of Medical devices, and does anyone really care? I guess John Oliver does! And this 20 minute video on the boringness of my job may finally answer why I do this, why I choose to consult, and why everyone needs big pharma and med device to back off - show us the data, charge appropriately and not price gouge us, and get out of not be d with our legislature. Enjoy!

https://www.youtube.com/watch?v=-tIdzNlExrw

The Healthcare fear with the GOP

Obama care was a godsend to me.  I was diagnosed as a Type 1 diabetic in my mid-30's . Right about the time the market crashed in 2008, and the recession hit, Obamacare enabled to me to get my life saving insulin and medical devices.  No longer were insurance companies able to discriminate and deny one coverage based on a pre-existing condition.  And let's face it, if you are human, you are a pre-existing condition. Granted, there was no price control re: what the insurance companies could charge someone with diabetes, at least I had the option and the access to coverage for a disease that easily costs 20k a month sans insurance.

“For many years, the type-1 diabetes community had to battle with insurers that were allowed to deny coverage or charge significantly more to cover people with pre-existing conditions and we want to ensure that our community does not have these same battles in the future,” JDRF said in a statement.

The 2010 Affordable Care Act changed that by requiring health insurance companies to accept everyone who applied for coverage. In return, the ACA required that just about everyone get health insurance or pay a special tax.

The idea is to mix healthy people together with sicker people, with everyone paying premiums, so that the companies have enough money to pay out everyone’s claims.

Before Obamacare, pre-existing conditions that cost people coverage, or led to very high premiums, included:

  • Pregnancy
  • Diabetes
  • Heart disease
  • Genetic conditions
  • Injuries
  • Epilepsy
  • Cancer
  • Mental disorders

Now, I am having trouble sleeping at night with the new Senate bill proposal that will will threaten my insurance and my costly pre-existing condition.  I thankfully have insurance through my half-time job as my employer understands my situation, perhaps it helps his own son is Type 1.  -Head hunters contact me daily for opportunities, but I can not do any contracting or consulting without the permanence of healthcare.  I feel like I am stuck in a rock and hard place, working half time to maintain my healthcare, joining the millenial economy to take a roommate and sell clothes online and some consulting only locally to make up the difference of the need to pay my mortgage.  I work 3 jobs.

If you are not familiar with the consequences of the bill, I have distilled them here for you.

1. The Senate bill will open the door to states forcing people with pre-existing conditions into segregated markets that will lead them to pay far, far higher costs than everyone else. People with pre-existing conditions could run into new annual or lifetime limits on how much insurance coverage they can get. That means those with the most serious chronic health conditions (and their families) will be at increased risk of financial devastation and even bankruptcy. The bottom line is that the backdoor discrimination the Senate plan allows against those with pre-existing conditions is as cruel as the discrimination in the House bill which the Senate claimed to fix. (Atlantic, 2017)

2. “If a state decides that prescription drugs are no longer an essential health benefit, a plan could cap the amount it covers for cancer drugs—or decide to not cover cancer drugs at all—leaving patients to pay the entire bill.”

3. With the broad waivers like those possible under the Senate bill, one could expect that Essential Health Benefits like covering drug-abuse treatment, including for those with opioid abuse, and mental illnesses and maternity coverage could be dropped in various states, meaning more discrimination against women and millions with mental illness or histories of drug abuse.

So I urge you, write, call your senators.  Get in touch with your .org mine is JDRF to see what activist issue groups are taking for pre-existing diseases.  

Cybersecurity in Medical Devices and FDA

In the world of medical devices being in the cloud and applications on the interwebs, FDA has stepped up requirements for cybersecurity.   It's not just banking, your identity being hacked with your credits cards or tax retunrs, St. Jude and Medtronic were both hacked in 2014 (https://www.meddeviceonline.com/doc/hacked-medtronic-boston-scientific-st-jude-networks-suffer-cybersecurity-breaches-0001).

I think I first saw this way back in 2005 while I worked at pacemaker/defibrillator company being joked at in a cartoon showing Dick Cheney and his defibrillator being hacked forcing an arrhythmia.  It showed Dick Cheney signing a document in normal sinus rhythm and them bam - tachycardia.  And this was also an episode of Homeland (https//www.telegraph.co.uk/news/science/science-news/11212777/Terrorists-could-hack-pacemakers-like-in-Homeland-say-security-experts.html).

FDA and ISO are now highly depending on assessment of risk, and cybersecurity is not an exception.  FDA has released numerous guidance documents listed below where identifying your assets and assessing the threat risk and vulnerability of your systems is first and foremost.  

If you interface with the internet in anyway, be aware that you must address this in your premarket submissions or you for sure get a deficiency.