Week 5

          With week five over, I feel pretty good about where I am at with my internship and my SRP as we head into spring break. As usual, I will begin with my internship. Though I still have yet to firmly grasp an understanding of the several types of code in various testing programs, I am becoming a skilled operator on the IC Test Floor (even though it doesn't require much skill). Each day we seem to encounter a new problem with one of the hundreds of tests, however I come back the next day or the next week and the problem has been fixed after careful analysis and changes, but once again a new problem arises that needs attention. As the weeks have passed, one by one tests have been checked off in the report until hopefully there will be no more tests to run and the report as well as the data can be sent down the road. Of course there are many more steps in testing and regulation that occur down the road by medical device companies themselves. In fact, since the FDA lacks an efficient system to monitor Medtronic's implantable devices, Medtronic has assumed the responsibility of supervising its devices both to make up for any mistakes the FDA makes as well as collect information regarding the status of devices after implant.

          As you see in this flow chart, once a medical device is designed, developed, and tested, depending upon the class level of the device, the FDA can review a device anywhere from three months to twenty four months after the submission. Now this is the real interesting part and all a true story. A friend of my father's needed a specific surgery in order to eliminate the tremendous pain in his back. His doctor told him he needed the surgery soon but it had not been approved in the US and was currently under review by the FDA and still had a potentially long way to go before patients could access the new surgery. Thus, he flew to Germany and had the surgery there where it was already approved by the EU and several committees. The surgery was very efficient, flawless, and rid him of all back pain. Some people argue the FDA's regulation is much safer and humane, though much more time-consuming, whereas others argue the EU's regulation is reasonable time-wise and efficient in terms of necessary approvals that allow patients faster access to therapy.

          Essentially, just as PG-13 movies in Europe are rated R in the United States, medical devices are less stringently regulated in Europe than they are in the United States. The EU operates in a fashion that treats their people as guinea pigs, in which of course some say is inhumane while others say is logical. Now this is where medical device companies come in. American medical companies are gradually moving their headquarters to Europe in order to decrease profit loss due to taxation. However, the United States makes up a little less than half the medical device market while the EU makes up just twenty-five percent of the global market, meaning if companies want to engage the largest market, they must still go through the regulatory processes of the FDA. Thus, in the future, it is expected that more companies will use Europe as an initial test run of their devices, at least until the EU makes their regulation more strict. Altogether, both the United States and Europe have a lot to learn from each other and their regulation will most likely become more and more similar as their systems become safer and simpler. 

          Overall, the internship is going great and my research into the differences between the EU and the FDA is truly eye-opening. I will definitely discuss these differences more, but as I have said before, there is so much information to handle and process that for now I am simply giving a synopsis. 

 

 Week 4 

          Well, the fourth week is over and my eyes are sore from reading both code and articles. First, I will start with my internship. One of my main functions during my internship is to function as an operator. Essentially, I load a test onto the computer, plug a chip into a large tester, and then sometimes attach a massive hairdryer piece of equipment, which can range from -20 degrees C to 135 degrees C, before starting the test. I let the test run for any given time period and  once the test is complete, I inspect the data to ensure any failures are either expected or are barely out of specification, in which now and then, chips need to be retested. If a chip still fails a test and should not after retesting, then the oscilloscope must be brought out to test the chip manually as I discussed in my prior post.

          Now, onto my research. Most people simply trust that the medical devices that are implanted into them are working properly, but people may not know that there have been many malfunctions and even deaths due to medical devices. I am not trying to scare anyone, but just give the facts. We trust that the medicine we take will truly help our sickness or we trust that our car's airbags will not shoot shrapnel out if we ever crash or we trust that our friends will catch us as seen below. However, there are times when our trust can not live up to our expectations. 

          One of the primary factors that leads to us trusting so much in our lives is the regulatory practices completed by administrations such as the Food and Drug Administration. We too often assume everything we use or take is safe for us without ever looking into the regulation ourselves. I am not saying that we must halt our lives to investigate every aspect of well, everything, otherwise we would not really be living our lives to the fullest. However, I do believe that if either you yourself, a family member, or close friend is about to receive an implantable device, about to take a new medicine, or even about to buy a new car, some research needs to be done to ensure what is being used is safe and reliable.

          In 2009, Medtronic voluntarily recalled 40,000 pacemakers that were implanted due to a .17%-.30% lifetime failure rate, in which 100 device failures were ultimately found. Thus, out of that batch of pacemakers, .0025% caused a shorter life span. However, with all medical procedures, people must ask themselves the difficult question of whether or not a medical procedure had truly prolonged someone's life. In 2011, the number one most implanted medical device was artificial eye lenses, of which there was a 1%-2% chance of retinal detachment that when left untreated could have led to complete vision loss in the eye treated. Johnson and Johnson in 2010 had to recall hip replacements of 93,000 patients, in which another surgery was required for one out of eight patients after five years. This data can all be found at http://247wallst.com/healthcare-economy/2011/07/18/the-eleven-most-implanted-medical-devices-in-america/2/. With all this information, I hope more people consider fully and extensively researching an implantable medical device before having a surgery because there are sometimes malfunctions and there are issues that arise over time despite the years of testing and pre-market regulation.
        
           Now, back to the FDA regulation. All implantable medical devices are considered Class III devices and receive more intense scrutiny as well as require a Pre-Market Approval (PMA). A PMA requires a company to submit summaries of non-clinical data and clinical data, extensive literature regarding the device, and a thorough inspection of the manufacturing facility. Class I and Class II medical devices usually only require companies to submit a 510(k) notification demonstrating that a device is substantially equivalent to a device already on the market. This process is much less time consuming and only needs FDA clearance rather than an intense inspection. I will continue to talk about FDA regulation in future posts since there is just so much information.

 

           Since so many people do receive medical device implants, I am very glad to see through my internship and my research how much testing and paperwork goes into the overall process of implanting medical devices. The next couple weeks I plan to dig into the global interaction of regulation administrations and how medical companies make use of multiple administrations.

Week 3

          During this past week, I learned how noise can interfere with certain tests and thus, those certain tests must be run manually on an oscilloscope. An oscilloscope is basically an advanced meter that is capable of digitizing multiple signals at once while displaying the many waveforms on the screen. We used the oscilloscope because the noise, which arises externally from other test signals, testers or equipment, was impacting the test circuitry causing the test to fail.

           Essentially, an oscilloscope functions to display an electrical signal as it changes over time. Oscilloscopes measure primarily time-based and voltage-based characteristics such as frequency, period, and rise/fall time and amplitude, maximums/minimums, and means respectively. Leads are plugged into the bottom, where those five outputs are, and connected to test points on the silicon chip. Before measuring data though, the trigger must be set, which will tell the oscilloscope what portion of the signal to trigger on and begin measuring. For example, if you desire to only view the graph of the negative slope of a signal, you record that with the trigger, and data is collected starting with the first sight of a negative slope, which can be seen on the graph of the scope pictured above.

          I was also introduced to a lab setup that included a saline tank, which is designed to simulate the conductivity of the human body where a pacemaker would be implanted. The tank is filled with sodium chloride and water and several pH probes are placed in tank to ensure the water remains at the same pH throughout various locations in the saline tank. The pacemaker leads are submerged in the water and are attached to external bench equipment. One interesting aspect of this form of testing is that there are many different types of leads and they all must be analyzed to ensure proper operation.

          The internship is going great and I am learning so much every day. I have already gained some insight into the various testing methods, but in the coming weeks, I hope to gain some new insight into the overall process of the regulation behind medical devices, specifically the involvement between medical companies and the FDA.