Week 10 

          So, I pretty much wrapped up week ten with my week nine post, but wanted to wait a while to actually write this post because today was my last official day for my internship. I was very excited to go into Medtronic today because I was able to do a tour with my father. We learned of the facilities that Medtronic has and also the business side of Medtronic. For example, how they bought Covidian based in Ireland and how they plan to start making new sorts of devices. The tour was going pretty well the whole time except for when we started to discuss the current medical devices and how they are implanted. For example, I learned about a tiny implantable device used to record the electrical signals from the heart, a pacemaker with several lead connections, and a device designed to rid Parkinson's disease. The actual discussion of how these devices are implanted was a bit more graphic and I learned that for the Parkinson's device surgery, a patient is actually conscious for a majority of the time while the doctor pokes around in the brain. I was fine with the overall discussion of the procedures, or at least I thought. My stomach was starting to hurt and I thought it was because it was nearing lunchtime, but I was wrong. Don't worry I didn't puke, but I did faint. My vision soon went black and was out for four minutes. When I finally came to, there were about seven people around me and I was in shock. I have never fainted before. I recovered quickly and eventually everyone left as I began to walk around. It was just a crazy experience! Overall, it was a odd way to end my last day at my internship. 

          I learned so much through this internship and project and greatly appreciate everyone who has supported me. Hopefully, I have made an impact by doing this research and I hope people continue to look into the rigorous testing behind such awesome and incredible life-saving devices. The video I have below is kind of difficult to watch, but describes a patient who had a DBS or deep brain stimulation device implanted into him. Just know people like Gary are now living amazing lives because of the continuous hard work put into such important implantable medical devices. 

          

 Week 9 

          As my project is slowly coming to an end, so is the flow of new interesting topics. With my internship, I have simply continued to work as an operator, but as my father's team nears the end of their own project, I have helped make many more graphs and presentations. Basically, I am formatting all the data that has been collected as well as assisting in organizing the final report that will be sent off to the production groups. At the production level, the data will be used to adjust any programming and such in the silicon chips that will be in the actual pacemakers people will be implanted with.

          It has been an absolute blast taking this stepping stone before college this fall and has been awesome to truly see how much I have learned from others these past months. Overall, this project has been quite worthwhile as I have not only seen both what I want to do and don't want to do in my own future, but have been given the opportunity to hopefully impact the world in a positive way by sharing my research. 

Week 8 

          This last week I learned that many implantable medical device companies make programmers for doctors and nurses to use that check up on the status of the implantable device. Before I begin discussing the programmers specifically, one interesting thing is that the FDA often relies on the medical companies to make their own regulatory devices. Medical device companies make programmers to collect data on how the devices are operating and then use that data to make improvements for the next up-incoming device. Now, more in detail on the programmer. The programmer is designed to check a variety of parameters such as the battery level, the pacing rate, impedance (detection of loose screws or lead fractures), threshold (minimum amount of energy required to depolarize chamber being paced), and the amount of time the patient is pacing on his/her own. When a patient visits a doctor, the doctor places the programming head of the programmer onto the patient's chest where the medical device was implanted, which then receives the information and sends the visual data onto the programmer screen. With the information collected regarding the device and how a patient's heart functions, in the case of a pacemaker programmer, the doctor can adjust the therapy. All changes are sent by the doctor to the pacemaker making the process of altering a medical device much easier as no surgery is involved.

       

          In 2009, Carol Kasyjanski of New York received the first Internet-based pacemaker by St. Jude Medical. When Kasyjanski visits home, at least once a day, the pacemaker downloads all information collected, such as that by a programmer, and automatically checks the performance of the pacemaker as well as the condition of her heart. All information is then uploaded to a central server where her doctor may browse the data collection at his/her leisure. In addition, any abnormalities or dangers found by the pacemaker notifies the doctor at once. Internet connected medical devices will most likely by entering the market in the next decades as this massive technology movement continues. Few devices currently are connected to the Internet as there are many more systems that need revising and perfecting. For one, collecting data requires memory space, which in turn requires greater energy consumption. With so many updates as well as the desire to make medical devices smaller and smaller, there needs to be changes to the internal system while still ensuring the device functions properly and safely. However, with connection to the Internet, devices need to be better secured. In a 2012 episode of the TV show Homeland, a Vice President is assassinated by a terrorist who hacks his pacemaker and accelerates the pacing until he dies of a heart attack. I am not trying to scare anyone, but there needs to be serious caution as the Internet becomes more prominent in medical devices. If a specific medical device that happens to have Internet access is needed by a patient, the good thing is that the wireless function can be disconnected.

       

          Overall, the integration of the Internet into medical devices both offers a more efficient and convenient addition as well as some realistic concerns as hackers become more and more prevalent. For now though, almost all people with pacemakers will continue to make the trip to the doctor for a routine check-up by the programmer.  

 Week 6 & 7 

          With spring break over and a lot of time to research how devices are being regulated, I feel I need to extend the subject of my last post about the FDA and EU. I am going to discuss the main debate in the medical device industry right now; safety concerns and approval speed. You can check out where I've received this info at http://mullingsgroup.com/medical-device-debate-balances-safety-concerns-approval-speed/, but I will convey the debate in my own fashion. One interesting thing is that this article is from 2012, but very little has changed policy-wise to improve the system. Steven Baker, a 56 year old from Minnesota, received a FDA-approved artificial elbow that malfunctioned one day while he was passing through a metal detector. The device locked up leaving him in tremendous pain. He argues that the FDA needs to toughen its standards when regulating devices so that there are no faulty devices that make the situation worse than it was before he had the surgery. Thus, his concern is the FDA's incapability to safely approve medical devices. On the other hand, there are people such as my father's friend or the six million people that travel each year to Europe to have a surgery, device implant, or simple procedure. A majority of people who do travel to Europe do so because American healthcare is expensive, however, there are many individuals that require a medical device that simply has not been released or approved yet in the United States. Thus, there is also a concern over approval speed. I, probably like most people, can see both sides of this debate.

          To ensure that these medical devices be regulated to the FDA's fullest capability as well as be approved in a timely fashion for people who need surgery rather quickly, it seems there needs to be almost two medical device regulatory departments; one for extensive evaluations, one for time-sensitive situations. People such as Steven do not want to have to receive a medical device that ends up causing more of a problem than prior to the device being implanted. They would ease any pain with smaller less significant medicines or surgeries until the permanent device is completely and thoroughly examined by the FDA. However, there are many others who simply need a newer version of an implantable medical device that is not yet released in the United States. They would go through the time-sensitive department to receive a new medical device not fully regulated, but of course at the complete discretion of both the FDA and device company.  I am not attempting to mend any government problems, but rather am voicing my opinion on how I believe the regulation should be done in order for more Americans to receive an implantable medical device in both a safe and timely manner. There comes a point where people have to ask themselves whether they can live with the pain one more day, week, or month. Is the pain worth waiting for a safe and approved device that might not be available for a couple more years? However, people eventually have to weigh the pros and cons. Clearly though, many people do travel to other countries to receive implantable devices, in which most do go out of country for the expenses, however, people take that risk so who is to say people will not take that risk in the United States if a medical device is available here.

         

                          

          The regulation and even testing of implantable medical devices is incredibly difficult. In the case of testing, often companies determine that a device is sufficient and reliable to be implanted even though there may be some small aspects with the device that fail to operate properly even though that system is not a major part of the device that is life-sustaining. A majority of the time devices do work properly, but occasionally there is a recall across the medical device industry and that makes people wonder whether that small aspect that failed caused the device to be recalled and though sad to say, caused people to suffer. The same goes with the FDA and regulatory committees as they approved the recalled device and made the terrible decision to release the device into the market. Though a majority of this industry is statistical, there are many life or death situations, moral difficulties, and emotional decisions for medical device companies, regulation committees, and even the patients.

 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.