Weekly Reflection 10/6
This week we had two speakers come in who both had experience in the industry and both happened to be in the manufacturing side. Dr. Bose dove into the aspect of drug manufacturing while Dr. Gettens focused on the medical device manufacturing side. For both industries there is much oversight and regulation that goes into getting these product to market both safely and effectively.
I think when it comes to the drug approval process there is much more entailed then in the medical device industry. Although both harp on the concept that all final products have to have legitimate proof that they are safe and effective, the drug process is much more extensive and taxing. Not only does it cost millions of dollars and take many years, there is a lot of excess time and effort put into to training employees, proper documentation, and general maintenance. During Dr. Bose's presentation he talked a lot about SOP and GMPC which are standard operational practices and good manufacturing practice concepts. When it comes to these ideas you have to do a multitude of logging and documentation in order to make sure that everything is being done up to par and nothing is going to be detrimental to the products success in the future. I feel as though this is much more important in the drug manufacturing industry because there are many more volunteers that are facing effects of the drugs day in day out during a trial and cutting corners could put their lives at risk. He brought up some examples of this happening in real life; Thalidomide babies and the New England Manufacturing. The first example was about a compound that was used for morning sickness with pregnant women, which was very effective, but later down the line when the babies were born they were facing deformities or death due to the drug. The lack of SOP and GMPC lead to lives being altered for the worse. The second example is of a company that manufactured an antibiotic but later they found that the drug was contaminated in the lab and it lead to patients developing meningitis and some deaths. Through these examples I was better able to understand that even though all we hear about is safety and effectiveness, it is very important for these steps to be quadruple checked before proceeding to the next. This does still come into play with medical devices though. In this industry the devices are split up into categories. Class 1 is considered "simple design and minimal harm" devices that can range from band aids up to a bone saw. Class 2 are "more complex and non invasive" like sutures or powered wheelchairs. Class 3 are devices that are "life sustaining and implantable" which can be heart valves or pacemakers. Breaking these devices down into groups makes sense but to me the interesting part is the clearing versus approving aspect. The class 1 devices just have to be pre-market cleared meaning basically that the FDA just has to know what you're doing but not actually approve the whole device. This baffles me since even tho they are not dangerous products (depending upon the case) they can still be sent to market. I know the FDA regulates this but if something goes wrong, how do you defend it? The class 2 and 3 devices need to be approved but if you think of this in the drug aspect, if you broke them up into classes and decided to clear versus approve some of them then lives could be at risk. I just feel as though there should be consistency across the industry in order to make sure that every product coming out of it is the safest and most effective. With the plague of medical errors being made in he industry, there must be complete and utter dedication to these aspects of all products being sold in the market.
I think when it comes to the drug approval process there is much more entailed then in the medical device industry. Although both harp on the concept that all final products have to have legitimate proof that they are safe and effective, the drug process is much more extensive and taxing. Not only does it cost millions of dollars and take many years, there is a lot of excess time and effort put into to training employees, proper documentation, and general maintenance. During Dr. Bose's presentation he talked a lot about SOP and GMPC which are standard operational practices and good manufacturing practice concepts. When it comes to these ideas you have to do a multitude of logging and documentation in order to make sure that everything is being done up to par and nothing is going to be detrimental to the products success in the future. I feel as though this is much more important in the drug manufacturing industry because there are many more volunteers that are facing effects of the drugs day in day out during a trial and cutting corners could put their lives at risk. He brought up some examples of this happening in real life; Thalidomide babies and the New England Manufacturing. The first example was about a compound that was used for morning sickness with pregnant women, which was very effective, but later down the line when the babies were born they were facing deformities or death due to the drug. The lack of SOP and GMPC lead to lives being altered for the worse. The second example is of a company that manufactured an antibiotic but later they found that the drug was contaminated in the lab and it lead to patients developing meningitis and some deaths. Through these examples I was better able to understand that even though all we hear about is safety and effectiveness, it is very important for these steps to be quadruple checked before proceeding to the next. This does still come into play with medical devices though. In this industry the devices are split up into categories. Class 1 is considered "simple design and minimal harm" devices that can range from band aids up to a bone saw. Class 2 are "more complex and non invasive" like sutures or powered wheelchairs. Class 3 are devices that are "life sustaining and implantable" which can be heart valves or pacemakers. Breaking these devices down into groups makes sense but to me the interesting part is the clearing versus approving aspect. The class 1 devices just have to be pre-market cleared meaning basically that the FDA just has to know what you're doing but not actually approve the whole device. This baffles me since even tho they are not dangerous products (depending upon the case) they can still be sent to market. I know the FDA regulates this but if something goes wrong, how do you defend it? The class 2 and 3 devices need to be approved but if you think of this in the drug aspect, if you broke them up into classes and decided to clear versus approve some of them then lives could be at risk. I just feel as though there should be consistency across the industry in order to make sure that every product coming out of it is the safest and most effective. With the plague of medical errors being made in he industry, there must be complete and utter dedication to these aspects of all products being sold in the market.
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