7A – Testing the Hypothesis, Part 1
The European Union is in the process of revising all medical device regulations that will change how manufacturers develop, market, and gain approval of their products because cybersecurity in high tech products is a rising concern and this change has led the FDA and other countries around the world to do the same.
There are many parties involved all around the world.
Not all drugs or products are a challenge, only the high-tech ones that can have a bluetooth connection that health practitioners manage are ones in the scope of concern.
Perhaps some people will blame the medical engineers for producing these technologies or the health practitioners in charge of controlling these devices after the sale of the product.
In summary from what I learned through interviews, this process is necessary. What prompted this was crisis in breast implants and hip replacements that prompted the regulatory reform. This change will give national regulators more oversight and control of the medical devices industry. Thing such as advancing technologies and bluetooth connections are all steps in a path to a higher tech and better medical services. Unfortunately everything comes with trial and error, but in our society we are always advancing in sectors like these and it is inevitable to stop it.
There are many parties involved all around the world.
Not all drugs or products are a challenge, only the high-tech ones that can have a bluetooth connection that health practitioners manage are ones in the scope of concern.
Perhaps some people will blame the medical engineers for producing these technologies or the health practitioners in charge of controlling these devices after the sale of the product.
In summary from what I learned through interviews, this process is necessary. What prompted this was crisis in breast implants and hip replacements that prompted the regulatory reform. This change will give national regulators more oversight and control of the medical devices industry. Thing such as advancing technologies and bluetooth connections are all steps in a path to a higher tech and better medical services. Unfortunately everything comes with trial and error, but in our society we are always advancing in sectors like these and it is inevitable to stop it.
Fabiana, this opportunity is extremely interesting as it has a large significance on many people. I am one of those who believes that cybersecurity is going to be in high demand in the future, especially when it relates to regulations on medical devices. Hearing the information from your interviews was surprising as I would have never guessed that the reason behind the regulation was implants and hip replacements. I also like that the opportunity will put more responsibility in the hands of the regulators. Thanks for sharing, keep up the good work!
ReplyDeleteFabiana,
DeleteThis is a great opportunity that really caught my attention. The world is an ever-changing place and medical advances and technology advances in general are the future, being able to create something safe and effective can be so beneficial. Cybersecurity is something that really needs to be kept in check. Great post keep it up.
Maybe add titles to each of your points to make your blog more clear.
DeleteFabiana,
ReplyDeleteThis is a great opportunity that really caught my attention. The world is an ever-changing place and medical advances and technology advances in general are the future, being able to create something safe and effective can be so beneficial. Cybersecurity is something that really needs to be kept in check. Great post keep it up. Maybe add titles to each of your points to make your blog more clear.
Hey Fabiana,
ReplyDeleteI really like your opportunity alot especially because it gives reference to the medical field. The medical field is forever changing in all different aspects. The advancement of medicine also comes with a few knicks in the process. I think it is definitely a need to make things more safe and beneificial not only for the people but for specialist and doctors all around the world. So I completely agree that the cybersecurity aspect always needs to be updated checked twice and kept up to standard.