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									Clinical Trials for Medical Devices - Medical Device Courses Forum				            </title>
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            <description>Medical Device Courses Discussion Board</description>
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                        <title>Cost and Time of Device Clearance/Approval</title>
                        <link>https://medicaldevicecourses.com/forums/clinical-trials-for-medical-devices/cost-and-time-of-device-clearance-approval/</link>
                        <pubDate>Wed, 25 Apr 2018 00:36:10 +0000</pubDate>
                        <description><![CDATA[Hi all,
Congratulations! We have completed MDD &amp; AMDD. I found an interesting topic we should discuss or at least we should have idea about it, &quot;Cost and Time of Device Clearance/Approva...]]></description>
                        <content:encoded><![CDATA[Hi all,
Congratulations! We have completed MDD &amp; AMDD. I found an interesting topic we should discuss or at least we should have idea about it, "Cost and Time of Device Clearance/Approval".
How much does FDA approval cost for new medical devices?and how long it takes to get approval for your medical device? (note it depends on too many things i.e 510(k), PMA)
Please share with us your experience about Cost and Time of Device Clearance/Approval! or search on the web and look at the numbers!
thanks
Hint: emergobyul/resources/research/fda-510k-review-times-research
ryortho/breaking/fdas-510k-clearance-performance-remains-average]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/clinical-trials-for-medical-devices/">Clinical Trials for Medical Devices</category>                        <dc:creator>merzkrashed</dc:creator>
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                    </item>
				                    <item>
                        <title>AMDD</title>
                        <link>https://medicaldevicecourses.com/forums/clinical-trials-for-medical-devices/amdd/</link>
                        <pubDate>Sat, 29 Apr 2017 00:03:13 +0000</pubDate>
                        <description><![CDATA[Hello everyone, As we come to a close to finish AMDD we have learn a lot of new material that we can apply to our careers. I know some of the people here have jobs and had seem some of the m...]]></description>
                        <content:encoded><![CDATA[Hello everyone, As we come to a close to finish AMDD we have learn a lot of new material that we can apply to our careers. I know some of the people here have jobs and had seem some of the material we have learn, which we could say that this class was very beneficial to do for the sake of learning how industry actually do things. I have taken other classes in my master and yes I have learn stuff but I believe MDD and AMDD actually help me a lot more in understanding what career path as a biomedical engineer im going to take than any  other classes. Do anyone believe or think that NJIT should look into finding more classes like this for the master program that help us to have a better view of the real industry?]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/clinical-trials-for-medical-devices/">Clinical Trials for Medical Devices</category>                        <dc:creator>gh56</dc:creator>
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				                    <item>
                        <title>Simulation Experience</title>
                        <link>https://medicaldevicecourses.com/forums/clinical-trials-for-medical-devices/simulation-experience/</link>
                        <pubDate>Wed, 26 Apr 2017 11:47:25 +0000</pubDate>
                        <description><![CDATA[As we are on our last simulation of the semester. I wanted to know what everyone learned from these simulations. Do you think solving these simulations gave you a better idea of how industry...]]></description>
                        <content:encoded><![CDATA[As we are on our last simulation of the semester. I wanted to know what everyone learned from these simulations. Do you think solving these simulations gave you a better idea of how industry jobs work? And what were the pros and cons of working with a team and how you would implement what you learned in your real industry jobs?

My personal experience, I actually learned a lot from these simulations because all of the lecture slides made more sense to me and it was almost more hands on than just going through a power point lecture. 

Share your thoughts.]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/clinical-trials-for-medical-devices/">Clinical Trials for Medical Devices</category>                        <dc:creator>tn58</dc:creator>
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                    </item>
				                    <item>
                        <title>Unexpected Clinical Study Results</title>
                        <link>https://medicaldevicecourses.com/forums/clinical-trials-for-medical-devices/unexpected-clinical-study-results/</link>
                        <pubDate>Sat, 22 Apr 2017 17:36:44 +0000</pubDate>
                        <description><![CDATA[All clinical studies for medical devices are conducted with the best intention to benefit humans. Based on this week&#039;s lecture,  Dr. Simon mentioned that each subject should be informed with...]]></description>
                        <content:encoded><![CDATA[All clinical studies for medical devices are conducted with the best intention to benefit humans. Based on this week's lecture,  Dr. Simon mentioned that each subject should be informed with a consent form about any reasonably foreseeable risks or discomforts, but we all know that unfortunate results can occur from time to time. Does anybody have information about what kind of results could shut down a clinical study? 

and if a clinical study is shut down, who will be the responsible party for not doing the proper due deligance prior to the study (i.e. IRB or the manufacturer)?]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/clinical-trials-for-medical-devices/">Clinical Trials for Medical Devices</category>                        <dc:creator>Fady Khalla</dc:creator>
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				                    <item>
                        <title>Clinical Study Location/cost vs. results</title>
                        <link>https://medicaldevicecourses.com/forums/clinical-trials-for-medical-devices/clinical-study-locationcost-vs-results/</link>
                        <pubDate>Sat, 22 Apr 2017 15:17:42 +0000</pubDate>
                        <description><![CDATA[Through this week&#039;s lecture, we learned more about clinical studies and their setup. One of the major points of considerations during clinical trial design is the location of where the study...]]></description>
                        <content:encoded><![CDATA[Through this week's lecture, we learned more about clinical studies and their setup. One of the major points of considerations during clinical trial design is the location of where the study will be conducted and cost of the study. Do you think that some organizations may choose to conduct a clinical study in a developing country to save on the costs of maintaining the study within the US?]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/clinical-trials-for-medical-devices/">Clinical Trials for Medical Devices</category>                        <dc:creator>Fady Khalla</dc:creator>
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				                    <item>
                        <title>Types of Clinical Studies</title>
                        <link>https://medicaldevicecourses.com/forums/clinical-trials-for-medical-devices/types-of-clinical-studies/</link>
                        <pubDate>Sat, 22 Apr 2017 11:14:52 +0000</pubDate>
                        <description><![CDATA[As Dr. Simon mentioned in his lecture there are different types of clinical studies. This includes prospective clinical study which is collecting data in real time or retrospective which is ...]]></description>
                        <content:encoded><![CDATA[As Dr. Simon mentioned in his lecture there are different types of clinical studies. This includes prospective clinical study which is collecting data in real time or retrospective which is using old data to be analyzed. As well as, a blinded study which may differ between single, double, and triple blind. Lastly there are randomized studies to prevent any bias, and placebos to compare patients who are using the real drug/device. My question is, based on your experience at your workplace have you observed any of the different types of studies and how was the study executed?]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/clinical-trials-for-medical-devices/">Clinical Trials for Medical Devices</category>                        <dc:creator>Viraj D</dc:creator>
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				                    <item>
                        <title>career path</title>
                        <link>https://medicaldevicecourses.com/forums/clinical-trials-for-medical-devices/career-path/</link>
                        <pubDate>Sat, 22 Apr 2017 01:59:34 +0000</pubDate>
                        <description><![CDATA[Hello everyone, so this week lecture is about Clinical Research and we learn a lot about it, i personally do not see myself working on this the reason is because it doesn&#039;t seem fun or i don...]]></description>
                        <content:encoded><![CDATA[Hello everyone, so this week lecture is about Clinical Research and we learn a lot about it, i personally do not see myself working on this the reason is because it doesn't seem fun or i don't think i will like it at all. has anyone ever considered clinical research as a career path? what make you want to follow this career path?]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/clinical-trials-for-medical-devices/">Clinical Trials for Medical Devices</category>                        <dc:creator>gh56</dc:creator>
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				                    <item>
                        <title>Significant risk vs Non-significant Risk</title>
                        <link>https://medicaldevicecourses.com/forums/clinical-trials-for-medical-devices/significant-risk-vs-non-significant-risk/</link>
                        <pubDate>Fri, 21 Apr 2017 23:15:51 +0000</pubDate>
                        <description><![CDATA[During lecture, Dr. Simon explained that clinical trials are classified as significant risk or non-significant risk. The level of risk is determined by how much harm the subject could acquir...]]></description>
                        <content:encoded><![CDATA[During lecture, Dr. Simon explained that clinical trials are classified as significant risk or non-significant risk. The level of risk is determined by how much harm the subject could acquire from the study. Significant risk (SR) is a study that that presents potential for serious risk to health, safety, or welfare of subject (like implants), while non-significant risk (NSR) is a study that does not meet the definition of the significant risk. 
From your point of view, knowledge or experience in the industry, can you provide examples of devices the are classified as NSR or SR?]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/clinical-trials-for-medical-devices/">Clinical Trials for Medical Devices</category>                        <dc:creator>neb2</dc:creator>
                        <guid isPermaLink="true">https://medicaldevicecourses.com/forums/clinical-trials-for-medical-devices/significant-risk-vs-non-significant-risk/</guid>
                    </item>
				                    <item>
                        <title>CROs</title>
                        <link>https://medicaldevicecourses.com/forums/clinical-trials-for-medical-devices/cros/</link>
                        <pubDate>Mon, 17 Apr 2017 13:14:06 +0000</pubDate>
                        <description><![CDATA[CROs are Contract Research Organizations that provide support to companies for their research services as outsourced contract based. 

As mentioned in the lecture, the sponsor usually transf...]]></description>
                        <content:encoded><![CDATA[CROs are Contract Research Organizations that provide support to companies for their research services as outsourced contract based. 

As mentioned in the lecture, the sponsor usually transfers one or more of his/her responsibilities to these CROs. Out of all the responsibilities that Dr. Simon listed, which ones would a good sponsor never transfer over to a CRO? In other words, what are the advantages and disadvantages of transferring responsibilities to Clinical Research Organizations?]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/clinical-trials-for-medical-devices/">Clinical Trials for Medical Devices</category>                        <dc:creator>tn58</dc:creator>
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				                    <item>
                        <title>Consent and predicted outcome</title>
                        <link>https://medicaldevicecourses.com/forums/clinical-trials-for-medical-devices/consent-and-predicted-outcome/</link>
                        <pubDate>Mon, 17 Apr 2017 12:35:48 +0000</pubDate>
                        <description><![CDATA[As the lecture focused heavily on the consent portion, and addresses that clinical trail cannot take place if it is known before time that death is a possible outcome. This had me wondering,...]]></description>
                        <content:encoded><![CDATA[As the lecture focused heavily on the consent portion, and addresses that clinical trail cannot take place if it is known before time that death is a possible outcome. This had me wondering, how can you possibly predict that before hand? Isn't there always a margin or error in animal studies vs. human studies. They don't necessarily have the give the same result. For example, have there ever been cases where extensive animal studies gave continuous expected results but when human trials began the results were unexpected. 

What would be the outcome if a human subject suffers unexpected results? Where does this lead the project or the company responsible for approving clinical trials?]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/clinical-trials-for-medical-devices/">Clinical Trials for Medical Devices</category>                        <dc:creator>tn58</dc:creator>
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