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JustinMB replied to the topic "Organization types of medical devices?" – 2 years, 11 months ago
At my company I would follow the functional organization chart. It’s a form of arrangement that enables seamless cooperation across the flat. I also appreciate the fact that you do not have to answer to several persons. There will be… Read more»
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JustinMB replied to the topic "Written Agreement v/s Verbal Agreement" – 2 years, 11 months ago
A verbal agreement is formed when two or more parties reach an agreement without the use of written documents (known formally as an oral contract). The legality of these verbal agreements, on the other hand, can be a bit murky…. Read more»
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JustinMB replied to the topic "NDA vs Patents" – 2 years, 11 months ago
No an NDA is not an substitute for a patent. While an NDA gives you a limited level of protection (which in many cases can easily be bypassed), a patent offers you rock-solid, legally binding, enforceable-by-stiff-penalties proof of idea ownership…. Read more»
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JustinMB replied to the topic "Dealing with risk" – 2 years, 11 months ago
When dealing with risk, there are some instances where it would it be okay to accept the risk in medical device development. When the benefit of the consumer is greater than that of the risk of releasing the product. An… Read more»
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JustinMB replied to the topic "Factors Contributing to Risk Values" – 2 years, 11 months ago
Some of factors that could be used to determine risk are “how many individuals would be affected?” “When was the last time the failure happened?” as well as “What is the likelihood of the failure occurring?”. You can also use… Read more»
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JustinMB replied to the topic "Benefits of post-market surveillance" – 2 years, 11 months ago
Post-market surveillance is very beneficial as it allows companies to see the long term results of their product as well as how they affect the consumer in their daily life. Post data can offer valuable information that can show whether… Read more»
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JustinMB replied to the topic "Design Verification Ethics" – 2 years, 12 months ago
I feel as though many companies are guilty of this to some extent. Maybe they need the product out now for revenue and they feel they can fix what they missed in an update or they feel as though the… Read more»
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JustinMB replied to the topic "Medical Device Clinical Trials vs Drug Trials" – 2 years, 12 months ago
As you said, both have many similarities however there are some differences. Drug trials are testing for safety and tolerability along with pharmacokinetics; medical device trials are mainly checking for the safety and the performance of the device so therefore… Read more»
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JustinMB replied to the topic "Consequences Of Insufficient Design Controls" – 2 years, 12 months ago
Without proper design controls the whole project is in high jeopardy of failing. The product/device can be missing requirements or be built improperly or may even be harmful to the patient its supposed to help. Many injuries, deaths, and lawsuits… Read more»
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JustinMB replied to the topic "Clinical Studies" – 3 years ago
There certainly are advantages and disadvantages to clinical test. An advantage is that we have ways to test if drugs or devices are suitable for sale and public use. A disadvantage is how dangerous some can be as they may require… Read more»
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JustinMB replied to the topic "Placebo-controlled trials: Are they ethical? Are they necessary ?" – 3 years ago
I believe the use of PCTs are ethical as well as necessary. Placebos allow studies to have a control they can test against the baseline of a patient/participant. Thanks to placebos we can see if a change in participant or… Read more»
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JustinMB replied to the topic "Where to Find Historical Clinical Trials?" – 3 years ago
You can find the results for different clinical trials online for medications, medical devices, etc. Clinicaltrials.gov offers key facts about registered trials, including study design, administrative information, and results summaries. It is a database resource that is open to the… Read more»
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JustinMB replied to the topic "Discussion Topic: The Fifth "P" of Marketing" – 3 years ago
Engagement and participation are a major part of almost any brand. The most common way of Participation in todays society is social media. Different companies and sites have accounts on different social media sites to promote and engage with potential… Read more»
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JustinMB replied to the topic "Advertising" – 3 years ago
I agree advertisement is a =n important part of almost any brand, business, or company. A promotion and advertisement that comes to mind when thinking of successful commercials are the late 90s and early 2000s Kool-Aid commercials. The iconic scenes… Read more»
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JustinMB replied to the topic "Brand Coloring" – 3 years ago
Coloring is an important component to think about when branding a product/company. Many colors have inherent meanings people tend to associate with them. This is an essential consideration because people also have highly personal relationships with colors. A company that… Read more»
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JustinMB replied to the topic "Drugs banned in US but not in other countries" – 3 years ago
A drug that was banned in the US is aprotinin. It was used to reduce bleeding during complex surgeries. However, it showed increase in deaths form 4% to 6% and studies were shown to back it up. It was removed… Read more»
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JustinMB replied to the topic "The Timing of Approving Medical Devices" – 3 years ago
Although there are many steps, I believe they are necessary to ensure the safety of medical devices. The number of devices that are in process of approval are in high amount and have a buildup. The lack of models and… Read more»
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JustinMB replied to the topic "FDA rules too strict?" – 3 years ago
No I dont think the FDA is too rigid and tough to the point where they might be slowing down the process of the product and possibly restricting future innovations. There have been many reports of medical devices having malfunctions… Read more»
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JustinMB replied to the topic "Animals used for research and for food" – 3 years ago
Animal research be looked at in such a negative light while many more animals annually are being killed for food due to the fact that people may be misinformed, they let headlines, hearsay, personal bias, and many other factors sway their… Read more»
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JustinMB replied to the topic "Funding in Academia Vs Industry" – 3 years ago
The consequences of not finishing research in Academia could be strike against your grade or your record but you will most likely be able to turn in the assignment late or you can be removed from the research team and… Read more»
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