Medical Device Courses | JustinMB | Activity

JustinMB replied to the topic "Organization types of medical devices?" -

Tue, 19 Apr 2022 00:32:26 -0400

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»

JustinMB replied to the topic "Written Agreement v/s Verbal Agreement" -

Tue, 19 Apr 2022 00:19:34 -0400

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»

JustinMB replied to the topic "NDA vs Patents" -

Tue, 19 Apr 2022 00:01:13 -0400

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»

JustinMB replied to the topic "Dealing with risk" -

Tue, 12 Apr 2022 22:52:25 -0400

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»

JustinMB replied to the topic "Factors Contributing to Risk Values" -

Tue, 12 Apr 2022 19:25:04 -0400

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»

JustinMB replied to the topic "Benefits of post-market surveillance" -

Tue, 12 Apr 2022 19:19:09 -0400

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»

JustinMB replied to the topic "Design Verification Ethics" -

Sun, 10 Apr 2022 01:54:01 -0400

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»

JustinMB replied to the topic "Medical Device Clinical Trials vs Drug Trials" -

Sun, 10 Apr 2022 01:38:32 -0400

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»

JustinMB replied to the topic "Consequences Of Insufficient Design Controls" -

Sun, 10 Apr 2022 01:22:23 -0400

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»

JustinMB replied to the topic "Clinical Studies" -

Mon, 28 Mar 2022 20:02:37 -0400

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»

JustinMB replied to the topic "Placebo-controlled trials: Are they ethical? Are they necessary ?" -

Mon, 28 Mar 2022 19:53:43 -0400

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»

JustinMB replied to the topic "Where to Find Historical Clinical Trials?" -

Mon, 28 Mar 2022 19:27:48 -0400

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»

JustinMB replied to the topic "Discussion Topic: The Fifth "P" of Marketing" -

Sun, 27 Mar 2022 01:01:09 -0400

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»

JustinMB replied to the topic "Advertising" -

Fri, 25 Mar 2022 19:42:51 -0400

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»

JustinMB replied to the topic "Brand Coloring" -

Tue, 22 Mar 2022 18:40:17 -0400

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»

JustinMB replied to the topic "Drugs banned in US but not in other countries" -

Mon, 14 Mar 2022 17:11:11 -0400

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»

JustinMB replied to the topic "The Timing of Approving Medical Devices" -

Mon, 14 Mar 2022 17:03:02 -0400

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»

JustinMB replied to the topic "FDA rules too strict?" -

Mon, 14 Mar 2022 16:55:43 -0400

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»

JustinMB replied to the topic "Animals used for research and for food" -

Mon, 07 Mar 2022 17:27:51 -0500

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»

JustinMB replied to the topic "Funding in Academia Vs Industry" -

Mon, 07 Mar 2022 14:37:28 -0500

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»

JustinMB replied to the topic "Project Management in the Age of Covid-19" -

Sat, 05 Mar 2022 18:44:07 -0500

Posted by: @elizabetharcher During this week’s lecture, the importance of communication as a project manager was discussed and how without communication between several sectors, a project will not be successful. Throughout the pandemic, with the new normal of working from… Read more»

JustinMB replied to the topic "Exceeding the budget" -

Sat, 05 Mar 2022 18:44:06 -0500

One way the project manager resolve this predicament is by reviewing the budget and cost of past projects. Since there is a history of failing to account for risks and contingencies, he should review the receipts and transcripts and see… Read more»