Medical Device Courses | zbw2 | Activity

zbw2 replied to the topic "How was this class helpful" -

Wed, 15 May 2019 19:16:07 -0400

I think the greatest value this class provided by familiarizing ourselves with details of the Medical Device process which will inevitably improve your learning curve when operating at a device company. Even If you already have experience at a device… Read more»

zbw2 replied to the topic "Why do people work?" -

Wed, 15 May 2019 19:15:29 -0400

zbw2 replied to the topic "What’s Your Motivator?" -

Wed, 15 May 2019 19:14:42 -0400

zbw2 replied to the topic "Overworked Americans vs. Motivation" -

Wed, 15 May 2019 19:14:42 -0400

I think WMS7’s experience working overtime to complete a project on time is likely a main reason people work overtime. while many people are motivated, the motivation is not necessarily to finish the project early but to finish the project… Read more»

zbw2 replied to the topic "Closing Phase" -

Wed, 15 May 2019 19:07:42 -0400

something mentioned in the lecture which seems like common sense but likely proves to be extremely tedious is to review all materials before submitting to manufacturing to ensure there are no mistakes. a document such as the project closure document… Read more»

zbw2 replied to the topic "Points to look for while out sourcing" -

Wed, 15 May 2019 19:06:16 -0400

As a PM, one of my greatest concerns would be time to prototype and manufacturing timeline. Depending on the equipment available and existing projects at a manufacturing company, the production time for a required part may vary. If the company… Read more»

zbw2 replied to the topic "Design validation" -

Wed, 15 May 2019 19:05:47 -0400

design verification is ensuring that the product that you just spent an extended period of time does what you intended it to do. without design verification there is no way of proving the efficacy of the device. this ultimately can… Read more»

zbw2 replied to the topic "PM: Timeline, Risk, Social Approaches" -

Wed, 15 May 2019 19:05:46 -0400

Ial4’s suggestion to consult with Dr. Malekai is correct for avoiding timeline issues about the animal study, however in this simulation, the initial timeline submitted to management was out of your control. what we can learn from this simulation as… Read more»

zbw2 replied to the topic "Communication and Responsiveness" -

Wed, 15 May 2019 19:05:30 -0400

I think monique expressed how to communicate effectly as personal issues can often affect a persons ability to function. Therefore, speaking to the person and being understanding of their situation can often improve their ability to function,and make them feel… Read more»

zbw2 replied to the topic "Flaw in the design process" -

Wed, 15 May 2019 19:03:13 -0400

I think it is the responsibility of the device producer to ensure that adequate measures are taken to ensure proper validation and quality. while FDA regulations are expansive and precise, they are not perfect. therefore, every company’s main goal should… Read more»

zbw2 replied to the topic "Safety Recalls" -

Wed, 15 May 2019 19:02:10 -0400

I agree with the answer posted above that a recall would not be take place with faulty adhesive on labels as it does not have an affect on the safety of the contents inside the bottle. Mislabeling however would be… Read more»

zbw2 replied to the topic "Project Manager Skills" -

Wed, 15 May 2019 19:00:53 -0400

as some have mentioned previously, I believe the project manager should be a great problem solver. on any team, each member should be capable of completing tasks on their own. it is when there are conflicts of opinion or challenges… Read more»

zbw2 replied to the topic "Thoughts and Questions Related to Untested Medicine" -

Wed, 15 May 2019 19:00:46 -0400

While some research states that belief may be a contributing factor in the effectiveness of acupuncture, the NIH acknowledges that “Acupuncture may help ease types of pain that are often chronic such as low-back pain, neck pain, and osteoarthritis/knee pain”…. Read more»

zbw2 replied to the topic "Pros and Cons of the 3 Organizational Structures" -

Wed, 15 May 2019 19:00:25 -0400

I believe project based is ideal for smaller companies because each team can focus without being distracted by details of other projects. however, larger companies or companies with multiple integrated projects would benefit from matrix structure. as some have mentioned… Read more»

zbw2 replied to the topic "A advertising a sum of its parts?" -

Wed, 15 May 2019 18:59:45 -0400

In agreement with ashley, it is not the responsibility of the company to retest their device, especially since they are not making any claims about extreme sports. Also, according to the FDA Mission statement, “The Food and Drug Administration is… Read more»

zbw2 replied to the topic "FDA about upgraded device" -

Wed, 15 May 2019 18:59:43 -0400

to follow up on what was posted above, for software updates, which may seem trivial, device approval is based on if the update “could significantly affect the safety or effectiveness of the device”. an excerpt of this FDA guidance publication… Read more»

zbw2 replied to the topic "Thoughts and Questions Related to Untested Medicine" -

Wed, 15 May 2019 18:59:33 -0400

considering the immediate risks of both acupuncture and transcutaneous electrical nerve stimulation are well documented and are minimal when performed by an experienced practitioner, and electroacupuncture is a combination of the two practices, i don’t believe it should be banned…. Read more»

zbw2 replied to the topic "Simulations" -

Wed, 15 May 2019 18:57:29 -0400

Often times with group projects information is delayed because everyone works on a different schedule. at my current job, our in person meetings are organized, however are not given a time limit to ensure all avenues of thinking/troubleshooting are exhausted…. Read more»

zbw2 replied to the topic "NDA vs Patents" -

Wed, 15 May 2019 18:57:09 -0400

In my experience, NDAs have been sufficient in protecting ideas during development. patents, even provisional ones must include every detail of the device. if the device is still in development, you don’t necessarily want to patent a feature that will… Read more»

zbw2 replied to the topic "Terms length in NDA and why to use it." -

Wed, 15 May 2019 18:57:07 -0400

In many CDAs or NDAs it will be stated that the information belongs to the disclosing party, therefore any version or permutation of the information is still covered by the agreement. I believe in this situation specifically, the disclosing party… Read more»

zbw2 replied to the topic "Written Agreement v/s Verbal Agreement" -

Wed, 15 May 2019 18:57:01 -0400

@rachel, I do not believe a guardians medical decision counts as a verbal agreement as the doctor/hospital is seeking consent to perform an emergency procedure rather than exchange goods. in the case that the procedure is not an emergency, a… Read more»

zbw2 replied to the topic "Manage Risk" -

Wed, 15 May 2019 18:52:12 -0400

I believe risks should be handled differently depending on how critical the part of the device the risk is associated with. the most critical parts will likely be handled with acceptance or transference regardless of the risk level, unless the… Read more»

zbw2 replied to the topic "Risk Management - Identification" -

Wed, 15 May 2019 18:52:11 -0400

I mentioned in the Risk management meeting thread of a system to follow when brainstorming for potential risks During the brainstorming process identifying risks, priority should be placed on the risk of the most critical parts of the device that… Read more»

zbw2 replied to the topic "How to run a risk management meeting ?" -

Wed, 15 May 2019 18:52:10 -0400

while many have mentioned FMECA as the main tool for identifying risk, I believe during the brainstorming process identifying risks, priority should be placed on the risk of the most critical parts of the device that cannot be avoided, followed… Read more»

zbw2 replied to the topic "Design Controls in the other countries" -

Wed, 15 May 2019 17:08:11 -0400

zbw2 replied to the topic "Design Controls in the other countries" -

Wed, 15 May 2019 17:08:11 -0400

China is one country with a comprehensive design control system regulated by the Chinese Food an Drug Administration(CFDA). since 2013 the CFDA has been revamping their medical device controls. in march of 2015 the CFDA “revised [their] Good Manufacturing Practice… Read more»

zbw2 replied to the topic "Clinical Trial Experiment" -

Wed, 15 May 2019 17:08:02 -0400

I did my Bachelors at Long Island University, Brooklyn where I did subject based research. while devices were used, the purpose was to test the effects of the activity on the subjects rather than the efficacy of a device. many,… Read more»

zbw2 replied to the topic "Who should own clinical trial Inventions?" -

Wed, 15 May 2019 17:08:01 -0400

With any clinical trial, the ownership of the intellectual property will be established in the contracts between both employer and employee and between the sponsor and any contracted assistance. I think the IP should belong to which ever party owns… Read more»

zbw2 replied to the topic "Discussion Topic: Having a "clinical background"" -

Wed, 15 May 2019 17:06:53 -0400

I can understand clinical experience being desired for an investigator, however research experience and good communication/people skills seem to be more important. While clinical experience icludes patient interactions and the administration various treatments, unless completion of the trials requires some… Read more»

zbw2 replied to the topic "Discussion Topic: Mission and Vision statements" -

Wed, 15 May 2019 17:06:06 -0400

Fresenius Medical Care Vision Statement: “Creating a future worth living. For patients. Worldwide. Every Day.” “About four decades of experience in dialysis, innovative research, the global leader in dialysis services and products – that is Fresenius Medical Care. Patients with… Read more»

zbw2 replied to the topic "Marketing Strategy" -

Wed, 15 May 2019 17:05:42 -0400

Music videos are the prime location for many tobacco and alcohol brands that do not typically run television advertisements. While these music videos are showed on cable and satellite video channels, most of its views occur on youtube. this is… Read more»

zbw2 replied to the topic "Discussion Topic: The Fifth "P" of Marketing" -

Wed, 15 May 2019 17:05:41 -0400

Another way companies utilize participation is with crowdfunding. Companies like Kickstarter have allowed companies, usually startups, to run a ‘campaign’ to fund a product. the ‘backers’ are treated as ground floor contributors and are encouraged to feel some kinship with… Read more»

zbw2 replied to the topic "S-Corp vs C-Corp" -

Wed, 15 May 2019 17:04:50 -0400

to elaborate further on what Ibraheem stated, the biggest difference between s-corps and c-corps is that unlike c corps, s corps income is passed through so taxes are only applied directly to the owners, rather than c corps taxation both… Read more»

zbw2 replied to the topic "Public vs. Private Companies" -

Wed, 15 May 2019 17:04:27 -0400

A company’s success is not dependent on whether or not it is publiclt traded. In fact the decision to go public is usually made based on how the owner(s) is/are seeking to profit. Many business owners make their fortune by… Read more»

zbw2 replied to the topic "Discussion Topic: Inc. vs. LLC in the US" -

Wed, 15 May 2019 17:04:18 -0400

If you are looking to continue to build your company privately, an LLC is a good option. Because LLCs are passed through entities they are only taxed only once. Also with an LLC you get the Liability protection of a… Read more»

zbw2 replied to the topic "Regulations with quality" -

Wed, 15 May 2019 17:03:51 -0400

While it may be true that some “current intervention practices de-incentive quality”, FDA regulations are intended to prevent harm to the device user, not to ensure quality. It is up to the discretion of the company to produce a product… Read more»

zbw2 replied to the topic "Relation of Quality with other department." -

Wed, 15 May 2019 17:03:10 -0400

I agree with dbonanno1 and dag56 on the integration of R&D and quality. by having R&D Engineers work in conjunction with Quality during the design process, delays can be minimized as procedures can be done properly the first time. it… Read more»

zbw2 replied to the topic "Discussion Topic: The cost of Quality" -

Wed, 15 May 2019 17:03:01 -0400

For everyday tasks, “its too much work” is never a good reason not to do a particular task. the same applies to QA/QC systems. while these systems can be quite onerous to maintain, I think most people would rather good… Read more»

zbw2 replied to the topic "FDA rules too strict?" -

Wed, 15 May 2019 17:02:43 -0400

Its not just Dietary supplements that the FDA needs more regulation on. some prescription drugs get to market unapproved. when the FDA finally gets around to getting these drugs off the market, the companies are given a long period of… Read more»

zbw2 replied to the topic "Changes in FDA under Trump's Administration" -

Wed, 15 May 2019 17:02:42 -0400

although the FDA will potentially have more money in the long run, the delay in negotiation for a new deal will cause “substantial layoffs at the [FDA]” as the article Alexandra posted stated. this will definitely slow down review time… Read more»

zbw2 replied to the topic "Precision and Accuracy" -

Wed, 15 May 2019 17:02:32 -0400

In agreement with what Ibraheem stated above, Precision and Accuracy are most at risk with aging devices as use brings wear and fatigue. Part 21 CFR 820.72 of the FDA Medical Device regulations defines the rubric for calibration standards. proper… Read more»

zbw2 replied to the topic "Research for the Fututre or Now?" -

Wed, 15 May 2019 17:00:51 -0400

I personally would like to work in the industry, and I would also like to work on products that will reach the market in my lifetime. However I agree with krp76 that academic research does not only means long term… Read more»

zbw2 replied to the topic "Discussion Topic: Beyond experimental design issues" -

Wed, 15 May 2019 17:00:15 -0400

assuming the university to which the study was outsourced to is competent to properly complete the task, as alexandrabuga stated, explicit instructions are vital for proper execution of the animal study. as bb254 stated, because of the distance of the… Read more»

zbw2 replied to the topic "Approaches to Research" -

Wed, 15 May 2019 17:00:15 -0400

Many instances of Research in industry is approached with only the final goal in mind. because of the confidentiality required in business, any discoveries are not reported on publicly further delaying gratification from the work done. In academia, however, researchers… Read more»

zbw2 replied to the topic "Professions in Academia and the Industry" -

Wed, 15 May 2019 16:59:07 -0400

Although I have yet to work in industry, I would like to work as a design engineer. I can see how familiarity with FDA regulations can be a great asset/necessity for Design/R&D Engineers when designing as things such as material… Read more»

zbw2 replied to the topic "Discussion Topic: Practical vs. Informational courses" -

Wed, 15 May 2019 16:58:48 -0400

As I enter my second Year I must agree with kak33 and a few others about receiving proper preparation for industry. however i believe it depends on what part of the industry you are interested in and whether your focus… Read more»

zbw2 replied to the topic "Advice for Biomedical Engineering Students" -

Wed, 15 May 2019 16:58:26 -0400

Networking and co-op/internships play are important. as per my experience, as a MS student coming from a BS in bio, taking a diverse courseload can be very useful in narrowing your list of potential careers in BME. Because my undergraduate… Read more»

zbw2 replied to the topic How was this class helpful in the forum Project Management Application: Clinical Trial

Sun, 29 Apr 2018 22:32:09 -0400

zbw2 replied to the topic Why do people work? in the forum Project Management Application: Clinical Trial

Mon, 23 Apr 2018 03:53:51 -0400

many of my colleagues have expressed to me that they love their job mainly because of the people they work with and because of how exciting their work is. I will also stay at my company because of the supportive staff. In fact, I am surprised that “working with great people” is not number one as no matter what the topic of the work, your…[Read more]

zbw2 replied to the topic What’s Your Motivator? in the forum Project Management Application: Clinical Trial

Sat, 21 Apr 2018 05:45:30 -0400

my biggest motivation is taking care of my family. a few semesters ago I was working on a product design that I had to have the draft finished by the about the end of the semester as the project was to begin prototyping. that semester i had 12 credits including 2 classes with Dr.Roman. I stayed up just about every night during that semester to…[Read more]