Medical Device Courses | jnm22 | Activity

jnm22 replied to the topic "Clinical Study Location/cost vs. results" -

Wed, 15 May 2019 16:57:21 -0400

That is a little scary to me as cost shouldn’t really be an issue in a clinical trial over quality. Not saying that the quality will be bad in other countries but it is a risk that is being taken… Read more»

jnm22 replied to the topic "AMDD" -

Wed, 15 May 2019 16:57:21 -0400

Both versions of this course is very useful. I took both of them while working and wish I took it before I started working as they do give you an idea of what to expect in industry. Maybe it should… Read more»

jnm22 replied to the topic "Unexpected Clinical Study Results" -

Wed, 15 May 2019 16:57:20 -0400

Hey tn58, that is true. A problem in the trail even if it gets fixed is a big loss. Not only is money spent during the investigation but no matter what happens after it, it is bad press. With us… Read more»

jnm22 replied to the topic "career path" -

Wed, 15 May 2019 16:56:33 -0400

Lol that is funny. When I was in school I thought being a CRA was cool and a easy way to travel for free and work from home! I have a friend who is a CRA and now that she… Read more»

jnm22 replied to the topic "Types of Clinical Studies" -

Wed, 15 May 2019 16:56:33 -0400

I’ve been ok an investor double blind study ( data was collected in real time and we didn’t know who had placebo and who didn’t). On the scientist side of things it’s exciting to have samples run it and see… Read more»

jnm22 replied to the topic "Unexpected Clinical Study Results" -

Wed, 15 May 2019 16:56:33 -0400

My company had a study go on “pause” due to an unexpected side effect. The people enrolled were not administered anymore doses and others were prevented from joining until the problem was solved. An investigation was done and It had… Read more»

jnm22 replied to the topic "Clinical Study Location/cost vs. results" -

Wed, 15 May 2019 16:56:32 -0400

I don’t think it’s possible because yea cost is a factor but it has to make sense. If the study is focused on a disease that predominantly affects that area yes but if it doesn’t I doubt it. My company… Read more»

jnm22 replied to the topic "Improving GMPs" -

Wed, 15 May 2019 16:56:07 -0400

I think technology can make it both easier and harder to comply with GMP regulation and they key is to update along side of regulation. It is important to review the guidelines and have everything understood before improving processing that… Read more»

jnm22 replied to the topic "Management Responsibility" -

Wed, 15 May 2019 16:56:07 -0400

I agree with Luisa, this situation makes room for contractors to be hired as it is easier to hire and terminate and less costly than a company employee. This is why timelines on the PM side are so important as… Read more»

jnm22 replied to the topic "Internal Audits for small organizations" -

Wed, 15 May 2019 16:56:06 -0400

Yes usually an outside contractor can come in and perform the audit. Also can’t employees be trained? I know it is not the same thing but in my company we have a safety audit team that is composed of just… Read more»

jnm22 replied to the topic "No GMPs" -

Wed, 15 May 2019 16:54:45 -0400

Hi I also agree that it would be more of a60-40 situation where maybe 40% of companies would chose no GMP. Yet those who do will have a competitive advantage in the market and have more trust from the consumer…. Read more»

jnm22 replied to the topic "Discussion Topic: When Quality Systems change in the middle of a project" -

Wed, 15 May 2019 16:54:44 -0400

I agree with Fady that this should be a case by case scenario. Depending on how far along the products are. If it is not handled like that a lot of money and time will be spent and it won’t… Read more»

jnm22 replied to the topic "Discussion Topic: Vagueness of GMP's" -

Wed, 15 May 2019 16:54:44 -0400

I also don’t think the ambiguity sets companies up for failure. There are so many different types of assays and ways to create products within medical device and drugs that it’s almost impossible to be specific. So it has to… Read more»

jnm22 replied to the topic "Product Failure" -

Wed, 15 May 2019 16:54:13 -0400

Hey all, thanks for sharing your experience or even things that were in the news.Pfizer also had a recall on three of their drugs in 2014 once it was reported that a container of one drug had some capsules that… Read more»

jnm22 replied to the topic "Go or Kill" -

Wed, 15 May 2019 16:54:07 -0400

From my experience and knowledge a lot of things get killed but really get placed on the back burner as priority shifts with the intent of getting back to it later. As Michelle said it really depends on how far… Read more»

jnm22 replied to the topic "product manager role" -

Wed, 15 May 2019 16:54:07 -0400

This was new to me as I had no idea something such as a product manager existed. I think the most important would be for the to stay on top of the industry and market data as everything else seems… Read more»

jnm22 replied to the topic "Interpersonal Skills" -

Wed, 15 May 2019 16:54:06 -0400

Completely agree it is a combination of both. While your business training is needed so you know to keep the company first it is all communication/interpersonal skills. That is why they don’t just send anyone to make deals but usually… Read more»

jnm22 replied to the topic "Product Life Cycle Curve" -

Wed, 15 May 2019 16:54:04 -0400

I think the most expensive part will always be the research and development phase as a lot of money is wasted by ideas that don’t work or even scaling the idea up and down. Money is spent from testing, contracting,… Read more»

jnm22 replied to the topic "Process Revalidation" -

Wed, 15 May 2019 16:51:45 -0400

Hey, In my company everytime an equipment that has been validated gets moved to a new room it has to be revalidated IOQ/PQ. Similar to what sns34 said it is due to the conditions of the new location, and anything… Read more»

jnm22 replied to the topic "Holistic Qualification" -

Wed, 15 May 2019 16:51:45 -0400

Hm, this is interesting because I thought all validations were essentially a holistic approach. You don’t really validate just one aspect of the product but everything that will touch/create it so in a sense it is always holistic no?

jnm22 replied to the topic "Types of Validation" -

Wed, 15 May 2019 16:51:42 -0400

Our validation is done on SOPs, equipment and the assay for the drug. For the assay it is tested a certain amount of times against a standard to make sure it falls within in range. The machines have to be… Read more»

jnm22 replied to the topic "SOP: how much detail before too much detail?" -

Wed, 15 May 2019 16:50:17 -0400

I think writing SOPs are a very hard thing to do. No only do you not know when it is too detailed or not detailed enough, as the author its hard to put yourself in the shoes of someone who… Read more»

jnm22 replied to the topic "DHF vs. DHR" -

Wed, 15 May 2019 16:49:48 -0400

I think it depends on your department. I work in development so we only deal with DHF and if you were in manufacturing or production it would be a DHR. Also an easy way to differentiate DHF is all encompassing… Read more»

jnm22 replied to the topic "Discussion Topic: ECO's" -

Wed, 15 May 2019 16:49:48 -0400

I haven’t used an ECO but I think it is used more in manufacturing/ production and not in development as changes made there are much easier. My only question is if it is a major change what are the following… Read more»

jnm22 replied to the topic "Discussion Topic: Post-market surveillance" -

Wed, 15 May 2019 16:49:42 -0400

Hey I think in pharma as mj34 said it is usually from the patient and Doctors. They provide us with feedback on how the drug is working and any adverse effects. Also on the company end even when a drug… Read more»

jnm22 replied to the topic "Discussion Topic: Verification vs. Validation" -

Wed, 15 May 2019 16:48:39 -0400

Luisa gave a very good answer to the question. I will add the while both process focus our the same outcome they are also very different. The design V&V focuses on the design while the process V&V focuses more on… Read more»

jnm22 replied to the topic "DHF vs. Tech File/Design Dossier" -

Wed, 15 May 2019 16:48:35 -0400

I think the DHF is more useful than the tech file. With a complete DHF it shouldn’t be difficult to get the actual design of the device as that is where the SOP is. The tech file is just a… Read more»

jnm22 replied to the topic "Discussion Topic: Is the DHF a living document?" -

Wed, 15 May 2019 16:48:35 -0400

Hello, I also believe that a DHF is not a living document from my experience and just from the purpose of it. It is for the initial design and any changes that will be made shouldn’t alter the initial design…. Read more»

jnm22 replied to the topic "Combination Products in EU" -

Wed, 15 May 2019 16:48:19 -0400

Hey so what did you end up filing it as? This is interesting as I didn’t know you chose the notified body unless you work in regulatory then that makes sense. Even still I believe there are checklist involved and… Read more»

jnm22 replied to the topic "Discussion Topic: Easier regulatory in EU?" -

Wed, 15 May 2019 16:48:19 -0400

So shouldn’t the EU also have systems in place to prevent tragedies? Shouldn’t they learn from the FDA and take precaution? I personally think that the FDA might prohibit research and great products to coming to market quickly but at… Read more»

jnm22 replied to the topic "Discussion Topic: Easier regulatory in EU?" -

Wed, 15 May 2019 16:48:18 -0400

Hey I agree that this is true but it also makes me worry about products coming from the EU. Due to the fact that the process is quicker and easier are product equally safe? I can’t imagine shortened/non-existent clinical trials… Read more»

jnm22 replied to the topic "Discussion Topic: Your Field or Profession" -

Wed, 15 May 2019 16:47:25 -0400

Hey gh56, There is a graduate course on BioMEMs with Perez and it is very interesting where we read plenty of articles about the current practices. Yes I have been fascinated by 3D printing for a long time and I… Read more»

jnm22 replied to the topic "Discussion Topic: Your Field or Profession" -

Wed, 15 May 2019 16:45:13 -0400

Hi Andrew, Yes this is a very common trend, that depends on company size but. My company is fortunate enough to have comparative medicine onsite so they do a lot of our pre-clinical animal studies but we do use CR… Read more»

jnm22 replied to the topic "Discussion Topic: Your Field or Profession" -

Wed, 15 May 2019 16:45:12 -0400

Hey, I also work in the pharmaceutical industry but I try to keep my self up to date with 3D printing for regenerative medicine along with BioMEMS. These two trends are huge and I personally think really are the future…. Read more»

jnm22 replied to the topic "Restrictions for physician's gifts" -

Wed, 15 May 2019 16:45:00 -0400

My company also has rules against gift giving for protection against lawsuits. Personally I think instead of restricting the process they should just ban it. Doctors shouldn’t have to be bought and should just go off of the science or… Read more»

jnm22 replied to the topic "Written Agreement v/s Verbal Agreement" -

Wed, 15 May 2019 16:44:59 -0400

I find that to be very surprising as I did not know verbal agreements were something that is acknowledged by the law. The quote above says “as long as there is enough evidence” but what is enough evidence? An email… Read more»

jnm22 replied to the topic "Discussion Topic: Course conclusion and impressions" -

Wed, 15 May 2019 16:43:59 -0400

I thought this course was very useful as well and I am already working in industry. I liked that you showed us every division within medical devices and their importance. Honestly I wish I took it before I started working… Read more»

jnm22 replied to the topic "Forming a Project Team" -

Wed, 15 May 2019 16:43:11 -0400

As a lot of people have mentioned choosing your team members is not that realistic in the real world. People are just assigned projects based on their role. It would be best and helpful if the person is also knowledgeable… Read more»

jnm22 replied to the topic "Organization types of medical devices?" -

Wed, 15 May 2019 16:40:54 -0400

Hey, Thanks for the link. If I were to start my own company I would go for a matrix organiation as it makes the most sense to me. I think the combination of functional organziation and project base divison is… Read more»

jnm22 replied to the topic "Discussion Topic: Your organizational type" -

Wed, 15 May 2019 16:40:53 -0400

I am not sure what type of organization my job is. It seems to be a mixture of functional and matrix. Project managers are assigned to a project from their manager and the project can expand to different departments/groups depending… Read more»

jnm22 replied to the topic "Expense of Regulations" -

Wed, 15 May 2019 16:39:37 -0400

Wow, that is very interesting. I didn’t know that you had to pay to view standards but it makes sense. As Kaitlin said they are essentially doing you a service by helping you stay in compliance. It is comparable to… Read more»

jnm22 replied to the topic "Risk analysis in real company" -

Wed, 15 May 2019 16:39:37 -0400

In pharma risk analysis deals with biologics so all suggestions and concerns from the team are used to create the animal study. For example we recently were working on a drug and we feared it would have a certain side… Read more»

jnm22 replied to the topic "Factors to Consider While making Gantt Chart" -

Wed, 15 May 2019 16:39:07 -0400

I think mistakes should be taken into consideration when making a gantt chart.There should be room for error for materials and even in the lab. There should be a soft deadline and a hard one with weeks in between in… Read more»

jnm22 replied to the topic "Design Transfer" -

Wed, 15 May 2019 16:39:05 -0400

I think there are pros and cons to outsourcing and it is dependent on your device and companies. Some companies lack infrastructure, or manpower and have to outsrouce others don’t and keep it inhouse. Other companies outsource so they can… Read more»

jnm22 replied to the topic "Design Transfer and Challenges" -

Wed, 15 May 2019 16:39:03 -0400

While these are all good points no one has mentioned simply scale up. Everything on the design sale or in R&Dis on a smaller scale and transfer to manufacturing is just difficult. If parts are being machined machines have to… Read more»

jnm22 replied to the topic "Discussion Topic: Supplemental on DHF and DMR" -

Wed, 15 May 2019 16:38:00 -0400

That is interesting, before I red Dr. Simons comment I also thought it was needed as a lot of the things in the deism control seem to be standard steps in device development. In terms of which one is better… Read more»

jnm22 replied to the topic "Design Controls for Legacy Combination Products" -

Wed, 15 May 2019 16:37:59 -0400

I also didn’t think it would be difficult. There had to be some type of lab notebook or documentation process for the development part and for testing just pull the materials from manufacturing and go from there. I think the… Read more»

jnm22 replied to the topic "Important Part of DDP" -

Wed, 15 May 2019 16:37:59 -0400

Hello, I also agree with you that quality is the most important. The whole project ( roles/responsibilities, gant chart) is based on this product and if the product doesn’t work well everything will get delayed or worst people will fired…. Read more»

jnm22 posted a new topic "Risk management and Labels" -

Wed, 15 May 2019 16:33:14 -0400

As I was going through the lecture I realized a lot of risk management is done before the product hits the market or done on the company side. This made me think of labels and instructions for use. I read… Read more»

jnm22 replied to the topic Clinical Study Location/cost vs. results in the forum Clinical Trials for Medical Devices

Sun, 30 Apr 2017 04:36:26 -0400