Medical Device Courses | Michael_Patel | Activity

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

Mon, 02 Dec 2024 04:01:59 -0500

Hi kbs27,In my past, I once had a verbal contract go bad, leading to a messy lawsuit because key details weren’t documented. I wont get into the details too much but I was not paid for work that I did… Read more»

Michael_Patel replied to the topic "Advamed Guidelines" -

Mon, 02 Dec 2024 03:58:28 -0500

Hi jj52,An unreasonable location for a sponsored event might include luxury resorts or exotic destinations that primarily promote leisure rather than professional development. My father, at his old company, went to a trip to Hawaii for being a top performer… Read more»

Michael_Patel replied to the topic "Advice before signing an NDA" -

Mon, 02 Dec 2024 03:53:34 -0500

Hi merzkrashed,If you are ever in the situation, when signing NDA, carefully review its terms to ensure clarity and fairness. Ensure that the scope of confidentiality specifically defines the protected information. Pay attention to the time period for confidentiality and… Read more»

Michael_Patel replied to the topic "Expense of Regulations" -

Mon, 18 Nov 2024 00:25:31 -0500

Hi sdl3,I feel as if regulations likely cost money because they are developed by organizations that invest significant resources in research and maintenance of up-to-date standards. Thus charging for access helps fund this work. However, it can be challenging, especially… Read more»

Michael_Patel replied to the topic "To risk manage or not to risk manage?" -

Mon, 18 Nov 2024 00:22:35 -0500

Hi rajamharrison,It goes without saying that risk management is absolutely an essential part of the planning phase. Identifying potential risks early helps prevent costly issues later. Yes, there is a lot of money that may seem like its being “wasted”… Read more»

Michael_Patel replied to the topic "Risk Management Tools" -

Mon, 18 Nov 2024 00:20:15 -0500

Hi traceymraw,In the past for projects at work, I’ve used brainstorming and the Fishbone Diagram for identifying and organizing potential risks in projects. I find the Fishbone Diagram most beneficial because it helps visually break down the root causes of… Read more»

Michael_Patel replied to the topic "Feeling Safer?" -

Mon, 11 Nov 2024 03:45:07 -0500

Hi elm33,Yes after this week’s lecture and learning about validation and verification processes I do feel safer using medical devices. We learned that these steps are in place to ensure that devices meet strict design standards and work effectively in… Read more»

Michael_Patel replied to the topic "Design Verification Ethics" -

Mon, 11 Nov 2024 03:40:15 -0500

Hi cem34,It goes without saying that neglecting to record unsuccessful instances during design verification in the name of saving time is a serious ethical violation. This increases risk and reduces the reliability and safety of the final product. Recording all… Read more»

Michael_Patel replied to the topic "Benefits of Software Validation" -

Mon, 11 Nov 2024 03:25:05 -0500

Hey jbh8,In addition to decreased failure rates and fewer recalls, software validation improves user trust and satisfaction. This is because validated software ensures reliable performance which ends up enhancing the user’s experience. Also, in regulatory compliance, validated software meets industry… Read more»

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

Mon, 04 Nov 2024 03:54:39 -0500

Hi la82,You are right design control is an integral part of product development, but issues can arise if it’s poorly managed. Without proper design control, specific requirements can be overlooked, which may lead to safety risks or issues when trying… Read more»

Michael_Patel replied to the topic "Design control and risk management" -

Mon, 04 Nov 2024 03:47:40 -0500

Hi sumayia-chowdhury,Design control teams mitigates risk by implementing a structured, step-by-step process throughout the development of a product. By setting clear requirements, conducting reviews, and performing tests to verify a products ability, they can confirm that the design meets user… Read more»

Michael_Patel replied to the topic "Design Output" -

Mon, 04 Nov 2024 03:27:09 -0500

Hi hodafattel,You are right in saying that inputs usually have outputs, but not always directly. For instance, a DID might specify user needs like “easy to use” or “durable,” which aren’t standalone outputs but guide multiple outputs . In these… Read more»

Michael_Patel replied to the topic "What is not seen in Clinical Trials?" -

Mon, 28 Oct 2024 00:10:11 -0400

Hi sn64,Clinical trials may miss long-term side effects, rare adverse reactions, and interactions with other medications due to limited sample size and other factors. Also, they can lack diversity in age, ethnicity, and health conditions, which can show if the… Read more»

Michael_Patel replied to the topic "Double Blind Vs Single blind Study" -

Mon, 28 Oct 2024 00:03:09 -0400

Hi smitshah,Double-blind studies are critical because they prevent both patient and investigator biases which can affect the study outcomes. If the investigator knows who is receiving the active drug or placebo, they could possibly interpret patient responses. This bias is… Read more»

Michael_Patel replied to the topic "WHAT IS THE OBJECTIVE OF CLINICAL TESTING ON PHARMACEUTICA DRUGS?" -

Sun, 27 Oct 2024 23:51:36 -0400

Hi amd29,I feel as if clinical testing of pharmaceutical drugs is ESSENTIAL to assess their safety, efficacy, and potential side effects. Unlike medical devices, drugs interact with the body in complex ways, so testing helps ensure they work as intended… Read more»

Michael_Patel replied to the topic "Family Businesses" -

Mon, 14 Oct 2024 03:59:31 -0400

From what I learned in my own family business this is a tricky process. Although they did not own sole-proprietorships after doing research I found there are some ways to work around this. Convert to an LLP and then workout… Read more»

Michael_Patel replied to the topic "Types of Corporations" -

Mon, 14 Oct 2024 03:48:27 -0400

I would pick an LLC and I currently am an owner of a few LLC’s due to some specific reasons. Firstly let me briefly explain that my friends and I started a merchandise company and we registered it as an… Read more»

Michael_Patel replied to the topic "MBA/ Business degree for Engineers" -

Mon, 14 Oct 2024 03:41:42 -0400

Hi knd26.First off, I wanted to say that I liked the curiosity that you brought with this post as it made me wonder the same thing. I feel as if the term business could mean so many things and it… Read more»

Michael_Patel replied to the topic "What are some ways Document Control can improve?" -

Mon, 07 Oct 2024 03:59:17 -0400

This was a very interesting point that I had never had to deal with prior to reading this discussion. If the complaint is that there is too much precision required than there are a few solutions. Firstly, it is important… Read more»

Michael_Patel replied to the topic "Emerging technologies and QA" -

Mon, 07 Oct 2024 03:55:12 -0400

This was a great discussion to mention. Since we are now entering the age in which the world is beginning to heavily rely on artificial intelligence its is almost certain that it will be in every industry. For example, in… Read more»

Michael_Patel replied to the topic "Discussion Topic: Quality Assurance vs. Quality Control" -

Mon, 07 Oct 2024 02:07:10 -0400

QA focuses more on preventing defects by observing the process that involves the development of, lets say a device. QC is about detecting defects on the final product once it is finished. One involves training in studying the processes behind… Read more»

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

Mon, 30 Sep 2024 03:57:54 -0400

Hi sahitya-sadineni,First off I wanted to say that you posed a very interesting topic. I view this discussion in two ways. One one hand, the approval processes for drugs and medical devices are essential for protecting public health. On the… Read more»

Michael_Patel replied to the topic "Discussion Topic: e-cigarettes" -

Mon, 30 Sep 2024 03:51:17 -0400

Hi orleron,To answer some of the questions you asked i will keep it simple then expand briefly on the modern state of this topic. Yes, the FDA does regulate E-cigarettes and the FDA extended its regulatory authority to include e-cigarettes… Read more»

Michael_Patel replied to the topic "Role of clinical trials for medical devices & pharmaceuticals" -

Mon, 30 Sep 2024 03:40:39 -0400

Hi samiha-khan,I stumbled upon your post and it made me realize and think about something that I had learned in another one of my classes. First let me answer the question you proposed. Clinical trials are crucial for medical device… Read more»

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

Mon, 23 Sep 2024 04:01:22 -0400

Hi mmd 55,I appreciate you proposing this question as it did make me think and do a little research into why this is the case. As someone who comes from a family of vegetarians, I would like to believe that… Read more»

Michael_Patel replied to the topic "Gantt Chart for Project Management" -

Mon, 16 Sep 2024 03:58:41 -0400

Hello cem34,I recently discovered what Gantt chart was in the last year. I had a course where we were developing a medical device and a part of this process was creating a Gantt chart for all of our project milestones…. Read more»

Michael_Patel replied to the topic "Milestones Missed: Failure or Success?" -

Mon, 16 Sep 2024 03:52:04 -0400

Hruship101,I liked the question you brought up. I think it is super situational. We learned about that in the planning phase there are different types of Gantt chart situations. For example, a finish to start situation requires for the last task… Read more»

Michael_Patel replied to the topic "When Does It Makes Sense To Give Up On A Project?" -

Mon, 16 Sep 2024 03:29:28 -0400

I wanted to start off by saying that there is definitely a point where a project needs to be shutdown. I have owned some businesses in the past 3 years and would like to share a personal experience that I… Read more»