Medical Device Courses | hayderk | Activity

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

Sat, 02 Dec 2023 03:29:49 -0500

The discussion on Non-Disclosure Agreements (NDAs) rightly emphasizes the importance of clearly defining the scope of information usage. However, a more robust NDA should not only specify restrictions but also incorporate preventive measures against potential modifications or misuse of the… Read more»

hayderk replied to the topic "The Eight Fundamentals of Legal and Consultants" -

Sat, 02 Dec 2023 03:22:02 -0500

The list of goals in consulting and legal work is good, but it could mention how these goals often overlap and change as things go along. In transitioning between these objectives is a critical aspect often shaped by the evolving… Read more»

hayderk replied to the topic "International Contract Law" -

Sat, 02 Dec 2023 03:15:10 -0500

Legalities become crucial when dealing with laws. The inclusion of clear and transparent jurisdictional clauses, would specify the legal jurisdiction that will govern the contract and any potential disputes. In addition emphasizing standardized protocols beyond just dispute resolution is crucial,… Read more»

hayderk replied to the topic "Two Types of Risk" -

Sun, 19 Nov 2023 21:03:25 -0500

The way I see it is that internal risks are like the name suggests, it exists inside or within the company. Hence a few examples could be operational risks (day-to-day operations or equipment or processes), financials risks (funding for departments,… Read more»

hayderk posted a new topic "Process FMEA (PFMEA)" -

Sun, 19 Nov 2023 20:58:07 -0500

Process Failure Mode and Effect Analysis is the systematic method for evaluating and prioritizing potential failure modes in a manufacturing or operational process, assessing their potential effects, and identifying preventive measures. In many applications of medical devices, I’ve seen it… Read more»

hayderk replied to the topic "Risk Management: Risk v.s. Reward" -

Sun, 19 Nov 2023 20:50:36 -0500

In biotechnology risk vs reward is a dangerous territory to consider. As other posts have suggested, its because our effects in the field directly impact someone’s life, and in most cases it isn’t just one. In other industries, the balance… Read more»

hayderk replied to the topic "Evaluating in the RM process" -

Sun, 19 Nov 2023 20:43:33 -0500

AEDs are portable electronic devices designed to deliver an electric shock to the heart in cases of sudden cardiac arrest. In addition to environmental considerations and maintenance, another critical aspect of AED’s risk analysis is the potential for user error…. Read more»

hayderk replied to the topic "Gantt Chart Thought Process and Considerations" -

Fri, 10 Nov 2023 01:35:05 -0500

Many of y’all point valid discussions about Gantt charts. In my experience both within Capstone and a company environment is to understand that the chart is not a schedule in the way one dominos. Weird way to say this but,… Read more»

hayderk liked forum post "Gantt Chart Thought Process and Considerations" -

Fri, 10 Nov 2023 01:15:59 -0500

hayderk replied to the topic "Capstone Project Proposals (Shortened PDF)" -

Fri, 10 Nov 2023 01:12:38 -0500

@atk27njit-edu To add detail (we were in the same Capstone Group) the project focused on developing an upper extremity spasticity simulator to help educate clinicians and reduce inter-rater variability in the Modified Ashworth Scale (MAS). The one thing within documentation… Read more»

hayderk replied to the topic "Design Input Requirement Categories" -

Fri, 10 Nov 2023 00:58:48 -0500

A device that has really had my attention for a while and of one I want to discuss in this forum is the Left Ventricular Assist Device also commonly known as the LVAD. The functional requirement of the LVAD is… Read more»

hayderk replied to the topic "Retrospective studies" -

Sun, 29 Oct 2023 00:04:24 -0400

While I understand Meta-analysis has issues involving the differences in methodologies, populations, or other variables in addition to the quality and acceptance for viable information, it does however represent a good role for post-market research’s. Furthermore, the consolidated evidence generated… Read more»

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

Sat, 28 Oct 2023 23:14:16 -0400

While I acknowledge the points you’ve all raised, I would like to bring attention to the potential diversity in responses to pharmaceutical drugs. While antibiotics have indeed been instrumental in treating infections, it’s essential to recognize that not all medical… Read more»

hayderk replied to the topic "What role would best fit your experience/skillset in clinical research?" -

Sat, 28 Oct 2023 23:05:26 -0400

I have had the opportunity to be involved in the developments of such trials when I was under my research role. I vastly underestimated the amount of documentation, time, approvals, and calls you have to do and honestly was a… Read more»

hayderk replied to the topic "Medical Device SWOT Analysis" -

Fri, 20 Oct 2023 02:56:56 -0400

I’ll do Becton, Dickinson and Company (BD). 1. Strengths: -Diverse Product Portfolio -Global Presence -Focus on Innovation -Critical Role in Healthcare Infrastructure –> supplying essential products 2. Weaknesses: -Regulatory Compliance Pressures -Integration Challenges from Acquisitions –> Adding new lines and… Read more»

hayderk replied to the topic "Branding as an Engineer" -

Fri, 20 Oct 2023 02:31:12 -0400

I think in the world of branding itself, you really just need to know your customer. Of course you can’t target everyone (unless you specialize in sales) but for us BMEs we can specialize in knowing a small group’s medical… Read more»

hayderk replied to the topic "Marketing and Advertising: Can the two collide?" -

Fri, 20 Oct 2023 02:21:00 -0400

In the world of marketing medical devices, it’s like navigating a constantly shifting terrain. Lately, there’s been this interesting move to directly educate patients about cutting-edge technologies. It’s empowering; patients are becoming involved about their healthcare options. But here’s the… Read more»

hayderk replied to the topic "First Job: What type of company to choose?" -

Sun, 15 Oct 2023 03:54:47 -0400

@atk27njit-edu I agree with many points you bring up, but wanted to add that smaller companies usually have positions that blend multiple roles. So while you may have worked as a design engineer per say, at a smaller company you… Read more»

hayderk replied to the topic "Company Ratios" -

Sun, 15 Oct 2023 03:28:12 -0400

While I agree with many of y’alls comments, the common theme I’ve seen is that ratios are dependent on company stage. What I mean by this is that its a game of large vs small perspective. In the beginning, small… Read more»

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

Sun, 08 Oct 2023 20:43:14 -0400

Issue with AI within QA is traceability, like @am2343 or @Christoph have said. Traceability is the the golden ticket to quality and especially in audit. Mistakes from AI has almost zero traceability expect to the individual who employed it and… Read more»

hayderk replied to the topic "QA/QC for a Medical Device Project" -

Sun, 08 Oct 2023 20:30:42 -0400

In my experience I’ve had experience with more so quality control than assurance. Things I’ve done include work orders, inspections, testing, etc… I’ve created, revised, and seen executions of work instructions so that would be my small experience into quality… Read more»

hayderk posted a new topic "Role of Industry Standards for Regulatory" -

Sat, 30 Sep 2023 17:52:01 -0400

Technological advancements are more often than not employed into industry standards and procedures. As a result practices have changed to accommodate newer times, and instances such as the 510(k) need revision. That got me thinking of how industry-specific standards in… Read more»

hayderk replied to the topic "Responses to Public Health Emergencies" -

Sat, 30 Sep 2023 17:39:24 -0400

While most responses go back and forth on the FDA’s response to the Pandemic, I’d argue that it did a great job under the circumstances, but is perceived badly because of the amount of misinformation other organizations and even individuals… Read more»

hayderk replied to the topic "Product Labeling" -

Sat, 30 Sep 2023 17:12:00 -0400

Its on the responsibility for both the store and manufacturer in respect to when it was damaged. Leaving a company, the manufacturer should ensure that labels are present and in good condition, accounting for how they will be packaged as… Read more»

hayderk posted a new topic "Skills to get into research" -

Fri, 22 Sep 2023 01:57:20 -0400

There are many backgrounds as there are many fields within research. Applying for both jobs and to professors to carry research must carry some value to what you bring as either a lead, analyst, or scientist. Seeing the differences between… Read more»

hayderk replied to the topic "When researching, are you Academia or Industry?" -

Fri, 22 Sep 2023 01:46:35 -0400

I’ve researched a fair bit under academia and have to say the flexibility to ultimately switch to 4-5 projects at any point provides such a breath of relief to the monotonous day to day cycle a job might have. I’ve… Read more»

hayderk replied to the topic "The Five Phases of Medical Device Development" -

Fri, 22 Sep 2023 01:35:57 -0400

@anywilliamsmsm-edu Instances where you’d have to wait for a step/process to completely finish before starting a new one would consist of either quality managements to product end-of-line testing. In the sense of Pre-clinical devices, some that come to mind include… Read more»

hayderk replied to the topic "Quality and Risk Management in the Project Life Cycle" -

Sun, 17 Sep 2023 23:43:49 -0400

Traceability is a must, and I’m glad that you mention that. Quality is really cause and effect to a desired goal. Therefore documentation apps such as IFS can help catalog these measures and employ process to determine best parameters… Read more»

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

Sun, 17 Sep 2023 23:27:59 -0400

As the earlier replies by @jj52 and @fh28, the time to identify the project’s survivability is during the initiating and planning phase. But to account for situations where, in the case of the pandemic, things occur that no one could’ve… Read more»

hayderk replied to the topic "Project Management Apps" -

Sun, 17 Sep 2023 23:14:57 -0400

In my experience applying strengths of a few apps can ultimately be better than restricting to one. My history with Slack is okay at best, I felt that if numerous projects were running, and each project had its own department… Read more»

hayderk replied to the topic "Thoughts on BS, MS, and PhD in BME" -

Sun, 10 Sep 2023 17:40:46 -0400

I might be an odd ball out compared to most comments, but I wanted to add that education in it of its own isn’t going to warrant a job right into the industry. While I understand the post asks for… Read more»

hayderk replied to the topic "Software engineering addition to Biomedical Engineering" -

Sun, 10 Sep 2023 17:05:38 -0400

I’ve seen the trend for learning more and more coding languages as a result of being BME. My first two years focused only on MATLAB, and then exploded into learning C#, Python, G-Code, M-Code, ladder logic and even C++ for… Read more»

hayderk replied to the topic "Biomedical Engineers vs. Mechanical Engineers: Who has the advantage in Biomechanics?" -

Sun, 10 Sep 2023 16:45:27 -0400

@atk27njit-edu I’ve definitely seen a similar pattern between ME vs BME at my own work, but I think the ability of a BME is something you can’t downplay when compared to ME. For starters while I do agree that BME… Read more»

hayderk became a registered member

Sun, 10 Sep 2023 16:17:01 -0400