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»

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»

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»

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»

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»

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»

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»

@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»

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»

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»

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»

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»

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»

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»

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»

@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»

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»

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»