When creating test methods and protocols, key factors include ensuring that the tests accurately simulate the device’s real-world use, assessing risk to patient safety, regulatory compliance, and repeatability. Each test should align with critical design inputs, measure the appropriate performance…   Read more»

Design controls are critical to mitigating potential risks in product development. They guide the design process to make sure a medical device meets safety and performance requirements. By establishing clear design inputs, conducting risk assessments, and performing verification and validation…   Read more»

Blinding is a very useful method for researchers to minimize the placebo effect in clinical trials. In single blinding, participants do not know whether they are receiving the active treatment or a placebo. In double blinding, neither the participants nor…   Read more»

I think having a standardized process in place to prepare for unexpected outcomes is always better than not having anything predefined. Without this, adverse outcomes could lead to confusion, blaming, and slowing or halting the clinical trial process. When unexpected…   Read more»

If I was involved in a clinical trial, I’d like to work as the clinical research associate. This position speaks to me because it is very hands-on and involved in all the stages of a clinical trial. This role would…   Read more»

Product Development focuses on the research and creation of new products, involving innovation, prototyping, and testing based on market needs. It requires collaboration among engineering, design, and marketing to bring a product concept to life. Product Management is responsible for…   Read more»

I’ve seen the fifth “P” in marketing on streaming services. Sometimes, instead of showing just any ad, the viewer is given an option between two ads. The viewer is meant to choose the ad that is more interesting to them…   Read more»

Though I’d much prefer to work in product development than sales or marketing, I can see the allure of transitioning to a sales or marketing position after working as an engineer. Once you know the ins and outs of a…   Read more»

In a public company, there is more pressure to deliver short-term financial results to reach quarterly goals set by shareholders. To meet these goals, management may place more constraints on engineers  spending for R&D, quality, and other operational costs. This…   Read more»

Many of the above responses focus on growing the company and attracting investors, so they choose an INC. Personally, a mid-size company making moderate revenue would be safer operating as an LLC. An LLC provides strong legal protection by separating…   Read more»

I never really thought of taking a business course at NJIT until this week’s lecture. This past lecture has enlightened me that knowing the ins and outs of the business world could be helpful before starting a job in industry….   Read more»

Ensuring the safety and efficacy of medical devices through QC and QA takes quite the balancing act between technological advancements and regulatory requirements. Key challenges include keeping up with evolving standards from regulatory bodies like the FDA and ISO, ensuring…   Read more»

I agree with several of the replies above, that continuous involvement with projects can improve relations between Quality and R&D. I do not yet work in industry, but internship experience has shown me the underlying tension between the Quality department…   Read more»

I agree that the quality department is one of the most important in a medical device company. I view QA/QC as a mini FDA within a company that is continuously evaluating products and processes to prepare the company for audits…   Read more»

The FDA’s goal is to ensure medical devices are completely safe for the public, but in reality a 100% safe device is probably not going to exist past a class I. Unless if we’re talking about band-aids and tongue depressors,…   Read more»

When it comes to the FDA, I think strict is a positive. It is of utmost importance that the FDA is strict, unbiased, and efficient to keep American people safe. If we have to choose to lie on one side…   Read more»

Though the 510K process requirement of connecting current devices to those manufactured in 1976 may seem nonsensical, it is important to note that direct comparisons are not always necessary. This means that a chain of similar devices can be compared…   Read more»

It is difficult to say whether research for the future or the present is more important, both are necessary for the advancement of medical knowledge in society. I would make the argument that research for the future can have pitfalls where it…   Read more»

I’m actually quite surprised that no responses have brought up bioreactors yet. Yes, it is true that the Institutional Animal Care and Use Committee (IUCUC) have set up a system to make animal testing the most ethical it can be,…   Read more»

Extensive in vitro and in vivo testing is required to solidify the biocompatibility of a medical device throughout its entire lifecycle. Depending on the device, its life cycle within the human body could be varied from a few days to…   Read more»