While it is certainly worth arguing that a Design Matrix with the four columns listed above (inputs, specifications, validation, and verification) can provide enough critical information to complete a matrix, I believe that adding additional columns could enhance the matrix’s…   Read more»

For my capstone project, my team and I designed and developed a mechano-myography (MMG) armband that was able to track the mechanical vibrations of the upper arm while also measuring the changes in circumference during a muscle contraction. The armband…   Read more»

Using a risk-based strategy that is customized for every phase of the product lifecycle is another essential component of validation. By concentrating validation efforts on high-impact areas, such as components having the greatest potential to alter product safety or efficacy,…   Read more»

You make some really good comments about basing success criteria with historical data and frequent evaluations. Incorporating user-centered design input early in the development process is an additional layer to take into account. This can help improve success metrics and…   Read more»

You give a concise overview of design controls and how they help guarantee device safety and FDA compliance. Building on this, the strategic influence of design controls on product lifecycle management and market competitiveness is another topic worth talking about….   Read more»

In clinical trials, effective communication among sponsors, investigators, CROs, and IRBs is crucial when handling unexpected adverse events. I believe that it would be beneficial to have a standardized, predefined process for addressing unexpected adverse events, but there is also…   Read more»

I think in most cases it is appropriate to offer patients in a clinical trial payment for their participation. Being involved in a clinical trial often involves time and travel of being treated and coming back for check-ups, which can…   Read more»

There are many ethical issues that could arise when using AI in clinical trials. When it comes to selection of participants, it is possible for AI systems to unintentionally show bias based on the data that was used to train…   Read more»

I agree that it’s essential to engage stakeholders from various departments—such as engineering, quality assurance, and marketing—to gather diverse perspectives. This collaborative approach fosters a comprehensive understanding of the product and its intended outcomes. Second, the team should conduct a…   Read more»

For my capstone project, my team and I are currently developing a syringe mixer and pumper designed to evenly distribute microbubbles—specifically, mono-lipid bubbles containing treatment—within a saline solution. The primary challenge we have encountered has been related to motor issues,…   Read more»

I agree that device validation is crucial for ensuring that a product meets user needs and expectations. However, it’s important to recognize that there are several types of validation processes that play a vital role in overall product quality.  …   Read more»

I agree with others comment. I believe that Double-blind studies are preferred because they reduce bias from both patients and investigators. In single-blind studies, if investigators know who receives the treatment, it can influence their assessments, expectations, or behavior toward…   Read more»

I think that Paying patients in clinical trials is ethical if it fairly compensates them for their time and risk. However, it can be problematic if high payments coerce vulnerable individuals to participate despite risks. The key is to balance…   Read more»

Thats a good question. AI in clinical trials raises ethical concerns like bias in participant selection, opaque data analysis, and privacy risks. Bias can lead to unrepresentative trial groups, reducing the reliability of results, while opaque AI systems make findings…   Read more»

Payment gives recognition to the participants’ time and risks, which enhances the recruitment process, and boosts diversity. On the other hand, ethical concerns regarding coercion arise. Financial incentives may lead the most vulnerable people to participate in studies for the…   Read more»

Placebo affects do not negatively impact a clinical trial. The Placebo group if compared with itself before comparing with the treatment group. Over many subjects, placebos results generally show insignificant data, with varying responses. Even in the case where some…   Read more»

A double-blind study design is crucial in clinical trials to eliminate biases that can distort results. The fact that a single-blind study reduces participant bias does not account for the influence of the investigators themselves. If the researchers are aware…   Read more»

I believe that in some cases it’s ok, where in other cases it’s not. In the case of a drug that required an IDE, it might be a good incentive just in case the patient may require additional treatments from…   Read more»

In a double-blind study, both the Investigator and Patient don’t know whether they’re being given the placebo or actual results. In a single-blind study, only the patient doesn’t know what’s being given to them. A double-blind study is better in…   Read more»