What I think is a major requirement that could be made into a hypothetical international contract law is a mandatory ethical compliance clause. This would require all parties to adhere to universally recognized standards, such as fair labor practices, environmental…   Read more»

To maintain a balance between abiding by an NDA and ensuring transparency, companies should draft NDAs that are very specific, clearly outlining what constitutes confidential information. Companies should give consultants enough access to relevant data to understand project goals and…   Read more»

Upper management requires strategic thinking to see the big picture, set long-term goals, and align organizational objectives. It also is important for upper management to be decisive in making high-stakes decisions that may be unpopular among the company. Finally, I…   Read more»

Organizational structures significantly impact projects and project management by defining authority, communication, and resource allocation. In afunctional organization, teams work within their departments, leading to clear hierarchies but potential silos. Project-based organizations centralize control around the project manager, enabling fast……[Read more]

In my time as an intern in the medical device industry, I believe my company worked as a functional organization. The departments mostly worked separately on their own projects with big decisions made by the department heads. Though I haven’t…   Read more»

It is quite dangerous to mix cost/benefit analysis in with risk analysis and it is not advised to do so. Here’s an example of why: Changing the design is often the best way to mitigate risk, but it is often…   Read more»

Though risk management is a continuous process and must be done throughout the entirety of a product’s lifecycle, I think it is undoubtedly most important in the early stages. Evaluating risk during the planning phase allows a project team to…   Read more»

I don’t think that accepting risk has any effect on the probability of harm. Logically, the only way to affect the probability of harm is to avoid or mitigate the risk, decreasing the probability of harm. Accepting that there is…   Read more»

Design teams prioritize customer feedback by analyzing it against the product’s intended use, market needs, and regulatory requirements. In cases where feedback is ambiguous or conflicting, teams can use techniques like focus groups and surveys to clarify. Critical feedback that…   Read more»

I agree that it is possible to conduct validation and verification simultaneously in some cases, but that should not be the norm or the goal. It’s best to keep verification and validation separate to ensure clarity in evaluating if the…   Read more»

  To define success criteria, a team should start by thoroughly understanding the device’s intended use, regulatory requirements, and user needs. The team must collaborate with stakeholders to outline clear, measurable, and objective performance metrics based on design inputs and…   Read more»

I think it is very possible for teams to log additional design inputs beyond the basic requirements, especially when trying to anticipate factors impacting long-term performance, regulatory shifts, or future iterations. Over-engineered design controls are meant to prepare a product…   Read more»

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»