I agree that the largest challenge that would come with misclassifying a device is stunting your timeline. Additionally, more resources and a deeper budget may be necessary to complete additional testing for a misclassified device. I think filing for a…   Read more»

I agree that AI-driven medical devices should be even more highly regulated than other devices because of their potential to evolve over time. I think certain guidelines must be put in place to ensure that the device is still FDA…   Read more»

Drugs and medical devices are quite different and their general regulatory pathways reflect those differences. A medical device is some sort of mechanical instrument that’s purpose is not dependent on chemical action or being metabolized. Drugs, on the other hand,…   Read more»

I’d also agree that inadequate risk management is the most common regulatory pitfall in medical device development. Classification of the device can be a difficulty in the project management process as mentioned above. I’d like to add that submitting an…   Read more»

I’m quite surprised by all the previous responses choosing the hands-off approach to project managing, because I think there are a lot of benefits to being more hands-on. I agree with the points that too much involvement, meetings, or micro-managing…   Read more»

Generally, the most effective communication is early and often. This applies to all walks of life, not just project management. Specifically on a project team, this type of communication could be defined as clear goal setting, frequent status updates, weekly…   Read more»

I anticipate the biggest risks in medical device project management in the regulatory process. The road to regulatory approval for medical devices in the US is unlike any other products. Devices are monitored closely by the FDA and must adhere…   Read more»

An unreasonable location for a sponsored event could be an exotic destination far from the offices of the employees traveling there. Even so, employees in Florida likely cannot have a sponsored event on a beachfront resort as this would seem…   Read more»

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»