I agree that a good strategy for accurate cost estimation of a medical device project is to compare to the cost of a similar past project. However, that information may not be available if the project is very novel or…   Read more»

Many of the past responses include questions like what, when, and where. I think these are important questions to ask, and I’d like to add questions about conditions, reproducibility, and the overall effect. At the start of a root cause…   Read more»

Finding a middle-ground to balance innovation and patient safety in medical device development requires a structured yet flexible risk management approach. One of the most effective strategies is using a risk-based framework to ensure that potential hazards are systematically identified,…   Read more»

Effective risk management in medical device development requires balancing safety, efficiency, and cost. While minimizing risk is essential (especially under ISO 14971 guidelines), overly cautious approaches can delay innovation and inflate costs. It is important to prioritize early-stage risk assessments…   Read more»

I agree that real-time monitoring is the best way an organization can create a culture that embraces the PDCA cycle. As mentioned, regularly scheduled team meeting should incorporate PDCA and a tracking system should be employed to ensure continuous improvement…   Read more»

I agree that it is unwise to jump to design modifications without performing additional tests. It is necessary to pin point where the problem is before trying to solve it. I agree with the above idea that the ethanol wipe…   Read more»

I think it could be necessary to vary testing parameters within regulatory guidelines to come to a favorable outcome after failure. Though it may be difficult to change test parameters if they have already been set and approved, it may…   Read more»

I agree with the above, well-defined roles are crucial to the long-term success of a project team. It is best to allow group members to define their roles themselves if possible so they are personally responsible for their own work…   Read more»

I agree with what has been said above, that determining specs is an extremely important and delicate part of the design process. The specs must be tight enough so that the product can provide its intended function and also loose…   Read more»

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»