A work breakdown structure (WBS) facilitates better project planning by providing a clear definition of the project’s scope and breaking it down into manageable tasks, ensuring that all necessary work is identified, and no critical tasks are overlooked. This allows…   Read more»

In order to create a robust final product, it is important to understand the worst-case scenario outcomes. If a product undergoes rigorous testing of worst-case scenarios, it will be assumed to last under less severe and more realistic conditions. In…   Read more»

I completely agree with your perspective that the Design History File (DHF) should be treated as an active part of the product development process rather than an afterthought. Maintaining a well-organized DHF not only helps meet FDA regulatory requirements but…   Read more»

The verification failure shows the importance of integrating a strong risk management framework and focusing on continuous improvement in medical device projects. Conducting a FMEA early in the design process is a way to predict and plan for risks before…   Read more»

Balancing structure and flexibility in medical device development requires developing an approach that fits organizational structure with project needs while maintaining regulatory compliance and innovation. A functional structure provides stability and technical expertise, making it good for R&D efforts. To…   Read more»

Filing for FDA approval of a misclassified device can cause major hinderances to the entire process, whether the company filed a class II device as class III or the other way around. The time from submitting an application for approval…   Read more»

Organizations can find a balance between regulatory compliance and innovation without compromising agility by practicing open communication, involving regulatory experts early in the development process, and incorporating validations into the development process. Viewing validation and verification as their own separate…   Read more»

When considering using new technology in a project, the PM must take into consideration the impact to the overall cost and timeline of the project. If the new technology is extremely expensive and will take time away from the project…   Read more»

A strong regulatory strategy is essential for effective project management in the medical device industry, as it reduces risks such as costly delays, failed approvals, or market withdrawal. One of the most important elements of regulatory project management is identifying…   Read more»

The biggest regulatory challenge in developing emerging medical technologies involving AI or machine learning is finding a balance between adhering to strict regulatory safety standards and finding flexibility to make advances. In my opinion, regulatory agencies should take steps to…   Read more»

A project manager can keep project goals dynamic while avoiding scope creep and ensuring successful delivery by establishing a strong framework for continuously updating goals as they change and communication with stakeholders. At the start of a project, the PM…   Read more»

When it comes to working within a team virtually, I find that the best way to effectively communicate is finding the right platform and giving everyone enough time to engage. The first aspect of team communication is choosing a platform…   Read more»

In my opinion, a balanced combination of in-person and virtual communication can be used in successful project management. I do not think it necessary to go all in on either method of communication, but to acknowledge the benefits to each….   Read more»

Verbal contracts are much less common than written contracts in the medical device industry, but they can be important in situations where an immediate agreement or quick decision is required. Companies use a variety of strategies to ensure that verbal…   Read more»

To keep up with the shift toward value-based healthcare, medical device companies should prioritize patient outcomes, operational efficiency, and working closely with healthcare stakeholders. One approach is focusing on patient outcomes by developing products that demonstrate obvious clinical benefits, including…   Read more»

Risk management is extremely important to the medical device sector. Here are a few examples of each of the 4 strategies discussed in the lecture related to a hypothetical heart implant company: Risk avoidance: A company is developing a heart…   Read more»

There are ISO and FDA standards that frame how risk management should be handled when it comes to medical devices. According to ISO 14971, risk analysis should include identifying potential hazards and estimate associated risks, risk control should include implementing…   Read more»

When companies interpret standards like ISO 13485 and 21 CFR 820.30, several factors influence their approach. These interpretations show the balance between strict regulatory compliance and the company’s operational needs, and choices can vary depending on the company’s goals. Some…   Read more»

Verification and validation each have their own distinct purposes. Verification ensures that a design meets specific technical requirements and validation ensures that the design meets the user needs. Although they are different, there are situations where these processes can be…   Read more»

Customer feedback is very important to the design input process because it drives user needs. In some cases, feedback can be ambiguous and cause challenges in translating the designs into reality. Some ways that design teams can handle this are…   Read more»