I agree that risk avoidance is most effectively incorporated during the product design phase. One often overlooked advantage of this phase is the ability to leverage predictive risk analysis tools to proactively identify and eliminate potential hazards before they become…   Read more»

Staying ahead of regulatory changes is incredibly crucial, I agree. Another effective approach is participating in regulatory harmonization initiatives. Harmonization of regulatory requirements has a lot of benefits, including but not limited to, promoting competition and efficiency, reducing clinical testing…   Read more»

Another effective approach to ensure that all elements of the project are properly coordinated is by using a Project Management Plan (PMP). This acts as a comprehensive document that consolidates strategies for each knowledge area. It provides clear guidance on…   Read more»

A lack of clarity in project proposals can certainly lead to challenges down the road. One strategy that can be used to overcome this is a gap analysis. A gap analysis can help identify discrepancies between the current state of…   Read more»

To build on the early start and early finish dates, these dates can also provide project teams with “buffer zones” that can help to absorb delays or regulatory setbacks. By identifying ES and EF dates, project managers can accurately determine…   Read more»

Project and program managers also have a big difference in decision-making and risk management. Project managers focus on mitigating risks within a single project. They are tasked with making sure deliverables stay on schedule and within budget while meeting stakeholder…   Read more»

Risk assessment and scenario planning could also serve as additional tools for stakeholder alignment. When verification failures occur, project teams can proactively manage stakeholder expectations by conducting impact assessments. These would evaluate the cost, risk, and timeline changes related to…   Read more»

Great points! I also think that a hybrid approach could be a strong alternative that could maintain the clarity of separate documents while still improving efficiency. Instead of two entirely different documents, companies could use a linked document system where…   Read more»

I would like to expand on risk assessment during the change control process. Changes, by nature, can introduce new risks. This comes either via product performance, production capabilities, or regulatory compliance. These risks may not be obvious out of the…   Read more»

TMV is crucial for ensuring reproducibility and consistency not just during product development, but also across different production batches and locations. A validated test method reduces variability between testers, equipment, and environments and helps to maintain compliance with regulatory standards….   Read more»

I would like to add that companies can further enhance the effectiveness of these reviews by adding in simulation and prototyping early in the process. Using virtual simulations such as finite element analysis can help identify design flaws early and…   Read more»

All of these responses provide valuable insights into conflict resolution strategies. I’d like to expand on the importance of emotional intelligence (EQ) in resolving conflicts. A project manager who can recognize and manage their own emotions and understand the emotions…   Read more»

Hey Mirna, I think it’s great that you have a specific career path in mind for your future. While I am not a project manager myself, I have a similar end goal. I’ve looked into the proper steps in transitioning…   Read more»

I agree that balancing in-house and external expertise can be beneficial, however, I would also like to emphasize the product development timeline and regulatory complexity. For projects with tight deadlines, relying only on external consultants can lead to bottlenecks due…   Read more»

The challenges in managing medical device projects are definitely multifaceted, but in my opinion, one of the largest challenges lies in balancing cross-functional collaboration. Medical device projects typically require input from a large set of diverse teams. Be it engineering,…   Read more»

I’d like to add that one of the compounding challenges in this area is how regulatory risks can cascade into other risk categories, such as financial and market risks. Delays in FDA approval not only increase cost because of extended…   Read more»

I agree that where the value goes depends case-by-case. I would also add that a project manager could/should also weigh long vs short-term impacts of favoring one stakeholder group over another. Prioritizing customer needs may foster brand loyalty and growth,…   Read more»

As a business owner, having a detailed and structured plan in place for potential emergencies is essential to ensure the continuity of operations and protect the company’s stability. I believe it is crucial to designate a temporary replacement who can…   Read more»

In medical device consulting agreements, proactive conflict resolution strategies often focus on creating efficient and equitable processes. Incorporating multi-tiered dispute resolution mechanisms, such as negotiation and mediation before arbitration, can foster collaboration and potentially resolve issues early. To address jurisdiction…   Read…[Read more]

Fair market value (FMV) compensation for healthcare professionals is a cornerstone of compliance under the AdvaMed Code of Ethics. It ensures that financial agreements are free from any undue influence on the purchase or promotion of medical devices. To verify…   Read more»