I agree, filing in a wrong classification could result in significant delays and could also lead to financial burdens depending on the class type. Filing a Class III device as Class II is riskier, as the FDA may require more…   Read more»

I would prefer a boss who is more hands-off but provides clear expectations and guidance when needed. A hands-off approach fosters independence, allowing team members to take ownership of their work and develop problem-solving skills. At the same time complete…   Read more»

Effective communication in a project team requires clarity of expectations and regular status updates. By having a shard communication app or a project board platform on which everyone can track the progress and deadlines helps keep them updated without needing to meet constantly. Furthermore, it’s…   Read more»

It is important to have a foundational knowledge of project management even for those who don’t plan to pursue it as a career. It definitely helps someone understand how projects are structured and the importance of timelines. It also enhances…   Read more»

I personally believe that much of leadership is nurtured with experience and mentorship rather than something one is born with.  A project manager refines his leadership by overcoming obstacles, learning from mentors, and accepting changing dynamics from team members. Skills such as communication, problem-solving, and resilience do not…[Read more]

I think drugs and medical devices differ not only in their mechanism but also in their level of patient dependence. Drugs depend on biochemical processes of the body to produce their effect, while most medical devices act either independently or…   Read more»

I believe large teams are more effective however, an effective strategy has to be there for involvement in terms of productivity. Large teams have the advantage in experience and broad views that might lead to a better decision. At the…   Read more»

A project manager can maintain dynamic goals by adding regular reviews and updates throughout the project, making sure they match with changing business needs. By setting clear limits for changes, the PM can tell apart needed changes from unnecessary additions. In addition, defining what success looks like for each task ensures any updates ar…[Read more]

One possible way international contract law could be structured is by including international contract law is to make a single enforcement system. This system would make sure contracts are followed the same way in all countries that take part. It…   Read more»

A good way to make verbal contracts binding would be to send follow-up emails right after discussions. The follow-up emails can summarize everything discussed over the conversation in writing. Once all the details, including any agreements reached, are written in an email and confirmation sought from the other party, then confusion can be cleare…[Read more]

The key to an effective project team is in understanding the goals and the required skills to get the job done. It’s very tempting to want to work with people that you get on well with, but it’s about the…   Read more»

To make single person decision making work better, setting up a “predecision consultation” process can help. This means the decision maker holds short meetings with key team members to gather different ideas and expertise. After making the final decision, they…   Read more»

For medical device companies to succeed in the value-based healthcare marketplace, their strategies have to be put in line with patient-centric and cost-effective solutions. A very effective strategy would be co-creation strategies through collaboration with healthcare providers and patients in…   Read more»

Risk management is not only crucial in medical devices where patient safety is a top priority. It not only ensures compliance with regulations such as ISO 14971 but at the same time, it is also important for a company’s reputation…   Read more»

I completely agree that proper training is critical to avoid mistakes with biohazard protocols. For example, take the case of a newcomer in a biology lab who is assigned to sterilize re-useable pipettes that have been used for non-pathogenetic but…   Read more»

I agree, after learning about verification and validation this week, I’ve gained so much knowledge about the safety and reliability of the medical devices we use. It definitely makes me feel much more confident in its safety and reliability.  Verification…   Read more»