For many products, companies are required to follow GLP and other good practices as mentioned previously. These good practice rules give companies an outline on standard protocols to follow when it comes to the study itself and record keeping of…   Read more»

One way to prepare for challenges in the product development process early is to organize review meetings with team leaders from cross-functional teams. When project members from different teams, for example engineering and compliance, are able to express their uncertainties…   Read more»

Making sure that relevant metrics are collected efficiently and correctly are indeed an important step in the project process. One way to make sure the metrics that are collected are relevant with the goals of the current project objective. Revising…   Read more»

Cross-functional teams are essential to many projects, and omitting a sequence of activities can significantly impact their purpose. The purpose of these teams is to allocate project resource effectively and distribute project tasks efficiently. When a project’s schedule is being…   Read more»

One way to make sure that all project documents remain accurate and update is by maintaining and utilizing version control software, along with access control. As mentioned, suppliers and manufacturers can run into issues with their schedule, which can impact…   Read more»

An important factor to consider which is equally important as pre-market approval is post-market surveillance of medical devices. A rigorous and well-made pre-market portion of a medical device project is essential for the approval and success of the device. An…   Read more»

Hello all,My name is Paul and I am a BME masters student at NJIT. Here is my LinkedIn: https://www.linkedin.com/in/paul-zukowski/
 

As mentioned before, a RACI can certainly help decrease the ambiguity associated with the development of a syringe that does not leak and clump. However, a RACI does not directly address the risks that can occur, especially when engaging in…   Read more»

Designing a risk assessment properly by taking into account all the details that can contribute to risk in a project can help strengthen a verification protocol considerably. Identifying errors or potential points of failure in terms of the compliance or…   Read more»

One consideration when it comes to the length of times associated with change orders is the regulatory body a project manager is dealing with. The FDA and the EUMDR have different processes when it comes to fulfilling a ECO. In…   Read more»

Curing patients could be a sustainable business practice, however it does not seem reasonable. With a business model that prioritizes curing patients, a plethora of ethical dilemmas could come into play. By offering life-changing treatments through curing chronic issues, a…   Read more»

One important aspect of task scheduling that hasn’t been mentioned is the important of incorporating slack when scheduling tasks. Slack is important to a project as it allows for a project manager and their teams to evaluate how long a…   Read more»

Scope management directly influences the cost and time management of a project. As the scope increases, it comes with the expense of a higher cost (usually). Increasing scope can also alter the timeline in a way that is not beneficial…   Read more»

A project can be well-coordinated while taking account into the 10 knowledge areas is the implementation of a change control process. Managing the 10 knowledge areas and coordinating all elements within the project, but when a project is on the…   Read more»

In regards to the initiation process in medical device projects, one key input is risk management and planning to mitigate risk. This input is often overlooked by many as risk management may not be taken as seriously as it should….   Read more»

The FDA should have some indirect impact on verification and validation tests. Ideally, these would be guidelines for companies should follow, but should not be strict standards. Regulatory requirements already have a strong impact on medical devices, especially smaller startups…   Read more»

EEFS should be considered multiple times during the project management lifecycle. As with risk management, holding regular meetings to assess EEFS is critical for the success of a project. Communication can play a key role in how EEFS are managed….   Read more»

One main factor that can contribute to how a project management could set up a project organization can be based off of the overall status of the team communication and collaboration. Project-based organization allows for the most simple communication protocols…   Read more»

An essential strategy for avoiding scope creep and delivering a successful project is developing a dynamic risk management strategy. Dynamic risk management is based upon the idea that it can catch scope creep early before it starts to affect the…   Read more»

@ms3548 Underestimating regulatory requirements is indeed a common pitfall that does not get enough attention in my view. Implementing steps for early and continuous regulatory engagement can ensure a company can properly plan their pathway for receiving approval for their…   Read more»