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»

Regulatory agencies should feel the need to adapt faster to keep up with the innovation happening in the medical device field. As it was mentioned, AI may become much more prominent in modern medical as it has potential to be…   Read more»

Hurdles may not be the right term to use when accidently classifying a device as a Class III instead of a Class II. From a project management prospective, misclassifying a medical device within the wrong section can be detrimental. The…   Read more»

Intended use and the technological features of a device is usually the focus when determining which regulations apply to a product. Small distinctions in the function of a medical device can solidify which category the medical device would fall into….   Read more»

One product that comes to mind when discussing product life cycles is the stethoscope. The acoustic stethoscope has been used since at least the 1850s and has stayed as a reliable tool for clinicians. Electronic stethoscopes have entered the market,…   Read more»

Traceability and adaptability requires a systemic change control process in order to maintain efficiency. One example of this would be features embedded within digital project management tools. A traceability matrix which is updated based on a version-controlled requirements document could…   Read more»