There are a few communication strategies that can be employed. If sending an email doesn’t work, I usually direct message them. If that doesn’t work, I put a meeting on that person’s calendar. At that point, if there is extreme…   Read more»

The previous replies explain the definition of test method validation quite well, but to answer your question simply on the role of TMV in design controls: test methods are developed for two main reasons in the product development world, 1….   Read more»

Even though the overall structure is similar, in practice, they are executed differently because the actual tests in design verification are completely different that the tests executed for design validation. As the previous two replies explain, the goals for these…   Read more»

Design reviews are formal, structured meetings that occur at the end of important design controls milestones (at the end of design input, output, verification, validation, and transfer). To effectively run these meetings, an agenda must be sent out ahead of…   Read more»

Its true that sometimes it feels like upper management and their timelines are the biggest challenges in a project (and many times that is the actual case), but that is the reality for most large corporations and project managers and…   Read more»

First, its important to consider the organizational structure when discussing what skills a certain role needs. In regulatory, there will be a department director that oversees multiple regulatory project leads (these are the RA point of contact for every project),…   Read more»

I think there are multiple levels to the culture that an employee will experience in a company. On the smallest level there is the peer-peer relationship. Then there is the manager-direct report relationship. Then there is the project manager-team relationship….   Read more»

Medical device development is indeed a unique industry that requires very unique project management and creative decision making in order to comply with regulations, create a functional and effective technological solution, and manage a diverse team. In my experience in…   Read more»

I have never encountered a non-compete agreement but I have been asked to sign non-disclosure agreements. Does anyone know the difference between the two? From what I understand, NCA is just a one-way contract to prevent employees from disclosing information…   Read more»

Additionally, a trade secret only works if no one else comes up with the same idea, recipe, design, etc. on their own. If another company is able to replicate your product without any of their employees having violated any confidentiality…   Read more»

It is customary in medical device companies to allow for meals with health care professionals (HCP) where the company representative will pay for the meal. There is typically a limit to how much the meal can cost and regulations around…   Read more»

In the last two years, I have noticed a shift in medical device companies organizational structure and a push from my company’s management to transition to a matrix organization with a project management office (PMO). This is because a PMO…   Read more»

Juggling multiple projects is definitely challenging, but it can be really beneficial to have your hands in several initiative in the company as you can take lessons learned from one project and apply it to another. To avoid getting overwhelmed,…   Read more»

I have noticed that in recent times most companies are trying to be more inclusive of diverse perspectives, including younger professionals, although there are definitely still those who feel entitled due to their seniority within the company. A new manager…   Read more»

Internal risks are easier to identify and manage than external risks. An example of internal risk can be in the QA inspection method implemented. If the inspection test method has inherent risks (operator error, variability in equipment, etc) then defective…   Read more»

As mentioned above, there are clear advantages to risk management that makes it absolutely necessary for product development and launch. However, there are some things to watch out for. One issue is if the team goes ‘down the rabbit hole’…   Read more»