A consulting agreement could become risky (legally) when the arrangment stops looking like an actual need for expertise and more like a financial relationship that is tied to clinical influence. In pr...

An NDA and patent are utilized for different purposes and one can't be used to substitute for each other. An NDA can control WHO the information is shared with and can prevent collaborators, contracto...

While verbal agreements can occur naturally in early conversations or iterations of a project, they shouldn't be treated as binding in most capacities, especially in the medical device industry. The l...

A way to make the matrix organization work is treating the communication as if it were a designed system rather than something that just occurs between the managers. In matrix breakdowns, the problem ...

When answering this question, it is important to look at the type of work the team is actually accomplishing. In a medical device development, teams are not always working on a uniform task or accompl...

One way to resolve or do away (as best as one can) with a "two-boss problem" is to formalize decision rights at the hierarchal level rather than just roles. In a lot of teams, both managers (in this c...

When answering this question, I am tempted to say that the risk should strive for a zero-chance, but that is impossible. Devices and products will always carry some risk, although they will be put to ...

There are a few conflicts that could arise when it comes risk management and the project team being involved in the same tasks. One is the distribution workload for the project. Having the same group ...

When discussing mitigation going "too far", I think it is important to analyze whether a control is actually improving the device in an impactful or meaningful way, rather than just being work to plac...

Whether or not a company utilizes design controls as a tool or a checkbox ultimately comes down to their internal culture and the overall attitude within. Companies, whether big or small, that value a...

I think balance really can come down to defining the purpose for each document tier. Perhaps removing informal working logs or notebooks that are not officially updated changes in the DDP (such as des...

Similarly, as everyone has mentioned, I also believe that this incident (Therac-25) caused a fundamental rethinking and reshaping of how the industry approaches both software safety and design. With t...

Yes, I, along with a lot of others I am hoping, do feel safer knowing medical devices go through the verification and validation process not just now, but for the future as well. Off the top of my hea...

To me, balancing the user needs alongside business goals seems like a hard challenge to accomplish, although also an important part of the development process. From any viewpoint, the ideal position i...

While I don't currently work in the medical device industry, the understanding and learning of the difference between verification and validation are essential and closely related cogs in the design c...