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 practice, the turning point would most likely appear when…   Read more»

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, contractors and investors from being able to…   Read more»

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 level of regulation, document, and potential liability make it too…   Read more»

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 is not necessarily that people aren’t talking,…   Read more»

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 accomplishing everything simultaneously, rather, they can…   Read more»

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 case) technically…   Read more»

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 an acceptable level of risk…   Read more»

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 work on two different sectors…   Read more»

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 place on a table for risk. Devices…   Read more»

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 accountability, learning, and growth will naturally treat…   Read more»

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 design changes that affect verification, validation or…   Read more»

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 that said, it isn’t only just verification that is changing, but…   Read more»

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 head, I…   Read more»

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 is that the device proposed not only is specified…   Read more»

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 control process. Verification is the involvement of checking that the…   Read more»

The placebo effect is a great example of how phycological and physiological systems in our bodies are so deeply intertwined with each other. This makes it both a challenge and a learning opportunity in clinical research and study. Viewing it…   Read more»

Biomedical engineers I believe play a significant role in clinical research and can be the bridge to piece a lot of aspects together. The background in the field has big focuses on design controls, systems thinking and even data analytics;…   Read more»

While clinical research can feel like it’s being weighed down by the scope of the idea or complexity, every process and layer within it from approval and documentation to analysis is there for good reason. The challenge I think lies…   Read more»

I know I am not unique in saying this, but I feel a little invested in answering this because I had to go through the process of getting a dental implant that took a long while. Also the way I…   Read more»

There is such a wide variety of medical devices out there and variations that innovation on its own would rarely help in its own success, or at least propel it forward to the spotlight. Strategic and targeted positioning in marketing…   Read more»