Criteria definition with consultation of the target user is the best way to transform the user needs into operable specifications. This can be done with an initial loose interpretation of the users needs which will then need to be validated…   Read more»

I think balance comes with a clearly defined purpose for updating the living documentation. This would look more like making moderate to significant changes to the documentation and saving the minor changes for an moderate change to avoid fatigue.  A…   Read more»

I believe companies do treat design controls as a checkbox however they recognize that this can often lead to an increase in efficiency in product design. Not filling out these forms often lead to a scramble through history design changes…   Read more»

The addition of new risk controls will almost always add a level of complexity, but the moment a risk control creates additional risks is when it has come too far. At this point in the risk control design, I would…   Read more»

FMEAs are critical in understanding the predictable flaws in a product and because of such, is a vital form to complete. However as mentioned, actual user interaction can be extremely unpredictable. In my experience, if a customer can find a…   Read more»

In the ideal world, I think absolute 0 risk would be maintainable and the gold standard for innovation, however no amount of testing or mitigation in the real world can account for the imperfections we may not even know about….   Read more»

I think the optimal way to speak up about an issue or a flaw in a project is to push for a team meeting to address the issue while focusing solely on how to overcome the issue at hand. A…   Read more»

I think the main gap between design controls and project management is the amount of paperwork involved. In my experience, teams found any work that took them from working on the device to be unwanted and frustrating despite being a…   Read more»

I believe the determining factor to this discussion is the size of the company and how many projects are going on at once. In my experience, I have been both part of a larger corporation, and a smaller company and…   Read more»

I find the $100 dollar a gift limitation to be extremely futile, considering there is no period in which a gift cannot be provided. Even if there was a cool down period for these gifts, I’m sure bad actors will…   Read more»

NDAs have been used heavily in many many industries and I believe in most they have their purpose. Companies should have a right to protect the secrets that allow their company to be unique. There are however some instances in…   Read more»

I think verbal contracts can be highly dangerous if taken as is even if recorded. As mentioned earlier in the discussion, I agree that they should be used strictly as a tool to initiate contact between companies. In order for…   Read more»

I completely agree that significant impacts to the medical community are completely trivialized by a catchy phrase or a memorable nick name, with all the important fine details sped up with people dancing in the background. I find it extremely…   Read more»

I think you bring up a good point when considering this newer technology in advertising strategies. There are many advantages to AI, as you suggested the primary one is quicker analysis of heaps of data but it does also come…   Read more»

As you suggested, marketing is vital for a product to thrive in the current product environment. Theres an extremely diverse market when it comes to the medical industry, so it’s extremely rewarding for a marketer to get the edge on…   Read more»

Verbal agreements still play a role in early conversations, but they’re best viewed as relationship-building tools rather than anything that should carry operational or legal weight in the medical device industry. Early-stage collaborations often begin with verbal alignment—agreeing to explore…   Read more»

NDAs in the medical device and biotech space are often used more aggressively than truly necessary, largely because companies operate in an environment where intellectual property, early design concepts, competitive positioning, and regulatory strategies can be extremely valuable and easily…   Read more»

Several high-profile scandals in the 1990s and 2000s directly shaped today’s AdvaMed and DOJ-enforced compliance rules, most notably the 2007 orthopedic device investigation in which major companies paid surgeons sham consulting fees, luxurious travel, and research “grants” tied to product…   Read more»

The AdvaMed and DOJ oversight has become so strict since scandals have become large-scale and public. One example is the 2007 orthopedic device kickback scandal. In this scandal, major companies like Zimmer, DePuy, and Biomet were investigated for paying surgeons…   Read more»

When it comes to the restrictions around gifting and meals in industry, the physician interactions definitely seem and feel overly strict. It is especially when viewed through normal social interaction and courtesy behavior. In everyday life, paying for someone’s meal,…   Read more»