Just to add to what has been stated, In my opinion I would prefer a written agreement instead of verbal. I believe that whenever there is a mutual understanding of what is decided, then legal issues can be prevented or…   Read more»

It’s also important to note that a NDA is a contract. And contract law is an entirely separate field from patent law. How contracts are interpreted is a matter of state law, and interpretations vary from state to state.

In addition to what has been stated, I’d like to add: Neutral Evaluation In neutral evaluation, each party gets a chance to present the case to a neutral person called an “evaluator.” The evaluator then gives an opinion on the…   Read more»

Hello everyone, Although I understand Roberto’s perspective, I also agree that the restrictions are important and necessary. Effective January 2012, the Sunshine Act required that pharmaceutical companies and durable medical equipments suppliers report gifts to physicians in excess of $25….   Read more»

I will have to agree as well. I would prefer the matrix organization as it also allows for greater flexibility in terms of outsourcing. In my experience, some projects that can be done outside the company are easily contracted and…   Read more»

In my current job, I work in a project based/matrix organization. Depending on the need, I am pulled into projects outside my direct functional therapeutic area as needed. I like the matrix structure since it allows for enhanced growth and…   Read more»

I agree that project teams should consist of representatives from each function in order to receive contribution from all roles. I have noticed in my experience, that having a mixture of people with varying levels of expertise can be helpful…   Read more»

Very interesting article, Khemraj. I agree with you. Just to add it is very easy for risk managers to become occupationally tunnel-visioned. However, the job is to manage risk, not to avoid it unnecessarily. Every business action involves risk. Even…   Read more»

I like how you pointed out the importance of avoidance in high severity scenarios. It is also important to know in terms of cost, risk acceptance does not reduce any effects however it is still considered a strategy. This strategy…   Read more»

I agree with you Luisa, I’d also like to add that risk transference is the involvement of handing risk off to a willing third party. In my opinion, in the case of low severity I think it is a good…   Read more»

Personally, I would hope the techs and surgeon’s are aware of what is in the label (such as the risks) prior to using the product. Perhaps through training taken in advance. I agree , that in the surgery example, it…   Read more»

Great post. Just to add onto what has been stated. Risk ranking and filtering is also particularly helpful in situations in which the portfolio of risks and the underlying consequences to be managed are diverse and difficult to compare using…   Read more»

I agree that the risk analysis is team based and involves checks along the way. The team should begin with a thorough identification of all potential and/or known hazards and develop an estimation of the risk(s) for each hazard. In…   Read more»

Hi Grzegorz, it is true like you have said that design control is important in order to ensure quality and correct errors. It is also important to note that design controls are required for all Class II and Class III…   Read more»

I agree that in certain instances, it could benefit the company to outsource the design transfer. For one thing, it is more cost effective. If the vendor follows all the specifications and is trained well than effective design transfer can…   Read more»

Thank you Himang for the great question. I don’t have experience conducting design review meetings. But from experience in review meetings as a whole, I can say it is best to keep the number of invitees medium sized since when…   Read more»

Although I agree with you Murad on clearly establishing roles and responsibilities, I think that the scope is also important to acknowledge early on in order to make sure the team stays on track and doesn’t veer off course. Working…   Read more»

I would have to disagree that I don’t think there is any one aspect of the Design Development plan that is more important than the other. In order to produce a high quality product there needs to be good communication…   Read more»

I agree with the statement that one of the flaws of design transfer occurs when there is an issue in transition of a product design to manufacturing environment. In order to ensure that the design of the medical device can…   Read more»