I do not necessarily have a preference for a larger or smaller project team. The size of the project team should be determined by the workload needed to complete the project. It is one of the project manager’s duties to…   Read more»

As a new engineer, I sometimes have trouble assessing priorities for a project I’m not familiar with. Upon becoming familiar with the project, the major milestones needed to complete the project become more clear. Determining how long these milestones take…   Read more»

I have spent my career so far as an engineer only. However, I often think of what attributes my project managers are looking for in me. There are many things that contribute to being a good team member: determination, knowledge,…   Read more»

As an engineer, I would prefer a regulatory role in the product development phase. During the development, regulatory must give the engineering team guidance to ensure their activity meets FDA requirements.  In this role they can outline the requirements to…   Read more»

I have used FMEA extensively and consider it to be extremely productive. Specifically, a design FMEA allows the device or part to be analyzed on a feature by feature basis. Each feature is evaluated and assigned a risk value. This…   Read more»

The fact that the risk management file is a living document is one of the most important aspects of this area. Risk management is a constant cycle of analysis, evaluation, management, and measurement. This process continues far beyond the release…   Read more»

I think one of the most interesting risk factors is the probability of a harmful event. The FDA factors the proportion of the intended population that would experience that event and how many times it would occur. It is important…   Read more»

I believe that upper management should have a better idea of the overall function of the company. They should be knowledgeable about the goals and future of the company. It is also important to have some experience in middle management…   Read more»

FOrming a project team can prove to be difficult but I will share some of my observations. It is sometimes good to form a team which with you have a good relationship. You are aware of the extent of their…   Read more»

Hello. I am writing this discussion late so I have the benefit of having completed the Medical Device Development Project. I had the role of regulatory and was in charge of completing the regulatory rationale. I think one of the…   Read more»

Interesting topic. I was not aware of such restrictions on physicians. I think the idea of these restrictions is to maintain a sense of integrity and professionalism in the medical field. Physicians are often directly responsible for the health and…   Read more»

Consultants can be extremely beneficial if a company requires advice in a specific field or niche area. I believe the main benefit of hiring a consultant is the lack of need to train this person in said field. In most…   Read more»

The main thing to consider before signing is the contents of the NDA. Specifically, what restrictions does the NDA impose on you. NDAs are an agreement between the employer and employee to protect trade secrets and confidential information. The company…   Read more»

The DID and DSD tie in very nicely when developing Verification and Validation procedures. The Design Input Document should be used for Validation, where the resultant function of the product is assured to meet consumer needs. The Design Specification Document…   Read more»

Outsourcing manufacturing is often cost-effective for companies. Cheaper materials and optimized manufacturing processes can lead to cheaper products and faster production. However, outsourcing can also lead to sub-optimal quality inspection. Outsourcing manufacturing will require a more extensive Design Transfer Process….   Read more»

One of the most important factors of the engineering design process is ” If it is not documented, then it never happened”. This applies to meetings too. Someone should be keeping track of the meeting conversation in some sort of…   Read more»

I think any ethical issues related to the Right to Try Act can be mitigated by clear communication between the physicians and the patients. The RTA specifies that the patient must be diagnosed with a terminal illness. I think participation…   Read more»

Posted by: @amd29 No one has ever claimed that their disease was cured by some pharmaceutical drug; in other words, pharmaceutical drugs have never actually improved the direction of human wellbeing. I think this statement is just false. I guess…   Read more»

I disagree with your statement that “placebo treatment is better than no treatment at all”. In fact, I think that is the biggest ethical dilemma in utilizing PCTs. Medical professionals have the responsibility to provide optimal medical care to the…   Read more»

I think manipulation is a harsh term compared to other similar terms such as “persuasion”. Yes, I think in the most general sense, marketing can be considered manipulation. It’s the marketing team’s job to get as many people as they…   Read more»