I agree that deviations are important to keep included in both validations and verification reports. Deviations can provide important information that ultimately can change the whole output or scope of the verification. There was a verification protocol/report that I was aiding with in which there was not enough test coupons to meet the…[Read more]

Similar to the posts above, I experienced an issue during my capstone project of missing a milestone. My team was developing an ultrasonic transducer for therapuetic use. Some of the components which was going to be used for the transducer was lost during shipment. This set our timeline back quite a bit but instead of waiting for those parts to be…[Read more]

It is important to understand the other individuals point of view. There can be a multitude of reasons why the other individual is unresponsive or willing to have sit down meetings. Generally, if you are able to form a relationship with the individual in industry, they are more willing to listen and be of help. That open line of communication is…[Read more]

Within my company there was a project I worked on where we looked to have a new titanium bone screw system used with foot for bunionectomies, fractures and osteotomies released. The system was acquired through a product acquisition. There were lots of eyes on these components of the project however one aspect that seemed rather irrelevant was an…[Read more]

Gantt charts provide a nice holistic visual representation of all the tasks within a project and the timeline proposed to be followed. Within those tasks we can see the breakdown of the sub tasks as well as what needs to be completed prior to that beginning of that task. Overall the gantt chart provides a nice comprehensive timeline of the…[Read more]

Project planning as the majority of the posts above indicated is important and overall sets the foundation and path moving forward for the project. The planning phase I do agree that returning to activities at an earlier phase doesn’t mean we are moving backwards. There are things within a project that may not necessarily be accounted or p…[Read more]

Within the company I work for, although I am not directly involved within the design review meetings, I have spoken to a couple R&D engineers who partake in these meetings. They describe the culture as stressful. The meetings generally are always of high priority to get a design submitted to the proto-type shop in order to test it within the…[Read more]

Ethically speaking, I do not believe any project manager should feel the need to work those under his wing to exhaustion. The overall goal and objectives for the project are set forth in the beginning and if you are working your employees to the brink of exhaustion then you as a project manager did not plan accordingly or ask for sufficient…[Read more]

I agree with the majority of the above sentiments. Another important perspective to obtain would be that of the surgeon. Within my company, the R&D engineers work directly with the surgeons on designs and get their direct feedback on whether something like this would be feasible. They aid in developing some inputs to a design from their shear…[Read more]

In my experience with suppliers, they are always open to providing suggestions for process monitoring, potential avenues of future risk, and additional cleaning steps to ensure the safety of the product. This can come in handy with risk management because not only would they have seen how your product of design is being manufactured, they would…[Read more]

Typically within the medical device company I work in, design changes are generally driven through an engineering change request. These ECRs generally have five phases where phase one is when the overall scope of the change in encompassed with the proposal as well. The submitter of the change drives the ECR and drafts the first phase and is…[Read more]

I think it would be wise to get everyone familiarized before starting risk management meetings with the ISO 14971 standard. Before even running these risk management meetings it is important that everyone in the group that I am in charge of have a baseline understanding of ISO 14971 and basically what a risk/hazard is. Towards the beginning…[Read more]

Currently, I work for a medical device company within the north jersey area. From my experience so far with the company, I would argue that is a functional organization. With such a large company it is difficult not to separate out departments as opposed to have specified groups with multiple experts from different departments. There are projects…[Read more]

I agree with the sentiments above in regards to picking project teams. Overall it is important to take a look not only at the team from a technical standpoint but from an interpersonal standpoint as well. If a team cannot seem to mesh well in terms of their personalities, it is rather difficult to progress a project to its end goal.
If…[Read more]

Risk management, from my understanding, is the act of ensuring your device is free from unacceptable harm. I believe the first step in any risk management plan is to determine your potential sources of harm that are directly related to the medical device. For example if you have a medical device that emits an electrical output, one hazard to…[Read more]

For the case of the syringe, it would depend on the interaction with the body. I think that would have rather large implications and would dictate the various routes that may have to be pursued. For the syringe, the plastic portion would not come in direct contact with the body per se so I do not believe the product would have to be reclassified…[Read more]

I agree with the sentiments stated above as well. Overall you want to put a product out in the market that will in no way harm the patient and that can only be down through clinical or animal testing. There was just so much done in the past in regards to uninformed consent (Tuskegee syphilis study) or unjust clinical trials (Nuremberg trials) to…[Read more]

In my current position, I work within a functional organization. From the lectures I can understand how the disadvantages come about however I have no run into an issue of having silos form between different groups. Every team has their own agenda but when it comes to completing a common task I have not run into any issues. Part of my job…[Read more]

In response to ak977, I do believe that those are valid concerns to have over privacy. What I would propose as a potential solution is to have the transmitted data password protected, where the individual sending or receiving the information are the only two with that password to view. We do live in a data dependent society where multiple forms of…[Read more]

I would argue that this product is a combination product. Abilify was first approved in 2002 and approved for use to treat Schizophrenia however the new novel aspect of this design is the sensor technology which tracks the ingestion of the pill. This product would elicit a chemical reaction in the body so it could not classify as just a…[Read more]