Medical Device Courses | aij5 | Activity

aij5 replied to the topic "Skills Learned in this Class" -

Wed, 15 May 2019 19:16:24 -0400

Interaction through online means was actually a rather useful skill to further develop through this class. Social skills are key in industry and everything is digital based where alot meetings and communication are through online portals. These skills are crucial… Read more»

aij5 replied to the topic "How to make good relation with vendors" -

Wed, 15 May 2019 19:16:23 -0400

An important aspect is proper communication via email or video conferences. communication can remedy many issues and also help strengthen a relationship to begin with. One thing I have noted with suppliers is ensuring that the expectations of the product… Read more»

aij5 replied to the topic "Disconnect in rewarding motivation" -

Wed, 15 May 2019 19:15:43 -0400

aij5 replied to the topic "What is retention ?" -

Wed, 15 May 2019 19:15:35 -0400

aij5 replied to the topic "Overworked Americans vs. Motivation" -

Wed, 15 May 2019 19:15:35 -0400

aij5 replied to the topic "What’s Your Motivator?" -

Wed, 15 May 2019 19:15:34 -0400

aij5 replied to the topic "Let's Be Motivated!!!" -

Wed, 15 May 2019 19:14:13 -0400

aij5 replied to the topic "Why do people leave work?" -

Wed, 15 May 2019 19:14:12 -0400

aij5 replied to the topic "Engineer vs. Manager" -

Wed, 15 May 2019 19:14:10 -0400

I believe most of us go into engineering hoping to start out on the technical side of things. For me, that was what I was interested in for sure. I enjoy utilizing the skill set learned through school and internships… Read more»

aij5 replied to the topic "Communication Management" -

Wed, 15 May 2019 19:13:26 -0400

Communication is imperative to the success of any project, especially with larger companies. One thing I think is important is for the project manager to have a proper communication stream with upper management and then that can be disbursed through… Read more»

aij5 replied to the topic "Single Source/Dual Source" -

Wed, 15 May 2019 19:13:25 -0400

Agreed, I do not see much value from selecting an alternate source from the same company. I also do not see as much value in selecting a second source all the time for critical components. Other measures can also be… Read more»

aij5 replied to the topic "Importance of Human Resource Management" -

Wed, 15 May 2019 19:13:24 -0400

I think human resource management plays a key role in ensuring employee turnover is not high. There are rather steep learning curves from company to company and if one medical device company has to continually turn over new employees and… Read more»

aij5 replied to the topic "how the PM handles budget cut?" -

Wed, 15 May 2019 19:12:23 -0400

Within my company, budget cuts are typically handled through re-distribution of responsibilities. The project manager of my team took on a lot more responsibility once cuts were administered. Additionally, we borrowed resources from other groups that we closely worked with… Read more»

aij5 replied to the topic "kinds of changes in PM" -

Wed, 15 May 2019 19:12:22 -0400

The comments above really touched upon the different types of changes in the monitoring and controlling phase. Within larger companies typically what I have noted is that ECOs are much more common than NDCs or DNCs. With my current position… Read more»

aij5 replied to the topic "Sucess Factors" -

Wed, 15 May 2019 19:12:22 -0400

I would have to agree that out of the five listed, effective communication is key for any project. From my experience, alot of projects have teams that are spread across evenly throughout the world. Effective communication is key to allow… Read more»

aij5 replied to the topic "Factors affect schedule variance (SV)" -

Wed, 15 May 2019 19:06:56 -0400

There a multitude of ways schedule variance can occur within industry. We learned from the lecture that schedule variance is the difference between your earned value and planned value. Generally if you have a negative schedule variance, means you are… Read more»

aij5 replied to the topic "Factors to look for while evaluating change request" -

Wed, 15 May 2019 19:06:55 -0400

I believe it is important to assess the change from a patient impact point of view. Any small design change can have rather large implications to sterility, packaging, or even biocompatibility. These types of changes should be heavily considered and… Read more»

aij5 replied to the topic "Project Changes" -

Wed, 15 May 2019 19:06:54 -0400

With my current position I deal with a lot of ECO since the product line I work with was from an acquired company and currently out in the market. The ECO was initiated after staining was observed on one of… Read more»

aij5 replied to the topic "Verification Testing Deviations and Failures" -

Wed, 15 May 2019 19:05:33 -0400

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… Read more»

aij5 replied to the topic "Missing a Milestone Experience" -

Wed, 15 May 2019 19:05:33 -0400

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… Read more»

aij5 replied to the topic "Communication and Responsiveness" -

Wed, 15 May 2019 19:05:32 -0400

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… Read more»

aij5 replied to the topic "Discussion Topic: The critical path" -

Wed, 15 May 2019 19:04:27 -0400

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… Read more»

aij5 replied to the topic "Mapping- Gantt Chart" -

Wed, 15 May 2019 19:04:26 -0400

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… Read more»

aij5 replied to the topic "Overlapping activities" -

Wed, 15 May 2019 19:04:25 -0400

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… Read more»

aij5 replied to the topic "Design Review Meeting Culture" -

Wed, 15 May 2019 19:03:21 -0400

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… Read more»

aij5 replied to the topic "Project Scope: When the timeline you have doesn't work" -

Wed, 15 May 2019 19:03:21 -0400

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… Read more»

aij5 replied to the topic "Inputs for Design Input Document" -

Wed, 15 May 2019 19:03:20 -0400

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… Read more»

aij5 replied to the topic "Mange Project Risks" -

Wed, 15 May 2019 19:02:29 -0400

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… Read more»

aij5 replied to the topic "Design Change Request" -

Wed, 15 May 2019 19:02:19 -0400

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… Read more»

aij5 replied to the topic "The best strategy in running Risk Management Meeting" -

Wed, 15 May 2019 19:02:18 -0400

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… Read more»

aij5 replied to the topic "Discussion Topic: State of your Organization" -

Wed, 15 May 2019 19:01:20 -0400

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… Read more»

aij5 replied to the topic "Project management team" -

Wed, 15 May 2019 19:01:20 -0400

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… Read more»

aij5 replied to the topic "What is Risk Management Plan?" -

Wed, 15 May 2019 19:01:20 -0400

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… Read more»

aij5 replied to the topic "Does Product Classification also depend on the Material of the Product used?" -

Wed, 15 May 2019 19:00:11 -0400

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… Read more»

aij5 replied to the topic "Clinical Trials Discussion" -

Wed, 15 May 2019 18:59:58 -0400

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… Read more»

aij5 replied to the topic "Experience with Project Organizations" -

Wed, 15 May 2019 18:59:58 -0400

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… Read more»

aij5 replied to the topic "FDA Approves First Digital Pill in USA" -

Wed, 15 May 2019 18:59:44 -0400

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… Read more»

aij5 replied to the topic "FDA Approves First Digital Pill in USA" -

Wed, 15 May 2019 18:59:41 -0400

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… Read more»

aij5 replied to the topic "Discussion Topic: Share your project management experience" -

Wed, 15 May 2019 18:59:15 -0400

I work on the Merger’s and Acquisitions team for my company and our main projects when it comes to purchasing an outside company is to integrate and remediate the company to our standards. Generally we use a gantt chart to… Read more»

aij5 replied to the topic "Fitbit: A Medical-Grade Device?" -

Wed, 15 May 2019 18:58:54 -0400

Replying to Amin’s post on the intended use of Medical devices. I believe the company developing the device should do their due diligence in determining potential adverse effects of how their device is interpreted and used. A company should be… Read more»

aij5 replied to the topic "Determining project priority" -

Wed, 15 May 2019 18:58:54 -0400

I think an important factor that should be taken into account is the consumer need and patient market when determining the priority for the projects. A project that does not receive the funding most likely is receiving less interest or… Read more»

aij5 replied to the topic "Discussion Topic: Projects of all types" -

Wed, 15 May 2019 18:58:47 -0400

Project Management deals with different complexities within different industries. Say for example, within the medical device industry, there are different federal regulations such as the FDA or even ISO Standards that must be adhered to in order to be compliant…. Read more»

aij5 replied to the topic Skills Learned in this Class in the forum Project Management Application: Clinical Trial

Mon, 30 Apr 2018 01:57:12 -0400

aij5 replied to the topic How to make good relation with vendors in the forum Project Management Application: Clinical Trial

Mon, 30 Apr 2018 01:54:13 -0400

aij5 replied to the topic Disconnect in rewarding motivation in the forum Project Management Application: Clinical Trial

Thu, 26 Apr 2018 13:51:20 -0400

I have seen the opposite actually in industry so far in regards to rewarding “individual effort”. There were a few rather big milestones hit upon my time at my company and generally the entire project team got recognition rather than individual recognition. I think it is based up to the managers discretion and the theme in the company I work for…[Read more]

aij5 replied to the topic What is retention ? in the forum Project Management Application: Clinical Trial

Tue, 24 Apr 2018 16:34:28 -0400

There are rather evident benefits to retaining talent. But it is also dependent on the job in which you are retaining the talent for. If it is a rather skilled position, like a CNC machinist or a design engineer, retaining talent for those roles may be more important than other positions that can be easily replaceable. It ensures smooth flow of…[Read more]

aij5 replied to the topic Overworked Americans vs. Motivation in the forum Project Management Application: Clinical Trial

Tue, 24 Apr 2018 14:01:49 -0400

I think there are a few factors to this question. Some people can very well be very involved in their project and want to see a project come to fruition. Which can very well be a motivating factor that causes some to work more than 40 hours a week. Another factor could be through watching others and believing that the norm is to work more than 40…[Read more]

aij5 replied to the topic What’s Your Motivator? in the forum Project Management Application: Clinical Trial

Tue, 24 Apr 2018 04:36:32 -0400

Typically what motivates me is that my work can directly effect a patient so taking that into mind it helps me be motivated. This thought helps me maintain a standard of work and also use a strong code of ethics especially on the quality side. I used to work with insulin pumps at a previous job and my manager actually brought in a young girl that…[Read more]

aij5 replied to the topic Let's Be Motivated!!! in the forum Project Management Application: Clinical Trial

Tue, 17 Apr 2018 01:12:54 -0400

I do believe that a managers motivation can directly feed into the project teams motivation. If the leader of the project is not passionate or motivated about a project it is tough to believe the team would be. Simple compliments and recognition can go a long way in a project team. Not saying compliment every single little thing but complementing…[Read more]

aij5 replied to the topic Why do people leave work? in the forum Project Management Application: Clinical Trial

Tue, 17 Apr 2018 01:07:29 -0400

As everyone stated above, there are a whole host of reasons why someone would leave their job. I think a main contributing factor is due to mundane projects and day to day activities. I have heard countless times from colleagues that they have left work because what started out to be an exciting task turned out to be repeated day in a day out.…[Read more]