Medical Device Courses | ap962 | Activity

ap962 replied to the topic "Why do people work?" -

Wed, 15 May 2019 19:15:58 -0400

ap962 replied to the topic "How to make good relation with vendors" -

Wed, 15 May 2019 19:15:57 -0400

ap962 replied to the topic "Clinical Project Team Roles" -

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

I would like to work in the Regulatory department if I was part of a clinical project team. Being someone who is always thorough with every step she takes, always planning two steps ahead and always ready with a plan… Read more»

ap962 replied to the topic "Engineer vs. Manager" -

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

I would like continue being an engineer. I would like to find my area of interest, build my expertise over the years and a reputation in the industry. Once, I’m at the senior, expert level, I would like move ahead… Read more»

ap962 replied to the topic "What’s Your Motivator?" -

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

ap962 replied to the topic "Six Sigma and Project Management" -

Wed, 15 May 2019 19:13:57 -0400

The Six Sigma methodology DMAIC (Define, Measure, Analyze, Improve, Control) offers a structured and disciplined process for solving business problems. Six Sigma uses tools designed to identify root causes for the defects in processes that keep an organization from providing… Read more»

ap962 replied to the topic "Designing effective Communication management Plan" -

Wed, 15 May 2019 19:13:53 -0400

I agree that there should be a common communication management plan that is included as the SOP. This assists in the effective dissemination of information.The information distribution can be designed in compatibility to the project organization chart ensure easy flow… Read more»

ap962 replied to the topic "QA vs QC" -

Wed, 15 May 2019 19:13:49 -0400

Quality assurance is a management or oversight function, it deals with setting policy and running an administrative system of management control that cover planning, implementation and review of data collection activities and the use of data in decision making. Where… Read more»

ap962 replied to the topic "Sucess Factors" -

Wed, 15 May 2019 19:12:28 -0400

Each factor has its own contribution towards a successful project completion. 1)Agreeing on the project goals helps the team have a clear idea of what is expected of them, and sets unanimity amongst the team members. 2)Effective Communication is one… Read more»

ap962 replied to the topic "Post-project lessons learned" -

Wed, 15 May 2019 19:07:34 -0400

ap962 replied to the topic "Design Transfer" -

Wed, 15 May 2019 19:07:29 -0400

The factors that need to be considered during design transfer are that complete information is provided to production about the manufacturing of the product. This includes manufacturing work instructions, Item Master, Quality inspection work instructions, Procurement instructions, drawings, tooling specifications,… Read more»

ap962 replied to the topic "Design validation" -

Wed, 15 May 2019 19:06:10 -0400

Design Validation is carried out by by examination and provision of objective evidence that ensures that device specifications conform with user needs and intended uses. It includes testing of production units under actual or simulated use conditions, software validation and… Read more»

ap962 replied to the topic "Points to look for while out sourcing" -

Wed, 15 May 2019 19:06:03 -0400

ap962 replied to the topic "Review of Combination products" -

Wed, 15 May 2019 19:05:17 -0400

I would further like to continue this topic by asking what types of marketing applications are required for a combination product?

ap962 replied to the topic "Review of Combination products" -

Wed, 15 May 2019 19:05:16 -0400

Combination products are assigned to a FDA center that will have primary jurisdiction for its premarket review and regulation. Consistent with section 503(g)(1) of the Act, assignment to a center with primary jurisdiction for premarket review and post-market regulation, or… Read more»

ap962 replied to the topic "Inputs for Design Input Document" -

Wed, 15 May 2019 19:04:22 -0400

I agree with all the points that Devarshi has made and would also like to add that Solid Design Inputs makes the rest of medical device product development easier too. Once Design Inputs are defined, you are ready to engage… Read more»

ap962 replied to the topic "Design Review Meeting" -

Wed, 15 May 2019 19:04:21 -0400

In the final semester of my undergrad we were required to work on a project that would be equivalent to the capstone project here in NJIT. Each team was assigned an Internal guide who would help us plan our project… Read more»

ap962 replied to the topic "Engineering change order" -

Wed, 15 May 2019 19:03:05 -0400

The objective of ECOs and any other change orders is to legitimately archive the proposed changes for tracebility purposes. Any necessary changes of the design or documentation go through COs. The COs are reviewed and sent to the necessary dpartments… Read more»

ap962 replied to the topic "Risk Management" -

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

A product risk can occur due to a defect in the drug release mechanism in a drug delivering device. Under FMEA a drug delivering device would be a Concept Design / Hardware risk where the probability of success of design… Read more»

ap962 replied to the topic "Categorization of Medical Devices" -

Wed, 15 May 2019 19:02:00 -0400

That is an interesting topic. Medical Devices are categorized based on the risk associated with the usage of the device. The categorization is based on different parameters such as 1. The general regulatory controls: General controls are the fundamental provisions… Read more»

ap962 replied to the topic "How to initiate project successfully" -

Wed, 15 May 2019 19:01:55 -0400

According to me, the first, and most critical, step to initiate a project is defining the extent of the project. What is it you should achieve or make? What is the task objective? Similarly important is defining what is excluded… Read more»

ap962 replied to the topic "Does Product Classification also depend on the Material of the Product used?" -

Wed, 15 May 2019 19:01:05 -0400

I agree with all the comments made here, and would like to add mah52’s plastic syringe example that as plastic is chemically inert, use of a different grade plastic material would not require a PMA. Also the syringe wouldn’t be… Read more»

ap962 replied to the topic "Initiating a Project Idea" -

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

We’re full of ideas of what would make the best business plan and are convinced that it will earn us plenty of money. To convert these ideas into words and convince investors to see the success of this idea as… Read more»

ap962 replied to the topic "Pros and Cons of the 3 Organizational Structures" -

Wed, 15 May 2019 19:01:00 -0400

I would like to work in a matrix based organization. I agree with the points made by smitshah and srg36. I would like to add this type of organization will result in good management of resources, it encourages people from… Read more»

ap962 replied to the topic "FDA Regulations of Medical Device-Drug" -

Wed, 15 May 2019 18:59:43 -0400

The Food and Drug Administration (FDA) is amending its combination product regulations to define “mode of action” (MOA) and “primary mode of action” (PMOA). Where, MOA is the means by which a therapeutic product achieves an intended effect or action…. Read more»

ap962 replied to the topic "Challenges in the Global Regulatory Environment" -

Wed, 15 May 2019 18:59:35 -0400

I took Dr Collins class “Biomaterials” last spring, and this discussion took me back to a discussion we had in class about the Global Regulatory Environment. The FDA has very stringent rules, that they are adamant into applying. Whereas other… Read more»

ap962 replied to the topic "Fitbit Medical Device?" -

Wed, 15 May 2019 18:59:27 -0400

In my opinion the Fitbit should be classified as a Class 1 device as similar device exist in the market. This will help decrease the testing period as their are similar devices that prove that such devices are safe and… Read more»

ap962 replied to the topic "Discussion Topic: State of your Organization" -

Wed, 15 May 2019 18:58:28 -0400

During my internship in the Saad Research and Development center, I worked in a Matrix based industry. There were two organizations locally and two internationally that were funding the research that were going on in the center. From this experience… Read more»

ap962 replied to the topic "Ideal project team" -

Wed, 15 May 2019 18:58:23 -0400

I agree with the baseline points that everyone has made that a good team compromises of individuals with good communication, are hard working and have a knowledge of the problem. These are some qualities that you would find in any… Read more»

ap962 replied to the topic "Interpersonal skills vs technical knowledge" -

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

As much as I agree with everyone about the importance of technical skills, it’s important to note that employers prefer to train people they bring into work so that they are able to deliver what’s expected of them perfectly and… Read more»

ap962 posted a new topic "Closing Phase" -

Wed, 15 May 2019 16:35:40 -0400

The end of the Monitoring and Controlling Phase is marked by the Closing Phase. What are steps that need to be followed to ensure that phase is carried out effectively?

ap962 posted a new topic "Project Execution" -

Wed, 15 May 2019 16:35:34 -0400

This weeks lecture talks about project planning and execution. As a Project Manager, what are the key factors that need to be taken into consideration for a successful project execution?
Also, what factors you would as a Manager emphasize on?

ap962 posted a new topic "Unapproved Device" -

Wed, 15 May 2019 16:35:15 -0400

As well know, all medical devices require approval so that they can be used. What do you think happens in the case of an emergency? Can a physician use an unapproved device, if it has the potential to cure a… Read more»

ap962 replied to the topic Why do people work? in the forum Project Management Application: Clinical Trial

Sun, 29 Apr 2018 01:28:49 -0400

I enjoyed reading all the comments in the post and was pleasantly surprised to see how similar the views of everyone here are to the consensus posted in the question. I too would personally agree with the overall results of the study. Money is one of the driving forces for us to work hard and be successful so that we can provide a comfortable,…[Read more]

ap962 replied to the topic How to make good relation with vendors in the forum Project Management Application: Clinical Trial

Sun, 29 Apr 2018 00:36:36 -0400

To ensure a good relationship with vendors we need to keep the following points in mind:
1. Explain your business goals making sure the vendor understands your vision.
2. Pay your bills on time.
3. Assign a dedicated vendor manager.
4. Find out what the vendor needs from you.
5. When mistakes happen, don’t point fingers.
6. Refer a trusted v…[Read more]

ap962 replied to the topic Clinical Project Team Roles in the forum Project Management Application: Clinical Trial

Mon, 23 Apr 2018 01:23:38 -0400

ap962 replied to the topic Engineer vs. Manager in the forum Project Management Application: Clinical Trial

Mon, 23 Apr 2018 00:41:37 -0400

ap962 replied to the topic What’s Your Motivator? in the forum Project Management Application: Clinical Trial

Mon, 23 Apr 2018 00:29:02 -0400

What motivates me to work the hardest and put my best foot forward is my desire to learn new things. I work the hardest on a project and like doing everything from scratch because I love how much I learn along the way. The success that comes along with that gives me a sense of independence and accomplishment. Every little win counts toward…[Read more]

ap962 replied to the topic Six Sigma and Project Management in the forum Project Management Knowledge Areas

Mon, 16 Apr 2018 02:48:05 -0400

ap962 replied to the topic Designing effective Communication management Plan in the forum Project Management Knowledge Areas

Mon, 16 Apr 2018 01:33:27 -0400

ap962 replied to the topic QA vs QC in the forum Project Management Knowledge Areas

Mon, 16 Apr 2018 00:44:18 -0400

ap962 replied to the topic Sucess Factors in the forum Project Management Process and Medical Device Development

Mon, 02 Apr 2018 01:43:09 -0400

Each factor has its own contribution towards a successful project completion.
1)Agreeing on the project goals helps the team have a clear idea of what is expected of them, and sets unanimity amongst the team members.
2)Effective Communication is one of the most important factors in a successful project. Lack of communication can lead to…[Read more]

ap962 started the topic Closing Phase in the forum Project Management Process and Medical Device Development

Mon, 26 Mar 2018 02:21:17 -0400

The end of the Monitoring and Controlling Phase is marked by the Closing Phase. What are steps that need to be followed to ensure that phase is carried out effectively?

ap962 replied to the topic Post-project lessons learned in the forum Project Management Process and Medical Device Development

Mon, 26 Mar 2018 01:30:15 -0400

At the completion of my capstone project, the most important learning that I took away from it was the importance and significance of the Planning stage during a project. Though the project was completed in time, if we had deviced an effective Design Development Plan. This would have provided us with the oppurtunity to carry out more experiments…[Read more]

ap962 replied to the topic Design Transfer in the forum Project Management Process and Medical Device Development

Mon, 26 Mar 2018 00:54:14 -0400

ap962 replied to the topic Design validation in the forum Project Management Process and Medical Device Development

Mon, 12 Mar 2018 01:44:20 -0400

ap962 started the topic Project Execution in the forum Project Management Process and Medical Device Development

Mon, 12 Mar 2018 00:51:58 -0400

ap962 replied to the topic Points to look for while out sourcing in the forum Project Management Process and Medical Device Development

Mon, 12 Mar 2018 00:36:40 -0400

While selecting from a list of vendors the PM needs to keep a number of things in mind :
1. Legal and Regulatory Compliance of the vendor
2. Financial Condition of the company to make sure it can reach the projected goal.
3. Business Experience and Reputation
4. Qualifications, Backgrounds, and Reputations of Company Principals
5. Risk Management…[Read more]

ap962 replied to the topic Review of Combination products in the forum Project Management Process and Medical Device Development

Mon, 05 Mar 2018 01:53:42 -0500

I would further like to continue this topic by asking what types of marketing applications are required for a combination product?

ap962 replied to the topic Review of Combination products in the forum Project Management Process and Medical Device Development

Mon, 05 Mar 2018 01:50:06 -0500