Medical Device Courses | mt644 | Activity

mt644 replied to the topic "Transference of Risk in Medical Device Companies" -

Sun, 18 Feb 2024 18:24:17 -0500

To further add to the discussion, in cases where a medical device incorporates technology developed externally, technology transfer agreements can transfer the risks associated with the technology’s performance and intellectual property ownership to the originating entity. Also, collaborating with strategic… Read more»

mt644 replied to the topic "Making connections between people and schools" -

Sun, 18 Feb 2024 17:58:44 -0500

Hello everyone,
My name Mariya, and I am a Master’s student in BME department at NJIT.
Here is my LinkedIn page: https://www.linkedin.com/in/mariya58/
I look forward to connecting with you!

mt644 posted a new topic "PMI Talent triangle" -

Sun, 18 Feb 2024 17:54:09 -0500

Exploring the PMI triangle discussed in PMBOK Chapter 3, it raises the question of the significance of strategic and business management skills, coupled with leadership qualities, for a Project Manager. While technical and project management skills are essential, what is… Read more»

mt644 replied to the topic "Avoidance in each Project Area" -

Sun, 18 Feb 2024 16:49:20 -0500

I second to the fact that avoidance is easily incorporated in the product design phase due to multiple reasons, such as 1. During product design phase there are many changes to be made according to the practicality and feasibility of… Read more»

mt644 replied to the topic "PM Leadership Styles" -

Sun, 18 Feb 2024 00:09:27 -0500

I side with @afshinsadri, that the effectiveness of a leadership style depends on the nature of the project, team dynamics, and organizational culture, and project managers may need to adapt their leadership style based on these factors to achieve optimal… Read more»

mt644 replied to the topic "Initiating Medical Device Projects" -

Wed, 14 Feb 2024 20:36:15 -0500

The medical device industry, like any other, faces specific challenges during the project initiation phase. Some of the challenges and probable ways to address them that come to my mind are: – 1. Changes to project scope can happen due… Read more»

mt644 posted a new topic "Strategies for Conducting Effective Design Review Meetings" -

Sun, 04 Feb 2024 19:31:32 -0500

This week was focused on Project, Products and Organizations. Towards the end that is after Input, Verification, Validation and Transfer comes the Design Review Meetings. My questions is, as a project managers, what strategies and best practices do you find… Read more»

mt644 replied to the topic "Project Manager Experience" -

Sun, 04 Feb 2024 19:07:58 -0500

This an interesting and a wide topic of discussion. In my opinion as an Engineer, in the medical device industry, a project manager with an academic background, including basic science or advanced degrees like a PhD, offers valuable skills. Their… Read more»

mt644 replied to the topic "What are the significance of project sub plan in project management system ?" -

Sun, 04 Feb 2024 18:53:14 -0500

Within a Design and Development Plan (DDP), sub-planning planning involves breaking down the overall design and development process into discrete elements, each of which needs a customized strategy. For instance, within a software development project, specialized sub-plans may be created… Read more»

mt644 replied to the topic "What are challenges will we face if we missclassify a medical device ?" -

Sun, 28 Jan 2024 23:00:49 -0500

Misclassification of a medical device can harm the manufacturer’s reputation. Stakeholders, including healthcare providers and end users, rely on accurate information about device classification to make informed decisions. Misclassification may erode trust and confidence in the company’s products. Incorrect packaging… Read more»

mt644 replied to the topic "Difference between drug and medical device?" -

Sun, 28 Jan 2024 22:46:51 -0500

Additionally, the way that medications and medical equipment are administered differs significantly from one another. Usually, drugs are given by ingestion, injection, or inhalation, allowing them to circulate throughout the body via the bloodstream. On the other hand, medical devices are… Read more»

mt644 posted a new topic "Pre-market Approval (PMA) vs. 510(k" -

Sun, 28 Jan 2024 19:24:54 -0500

The FDA plays a pivotal role in ensuring the safety and efficacy of medical devices. Understanding and adhering to FDA regulations is not only a legal requirement but also a fundamental aspect of delivering high-quality healthcare solutions. This week was… Read more»

mt644 replied to the topic "How can industrial companies improve their quality through hospital medical management?"" -

Wed, 24 Jan 2024 15:41:43 -0500

According to W. Edwards Deming, the father of modern quality theory and the science of process management, higher quality outcomes eliminate waste/Healthcare waste (i.e., any consumption of resources that doesn’t optimally benefit the patient), and value is the best quality result… Read more»

mt644 replied to the topic "Project Management in the Biomedical Industry" -

Wed, 24 Jan 2024 15:41:42 -0500

As highlighted by @Zeinab Amoabediny development of medical devices is a complex process and also involves interdisciplinary collaborations such as engineering, design, regulatory affairs, and clinical experts. Interdisciplinary collaboration is a fundamental aspect of the medical device development process, and… Read more»

mt644 replied to the topic "PDCA cycle in Biomedical Engineering" -

Wed, 24 Jan 2024 15:41:41 -0500

In the PDCA process within the field of Biomedical Engineering, employees with different specialties are often involved in all stages of the cycle. The multidisciplinary nature of Biomedical Engineering projects requires collaboration among professionals with diverse expertise, including engineers, clinicians,… Read more»