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»

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!
 

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»

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»

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»

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»

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»

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»

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»

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»

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»

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»