As a project manager, I would prefer a cast of members that have a broad range of skills that all gets tied together through an underlying skill that would be prioritized as the most essential and foundational skill for the…   Read more»

In the company that I work at, we used project management software to track different timelines and projects all at once. It is organized through various parent and child tabs, with each parent tab being a major part of the…   Read more»

I think that these review meetings need to be adequately prepared beforehand, both in terms of document organization and the relevant document trail that might be associated with it, in order to be considered effective and useful. If the meeting…   Read more»

In my opinion, project managers with diverse backgrounds offer unique strengths that can greatly benefit project teams. Those with academic-focused backgrounds can bring strong analytical skills from their rigorous research and critical thinking methodologies which would help in risk assessment…   Read more»

1. Drug has chemical reaction and medical device do not have chemical reaction.  any other differences ?   Well, there are alot of differences between a drug and a medical device, both in application and definition. By definition, a medicinal…   Read more»

Personally, I think company culture is a major aspect of any company, but especially a medical device company, to fuel talent retention and attraction. It is important for any company to make their talent feel welcomed, productive, useful, and rewarded…   Read more»

If there is an idea that has the potential to be an extremely profitable or life-changing device, then money should never be a concern. One reason is that there are many routes, as a business, for you to be able…   Read more»

In a general sense, a good project team should include a couple different types of individuals, including subject matter experts (SMEs) that may handle a more specialized technical role like advanced programming or mechanics-related issues, as well as more versatile…   Read more»

Personally, I think that the team makeup should be dependent on the project type and objective. In terms of a multi-perspective project like the development or invention of a new product, working with teams that are filled with individuals with…   Read more»

Like many of the commentators here, emotional intelligence, or atleast the acknowledgment of some degree of emotional understanding, has some link to a personality type. Some personality types may be more inclined to reach out and communicate when things are…   Read more»

Kickbacks are a truly frightening example of corruption and illegal preference because it blurs the line of authenticity and faithfulness of a free making decision that is for the best rather than being under the influence. My first exposure to…   Read more»

My dad had gone through this issue during the 2008 financial crisis, so I am familiar with this experience. In his case, him and his coworkers had exceptional leverage with his company to negotiate the severance package which includes pay,…   Read more»

Non-compete agreements typically barr you from working with a competitor on a similar product that you had previously worked on. In my experience, it was not an umbrella restriction that prevented you from moving into a job that was in…   Read more»

I prefer the hierarchal organizational structure because it provides clear and coherent structure of what the leadership and continuity of reporting is. My opinion is based on my own experiences, having worked in only hierarchal-structure organized companies and it was…   Read more»

There are a wide variety of organizational structures, each serving its own benefits and cons that suits their own respective business goals and objectives. Therefore in my opinion, there is no “best organizational structure” that every corporation should follow.  …   Read more»

Speaking from Nov. 2023, the specifications for Prof. Simon’s final project have remained relatively the same. Currently, my team is still in the drafting phase, working to find resources and develop our own individual department assignments based on our team’s…   Read more»

I think the term is meant to signify the balance between reducing risks as much as cost effectively possible for that medical device. The transition from ALARP to AFAP suggests that there is more emphasis on reducing risk as much…   Read more»

In the medical device industry, risk management is critical to ensuring patient’s safety and regulatory compliancy of both federal and international governments. Throughout the device’s life cycle, possible risks must be identified, analyzed, and evaluated as part of a systematic…   Read more»

Going based off the forum post title question, I think that it is absolutely essential for the medical devices to have risk assessments. Firstly, medical devices and alike are often the frontline treatment for many medical and health issues, which…   Read more»

Whether or not a company has good ethical responsibility to put out a good, safe product, they are upmost certainly minded with some sort of fiscal responsibility to make a profit. So they certainly have a motivation to put out…   Read more»