The product I chosen for SWOT analysis is the LIFEPAK automatic electrical defibrillator product series manufactured by Physio-Control, recently acquired by Stryker. Physio-Control reported $503 mill...

Assessing marketing is a new exercise for me. Prior to taking this course my perspective of marketing was its role was limited to conveying company information to potential customers. But this weeks l...

I looked at the vision/mission statements the following medical device companies: Siemens-Healthineers, Medtronic, Abbott, Beckman-Coulter, and Stryker. What they all have in common is a recognition t...

A comparison of LLC versus LLP related to management, taxation, liability can be used to illustrate their difference as follows. Regarding management LLC may be management is not limited to members. ...

Quality Assurance can be made more efficient and accurate by emerging technologies by facilitating more traceability in the methods used to produce medical devices RFID in the supply chain, Computer a...

To a layman, a surperficial assessment of 510K process is that it is nonsensical.WHY are devices being compared to devices created 40 years ago.This makes no sense to me. Why arent the just assessed o...

This is a great question.From reading the FDA regulatory articles provided the main concern of any medical device is two things1) Is it safe, 2) Is it effective.From business startup prospective I thi...

So there is actually a long list of medical device recall that have occured this year alone.What is very interesting is I did not realize there was a public listing available of all such devices acces...

An example of an FDA approved medical device using a mobile app is shown here The article sites efficacy statistics but not safety since there are no safety risks associated with this app. Here is a ...

Is animal testing ethical? are there any alternatives?This question arises in the context of preclinical testing. What then is the purpose of preclinical testing?It is testing that is done in an attem...

Is missing a milestone a failure or success for the overall project? My first answer to this question is it depends on the consequences resulting from missing the milestone. Multiple factors need to b...

My opinion is that the planning phase is the most important. The planning phase establishes the "what by when". It defines what deliverables are expected when. During the planing phase resources are a...

Academics is academics. Industry is industry.Definitely there is a practical learning curve to be traversed when one leaves academia and enters industry.The 7/10 ratio works well. Coops and internship...

My advice is volunteer at a hospital, listen to podcast about medical devices and attend trade shows I think the most important advice is to take an inventory of your objectives and your skills.Then...