@jvv6What skills would you mainly prefer if you had to build a project team.A team having the set of technical expertise for the project at hand is a must.However, I think a few added skills that would be very useful…   Read more»

No there is nothing that should be done about this. General attitude being conveyed is that gifts are not to be used to unduly influence healthcare providers in their decisions. Regarding the lack of inclusion of spouses meals, i think…   Read more»

When a company is engaged in building a medical device, the company may not have all the areas of expertise hired as employees. Resource of a domain expert may or may not be required on a long term basis. This…   Read more»

An NDA is definitely not a substitute for a patent.1. The scope of  a NDA’s application is limited to the  two parties explicitly included in the NDA. A patents scope of  protection implicitly includes any party or person within the…   Read more»

Wonderful question. I work in a matrix organization. Interestingly, it was originally more of a functional organization. But in an attempt to be more effective in addressing project needs a decision was made to transition more toward a project based…   Read more»

We had our first in person meeting two fridays ago. We spent most of the meeting defining relevant requirement for the DID. It was a fun collaborative experience. I have worked in the industry for some time but it was…   Read more»

In my opinion the best organization structure is the matrix.It provides the best balance between maximizing human resources utilization and role specific development via representation at the a the role specific department manager  level.I think it offers also a better…   Read more»

Definitely in agreement with much of what has been said.Two ideas put forward so far best capture the contrast between the DID and DSD.The idea that they are each for different audience, and the idea that the DID represent a…   Read more»

There has been much offered so far to answer the question “What are Design Controls”.Working at a medical device company fory  several years i would like to offer what i observed from my experience. Not necessarily a definitive answer but…   Read more»

There is no complete correspondence between animal testing and humans.Doing tests on tissue apart from a live person is not always possible.So there is no way to get conclusive results wi

I think consent should by all means be secured from patient prior to using materials or data from patients. It is crucial people and therefore patient have complete control over being. At the core of slavery of African for several…   Read more»

A double blind study help to eliminate bias of doctors participating. It is within the realm possibility to have a doctor whom may be willing to influence a study out come for monetary gain. The doctor could have accessed to…   Read more»

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 $503 million in sales in fiscal 2015,680 million US$ in 2019,STRENGTHPhysio-Control Strength makes several models of automatic…   Read more»

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 lecture taught me that marketing includes the role…   Read more»

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 that they are assisting heath care provider to help care for patient health.  The…   Read more»

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. While for a LLP management is limited to members.Regarding…   Read more»

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 aided selection test for validation. After market tracking of device…   Read more»

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 think the challenges is to assess if there…   Read more»