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Christoph replied to the topic "Ideal project team" – 4 years, 2 months ago
@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»
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Christoph replied to the topic "Restrictions for physician's gifts" – 4 years, 3 months ago
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»
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Christoph replied to the topic "Consultants in the Medical Device Industry" – 4 years, 3 months ago
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»
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Christoph replied to the topic "NDA vs Patents" – 4 years, 3 months ago
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»
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Christoph replied to the topic "Matrix Organization- Conflict" – 4 years, 4 months ago
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»
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Christoph liked forum post "Matrix Organization- Conflict" – 4 years, 4 months ago
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Christoph replied to the topic "Medical Device Project" – 4 years, 4 months ago
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»
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Christoph replied to the topic "Organization Type vs. Effectiveness" – 4 years, 4 months ago
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»
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Christoph replied to the topic "Customer Needs and Design Input" – 4 years, 4 months ago
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»
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Christoph replied to the topic "What are Design Controls?" – 4 years, 4 months ago
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»
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Christoph replied to the topic "Clinical Studies" – 4 years, 5 months ago
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
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Christoph replied to the topic "Informed consent: What if Henrietta Lacks checked No for research use?" – 4 years, 5 months ago
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»
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Christoph replied to the topic "Double Blind Vs Single blind Study" – 4 years, 5 months ago
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»
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Christoph replied to the topic "Medical Device SWOT Analysis" – 4 years, 5 months ago
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»
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Christoph replied to the topic "WHAT IS MARKETING TO YOU?" – 4 years, 5 months ago
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»
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Christoph replied to the topic "Discussion Topic: Mission and Vision statements" – 4 years, 5 months ago
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»
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Christoph replied to the topic "LLC vs LLP" – 4 years, 5 months ago
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»
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Christoph replied to the topic "Emerging technologies and QA" – 4 years, 5 months ago
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»
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Christoph posted a new topic "510K is Nonsense" – 4 years, 6 months ago
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 on their own merits.This seem like… Read more»
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Christoph replied to the topic "Discussion Topic: Make a few, sell a few" – 4 years, 6 months ago
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»
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