In my line of work, I had extensive experience in the manufacturing and testing of high throughput, immunoassay, analytical instruments that are used in many hospitals around the world. Having this experience and knowledge, if I were to apply to Roche which is a rival company with a similar (yet inferior) instrument on the market, my Non-Compete…[Read more]

To add to the discussion about advice when signing an NDA, I would like to emphasize the point of fully understanding the magnitude of consequences that may be leveraged against you on the occasion that the agreement is broken. While I also believe some of the more common points like duration and responsibilities are important like hc255 had…[Read more]

When looking inward at myself and asking if I would be a better suited in upper management or middle management, I would say that it is a tough decision. However, I would have to choose upper management because I believe that I am more in tune with seeing the bigger picture and communicating to others our companies potential. I strongly believe…[Read more]

If I were charged with forming a project team, I would assemble a group of individuals with similar guidelines as aaq2 mentioned above valuing skills and abilities the most. However, it is important to note that I would also heavily emphasize (perhaps most of all) that my team I select individually know their place and responsibilities in the…[Read more]

In my current position, I believe it is mostly a functional-based organizational structure with minor aspects of matrix organizational structure. For the most part, there are supervisors (functional managers) of different departments. My direct supervisor has a lot of power when dictating what needs to get done and the timetable it needs to get…[Read more]

In general, I agree with the above comments that state that lower risks can mostly reasonably be managed by using the strategies acceptance and/ or mitigation. This makes sense because if it is relatively low risk, the consumer most likely will not experience any ill effects and excessive mitigation attempts could cause excessive funds to be spent…[Read more]

To add to what was said above by both Mark and amandaally1029 in the above comments, another factor to consider would be the “Availability of alternative treatments or diagnostics”. This is a critical factor to consider because it would not only directly affect the need for your product, but the likelihood of the FDA signing off on the pro…[Read more]

Adding to what was mentioned by amandaally1029 above after the risk analysis is completed in the FMECA technique; a critical decision must then be made by the heads of the company. That decision is: does this product’s risk outweigh the potential monetary gain that we hope to achieve though marketing the final design? This critical decision must b…[Read more]

In agreeance with Scott’s comment about the extent of the validation required, I have experience with similar guidelines in my position. Firstly, a standard is set for the immunoassay instrument to meet of the concentration of known analyte it is able to detect in its optimal operating state. Multiple R&D instruments are repeatedly built and t…[Read more]

Siemens Atellica Solution Immunoassay Analyzer:

The extensive verification process of the Immunoassay Analyzer’s generally consists of the instrument and laboratory diagnostic verification. In the instrument verification state, each subassembly must pass its designated test, confirming that it is working as an individual part, before being i…[Read more]

Adding to what myton said above, the process of verification also is generally an internal check to make sure the product follows its initial design specification. A good product will stay true to these original regulations, specifications, and regulations that were originally mandated in the development phase. In addition, the verification…[Read more]

In addition to the detailed outline of meeting minutes made by woolynn and others above, I would like to add that the minutes are not an exact transcription of what each individual had said in the meeting, rather a comprehensive summary of the main points that were discussed. It should, however, show ownership of major ideas and decisions made as…[Read more]

As many have said above Gantt charts are one way of organizing the timetable of mini projects that comprise the overall product. My experience in industry pertaining to Gantt charts involves working with the manufacturing supervisors to come up with a feasible time table for going from NPD to NPI with the diagnostic instrument. Because of the huge…[Read more]

After doing some research, I chose to pick an area where design controls were not in place. Within the African continent, only 7% of the 46 sub-Saharan countries had a regulatory policy, National Medicines Regulatory Authorities (NMRA), in place (2005). The rest of the countries in the continent have either minimal regulatory policy in place…[Read more]

It is my personal opinion that when a person consents (signs) to having an operation/ procedure done which results in the removal of an organ/ bodily fluid, the patient waives any rights/ ownership they had over the now extracted substance. This rejected organ/ substance is now an independent body that cannot be claimed by the patient, rather…[Read more]

In addition to the valid pros reshanm and ppp23 made, I would like to highlight that in a lot of cases, the patient volunteering to undergo clinical trials does not have to pay much (if any) out for their own pocket. It is true that insurance companies mostly will not pay for these experimental clinical trials, however, the organization itself…[Read more]

It is my belief that placebo controlled studies are necessary and ethical, yet should not be the “proof” that a drug/ medical-device combination is effective. This is due to the many curiosities that still surround the idea of a placebo and its potential to alter both the subject’s perception and physical wellbeing. Many underestimate the power…[Read more]

Siemens

Vision: A world of proven talent delivering breakthrough innovations giving our customers a unique competitive edge enabling societies to master their most vital challenges and creating sustainable value.

Mission: Within the scope of Siemens’ core activities, to find the best way of combining and developing our know-how and expertise, s…[Read more]

While some products hold firm to the traditional television commercials, there are a great deal that are utilizing different mediums of advertisement to market their product to their target audience. As mentioned by amandaally1209 above, some companies have already made the move towards exclusively social media promotion to reach a greater number…[Read more]

Recently, some of the more clever and effective ways I have seen a device/ product marketed is to have paired with a celebrity/ athlete that can make a personal connection. As Dr. Simon mentioned above, ads can now be blocked so companies are targeting the things people want to see on social media (their favorite athletes/ celebrities/ pages). For…[Read more]