Organizational type depends on the goals of the company. Larger companies with multiple product lines and established brands would benefit from a matrix organization. In this situation the main advantage is the information flow between departments and knowledge transfer between projects. This is key with larger companies, since the large amount of…[Read more]

I agree with Ginger that it would be ideal to work with people are knowledgeable and easy to collaborate with. In my current role as a Process Engineer I work in a matrix organization and have to deal with many different departments internally along with contract manufacturers both in the US and internationally. For the most part everyone is…[Read more]

My current role is that of process engineer at my company, within the manufacturing and science technology division. During this phase of the products life cycle we have to assess risks that arise from global investigations usually related to user complaint rates. So far I have been a part of 2 global investigations that are launched and initially…[Read more]

The best strategy in running risk management meetings is to ensure understanding of the device. A basic understanding of the device components, it’s functionality, and how the end user will be utilizing the device are all key in recognizing risks associated with the device. From the initial meeting onward a running list of potential risks should…[Read more]

I agree with aaq2 in respect to mitigation being the best strategy for countering high severity risk. I do not agree with the fact that risk acceptance is wise option based off cost of acceptance being less than the cost of mitigation. Perhaps in the short term the cost of mitigation may be greater compared to risk acceptance, however in the…[Read more]

I agree with dbonanno1 that you can rationalize failures during the verification process. For example, at work we have a new combination product releasing and I was part of the team conducting verification shipping study. As a precautionary action in the verification protocol that was drafted we put in that any breakage to packaging would not need…[Read more]

A successful validation process will ensure that each requirement for a use is fulfilled, essentially end user needs are met. An important aspect of a validation plan is knowing your target customer/end user so that you can confirm that the needs they have are met. In addition to this there are multi functional teams that are responsible for the…[Read more]

As mentioned in previous posts design verification is an important step in design control process to ensure that the inputs are equal to the design outputs. Verification is an important step as the testing done during verification can satisfy both regulatory requirements and end user requirements ensuring a safe and effective product. One…[Read more]

Ensuring that your DHF is constantly updated is the best practice in ensuring that it will have all the necessary documents during an audit. As discussed in the past 2 weeks of class the DHF is a living document and as such everyone involved on the team should have access in editing and updating the document in order to ensure proper inputs. The…[Read more]

Insufficient design controls will result in a loss for the company. The loss will occur first off by the product not making it to market and this will result in a trickle down effect. As the time, money, and energy focused into the product will be a waste and the company will most likely have to make cutbacks and perhaps, depending on the scale of…[Read more]

Since the DHF is important for both informative purposes and audit it is essential that the file maintain accurate information as a “living document”. The best step towards this is having a dedicated team in the product development phase assigned this task. In larger companies the roles that employees have are multi-purpose and there are dedicated…[Read more]

Design controls are mandated by the FDA according to 21 CFR (Code of Federal Regulations) towards medical device manufacturers. They are guidelines that help to ensure a proper quality device is created and provide checks and balances for the manufacturer. Primary application of design controls is during the product development phase as they…[Read more]

Placebos have been viewed as a necessary process in bolstering scientific proof on the effectiveness of products and evidence that one product is superior to another, within many industries. Personally I believe that placebos are necessary in order to gain the most input on a product, however it is an ethical grey area in which many pros and cons…[Read more]

In my opinion double blind studies are more accurate as it sets a reliable baseline for the trial. As an example from the lecture would be the double blind multi-center study. In this example Dr. Simon shows that a doctor’s competence affected the study and since it was a multi-center study and double blind you can prove that the baselines were…[Read more]

Having clinical trial experience is definitely advantageous in the medical device field as you encounter problems that may not have been thought about during the design of the product, and gives good insight into human factors of the product. After completing my BS degree I actually worked at a pain management clinic as a clinical research…[Read more]

There are multiple strategies that medical device companies utilize to roll out their devices. Medical device companies utilize strategies that are focused on marketing products towards medical professionals and utilizing academic and medical conferences in order to spread the word on their device. Research papers, clinical trials, and independent…[Read more]

One grand strategy that is frequently used in medical devices and technology companies is product development. Product development deals with the company investing heavily in research and development in order to launch new and innovative products to market. The overall strategy of investing heavily into R&D provides a competitive advantage to the…[Read more]

Interesting video with of course an exaggerated view but definitely touches on a lot of the concepts discussed in this weeks topic. Due to the lack of technical expertise each department was not able to focus in on the problem and would instead make more suggestions that complicated the task more and more. With each discussion instead of coming…[Read more]

Netflix financials and state of company.

P/E ratio: 244.39
Gross Margin: 31.72
Operating Margin: 4.3
ROI: 3.49
Revenue: 8.83 Billion
Market Cap: 86.13 Billion
Share Price: $199.49
EPS: 0.15 vs 0.16 expected (July 2017)

From these financials it is clear from the P/E ratio and the projected growth of the stock that the company is in a rampant…[Read more]

Public vs Private companies, the largest difference between the two is that private companies are not publicly traded, while public companies have shares traded on exchange funds available to the public. The main reason a company chooses to go public is to raise capital in order to continue to grow and expand the company. The pro behind the move…[Read more]