Posted by: @orleron Well, you did it! You made it to the end of Medical Device Development. The original intent of this course was to teach you what professionals in the medical device field do in the real world if…   Read more»

Posted by: @kbs27 Hi all, In the video lecture Dr.Simon mentioned about two terms of contract,Written & Verbal agreement. He said that verbal contract can be legal but what if the due to dispute or other reason the verbal agreement…   Read more»

Posted by: @amd29 Quite recently Dr. Simon organized us into project teams. And strangely, I became a part of one before I knew it. The approach of forming the team was weird.Personally, after experiencing with the Functional Organizational type in…   Read more»

A Risk Management File (RMF) is where you keep risk management activities, documentation, and records. A Risk Management File contains proof of Risk Management Plan. Hazard Analysis, Hazard Evaluation. “set of records and other documents that are produced by risk management”….   Read more»

Posted by: @lmathis When dealing with risk, in what instances would it be okay to accept the risk in medical device development? Is it worth accepting?  I would say anything with pointy or sharp ends, electricity, or ventilators, etc. All…   Read more»

Posted by: @fgk4 The ISO 14971:2012 “Risk management for medical devices” requires manufacturers to reduce risk As Far As Possible without any economical consideration. I consider this a huge Conundrum for all medical device manufacturers. It is a gray area…   Read more»

Posted by: @tulikadasp Product development is inherently an evolutionary process. While change is a healthy and necessary part of product development, quality can only be maintained if those changes are controlled and documented. Design control involves establishing procedures to identify,…   Read more»

Posted by: @smk45 While watching this week’s lecture on design control, I tried to figure out the main difference between Design Verification and Design Validation. Both are used to make sure that the design outputs align with the design inputs….   Read more»

Posted by: @hg93 “Design Controls” is a FDA term and defined in FDA 21 CFR 820.30. Design Controls are an integrated set of management practices (policies, processes and procedures) which are applied to control design activities while assessing quality and…   Read more»

Posted by: @jr377 This year, the Right to Try act was signed into federal law. This law allows patients to request the use of investigational drugs (without FDA involvement or state law). There was a current “compassionate use” framework, but…   Read more»

Posted by: @savery115 Clinical trials and research is designed to expose a limited sample of subjects to potential new treatments. Human tests of a medical intervention typically pose risk to subjects despite the amount of laboratory and pre-clinical trails conducted…   Read more»

Posted by: @mejefferson During the current pandemic, there are over 100 vaccines being tested on humans worldwide. The average human today is a subject for a vaccine. Do you think that different vaccines may work on different people due to…   Read more»

Posted by: @jailynp26 YES! research market is needed because it can show you what people are interested in at that time. It can show what is missing from the scenes was well. Focusing on what people are buying and creating…   Read more»

Posted by: @sahitya-sadineni After watching the videos from this week’s lecture, we have learned about the various company types. While thinking about this, would you consider turning down a position based on the type of company it is? For me…   Read more»

Posted by: @sahitya-sadineni In my personal opinion, partnerships and sole proprietorship are very similar but with lower risk when investing due to the split of initial costs for partnerships. Partnership sounds amazing for whenever two people share the same objectives…   Read more»

Posted by: @manolo In week one, Dr. Simon went over different aspects of working in Academia vs Industry. He asked us to make an argument for working in either option. As we start going into each role of Medical Device…   Read more»

Posted by: @bb254 Based on this week’s lecture there are numerous differences on how research is approached in an academia compared to industry. Name two ways that research is approached in academia versus industry. Out of the two approaches which…   Read more»

Posted by: @hm243 In industry, research is done to make discoveries for products that can help people right away, while in academia, research create results for the long run. I feel that both types of research are important and necessary….   Read more»

Posted by: @hm243 In industry, research is done to make discoveries for products that can help people right away, while in academia, research create results for the long run. I feel that both types of research are important and necessary….   Read more»

Posted by: @sahitya-sadineni Precision and accuracy are very important to the scientific field. Accuracy is how close the value is to a standard while precision refers to how close the values are. What roles do precision and accuracy play into…   Read more»