I believe that teams should be empowered to make decisions and this is critical for product development to be effective and efficient. I agree with the previous post from srg36 that interdepartmental team building events can help. From my experience,…   Read more»

I agree with all previous responses that pointed out best practices to form a good project team. From my experience, we do not get to choose who we will work with so we have to be professionals and learn to…   Read more»

Companies structured based on functional, project, and matrix organization have their individual advantages and disadvantages, as discussed during this week’s lecture. I work in a hybrid organization that utilizes functional and matrix structure. The hybrid organizational approach uses project managers…   Read more»

ISO 14971 is the standard well recognized by FDA and other regulatory agencies around the world for Risk Management. Some of the key aspects required to comply with ISO 14971 and therefore to be considered to have a risk management…   Read more»

To add to previous posts on this forum, an approach I have seen is to breakdown risk analysis in three parts; design, manufacturing, and use of finished product. These analyses may involve experts from each area of focus, for example;…   Read more»

To add to other posts on this forum, another factor to consider during benefit-risk analysis is patient perspectives. If the risks are identifiable and definable, risk tolerance will vary among patients, and this will affect individual patient decisions as to…   Read more»

Just to clarify, the term audit is used when an internal company department performs evaluation of the company procedures, processes, facilities, etc. whereas inspection is when a regulatory agency visits a company to review the company documents, processes, procedures, facilities,…   Read more»

Appropriate procedures for design controls is a critical requirement of 21 CFR 820.30 to ensure the product development follows a systematic approach while documenting the decisions made along the way. Insufficient/ Inappropriate design control procedures will result in inconsistency developing…   Read more»

Design validation ensures that the device conforms to defined user needs and intended use(s). While some design validation can be done through “bench testing” most likely if the device requires user interface it will be essential to perform human factors…   Read more»

Risk analysis is part of Design Control System and one of the aspects regulatory agencies look for is the integration of risk management to complaint handling. Establishing a risk management file is critical and more importantly is establishing a feedback…   Read more»

While I understand the importance of Henrietta’s harvested cells brought to advancement of research and benefits to society, I believe her cells were taken without her consent. Her rights were violated, but there were few laws in place at the…   Read more»

If I was involved in a clinical trial I would like to support the study as clinical investigator. As others fellow students alluded to the clinical investigator’s primary responsibility is to ensure the research expectations are met including regulatory requirements…   Read more»

Clinical background is not required for all functional roles in a clinical study as stated by many in previous posts, although I think it is critical to have experts with clinical background in the study depending on the type of…   Read more»

One approach currently used by medical device companies is to showcase their products during medical device conferences/ summits/ expos that are attended by physicians, other technology companies, patients, etc. Although with empowering customers being online and performing health-related research, there…   Read more»

A medical device company of mid-size with 50 people and $10 million in revenue should exist as “Inc.” as opposed to “LLC”. As stated previously by others in the forum, there is a drawback of double taxation which can be…   Read more»

The legal structure is one of the most important decisions in the start up process. The choice will depend on the best advantages that a structure provides based on the company needs, risks, and ability to grow. I think the…   Read more»

I did some research on Medtronic, these are my findings: Gross Profit Margin = indicates the percentage of revenue available to cover operating and other expenditures: 0.6873 (2017), 0.6829 (2016), 0.6886 (2015). For last three years this ration stayed pretty…   Read more»

I believe that conflicts between R&D and Quality departments can be significantly reduced if both functions understand their role. For example, the R&D department considers itself responsible for quality of the product and the Quality department feels equally responsible for…   Read more»

One of the issues that I experienced is how the quality organization of a company was structured. There was a quality department designated to support development (R&D) products and another quality department designated to support marketed products. The issue was…   Read more»

The complain that Quality is a burden must come from people that do not understand the history of manufacturing mistakes that resulted in products that put people’s lives at risk and intricacy processes of ensuring quality of the product. I…   Read more»