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 evaluation in which representative production units are tested under actual or simulated use…[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 loop from post market surveillance (e.g. product complaints, complaint investigations,…[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 time to protect her an other patients in the same situation from cells being harvested without consent and…[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 and guidelines for Good Clinical Practices. This role stood out to me as it…[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 device/ combination product being studied. For example, a study in which the objective is to evaluate an implant will…[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 is a shift of practices. While physician…[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 important, although the benefits of going public and expanding revenue and increase workforce outweigh this shortcoming.…[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 LLC is the best hybrid structure that allows partners, shareholders, and/or owners to limit their personal liabilities while…[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 much stable with slight GPM deterioration between 2015 and 2016, but improved in 2017…[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 designing the product right. These departments focus on their role and at…[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 that these departments were not integrated and during ‘hand-off’ of the product from…[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 worked for a company that was under consent decree and lack of quality assurance was one of the issues that…[Read more]

I agree with srg36 that there is always the potential for unforeseeable risks that were not visible to the manufacturer or the FDA at the time of approval. Last month medical device maker Abbott voluntarily recalled 465,000 pacemakers to install a firmware update to patch cybersecurity vulnerabilities in the devices. The vulnerabilities could…[Read more]

There has been some updates to the 510(k) information in response to the IOM report to clarify that FDA includes in its 510(k) review the safety and effectiveness of the medical device, although no significant changes were made to the 510(k) process itself.

FDA has issued a memorandum (link below) in January clarifying that its review of the…[Read more]

Combination product: Insulin glargine pen injector

The pen injector is intended to deliver long-acting insulin used to tread adults with type 2 diabetes and adults and pediatric patients (children 6 years and older) with type 1 diabetes for control of high blood sugar. The PMOA is assigned to the insulin glargine and most recently been filed with…[Read more]

Assessing the material biocompatibility of the product (including the material of construction and final device) is critical for successful commercialization. The tests should follow ISO 10993 and type of tests will depend on application and exposure. For example, for an implant device in contact with tissue/bone it will require cytotoxicity,…[Read more]

There is a great rewarding feeling when a product realization you worked on reaches hands of people including closed ones and help them live a better life. Both long and short term research are important and necessary. Long term research would usually strive to solve problem(s) that require technological and/or science innovation; methods,…[Read more]

Research in the industry is generally faster and tend to be more successful. I would attribute many factors to the difference in performing research in the industry vs. academia. As per the lecture notes, the main reason for research in industry is money, therefore there are more funds being invested to drive research and results. Another…[Read more]

In my experience, I have encountered two project managers in a project. The project managers responsibilities were split; one was responsible for overseeing development activities at suppliers and the other development activities at our company. This approach was successful and I believe the main reason is because their responsibilities were well…[Read more]

Portfolio is composed of all the programs that the company has and programs are composed of projects which in turn are composed of tasks as described in this week’s lecture. Companies make strategic choices in which activities to implement in order to deliver their vision. The grouping of programs into portfolios facilitate their management.…[Read more]