I believe no matter how flawless a medical device design and manufacturing process is, there is still potential for users to be harmed (e.g. use error). That said, the manufacturer is responsible for understanding all risks related to the medical device and controlling those risks (reducing them as far as possible) within an acceptable level. With…[Read more]

Verification and validation are distinct, but related activities that combined demonstrate through objective evidence that the medical device meets the design requirements defined and the medical device meets user needs and intended use. Before talking about timing of V&V, it is important to differentiate between PROCESS validation and DESIGN…[Read more]

I agree with what was said in previous posts about regulatory compliance challenges, but I also think these challenges will only increase at least for the next 10-20 years. Given the EU Medical Device Regulations (MDR) 2017/745 that will take effect in mid-2020, EU is now driving the requirements for Medical Devices in my opinion, and it will not…[Read more]

The beginning of a project can be the calm before the storm or an insane rush to get things sorted and ready for the main project team work to start. As per PMBOK, the project is composed of five process groups/ phases: initiating, planning, executing, monitoring and controlling, and closing. The beginning of a project is critical for its future…[Read more]

Using a similar but different example, birth control implants are also combination products. The implant is a tiny, thin rod about the size of a matchstick. A doctor inserts the implant under the skin of the user’s upper arm. It releases the hormone progestin to stop the user from getting pregnant. In this case the implant is made of ethylene v…[Read more]

A project manager requires many skills in order to succeed. There is no one sole skill that will allow the project manager to be successful. As emphasized in the PMBOK, effective project managers require a balance of technical, interpersonal, and conceptual skills that help them analyze situations and interact appropriately. In addition the…[Read more]

The experience I have comes from working within a device development group in a big pharma company organized in a project based environment. The organization structure is based on teams with specific goals. Main business goals for big pharm companies is to develop drugs so most of the medical devices I was involved in working on were part of…[Read more]

The beginning of a project is critical to the program as it is when objectives, scope, purpose, and deliverables to be produced are defined. Early in the program there can be a lot of unknowns especially if the project involves developing novel medical devices. It takes time and expertise from subject matter experts from multiple areas to define…[Read more]

The NDA is a great mechanism to protect the company during partner ventures, but not a substitute for a patent. For example, you find out that company ABC (to whom you never told your idea), has put out the same idea that you had. You cannot prove how they found out about your idea, but it does not matter. If a patent is in place and it is clear…[Read more]

The gift restrictions are established by the Sunshine Act that came into effect in 2010 and it required companies such as pharmaceutical and medical device, including durable medical equipment suppliers, to report gifts above $25. While I understand the perspective of the post initiator, I believe that the restrictions are crucial to create a fair…[Read more]

I really enjoyed this course. The course is well structured and provides pretty good insight of the device development process and design controls. As a professional with multiple years in the pharma-med dev. industry I have learned from this course and find it to be an invaluable course. I particularly enjoyed the final project structure in which…[Read more]

In addition to the examples mentioned in previous posts, Olympus Corp. of Americas (OCA), the United States’s largest distributor of endoscopes and related medical equipment, will pay 623.2 million to resolve criminal charges and civil claims relating to a scheme to pay kickbacks to doctors and hospitals. The criminal complaint against OCA, which…[Read more]

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, I have seen monthly meetings where teams provide updates on projects and their issues and/or share…[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 work together as a team and always focus on what is in the best for the company overall. With that said, project managers play a key role in…[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 that work with functional area r…[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 process are:

Establish a risk management plan (RMP): the plan will define upfront the process (during development…[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; the risk analysis related to design would include engineers involved in the design of the device to identify ways…[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 whether the risks are acceptable in exchange for a probable benefit. As mentioned in the…[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, etc. In my experience, regulatory agencies do not ask for the DHF…[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 products which could translate to product failures…[Read more]