Dr. Simon, I appreciate the material that you are teaching in this class as it is extremely applicable to the industry. This course has allowed be to expand my knowledge in my current position and has allowed me to use…   Read more»

False Claims Act violations can result in the following: • Damages penalty triples the amount of money defrauded from the government • Claim penalties from $11,000 – $22,000 for each claim that violates the False Claims Act Anti-kickback Status (AKS)…   Read more»

Currently, I work in a Matrix Organization which is project-based, where there is a representative per functional group that is responsible for successfully moving the project through the developmental phases and creating the documents required for the DHF. Each project…   Read more»

I am surprised to hear as well that instructions for use (IFU) and labels are deemed as the least effective way to solve residual risk since the amount of effort that is taken to ensure the content on the packaging…   Read more»

As hc225 mentioned, from experience in the industry, AQL levels are in place for the critical dimensions from the technical drawings of the product. Quality Control (QC) measures are conducted for every batch of product. As I have experienced with…   Read more»

Hello, I have recently participated in a Medical Device Single Audit Program (MDSAP) audit and am currently preparing for the second part of the same audit within the end of this year. MDSAP is a single audit for medical devices…   Read more»

Hello, General consequences of insufficient design controls: • Design not meeting the needs or wants of the intended market/customer • Faulty product in the market requiring replacements • Product having a negative ROI • Product success = company reputation; potentially…   Read more»

Hello, I have some experience developing Gantt charts through my undergraduate program and through industrial experience. From my perspective, some important factors before starting the Gantt chart are as follows: • Define generic key milestones of the project • Identify…   Read more»

As a Project Coordinator who takes the meeting minutes from each meeting, I agree with Dr. Simon’s push on the importance of taking meeting minutes. Meeting minutes captures the discussions of the meetings with the program team – allowing those…   Read more»

Through my experience working as a Project Coordinator in the medical industry, I have encountered a two verification tests that didn’t meet the design requirements that were in place for that product. We were verifying a modification of an existing…   Read more»

Guidance for Clinical Trial Sponsors: https://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm127073.pdf I would select to be a sponsor for clinical research because they are responsible for initiating the clinical investigation, documenting the research, and submitting the IDE with Regulatory. Sponsors are Medical/Clinical subject matter…[Read more]

Marketing research indicates that approximately 80% of visual information is based on color and a person can only keep 3-4 pieces of information stored in short term memory at one time. A lot of time, money, and effort is placed…   Read more»

From experience in the industry, the company’s Marketing lead for that project will reach out to their sales team in each region or country and have initial discussions to understand the markets needs, wants, and anticipated interest in the product…   Read more»

Marketing is having the ability to understand the customer’s needs and wants and utilizing those specific tenders into design inputs and marketing outputs. Sales is understanding the design outputs and communicating them as benefits that will meet the customers’ needs…   Read more»

Private companies, in my opinion, have more of a small business feel even though they can be very large in size. They have a small number of owners, they are not traded publicly, yet the shares are amongst its employees….   Read more»

I think when a company is selecting between corporation (Inc) or limited liability company (LLC), it needs to weigh the pros and cons against the company’s overall mission. If a mid-size company with 50 people and $10 million in revenue…   Read more»

The company’s SOPs in Quality Control (QC) should ensure meeting all regulatory requirements for their medical products, and should include preventative actions to ensure avoidance of receiving a Form 483. An assumption of mine would be perhaps the company is…   Read more»

I definitely agree with your response alexandrabuga. From a global standpoint, both 21 CFR 820 and ISO 13485 are guidelines for medical device companies to use for not only documenting, but ensuring procedures for controlling quality are in place and…   Read more»

I have participated in 1 unannounced FDA audit and 1 MDSAP mock audit in the medical industry before. Prior to each audit, there are a series of training sessions for audit preparation that is mandatory for those who will be…   Read more»

Like any other project, the Project Manager is fully involved in pre-clinical studies. PMs are involved in the preparation of the business case and need for the study, developing the schedule, budget, and coordinating the team through each stage (planning,…   Read more»