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 what I have learned in this class directly in the industry. Thank you for educating not only myself, but my peers in medical…[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) violations can result in the following:
• Criminal penalties include fines up to $25,000 and 5 yea…[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 is assigned a project team, where there is a selected global program lead,…[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 and labeling meets regulatory requirements. Regulatory and quality are heavily involved in the artwork approval process for 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 a Class I medical product in the US, but a Class II medical product in EU, sample size per QC test is…[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 that covers regulatory requirements for the US, Canada, Brazil, Australia, and Japan.

For more information:…[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 harm the company’s identity
• Product providing misundersta…[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 target dates for the key milestones
• Define functional groups that will…[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 who are absent to catch up on what they missed and to record any decisions that are made in the mee…[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 product, so there was hesitance in changing the specifications from the original product that a…[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…[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 into choosing colors for a new medical product since the color needs to attract attention and inform efficiently. In the…[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 before the developing stages begin. This is where I would agree with yze3’s point of view where mar…[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 and wants to sell the products.
Both Sales and Marketing require com…[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. Public companies can be traded publicly and must report their financial data quarterly, so in my opinion they will receive more…[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 wants to expand globally, then I would agree with bb254 and several of my other classmates, where selecting to b…[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 new to the industry and is still developing its quality procedures, or from the other s…[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 the medical device or in-vitro diagnostic (IVD) are complaint with regulations. With the use of…[Read more]