This is a good point you bring up, however I do not fully agree with the skepticism disconnect in how the industry rewards motivation. While this is definitely an issue within any industry, based off my experience it is in…   Read more»

For many companies, particularly the smaller ones engaged in clinical trials, outsourcing might not be so much a choice, but a necessity. As we know, clinical trials can be often very complex projects and it isn’t often feasible to conduct…   Read more»

When identifying project priorities it is important to keep in mind some guidelines that can help balance these priorities within the project scope. Before funding a product design project, priorities must be studied, particularly in the case of medical devices….   Read more»

What motivates me is the desire to make products for those less fortunate and to know that I have made a positive difference in someone’s quality of life. An example is my current job in which I am part of…   Read more»

Studies show that Americans work longer hours and have more stress-related illness than their European and Japanese counterparts. Some of this is due to stagnant wages and outdated overtime laws, but some of the problem is embedded into, particularly in…   Read more»

In order to prepare a schedule and budget for a clinical trial there are several factors to consider. The schedule of clinical trials is basically an outline that contains all the activities that will be performed during the clinical trial….   Read more»

QA/QC is the combination of quality assurance, the process or set of processes used to measure and assure the quality of a product, and quality control, the process of ensuring products and services meet consumer expectations. Quality assurance is process…   Read more»

The Six Sigma methodology offers a structured and disciplined process for solving business problems and ensuring product/processes are within acceptable margins of error. Six Sigma uses tools designed to identify root causes for the defects in processes that keep an…   Read more»

Adding to previous posts, one other factor to consider are the regulations about supplier selection and management in 21 CFR 830.50. FDA scrutiny on supplier selection, criteria used, and more importantly how sponsors control their supplier has increased in the…   Read more»

Design verification means confirming by objective evidence (i.e. testing) that the design outputs meet design inputs. Design Verification is one of the most important activities in the development phase of a medical device. It is a rigid rule as there…   Read more»

I agree with previous posts to contact the vendor to identify the problem and a solution. However, this is not an unusual issue and typically the way that companies control these problems is by establishing specifications for which the vendor…   Read more»

There are many factors that can affect schedule variance (SV) such change requests, issues with suppliers of materials/ components to mention a couple. These factors can impact in the timeline of a project and increase project spending. For all problems…   Read more»

The different kinds of changes, as mentioned in previous posts, are Non-Essential Design Change (NDC), Design Change Number, and Engineering Change Order. Each one of these carry a workload in order to implement the change. All of them require following…   Read more»

It will be prudent to include buffers in the project plan to account to the unexpected. This is a practice in two companies I have worked for developing medical devices and combination products. I always include buffers in my timeline…   Read more»

Change control is another well-know concept that focuses on managing change to prevent unintended consequences. The regulations provide for change control primarily through the assigned responsibilities of the quality control unit. Certain major manufacturing changes (e.g., changes that alter specifications,…   Read more»

Echoing several responses above, the PM has many important responsibilities. However, I believe that these responsibilities would not be as challenging as communicating effectively amongst all department/ functional areas working together on the project. There needs to be a great…   Read more»

This type of scenario was part of the mini-sim this week in which we were asked to deal with delays in timeline which happened due to incorrect task duration. Creation of WBS and task duration is a critical activity that…   Read more»

One of approaches to take would be to look “easy” fixes first (e.g. improve packaging configuration first, then propose modifications to the device, then propose modifications to the combination product) so we can try to identify the root cause, followed…   Read more»

Risk/ Benefit Ratio is an assessment of the risks against their benefit. Ideally the benefit has to outweigh risks in order for the company to accept the risk. Typically, risk analysis has a qualitative component and the result feeds into…   Read more»

A successful project will include risk management as part of planning phase. As stated by the professor, “if you fail to plan, plan to fail”. Risk management will help the company anticipate issues/ problems and identify mitigations ahead of time…   Read more»