Proactively planning your resource and talent usage accurately is key. It’s important to stick to the initial plan and not take up change requests during project execution as this can result in delays and added costs. Project managers often rely on various collaborative…   Read more»

A project organization is a structure that facilitates the coordination and implementation of project activities. It creates an environment that fosters interactions among the team members with a minimum amount of disruptions, overlaps and conflict.The way your organization is structured…   Read more»

 A project organization is a structure that facilitates the coordination and implementation of project activities. It creates an environment that fosters interactions among the team members with a minimum amount of disruptions, overlaps and conflict.The way your organization is structured…   Read more»

A good example of the importance of trade secret protections is Coca Cola’s recipe, a secret so closely guarded that it’s locked safely away in a vault and is known only to two executives, and these two individuals are forbidden…   Read more»

For this product to get FDA approval the process should entail: – The assessment of everything. All upper management and department heads, trusted supplies, and influential stakeholders (hospitals, doctors, etc) will need to participate. This is a very delicate matter…   Read more»

Proactive Risk Management provides a unique approach that models the scalability of risk to any size project or program and easily deployable into any product development or project management life cycle. It offers methods for identifying drivers (causes) of risks so…   Read more»

One important characteristic of developing a solid risk profile is establishing design controls intended to demonstrate that a medical device has been designed to address the needs of users and patients, designed to meet inputs and requirements, proven to meet…   Read more»

There are some key differences between Medical Device and Drug Clinical Trials. In most drug trials, therapies are tested on a small group of healthy individuals first, then administered to incrementally larger populations. Medical device trials typically only involve subjects…   Read more»

Animal models to predict human conditions in biomedical research relies on the notion that basic processes are sufficiently similar across species to allow extrapolation. Animal model validity has similarities between the model and the human condition it is intended to…   Read more»

Companies may take the wrong approach to metrics if they measure only results obtained over a long period of time (retroactive). An alternative approach is to supplement the standard performance metrics with predictive metrics. This type of metric measures is a driver…   Read more»

Although monetary rewards are important, recognition is even more important for professionals. High performing employees expect to be recognized, but do not necessarily expect to be rewarded. Sometimes a small token of appreciation may go a long way towards motivating…   Read more»

After a clinical trial ends, the results are often peer reviewed before being published in a scientific journal to ensure accuracy and integrity. This means that other medical experts who were not involved with the study will examine the results…   Read more»

In the article titled “The Fascinating Mechanisms and Implications of the Placebo Effect” written by Colloca they stated that when a person expects and experiences a placebo effect, cognitive and emotional circuitries are activated with experience of pain reduction and…   Read more»

Scenario: Let’s say we have a company who is making female hygiene items more access to women and girls in developing countries. The sourcing for these items come from banana leaves that are refined and then converted in things like…   Read more»

Company Size Finances Stryker 43,000 employees $ 4 Billion GE Healthcare 54,000 employees $ 18 Billion   Stryker- is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. We…   Read more»

You probably won’t get the chance to see this, however, yes I have definitely meet many people in your situation (DON’T BE DISCOURAGED). Taking on a solo-preneurship takes adequate planning, assessment, and diligent execution, so it’s no small task. I…   Read more»

Advantages: – majority of interruptions for inspection activities no longer occur -so regulatory staff are not constantly forced to prepare for numerous and varying inspections or audits resulting in a reduction of personnel supporting inspections being drawn away from their…   Read more»

There are quite a bit of skills required for both regulatory affairs and quality assurance that overlap. To excel in these fields, you must be technically savvy, well-organized, and highly adaptable. Both roles require the use of available tools to accurately…   Read more»

As highlighted before risk management and training are critical aspects of ensuring quality of medical devices. The research conducted during risk assessment lays out scenarios that illustrates a medical device’s potential use and misuse, financial implications or barriers, as well as…   Read more»

This guidelines are a good start to helping to outline and provide ethical standards to uphold. However, everyone that is involved in the animal research process needs to hold themselves accountable. The reason being is that the unethical mistreatment of…   Read more»