Trade secret law is a source of protection for intellectual property that serves as an alternative to patent or trademark law. Whereas patent and trademark law require that the intellectual property to be protected be publicly “disclosed” (for example, through a…   Read more»

Trade secret law is a source of protection for intellectual property that serves as an alternative to patent or trademark law. Whereas patent and trademark law require that the intellectual property to be protected be publicly “disclosed” (for example, through a…   Read more»

I honestly think it varies based upon what each individual’s needs are. A projectized organization is the ideal organization type for a project manager. Project managers are the real bosses here, with the freedom to apply your expertise and have a…   Read more»

Working in a matrix organization, as mentioned before can be overwhelming. The tasks are normally bountiful and if not prepared, you can easily be lost. A Matrix Organization is one in which there are multiple managerial accountability and responsibility systems,…   Read more»

When deciding if risk is acceptable, I think you should consider the following to see if it’s worth the risk. Risk cannot be completely eliminated, so sometimes you have to take the best of the worst. Even when taking the…   Read more»

Post-market surveillance is a set of activities conducted by manufacturers, to collect and evaluate experience gained from medical devices that have been placed on the market, and to identify the need to take any action. Post-market surveillance is a crucial…   Read more»

Risk management involves the identification, understand, control, and prevent failures that can result in hazards when people use medical devices. Manufacturers are expected to identify possible hazards associated with the design in both normal and fault conditions. The risks associated…   Read more»

Medical device verification and validation (V&V) are crucial steps in the medical device development process. Verification and validation are necessary to comply with regulations and design a high-quality product that results in fewer mistakes, better repeatability, lower production costs and…   Read more»

With poor design controls, you will bestow unnecessary risks. With these risks, you will need a team to mitigate them by coming in early enough in the design planning to prevent this. You will need a group of people to…   Read more»

New medical devices offer fresh opportunities for your company to improve health outcomes, push the boundaries of medical innovation, and grow your business. But medical devices also carry varying levels of risk that must be carefully managed. As the product…   Read more»

Blinding covers any of the numerous participants of the clinical trial, e.g., researchers, subjects, technicians, and data analysts. Single-, double-, and triple-blinding are commonly used blinding strategies in clinical research. A single-blind study masks the subjects from knowing which study…   Read more»

The use of placebo controls in clinical trials remains controversial. Ethical analysis and international ethical guidance permit the use of placebo controls in randomized trials when scientifically indicated in four cases: (1) when there is no proven effective treatment for…   Read more»

The objective of the Right to Try Act seems beyond reproach, the law purports to provide a new avenue to treatment for patients with terminal illnesses after they have exhausted all other options and for whom no suitable clinical trial…   Read more»

The decision to form either a limited liability company (LLC) or a corporation depends on the type of business an individual is creating, the possible tax consequences of forming the entity, and other considerations. Both types of entities have the…   Read more»

Color psychology is the study of how certain colors impact human behavior. Different colors have different meanings, connotations, and psychological effects that vary across different cultures. Along with cultural differences, color psychology is largely impacted by personal preference. Color psychology…   Read more»

Participation involves engaging with patients in a genuine and transparent way. For pharma and medical device manufacturers, reaching and engaging today’s busy physicians and C-suite executives is more challenging than ever. According to Physicians, they, are so busy they have…   Read more»

At present, one of the leading causes of death in the U.S. is believed to be adverse drug reactions. More than 20 million patients have taken at least 1 of the 5 drugs withdrawn from the market between September 1997…   Read more»

Quality is an important factor when it comes to any product or service. With the high market competition, quality has become the market differentiator for almost all products and services. Quality control is essential to building a successful business that…   Read more»

Solving quality management issues keeps your life sciences organization on the right side of the FDA. However, compliance isn’t the only benefit. Excellence in quality management helps your organization produce the best medical devices on the market. It helps you…   Read more»

The consequences of not finishing research in academia are more so on the students’ fear of failing or fear of success. Students who want to succeed are often, understandably, afraid of failure. Similarly, parents of students are afraid of seeing…   Read more»