An NDA and a patent both help protect ideas, but they are not substitutes for each other. An NDA is a private agreement that keeps information confidential between the parties involved. It only works as long as everyone follows the…   Read more»

If you’re asked to sign an NDA, the main thing to remember is that you should never sign something you don’t fully understand. An NDA is still a legal contract, so you should read it carefully and make sure every…   Read more»

A verbal/oral agreement is essentially the same thing, both mean an agreement made through spoken communication. Verbal agreements can be legally binding, but the biggest problem is proving what was actually said if a dispute comes up. That’s why relying…   Read more»

If I had to choose, I’d prefer working in a matrix-based organization as well. It offers the best mix of both worlds: the deep expertise of functional teams and the clear goals and accountability of project-based work. It also encourages…   Read more»

Successful Scenario (Strong Matrix)A medical device company launches a new imaging probe. The project manager controls all budget and timeline aspects and decision-making authority but R&D and QA and marketing teams contribute their expertise through project-wide direction. The PM uses…   Read more»

Medical device companies need to change their internal operations because healthcare organizations now use value-based care models which require them to focus on patient outcomes instead of device sales. Medical device companies can reach their targets through these organizational development…   Read more»

I definitely believe risk management is an important part of the planning phase. It’s not a waste of money or time. In fact, it often saves both in the long run. Identifying potential risks early helps teams prepare for what…   Read more»

It’s important to look at hazards and hazardous situations separately because they happen at different stages of risk. A hazard is something that can cause harm, while a hazardous situation is when someone is actually exposed to that hazard. By…   Read more»

A real example of this happened during the 2014 Ebola outbreak, when healthcare workers in West Africa faced serious exposure risks. The hazard was the Ebola virus present in infected patients’ blood and bodily fluids. The hazardous situation occurred when…   Read more»

I think risk acceptance means recognizing a risk but choosing not to take any immediate action because the potential impact is minor or the cost of controlling it is too high compared to the benefit. I don’t think accepting a…   Read more»

Yes, I definitely feel safer knowing that validation and verification are key parts of the medical device development process. The process verifies that all devices fulfill their design requirements while providing safe and efficient performance in actual operational environments. The…   Read more»

Risk management operates together with design verification and validation to detect all possible hazards which get evaluated and managed from start to finish during medical device development. The activities of risk assessment and mitigation receive coordination through three main techniques…   Read more»

Medical device development needs design control as its fundamental requirement to confirm that products meet safety standards and quality benchmarks and user requirements. Design control systems that operate with insufficient strength or improper application create major issues which result in…   Read more»

The placebo effect creates difficulties in clinical trial result analysis because it demonstrates how mental factors can affect actual physical health results. The brains of patients who receive sham treatments show the same level of improvement as those who receive…   Read more»

Researchers use various approaches to minimize placebo effects while confirming that their results show the genuine effects of treatments. The most common approach is blinding. Single-blind studies protect against bias because participants remain unaware about whether they receive actual treatment…   Read more»

The use of AI in clinical trials generates major ethical concerns which endanger both research reliability and participant confidence. The main problem stems from unfair selection procedures that researchers used to pick their study participants. AI algorithms develop biases when…   Read more»

The two fields of marketing and advertising operate in tandem yet they perform distinct functions because marketing handles strategic planning and advertising executes the plans. The two fields of biotechnology and medical devices require exact audience targeting to achieve successful…   Read more»

Storytelling stands as the main sales and marketing tool because it develops emotional customer connections through stories instead of using only logical approaches. A good story turns a product into an experience and a brand into something people can relate…   Read more»

Engineers working in different organizations decide to enter sales or marketing roles when they want to advance their careers past their technical expertise. It’s less common to see the reverse, since engineering requires specific technical qualifications, while sales and marketing…   Read more»

That’s a great question, I’ve thought about this too. The success of starting a business as an engineer or scientist does not require an MBA but it depends on individual circumstances and business nature. Engineers and scientists already have solid…   Read more»