I did some research on marketing strategy, adding to the discussion, there are seven Ps for marketing: product, price, promotion, place, participation, positioning and people. People: To be successful in business, you must develop the habit of thinking in terms…   Read more»

As we have learned from Dr.Simon MDD1 (Medical Device Development 1) on WEEK 4 about combination product: Definition of Combination Product Primary mode of action = the single mode of action of a combination product that provides the most important…   Read more»

Mobile medical apps are mobile apps that meet the definition of a “device” which are intended either: 1- To be used as an accessory to a regulated medical device; or 2- To transform a mobile platform into a regulated medical…   Read more»

Further, according to FDA, a “general wellness product” falls into one of two categories, and either: Has (1) an intended use that relates to a maintaining or encouraging a general state of health or a healthy activity, or (2) an…   Read more»

I think it all comes down to communication and accountability. The team should have some sort of idea what the others are working on. Another thing of the key characteristics of an effective project team is that the team members…   Read more»

I found too many companies charged for illegal kickbacks violations for example: 1- In North Carolina, Minneapolis-based Cardiovascular Systems, Inc. (CSI), has agreed to pay $8 million to resolve allegations that it paid illegal kickbacks to induce physicians to use…   Read more»

YES you can start your project based on a verbal agreement, but you need to make a prove for this verbal agreement, but if you failed to prove the agreement so you will be a loser. As we learned a…   Read more»

I think every one studying BME should take this class. I have learned a lot about medical device development. This course helped me to learn a lot about the regulations in and out of US, how to make a design…   Read more»

Middle Manager, I think ‘middle managers’ are an employer’s most important leaders .Although middle managers may be work under increased pressure and feel more stressed,but they are strongly committed to the work itself. A middle manager’s role may emphasize: -…   Read more»

I think Project-based Organization manager is better than being a manager in a matrix-organization. A project-based organization manager have a lot of power and easier to run projects because the entire structure is set up for that purpose. Also, in…   Read more»

I would like to work in matrix-organization, which all departments work closely together and communicate with each other frequently to solve issues (teamwork).The structure of a matrix organization, which is built on relationships between departments as a matrix, is better…   Read more»

As we have learned, Risk Management is done on multiple areas of a project, not just one:The product, The product design, and The manufacturing process. A method to analyze risk Looks at: HOW something can fail SEVERITY of the consequences…   Read more»

A key for each medical device company is: Keeping up with changes to ISO 13485: ” specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently…   Read more»

Example For Verification process: If you said in Design Input Requirements ” The MRI machine’s electrical system shall operate at 120V at less than 16 amps ” So, for Design Process ” Components such as motors, actuators and LEDs rated…   Read more»

What do you mean ‘Test-ab’?

I did research about the regulations in India, and I found that, India is one of the largest medical device markets in Asia, and is still growing at an impressive rate. Prior to 2005, no medical device regulations existed in…   Read more»

For me, CRO, because CRO is like the “middle man” between the Sponsor and the research sites. CRO get hired by sponsor, I’d say about 90% of Sponsors use CROs because the Sponsor’s specialty is creating the drug and developing…   Read more»

Having a clinical background gives a biomedical engineer ability to solve clinical problems. Biomedical Engineers work with a broad range of professionals ranging from other engineering specialties, to basic laboratory scientists, to physicians and nurses,so if you want to be…   Read more»

SWOT Analysis Philips Healthcare: Philips Mission “Improving people’s lives through meaningful innovation.” .Philips branches in 60 countries and they selling products to over than 100 countries.Philips very successful in medical imaging technology – CT, MRI and ultrasound. other products: X-ray,…   Read more»

Emotional intelligence (EI) is defined as the ability to understand our emotions and manage them effectively as well as to understand and effectively manage the emotions of other employees. Strong EI in sales person means the ability to understand the…   Read more»