A great example for the 5th P (Participation) in marketing, A pharmaceutical marketer intelligently stepped into the participation waters by offering patients ways to participate in treatment “communities.” The company supports disease-state awareness events, surrounding them with information and interaction…   Read more»

Mission statement explains the company’s reason for existence. It describes the company, what it does and its overall intention. The mission statement supports the vision and serves to communicate purpose and direction to employees, customers, vendors and other stakeholders. The…   Read more»

Choosing the best structure for your business, depends on the the business needs. Probably the most important thing on choosing your company structure “TAXES”.Because each business form comes with different tax consequences, you will want to make your selection wisely…   Read more»

LLC protects you from the personal risks involved if a lawsuit were to arise concerning your business — safeguarding your personal assets. LLC gives flexibility in management and taxes are not paid at the business level. Many business owners consider…   Read more»

In a sole proprietorship, the owner of the business and the business are a single entity. Only one person owns the company and instead of paying corporate taxes, the owner pays personal income tax on any profit. The process to…   Read more»

I did research on Stryker, I found: SYK Gross Profit Margin (Quarterly) Range, Past 5 Years: Minimum 64.47% Maximum 68.29% Average 66.37% Net Profit Margin (Quarterly):12.98% Return on Equity (ROE):17.81% Return on invested capital (ROIC): 12.93% Return On Investment (ROI):…   Read more»

To be prepared for an audit, you will need to periodically review your quality system records (DHRs) for these areas. While you can’t be certain exactly what an auditor will ask, you can use the objectives and sample questions below…   Read more»

Quality costs are the all the costs that a manufacturer incurs to ensure it produces a quality product. Quality costs to prevent low-quality production costs and costs that arise after a low quality product is produced, so the cost of…   Read more»

Also in 2016 the FDA recalled Dexcom G4 Platinum and G5 Mobile continuous glucose monitoring system receivers, due to complaints that the audible alarm may not activate the receiver when patients experience low or high glucose levels. This is an…   Read more»

An example of a combination product: Bone morphogenetic proteins (BMPs) are a class of proteins that induce bone formation. New technology in orthopedic repair combines BMPs with a carrier matrix to create a combination product that, when implanted in a…   Read more»

Here another example: No More 510(k)-only PMA required for all Automated External Defibrillators (AEDs) FDA has finalized a change in policy that will soon require all Automated External Defibrillators (AEDs) to undergo a more rigorous regulatory review process meant to…   Read more»

I found some examples of mobile medical applications the FDA has cleared or approved since 1997 from this link https://www.fda.gov/MedicalDevices/DigitalHealth/MobileMedicalApplications/ucm368784.htm , also, FDA regulates mobile medical apps so Consumers can use both mobile medical apps and mobile apps to manage…   Read more»

I consider it ethical to experiment on animals if the tests are done in the name of medicine.Experimenting on animals is often the best or only option in order to test new medicines or treatments. Without animal testing, it would…   Read more»

When we test the biocompatibility of material especially for medical devices,there are some categories depending on final usages.As mentioned above, cytotoxicity, skin irritation, sensitization, systemic toxicity, and so on.ISO 10993 describes the biocompatibility test for medical devices.However, when you chek…   Read more»

In general,to make sure you were successful with your end product: -Set measurable objectives for how product adoption will be achieved by customers during and after the product launch and determine your product launch timeline – Strategy and Tactical Planning,…   Read more»

Missing a milestone considered to be failure for your project.YES Its YOUR fault! for example, missing deadlines, this is one of the surest breaking points in the client / agency relationship. Project deadlines can either be communicated to you in…   Read more»

I graduated from Electrical Engineering and currently I work in the medical imaging technology,(CAT scans,MRIs, nuclear cameras,…), I love this field.So, I decided to get my MS degree in BME.I find this class will be a great opportunity to learn…   Read more»

Portfolio management ensures that an organization can leverage its project selection and execution success. It refers to the centralized management of one or more project portfolios to achieve strategic objectives. Our research has shown that portfolio management is a way…   Read more»

The FDA regulations is the biggest challenge for any medical device project!,In general, some of those regulations: -Good manufacturing practices -Standards and Reporting Adverse Events to FDA registration, -Labeling and classification. submission for 501k or PMA, and finally premarket approval.So…   Read more»

Also, monitoring and controlling phase plays a very important phase, since we need to measure the results against baselines during this stage. I think Calculations in any project is a very important part to stay in the range of allowed…   Read more»