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 new products as well as better treatments. Their expertise is not necessarily in managing clinical trials and submitt…[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 at the forefront of the role you in, having a clinical background will…[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, Nuclear medicine, Patient monitoring, and medical s…[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 client’s needs, to manage various kinds of selling problems and to deal with possible emotional t…[Read more]

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 opportunities. This is typically don…[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 mission can change to reflect a company’s priorities and methods to…[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 and choose the structure that most closely matches your business’s needs.
So, if…[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 taxation to be the most noteworthy difference between S corporations and C corporations. C corps a…[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 change a business structure (for example, change from a sole proprietorship to a corporation or partnership) is the same…[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): 4.88% (Jun 30 2017)…[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 to review your quality system the way an auditor will during an inspection.
Also, you need to make sure you are f…[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 poor quality can cause rework, retesting, delay,and loosing money too.
I think the success of any medical device…[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 essential feature of the device that protects persons with type 1 and type 2 diabetes from experiencing…[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 bony defect, initiates bone formation (osteoinduction) and provides local containment and cell…[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 ensure the devices—which have failed in tens of thousands of reported cases s…[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 their own health and wellness, such…[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 be much more difficult to undertake experiments, and would slow the development of potentially life saving medicines.…[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 the biocompatibility of medical…[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, the timeline enables members of the company and client teams to have a clear…[Read more]