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Medical Device CRO Blog

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China-Made Device Knock Offs a Source of Concern

  
  
  
China Made Device Knock Offs a Source of Concern

Medtech companies in the U.S. are concerned about Chinese device manufacturers stealing their intellectual property and making knock-offs that replicate American devices.  However, these devices are not as safe according to Advamed.

Should Sham Procedures Become a More Integral Part of Medical Device Trials?

  
  
  
Sham Procedure

Currently hypertension affects 30.4% of the American population and is projected to cost the nation 91.4 billion dollars a year in 2015.  A subset of hypertensive patients have what is referred to as resistant hypertension.  This refers to a patient receiving three or more anti-hypertensive medications without receiving adequate benefit.  Because of this arbitrary definition, the number of people afflicted with resistant hypertension has varied between 5% in general medical practice and 50% in nephrology clinics. As an alternative to additional anti-hypertensive medication, renal denervation has been used as a therapy to combat high blood pressure.

Should THIS be the Next Global Priority?

  
  
  
Should THIS be the Next Global Priority

Back in 2012 an article was published in PLOS titled “Strengthening Medical Product Regulation in Low- and Middle-Income Countries” which strongly suggests developing countries must become a global health priority. In fact, The World Health Organization (WHO) recognizes regulatory system functions as one of the six core building blocks of health systems.

The Value of Top Monitors

  
  
  
Monitoring Attributes

Monitors that perform their job at a high level can drive the growth and reputation of their company. The companies that employ these monitors are equipped to meet the needs of their clients and ensure that patient safety and data integrity are maximized.

What Exactly Are Device-Drug Combination Products?

  
  
  
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The area of combination products is an exciting expanse of potential innovation and discovery for both the medical device and drug industries. But what exactly are combination products? According to 21 CFR 3.2(e), they are defined as:

5 Reasons Patients Withdraw from Clinical Studies

  
  
  
5 Reasons Patients Withdraw from Clinical Studies

In a clinical research, patients are the most important key to a study. Subject retention is vital for data integrity, and lack of subject participation can have costly delays for the Sponsor.  Since research sites spend a great deal of time and effort finding qualified subjects, they should also be equipped with reasons subjects withdraw to help prevent this from happening.

Cell Therapy: The Fourth Pillar of HealthCare

  
  
  
Cell Therapy   The Fourth Pillar of HealthCare

As the cell therapy market continues to grow, it’s important to note the similarities between medical device and cell therapy clinical trials. To help illustrate this, we’ve created an infographic, “Cell Therapy: The Fourth Pillar of Healthcare,” which is available for download.

What Makes a Device Class III?

  
  
  
What Makes a Device Class III

According to an article in “The Gray Sheet” the FDA is proposing new regulatory language to determine what devices designated Class III devices and not suitable for down-classification.

FDA Updates HDE Guidelines

  
  
  
FDA Updates HDE Guidelines

FDA is updating guidance on its humanitarian device exemption program to clarify an expanded profit allowance and a potentially less-restrictive upper-limit on the number of qualifying HDE devices that can be sold for profit in a given year.

1747 - James Lind

  
  
  
1747 - James Lind

You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014 calendar year.

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