Aptiv Solutions

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So far Aptiv Solutions has created 8 blog entries.

Differences Between Medical Device and Pharmaceutical Clinical Trials – A Primer

Given that the size of the pharmaceutical industry at times overshadows the medical device market, it is no surprise that companies that are just getting started in device development sometimes need clarification about the regulatory implications and practical differences between pharma clinical trials and medical device clinical trials. We’ve put together a basic primer to help guide readers through the [...]

Taming the Monster – The Economic Benefits of Adaptive Trials

There is no question that pharmaceutical companies large and small are feeling the financial pressures associated with deploying large clinical trials. Traditional trial designs can be overly cumbersome and expensive, particularly when applied to large populations of patients over the course of a lengthy investigation. This inescapable fact has lead many investigators to consider alternative pathways to gathering the safety and [...]

Today Show Hypes Medical Device Reprocessing Safety Issues

A recent segment on the Today show highlighted public concerns regarding hospital acquired infections – specifically, those that can be contracted from medical devices and surgical instruments. The report presented the case that even if proper sterilization processes are followed, there remains a strong chance that surgical equipment will be contaminated with blood, tissue, and fluids from previous patients. [...]

FDA Doubles Medical Device User Fees

Is the pathway to quicker medical device regulatory approval or clearance to be found through the establishment of higher fees on the part of the Food and Drug Administration? It would seem so, given that the FDA has recently announced a new program that will double the amount of the user fees currently paid by the biggest players in the medical device [...]

Medical Devices and the EU Path

Over the past decade it has become common for some medical device companies to introduce a product to the European market prior to attempting to gain FDA approval and sell the same device in the United States. In some cases, depending on the classification and technology of the device, Europe can provide a quicker route to marketability. […]

FDA Partners With Private Industry Groups To Streamline Medical Device Approval Process

The FDA’s search for a more efficient medical device approval process continues full steam ahead with the latest announcement that the Administration is looking to leverage partnerships within the industry in order to achieve this particular goal. Although the relationship is being described as ‘informal,’ the FDA will be working together with Biocom in order to bring greater ‘clarity, predictability [...]

Tufts Report Reveals Increased Pharma Interest in Adaptive Trials

Improving the efficiency of clinical trials has become one of the most important priorities for pharmaceutical companies around the world. In its annual R&D management report, the Tufts Center for the Study of Drug Development (CSDD) recently estimated the full price of bringing a new drug to market at over $1.3 billion. The report indicated that any areas where R&D costs [...]

Adaptive Clinical Trials Can Bring You “Beyond the Shadow of a Drought”

R&D production in the pharmaceutical industry has fallen more than 70% over the last 15 years, according to a recently published report, “Beyond the Shadow of a Drought: The need for a new mindset in pharma R&D,” by a group of analysts at the Oliver Wyman consulting firm.  According to this insightful analysis, the underlying causes have not seemed too alarming [...]