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Regulatory research on IDE exemptions: A case study in persistence (part 1)
A client presented us with a simple question – Do we need to submit an Investigational Device...
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Science of Patient Input (SPI) Part 3
Patient input into study design – participation considerations. The last, in a series about the science of...
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Science of Patient Input (SPI): Part two
Patient input into study design – endpoints of value and thresholds of “significance”. The second of three,...
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Science of Patient Input (SPI): Part one
The first of three, in a series about the science of patient input. It is tempting to...
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Developing Inclusion/Exclusion Criteria for Clinical Trials
There is frequently confusion about what items should be listed as inclusion criteria and what should be...
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Honoring Ours and Serving Others
On August 31st, Med Institute celebrated another year of honoring employees at the annual awards banquet. The...
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Clinical Trials for Medical Device Innovators Part V: Important Points
The fifth and final, in a blog series about clinical trials for medical device innovators. Read part...
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Clinical Trials for Medical Device Innovators Part IV: Cost Drivers for Clinical Trials
The fourth, in a blog series about clinical trials for medical device innovators. Read part I: Designing...
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Clinical Trials for Medical Device Innovators Part III: Managing Clinical Trials
The third, in a blog series about clinical trials for medical device innovators. Read part I: Designing...
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Clinical Trials for Medical Device Innovators Part II: Regulatory Considerations for Clinical Studies
The second, in a blog series about clinical trials for medical device innovators. Read part I: Designing...
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Clinical Trials for Medical Device Innovators Part I: Introduction and Designing Clinical Trials
The first, in a blog series about clinical trials for medical device innovators. In 2017, Cook was...
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White Paper: Radial Force
Radial Force Testing Radial force testing is used to determine the stiffness (hoop strength) of a medical...
