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Compliance In Focus
Posted by John Lehmann on Thu, Jun 6, 2013

Virtual Prototyping Could Impact Clinical Trials

Virtual Prototyping Could Impact Clinical TrialsI ran across an article in MDDI on virtual prototyping that could have an impact on clinical trials.  There is mixed opinion on the value of clinical trials.  Advocates claim they are necessary to ensure patient safety, while many in the device industry argue trials are only necessary for complex medical devices.

However, there is almost universal agreement that these trials are expensive and enrollment is challenging.  So what can be done to help alleviate these issues?

The article highlights the Mechanical Engineering and Computer Science departments at the University of Minnesota.  They have built a prototyping device that can help reduce the clinical trial burden that many companies face.  Only three of these devices exist – one at UM’s Medical Device Center, one at Boston Scientific under a joint development program and the third at the University’s Computer Science department.

The prototype device helps cut down the number of recruits a company needs.  How is this done?  A company would be able to virtually prototype and implant a medical device allowing companies to collect data and modify the device.  The article contains a video that goes into more detail.  Saurav Pau, Director of the Medical Devices Center’s Innovation Fellows program indicates that CDRH Director Jeffrey Shuren is aware of the device.

The goal is for the device to be ultimately approved, the clinical trial data requirements minimized and also count toward an FDA submission.  Thus, helping speed the timing of the trial and impacting overall costs.

What are your thoughts on virtual prototyping and do you believe it will have an impact on clinical trials.  Please share your thoughts below.

Photo Credit:malavoda

Product Accountability in Clinical Trials

Topics: Virtual Prototyping, Medical Device Innovation, Clinical Research


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