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Challenge

Regulation doesn't have to be a barrier to innovation.

A client was developing a software package using Big Data to provide clinical decision support for physicians. They initially believed a premarket approval (PMA) could be required for the product depending on the claims that would be made. They were also concerned about the potential cost of clinical trials and the overall timing of bringing the product to market.


Solution

Challenge conventional thinking.

R&Q was brought in to provide regulatory guidance and assembled a panel of five regulatory experts with diverse experience to participate in a roundtable discussion and assessment of options, which ranged from a PMA, to a 510(k), all the way to no need to file a submission at all. The assessment began with the development of a risk matrix of submission options, then the panel used Force Field Analysis to weigh each of the options. This enabled the panel to explore the business needs of the client and debate the potential regulatory pathways, corresponding timelines, and cost to bring the client’s product to the marketplace.

 

Results

Knowledge is power.

R&Q identified the risks and allowable claims associated with each of the potential regulatory pathways and enabled the client to make the best strategic decision for their company, which was a no submission pathway based on enforcement discretion.


 

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Case Study Regulatory Strategy For Medical Devices PDF

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