Reducing Regulatory Barriers to Market Success: A Case Study

From PMA to 510(k)

An emerging company developed a pediatric implant with the potential to increase patient compliance and make existing therapies more effective. Based on positive clinical results, the company identified a wide array of intended uses for their device.

The company had the resources to get to market via the 510(k) pathway, but multiple evaluations from various regulatory professionals identified the product as a Class III Medical Device. A Class III device required a Premarket Approval (PMA) rather than a 510(k).

The company did not have the resources to pursue a PMA, and turned to MethodSense to understand if there was any way to bring the device to market safely with the resources at hand.

Problem Assessment: MethodSense assessed the product’s pathway through the FDA and evaluated the company’s goals and resources. MethodSense analyzed the product’s capabilities and clinical results, proposed intended use, and products already cleared by FDA to understand alternative regulations and pathways to market.

Solution: MethodSense shifted the regulatory strategy focus on avenues that could provide immediate market entry, and sustainable growth. This included a multi-step regulatory pathway strategy for the product that could include multiple submissions; with each, the company could expand its market, and gain additional capital and corporate resources.

The strategy shift enabled the company to acquire initial capital, obtain 510(k) clearance as a Class II product, and support a later PMA. MethodSense’s strategy allowed this company to take confident strides along their regulatory pathway and positioned the company for long-term market success.

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