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What’s next after receiving 510(k) regulatory clearance from the FDA?

Market access for medtech companies

While medical technology (medtech) companies can benefit from the expedited U.S. Food and Drug Administration (FDA) clearance afforded through the 510(k) pathway, few organizations are aptly positioned for market access success prior to, or even after, receiving 510(k) clearance.

Ever-rising healthcare costs and the growing treatment of chronic conditions have resulted in the healthcare industry shifting from a position of volume to one of value, where more focus is placed on preventative care and maintenance of a healthier population. (This is also known as value-based care or contracting (VBC).)

As a result of this change, the successful introduction of new technologies is now contingent on an organization’s ability to address these shifts and demonstrate the clinical and economic value of its technology to both payers and providers.

Moreover, device manufacturers are faced with an increasingly competitive market in which one’s ability to effectively develop and communicate value propositions is critical for market coverage and adoption. Organizations must be ready and able to demonstrate their product value to stakeholders within the healthcare industry, including payers, providers, patients, physicians and regulators. Organizations should also develop comprehensive market access plans to effectively address the needs of healthcare system parties in order to increase their chances of success.

Among all the strategies needed for market access success, the most critical are:

Each of the above strategies links to an additional Baker Tilly article highlighting additional next steps for medtech companies that have received 510(k) regulatory clearance from the FDA.

Given the competition in the U.S. market, and the shift to value from volume, it’s critical for medtech companies to proactively develop comprehensive strategies to ensure market access success in each of these key areas.

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Recently receive your 510(k) clearance from the FDA?

Baker Tilly’s market access services team can help medtech companies achieve their market access needs, answering questions, providing guidance and walking organizations through the next steps in the wake of receiving 510(k) regulatory clearance. For more information or to begin a conversation

John Finan
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