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Suggestions for Success

Many important medical innovations come from small companies and inventor-funded start-ups. CROs and consultancies play a significant role in bringing these innovations to market because start-ups and other small businesses typically lack the experience and resources necessary to successfully navigate the clinical and regulatory pathway on their own. With little or no revenue from existing products, small medical technology companies also have a compelling need to set a foundational strategy, gain market access and become financially viable usually in the context of ambitious timelines and finite budget constraints.

Recent changes in the global economic and regulatory landscape have increased the time/cost burden of innovation for medical device companies. For instance, Europe's new regulations, slated to take full effect in 2020 in parallel with the recently revised quality system standard for medical devices (ISO 13485:2016), will reclassify many devices and tighten the requirements for clinical data, quality assurance and risk management (1-3).

In the US, the recently revised FDA user fees for medical device premarket submissions will increase by at least 33% for all application types, beginning in 2018, with further incremental costs added annually over the succeeding four years (4,5). The most significant increase pertains to De Novo requests, which refer to the FDA process for manufacturers to commercialise novel and cutting-edge products in the US. Previously free of charge, these will now cost $93,229 for large companies and $23,307 for small businesses with annual sales less than $100 million in 2018. However, the news is not all bad. The FDA, for its part, promises increased predictability and a faster review process. The average time taken to provide a final determination for De Novo requests is supposed to drop from 249 to 120 days after implementing the new user fees (6,7). Despite this, sweeping increases in the cost of registering new devices may strike a disproportionate blow to smaller medical device companies short on the knowledge, time or funds necessary to adapt.


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Nuala Ronan is co-founder and managing partner of Databean, a collaborative research organisation supporting medical technology and biological technology start-ups. Her expertise in the clinical, regulatory and data management requirements, essential for successful execution of global clinical trials, stems from more than 20 years of leadership in academic and industry sponsored clinical research. Nuala holds a degree in nursing and pre-medical studies, and she can quickly assess the value of new technologies and works hard to bring them to fruition.

Deborah Arthur is Databeans key regulatory strategist. Having served as Vice President of Regulatory and Quality for several medical device companies, including Cochlear Americas, MetaCure and Symphonix Devices, she has extensive experience with regulatory authorities around the world.

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Nuala Ronan
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Deborah Arthur
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