Medical Device Opportunities:
PMA Approvals Blast Off in H1 of 2015


In addition to covering updates on clinical drug products, PharmSource’s research team also covers the clinical progress of medical devices and diagnostics. In our research of the latter, we’ve noted a dramatic upswing in premarket approvals (PMAs) in 2015 YTD.

A PMA is a marketing application required for Class III medical devices, which are also known as high-risk devices. The PMA is the most stringent type of device marketing application and is usually supported by scientific evidence, unlike a 510(k) which can receive clearance if the device is substantially equivalent to a legally marketed device that is not subject to a PMA.

As shown in the graph below, there was a very modest increase in the total number of device PMA approvals from 2013 to 2014 (21 and 24, respectively). However, in H1 of 2015 alone, there are already 24 PMA approvals. With six more months to go, and a monthly average of 62¹ PMAs under review in 2015, PMA approvals seem headed for a steep growth trend.

An important regulatory factor impacting the increase in PMA approvals may be FDA’s recent efforts to reduce time to premarket review for certain medical devices. For example, in April 2015, FDA initiated the Expedited Access Pathway (EAP), a voluntary program for certain medical devices for patients with life-threatening or irreversibly debilitating conditions. The EAP program allows device sponsors to work with FDA to reduce the time and cost from development to marketing decision without changing FDA’s PMA approval standard (to read more about the EAP program click here). FDA has also issued a guidance to focus on quality data collection, including the balance of premarket and postmarket data, in order to provide patients with timely access to medical devices.

The average approval time for medical devices, from receipt of application to decision time, has been decreasing over the past few years. The graph above shows a slight decrease in average decision times from 2013 to 2014 (154.5 days to 151.6 days, respectively) trending to shorter time-to-approval in Q1 of 2015, with an average of 136.3 days.

Funding in medical devices has increased in the past few years and may be a factor in the growth of PMA approvals. According to the MoneyTree Life Sciences Report (from PricewaterhouseCoopers and the National Venture Capital Associated) based on data provided by Thomson Reuters, first-time biotech and medical device financings increased in Q4 2014 by 7% in dollar value. The report is consistent with data reported in the PharmSource Lead Sheet, which also shows an increase in the amount of funding from 2013 to 2014 for medical device and diagnostic companies. As reported in the PharmSource Lead Sheet, companies use the funding in various ways, including for R&D of new medical devices and further development of existing products with additional clinical studies and to support the regulatory approval process.

The PharmSource Lead Sheet Devices & Diagnostics Edition includes weekly updates on PMA products, corporate financings and much more. Medical devices and diagnostic products are categorized by development phase (from preclinical to postmarketing). Each product is described in detail, with specific information on therapeutic area, purpose of the device, type of device and much more. Stay up-to-date on the fast-growing clinical medical device and diagnostic sector with the PharmSource Lead Sheet!

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Judy Nanthavong is a Senior Research Analyst at PharmSource, and specializes in covering events related to medical devices and diagnostics. Prior to joining the company as a full-time, permanent staff member, she previously worked here as a student intern. Judy holds a BS degree in Health Science, Health Systems Management from George Mason University.

More posts by Judy Nanthavong