Despite its efforts to accelerate the approval of medical devices, the US FDA has slowed down somewhat in recent months. 19 first-time PMAs and HDEs – the approvals for the most innovative high-risk devices – were awarded by the agency in the first half of 2016, down slightly from the 26 greenlit in the first half of 2015.
Perhaps the larger companies have been too preoccupied with integrating their acquisitions to have put the same effort into gaining approval for their products. Or perhaps the venture crisis, present for several years and becoming ever more pronounced, means that smaller groups cannot get their devices to market. It is not time to panic yet, but this could be an early warning of difficulties to come.
The cardiology segment saw the second fastest approvals on average despite also seeing the most: seven devices have been approved so far this year at an average speed of 9.5 months. Ophthalmic devices were approved faster still, but there was only one of these: Revision Optics’ Raindrop, an implantable device that changes the shape of the cornea to improve near vision, was approved in 9.2 months.
In vitro diagnostics would have been by far the fastest device class to be approved were it not for Epi proColon, the colorectal cancer test developed by Epigenomics. This was approved in April via a highly unusual appeal process, but this was the end of a long road – it was more than three years from submission to approval (FDA finds Epigenomics appealing, April 13, 2016). Without this outlier, IVDs would have been approved in an average of just 5.2 months.
The wooden spoon, however, goes to Storz Medical for its Duolith SD1 shock wave therapy system, approved in January to treat heel pain due to chronic proximal plantar fasciitis. The system took more than seven years to win approval.
|Average review times of first-time PMAs and HDEs by therapy area (months)|
|EvaluateMedTech device classification||2013||2014||2015||H1 2016|
|Anaesthesia & respiratory||61.3||18.5||-||-|
|Ear, nose & throat||-||9.5||-||-|
|General & plastic surgery||68.2||28.7||-||-|
|General hospital & healthcare supply||-||-||-||39.8|
|In vitro diagnostics||8.6||13.3||11.3||12.0|
|Obstetrics & gynaecology||-||-||12.9||-|
There is another path to the US market for devices that are like nothing that has come before: the de novo 510(k) clearance route. This may be used for products that are as innovative as those that take the PMA or HDE routes to market, but pose less risk to patients.
10 devices reached the US market via this route in the first half – the same number as in the first half of 2015. But they took longer: an average of 15.1 months compared with 11.9 for the first six months of 2015. This was the slowest average de novo approval time since 2012.
In fact a look at de novos over the past decade reveals a clear pattern, the number granted rising steadily to a high of 28 in 2014 and then decreasing. It is easily possible that the total for 2016 will equal or surpass that of last year.
|De novo clearances by year|
|Year||Number||Ave time (months)|
The same cannot be said for PMAs and HDEs. If the FDA keeps the approvals coming at a steady rate over the rest of the year we can expect just 38, which would represent a 34% drop from the 51 awarded last year.
It seems counterintuitive that the agency would push through reforms like the Expedited Access Pathway only to permit fewer devices to reach market. But there is always a certain amount of variability here, and in any case the FDA can only work with what it is given: if companies are not submitting as many applications, or if those submissions are not of sufficiently high quality, there is little the agency can do.
The steady pace of de novos offers some reassurance when it comes to innovation. Where high-risk devices, often implants or complicated systems used during interventional procedures, tend to be manufactured by the very biggest medtech companies, the kinds of devices that use the de novo path are in many cases the sole product of a private company.
Examples among this year’s haul include Levita Magnetics’ Magnetic Surgical System, which uses magnetic retraction to grasp and retract tissue and organs in laparoscopic cholecystectomy procedures and the Pediatric Vision Scanner developed by REBIScan which can, in a 2.5 second procedure, detect strabismus, amblyopia and other serious eye conditions in children as young as two.
If these devices make it to market their developers stand a better chance of being bought by a larger group, rewarding them and allowing new technologies to reach patients – while sustaining large and mid-size medtech groups along the way.