Diagnostics specialists win the US device approval race

Roche is notorious among the large medical device and diagnostic developers for the speed at which its innovative products gain FDA approval. The company’s medical technologies are exclusively in vitro diagnostics (IVDs), and these tend to pass through the regulatory process rapidly, being relatively simple and posing few risks to the patient. 

But an analysis of innovative device approvals over the past five years shows that Roche’s applications are granted even more rapidly than IVDs in general – more than three months faster, on average. 

Partly this can be put down to experience. Roche obtained 20 FDA approvals for innovative devices between 2014 and the end of September 2019, many of which are run on established instruments and therefore require minimal investigation. Companies that do not make such regular submissions, or that go to regulators with less well-characterised technologies, will naturally take longer. 

The slowest IVD approval of 2019, for example, was that of the Sangia prostate specific antigen blood test developed by Opko Health; this took 14.8 months. Opko is a diversified company, and its lack of specialism in IVDs might have contributed to the relative lag.

A look at the cohort with the most approvals over the past five years shows how much of a lead Roche has opened up over its rivals.

The table below includes only those companies with more than five innovative device approvals – first-time PMAs, humanitarian device exemptions and de novo 510(k) clearances – in the five-year period.

The second fastest after Roche is Qiagen, which also specialises in IVDs. The group has been in trouble for some time, with its efforts to break into next-generation sequencing having misfired (Storm-tossed Qiagen plots a course to higher growth, October 8, 2019). At least its approach to regulatory affairs seems to bear fruit.

In and out

As well as the differences between the companies, interesting enough in themselves, it is worth examining their strategies when it comes to buying in new devices. Roche develops almost all its products in house, but two of its 20 approvals were applied for by a different company that Roche subsequently acquired – Foundation Medicine – and both were approved in less than six months. 

Some groups have made a success, from a regulatory standpoint, of their acquisitions. Boston Scientific has bought an astonishing 27 companies since the beginning of 2014, and the devices resulting from those deals were approved five months faster, on average, than those resulting from its own R&D labs. 

But relying on bought-in technologies is a hit-and-miss strategy. The 31% of approved devices Abbott gained from acquisitions took more than two years longer, on average, to get their green lights than those it developed organically. Abbott’s slowest was the Amplatzer VSD occluder, a catheter-based device intended for closure of post-heart attack muscular ventricular septal defects, which was granted a human device exemption nine and a half years after its originator, Aga Medical, filed it. 

Asahi Kasei’s inorganic products have also been slow to gain the FDA’s blessing. One example is its ResQCPR System, a non-invasive therapy to boost blood circulation in patients with non-traumatic cardiac arrest. This was approved nearly four years after its initial developer, Advanced Circulatory Systems, which was bought by Asahi Kasei in 2014, submitted it.

The speed of likely approvals is probably not the foremost consideration to occupy a group mulling a takeover – the size of the market and forecast sales for the target’s devices would probably be of more consequence, with buyers happy to wait for the FDA’s nod provided the return is great enough. Sooner, however, is undeniably better than later.