Luck, strategy and FDA device approvals

Experience and high staff levels help companies negotiate FDA approval – but luck plays a part.

When trying to shepherd a new medical device through the FDA review process, every day counts: the faster it can be brought to the world’s largest market, the sooner the money rolls in. An analysis of innovative device approvals over the last five years shows that Roche is the company whose devices have been approved by the FDA most rapidly, whereas Johnson & Johnson has received more sluggish treatment from the agency.

And it appears that buying in innovation might not be the quickest route to market. Products developed in-house get approved an average of seven months faster than those obtained via acquisitions, and again J&J, which relies heavily on bought-in devices, comes out poorly (see table).

The analysis below includes those companies that have received five or more premarket approvals, humanitarian device exemptions or de novo 510(k) clearances since January 2012. Devices were considered bought in if the approval applicant name was that of a company later acquired; for example the PMA for the Brio neurostimulator was applied for by St Jude Medical, but the device is now owned by Abbott.

Innovative device approvals 2012-17 by company
Company Number of approvals Average approval time (months)
Roche 21 7.4
C. R. Bard 5 9.3
Boston Scientific 11 10.2
Edwards Lifesciences 5 13.0
Qiagen 5 13.5
Medtronic 21 16.5
Siemens 5 17.7
Abbott Laboratories 23 21.7
Johnson & Johnson 7 24.6
Average 14.9
Source: EvaluateMedTech.

With an average approval time of 7.4 months, Roche has managed to achieve FDA approval for its innovative devices more rapidly than any other group in this cohort. Partly this is because diagnostic tests are relatively simple products and generally take the least time to win approval, being the only type of product to take less than a year, on average, to get through FDA review.

But that alone does not explain Roche’s success. Qiagen is also a diagnostics group, but it took nearly twice as long, on average, to get its five tests approved.

Perhaps experience and decent staffing levels help companies negotiate the PMA pathway. But in that case Medtronic and Abbott might be expected to obtain swifter passage of their devices than they actually manage – Abbott in particular, since seven of its 23 approvals were diagnostics.

Caveat emptor

At first glance it may seem unsurprising that devices obtained by companies via acquisitions of their makers take longer to make their way through the review process than devices developed organically. After all, companies seeking to grow inorganically often buy in innovation, opting for products unlike anything already on sale, so in theory there will be no direct competition.

Innovative device approvals 2012-17 by company strategy
Company % developed in-house Average approval time in-house (months) Average approval time bought in (months)
Roche 100% 7.4 -
C. R. Bard 100% 9.3 -
Edwards Lifesciences 100% 13.0 -
Qiagen 100% 13.5 -
Siemens 100% 17.7 -
Medtronic 90% 15.7 22.6
Boston Scientific 82% 10.6 8.4
Abbott Laboratories 61% 12.5 34.3
Johnson & Johnson 43% 12.0 34.1
Average 12.4 24.9
Source: EvaluateMedTech.

But this analysis only considers such products – those that could not get clearance via the quicker and cheaper 510(k) route as they have no predicate. Even the in-house products are innovative.

Moreover, acquirers might be expected to buy devices with robust clinical data that ought to speed their passage to market. So why do the bought-in products take longer?

Part of the reason is that a buyer will only scrutinise a device’s clinical dataset in forensic detail when it is considering a smaller tuck-in deal. When making a scale play the approval trajectory of each individual technology is not so important, since the deal will take time to integrate anyway.

The obvious exemplar in this cohort is Abbott’s takeover of St. Jude Medical. Of Abbott’s 23 approvals over the past five years, nine listed St. Jude – or a company bought by St. Jude in the interim, such as Thoratec – as the applicant. Those nine products took an average of 34.3 months to gain approval, nearly three times longer than Abbott’s in-house devices.

Innovative but inorganic

Perhaps the most interesting case is Johnson & Johnson. Just three of J&J’s seven approved products were developed organically – the other four were applied for by companies it subsequently bought. J&J is the only company in this group to have bought in the majority of its approved devices.

Johnson & Johnson's innovative FDA approvals, 2012-2017
Applicant Strategy Device name (FDA) EvaluateMedTech device classification - L3 Pathway Approval date FDA review time (months)
Mentor Acquired Jan 2009 MemoryShape Breast prosthesis PMA June 14, 2013 80.4
Abbott Medical Optics  Acquired Feb 2017 Healon EndoCoat Viscoelastics PMA July 2, 2012 16.3
Torax Medical  Acquired Mar 2017 Linx Other gastrointestinal therapeutic devices PMA March 22, 2012 14.7
Torax Medical Acquired Mar 2017 Fenix Other gastrointestinal therapeutic devices HDE December 18, 2015 25.0
Ethicon Endo-Surgery In-house (J&J subsidiary) Percutaneous surgical set General and plastic surgery devices De novo 510(k) April 30, 2012 7.3
Acclarent  In-house (J&J subsidiary) Acclarent Aera Ear, nose, and throat devices De novo 510(k) September 16, 2016 9.3
Animas  In-house (J&J subsidiary) Animas Vibe Insulin pumps PMA November 25, 2014 19.3
Source: EvaluateMedTech.

This does not appear to have served it well. The devices it developed organically gained FDA approval in around a year on average, whereas those it acquired took early three. Naturally enough the de novo clearances, both awarded to in-house devices, were quicker than the PMAs and HDE – de novos are the pathway for lower-risk devices, so these generally require less scrutiny.

Perhaps J&J does not give much consideration to the speed of US approvals when weighing a potential acquisition; after all it is big enough and old enough to weather the vicissitudes of the FDA. And luck will play a part here, with factors such as FDA funding and even the weather affecting timings. Even so, J&J might want to revisit its strategy.

To contact the writer of this story email Elizabeth Cairns in London at [email protected] or follow @LizVantage on Twitter

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