The management at Meril Life Sciences knew the risks but rolled the dice anyway.
In 2013, the stent manufacturer based in Vapi, Gujarat launched its most ambitious research program yet. A new type of stent—a wafer-thin metal mesh scaffold that props open clogged arteries—had come into the market and was being hailed globally as a breakthrough in treating coronary heart disease.
The requirement of the new version
The USP of this stent, called “Absorb” and manufactured by Abbott Laboratories in Illinois, was that it would disappear in approximately three years, returning the blood vessel to a near-native state.
A disappearing stent, if you will. Abbott launched Absorb in India in Dec 2012, more than three years before the US approved it for sale.
Merril’s management wanted to produce its own version, but cheaper than Abbott’s Rs 1.95 lakh-device ($2,684). By 2017, they had developed “MeRes100”. Indian regulators soon approved it for sale. Merril claims it invested between Rs 150 and 200 crore ($21 to 27.5 million). It saw a big market—tens of millions of Indians die from cardiovascular disease every year and more than half a million people get stents. Even if Meril supplied a fraction of those people with its high-end device, it would laugh all the way to the bank.
But MeRes100 never launched in India.
Instead, the device got caught in a perfect storm of bad publicity and regulation. Rumors about Abbott’s Absorb having some risk of heart attack, thrombosis (blood clot) and death in patients surfaced, tainting MeRes100 by extension. In Sept 2017, Abbott pulled Absorb from the market.
Reporting to the US regulators
More than 500 injuries and deaths related to the device have been reported to US regulators. “There is a kind of atmosphere that’s been created because of Absorb that [MeRes100] will not work,” said Gautam Tripathy, national sales head at Meril. At the same time, Indian regulators capped stent prices at Rs 29,600, eating into Meril’s potential profits.
Meril claims it has succeeded where Abbott failed. That’d be remarkable; Meril’s revenue last year was $40 million (Rs 288 crore), 1/700th of Abbott’s $28 billion (Rs 2 lakh crore). And the company has yet to prove that MeRes100 is any better than existing stents, experts say.
In the wake of Abbott’s failure, Meril needs to up its scrutiny and follow hundreds of patients for multiple years before saying with confidence that its device is better than existing stents. That’d be the standard for approval in the US. And that’d cost hundreds of crores of rupees, money that few Indian device manufacturers have in their R&D budgets.
In fact, the economics of clinical trials makes such little sense for Indian companies that it was only the past weekend—more than 22 years after the development of the first Indian stent—that a domestic stent maker, Sahajanand Medical Technologies, completed a clinical trial that’s truly comparable to ones by multinationals like Abbott.
Meril has asked regulators for a price cap exemption so it can earn revenue and invest in readying MeRes100 for better-regulated markets. But if an exemption is granted, Indian patients might get implanted with an unproven device whose cousin failed spectacularly.
The Absorb Saga
Indian medical device companies make money by staying cheap. There are four ways to go about this: put in fewer features, invest less in R&D, maintain economies of scale or lower the labor cost.
Stent manufacturing is almost entirely automated, leaving little room to save on labor. Indian companies move less volume than major global players like Abbott, so it is challenging to achieve economies of scale. Their products tend to be well-featured. That leaves the fourth option. Companies invest less in R&D and their innovations tend to be incremental, not breakthrough.
Meril’s MeRes100 was built on the back of Abbott. Imagine a clogged blood vessel. To open it up, a doctor would perform an angioplasty and insert a tiny stent into the artery to prop it open. Stents are typically made of metal and once implanted, they will remain in the blood vessel for life.
The patient’s vessel never really gets back to normal, pulsating and constricting as a native one would. So, in 2003, Abbott began developing stents made of polymer that’d disappear after controlling the blockage. Following a successful clinical trial in 101 patients, Abbott received European approval in 2011. It began selling the stents in Europe in 2012. By December, Absorb had made its way into India.