BioAssets: Convergence as Marketing Play

If the current controversy about drug-eluting stent safety proves anything—the nervous debate whether, according to a number of clinical studies reported this fall, drug-eluting stents (DES) lead to higher thrombosis rates than bare metal stents—it’s that, from a product development point of view, the combination of drugs and device technology may be even more difficult than many people—especially device executives--anticipated. Particularly where DES are concerned, most device companies—who have led the charge in true drug/device convergence—sought to mitigate the inherent pharma risk of convergence by using compounds already on the market, focusing instead on refining the traditional device attributes, such as ease of use and delivery, of their combination products. The emergence downstream of reports of higher incidence of thrombosis years after implantation of the stent is the kind of safety risk that pharmaceutical companies routinely prepare themselves for, but that device companies rarely do—the safety and efficacy of most devices are matters of procedural success and therefore known almost immediately. For this reason alone, the safety controversy has huge implications not just for DES themselves, but for device companies pursuing convergence strategies more broadly, raising the fundamental question: can device firms truly mitigate risk when pursuing drug/device combinations? (See "At TCT, DES Use and Safety Concerns: Irrational Exuberance or Irrational Anxiety?" IN VIVO, November 2006. Also see "At TCT, DES Use and Safety Concerns: Irrational Exuberance or Irrational Anxiety?" - In Vivo, 1 November, 2006.)

But risk mitigation in most convergence categories is almost entirely a matter of product development. What if drug/device convergence—the combination...