Time was when a device was a device, a drug was a drug and biotech was . . . well, still in R&D. When is a device a device? When is a duck a duck? If it walks like a duck, sounds like a duck and looks like a duck, it’s a duck — or is it? You have to make certain that you carefully define your assumption of what defines a "duck" versus what is like a duck in appearance or what has duck-like qualities or what has aquatic grazing tendencies similar to ducks but in fact is a quite unrelated waterfowl.
Over the recent past (say, five years), the steady rate of development to make products do more, perform at higher standards, and to play more roles in achieving a more aggressive goal in clinical outcomes is seriously complicating any effort to categorize a technology into such previously neat niches. And it isn’t just at these higher levels of definition (of course, devices like stents are coated to impede restenosis, others in tissue engineering are made of materials designed to stimulate cellular in-growth and then just dissolve); it’s the subtle distinctions between otherwise similar products that make some issues more blurry. Issues like trying to assess market potential. So, when is a fibrin sealant a glue and when is it a hemostatic agent? When does a device compete with a similarly designed device and when does it in fact compete with a lifestyle change? It’s not simple enough anymore to be able to distinguish equipment from reusables. We no have to be able to separately measure usage of disposables, reusables and (I abhor this term) reposables. Perhaps most importantly, at least in the eyes of the weary medtech manufactuters, is the idea that competition has long since been changed from being defined as those products performing a similar, albeit narrowly-defined function, like when the angioplasty manufacturer could reasonable consider his/her competitors to be all other manufacturers of devices that produce catheter-based recanalization of the atherosclerotic lumen. Oh, woe the angioplasty manufacturer who does not now also consider atherectomy, transmyocardial laser revascularization, bare metal stents, drug-eluting stents, traditional/open, MIDCAB (and similar) or and even percutaneous coronary artery bypass graft, let alone the classes of drugs and other non-device approaches to produce non-surgical reversal of atherosclerosis. But any analysis of an established market and/or technology sector (see MedMarket Diligence Reports), must find a way to wrap up the data and weigh it in specific "market segment" bundles. As carefully as any such effort is handled, with assumptions laid out carefully, rarely is it any guarantee (trust us on this score) that all clients will see any particular market the same way, and they will be all too ready to challenge the notion of a hemostat, calling it instead a sealant, or a glue or some other moiety of their choosing, or insisting that a <5% market share does not make a company a "minor" player. To argue this is, of course, their perogative. So, bear with those like us when, however tedious it may seem, we methodically define a duck in excruciatingly explicit term so we can ensure that we gotten all "ducks" in a row and counted.
See a selection of our reports here.