Running Ahead of the Pack in Technology Development
Executive Summary
Device companies have historically kept innovation simple, giving doctors new tools that look and feel very much like what they've used in the past. But what happens when device innovation runs ahead of customers' willingness to adopt new technology?
In so doing, VP sheds new light on nearly a century of thinking about what causes acute myocardial infarctions, particularly in asymptomatic patients. If the VP proponents are right, these people often suffer heart attacks not because plaque gradually builds up inside coronary arteries until blood flow is blocked, but because inflamed macrophages cause plaque to erode and suddenly erupt, releasing thrombus.
What's amazing is how quickly physicians are jumping on the VP bandwagon. Maybe it's just wishful thinking, but companies developing tools to detect and treat it insist that cardiologists are amazingly eager to throw out everything they've ever learned about coronary artery disease and embrace an entirely new paradigm.
The implications for device companies are enormous. Not only does VP view coronary artery disease as biological rather than structural, but as more research emerges, clinicians are finding that, consistent with a biological process, VP is likely to be systemic, that is, patients with it are likely to have it not just in one artery, but in several.
For cardiovascular companies, that means that developing tools to treat focal problems with structure-enhancing features doesn't cut it. Therapies based on altering biological processes trump those that just take a mechanical or structural approach to coronary disease. Who needs a balloon or stent to prop open an occluded artery if the occlusion isn't the issue. Drug-eluting stents, in this view, have a role not just for their structural properties, but more importantly as a drug delivery vehicle.
It's tempting to see VP as heralding a new era for device companies, one in which they have to be attuned to biology and systemic, non-mechanical approaches to therapy. But in one sense, VP represents not a new way of thinking about device development and, by implication, business models, but the most radical manifestation of a trend that has been evolving for the past several years.
It's been axiomatic in the device industry that the only sure path to success is to design tools and instruments that look a lot like those already used, but deliver a better result; the more a device differs from those currently in the armamentarium, the harder it is to convince physicians to use it. Heartport remains the poster child for a company that was, technologically speaking, too smart for its own good.
Pharmaceutical companies don't run into this problem: because a drug is, intrinsically, a therapeutic agent, those based on radically different mechanisms of action usually don't face an adoption problem. But device companies do, precisely because their products are only instrumentally therapeutic agents. Comfort, ease-of-use, familiarity—all are major issues for surgeons or interventionalists, who have to make the devices deliver the desired therapeutic benefit. Even the thermography companies in VP are hoping that their devices' similarity to other cath lab tools will help lower adoption hurdles, at least in the short-run.
But as technology pushes ahead, a development model based on giving physicians new iterations of existing devices seems overly limiting. As companies incorporate robotics and nanotechnology, biologics and pharmaceuticals in their devices, those devices may look, feel, and work nothing like products they already sell.
The second generation of minimally invasive surgery ran aground because surgeons didn't like the tools, not because MIS proved less valuable. More than once in recent months, we've sat with physicians who've expressed skepticism about things device companies and their investors are hoping will be promising breakthroughs. We're already living in a world in which the technological capabilities of device companies have begun to run ahead of their customers' ability or willingness to embrace new technology. From robotics in surgery to biologics in orthopedics—in many fields, suppliers will lead, not follow doctors in the development of new products. In this regard, the rapid embrace by cardiologists of VP is an outlier; in most cases, a radically new device is greeted with silence and skepticism at best.
At this year's TCT meeting, Gregg Stone, MD, noted that, all for the good, we're entering the era of evidence-based medicine. Drug-eluting stents have caused a stir not because they're easy to use or feel good in a physician's hand, but because rigorous clinical trial data has proven that they dramatically reduce restenosis. In the future, devices will gain adoption not because of some subjective assessment on the part of physicians, but because objective clinical trial data establishes their value.
Still, there are lots of examples of intriguing new devices that are languishing because the technology is running ahead of clinicians' willingness to adopt. A couple of years ago, at the height of the dot-com boom, a surgeon at one conference argued that in a world shaped by the enormous information-processing capability of the Internet, surgeons would have to learn to live with "disruption, dislocation, and discomfort," i.e., with a new generation of tools that deliver superior clinical value, but don't conform to devices they currently work with. That may be the new business model for device companies, and ironically, the biggest success hurdle for those companies may not be technological issues, but adoption.