An interview with Eberhard Grube, one of Germany's leading interventional cardiologists and a pioneer in medical devices who's had a role in changing the mindset of European physicians to bring together clinical practice and new product development. Grube discusses the role of the physician as clinical investigator, and the European perspective on product development.

As interest in vulnerable plaque heats up, medical device companies hope to capitalize on their earl y lead. But as vulnerable plaque shifts therapies from structural to biological, that lead many not last long. The second of a two-part series.

Vulnerable plaque is the hottest cardiovascular device opportunity in years. But in shifting thinking about coronary disease from structural to biological processes, it challenges what it means to be a device company. As more evidence suggests vulnerable plaque is a systemic rather than local problem and as the underlying assumptions about coronary disease shift from a structural view to a biological one, conventional device approaches are challenged.

Recent research points to unstable, rather than stenotic plaque, as a major cause of heart attacks. Cardiologists, as much as entrepreneurs and large companies, are therefore driving the creation of new cardiac detection platforms based on characterizing arterial plaque in order to identify patients that are unaware that they are at risk of suffering a myocardial infarction. First-generation detection tools are well along in development, but the scientific understanding about plaque is evolving so rapidly, technologies may be obsolete by the time they are ready for commercialization. Finally, looking for heart attack risk in symptomless patients means screening apparently healthy patients based on risk factors. Clinicians aren't yet prepared for the treatment implications and payers aren't ready for the economic burden of widespread screening, and this presents one of the greatest challenges for companies introducing new plaque detection technologies.