Outcomes from a postgraduate biomedical technology innovation training program: the first 12 years of Stanford Biodesign.

The Stanford Biodesign Program began in 2001 with a mission of helping to train leaders in biomedical technology innovation. A key feature of the program is a full-time postgraduate fellowship where multidisciplinary teams undergo a process of sourcing clinical needs, inventing solutions and planning for implementation of a business strategy. The program places a priority on needs identification, a formal process of selecting, researching and characterizing needs before beginning the process of inventing. Fellows and students from the program have gone on to careers that emphasize technology innovation across industry and academia. Biodesign trainees have started 26 companies within the program that have raised over $200 million and led to the creation of over 500 new jobs. More importantly, although most of these technologies are still at a very early stage, several projects have received regulatory approval and so far more than 150,000 patients have been treated by technologies invented by our trainees. This paper reviews the initial outcomes of the program and discusses lessons learned and future directions in terms of training priorities.

Troponin: messenger or actor?

Cardiac troponin (cTn) is a biomarker of myocardial damage. New generations of high-sensitivity assays find circulating cTn in virtually all subjects. Multiple studies in various populations and patient groups have found higher levels of cTn to be predictive of future heart failure. The author proposes that initial myocardial damage from various mechanisms may lead to anti-cTn antibodies that participate in ongoing myocardial damage that eventually results in heart failure.

Assessment of left ventricular function by echocardiography: a technique in evolution.

One of the earliest applications of clinical echocardiography was the evaluation of left ventricular (LV) size and function. The accuracy of the determination of global and regional LV function with echocardiography has improved as the technology has matured. The following paper discusses the advances in LV function assessment starting with Inge Edler's original A-mode and M-mode observation moving through two dimensional echocardiographic methods to new three dimensional echocardiographic assessment and even new Doppler and speckle myocardial methods. During the evolution of ultrasonic assessment of LV function, each new method has overcome limitations of previous ones, resulting in better appreciation of the LV geometry and volume and improved accuracy and reproducibility for quantitation. As discussed in this report, many of the echocardiographic methods used today to assess LV systolic function were envisioned by Harvey Feigenbaum more than 25 years ago. The future will undoubtedly see a new method of clinical cardiology care but with continued evolution, echocardiographic quantitation of LV function should remain a vital part of patient care.

Comparison of three-dimensional echocardiography to two-dimensional echocardiography and fluoroscopy for monitoring of endomyocardial biopsy.

Real-time 3-dimensional echocardiography (RT3DE) offers the rapid acquisition of quantitative and qualitative anatomic data without the use of geometric assumptions. This study was designed to test the feasibility and potential superiority of RT3DE versus 2-dimensional echocardiography (2DE) and standard fluoroscopy for monitoring endomyocardial biopsies (EMBs). Thirty-eight consecutive EMBs performed under fluoroscopic guidance in 26 patients were monitored using 2DE and RT3DE alternately. Two reviewers scored each biopsy pass for visualization of the tip of the bioptome and location of the actual biopsy. Overall image quality was noted as good or poor, and the effect of image quality on tip localization was analyzed. A total of 243 biopsy attempts were made during 38 EMBs. The location of the biopsy was determined in 74% of the biopsies monitored with RT3DE, whereas 2DE demonstrated the location with certainty in only 43% of the biopsies (p <0.0001). On a procedure-by-procedure comparison, RT3DE was found to show the bioptome tip better in 23 of 38 biopsies, compared with 1 of 38 for 2DE (p = 0.001). In 14 of 38 EMBs, neither method was clearly better. In conclusion, RT3DE improves the ability to see the location of the bioptome during EMB compared with 2DE and fluoroscopy.

An outline for public registration of clinical trials evaluating medical devices.

Public registration of clinical trials is fundamentally important to the integrity of the medical device development process. In addition to fulfilling obligations to those study volunteers, a complete record of trial results provides the general public, clinical community, and medical device manufacturers with a more accurate understanding as to how a specific therapeutic should be used. Although the issues associated with public disclosure of clinical trials are similar to the pharmaceutical industries, the iterative nature of device development introduces differences in what type of information needs to be disclosed during development and commercialization. The Second Dartmouth Device Development Symposium (3D2) held in October 2004 brought together thought leaders representing many of the stakeholders associated with medical device development. This consensus document arising from the proceedings of the 3D2 is offered to provide background to these issues and recommend pathways to implementation of device trial registration.

Conflict of interest.

The clinical research enterprise is increasingly scrutinized, in part because of the issue of conflict of interest. The issue is broad and its implications touch on a wide range of concerns, from the safety of patient care to the viability of a large industry. Numerous constituencies are affected by conflict of interest, and representatives of all of them convened in November 2002 for a one-and-a-half day discussion of the issues as well as possible solutions to both the perception and the actuality of such conflict. Participants included medical journal editors, news reporters, physician investigators, representatives of institutional conflict-of-interest oversight committees, representatives of the medical products industry, and Federal regulators. The resulting manuscript provides a review of the issues as well as desirable ways for each of the players to monitor themselves; each section thus contains provocative recommendations for eliminating conflict of interest to ensure that our vibrant health care system continues to foster exciting new advances to improve patient care.

Reversal of Phen-Fen associated valvular regurgitation documented by serial echocardiography.

We report a case of anorexigen-associated moderate to severe aortic and mitral regurgitation in which the regression of lesions was marked and well documented over more than 2 years. The stability of our patient, as well as the degree of regression of regurgitation documented in our patient, and others, suggests it is prudent both to observe such patients and to avoid operation until such observation has been carried out.