Technology Evolution: Is It Survival of the Fittest? Anthony Zietman, Michael Goitein, and Joel E. Tepper From the Massachusetts General Hospital; Harvard Medical School, Boston, MA; and the University of North Carolina/Lineberger Comprehen- sive Cancer Center, University of North Carolina School of Medicine, Chapel Hill, NC. Submitted March 25, 2010; accepted June 25, 2010; published online ahead of print at www.jco.org on August 9, 2010. Authors’ disclosures of potential con- flicts of interest and author contribu- tions are found at the end of this article. Corresponding author: Joel E. Tepper, MD, Department of Radiation Oncol- ogy, CB #7512, 101 Manning Dr, University of North Carolina School of Medicine, Chapel Hill, NC 27599-7512; e-mail: tepper@med.unc.edu. © 2010 by American Society of Clinical Oncology 0732-183X/10/2827-4275/$20.00 DOI: 10.1200/JCO.2010.29.4645 A B S T R A C T New technologies are constantly being developed and introduced into medical practice. Their potential or actual use raises questions of efficacy and cost. All too often financial considerations of profit primarily determine whether a technology will be adopted. In an era in which the need to control costs has become clear, this situation is undesirable. The assessment of efficacy can, however, be very difficult, and the control of financial aspects is likewise problematic. In this article, we address these problems and suggest potential solutions, using proton radiotherapy as an example that may be relevant to the development of other medical devices. J Clin Oncol 28:4275-4279. © 2010 by American Society of Clinical Oncology TECHNOLOGY EVOLUTION The term technology transfer is frequently em- ployed in the context of the adoption of new tech- nology, and this use is appropriate when the technology involves novel and untried aspects— as, for example, when magnetic resonance imag- ing was introduced. There is, however, another scenario that is much more common: a steady incremental development and improvement of existing, already transferred, technology. In radio- therapy, for example, there has been an evolution in treatment machines from orthovoltage x-rays to Cobalt-60 gamma-rays to linear accelerator- generated x-rays of increasingly higher energy. Such changes are generally efforts to improve efficacy and/or usability. We term this scenario technology evolution. In technology evolution, both the ex- pected changes in efficacy and the cost increases of each change may be modest, even if the net effect is substantial. Incremental evolutionary advances in technology tend to be made frequently, making ob- jective evaluation of cost-benefit extremely difficult. It is therefore unrealistic to imagine that such ad- vances can all be tested in formal clinical trials. DIFFERENCES BETWEEN NEW DRUGS AND A NEW OR EVOLVING TECHNOLOGY In the United States, medical devices are regulated differently from drugs. Each drug is a distinct bio- logic entity and is required to demonstrate medical efficacy with acceptably few adverse effects, while devices only have to do what they are supposed to do, and do it safely. Devices, particularly when they result from technological evolution, tend to provide a superior tool rather than new biology. Even in the application of basic biologic sciences to medicine, technology is refining the wave of the future. For example, the development of genomics, proteomics, and metabolomics are advances primarily of tech- nology and will depend on medical devices for their proper implementation. PROTON THERAPY Proton therapy represents a useful example of tech- nological evolution. It is an evolution in the sense that protons are very similar to well-established x-rays in that they deliver ionizing radiation with well-understood biologic effects, but they do so with an improved distribution of dose. In contrast, be- cause of the size of the investment required to estab- lish a large proton therapy center with three to four treatment rooms— currently on the order of up to $150 million—the use of protons represents an illus- trative extreme. The advantage of accelerated protons comes from the fact that they have a finite range in material, depositing essentially no dose beyond their end of range, and exhibit a sharp increase in dose near the end of range (the Bragg peak). 1 Consequently, an appropriately tailored proton beam completely spares the uninvolved normal tissues distal to the target, and generally deposits a lesser dose than that delivered to the target proximal to it. This is in contrast to conventional x-rays in radiation ther- apy that deliver substantial dose to normal tissues distal to the target. In terms of the relative cost of a single-treatment fraction, a published study 3 estimated that proton therapy was at present more JOURNAL OF CLINICAL ONCOLOGY S P E C I A L A R T I C L E VOLUME 28  NUMBER 27  SEPTEMBER 20 2010 © 2010 by American Society of Clinical Oncology 4275 Downloaded from ascopubs.org by 18.212.127.198 on June 6, 2022 from 018.212.127.198 Copyright © 2022 American Society of Clinical Oncology. All rights reserved.