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4 Development and Regulation of New Technologies
Pages 133-166

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From page 133...
... At the same time, biomedical research has become more complex and capital intensive, requiring enormous investments to develop technologies and to generate and analyze data. Traditionally, basic research and the early stages of medical technology development were the realm of government-funded projects at universities or the National Institutes of Health, whereas private companies were primarily involved in bringing technologies to the market and the clinic.
From page 134...
... A relative lack of patent protection can further diminish financial incentives and increase the risk for developing new technologies. New medical devices usually have some patent protection, but effective market exclusivity for devices is often shorter than the life of the patent because competitors can "invent around" device patents more easily than around new molecular entities like drugs (Medical Technology Leadership Forum, 1999~.
From page 135...
... Departments of Defense, Energy, and Commerce, and the Health Care Financing Administration. The initial goal of the consortium was to catalog the state of the art for breast imaging modalities and to identify the scientific and technological needs for application of the technologies to breast cancer detection, diagnosis, and treatment.
From page 136...
... 5 has more than $22 million in funding from NCI for a 5-year period. ACRIN's fundamental objectives are to assess the value of emerging and established medical imaging tools by evaluating their effects on patient outcomes and costs, to increase participation in clinical trials, and to train researchers in conducting clinical trials.
From page 137...
... Compared with the traditional two-step grant application process, which can be cumbersome, the Phased Innovation Award allows a single grant application for two previously distinct awards. The new award permits flexible research programs for up to 4 years.
From page 138...
... bAny project involving actual detection of breast tumors (screening, diagnosis, clinical trials) , development or refinement of diagnostic techniques or devices, education, or promotion of breast cancer detection.
From page 139...
... SOURCES: NCI. Anna Levy, NCI Office of Women's Health; Marilyn Gaston, NCI Inquiry and Reporting Section; Rosemary Cuddy, NCI Division of Extramural Activities.
From page 141...
... Key components of the strategy include supporting planning grants in national centers of excellence, furthering investigator-initiated research, bolstering the Information Storage, Curation, Analysis, and Retrieval program, coordinating work across the National Institutes of Health (NIH) , and building a computing infrastructure.
From page 142...
... of target cells in the context of the clinical settings for posttreatment recurrent neoplastic disease and metastatic disease and early subclinical or undetected preneoplastic disease. The aim of the project is to construct and demonstrate a prototype compact device that may be used in a variety of biomedical applications including in vitro and in viva spectroscopy and high-resolution imaging, mammography, diagnosis, and radiation therapy.
From page 143...
... was earmarked for research in mammography and breast imaging with the goal of applying military technology to mammography to improve its accuracy. The objective of BCRP is to fund the training of new scientists in the field, infrastructure enhancement, and investigator-initiated research with a balanced portfolio of research on the prevention, detection, diagnosis, and treatment of breast cancer (Table 4-4~.
From page 144...
... .12 The goal of ATP is to stimulate innovation by bridging the gap between the research laboratory and the marketplace. Through partnerships with the private sector, ATP's early stage investments aim to accelerate the development of novel technologies that promise significant and widespread benefits for the nation, in addition to a direct return to the innovators.
From page 145...
... DEVELOPMENT AND REGULATION OF NEW TECHNOLOGIES 145 Detection, Diagnosis, and sis Treatment - Total No. Awards Dollars No.
From page 146...
... About 80 percent of medical device companies are start-ups with less than 50 employees and thus have limited resources at their disposal to generate data and evidence for approval. The devices may cost thousands of dollars each, making distribution of devices for the purpose of conducting clinical trials very expensive.
From page 147...
... In 2000, more than 50 percent of venture capital money in health 7000 6000 In ~ 4000 o o . _ 5000 3000 2000 1 000 o 1997 1998 1999 2000 Healthcare Services 1111111 Medical Devices ~ Biotech + Pharma FIGURE 4-1 Venture capital investments in health care industries, 1997 to 2000.
From page 148...
... Furthermore, the percentage of total venture capital investment going into health care has plunged from about 25 percent traditionally to about 8 percent by the end of 2000 (Figure 4-2~. Only 2.5 percent of all 2000 venture capital investments was devoted to medical device companies (Figure 4 3~.14 Venture capital firms may view investment in the diagnostic and device areas of the health care sector as a high-risk proposition because of the length of time required to produce data for FDA approval and insurance coverage decisions and because of the uncertainty associated with those decisions.
From page 149...
... To understand the specific issues of FDA approval of technologies for breast cancer screening and diagnosis, it is necessary to first look at the general processes used by FDA. Technologies for the early detection of breast cancer will most likely involve either imaging devices or clinical laboratory devices, so the general description of FDA procedures provided here will focus briefly on these categories, which are overseen by the Center for Devices and Radiological Health of FDA.17 15Total retail prescription drug sales in 1999 were $121.7billion (http://www.nacds.org/ ; accessed December 15, 2000~.
From page 150...
... 150 be .~ H U V)
From page 151...
... , medical devices must now undergo an FDA review before being introduced into the market. There are two major pathways to FDA approval, known as "premarket notification" [510(k)
From page 152...
... does not provide a useful model of the development and approval process for screening and
From page 153...
... , not a device manufacturer (Shapiro, 1997~. Furthermore, because X-ray mammography was already in clinical use at the time of passage of the Medical Device Amendments of 1976, it was not required to undergo a rigorous FDA approval process to demonstrate safety and effectiveness (rather, it was "grandfathered [for more detail, see below and Chapter 5~.
From page 154...
... . However, FDA approval of detection technologies generally does not focus on clinical outcomes (Houn et al., 2000~.
From page 155...
... designed to assess effectiveness in clinical practice, assess cost-effectiveness, or test new indications for a drug that is already on the market. TABLE 4-7 Paradigm for Developmental Phases of Diagnostic Devices Trial Phase Design, Objective, and Endpoint Stage I (discovery)
From page 156...
... These include palpation aids, mammography, CAD, ultrasound, electrical impedance, scintimammography, MRI, thermography, infrared imaging, biopsy techniques, and ductal ravage (see Chapters 1 to 3~. To take a closer look at the FDA approval process for breast cancer detection devices, the remainder of this chapter examines several case studies in greater detail.
From page 157...
... The other problem with an agreement study is that even if a new technology is superior to the current standard, it would still fail the equivalency requirement because the difference in performance would be considered nonagreement. The Radiological Devices Panel met again in 1998 to discuss alternative study design options, but the members of the panel could not reach a consensus on how to proceed, so in September 1999, the agency issued letters to various FFDM sponsors requesting that they each discuss individual applications with FDA.
From page 158...
... 1999 Third FDA Radiological Devices Panel meeting on digital mammography Jan. 2000 FDA grants General Electric premarket approval, with conditions Nov.
From page 159...
... Similarly, the BioScan system, a thermal imaging device manufactured by OmniCorder, was cleared by the 510(k) process for use as a diagnostic adjunct for breast cancer detection.25 The device was deemed equivalent to other thermal imaging tech22Radiological Devices Panel Meeting Transcript, December 16,1999.
From page 160...
... The FDA policy and requirements for approval changed multiple times during the approval process. Throughout the discussions the advisory panel struggled with questions of whether digital mammography qualified as a "new" technology and how to define "safety and effectiveness." On the one hand, digital mammography exposes women to a similar level of ionizing radiation as analog film mammography, thus posing no additional direct physical harm to the woman.
From page 161...
... 1 ~ · 1 1 -- 1 1 1~ ~1 Q" US ~ 1~1 1 U1 ~ 1~1 ~ L1~ U1" L~ L1 1" ~ ~ 1~ coi~ectecr truck can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells." The label specifies that the device should be used only as an "adjunct to standard breast cancer detection methods, including mammography and physical exam." However, the company has not conducted clinical trials to determine the sensitivity and specificity of this technique and has not compared it with other screening and diagnostic methods. Thus, FDA required a precautionary statement in the label to indicate that "sensitivity/specificity data for ductal cytology from well controlled clinical trials is not currently available.
From page 162...
... TransScan is conducting additional studies to further validate the technology, as required by FDA as part of its premarket approval process. Post-approval studies must look at the clinical use of the T-Scan 2000 device and any consequent changes in sensitivity and specificity, as well as the effects of the menstrual cycle on the performance of the device.30 28Radiological Devices Panel Meeting, Center for Devices and Radiological Health, FDA, November 17,1997 (http://www.fda.gov/ohrms/dockets/ac/97/transcpt/3353tl.pdf)
From page 163...
... The Radiological Devices Panel reviewed the application in May 1998, and in June 1998, R2 Technology was granted premarket approval of its M1000 ImageChecker. FDA approved the technology on the condition that a post-approval study be performed to more accurately assess the effect of the device on the rates of truepositive and false-negative results.
From page 164...
... For medical devices, the FDA approval process adds an additional level of risk to the development process (as can coverage decisions, which will be discussed in the next chapter)
From page 165...
... The recently launched ACRIN trial for the study of digital mammography may provide an example of how screening studies could be conducted under this proposed mechan~sm. FDA approval is only the first hurdle that new technologies face once they have been developed.
From page 166...
... The authors of that report concluded that the underuse of screening mammography to detect breast cancer early, in conjunction with lack of adherence to diagnostic standards and treatment regimens, leads to reduced survival rates and, in some cases, compromised quality of life. A great variety of interventions targeted toward women have been developed with the intent of increasing breast cancer screening rates, including multimedia educational interventions and peer counseling.


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