1 2/6/12 DRAFT 2012 R&D 100 Award Entry Form 1. Developer Information A. Primary submitting organization: Organization Name: RTI International, Engineering Technology Unit Contact Name of Individual Submitting this Entry: Charles E. Rodes, PhD Address: 3040 E. Cornwallis Road, P.O. Box 12194 City/State: Research Triangle Park, NC Zip/Postal Code: 27709-2194 Country: USA Phone: 919-541-6749 FAX: 919-541-6936 Email: charlesr@rti.org Web URL: www.rti.org B. Joint Submitters: none 2. Product Information A. Product Name: RTI MicroPEM™ The RTI MicroPEM was conceived in 2006 by RTI International and developed during the past 5 years using both internal research funds and NIH/NIEHS grant support (U01ES016093; Dr. Rodes, RTI principal investigator). This tiny personal aerosol exposure characterization platform has applications in both environmental health studies, and as a clinical monitor to help asthmatics better manage exposures that might trigger adverse health problems. The prototype system was first offered for sale in 2011 to potential research partners to both assist in validating the performance in the hand of users, but also to help identify system modifications that would be of greatest value in moving the unit to commercialization. Unlike simple environmental concentration sensors, the MicroPEM applies on-board accelerometry to predict breathing volumes (liters/minute) so the system can also estimate for the first time, potential aerosol dose levels in micrograms/minute/kg of body weight. Integrated innovations include: very low pressure drop components maximize battery life; full laminar flow design to reduce internal losses and maximizes service intervals; proprietary laser focusing maximizes sensitivity while minimizing the compactness of the optical bench; internal capture of all aerosol sampled allows both acute and chronic scale health impacts to be investigated; creative injection molding of numerous components reduces both size and weight with batteries to less than 1/4th that of the current technology; and parallel collection of critical QA data ready validation of the collected data. B. Product Photos: See Figures 2-1a and 2-1b. 2 2/6/12 DRAFT sound damping module b a c Figure 2-1a, b, c. examples of the RTI MicroPEM used to monitor aerosol exposures of an asthmatic adult while driving (a) and a child playing (c); with the system open to show the compact component layout (b). A diagram of the (black) inlet and optical bench assembly is provided in Figure 11-1. 3. Briefly Describe What the Entry Is: The MicroPEM is a personal aerosol dose characterization system that enables linking environmental pollutants with health and will allow users to manage respiratory diseases. 4. When was the Product First Marketed?: The version 3.2 dMicroPEM was first offered to the potential user community for purchase on July 20, 2011. The offer document can be viewed at the footnoted web site1 and described the technological advances and specifications, how the technology can be used in environmental health studies, and noted that the initial (CDC-funded) application was to evaluate the impacts of aerosols on asthma severity levels for children who resided temporarily in the FEMA-provided housing following hurricanes Katrina and Rita. The 120+ units needed to study these children was being expanded to an initial build of 200 units (see Figure 4-1) to allow a broader range of user testing to assist RTI in more fully identify capabilities and validating performance in real applications. The initial offer price was $1,990 per unit, which was at least 60% lower than potentially competing technologies, following innovative manufacturing cost reduction steps funded by RTI to not Figure 4-1. first 130 unit built and tested only providing a robust technology, but just as importantly, a technology that for full functionality was sufficiently cost-effective at this early stage to be moved directly into user applications. A weblink to a video clip describing the MicroPEM is 2 provided . 1 2 http:\www.rti.org.xxxxxxx http\www.rti.org/xxxxxx 3 2/6/12 DRAFT 5. Has this product or an earlier version been entered in the R&D100 awards previously?: No 6. Principal/Primary investigor, deloper, inventor, or team lead: Developer Name: Charles E. Rodes, PhD Position: Senior Fellow, aerosol exposure research Address: 3040 E. Cornwallis Road, P.O. Box 12194 City/State: Research Triangle Park, NC Zip/Postal Code: 27709-2194 Country: USA Phone: 919-541-6749 FAX: 919-541-6936 Email: charlesr@rti.org 7. Product price in US dollars: The initial offering price was $1,990. A provisional patent for the MicroPEM system entitled "Aerosol Exposure Monitoring" was filed on October 27, 2011, and assigned #61/551,660. Earlier patents were awarded on utilizing motion sensing to track wearing compliance of personal exposure devices, including Lawless, "Portable air sampling apparatus including nonintrusive activity monitor and methods of using same", #'s 6,327,918 and 6,502,469. 8. List any patents or patents pending: 9. Describe your product's primary function as clearly as possible. What does it do?: The need for the RTI MicroPEM was established during 15 years of attempting to study exposures to aerosols by adults and children whose health was being compromised if there were susceptible populations. The exposure technologies for such studies have been expensive and unwieldy and difficult to deploy at the breathing zone level, often resulting in substantial exposure biases. Translating robust pollution sensors to personal level platforms has been the holy grail for health-based panel studies, but is only now being realized. The new v3.2 MicroPEM allows simple deployment approaches to characterize exposure levels that truly represents what participant are actually breathing. Cellphone sized sensors carried by participants allow minimally-biased exposure estimates and the least-biased estimates for those who are most-exposed. While large and complex pollutant sensors have been available to size and characterize airborne aerosol levels in ambient air and indoor settings, it has become clear that these device define only the median and interquartile ranges for cohorts, and typically do not capture the 4 2/6/12 DRAFT scenarios when individuals are most exposed. Rodes et al. (2010)3 showed that personal level characterizations were required to have an certainty that the exposures above the 90th percentile were sensed and captured. Otherwise, the exposure data had a limited range and association with diseases were much weaker or not existent. Brook et al. (2010) for example, found that key cardiovascular functions showed stronger and consistent correlations with exposures made at the personal level than general data collected at neighborhood monitoring sites4. Langrish et al. (2012)5 recently demonstrated that reducing personal exposures to aerosols can result in substantial improvements in cardiovascular health, which is a very important finding for those with weak or compromised vasuclar system such as the elderly. Utilizing an easy to carry personal aerosol exposure monitor will allow sensitive individuals to identify periods of elevated exposures and take actions to minimize subsequent levels. An example of a period of elevated exposures is shown in the MicroPEM PM10 data (particles nominally less than 10 micrometers which can pass the thorax during breathing) shown in Figure 9-1, where unusually high levels were recorded in a busy restaurant. Figure 9-1. MicroPEM exposure data collected from vest pocket location showing low indoor levels, but elevated sidewalk and restaurant aerosol levels. 3 Rodes, C., Lawless, P. A., Thornburg, J. W., Williams, R. W, and C Croghan (2010) "DEARS Particulate Matter Relationships for Personal, Indoor, Outdoor, and Central Site Settings for a General Population", Atmos. Env., 44:11, 1386-1399. 4 Brook, R., Bard, R., Burnett, R., Shin, H., Vette, A., Croghan, C., Phillips, M., Rodes, C., Thornburg, J. and R. Williams (2010), "Difference in Blood Pressure and Vascular Responses Associated with Ambient Fine Particulate Matter Exposures Measured at the Personal Versus Community Level", Occup. Env. Med, 68:224-230. 5 Langrish, J. et al. (2012), "Reducing Personal Exposure to Particulate Air Pollution Improves Cardiovascular Health in Patients with Coronary Heart Disease", Environmental Health Perspectives, published on-line, http://dx.doi.org/10.1289/e3hp.1103898, January 3, 2012. 5 2/6/12 DRAFT Translating sensor technologies into miniature but robust exposure characterization platforms that can and will be carried by individuals at the personal level is clearly the path forward for making substantive improvements in public health. For aerosol exposures, the personal platform must have the performance levels needed to accurately and precisely size and sense the aerosol into fractions that can be directly related to health, and have a detection limit of at least 1 microgram per cubic meter. Devising such suitably sensitive, accurate and precise aerosol sensor systems that have low enough burden levels to be carried or worn easily has simply not occurred prior to the MicroPEM. Recent RTI focus group testing has shown that exposure sensors need to approximate the size and weight of current smart phones, weigh less than ~250g, and have add no more than 3 decibels of noise to the backgraound to be acceptable to most U. S. adults and children. The units must also be power-frugal such that an inexpensive battery pack (3 alkaline AA batteries) will operate the unit reliable for up to 48 hour. Otherwise, frequent and costly battery changes will discourage extended use in health management programs. But health impacts from air pollutants are based not just on the concentrations in the environment, but how much of the pollutant is actually inhaled during breathing. For the first time, the MicroPEM technology utilizes on-board accerometric Figure 9-2. Adult ventilation rate obtained from scripted testing data collections that can be while wearing an MicroPEM during a range of typical activities. utilized to estimate ventilation volumes (cubic meters/min) in real-time, and then translate exposure levels (e.g. in micrograms per cubic meter) into the true body burden potential doses being experienced by the respiratory system in micrograms per minute. This was enabled by by a research collaboration between RTI International, Columbia University, MIT, and Stanford University that showed that accelerometric data if processed correctly were related linearly to ventilation rates for adults and children for at rest and ambulatory activities. The example data in Figure 9-2 (based on Rodes et al., 2012) show how the ventilation rate for a participant increased compared with the at rest (lying down) rate. For the normal activity of walking at 4 mph, the breathing rate is 6 2/6/12 DRAFT three times that at rest. That mean aerosol doses taken into the body would be 3x that suggested by simplistic concentrations, substantially underestimating the potential health impacts. Figure 9-3. MicroPEM "docking station" software screen shot shows how laboratory linear regression data allow predicting ventilation rates (right side scale) and actual doses from simple concentrations. The innovative "docking station" software written in Visual Studio to support the MicroPEM, allows the ventilation rate to be predicted in real-time, so that the dose can estimated in realtime, based on the concurrent aerosol concentration. Utilizing potential dose instead of the concentration data is expected to significantly improve the strength of associations utilized to predict adverse health changes. This feature alone could revolutionize health studies of aerosol impacts, and greatly improve the prediction accuracy for a subject during clinical applications. Importantly, the MicroPEM also collects aerosol data at two very different time scales - 1) integrated over extended daily or weekly periods for diseases such as cancers which are minimally-sensitive to short term pollutant level changes, and 2) in real-time for 7 2/6/12 DRAFT cardiopulmonary impacts that are, such as the onset of asthma attachks or adverse changes in heart rate variability. The integrated collections are made onto filters that can be archived and examined at a later date if adverse health response changes are observed. Utilizing the MicroPEM for responders in disaster responses could substantially increase the understanding as to how responders may have inadvertently been exposed during periods when not wearing protective gear. Rodes et al (2008) strongly recommended that such technologies be made available to characterize exposures for responders and the public during and in the aftermath of disasters.6 The MicroPEM will now make those recommendation a reality. Since many referee standard measurements for pollutant concentrations are based on integrated collections, this duality allows less than ideal but very low cost real-time sensors to be utilized but then validated as necessary against the parallel referee sample for critical applications. This reduces the cost and complexity of the MicroPEM while assuring that validation of the accuracy can be provided on an as needed basis. aerosol flow 10. How does it operate? What science is involved?: typically <25mm laser scattered light Figure 10-1. The integrated MicroPEM 2-stage sizing inlet, optical bench with 10mm path length, and integrated filter holder. Note that this design is very compact, and innovatively designed to allow the laser diode to be within 25mm of the sensing volume without creating excessive stray light scattering. 6 The RTI MicroPEM integrates a number of technologies into the system in order to collectively advance the state of the science of characterizing aerosol exposures and and translating them into both concentrations and potential doses in real-time. A tiny, dual-stage impactor set (see Figure 10-1) only 15mm in diameter sizes the aerosol entering the unit, passing the aerosol to the 10mm optical bench path length completely in laminar flow. The extraordinarily low Reynold's number minimizes internal losses and maximize run time without servicing. The innovative optical bench design allows the source laser to be <25mm from the sensing volume to Rodes, C., Pellizzari, E., Dellarco, M., Erickson, M., Vallero, D., Reissman, D., Lioy, P., Lippmann, M., Burke, T., and B. Goldstein (2008), "ISEA2007 Panel: Integration of Better Exposure Characterizations into Disaster Preparedness for Responders and the Public", JESEE, 18:541 - 550. 8 2/6/12 DRAFT achieve compactness, while still providing very low stray scattered light levels for nephelometry. Excess stray scattering can overwhelm the sensitivity of the nephelometer, resulting in high noise, and poor sensitivity. Properly conducted nephelometery utilizes the light scattered from aerosol suspended in air and calibrated in terms of mass concentrations utilizing a variety of aerosol challenges in controlled calibration chamber settings. The relative consistency of mixtures of particle types and refractive indicies in most ambient exposure scenarios allows fairly simplistic calibration regressions to be applied. A combination filter holder/orifice assembly then captures the sensed aerosol on an archivable very-low-pressure drop 25mm OD teflon filter that can serve as the archived "referee" sample against which to normalize the real-time data in appropriate. A tiny, downstream carbon vane pump operating at 0.5 lpm, provides the convective flow needed to size, sense and capture the aerosol, while minimizing the power required to operate for extended periods. A tiny 5mm square triaxial accelerometer chip is located on the unit motherboard which is located just below the filter holder. This chip moves with the system, and the signal is processed on-board and saved at the appropriate rates to allow determining if and when the unit is being worn, and the expected ventilation rate of the person. Conversion of the accelerometric data to ventilation rates and doses is accomplished during concentration data downloading. RTI International has long been an advocate of the importance of know whether wearing protocols were being followed, and holds several patents on how this can be done (see Section 8). A 16 MB on-board memory provides ample storage for both concentration data and QC parameters such as flow rate, filter pressure drop, battery voltage, wearing compliance, temperature, and relative humidity. This QC data is automatically downloaded with the aerosol exposure data and is used to define the quality of each filter sample and data set. 11. What are the building blocks of your technology? Describe the materials, composition, construction, or mechanism of action: The RTI MicroPEM's most important building blocks are the sensitive, but low-cost nephelometer to sense sized aerosols, operating at 780 nm wavelength. The laminar flow integration of the filtration system into the optical bench provides a very low pressure drop and minimizes aerosol losses that could cloud the senor optics. The inclusion of a triaxial accelerometer on-board that has been calibrated to predict inhalation volumes is perhaps the most innovative single design element in the system. Integrating these features into an extremely low pressure drop flow system, coupled with an aggessive electronics power management system design that only energizes key components when needed, maximizes the operating period to up to 48 hours when operating on batteries. The physical integration of these key components combined with a proprietary sound damping chamber, has altered the 9 2/6/12 DRAFT both burden level and form factor for the wearer provide very acceptable levels for both children and adults. Providing both real-time data and filter sample integration simultaneously, allow studying a range of diseases with both very short and very long exposure response periods. RTI International has also invested in very cost-effective construction and assembly technologies to bring the system cost to amazingly low levels compared to the competition. This shift in the paradigm to substantially lower unit costs (see cost comparison with competition in Table 12-4), even with a near 10-fold increase in the technologies applied, is simply precident setting. It will also allow consideration of the MicroPEM for extremely large, nationwide-scale studies that provide maximal benefits for the health of national populations. To illustrate the importance of the latter feature, Dr. Rodes was asked (7/19/2011) to present a webinar discussion for the NIH-supported National Children's Study on how the MicroPEM would benefit an effort attempting to follow the exposures and health of 100,000 U. S. children from birth to age 217. 12. Product comparison: A. List competitors, brand names, and model numbers Since the MicroPEM integrates a filtration system into the real-time optical bench design capable of being utilized at the personal exposure level, two classes of current techology exposure characterization competitors must be listed (see Tables 12-1 to 12-4). The most widely recognized competitor for realtime monitoring of sized aerosols is TSI, Inc. while SKC, Inc. has the most comparable aerosol sampling systems for integrated collection on filters. While stand-alone personal accelerometry modules such as the Phillips Actiwatch 2 are available, none of the exposure sensor competitors (TSI or otherwise) can currently predict potential dose at the personal level. Products must also be low-burden enough to be utilized at the personal level (worn). The TSI SidePak AM510 is the only TSI aerosol sensor that can reasonably be worn, but is sold primarily as an occupational monitor for health adults. B. Supply a table showing how key features compare to existing capabilities Table 12-1a. Comparison of competitor system functional capabilities Vendor/ Technology Personal level capability? Integrated Filter Exposure? Real-time Aerosol Sensing? On-board QC data storage? Realtime Accel.? Real-time Potential Dose? RTI MicroPEM v3.2 TSI SidePak AM510 TSI DustTrak 8520 SKC Impact System 100-3901 YES YES YES YES YES na na YES YES YES YES na YES NO NO NO YES NO NO NO YES NO NO NO na -feature not available 7 see: http://www.nationalchildrensstudy.gov/research/workshops/Pages/Rodes-RTI-webinar-7-19-2011.pdf 10 2/6/12 DRAFT Table 12-1b. Comparison of competitor system functional capabilities (continued) Aerosol sizing accuracy better than +/- 15% for 24+ hr periods? Vendor/ Technology Uses accelerometry to determine protocol wearing compliance? RTI MicroPEM v3.2 TSI SidePak AM510 TSI DustTrak 8520 SKC Impact System 100-3901 YES NO NO NO YES NO YES YES Real-time precision better than +/- 10% Real-time detection limit of 1 g/m3? YES NO NO na YES YES YES NO na -feature not available Table 12-2. Comparison of real-time aerosol nephelometry range and sensitivity Vendor/ Technology Concentration range, gs/m3 (see note) Detection sensitivity, g/m3 Temperature bias, RTI MicroPEM v3.2 TSI SidePak AM510 TSI DustTrak 8520 0 to 12,000 0 to 20,000 0 to 100,000 1 1 1 0.5 1.0 1.0 g/m3/oC Note: concentration upper limits exceeding 1,000 g/m3, while useful in some occupational settings, are not useful in residential health studies for the general public, as air pollution standards for aerosol exposure are typically less than 100 g/m3, while changes of as little as 10 g/m3 can alter asthma severity levels. Table 12-3. Comparison of competitor system weights and battery life as a personal monitor Vendor/ Technology Approximate weight with batteries, g. Approx. battery life, hrs RTI MicroPEM v3.2 TSI SidePak AM510 TSI DustTrak 8520 SKC Impact System 100-3901 230 540 1,505 2,300 up to 48 29 24 24 Table 12-4. Comparison of competitor purchase cost estimates (US$) Vendor Technology Approximate purchase cost, $ RTI MicroPEM v3.2 $1,990 TSI SidePak AM510 $3,895 TSI DustTrak 8520 $4,800+ SKC Impact System 100-3901 $3,380 Phillips Actiwatch 2 $1,460* Note: Directly comparable costing to the MicroPEM technology integration is not available. The total for the TSI Sidepak AM510, SKC Impact System, and the Phillips Actiwatch at $6,855 is the most direct cost comparison with the MicroPEM v3.2 at $1,990. While the Actiwatch is cost-effectively price, it only characterizing motion. 11 2/6/12 DRAFT equivalent Performance comparison color shading key with MicroPEM key: reduced sharply reduced Thus, the RTI MicroPEM: has a much broader range of functionalities than any competitor is the only system to provide estimated dose levels in real-time has equal or better performance for all key metrics compared to the competition is at least 50% smaller and lighter will operate on batteries at least 50% longer is the only aerosol personal platform that weighs <300g and meets the threshold for children collects the necessary QC on-board to fully validate the collected sample and data monitors protocol wearing compliance to show the monitor is used as intended costs one third of comparable merged technologies, even in limited quantity production. C. Describe how your product improves upon competitive products As demonstrated by Tables 12-1 through 12-4, the MicroPEM technology either meets or excels compared to the competition in both individual specifications and - most importantly - overall functionality. To be of greatest use in linking exposures and doses to adverse health effects, the sensor system must be carried at the personal level8. Only the MicroPEM even comes close to being sufficiently low burden to be considered for children (see Figure 1b), which from RTI focus group studies simply won't tolerate a device that weighs much more than 350g for extended periods. The 40+ hour battery life can be extended to integration periods as long as 1 week (168 hrs) using the on-board MicroPEM system cylcing option. While the aerosol sensing performance of the MicroPEM is comparable to the competition, the very cost effective manufacturing cost (injection molded) for the key MicroPEM components reduces the purchase investment significantly. But exposure measurements in terms of concentrations only do not take into account how hard an individual is breathing at the time from elevated levels of physical activity. The MicroPEM has been calibrated over a range of physiological tests and found to be an excellent estimator of adult ventilation volumes in liters/min (Rodes et al. 2012)9. This dramatic advance in providing estimated dose levels rather than simplistic concentration levels, should significantly improve the strengths of associations between exposures and health risks, and eventually facilitate smaller (fewer participants) studies to reach the same conclusions, thereby reducing the cost of healthcare. D. Describe the limitations of your product 8 Rodes, C. and J. Thornburg (2012) "Breathing Zone Exposure Assessment", Chapter 2 in Aerosols Handbook: Measurement, Dosimetry, and Health, L. Ruzer and N. Harley, eds., CRC Press, New York, NY. 9 Rodes, C., Chillrud, S., Haskell, W., Intille, S., ALbinali, F. and M. Rosenberger (2012) "Predicting Adult Pulmonary Ventilation Volume and Wearing Compliance by On-Board Accelerometry During Personal Level Exposure Assessments", in review, Atmos. Env., RTI International, Research Triangle Park, NC, 27709. 12 2/6/12 DRAFT Building the MicroPEM prototypes in "build" quantities of 200 or so has reduced the cost over single units, but it still remains at a higher cost level than would be desired for large scale studies. Clearly, economony of scale productions are expected to reduce the cost another 50% at the 1,000 quantity level. Also, the MicroPEM system needs more field rather than lab validation data to fully define the operational accuracy and precision limitations in realistic applications for daily use among adults and children. Efforts to collect this performance data are underway (and supported by CDC) with submittal of a peer journal paper expected by March, 2012. The system also needs to undergo one additional level of miniaturization to reduce weight another 50g and alter it's form factor to be closer to that of smart phones which are readily carried by both adults and children. Reducing the front-to-back width of the unit by 50% would significant enhance user acceptance, and would be enabled by having a smaller aerosol filter of 15mm OD rather than 25mm, which is currently being discussed but not yet commercially available. 13. Product Use: A. Describe the principal applications of this product: The MicroPEM system was designed specifically to enable a wide of studies allowing environmental pollutant exposures at the personal level (participant-worn) to be linked to subsequent adverse health outcomes. These include so-called panel studies where hundred or thousands of participants are recruited to have their exposure levels studied for a selected period, along with monitoring changes in their health or diseases status. Status changes are frequently documented as changes in severity levels such as increases in the use of asthma rescue medication, or in extreme cases, visits an emergency room for treatment. Panel studies are also supported by both the National Institutes of Health (NIH) and drug companies to study the efficacy of interventions when exposure levels become excessive. These studies are crucial to understanding how best to protecting public health, how to set environmental standard levels that are meaningful, as well as allowing retrospective assessments of health problems potentially resulting from unexpected exposures, such as during and in the aftermath of disasters such as 9/11. B. List all other applications for which your product can now be used: The use of the MicroPEM as a clinical tool would help wearers understand how to manage diseases. This would include diseases such as asthma and COPD which can have rapid disease severity changes (e.g. asthma attacks) when exposure levels change unexpectedly in scenarios such as following a smoking bus in traffic, or being in a room when carpet vaccuuming is occurring. In order for the MicroPEM to be useful in clinical applications, its fundamental design would change. Currently the MicroPEM was designed to be used transparently by a wearer, with no effort to communicate exposure levels to the participant. But in clinical applications, a more robust user inferface would be added primarily a miniature display - driven by smart software to allow the MicroPEM to not only recogize elevated exposure levels, but also recommend potential corrective actions to the user to minimize subsequent health level changes from occurring. 13 2/6/12 DRAFT 14. SUMMARY - Why should our product receive an R&D100 award?: The RTI MicroPEM represents at least an order-of-magnitude leap in the technology to characterize aerosol exposures in supporting health studies and leading to improved health for those with compromised health. This breakthrough technology integrates a range of technologies that currently aren't merged by any vendor, while reducing a number of design barriers that have existed for such devices for at least two decades. The hurdles cleared - simultaneously - inlude dramatic reductions in system cost, noise level, burden level, and power requirements, with concurrent dramatic improvements in the utility of the system, and providing definable data quality for both the real-time data and the archivable filter sample. The ability to take simplistic concentrations to the next level and predict the users ventilation rate and predicted body dose, is by itself, a singularly huge advance over the current technology. This latter advance in the science has the potential to greatly strengthen risk estimates from environmental pollutants for a wide range of wearers, but will ultimately reduce the number of participants studied to reach the same conclusions, thereby significantly reducing research costs. Even though pilot testing is still in progress, the technology benefits inherent in being able to apply potential doses to estimate relative risks (RR's), instead of concentrations, could increase the RR levels by as much as 50%. This should require supporting fewer studies to define the body of data needed to robustly support setting standard levels for environmental monitoring, or defining the mitigation levels needed to produce substantive health improvements. Utilization of the MicroPEM in studies such as the upcoming National Children's Study would reduce the purchase costs of the sensors by as much as $1M for this study alone. Utilizing potential dose to test the study hypotheses instead of simple concentration could reduce the number of participants that need to be recruited by as much as 15 to 20%, dependant on the range of activity levels inherent in the children. Additionally, the MicroPEM has a huge potential to become a very important clinical tool in helping both families and care providers manage a range of cardiopulmonary diseases for compromised adults and children. While this capability has only been planned to date, the possiblities are simply huge. 15. AFFIRMATION - By submitting we affirm that this is a fair and accurate representation of this product: 14 2/6/12 DRAFT APPENDIX A: SUBMITTER INFORMATION 1. Contact person to handle all arrangements on exhibits, banquets, and publicity: Name: Patrick Gibbons Organization: RTI International Address: 3040 E. Cornwallis Road, P.O. Box 12194 City/State: Research Triangle Park, NC Zip/Postal Code: 27709-2194 Country: USA Phone: 919-541-6170 FAX: 919-541-6136 Email: pgibbons@rti.org 2. Contact person for media and editorial inquiries: Name: Patrick Gibbons Organization: RTI International Address: 3040 E. Cornwallis Road, P.O. Box 12194 City/State: Research Triangle Park, NC Zip/Postal Code: 27709-2194 Country: USA Phone: 919-541-6170 FAX: 919-541-6136 Email: pgibbons@rti.org APPENDIX B: DEVELOPMENT TEAM INFORMATION Team Member Name: Charles E. Rodes, PhD (lead developer) Position: Senior Fellow, aerosol exposure research Organization Name: RTI International Address: 3040 E. Cornwallis Road, P.O. Box 12194 City/State: Research Triangle Park, NC Zip/Postal Code: 27709-2194 Country: USA Phone: 919-541-6749 FAX: 919-541-6936 Email: charlesr@rti.org Team Member Name: J. Randall Newsome Organization Name: RTI International Position: Senior Systems Technician 15 2/6/12 DRAFT Address: 3040 E. Cornwallis Road, P.O. Box 12194 City/State: Research Triangle Park, NC Zip/Postal Code: 27709-2194 Country: USA Phone: 919-541-6715 FAX: 919-541-6936 Email: jrn@rti.org Team Member Name: James Carlson Organization Name: RTI International Position: Senior Microelectronics Systems Design Address: 3040 E. Cornwallis Road, P.O. Box 12194 City/State: Research Triangle Park, NC Zip/Postal Code: 27709-2194 Country: USA Phone: 919-248-9238 FAX: 919-248-1955 Email: jcarlson@rti.org Team Member Name: Jeffrey Portzer Organization Name: RTI International Position: Senior CAD Systems Desing Address: 3040 E. Cornwallis Road, P.O. Box 12194 City/State: Research Triangle Park, NC Zip/Postal Code: 27709-2194 Country: USA Phone: 919-541-8025 FAX: 919-541-6936 Email: Team Member Name: Bradley Handziuk Organization Name: RTI International Position: Software Programming Design Address: 3040 E. Cornwallis Road, P.O. Box 12194 City/State: Research Triangle Park, NC Zip/Postal Code: 27709-2194 Country: USA Phone: 919-541-1257 16 2/6/12 DRAFT FAX: 919-541-6936 Email: bhandziuk@rti.org Team Member Name: Ryan Chartier Organization Name: RTI International Position: Software Programming Design Address: 3040 E. Cornwallis Road, P.O. Box 12194 City/State: Research Triangle Park, NC Zip/Postal Code: 27709-2194 Country: USA Phone: 919-541-6057 FAX: 919-541-6936 Email: rchartier@rti.org Team Member Name: Jonathan Thornburg, PhD Organization Name: RTI International Position: Aerosol Exposure Engineer Address: 3040 E. Cornwallis Road, P.O. Box 12194 City/State: Research Triangle Park, NC Zip/Postal Code: 27709-2194 Country: USA Phone: 919-541-5971 FAX: 919-541-6936 Email: jwt@rti.org Team Member Name: Phillip Lawless Organization Name: RTI International (Retired) Position: Aerosol Physicist Address: 3040 E. Cornwallis Road, P.O. Box 12194 City/State: Research Triangle Park, NC Zip/Postal Code: 27709-2194 Country: USA Phone: FAX: Email: