Applications and Marketability Benjamin Babineau Matthew Best Sean FarrellOutline Why This Project? Background Types of Biosensors Applications Commercially Available Biosensors Marketability Work Breakdown Schedule Resources Why This Project? Thereisagreatneedtocreatebiosensorsthatare mass-producible In the health field, it is imperative that the maximum amountofpeoplehaveaccesstoearlywarning diagnoses This project will attempt to bring understanding as to whycompaniesstrugglewithmanufacturing biosensors on a large, inexpensive scale Byexaminingandemployingeffectivemethodsthat havebeenusedtodate,commercialbiosensorscan become more prolific Background What is a biosensor? Analyticaldeviceforthedetectionofananalytethat combines a biological component with a physicochemical detector component Components Sensitive biological element Transducer or detector element Electronics and signal processors Background Detection Methods Photometric Opticalbiosensorsusethephenomenonofsurfaceplasmon resonance (SPR) Surfaceplasmonsaresurfaceelectromagneticwavesthat propagate in direction parallel to metal/dielectric interface. Excitation by light Electrochemical Electrochemicalbiosensorsuseareactionthatproducesor consumes electrons Background Ion Channel Switch Ion channel used to offer highly sensitive detection of target biological molecules Piezoelectric Uses crystals which undergo an elastic deformation when an electrical potential is applied Detects changes in the resonance frequency Other Methods Thermometric Magnetic Types of Biosensors (Analytes) Enzyme Electrode Enzymes Enzymes are immobilised on the surface of an electrode Current is generated when enzyme catalyses Immunosensor Antibodies Detects change in mass when antibody binds to antigen DNA Sensor DNA Microbial Sensor Microbial Cells Types of Biosensors (Detection Mode) Electrochemical Potentiometric Amperometric Voltametric Optical Florescence Adsorption Reflection Electrical Surface conductivity Electrolyte conductivity Types of Biosensors (Detection Mode) Mass sensitive Resonant frequency of piezocrystals Thermal Heat of reaction Heat of adsorption Applications Medical Glucose monitoring in diabetes patients Detection of pathogens In-home medical analysis and diagnosis Environmental Detection of pesticides and water contaminates Determining levels of toxic substances before and after bioremediation Detection of metabolites such as molds Remote sensing of airborne bacteria Food Industry Detection of drug residues, such as antibiotics and growth promoters, in food Commercially Available Biosensors Medical Industry Home Blood Glucose Monitors Precision Xtra ReliOn FreeStyle Lite OneTouch Ultra Medical Industry Home Blood Glucose Monitors (Continued) Determinesapproximateconcentrationofglucoseinthe blood Used mainly with people who have diabetes or hypoglycemia How They Work Today, most glucose monitors use an electrochemical method Glucoseinbloodreactswithanenzymeelectrodecontaining glucose oxidize The enzyme is reoxidized with an excess of mediator reagent Themediatorisreoxidizedbyareactionattheelectrodeanda current is created Thechargepassingtheelectrodeisproportionaltoglucose level Medical Industry i-STAT Portable Clinical Analyzer Handheld blood analyzer system Medical Industry i-STAT (Continued) Provides fast, accurate, and lab-quality results within minutes to accelerate decision makingprocess How It Works Uses Si in the sensor cartridge as a substrate and a conducting base; electronics are housed in thehandheld device Sensors are micro-fabricated thin film electrodes Depending on particular assay the electrical signalsproduced are measured by the i-STATs amperometric, potentiometric, or conductometric circuits. Environmental Industry Inagriculturalindustry,enzymebiosensorsareusedto detecttracesoforganophosphatesandcarbamatesfrom pesticides Oneofthemostsuccessfulcommercialbiosensorsin industry is used in wastewater quality control Biological oxygen demand analyzers Thoughlesslucrativethanmedicaldiagnostics,public concern and government funding is a large driving force for environmental biosensors Measurement of pollutants and environmental hazards Surface plasmon resonance (SPR) biosensors are most successful Environmental Industry inoLab BSB/BOD 740 Wastewater control Environmental Industry inoLab BSB/BOD 740 Laboratorydissolvedoxygenmeterforwastewater control BOD is a parameter used to measure the quality of water and treatment results in wastewater Developed for BODn measurements Described in Standard Methods for Examination of Water and Wastewater Management of up to 540 diluted samples Up to 7 daily routines for dilution ratios Food Industry Qualityisextremelyimportantthussoundand accurate biosensors are necessary Enzyme-based biosensors are common in this industry Measureaminoacids,carbohydrates,gases,alcohols, and much more Othercommerciallyavailablebiosensorsinclude antibody-based and nucleic acid based biosensors Mainly in trial and research laboratories Expected to yield substantial returns in the future Food Industry Specificfoodmarketsthatusebiosensorsinclude alcohol (wine and beer), yogurt, and soft drinks Immunosensorsareusedtoensurefoodsafetyby detecting pathogens in fresh meat, poultry, and fish In this particular market problems arise that limit use or effectiveness of biosensors Needforsterility,frequentcalibration,andanalyte dilution Niche Market Zeo Designed to analyze and improve sleep Niche Market Zeo (Continued) Composed of a wireless headband, bedside display, online analytical tools, and email- based personalized coaching program Zeo will calculate your ZQ, a number that summarizes your sleep quality and quantity Headbandusespatent-pendingSoftWavesensorto measuresleeppatternsusingtheelectricalsignals naturally produced by the brain Niche Market bodybugg Personal calorie management system Niche Market bodybugg (Continued) Uses multiple physiological sensors for sensor fusion Accelerometer Tri-axis micro-electro mechanical sensor that measures motion Heat Flux Sensor that measures heat being dissipated bythe body via a thermally resistant material Galvanic Skin Response Measures skin conductivity Skin Temperature Skin temperature measured using a thermistor-based sensor Marketability The Biosensor Market The biosensor market is dominated by only a few products Formedicaldiagnostics,approximately90%ofbiosensors areglucosemonitors,bloodgasmonitors,andelectrolyte or metabolite analyzers Halfofallbiosensorsproducedworldwideareglucose monitors Sales are projected at $1.28 billion in the US in 2012 Themajorityoftheremainingmarketincludesbiosensors directedatenvironmentalcontrol,fermentation monitoring, alcohol testing, and food control The Biosensor Market The United States and Europe captured 68.73% of the biosensor market in 2008 Duetolargedevelopmentandmanufacturingcosts, devicestendtobespecializedintoareasthewill receive the most response from the market Miniaturizationhasreducedthepriceofthe fabrication of the sensors Makes products more marketable The Biosensor Market Home blood glucose monitors Thematuringofthisparticularbiosensorhaveshown great insight into how the biosensor market works Showed some hurdles/issues that must be examined for success Robust interface Direct 30/30 by Eli Lilly Specificityseparatesignalfromanalyteofinterestfrom other signals Stability biological molecules can be housed long enough to gain valuable information The Biosensor Market Home blood glucose monitors (Cont.) This product, though extremely successful now, was not readily accepted initially The market at the time, diabetic patients and physicians, was not the same as it is today Thedeviceswereveryprimitivecomparedtowhatwesee today The manufacturing of the electromechanical strips were more difficult and expensive than expected Themarketwasdominatedbylargercompanieswhich made it difficult for small players to get involved Use in the Food Industry Thereisanincreasingdemandforbiosensorsinthe food industry Inthepastlittleattentionwasgiventousing biosensors to examine food for pathogens However,withariseofincidentsinvolving contaminatedfoodthereisnowaneedforasensor thatcanaccuratelyandquicklydetermineiffoodis contaminated There are few sensors designed to do this now but this is a major field of new research GTRI Food Safety Biosensor Duetorecentincidentswithcontaminatedfood validating food safety is becoming a major concern TheGeorgiaTechResearchInstitute(GTRI)is currently testing a new food safety biosensor Thissensorusesintegratedoptics,immunoassay techniques,andsurfacechemistrytodetermineif there are pathogens present Itiscapableofquicklyidentifyingthespeciesand concentrationofvariouspathogensincludingE.coli and Salmonella GTRI Food Safety Biosensor Thissystemiscurrentlybeingtestingina metropolitan Atlanta food processing plant This sensor allows early detection of pathogens which helpstokeepcontaminatedfoodfromreachingthe market Theseresearchershopethatsimilarsensorsmightbe usedtoidentifyotherhazardswithinthefood industry Ifthissensorisprovensuccessfulitwillbeusedasa modelforthefuturedevelopmentofsensorsforthe food industry Techniques for Commercialization Home blood glucose monitors Haveshownseveralkeystomakingcompetitive biosensors in the market Limiting cost both to the manufacturer and consumer Need for very high quality and accurate sensors Especiallyinthemedicalindustrywherepotentiallylife threatening illnesses are diagnosed Understanding the end users needs Sight impaired Transparency in users life Interface with a physicians work regime Techniques for Commercialization R&D of Commercial Sensors R&Dofcommercialbiosensorstendstofocusonthe creation of new sensors and the miniaturization of new sensors Researchtakesplaceatbothuniversitiesandprivate business Becauseofthehighcosttomanufacturebiosensors, miniaturizationallowsmoresensorstobemadewith less material, energy, and effort Newresearchkeepscompaniesanduniversitiesatthe head of this quickly changing field Techniques for Commercialization Miniaturization Need for analysis of a large number of assays Cost efficient if small amounts of reagents are used Allows formulti-analyte assays Academic research Duke University Developedarraysoftinyelectrodesthatmonitorheart electrical activity Developedasinglecm2chipwith400individually-addressablemicroelectrodesusedforspecialresolutionof analyte distribution in small areas Commercialization Issues Thecommercializationofbiosensorshaslagged behind their research and development Therearesignificantcostsandtechnicalbarriersthat can slow down or block the commercialization of new systems The amount of initial capital and technical knowledge thatisrequiredtostartdevelopingbiosensorsisso great that many new companies simply can not handle them Commercialization Issues Changesinmanufacturingprocesses,automation,and miniaturizationtechniquesmeanthatmanybiosensorsare already obsolete when they are released Customersarenotwillingtopayhighpricesofaproduct that is not the most advanced of its kind Asaresultcompaniesneedtosinkalargepercentageof theirbudgetintodevelopingnewtechnologiestostay competitive If a company does not have enough capital to develop these technologiesquicklyenough,eveniftheirproductwould normally be in high demand, they will not be successfulMarket Development The biosensor market is driven by market demand and by the companies that produce sensors Thisdemandcancomefromtheconsumer(market pull)oritcancomefromthedeveloper(technology push) Push and pull have very different market strategies and they must be treated differently Biosensorsthatarepulleddirectlybytheconsumer are generally more profitable and successful Technology Push of Biosensors Technologypushdealswiththedevelopmentof biosensors that may not address a true user need Theseproductsaredevelopedbyacompanywiththe desire to create a market demand Manycommercialbiosensorsaredesignedwiththe ideathatiftheyareavailablepeoplewilldevelopa need for them Generallylesssuccessfulandprofitableuntilthe product develops a need for its own distinct market Market Pull of Biosensors Market pull is generated by a true need for a product Productsthatarenecessaryforthehealthandwell-being of groups and individuals Thesesensorstendtoberelatedtomedicine,safety, and biological sensing Glucose sensors, pathogen detection, EKG sensors Thisiscurrentlythelargestandmostprofitablearea forthedevelopmentandcommercializationof biosensors Trends in the Medical Industry Themedicalindustrydemandsbiosensorsthatare fast, accurate, and noninvasive Sensingtimeneedstobereducedwhilemaintaining accuracyof the measurements Thereisagrowingdemandforsensorsthatare internal instead of external to the body Glucosesensorsthatareimplantablesousersarenot required to pick their fingers several times every day Work Breakdown Ben Research available commercial biosensors Obtain technical information of these biosensors Matt Marketability of biosensors Techniques used in industry Sean Miniaturization of biosensors Techniques and benefits Schedule Gantt Chart Commercially Available BiosensorsWeek of 1-Mar8-Mar15-Mar22-Mar29-Mar5-Apr12-Apr19-Apr26-Apr3-May10-May Activity Presentation 1 Report 1 Due Report 1 Review Due Report 2 Due Presentation 2 Report 2 Review Due Final Presentation Final Report Due Find Additional Commercial Biosensors Technical Information on Biosensors Marketability of Biosensors Availability of Biosensors Resources Fraunhofer-Gesellschaft. Plastic chips monitor body functions, research suggests. ScienceDaily 20 April 2010. 1 March Jeffrey D. Newman, Anthony P.F. Turner. Home Blood Glucose Biosensors: A Commercial Perspective Biosensors and Bioelectronics, Volume 20, Issue 12, 20th Anniversary of Biosensors and Bioelectronics, 15 June 2005, Pages 2435-2453 Reyes De Corcuera, Jose I., and Cavalieri, Ralph P. "Biosensors." Encyclopedia of Agricultural, Food, and Biological Engineering (2003): 119-23. Print. Resources Kress-Rogers, Erika. Instrumentation and Sensors for the Food Industry. Ed. Christopher Brimelow. Oxford: Butterworth-Heinemann, 2001. Print. Englehardt, Kirk J. "Food Safety Biosensor That Detects Pathogens Is Tested in Metro Atlanta Processing Plant." Georgia Tech Research Institute: Industry Solutions 2010. Web. Kuhn, Lance S. "Biosensors: Blockbuster or Bomb?" The Electrochemical Society (1998): 26-31. Print. Resources Rodriguez-Mozaz, Sara, Maria-Pilar Marco, Maria J. Lopez De Alda, and Damia Barcelo. "Biosensors for Environmental Applications: Future Development Trends." Pure and Applied Chemistry 76.4 (2004): 723-52. Print. Various Internet Sources