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Applications and Marketability Benjamin Babineau Matthew Best Sean Farrell.

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1 Applications and Marketability Benjamin Babineau Matthew Best Sean Farrell

2 Outline Why This Project? Background Types of Biosensors Applications Commercially Available Biosensors Marketability Work Breakdown Schedule Resources

3 Why This Project? There is a great need to create biosensors that are mass-producible In the health field, it is imperative that the maximum amount of people have access to early warning diagnoses This project will attempt to bring understanding as to why companies struggle with manufacturing biosensors on a large, inexpensive scale By examining and employing effective methods that have been used to date, commercial biosensors can become more prolific

4 Background What is a biosensor? Analytical device for the detection of an analyte that combines a biological component with a physicochemical detector component Components Sensitive biological element Transducer or detector element Electronics and signal processors

5 Background Detection Methods Photometric Optical biosensors use the phenomenon of surface plasmon resonance (SPR) Surface plasmons are surface electromagnetic waves that propagate in direction parallel to metal/dielectric interface. Excitation by light Electrochemical Electrochemical biosensors use a reaction that produces or consumes electrons

6 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

7 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

8 Types of Biosensors (Detection Mode) Electrochemical Potentiometric Amperometric Voltametric Optical Florescence Adsorption Reflection Electrical Surface conductivity Electrolyte conductivity

9 Types of Biosensors (Detection Mode) Mass sensitive Resonant frequency of piezocrystals Thermal Heat of reaction Heat of adsorption

10 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

11 Commercially Available Biosensors

12 Medical Industry Home Blood Glucose Monitors Precision Xtra ReliOn FreeStyle Lite OneTouch Ultra

13 Medical Industry Home Blood Glucose Monitors (Continued) Determines approximate concentration of glucose in the blood Used mainly with people who have diabetes or hypoglycemia How They Work Today, most glucose monitors use an electrochemical method Glucose in blood reacts with an enzyme electrode containing glucose oxidize The enzyme is reoxidized with an excess of mediator reagent The mediator is reoxidized by a reaction at the electrode and a current is created The charge passing the electrode is proportional to glucose level

14 Medical Industry i-STAT Portable Clinical Analyzer Handheld blood analyzer system

15 Medical Industry i-STAT (Continued) Provides fast, accurate, and lab-quality results within minutes to accelerate decision making process How It Works Uses Si in the sensor cartridge as a substrate and a conducting base; electronics are housed in the handheld device Sensors are micro-fabricated thin film electrodes Depending on particular assay the electrical signals produced are measured by the i-STAT’s amperometric, potentiometric, or conductometric circuits.

16 Environmental Industry In agricultural industry, enzyme biosensors are used to detect traces of organophosphates and carbamates from pesticides One of the most successful commercial biosensors in industry is used in wastewater quality control Biological oxygen demand analyzers Though less lucrative than medical diagnostics, 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

17 Environmental Industry inoLab BSB/BOD 740 Wastewater control

18 Environmental Industry inoLab BSB/BOD 740 Laboratory dissolved oxygen meter for wastewater 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

19 Food Industry Quality is extremely important thus sound and accurate biosensors are necessary Enzyme-based biosensors are common in this industry Measure amino acids, carbohydrates, gases, alcohols, and much more Other commercially available biosensors include antibody-based and nucleic acid based biosensors Mainly in trial and research laboratories Expected to yield substantial returns in the future

20 Food Industry Specific food markets that use biosensors include alcohol (wine and beer), yogurt, and soft drinks Immunosensors are used to ensure food safety by detecting pathogens in fresh meat, poultry, and fish In this particular market problems arise that limit use or effectiveness of biosensors Need for sterility, frequent calibration, and analyte dilution

21 Niche Market Zeo Designed to analyze and improve sleep

22 Niche Market Zeo (Continued) Composed of a wireless headband, bedside display, online analytical tools, and - based personalized coaching program Zeo will calculate your “ZQ”, a number that summarizes your sleep quality and quantity Headband uses patent-pending SoftWave sensor to measure sleep patterns using the electrical signals naturally produced by the brain

23 Niche Market bodybugg Personal calorie management system

24 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 by the body via a thermally resistant material Galvanic Skin Response Measures skin conductivity Skin Temperature Skin temperature measured using a thermistor-based sensor

25 Marketability

26 The Biosensor Market The biosensor market is dominated by only a few products For medical diagnostics, approximately 90% of biosensors are glucose monitors, blood gas monitors, and electrolyte or metabolite analyzers Half of all biosensors produced worldwide are glucose monitors Sales are projected at $1.28 billion in the US in 2012 The majority of the remaining market includes biosensors directed at environmental control, fermentation monitoring, alcohol testing, and food control

27 The Biosensor Market The United States and Europe captured 68.73% of the biosensor market in 2008 Due to large development and manufacturing costs, devices tend to be specialized into areas the will receive the most response from the market Miniaturization has reduced the price of the fabrication of the sensors Makes products more marketable

28 The Biosensor Market Home blood glucose monitors The maturing of this particular biosensor have shown 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 Specificity – separate signal from analyte of interest from other signals Stability – biological molecules can be housed long enough to gain valuable information

29 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 The devices were very primitive compared to what we see today The manufacturing of the electromechanical strips were more difficult and expensive than expected The market was dominated by larger companies which made it difficult for small players to get involved

30 Use in the Food Industry There is an increasing demand for biosensors in the food industry In the past little attention was given to using biosensors to examine food for pathogens However, with a rise of incidents involving contaminated food there is now a need for a sensor that can accurately and quickly determine if food is contaminated There are few sensors designed to do this now but this is a major field of new research

31 GTRI Food Safety Biosensor Due to recent incidents with contaminated food validating food safety is becoming a major concern The Georgia Tech Research Institute (GTRI) is currently testing a new food safety biosensor This sensor uses integrated optics, immunoassay techniques, and surface chemistry to determine if there are pathogens present It is capable of quickly identifying the species and concentration of various pathogens including E. coli and Salmonella

32 GTRI Food Safety Biosensor This system is currently being testing in a metropolitan Atlanta food processing plant This sensor allows early detection of pathogens which helps to keep contaminated food from reaching the market These researchers hope that similar sensors might be used to identify other hazards within the food industry If this sensor is proven successful it will be used as a model for the future development of sensors for the food industry

33 Techniques for Commercialization Home blood glucose monitors Have shown several keys to making competitive biosensors in the market Limiting cost both to the manufacturer and consumer Need for very high quality and accurate sensors Especially in the medical industry where potentially life threatening illnesses are diagnosed Understanding the end users needs Sight impaired Transparency in users life Interface with a physicians work regime

34 Techniques for Commercialization R&D of Commercial Sensors R&D of commercial biosensors tends to focus on the creation of new sensors and the miniaturization of new sensors Research takes place at both universities and private business Because of the high cost to manufacture biosensors, miniaturization allows more sensors to be made with less material, energy, and effort New research keeps companies and universities at the head of this quickly changing field

35 Techniques for Commercialization Miniaturization Need for analysis of a large number of assays Cost efficient if small amounts of reagents are used Allows for multi-analyte assays Academic research Duke University Developed arrays of tiny electrodes that monitor heart electrical activity Developed a single cm 2 chip with 400 individually- addressable microelectrodes used for special resolution of analyte distribution in small areas

36 Commercialization Issues The commercialization of biosensors has lagged behind their research and development There are significant costs and technical barriers that can slow down or block the commercialization of new systems The amount of initial capital and technical knowledge that is required to start developing biosensors is so great that many new companies simply can not handle them

37 Commercialization Issues Changes in manufacturing processes, automation, and miniaturization techniques mean that many biosensors are already obsolete when they are released Customers are not willing to pay high prices of a product that is not the most advanced of its kind As a result companies need to sink a large percentage of their budget into developing new technologies to stay competitive If a company does not have enough capital to develop these technologies quickly enough, even if their product would normally be in high demand, they will not be successful

38 Market Development The biosensor market is driven by market demand and by the companies that produce sensors This demand can come from the consumer (market pull) or it can come from the developer (technology push) Push and pull have very different market strategies and they must be treated differently Biosensors that are “pulled” directly by the consumer are generally more profitable and successful

39 Technology Push of Biosensors Technology push deals with the development of biosensors that may not address a true user need These products are developed by a company with the desire to create a market demand Many commercial biosensors are designed with the idea that if they are available people will develop a need for them Generally less successful and profitable until the product develops a need for its own distinct market

40 Market Pull of Biosensors Market pull is generated by a true need for a product Products that are necessary for the health and well- being of groups and individuals These sensors tend to be related to medicine, safety, and biological sensing Glucose sensors, pathogen detection, EKG sensors This is currently the largest and most profitable area for the development and commercialization of biosensors

41 Trends in the Medical Industry The medical industry demands biosensors that are fast, accurate, and noninvasive Sensing time needs to be reduced while maintaining accuracy of the measurements There is a growing demand for sensors that are internal instead of external to the body Glucose sensors that are implantable so users are not required to pick their fingers several times every day

42 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

43 Schedule Gantt Chart Commercially Available BiosensorsWeek of1-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

44 Resources Fraunhofer-Gesellschaft. “Plastic chips monitor body functions, research suggests.” ScienceDaily 20 April 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 Reyes De Corcuera, Jose I., and Cavalieri, Ralph P. "Biosensors." Encyclopedia of Agricultural, Food, and Biological Engineering (2003): Print.

45 Resources Kress-Rogers, Erika. Instrumentation and Sensors for the Food Industry. Ed. Christopher Brimelow. Oxford: Butterworth-Heinemann, Print. Englehardt, Kirk J. "Food Safety Biosensor That Detects Pathogens Is Tested in Metro Atlanta Processing Plant." Georgia Tech Research Institute: Industry Solutions Web. Kuhn, Lance S. "Biosensors: Blockbuster or Bomb?" The Electrochemical Society (1998): Print.

46 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): Print. Various Internet Sources


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