Commercially Available Biosensors
Ben Babineau, Matthew Best, Sean Farrell
University of Massachusetts, Lowell
Electrical Engineering Department
Final Report Submission
9 May 2011
Abstract
There is a great need to create biosensors that are mass-producible. If one were to survey
the entire market of biosensors, it would become apparent that it is a market in infancy. There
are two major factors within this and similar technology markets: popular demand and the state
of the technology. Naturally, those technologies that have market demand will be researched
with the most earnestness, while those with less demand may be ignored for a time. However,
there are of course many cases where the present technology has not advanced to a stage at
which it would be available to the marketplace. Perhaps most notably, cancer detection is in
high demand, but currently expensive in-lab equipment must be used. Not only from a
marketing standpoint, but even from a humanitarian perspective, it is clear that biosensors should
become affordable and commercially available. This paper will focus on the current status of the
biosensor market and future trends the market may follow. This will be demonstrated through
examples of different biosensors that have been introduced to the market such as home blood
glucose monitors, which have been very successful in the market, and biosensors such as the
bodybugg and Zeo, commercial biosensors which have their own niche market. The Zeo will be
examined in particular as a case study that will show its evolution from a prototype to the sensors
that can be seen in popular stores worldwide today. The different types of commercially
available biosensors will be examined and described according to the industry in which they
exist. Methods of making these biosensors more marketable such as miniaturization will also be
examined.
Table of Contents
1.0
Importance of this Topic ...................................................................................................... 3
2.0
Background on Biosensors .................................................................................................. 4
2.1 Background ........................................................................................................................... 4
2.2 Method of Detection ............................................................................................................. 5
2.3 Types of Analyte ................................................................................................................... 6
2.4 Biosensor Applications ......................................................................................................... 7
3.0
Commercially Available Biosensors.................................................................................... 7
3.1 Medical Industry ................................................................................................................... 7
3.1.1 Home Blood Glucose Meters ......................................................................................... 7
3.1.2 i-STAT Portable Clinical Analyzer ............................................................................... 9
3.2 Environmental Industry ...................................................................................................... 11
3.2.1 inoLab BSB/BOD 740 ................................................................................................. 11
3.3 Food Industry ...................................................................................................................... 13
3.4 Niche Market ...................................................................................................................... 14
3.4.1 bodybugg...................................................................................................................... 14
3.4.2 Zeo Personal Sleep Coach ........................................................................................... 15
4.0
Marketability ...................................................................................................................... 25
4.1 The Biosensor Market ......................................................................................................... 25
4.2 Commercialization Strategy................................................................................................ 28
4.3 Techniques for Commercialization ..................................................................................... 32
4.4 Current Research and Future Trends .................................................................................. 35
5.0
Conclusion ......................................................................................................................... 37
6.0 Resources ................................................................................................................................ 40
1.0 Importance of this Topic
In the health field, it is imperative that the maximum amount of people have access to
early warning diagnoses. Aside from conspiracy theories that state that greedy pharmaceutical
companies want us to be sick, the only logical answer to the question of why clinical biosensors
are not widely commercially available is that the state of technology forbids it. While modern
biosensors have been around in some form for many years, there are a number of instances
where the research in the respective field has not yielded a method to create affordable, massmarketable versions of the clinical or industrial apparatus. For many researchers, the proof-ofdesign prototype is astronomically expensive.
Biosensors, as with many technologically
advanced devices, must go through countless design revisions if they are to become viable for
mass production. It requires many researchers to create highly inventive methods in order to
manufacture their designs on a large scale. According to Karlheinz Bock, head of the Polytronic
Systems division of the German bioengineering company Fraunhofer IZM, in reference to an
innovative polymer based biosensor, “This example shows clearly the possibilities for
polytronics. In a networked world, oriented towards people, inexpensive, multifunctional
systems are needed -- for example in Assisted Living. In order to build up the infrastructure
necessary for this, electronic systems have to be produced in large quantities, in a cost-effective
manner on large substrates. And with polymer electronics, this would be perfectly possible…”
(Fraunhofer-Gesellschaft)
This paper will examine multiple sensors, that have been introduced into the biosensor
market and use these sensors as tools to measure what is required to gain both market and
consumer acceptance. By looking at products such as home blood glucose monitors, which have
paved the path to acceptance in the biosensor market, key takeaways will be examined to see
what made them successful. A case study of the Zeo Personal Sleep Coach is presented which
examines this niche biosensor from its infancy to its status today as a successful biosensor in the
commercial market. One Zeo, Inc. engineer gives his opinions on lessons learned and the
hardships the company faced before breaking into the market. This engineer also discussed
strategies used by his company to make his product more marketable to ensure greater
commercial success. Through these products and studies, conclusions will be made as to what is
necessary in order to produce a product that will be successful in this highly competitive market.
2.0 Background on Biosensors
2.1 Background
It is important to start this paper with a background on all different types of biosensors
because, unlike many papers which focus on one particular type of biosensor or application of
biosensors, this research will cover many different types of biosensors and applications of those
biosensors. In researching the topic of commercially available biosensors it became clear that
many products exist and each product will detect different analytes and use different detection
methods for those analytes. This section will present the reader with background knowledge on
different types of biosensors and their applications, which will prove beneficial when looking at
the specific products that are available in today’s market.
Biosensors are analytical devices that evaluate biological samples by transduction and
typically utilize the output signal to create a human interface. Biosensors can analyze any
physicochemical substance from a human. It is a general term that may be applied to any device
that senses and transmits information about a biological process from a subject. These devices
are self-contained and are capable of providing specific quantitative or semi-quantitative
analytical information using a biological recognition element which is in direct special contact
with a transduction element. A biosensor is made up of three different elements: the sensitive
biological element, transducer or detector element, and the electronics and signal processor
elements. This sensitive biological element is used to sense the biological material such as
tissue, cell receptors, enzymes, and antibodies. The transducer or detector element works in a
physicochemical manner (optical, electrochemical, etc.) and transforms the signal resulting from
the interaction the sensitive biological element and the biological element to a signal that can be
measured by the electronics and signal processing elements.
The electronic and signal
processing elements create an output that can be understood by the user (Li).
2.2 Method of Detection
Though these biosensors are made of the same three elements, each set of elements will
operate in a different manner making every biosensor different. One of the main differences
between each biosensor is the method in which the biosensor performs its detection. Many
optical biosensors use photometric detection which is based on the phenomenon of surface
plasmon resonance. This phenomenon uses the excitation of surface plasmons by light. Surface
plasmons are surface electromagnetic waves that propagate in a direction parallel to the
metal/dielectric interface. These oscillations are very sensitive to any change of its boundary,
such as the adsorption of molecules to the metal surface (Minh Hiep, 331-332). The method for
detection common in electrochemical biosensors is based on enzymatic catalysis of a reaction
that produces or consumes electrons. The sensor substrate usually contains three electrodes; a
reference, working, and sink electrode. The target analyte is involved in a reaction that occurs at
the active electrode surface, which produces ions that create a potential. The potential can be
measured at a fixed potential or the potential can be measured at zero current (Lud, 379-384). In
another method ion channels are used in a detection method. The use of an ion channel has been
shown to offer sensitive detection of target biological molecules. This can be done by imbedding
the ion channel and attaching it to a gold electrode, which creates and electrical circuit.
Molecules such as antibodies can be bound to the ion channel so that this molecule controls ion
flow through the channel. This process creates an electrical conduction, which is proportional to
the concentration of the target (Cornell, 580-583).
Piezoelectric sensors use crystals that
undergo an elastic deformation when an electrical potential is applied to them. There are other
methods used, which are more rare, such as thermometric or magnetic detection.
2.3 Types of Analyte
The different types of biosensors can usually be defined by either the analyte the
biosensor is examining or the detection method the biosensor is using. An enzyme electrode is a
type of biosensor where an enzyme is immobilized on the surface of the electrode, creating a
current that can be measured when the enzyme catalyses. An immunosensor is a biosensor that
detects changes in mass that occurs when an antibody binds to an antigen. A microbial biosensor
is a biosensor that couples microrganisms with a transducer to enable rapid, accurate, and
sensitive detection of microbial cells. Another type of biosensor defined by the analyte is a DNA
sensor, which is used for in the detection of DNA (Li).
Different types of biosensors use specific detection methods have been described above
such as: electrochemical and optical biosensors. A type of biosensor that is used to detect
surface conductivity or in a more specific case electrolyte conductivity, is an electrical biosensor.
Another type of biosensor is a mass sensitive biosensor which uses frequency adjustment in
piezocrystals or quarts resonators to detect changes in mass of different analytes. A thermal
biosensor can detect changes in temperature and can be used in specific applications such as the
detection in change of skin temperature. (Li).
2.4 Biosensor Applications
There are many different applications of the previously described biosensors; however,
not all of these applications can be made into commercial products for everyday use. The
different applications of biosensors can generally be separated by which field or industry will use
these biosensors. The different applications of biosensors can be broken down into categories
such as medical, environmental, food industry, and military applications of biosensors. The
largest application and the historical market driver of commercial biosensors and biosensors in
general is glucose monitoring in diabetes patients. Some other applications of biosensors in the
medical field are detection of pathogens, in-home medical analysis and diagnosis, measurement
of metabolites, insulin therapy, and can even be found in an artificial pancreas as an implantable
glucose sensor. Some environmental applications of biosensors include detection of pesticides
and water contaminants, determining levels of toxic substances before and after bioremediation,
detection of metabolites such as molds, and remote sensing of airborne bacteria. One major use
of biosensors in the food industry is the detection of drug residues, such and antibiotics and
growth promoters, in food. One military application of biosensors is seen in the use of dip stick
tests. These dip stick tests, which have been looked at by the US Army, are used to detect toxins
such as Q-fever, nerve agents, and yellow rain fungus (Mutharasan).
3.0 Commercially Available Biosensors
3.1 Medical Industry
3.1.1 Home Blood Glucose Meters
Although it could be stated that the majority of biosensor patents have not been marketed
towards consumers, important lessons can be learned from the companies that have ventured out
into the marketplace. By examining and employing the effective methods that have been used to
date, commercial biosensors can become more prolific. While observing the broad, though
admittedly relatively low grossing, spectrum of commercial products on the market, the most
successful by far is the portable glucose meter. Called by economists the historical market driver
of biosensor technology, the glucose meter has been in high demand for many years. These
home blood glucose monitors determine the approximate concentration of glucose in the blood.
These monitors are used by people who suffer from hypoglycemia or diabetes. Typically,
glucose monitors use an electrochemical method to measure the glucose concentration. These
biosensors utilize an enzyme electrode containing glucose oxidizer which reacts with the glucose
in the blood sample. The enzyme is then reoxidized with an excess of mediator reagent and
subsequently the mediator is reoxidized by a reaction at the electrode and a current is created.
The charge passing through the electrode is then indicative of the glucose level in the blood, thus
accurately delivering a message to the human interface (Davis, 1). Due to the high number of
diabetics and hypoglycemic people in developed countries, this product has enjoyed success
from a long list of competitors. Among some of the popular home blood glucose monitors
available in the United States are the FreeStyle Lite, ReliOn, Precision Xtra, and the OneTouch
Ultra. An example of some commercially available home blood glucose monitors can be seen in
Figure 1 which shows the ReliOn series of home blood glucose monitors, which are sold
exclusively at Wal-Mart and Sam’s Club.
Figure 1. ReliOn series of home blood glucose monitors.
Each product is of very comparable size and has been clinically observed to be of high accuracy.
The technology behind this device has improved leaps and bounds since its conception.
However, even a product as highly developed as this still has room for improvement. Typical
glucose monitors still require the user to prick the finger to draw a blood sample; a process some
find painful. However, companies have proposed the use of fluorescence as an indicator of
glucose concentration, with some clinical evidence. Glucose monitors also have the humanperpetuated problem of the lack of memory or present-mindedness to check the glucose levels
frequently enough. These devices are inherently slaves to the user and only are effective when
used frequently enough. Some developing products involve implanting a sensor or attaching
comfortable skin-mountable patches that will constantly perform glucose concentration tests,
informing the subject of dangerous glucose levels. Despite the drawbacks of the device, the
glucose monitor is perhaps the strongest example of an effective, inexpensive, mass-produced
biosensor.
3.1.2 i-STAT Portable Clinical Analyzer
The i-STAT Portable Clinical Analyzer is a versatile biosensor that has shown the path
that many medical-based biosensors must take to succeed. This device is a handheld blood
analyzer system with incredible capabilities. This system is made up of disposable cartridge
which houses the blood sensor and the handheld unit which houses the electronics; a picture of
the system can be seen in Figure 2a (Cartridges) and 2b (Handheld Unit).
Figure 2a. i-STAT disposable blood cartridges
Figure 2b. i-STAT handheld unit.
This product provides accurate lab-quality results on the order of minutes. The rapid delivery of
results enables medical professionals to make important situations in any environment (i-STAT).
Though this device is not available on the consumer market, it is a biosensor that has made it
beyond the realm of the industrial and laboratory-based market. The technology in devices such
as these must become less expensive so that they will be available on the consumer market. As
such devices can and have saved lives, this medical domain is the one with the highest demand in
the market.
The i-STAT system is at the cutting edge of diagnostic technology. This system shows
how miniaturization of components can lead to a well received commercial product. This system
shows the revolutionary integration of biochemical and silicon chip technologies to create a
nearly instantaneous blood analyzer with no sacrifice in accuracy or reliability. The sensors used
in the system are micro-fabricated thin film electrodes. The manufacturing process of this
technology is done in such a way that it can be done in a highly reproducible manner.
Depending on the particular assay, the electrical signals produced will be measure by one of
three different circuits: amperometric, potentiometric, or conductometric. The test cycle is
started by placing the cartridge containing the blood sample into the analyzer. During the cycle,
the analyzer pressed the front of the cartridge, causing a barb to puncture the pouch. When this
occurs, the calibrant fluid is released and flows over the sensor array for measurement. After this
occurs the analyzer presses the cartridge air bladder which pushes the calibrant solution into the
waste reservoir and sends the blood sample over the sensor for analysis. All blood and calibrant
solutions are contained within the cartridge for safe disposal (Microfluidic). An engineering
diagram of the cartridge, which shows the miniaturized parts, can be seen in Figure 3.
Figure 3. i-STAT cartridge
3.2 Environmental Industry
3.2.1 inoLab BSB/BOD 740
Though the majority of commercially available biosensors reside in the medical
marketplace, a few outside of that market have been able to be commercialized.
In the
agricultural industry, enzyme biosensors, based on the inhibition of cholinesterases, have been
used to detect traces of organophosphates and carbamates from pesticides. One commercially
available biosensor in the agricultural industry, and more specifically for wastewater quality
control, is biological oxygen demand (BOD) analyzers. These BOD analyzers are based on
micro-organisms like the bacteria Rhodococcus erythropolis immobilized in collagen or
polyacrylamide. (Reyes De Corcuera, 122). An example of a commercially available BOD
analyzer is the inoLab BSB/BOD 740.
This laboratory dissolved oxygen meter has been
developed for BODn measurements as described in the “Standard Methods for Examination of
Water and Wastewater”. A picture of the complete BSB/BOD 740 system can be seen in Figure
3.
Figure 3. inoLab BSB/BOD 740 system.
This system allows up to 7 of the users routines for frequently occurring dilution ratios. This
system also allows for the management of up to 540 diluted samples (www.wtw.com). Different
measurements types require different conditions in order for accurate testing to occur. For
example, standard BOD5 measurements, in which the effluent is pretreated and exposed to
bacteria and protozoa, require incubation at 20°C for 5 days. BOD biosensors have throughputs
of 2 to 20 samples per hour and can measure 0mg/L to 500mg/L BOD (Reyes De Corcuera,
122).
Many of the different instrumentations developed for the medical diagnostic market could
be adapted for the environmental market. Though the commercial returns on biosensors created
for the environmental industry are substantially less than that of the medical diagnostics, public
concern and government funding has generated a research effort for applications of biosensors
for the measurement of pollutants and other environmental hazards. Of those biosensors that are
commercially available in the environmental industry, surface plasmon resonance biosensors
constitute the most successful type in the commercial market (Rodriguez-Mozaz, 738).
3.3 Food Industry
In an industry such as the food industry, where quality is one of the most important
features, it is very important that sound and accurate inspection occur to ensure food safety is
kept in mind. As such, food must be chemically analyzed to ensure food quality and safety
standards are adhered to. There must be a process in place to ensure that this analysis occurs
between the delivery of raw material to the food-producing company and the delivery of the
produced food to the customer. One commonly used sensor in the analysis of food is enzymebased biosensors (Kress-Rogers, 714). Enzyme based biosensors used in food quality control
can be used in the measurement of amino acids, carbohydrates, gases, alcohols, and much more
(Reyes De Corcuera, 122). Some commercially available biosensors used in the food industry
detect constituents such as sugars, alcohols, and organic acids (Kress-Rogers, 714). The other
few commercially available biosensors in the food industry include antibody-based and nucleic
acid based biosensors, but are used mainly in trial and research laboratories. Though the market
is driven by medical biosensors, food industry biosensors are expected to yield substantial
returns in the future (Kress-Rogers, 740).
In this particular market, for this particular application of food quality and safety,
problems arise with biosensors that can limit their use or effectiveness. Their implementation in
this particular application is limited by the need of sterility, frequent calibration, and analyte
dilution. Some improvement or further research in these areas could lead to biosensors that
could have more impact in the commercial market. Biosensors that are commercially available
can also be used in specific food industries such as alcohol (wine and beer), yogurt, and soft
drink producers. Immunosensors can be used to ensure food safety by detecting pathogens in
fresh meat, poultry, and fish (Reyes De Corcuera, 122).
3.4 Niche Market
3.4.1 bodybugg
Another example of a commercially available biosensor is the bodybugg. This product is
an innovative personal calorie management system. A picture of how this particular biosensor is
used can be seen in Figure 4.
Figure 4. The bodybugg in use.
The bodybugg utilizes several physiological sensors to accomplish a high level of integration.
This biosensor uses a heat flux sensor that measures heat dissipation in the body through a
thermally resistant material that interfaces between the skin and the device (bodybugg, 1). The
bodybugg also measures skin conductivity with their galvanic skin response sensor. In addition,
the skin temperature of the user is measured using a thermistor-based sensor. These biosensors
are combined with the tri-axis microelectromechanical sensor that measures motion to comprise
a highly integrated physical health monitoring system.
The different sensors used in the
bodybugg can be seen pictorially in Figure 5.
Figure 5. “Sensor fusion” used in the bodybugg
This product exemplifies the type of biosensor device that demonstrates the non-disease related
marketability of biosensors in general. The bodybugg is a purely consumer-marketed product
and while helpful for physical awareness, is not a device designed for critical health monitoring
or illness prevention.
This small but important fact gives hope to the aspiring biosensor
companies hoping to find a niche in the consumer market.
3.4.2 Zeo Personal Sleep Coach
A great example of a commercially available biosensor that utilizes creative new methods
to bring complex in-lab equipment down to the consumer level is the Zeo. The Zeo system can
be seen in Figure 6.
Figure 6. Zeo Personal Sleep Coach system
This device was designed as a sleep analyzer that improves the user’s sleep by means of
educating them on the factors that lead to bad sleep. The researchers at Zeo, Inc. developed a
product that is composed of a wireless headband, bedside display, online analytical tools, and
even an email-based personalized coaching program. The biosensor, located on the center of the
headband uses the patent-pending SoftWave sensor to measure sleep patterns using the electrical
signals naturally produced by the human brain. The name SoftWave comes from the fact that the
sensor is similar to a mesh-surface; highly flexible and very lightweight. As the user sleeps, the
Zeo evaluates the quality and quantity of each stage of sleep throughout the night. This device
has been validated to be within a standard deviation of agreement with the full in-lab
polysomnogram more than 80% of the time. This scaled-down, cost-reduced version of such a
powerful test is very much indicative of the level of evolution that must transpire for many
biosensors to become commercially viable (My Zeo).
3.4.2.1 Zeo Case Study
To get a real representation of one actual companies’ evolution from a basic idea to a
commercially accepted product, the Zeo Personal Sleep Coach system by Zeo, Inc. will be
examined in depth. This is an interesting product to look at because it does not fit into a true part
(medical, environmental, food, etc.) of the biosensor market and thus had to pave its own path to
gain visibility, market acceptance, and more importantly, market success. This product will be
examined from its infancy as a prototype in 2003 to the product that can be seen today in stores
such as Best Buy, Brookstone, Sharper Image, Jordan’s Furniture, and J&R. The information
presented in the particular case study was supplied by Zeo, Inc., and more specifically from an
engineer who helped to develop the Zeo system, Takuji Nakano. Before getting into specific
topics such as lessons learned and ways to make this product marketable, photos of the Zeo
system supplied by Zeo, Inc. will be presented to show this product’s evolution pictorially in
Figures 7-15. Figure 7 shows the custom PSG system created by Zeo Inc in 2003.
Figure 7. Zeo Inc. custom PSG system in 2003
A PSG system, or polysomnogram, is an overnight recording of sleep patterns and behaviors
associated with sleep. This will help to determine the stages of sleep the test subject achieves as
well as the presence of sleep-related abnormalities (Sleep Studies). This is the core technology
that is used in the Zeo Personal Sleep Coach. The PSG system seen is far too big for personal
use, so the first step towards commercialization was miniaturization for personal, in-home use.
The prototype sensor bad headband seen in Figure 8 shows the initial attempt to take this
technology to the next stage of commercialization. Over the next year, the sensors package was
miniaturized and placed on a headband so that it was much more useable and friendly for the
consumer.
Figure 8. Zeo Inc. conceptual headband in 2004
Over the next year, the electronics were put on a breadboard and added to the system; this can be
seen in Figure 9.
Figure 9. Headband with breadboard electronics
Over this year Zeo Inc. also began to make changes to the headband which can be seen in
Figures 10 and 11.
Figure 10. Bottom view of headband
Figure 10. Top view of headband
With the headband evolving, Zeo, Inc. turned its focus to the electronics housing which can be
seen in the initial prototype seen in Figure 11. It is apparent in the figure that Zeo, Inc. was
beginning to make their product more attractive so that it would draw the attention of customers.
Figure 11. Alpha prototype for the user interface electronics housing
With the electronics taking form, Zeo, Inc. refocused its efforts on raising the headband to the
standards set by the electronics prototype; this effort is seen in Figures 12-14.
Figure 12. Headband prototype with PCB electronics in 2006
Figure 13. Front and back view of headband electronics
Figure 14 shows the evolution of the headband over the 3 year period.
Figure 14. Evolution of the Zeo headband
Figure 15 shows the final prototype of the Zeo headband before the final commercial product
was released.
Figure 15. Final Zeo headband prototype in 2007
The finalized commercial Zeo Personal Sleep Coach system can be seen in Figures 16-18.
Figure 16. Zeo Personal Sleep Coach headband
Figure 17. Zeo Personal Sleep Coach base station
Along with these images, Zeo, Inc., represented by Takuji, gave insight on some very
valuable topics related to creating a product that is accepted in the market. In regards to
decisions made to make the Zeo user friendly and marketable, Takuji stressed the need for
consumer testing. He stated that Zeo, Inc. performed a large amount of consumer testing,
especially for the headband design. He stated that this led to certain design features such as
pieces of fleece for ear comfort as well as a split in the back of the headband for users that have
long hair or pony tails. He said that consumer feedback was even used for the name of the
product and company itself. The company placed hundreds of names on paper and filtered it
down to a few dozen and finally Zeo was selected because it was “unique, friendly, yet high
tech”.
Another topic discussed was the lessons learned about product development in the
emerging biosensor market. On this topic, Takuji’s main focus was the fact that it takes longer
to get into the market than one might expect, especially with a sensor that needs to interact very
closely with the human body. He stated that much of the time was spent developing a product
that was useable by all types of users. They needed to make sure that the Zeo was useable with
“98% of head sizes, 98% of brainwave types, etc.” In a product like this the developer must
realize that every user is different and in order to make a product that can be widely accepted, it
must be one that can adapt and adjust to different features of any user.
The final topic discussed was the evolution of the prototype in terms of miniaturization,
simplification, and innovation. In order for the system as a whole to evolve, all of the different
parts that make up the complete system needed to be examined so that each could evolve in its
own way. A major driving factor for system evolution was requirements evolution. As the
requirements of the system became clearer the direction the system needed to go was more
visible. The PSG system (Figure 7) was previously used to stage sleep. In this particular system,
17 wired electrodes needed to be glued to a patients head and chest with monitoring being done
by a sleep scientist. This particular process was very inconvenient and costly. The Zeo needed
to give similar results, but in order to occur in the user’s home; the system needed to miniaturize
and become less costly to the user. Many different conductive materials were experimented
before the silverized fabric was chosen for the headband. These other fabrics were rigorously
tested through abrasive wash and sweat testing before a final decision was made. The earliest
complete prototype that was created by Zeo Inc. (Figure 9) used the silverized fabric wired to
three electrodes. This basic design needed to evolve in to the much more producible design
which uses PCB electronics (Figure 12). With this evolution the product became cheaper, faster,
and easier to produce, especially on a larger scale. The engineers at Zeo realized that in order to
optimize the user-friendliness and minimize the bulkiness of the headband, that the base unit
should be used to receive RF signals and perform the complex analyses external to the headband
unit. Therefore, the engineers designed this product to capture, filter, digitize, and wirelessly
transmit the EEG signals to the base unit. The importance of developing features in parallel was
also mentioned when discussing the PCB headband and base station electronics. Some of these
changes take time, Takuji stressed, in particular when looking at the sensor pad, whose design
and fabric changed many times over several years. This case study of the Zeo demonstrates that
in order for a new product to succeed in the biosensor market, a thoughtful, intelligent, and
structured process must be applied.
4.0 Marketability
4.1 The Biosensor Market
Although there are many different types of biosensors the biosensor market is dominated
by only a few products. For medical diagnostics about ninety percent of all biosensors are
glucose monitors, blood gas monitors, electrolyte analyzers, or metabolite analyzers. Over fifty
percent of the biosensors produced worldwide are employed in glucose meters (Global Industry
Analysts). These sensors are used for ordinary people or for medical professionals in the
professional office or hospital settings. These sensors need to be fast, accurate, and reliable as
they are used to measure biological systems which if monitored incorrectly can be disastrous.
The majority of the remaining percentages of biosensors are directed at detecting environmental
control, fermentation monitoring, alcohol testing, food control, and research in laboratories
(Kress-Rogers, 740). According to a report by Global Industry Analysts, Inc., it is estimated that
by 2012 the market for biosensors will reach $6.1 billion. This is a result of the need for medical
sensors that can deal with the growing population and increasing issues of chronic diseases such
as diabetes and obesity, as well as the need for environmental monitoring (Global Industry
Analysts).
Although many countries have a market for biosensors, the United States and Europe
have captured 69.73% of medical market for biosensors in 2008. The market in Asia-Pacific is
projected to reach $794 million by the year 2012. Since the costs to design, fabricate, and
market new biosensors is huge, most companies tend to stick to markets that they know they can
get the most gain. Therefore, sensors that can monitor multiple biological systems or can be
used in a variety of ways allow companies to get the greatest amount of profit from one type of
biosensor.
Bioluminescence-based biosensors gained immense popularity for testing water
quality in countries such as France, Germany, Spain, and Sweden. Revenues for biosensors used
in the environmental market are projected to rise greatly over the next few years and are
projected to reach $32.7 million in Germany alone (Global Industry Analysts).
Glucose monitors were one of the first widely developed and marketed biosensors and
remain the industry driver of the home consumer biosensor market. These biosensors have gone
through many changes and now can be used wirelessly and noninvasively. Because they have
such a large market these sensors are now designed, manufactured, and sold by many different
companies around the world. New advances in technology now allow sensors to be quicker,
more accurate, and easy to use compared to the older technologies they are replacing. The
United States has one of the largest markets for biosensors and glucose meters are projected to
make up to $1.28 billion in sales for the year 2012 (Global Industry Analysts).
One major thing that drove the biosensor market and more specifically, electrochemical
biosensors used for diabetes monitoring, was the desire for systems that patients could use
themselves while at home.
These devices were a significant part of the move towards
convenience and ease of use, both of which are necessary for success in the market. The blood
glucose market has shown us some of the necessary hurdles that must be made to obtain success
in this highly risky market. For example, in 1989 Eli Lilly began to market the Direct 30/30, a
reusable biosensor that promised to revolutionize the home glucose monitoring market; however,
was unsuccessful due to the non-robust user interface.
Another issue the home glucose
monitoring market demonstrated was the need for specificity. It is very important for the
biosensor to be able to separate the desired signal from the analyte of interest from other signals
that are present. Another hurdle that must be addressed in order for a biosensor to be successful
in the market is stability. Typically large biological molecules are not stable outside of the
environment for which they were designed. The biosensors must be designed with this in mind
so they can use these biological molecules in tests required to gain useful information. A third
common issue that must be designed around is sensitivity (Kuhn, 26-27).
Though home blood glucose monitors make up the majority of the biosensor market
today, when they were first introduced they were not readily accepted. The initial acceptance of
electrochemical sensors in general was very slow for several reasons. The market for glucose
biosensors, the diabetic population and physicians, was not the same as it is today. Also, the
devices at that time were very primitive and have evolved drastically to be the devices we now
see commercially available.
Another major problem was that the manufacturing of the
electrochemical strips proved to be more difficult and expensive than expected. This caused the
market to be dominated by larger market companies which made it very difficult for smaller
players to compete (Kuhn, 27).
4.2 Commercialization Strategy
Commercialization of biosensors has lagged significantly behind the research and
development of biosensors. Although there have been a large number of research projects and
papers as well as patents applying to new devices, the success of biosensors in the research and
development world has not yet translated to success in the commercial world (Lin, 99). There
are significant cost and technical barriers that block the commercialization of new sensors. New
products very rarely develop fully before changes in manufacturing processes, automation, and
miniaturization techniques render them obsolete. Therefore, companies spend lots of money on
the research and design side to stay competitive in their field. Successful systems must be able to
be versatile enough and have the ability to support different functions. The ability to support
multiple sensing capabilities allows biosensors to be competitive and to adapt to the changing
demands of the market (Luong, 492).
The biosensor market is a difficult market to emerge in as many companies find a hard
time creating a marketable sensor. Very often the “trial and error” approach is used to create a
marketable product; however, this usually does not create a desired product.
One of the
problems companies run into is that it is difficult to adapt a biosensor to a particular field when it
was intended for another. Another problem is the difficulty to evolve a biosensor from the
product seen on a lab bench to one that is ready for large scale manufacturing. In order to
perform the task of large scale manufacturing at low cost requires automation in fabrication
(Kress-Rogers, 756).
Due to significant upfront costs in research and design and the fact that many of these
designs simply are not successful means that many types of sensors fail and are never successful
on the market if they reach it at all. The demand for biosensors is driven by the needs and wants
of consumers as well as those of the companies that design, fabricate, and market those sensors.
When demand comes directly from the needs or wants of the consumer the demand is call market
pull. But when the demand comes from the companies that are producing the sensors it is called
technology push (Thusu).
As stated before, market pull comes directly from the consumer. Consumers have needs
for products such as glucose sensors, which monitor their blood sugar levels. Because a large
number of people require a sensor to test their blood every day, it made financial sense for a
company to create such a marketable product. Biosensors have been developed for a wide
variety of medical areas for personal use (Lin, 92). The demand for reliable, quick, and accurate
biosensors that can be used at home instead of in a hospital by a medical professional has
developed into the largest area of development of current biosensors. Another example of
market pull can happen within an area that was already developed as a direct result of market
pull. Personal glucose biosensors were developed as a result of the consumer need for a way to
test glucose levels at home without a medical professional being present. However, within the
glucose biosensor area other pull factors brought about new features to these sensors.
As
personal glucose sensors became more common the need for a sensor that was faster, more
accurate, and that required less blood became apparent.
Consumers wanted their glucose
monitors to function more accurately whist using less blood. Thus, a pull from the consumer
was created that had to be answered by the designers and manufacturers of glucose biosensors
(Thusu).
Industrial push takes place when a company or industry attempts to create a market for a
product they are developing. These devices may not represent a true user need as much as a
user’s want. Devices that reach the market through industrial push are developed in order to
create a new market. These devices often rely on their features as much as their actual purpose
in order to attract a consumer base. Companies hope that their devices will create a need within
the consumer community so that they will be able to develop and see new devices in that market
area. Due to the fact that these devices are generally not design and manufactured to address a
current consumer need but what the company making them hopes will be come a need, these
devices are often not very successful market contenders. Biosensors that have a definite
consumer need tend to outperform push products due to the fact that there is already a market in
place for them (Thusu). Therefore, these new devices do not need to create their own markets.
This means that creating push biosensors is much riskier than developing ones for an established
market. However, if a company is successful in developing a new market they maintain sole
control of over that market as the sole manufacturer.
The transitioning of biosensors, especially those that come from the nano- or macroworld, is a difficult task and only gets harder depending on the end-user’s age, health, education,
and overall comfort level with technology. One must consider the cost associated with this type
of user, especially if the technology is must be designed to avoid human intervention. These
companies must strive to make the technology transparent to the end user so that it will be
useable for an “average” person. Another issue that arises is that much of the problems that
could be addressed by these sensors do not occur in the western world where the majority of
research for these devices occurs. In certain parts of the world, mortality occurs from diseases
such as influenza, cholera, and polio or from issues such as malnutrition, poverty, poor hygiene,
or even unclean water. Many companies try to create smaller biosensors, yet do not look at these
fundamental issues listed above (Achyuthan, 1).
Another topic that must be considered in commercializing biosensors is the health
risk/safety issue that can arise when testing materials. In the race to create smaller devices,
companies sometimes overlook issues that could lead to human injury and as a result the
inevitable and expensive civil/criminal litigations that follow. This oversight may be a result of
the lack of guidance from state and federal agencies such as the Environmental Protection
Agency (EPA), the Food and Drug Administration (FDA), and Occupational Safety and Health
Administration (OSHA), in overseeing the materials that are in use by these companies and
devices. In the real world, pre-test sample preparation and processing are major roadblocks in
launching commercial biosensors. Unprocessed samples are harder for smaller sensors to handle
compared to “typical” biosensors such as home blood glucose monitors. As fabrication pushes
to the nano-level, the fabrication becomes more complex and can sometimes be hazardous and
not environmentally friendly (Achyuthan, 2).
4.3 Techniques for Commercialization
The early electrochemical biosensor market, more specifically the home blood glucose
monitoring market, has shown several keys necessary to making competitive biosensors in the
marketplace. Because the biosensor market is a near-commodity market, cost is a major issue.
Not only does the price of the biosensor for the user matter, the cost to manufacture the device is
also very important.
In the medical industry, these biosensors may be used to diagnose
potentially life-threatening illnesses; the devices must be of very high quality and accuracy.
Ultimately the end user must be kept in mind when designing the biosensors, so it is crucial to
understand their needs. For example, it might be important to make the biosensor easy to use for
a sight-impaired user group such as the elderly. These sensors must very user-friendly to
encourage frequent testing and better patient care and control. Another issue that this market
demonstrated was the need for the device to easily integrate into the consumer’s life or routine.
In the medical industry many of these sensors are used by physicians and must interface with
their work regime (Kuhn, 27).
Miniaturization also contributes to the reduction of costs in the fabrication of biosensors.
By making the sensors smaller less material can be used, they can be made more electrically
efficient, and the cost for making them can be greatly reduced. This makes the products more
marketable as people will be more likely to purchase them due to their lower cost.
Miniaturization of biosensors is essential for use in the field and the point of care. Electronic
components are continually getting smaller; however, certain components are still too expensive
to be used in disposable sensors. This is an issue that must be examined when creating sensors,
balancing the need to make components smaller, but making sure they will be used in a cost
effective manner to limit the cost of manufacturing of the overall sensor (Wojciechowski, 3455).
There are many advantages and disadvantages in the miniaturization of components in
order to miniaturize the overall biosensor. One such component that is often miniaturized in the
transducer commonly used in biosensors.
This section will examine fabrication and
miniaturization techniques used for biosensors, and more specifically transducers used in
biosensors. One need for a miniaturized biosensor is to ensure that it is small enough to
minimize damage done to cells or microcirculation in cells of the biological element being
examined. If a biosensor is placed in a bloodstream, for example, it must be small enough so
that it does not impede blood flow. Miniaturized transducers often have a much more rapid
response time than larger devices, which proves to be a great benefit in some cases. Companies
must be weary; however, as there are some issues that arise when miniaturization of biosensors
occurs. For example, smaller devices are often less durable than larger ones and will break
easier. Also, the signal may be smaller and more difficult to detect from these miniaturized
devices.
A large effort has been placed in developing reliable fabrication techniques for
miniaturizing electrochemical and optical transducers for biosensors (Buerk, 95).
The main type of transducer that will be examined is microelectrodes, or small-sized
electrodes. One technique to create these small-sized electrodes, which are used to make highly
detailed spatial measurements, is from pulled glass micropipettes.
The first use of these
electrodes was for cell membrane potential measurements. These measurements were done with
simple glass microelectrodes filled with psychological salt solutions. These glass pipettes are
usually beveled so the tip can penetrate into the tissue or cell easier and to lower the electrical
resistance of the tip. This beveling is most commonly done through mechanical grinding, and
more specifically a rotating surface covered with either diamond or alumina particles (Buerk,
96). Another type of microelectrode that is commonly seen is etched metal wire microelectrodes,
which are more durable than glass micropipettes.
Electrochemical etching techniques are
commonly used to create a metal microelectrode with a very fine tip (Buerk, 97). In the early
1990’s fabrication techniques for bare-tip glass-coated Pt microelectrodes were modified to
create electrodes at the nanometer scale. The ultramicroelectrodes, also known as nanodes, were
assessed by scanning electron microscopy at 50,000 times magnification. The technique used to
create these nanodes is basically the same as electrochemical etching and glass coating (Buerk,
103). It was this type of research that allowed for the possibility to miniaturize biosensors so that
they can be more widely available today.
The quest for rapid, reliable, sensitive, and inexpensive devices in applications such as
medical diagnostics, foods safety, environmental monitoring, and drug discovery is the driving
force behind the miniaturization of the bioanalytical laboratory.
This is because the
miniaturization of biosensors is a solution to most of these problems. In order to be cost
effective, the analysis of a large number of assays must be done with a small amount of reagents.
The analysis of 25,000 gene sequences is now possible simultaneously with one DNA microarray
chip, allowing for more analyzed sequence per cost and time involved. Another example of this
type of effort is the rapid analysis of thousands of environmental samples per day for the
detection of biological warfare agents. This type of work becomes feasible when miniaturized
biosensors are incorporated into systems. Along with high throughput screening, miniaturization
allows for work with multi-analyte assays. Examples of this could be one food sample analyzed
for different pathogens in one assay, one air sample analyzed for different biological warfare
agents in one assay, or one blood sample analyzed for clinical markers of interest in one step.
Another important aspect of miniaturized biosensors is the portability of such sensors. This
could be one of the largest features of a biosensor that could make it appealing to the consumer
(i.e. pocket-sized devices). This makes these devices more useable in more commercial venues
such as doctor’s offices, consumer’s homes, restaurants, public safety buildings, and even farms
(Gorton, 251-252).
Research in the field of commercial biosensors is done by both universities and
companies.
The research generally focuses on the creation of new sensors and the
miniaturization and cost reduction of current sensors. Biosensor research is still a fairly new
field and universities and companies are still learning how to make them as accurate, efficient,
cheap as possible. In one example of academic research, Duke University developed arrays of
tiny electrodes that monitor heart electrical activity.
In another research project, 400
individually-addressable microelectrodes were placed on a single 1 cm2 chip which allowed for
special resolution of analyte distribution in small areas (Kuhn, 31). This type of research shows
how miniaturization and microfabrication is being examined and is used as a means to reduce
cost and create a product that is more easily marketable.
4.4 Current Research and Future Trends
In the biosensor market, research and trends are driven by market demands and practices
to make these devices more marketable. Great strives are being made in the home blood glucose
monitoring market to improve this already market leader. With biosensors, especially ones used
in the medical industry, there is always a desire to create biosensors that will provide more
accurate results. Home blood glucose monitors are becoming less invasive and are beginning to
require smaller sample volumes due to an improved reagent to test. The smaller required sample
volume is a good trend for this biosensor, especially for those users who must prick their fingers
several times a day. In order to make these monitors become even less invasive and to push the
envelope, researchers are trying alternative methods to finger pricking. Some researchers are
trying to create implantable glucose sensors that use glucose oxidase immobilized at the surface
of a reference electrode combination. In another method, a wired enzyme/mediator combination
is stated to reduce oxygen dependencies of the sensor, and provide a reliable result continuously.
In a more difficult approach, some researchers are attempting to create a sensor that can measure
glucose without the use of biological specifiers. Another area of research and development is
making systems more robust for the user (Kuhn, 30-31).
Within the food industry, most research is focused on improving immobilization
techniques of the biological element to increase sensitivity, selectivity, and stability. Stability,
though critical, has received little attention compared to sensitivity and selectivity in part because
of the tendency to design disposable devices used typically in quality assurance laboratories.
The market of biosensors is typically driven by applications necessary in medical diagnosis
rather than use in the agricultural and food industries. One of these trends is miniaturization of
biosensors which is very important in the commercialization of biosensors, which was described
previously in this paper (Reyes De Corcuera, 122). In order for food industry based biosensors
to have an impact in the market they must be highly specific, rapid, and reliable to be useful for
the complex industry. The high specificity of the biomolecules such as enzymes, antibodies, or
nucleic acids must be kept in mind in order for the detection of one compound in the presence of
a large number of others. Other things that must be kept in mind with biosensors used in this
industry are integrated sample preparation, time reduction for analysis, and cost-efficient
production (Kress-Rogers, 740).
Some work in the field is currently being performed by the Georgia Tech Research
Institute (GTRI) who is testing a new food safety biosensor, which has been developed over the
past four years, that detects pathogens. GTRI is testing their biosensor in a metro Atlanta
processing plant and hope, with positive results, have created a biosensor that will lead to an
accurate, speedy, and low cost solution to food contamination. This device will be capable of
simultaneously identifying species and determining concentrations of multiple pathogens,
including E. coli and Salmonella in food products in less than two hours while operating on a
processing plant floor. According to Nile Hartman, a biosensor developer and research engineer
at GTRI, the biggest advantage of this biosensor is the “time reduction in assessing the presence
of contamination”. Laboratory tests have proven this biosensor to be very sensitive on the order
of 500 cells per millimeter in minutes, with hopes of future sensitivities of 100 cells per
millimeter. This is a great improvement from current laboratory equipment that has a sensitivity
of 500 cells per millimeter in eight to twenty-four hours at $12,000 to $20,000. These biosensors
will range from $1,000 to $5,000. GTRI believes that if this biosensor performs well in field
tests, which will last up to six months, it can gain market acceptance. (Englehardt)
This biosensor operates with three primary components: integrated optics, immunoassay
techniques, and surface chemistry tests.
The biosensor indirectly detects pathogens by
combining immunoassays with a chemical-sensing scheme. In the immunoassay, a series of
antibodies selectively recognize target bacteria. The “capture” antibody captures the target
bacteria and passes it along. The “reporter” antibodies contain enzyme urease, which break
downs down urea that is added and produces ammonia. The chemical sensor detects the
ammonia, which affects the optical properties of the sensor and changes are made in the
transmitted laser light. These changes reveal the presence and concentration of a specific
pathogen (Englehardt).
5.0 Conclusion
This paper has examined many different biosensors that range in application as well as
specific market. It is important to examine a wide range of sensors; however, because this
diversity gives different insights into what is necessary to create a successful product in the
biosensor market. Examining products in the medical market is very important because this is
the market that has seen the most success. With this great success comes lessons learned and
trends that can be examined by other markets to gain insight on necessary steps to be taken for
their own success. For example, looking at the home blood glucose meters it can be seen that
important area that needs to be examined is the user interface. As shown by the failure of the
Direct 30/30, it is very important that something as easily forgotten as the user interface be
examined so that users will be able to easily use the product. Other issues the glucose meter
demonstrated were the need for specificity, stability, and sensitivity, especially for those sensors
used in the medical market. Products such as the i-STAT present a completely different issue;
the need for proper disposal of the biological materials. This product has built in functionality
that ensures the user does not interact with the blood sample being examined. This prevents the
need for agencies such as the FDA, EPA, and OSHA to raise flags on the product.
Lessons can also be taken away from other biosensor markets. The food industry has
shown the need for sterility, frequent calibration, and analyte dilution. The main take away from
the biosensor being developed by the Georgia Tech Research Institute is the need for real world
testing. It is one thing to perform test and gain success in the lab, but it is completely different
and necessary to gain success in real world environments. This will give credibility to the
product and show that the technology is ready to transition from the laboratory environment.
The case study on the Zeo Personal Sleep Coach is perhaps the most insightful
commercialization process presented in this paper. Seeing this product start as an idea and
evolve into a successful product provides valuable information that can be used by others trying
to make their mark in the market. This study showed the importance for consumer testing.
Through this testing, the company was able make key changes that benefit the user as well as get
some feedback from these users so they can see some initial reaction to their product. This study
showed the need for patience as the process to develop a sensor can take longer than expected
and that requirements evolution will drive the development and evolution of the sensor itself. By
surveying and analyzing this selection of biosensors, it becomes apparent that no product will
reach commercial success in this market without implementing an involved and innovative
approach to design and marketing.
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