Module 011 – Emerging Technology in Medicine

This module contains the following topics:

1. Genomic Sequencing and the Emerging Medical Practice
2. The Digitization of Health Records

Genomic sequencing
The development of massively parallel sequencing (or next-generation sequencing) has
facilitated a rapid implementation of genomic sequencing in clinical medicine. Genomic
sequencing (GS) is now an essential tool for evaluating rare disorders, identifying
therapeutic targets in neoplasms, and screening for prenatal aneuploidy. Emerging
applications, such as GS for preconception carrier screening and predisposition screening
in healthy individuals, are being explored in research settings and utilized by members of
the public eager to incorporate genomic information into their health management. The
rapid pace of adoption has created challenges for all stakeholders in clinical GS, from
standardizing variant interpretation approaches in clinical molecular laboratories to
ensuring that nongeneticist clinicians are prepared for new types of clinical information.
Clinical GS faces a pivotal moment, as the vast potential of new quantities and types of data
enable further clinical innovation and complicated implementation questions continue to
be resolved.

Current and emerging clinical applications of GS

Diagnostic sequencing
To date, the diagnosis of rare Mendelian disease has been the primary clinical
application of sequencing the genomes of individual patients. Thousands of
pathogenic mutations identified through GS have been reported in recent years, and
novel gene-disease associations are proliferating. Early reports on clinical GS
demonstrated that identification of a causative mutation through GS can help to
formulate a treatment plan and in other cases offer new opportunities for
reproductive planning, as in the first publication reporting a successful diagnosis via
GS, which resulted in effective management for a severe autoimmune illness in a
young boy. Diagnostic GS is indicated for the detection of diagnostic genetic variants
in patients with suspected monogenic disorders after known single -gene candidates
have been eliminated from consideration or when a multigene testing panel has not
yielded a diagnosis. The vast majority of diagnostic GS to date has been performed in
children. However, patients can be of any age and presentations of Mendelian
disorders in adulthood are probably underrecognized.
The breadth of possible results from GS requires that thorough counseling and
evaluation be performed before ordering GS to ensure proper interpretation of
genomic variants, as well as careful clinical contextualization of the results. This
process should include gathering detailed family history information, systematically
evaluating the patient's and/or family's phenotype, reviewing medical literature and
databases for possible overlap with known syndromes or implicated biochemical
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pathways, and obtaining informed consent. Individuals who consent to clinical GS
should be aware that they may learn about disease risks that may also affect their
relatives.
Whereas many clinical molecular laboratories in academic medical centers and
commercial laboratories now offer exome sequencing, Baylor College of Medicine
and the University of California Los Angeles (UCLA) in the United States have
reported on the largest number of clinical sequencing cases and have estimated that
they find a causative mutation in 25% to 26% of cases overall, with lower diagnostic
rates for adults than for children. Of solved cases, a surprising percentage (4.6%)
appear to result from blended phenotypes of two separate Mendelian disorders, each
associated with distinct pathogenic variants. The combined impact of two distinct
Mendelian disease variants often leads to a hybrid phenotype that appears unique
and challenging to diagnose.
The application of GS to rare disease has understandably been of intense research
interest. In the United States, several National Institutes of Health (NIH) gra nt
programs, including the Clinical Sequencing Exploratory Research (CSER)
Consortium, the Centers for Mendelian Genomics, and the Undiagnosed Diseases
Program and Network, have been funded to investigate the application of GS to the
diagnosis of rare diseases. The scope of these efforts is broad and includes
establishing technical standards for GS and interpretative pipelines (i.e., variant
filtration algorithms and interpretation protocols), developing and implementing
reporting mechanisms, and evaluating the clinical, behavioral, legal, and ethical
impacts of GS on clinical practice.
Emerging application: preconception carrier screening
Although targeted carrier screening is well established (e.g., focused carrier
screening for conditions such as Gaucher, Tay-Sachs, and Canavan disease in
individuals of Ashkenazi Jewish descent), genomic technologies offer the opportunity
for broader, more comprehensive screening. Preconception screening for carrier
variants associated with rare, recessive disorders has been increasingly available in
recent years via targeted multiplex genotyping that screens for known mutations in
dozens of genes. These tests do not necessarily detect extremely rare or novel
genetic variants that an unaffected individual may carry, and therefore a “residual
risk” of being a carrier remains after negative testing.
Several companies now offer GS for preconception screening. GS affords the
opportunity to go beyond a selected subset of recessive disorders to evaluate and
report on genes associated with extremely rare recessive conditions. Preliminary
data from the MedSeq Project, which reports results on carrier variants in any gene
associated with known autosomal recessive disorders, suggest that approximately
90% of individuals in the general population are carriers for at least one recessive
disorder and that most carry two to four carrier variants. Due to imperfect coverage
of some genes and the low sensitivity of GS for certain types of genetic variation
(reviewed below), a negative result on GS does not eliminate the post-test
probability of being a carrier, though it generally improves upon the existing residual
risk of mutation panel-based approaches.
 Discovering that reproductive partners are each carrier for a severe recessive
condition enables preimplantation genetic diagnosis (PGD). PGD allows for testing of
embryos for a specific genetic variant (or variants, in the case of recessive diseases).
Embryos lacking the targeted genetic variants are then implanted, preventing
transmission of the genetic disease to offspring. PGD is a complicated and
controversial topic both technically and ethically, and has been reviewed thoroughly
elsewhere.
Emerging application: genetic predisposition screening
Several research studies and personal genomics companies have begun to report a
broad range of predispositional Mendelian variants to individuals. The general goal
of these initiatives is to provide genetically informed predictions of disease risk and
medication safety and efficacy, thereby enabling participants to make personalized
decisions for disease prevention. Although preliminary data has not demonstrated
significant risk of harm, benefits have not been systematically evaluated, and many
experts and professional organizations call for caution before adopting GS for
generally healthy individuals. To this end, the PeopleSeq (Personal Genome
Sequencing Outcomes) Consortium has been formed as the first systematic large -
scale longitudinal study of outcomes of predisposition sequencing and will seek to
collect short- and long-term data on participants in GS projects.
Monogenic variants for Mendelian syndromes that confer a significant risk for a
condition, such as the breast cancer susceptibility gene 1 and 2 (BRCA1/2) variants
associated with breast and ovarian cancer, may be revealed in GS of persons without
a personal or family history. In current clinical practice, these findings are discovered
secondary to diagnostic sequencing and are routinely reported for selected genes
believed to be clinically actionable. However, in predisposition screening, these
variants are a primary finding. Using strict variant-filtering criteria and all genes
associated with human disease, the MedSeq Project identified a monogenic variant in
21 out of 100 participants. Identification of these variants has enabled MedSeq
physicians to perform deep phenotyping (targeted medical examination and
assessment for manifestations of the associated conditions) of asymptomatic
individuals with monogenic variants.
GS can identify common genetic variants that have been associated with risk for
complex phenotypes, such as coronary artery disease and type 2 diabetes, in
genome-wide association studies (GWAS). Millions of individuals have undergone
genotyping for such variants via direct-to-consumer services such as 23andMe,
which have utilized chip arrays that identify genotypes at specific single-nucleotide
polymorphisms (SNPs). Because many variants identified in GWAS reside outside of
exons (protein-coding regions of the genome), such SNPs would not be detectable by
exome sequencing. Therefore, with regard to utilizing GS to identify these variants,
wholegenome sequencing, instead of exome sequencing, is required. Despite the
availability of relevant data from GS and the broad reporting of common disease
risks by personal genomic testing companies, there is limited evidence for the clinical
validity or utility of risk assessments from common genetic variation. GWAS variants
account for a small proportion of variability in the risk of multifactorial phenotypes,
known as the “missing heritability” problem (ie, other as yet unidentified genetic
factors or interactions between genetic variants must contribute to the heritability of
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 diseases). Additionally, risk-assessment methodologies to combine multiple variants
remain in flux, and reclassification of individuals from higher risk to average or lower
risk is expected to occur in most phenotypes as additional data accrue . Nevertheless,
some studies have shown that individuals make positive lifestyle changes and
become more engaged in their care after receiving such risk predictions .
Utilizing known associations between genetic variants and blood group and antigen
subtypes, GS can be used to predict clinically relevant hematological data, such as
blood group and platelet antigen types. Antigen subgroup status has potential
relevance for individuals who require multiple transfusions secondary to a chronic
medical condition, as well as for identifying potential donors who have rare blood
group antigens. The analytical algorithms have been developed and validated as part
of the MedSeq Project.
Finally, GS is a powerful tool to screen for multiple pharmacogenomic variants
simultaneously, creating the opportunity for personalized medication selectio n and
dosing regimens based on an individual's genotype or haplotype (group of genes
inherited together). Pharmacogenomic data offer the opportunity for querying
genomic data at the point of care as patients are prescribed medications for the first
time and new associations among drugs, genetic variants, and dosing requirements
or side effect risks are discovered and validated. The topic of pharmacogenomics will
be explored more comprehensively in two companion articles in this special issue.

The Digitization of Health Records

In medicine, the first information technology wave to hit the art and science of
healing was the digitization of medical files, now known as electronic health records
(EHRs). The data contained in EHRs in combination with other sources have the
potential to transform medical practice by leveraging data, technologies, and
healthcare delivery to improve the overall efficiency and quality of care at a
reasonable cost.
The widespread adoption of EHRs has generated large sets of data. The cr eative
merging of datasets collected from patients and physicians could be a viable avenue
to strengthen healthcare delivery. These massive datasets are currently understood
as a byproduct of medical practice instead of utilizable assets that could play pivotal
roles in patient care. Currently, for instance, most EHRs collect quantitative,
qualitative, and transactional data, all of which could be collated, analyzed, and
presented using sophisticated procedures and techniques that are now available to
make use of text-based documents containing disparate and unstructured data.
The purposeful use of data is not a mystery to medical practice. Since their humble
beginnings, evidence-based undertakings have been grounded in the principle that
questions answered through the scientific method were superior to anecdotes,
expert opinion, panels, and testimonials. In terms of acknowledging the value of data
and information in guiding a rational and logical decision-making process, medicine
has been at the forefront of adapting to modernity. However, physicians, nurses, and
healthcare facilities have been slow to embrace the newest methods to fully use the
data contained in EHRs. Let us examine four hidden benefits of EHRs.
 EHRs may augment the attainment of new knowledge through the automated and
systematic analysis of unstructured data by applying advanced computational
techniques that enable comprehensive data collection. The acquisition of structured
data to answer emerging clinical questions is onerous. Narrow and a utomatic
searches within EHRs using natural language processing (NLP) may be a less
expensive alternative. In fact, a 2011 study suggests that the automated identification
of postoperative complications within electronic medical records using NLP is far
superior to patient safety indicators linked to discharge coding. EHRs may assist in
the dissemination of new knowledge. As clinical practice evolves to incorporate the
latest evidence and facts guiding medical care, physicians encounter the daunting
task of sorting through large volumes of information to craft adequate and safe
treatment options for patients with diverse chronic illnesses. Tinkering with EHRs
can generate on-screen dashboards that can guide medical care decisions. Physicians
could receive pop-up messages informing them about clinical presentation,
diagnostic work, and therapeutic choices made by clinicians facing similar case
profiles. It appears that data-driven healthcare decision-support tools aid the
standardization of care and result in cost savings.
EHRs may help to blend medical practice with personalized clinical initiatives by
facilitating opportunities to utilize analytical methods and techniques that can
holistically integrate biology-based interdisciplinary fields of study (e.g.,
metabolomics, phenomics) with EHR datasets to streamline genomics research and
create a rich culture of cooperation.
EHRs may empower patients to play more active roles in caring for their health by
directly delivering information to these individuals. Patients not only can know
specific details about their health parameters and illnesses but also can present
medical records to other healthcare professionals when needed. The benefits of this
approach are twofold: information can be readily accessed without filling out forms
or having to interview patients with long questionnaires, and traditional health -
related data can be linked to other details associated with personal data, such as diet,
education, exercise, habits, hobbies, income, and military service.
There will surely be problems along the way. Current EHR systems and health
information exchange platforms are diverse and fragmented and have limited
interoperability. Privacy issues will very likely emerge as a concern, especially for the
protection of confidential information. Ultimately, interconnections between
technology and medicine are inevitable, which explains why medical informatics
plays a central role in healthcare.
An article by Palgon added the benefits of electronic health records:
In the early 1960s, when most hospitals and health systems were steeped in paper, a
handful of highly progressive healthcare providers embarked on a journey to
implement a computer-based patient record. Envisioning the benefits of electronic
health records to reduce, or even eliminate, paper in medical record keeping for
healthcare providers of all sizes and specialties, their bold steps forever changed the
way clinicians gather, document and review patient information.

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In 1972, the first electronic medical record system emerged, only to be shunned by
physicians due to its high cost. It was mainly used by government hospitals and few
forward thinking institutions.
Fast forward to 2017, and the benefits of electronic health records (EHR) are widely
recognized among healthcare providers. In fact, 98 percent of all hospitals now
demonstrate meaningful use and have adopted an EHR. On the ambulatory side,
the global EHR market expects 5.8% growth by 2021, growth that is fueled by
government mandates, the need to reduce costs and growing consumer demands to
enhance healthcare quality and delivery.
Growing Value for Providers, Patients
Despite growing use of electronic health records, the healthcare industry is nowhere
close to realizing the full benefits of the digitized record. While most providers
acknowledge the benefits and vision for the future, the growing pains created by
varying standards and the challenges of data exchange due to different electronic
formats remain a hurdle.
EHRs deliver advantages to healthcare providers and patients by enabling better
collection, storage and sharing of health information for the purpose of coordinated
care delivery. Electronic data storage and retrieval reduces the risk of lost patient
records and test results and offers more secure access over their paper predecessors,
which easily could be left on a desk and viewed by anyone walking by. This can be a
very important advantage and in better alignment with HIPAA compliance
requirements.
Another benefit of EHR technology is that it supports greater accuracy in records, as
healthcare providers are prompted to complete required data fields, use standard
terminology and check predefined boxes, not to mention the fact that the EHR has
purged the patient record of illegible physician notes. One specific benefit of
electronic health record technology is the speed in which clinicians can gain access to
critical test results and progress notes, eliminating delays in treatment caused by
missing data. Finally, electronic health records support enhanced patient safety by
collecting more complete data and providing secure access throughout the care
continuum.
On the other hand, electronic health records are not without their own challenges.
One of the biggest and perhaps most visible risks of electronic health records is data
security, as brought to light by the recent WannaCry ransomware cyber attack which
affected16 National Health Service hospitals in the UK. This massive hack effectively
took the hospitals offline, forcing suspension of services. In this attack, as in previous
ones, cyber criminals disrupted care and business operations by making personal
and clinical data contained in the electronic health records unavailable at the point of
care.
The negative impacts of cyber attacks are two-fold: risk to patient care and safety
and risk to patients’ financial health as other personal information is exposed to
unauthorized individuals with malicious intent. While data is potentially more secure
inside the four walls of the health system, the ability to share data to those who need
it to deliver care beyond those walls also offers the risk of unintended information
 exchange on a mass scale. Therefore, health systems need a comprehensive approach
to data security that includes all aspects of their operations, including the EHR.
Efficiency Supports Better Care
The benefits of electronic medical records are spread between healthcare providers
and patients and support the ultimate goal of effective exchange of data
(information) between providers caring for the same patient. In addition, electronic
health records can help physicians practice more efficiently by saving time with
electronic prescription, lab and imaging ordering and faster test result transactions.
The end goal is improved patient care and outcomes through better health and
disease management.
Enabling data integration into a single electronic medical record or single view, EHRs
make data accessible for the right person at the right time in the care delivery
process. But on a broader scale, health systems, like Accountable Care Organizations
(ACO) and highly integrated delivery systems that embrace EHR technology, are able
to integrate, aggregate and harmonize data across specialties, multiple EHRs in acute
and ambulatory settings, and financial, operational and claims data sources. This
allows providers to effectively collaborate and establish appropriate metrics to
support the overarching goal of coordinated, high quality care.
Hidden Data Provides Insight
While the benefits of electronic health records to store, manage and exchange patient
information are enormous, the advantages of using the EHR as a data source to
provide insight beyond individual patient care are immeasurable. However, a recent
survey showed that we still have ways to go. The survey noted that only 31 percent
of healthcare providers use their EHR analytics capabilities while another third
utilized a combination of the EHR capabilities and an outside vendor to analyze data.
Demonstrating the underutilization of this important aspect of the EHR, 11 percent
of respondents said they didn’t analyze EHR data at all.
For the greater patient (or population) good, health systems more than ever need to
understand and utilize the comprehensive set of data that the EHR can provide,
especially in combination with other EHRs and other data sources. ACOs know that
this integrated approach to data management and exchange can improve care. They
understand the benefits of using the collective data in electronic health records to
analyze specific patient populations, distinguish risk factors, identify trends in
disease treatment and predict future outcomes, all of which improve patient care,
outcomes and the cost of care.
To unlock this hidden benefit of the EHR, healthcare organizations need a flexible
and scalable platform that allows management and integration of complex data
across and, in some cases, beyond the enterprise. In many organizations, internal IT
resources do not have the time or ability to manage the increasing volume and
integration complexities of new and expanding sources of data. Choo sing cloud-
based technologies and a trusted partner to supplement internal IT resources helps
create a comprehensive data set in a secure and compliant manner.
The success of data management can be measured by the quality of the business
decisions and outcomes that are derived from the data. This requires moving beyond

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 simple data collection to a strategy and tools that are designed to improve data
integration, data exchange, and overall data management along with care and
business outcomes. A good place to start is analyzing the data that exists in the EHR
and leveraging that data for continual improvement.

References and Supplementary Materials

Online Supplementary Reading Materials
1. Genomic sequencing in clinical practice: applications, challenges, and o pportunities;
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5067147/; November 9, 2017
2. Future Opportunities for Genome Sequencing and Beyond: A Planning Worksho[ for
the National Genome Research Institute;
https://www.genome.gov/27559219/future-opportunities-for-genome-sequencing-
and-beyond/; November 9, 2017
3. Deploying whole genome sequencing in clinical practice and public health: Meeting
the challenge one bin at a time;
https://www.nature.com/gim/journal/v13/n6/full/gim9201182a.html; November 9,
2017
4. Electronic health records: beyond the digitization of medical files;
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3752637/; November 9, 2017
5. Digitizing Delivers: The Benefits of Electronic Health Records;
https://www.liaison.com/blog/2017/05/19/digitizing-delivers-benefits-electronic-
health-records-ehr/; November 9, 2017
6. The Digitization of Medical Records; https://rctom.hbs.org/submission/the-
digitization-of-medical-records/; November 9, 2017
7. Digitizing Healthcare: Why Having an Electronic Medical Record Matters;
http://possiblehealth.org/blog/electronic-medical-record/; November 9, 2017
 Module 010 – Sociology of Science

This module contains the following topic:

1. Sociology of Science

The Sociology of Science

Merton’s “The Sociology of Science: Theoretical and Empirical Investigations” has stated
the following regarding the Sociology of Science:
Science, like any other activity involving social collaboration, is subject to shifting fortunes.
Difficult as the notion may appear to those reared in a culture that grants scien ce a
prominent if not a commanding place in the scheme of things, it is evident that science is
not immune from attack, restraint and repression. Writing a little while ago, Veblen could
observe that the faith of western culture in science was unbounded, u nquestioned,
unrivaled. The revolt from science which then appeared so improbable as to concern only
the timid academician who would ponder all contingencies, however remote, has now been
forced upon the attention of scientist and layman alike. Local conta gions of anti-
intellectualism threaten to become epidemic.

Science and Society

Attacks on the integrity of science have led scientists to recognize their dependence
on particular types of social structure. An institution under attack must reexamine its
foundations, restate its objectives, seek out its rationale. Crisis invites self -appraisal.
Scientists have been jarred into a state of acute self-consciousness: consciousness of
self as an integral element of society with corresponding obligations and intere sts.
Scientists are compelled to vindicate the ways of science to man. They have come full
circle to the point of the reemergence of science in the modern world. Centuries ago,
when the institution of science could claim little independent warrant for social
support, natural philosophers were likewise led to justify science as a means to the
culturally validated ends of economic utility and the glorification of God. The pursuit
of science was then no self-evident value. With the unending flow of achievement,
however, the instrumental was transformed into the terminal, the means into the
end. Thus fortified, the scientist came to regard himself as independent of society and
to consider science as a self-validating enterprise which was in society but not of it.
Science refers to a variety of distinct though interrelated items. It is commonly used
to denote (1) a set of characteristic methods by means of which knowledge is
certified; (2) a stock of accumulated knowledge stemming from the application of
these methods; (3) a set of cultural values and mores governing the activities termed
scientific; or (4) any combination of the foregoing. For examining sociology of
science, we shall consider the mores with which the methods of science are hedged
about.
 The Ethos of Science

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The ethos of science is that affectively toned complex of values and norms
which is held to be binding on the man of science. These norms are expressed
in the form of prescriptions, proscriptions, preferences, and permissions.
They are legitimatized in terms of institutional values. These imperatives,
transmitted by precept and example and re-enforced by sanctions are in
varying degrees internalized by the scientist, thus fashioning his scientific
conscience or, if one prefers the latter-day phrase, his superego. Although the
ethos of science has not been codified, it can be inferred from the moral
consensus of scientists as expressed in use and wont, in countless writings on
the scientific spirit and in moral indignation directed. toward contraventions
of the ethos.

The institutional goal of science is the extension of certified knowledge. The

technical methods employed toward this end provide the relevant definition
of knowledge; empirically confirmed and logically consistent statements of,
regularities (which are, in effect, predictions). The institutional imperatives.
(mores) derive from the goal and the methods. The entire structure of
technical and moral norms implements the final objective. The technical norm
of empirical evidence, adequate and reliable, is a prerequisite for sustained'
true prediction; the technical norm of logical consistency, a prerequisite for
systematic and valid prediction. The mores of science possess a methodologic
rationale but they are binding, not only because they are procedurally
efficient, put because they are believed right and good. They are moral as well
as technical prescriptions. Four sets of institutional imperatives—
universalism, communism, disinterestedness, organized skepticism—are
taken to comprise the ethos of modern science.

o Universalism

Universalism finds immediate expression in the canon that truth-

claims, whatever their source, are' to be subjected to pre-established
impersonal criteria: consonant with observation and with previously
confirmed knowledge. The acceptance or rejection of claims entering
the lists of science is not to depend on the personal or social attributes
of their protagonist; his race, nationality, religion, class, and personal
qualities are as such irrelevant. Objectivity precludes particularism.
The circumstance that scientifically verified formulations refer in that
specific sense to objective sequences and correlations militates against
all efforts to impose particularistic criteria of validity.

However, the institution of science is part of a larger social structure

with which it is not always integrated. When the larger culture opposes
universalism, the ethos of science is subjected to serious strain.
Ethnocentrism is not compatible with universalism. Particularly in
times of international conflict, when the dominant definition 'Of the
situation is such as to emphasize national loyalties, the man of science
is subjected to the conflicting imperatives of scientific universalism
 and of ethnocentric particularism. The structure of the situation in
which he finds himself determines the social role that is called into
play. The man of science may be converted into a man of war —and act
accordingly.

However inadequately, it may be put into practice, the ethos of

democracy includes universalism as a dominant guiding principle.
Democratization is tantamount to the progressive elimination of
restraints upon the exercise and development of socially valued
capacities. Impersonal criteria of accomplishment and not fixation of
status characterize the open democratic society. Insofar as such
restraints do, persist, they are viewed as obstacles in the path of full
democratization. Thus, insofar as laissez-faire democracy permits the
accumulation of differential advantages for certain segments of the
population, differentials that are not bound up with demonstrated
differences in capacity, the democratic process leads to increasing
regulation by political authority. Under changing conditions, new
technical forms of organization must be introduced to preserve and
extend equality of opportunity. The political apparatus may be
required to put democratic values into practice and to maintain
universalistic standards.

o Communism

"Communism," in the nontechnical and extended sense of common

ownership of goods, is a second integral element of the scientific ethos.
The substantive findings of science are a product of social
collaboration and are assigned to the community. They constitute a
common heritage in which the equity of the individual producer is
severely limited. An eponymous law or theory does not enter into the
exclusive possession of the discoverer and his heirs, nor do the mores
bestow upon them special rights of use and disposition. Property rights
in science are whittled down to a bare minimum by the rationale of the
scientific ethic. The scientist's claim to "his" intellectual "property" is
limited to that of recognition .and esteem which, if the institution
functions with a modicum of efficiency, is roughly commensurate with
the significance of the increments brought to the common fund of
knowledge. Eponymy—for example, the Copernican system, Boyle's
law—is thus at once a mnemonic and a commemorative device.

Given such institutional emphasis upon recognition and esteem as the

sole property right of the scientist in his discoveries, the concern with
scientific priority becomes a "normal" response. Those controversies
over priority which punctuate the history of modern science are
generated by the institutional accent on originality. There issues
competitive cooperation. The products of competition are communized
and esteem accrues to the producer. Nations take up claims to priority,
and fresh entries into the commonwealth of science are tagged with.
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 the names of nationals: witness the controversy raging over the rival
claims, of Newton and Leibniz to the differential calculus. But all this
does not challenge the status of scientific knowledge as common
property.

The communism pf the scientific ethos is incompatible with the

definition of technology as "private property" in a capitalistic economy.
Current writings on the "frustration of science" reflect this conflict.
Patents proclaim exclusive rights of use and, often, nonuse. The
suppression of invention denies the rationale of scientific production
and diffusion, as may be seen from the court's decision in the case of
U.S. v. American Bell Telephone Co.: "The inventor is one who has
discovered something of value. It is his absolute property. He may
withhold the knowledge of it from the public." Responses to this
conflict-situation have varied. As a defensive measure, some scientists
have come to patent their work to ensure its being made available for
public use. Einstein, Millikan, Compton, Langmuir have taken out
patents} Scientists have been urged to become promoters of new
economic enterprises. Others seek to resolve the conflict by advocating
socialism} These proposals—both those which demand economic
returns for scientific discoveries and those which demand a change in
the social system to let science get on with the job—reflect
discrepancies in the conception of intellectual property.

o Disinterestedness

Science, as is the case with the professions in general, includes

disinterestedness as a basic institutional confuse institutional and
motivational levels of analysis. A passion for knowledge, idle curiosity,
altruistic concern with the benefit to humanity, and a host of. other
special motives have been attributed to the scientist. The quest for
distinctive motives appears to have been misdirected. It is rather a
distinctive pattern of institutional control of a wide range of motives
which characterizes the behavior of scientists. For once the institution
enjoins disinterested activity, it is to the interest of scientists to
conform on pain of sanctions and, insofar as the norm has been
internalized, on pain of psychological conflict

It is probable that the reputability of science and its lofty ethical status
in the estimate of the layman is in no small measure due to
technological achievements. Every new technology bears witness to
the integrity of the scientist. Science realizes its claims. However, its
authority can be and is appropriated for interested purposes, precisely
because the laity is often in no position to distinguish spurious from
genuine claims to such authority. The presumably scientific
pronouncements of totalitarian spokesmen on race or economy or
history are for the uninstructed laity of the same order as newspaper
 reports of an expanding universe or wave mechanics. In both
instances, they cannot be checked by the man-in-the-street and in both
instances, they may run counter to common sense. If anything, the
myths will seem more plausible and are certainly more
comprehensible to the general public than accredited scientific
theories, since they are closer to common-sense experience and to
cultural bias. Partly as a result of scientific achievements, therefore, the
population at large becomes susceptible to new mysticisms expressed
in apparently scientific terms. The borrowed authority of science
bestows prestige on the unscientific doctrine.

o Organized Skepticism

As we have seen in the preceding chapter, organized skepticism is

variously interrelated with the other elements of the scientific ethos. It
is both a methodological and an institutional mandate. The temporary
suspension of judgment and the detached scrutiny of beliefs in terms of
empirical and logical criteria have periodically involved science in
conflict with other institutions. Science which asks questions of fact,
including potentialities, concerning every aspect of nature and society
may come into conflict with other attitudes toward these same data
which have been crystallized and often ritualized by other institutions.
The scientific investigator does not preserve the cleavage between the
sacred and the profane, between that which requires uncritical respect
and that which can be objectively analyzed.

As we have noted, this appears to be the source of revolts against the

so-called intrusion of science into other spheres. Such resistance on the
part of organized religion has become less significant as compared
with that of economic and political groups. The opposition may exist
quite apart from the introduction of specific scientific discoveries
which appear to invalidate particular dogmas of church, economy, or
state. It is rather a diffuse, frequently vague, apprehension that
skepticism threatens the current distribution of power. Conflict
becomes accentuated whenever science extends its research to new
areas toward which there are institutionalized attitudes or whenever
other institutions extend their control over science. In modern
totalitarian society, anti-rationalism and the centralization of
institutional control both serve to limit the scope provided for
scientific activity.

References and Supplementary Materials

Online Supplementary Reading Materials
1. The Sociology of Science: Theoretical and Empirical Investigations;
http://www.collier.sts.vt.edu/5424/pdfs/merton_1973.pdf; November 9, 2017

Course Module
2. Sociology of Science;
http://students.ecs.soton.ac.uk/mwra1g13/msc/comp6037/pdfs/Sociology_of_Scien
ce.pdf; November 9, 2017
 Module 009 – Ethical, Social and Policy Issues of
Nanotechnology

This module contains the following topics:

1. Ethical and Social Issues and Implications of Nanotechnology
2. Policy Issues and Implications for Nanotechnology Commercialization
3. Risk Management of Nanotechnology

Ethical and social implications nanotechnology

As we design systems on a nanoscale, we develop the capability to redesign the structure of
all materials– natural and synthetic–along with rethinking the new possibilities of the
reconstruction of any and all materials. Such increases in design power present significant
social and ethical questions. To support sustainable, ethical, and economic
nanotechnological development, it is imperative that we educate all nanotechnology
stakeholders about the short-term and long-term benefits, limitations, and risks of
nanotechnology. Nanotechnology, like its predecessor technologies, will have an impact on
all areas. For example, in healthcare it is very likely that nanotechnology in the area of
medicine will include automated diagnosis. This in turn will translate into fewer patients
requiring physical evaluation, less time needed to make a diagnosis, less human error, and
wider access to health care facilities. And, with nanomedicines, if the average human life
span increases, the larger number of elderly persons requiring medical attention will likely
result in increased health expenditures. It is essential for nanotechnology stakeholders to
strive to achieve four social objectives: (1) developing a strong understanding of local and
global forces and issues that affect people and societies, (2) guiding local/global societies to
appropriate uses of technology, (3) alerting societies to technological risks and failures,
and (4) developing informed and ethical personal decision-making and leadership to solve
problems in a technological world.7 Advances in nanotechnology also present numerous
challenges and risks in health and environmental areas. Nanotechnology risk assessment
methods and protocols need to be developed and implemented by the regulatory bodies.
Eric Drexler, author of Engines of Creation, has identified four challenges in dealing with
the development, impact, and effects of nanotechnology on society.
(1) The Challenge of Technological Development (control over the structure of
matter)
(2) The Challenge of Technological Foresight (sense of the lower bounds of future
possibilities)
(3) The Challenge of Credibility and Understanding (clearer understanding of what
these technological possibilities are)
(4) The Challenge of Formulating Public Policy (formulating polices based on
understanding)

Lewenstein gave the following social and ethical issues in nanotechnology:

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 The list of social, ethical, legal, and cultural implications includes such issues as privacy,
avoiding a ‘nano-divide’, unintended consequences, university/industry relationships and
potential conflicts of interest, research ethics, and so on. It is widely acknowledged that,
precisely because the applications of nanotechnology are not yet clear, neither are the
ethical issues clear. And yet, many argue, the nano community must begin to address these
issues now, before they overwhelm nanotechnology and derail potential benefits.
Read the full document of his report here: http://www.hyle.org/journal/issues/11-
1/lewenstein.pdf
In addition, Wolfson had this to say:
Nanotechnology has an enormous potential to do good in society. However, like many
technologies, its introduction and implementation raise serious societal and ethical issues,
both for the scientists who are developing this technology and for the members o f the
public who may benefit from or be exposed to it. The purpose of this paper is to explore
some of these societal and ethical issues. The purpose is not to take policy positions or to
suggest solutions but merely to raise some of the important social issues. In this way, it is
hoped that this paper can form the basis of a discussion on the public policy ramifications
of nanotechnology, from which positions and solutions can begin to emerge.
Many of the social and ethical issues are the same as those that affect a wide range of other
high technologies. That is, while the technology is new, the issues it raises have been faced
before by researchers and society. We need to remind ourselves about the lessons we have
already learned about social and ethical issues that were raised by biotechnology (such as
from regulatory failures in gene therapy), from the development of nuclear technologies,
and from computer technologies.

The Risk Management Model in Nanotechnology

Goudarzi, et.al. has suggested the 10-step model for nanotechnology risk management in
related projects and believe that these considerations could considerably control the
hazardous effects of the materials in workplaces and the environment.
Step 1: A basic knowledge of the work is essential fo r doing an adequate assessment.
Therefore, workplace personnel who have extensive knowledge of the field should always
be involved.
Consultation between managers and employees benefits the assessment and will help in
providing information about the substances used, how the work is performed, exposure to
nanomaterials and commitment to quality control.
Project managers might do the assessments themselves when working in a small
workplace, or it might be necessary to establish a team in a larger workplace. The
assessment team should have abilities to understand the information in the protocols and
labels, inspect the conditions of work and forecast potential problems. They also should
communicate efficiently with employees and possible stakeholders for makin g valid
conclusions about exposures and risks and finally report the findings accurately.
Step 2: To be able to make a thorough risk assessment, divide the work into sections,
subsections and tasks or process-units according to Work Breakdown Structure (WBS).
 Step 3: Identify all nanoparticles that are, or will be, used or produced in every work unit
and process. A nanoparticle might be produced in the form of a powder, liquid, gel, vapor,
dust, mist or fume in the workplace.
Step 4: Identify the type of nanoparticle. Nanoparticles can be found in several forms, from
relatively safe such as engineered insoluble nanoparticles in a matrix to more hazardous
forms such as free nanoparticles.
Step 5: The supplier should provide information about the nanomater ials. However, for
most nanomaterials, Material Safety Data Sheets (MSDS) are not available, so it will be
necessary to obtain adequate information from other sources such as textbooks, provided
standards, technical reference sources, scientific papers, reports, trade journals, electronic
online databases or experience from a previous use of similar substances or processes.
Step 6: How are hazardous nanoparticles released into the work area? Are persons exposed
to hazardous nanoparticles through respiration, skin, ingestion or eye contact, or is there a
possibility of accidental injection into the body? A ‘walk through’ inspection will provide
information about each of the work units. It is important to talk to the employees at each
location and ensure that all persons that could be exposed to nanomaterials are covered. If
a new assignment, process or work unit is being planned but not yet in operation,
evaluation of the relevant work process, plan or design is needed.
 Is there nanoparticle exposure?
 How much and how long are the personnel exposed?
 Is there an intermittent or continuous exposure?
 Is there a frequent exposure?
 What kind of control measures could be used or proposed?
 Are the existing controls sufficient?
 Are there any risks related to the storage and transport of nanomaterials?
Step 7: A significant risk involves serious health effects to people in the workplace18, for
instance by inhalation of nanoparticles or working with highly toxic nanoparticles (e.g.
nanobased anticancer drugs). Consider the nature and severity of the hazard and the
degree of exposure of people involved in the process. For summarizing the evaluation
process, four decisions could be made:
Decision 1: There are not significant risks at the moment and they are not likely to
increase in the future. Executions: Go to step 9 and end current assessment but
review the assessment if the situation changes.
Decision 2: There are significant risks but they have already been effectively
controlled. There might be a possible increase in the future. Executions: Maintain
control procedures and minimize chances of higher exposure occurring. Establish
additional control procedures (see step 8) if a high-risk event occurs despite
previous precautions. Review assessment steps if the situation changes.
Decision 3: There are significant risks present and they are not adequately
controlled. Executions: Determine and implement actions for preventing or
controlling exposure immediately. Investigate and implement a possible stop in the
production. Begin reviewing if more controls are required. Evaluate the exposures
again if the upgraded control procedures are used. Establish employee -training
programs.
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 Decision 4: There are uncertainties about the risks involved – not enough
information or uncertainty about the degree of exposure. Executions: Find more
information or conduct a more detailed assessment. Request specialist advice if
necessary and decide using suitable actions presented in conclusion 1, 2 or 3. Apply
a good practice to minimize exposure meanwhile.
Step 8: If the assessment shows that there are significant risks to health, besides the
executions mentioned in step 7, further actions should be acquired if needed:
 Complementary employee training
 More precise monitoring procedures
 Health surveillance system
 First aid and emergency facilities
Step 9: The record should be concise and should include a description of the work unit,
name of assessor or assessment team personnel, date, time and a list of hazardous
nanomaterials used or produced in the project unit. It should also include a summary of the
process containing a description of normal operations in the project unit, with a note of any
changes observed or anticipated which might affect accuracy of assessment; risk
identification, including possible routes of exposure; procedure for assessment of
exposure; the degree of exposure and existing control procedures. The above mentioned
record should be saved either on paper or electronically in a permanent format.
Step 10: Review and regulation of the assessment is required if:
 There should be significant changes in project products, work, material, process or
control procedures
 Nanoparticle-related intoxication is reported
 Inadequate control procedures are reported
 New evidence about risks of nanoparticles emerges from recent publications
In these circumstances using a new or improved control method becomes reasonable.
Read the full report through this link: http://www.hypothesisjournal.com/wp-
content/uploads/2014/01/HJ330.pdf

References and Supplementary Materials

Online Supplementary Reading Materials
1. Ethical and social implications of nanotechnology;
http://www.qscience.com/doi/pdf/10.5339/qproc.2015.elc2014.57; November 9,
2017
2. What Counts as a ‘Social and Ethical Issue’ in Nanotechnology?;
http://www.hyle.org/journal/issues/11-1/lewenstein.pdf; November 9, 2017
3. Social and Ethical Issues in Nanotechnology: Lessons from Biotechnology and other
High Technologies;
https://www.blankrome.com/siteFiles/Publications/5B17637895210814D3535F12
76C22B89.pdf; November 9, 2017
 4. Nanotechnology risks: A 10-step risk management model in nanotechnology projects;
http://www.hypothesisjournal.com/wp-content/uploads/2014/01/HJ330.pdf;
November 9, 2017

Course Module
 Module 008 – Nanotechnology
commercialization and convergence with other
technologies

This module contains the following topics:

1. Commercialization of Nanotechnology
2. Convergence of Nanoscience with other technologies

Commercialization of Nanotechnology
Discoveries in nanotechnology have continued to increase as technologies have advanced
and commercialization strategies have become better implemented. In 2013, for example,
the number of patents issued under the nanotechnology classification, as defined by the
U.S. Patent and Trademark Office (USPTO), was 1,130. In fact, the last eight years (2006 -
2013) have shown steady growth in the number of patents issued, with approximately 4x
as many issued in 2013 as in 2006.
A variety of industries manufacture products incorporating nanotechnology including
biomedical devices, home appliances, batteries, industrial lubricants, computers, cameras,
food and beverage, clothing, cosmetics, fashion and manufacturing. To appropriately
measure nanotechnology’s commercial successes, it is essential to first define what it is
exactly. The National Nanotechnology Institute defines nanotechnology as “the
understanding and control of matter at dimensions between approximately 1 and 100
nanometers, where unique phenomena enable novel applications.” 9 The United States
Patent and Trademark Office (USPTO) applies a similar definition of nanotechnology
(Patent Classification 977) and further specifies more than 250 subclassifications including
nanostructures with biological material component (subclass 702), carbon nanotubes
(subclass 742), atomic force probe (subclass 863) and specified use of nanostructures for
medical, immunological, body treatment, or diagnosis (subclass 904), gene therapy
(subclass 916), dental (subclass 919) and carrying or transporting (subclass 963).
Commercialization Strategies
There are two basic commercialization strategies for nanotechnology - product
innovation or process innovation.
 Product Innovation
Changes and advances in nanotechnology have resulted in commercial
successes in a variety of different industries. In most instances,
nanotechnology is used to facilitate a product innovation, often in response
to anticipated and/or actual demand for specific product characteristics. For
example, “a tennis racket made from a composite material which includes
CNTs to improve its mechanical properties is an attempt to create a
differentiated and improved product to gain market share” or a nanofiber
that, when used in conjunction with other materials, yields stronger and

Course Module
 lighter bicycle frames. In these example, much like real life, nanotechnology
is use to augment current technologies to enhance products and/or
processes which already exists. Indeed, considered in this light, it often is
easier to identify nanotechnology as a process rather than a product.
Nanotechnology provides the means by which a desired characteristic can be
achieved within a product market that already exists. In such cases, the use of
nanotechnology becomes almost an incremental decision – one that allows
for the achievement of a requisite characteristic already valued by the
market. The numerous other characteristics also included in the technology
also are valued and thus the potential for royalty stacking comes into play.
 Process Innovation
By contrast, process innovations are more embedded, but potentially more
radical. These tend to be much broader, focusing on developing new
technologies and thus new markets. For example, consider a hypothetical
self-repairing nanomachine in which demand is driven by the entirety of the
product.
Funding
Research and development spending and commercialization costs represent
significant barriers to entry for firms wanting to enter the nanotechnology
market. Development and manufacturing of equipment can be cost
prohibitive for firms with limited access to capital. Further, it also is
necessary to develop and maintain sufficient levels of human capital. As with
most other industries, access to capital markets for funding is vital to success.
For nanotechnology, the single largest share of investment funds comes from
corporations. In 2010, worldwide corporate funding amounted to
approximately $9 billion while the second largest share of investment funds,
federal funding, was just over $1 billion.

Nanosciences and its Convergence with other Technologies

Nanosciences and nanotechnologies are a rapidly growing field that already generates
many hopes within the scientific and technological community of future discoveries,
developments, and solutions to a number of societal problems. Simultaneously, fears of
possible negative and uncontrolled impacts on humans and the environment are also
developing steadily. In this paper, we propose a typology to classify these fears, which are
shown to be associated with images, metaphors, and symbols deeply rooted in the Western
religious tradition. However, we think that it is necessary, and urgent, to discern between
the hype, notably due to the media coverage of the field, and reality. Strangely enough, the
idea that there might be a problem with nanotechnologies first emerged amongst the
community of experts and promoters of this field, at a time when the general public was
not even aware of the existence/emergence of a nanoworld. Is it only initially a media
phenomenon?
Whatever the answer, we may have the opportunity, perhaps for the first time in the
history of science and technology, to consider simultaneously the developments of new
scientific knowledge and engineering capabilities with its impact on society and the
 environment and, thus, to take in time appropriate decisions ‘to keep everything under
control’. In a potentially controversial context, political decision-makers have the
responsibility, with the active participation of scientists and engineers, to initiate,
stimulate, and organize the public debate. Their objective should be to clarify the actual
issues at stake, putting aside purely imaginary ones which rather belong to science fiction,
as well as to identify methodologies to tackle these issues and to implement regulations,
where necessary, to ‘master’ the development of nanotechnologies.
The difficulty of this task stems from the wide variety of (nano)objects, topics, and issues
associated with the expressions ‘nanosciences’ and ‘nanotechnologies’. Indeed,
nanoparticles, molecular robots, radiofrequency identification devices, etc., rais e different
questions and call for specific solutions. The possible toxicity of nanoparticles, which may
be released massively in the environment, poses a different problem than the wide
commercial diffusion of RFIDs, which may endanger the privacy of personal information,
even in a democratic society.
The convergence of bio, nano, and information technology
Nature has seen the evolution of extremely intelligent and complex adaptive systems
to drive the biological processes found in everyday life. For example, a cell can fuse
information-rich genetic processes with nanometer-scale sensors and actuators,
becoming one of the most efficient autonomous molecular systems. These basic
processes that occur at the molecular level lead us toward a compelling engin eering
approach: the fusion of biotechnology, nanotechnology, and information science.
Nanotechnology has enabled the production of new materials and molecular -scale
devices. Biotechnological advancements have allowed scientists to physically
manipulate genetic pathways or engineering strains of proteins to possess novel
functionalities. Informatics has served as the catalyst for organizing and
understanding vast knowledge from a system point of view.
The fusion of biotechnology, nanotechnology, and information science will culminate
in system architectures that can rival those that have taken millions of years to come
to fruition. With this comes the hope of achieving a fundamental comprehension of
how to manipulate and control cells on the molecular level. It will also enable us to
question just how much further we can push the envelope of human engineering.
The Institute for Cell Mimetic Space Exploration (CMISE) is one of four NASA
University Research, Engineering and Technology Institutes for developing
technologies on the nanometer scale for the study of biological phenomena. With
these unique nano modalities, the Center for Cell Control (CCC), a National Institute
of Health Nanomedicine Development Center, will apply engineering feedback
control schemes to direct information-rich biological cells towards therapeutic use.
Nature's Model for Bio, Nano, and Information Fusion: the Living Cell
The cell is the most fundamental biological unit, a magnificent, self-organized
system that performs the complex processes of life. A cell consists of a large
number of functional macromolecules, such as the millions of proteins with
sizes ranging from one to tens of nanometers. Self organization of these
nanometer-scale machineries confined within a fluidic capsule forms a live
cell at a size scale of only a few micrometers.

Course Module
 Cellular activities are manifestations of the intra- and intermolecular
transports and motions of cellular molecules. These activities result in a
comprehensive set of functionalities: to sense (monitor its biological
surroundings and responses), to decide (evaluate incoming signals and
trigger an optimal response through information analysis), and to actuate
(modify its nanometer-scale surrounding to make it more suitable for
survival). The cell's responses to the internal and external stimulations
through organized molecular activities, governed by a complex information
processing network, render it an ideal model for a bio, nano, and information
fusion system.

References and Supplementary Materials

Online Supplementary Reading Materials
1. Commercialization of Nanotechnology;
http://www.micronomics.com/articles/Nanotechnology_Commercialization.pdf;
November 8, 2017
2. New Initiatives to Accelerate the Commercialization of Nanotechnology;
https://www.nano.gov/May2015Forum; November 8, 2017
3. New Initiatives to Accelerate the Commercialization of Nanotechnology;
https://obamawhitehouse.archives.gov/blog/2015/05/20/new-initiatives-
accelerate-commercialization-nanotechnology; November 8, 2017
4. Nanosciences and its Convergence with other Technologies;
http://www.hyle.org/journal/issues/11-1/petit-laurent.pdf; November 8, 2017
5. The convergence of bio, nano, and information technology;
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2953859/; November 8, 2017
6. Science and technology convergence: with emphasis for nanotechnology-inspired
convergence; https://nsf.gov/crssprgm/nano/MCR_16-
0714f_JNR_Perspectives_Convergence_Science_by%20Bainbridge_and_Roco_19p.pdf ;
November 8, 2017
7. Patenting Natural Products after Myriad;
http://jolt.law.harvard.edu/assets/articlePDFs/v30/30HarvJLTech569.pdf;
November 8, 2017
8. Convergence and Multidisciplinarity in Nanotechnology;
https://arrow.dit.ie/cgi/viewcontent.cgi?referer=https://au.search.yahoo.com/&http
sredir=1&article=1106&context=buschmarart; November 8, 2017
 Module 007 – The Impact of Nanotechnology in
Business and Economy

This module contains the following topics:

1. Impact of Nanotechnology on Business
2. Effects of Nanotechnology on Economy

Impact of Nanotechnology on Business

The fundamental characteristics of nanotechnology have led analysts to suggest that it may
constitute a basis for long-term productivity and economic growth. It may also help to
address pressing national and global challenges in areas such as health care, energy, water
and climate change – you'll find plenty of examples here in our Nanowerk pages.
While sites like Nanowerk and others focus more on traditional science and technology
issues that highlight the broad-based nature of nanotechnology, others like consultants and
analysts go wild in predicting huge markets (hey guys – are we still on for a $3 trillion-
dollar market anytime soon?) and contributions to entrepreneurship and job creation.
Between those two areas, however, it is hard to obtain reliable information in terms of the
implications for nanotechnology companies and nanotech business in general. But it is
exactly this information that governments would need to determine how they should
structure their innovation policies.
– Nanotechnology is an enabling technology (or set of technologies) and the company case
studies show that this feature is a major reason for their entry into the field.
Nanotechnology allows for both the improvement of existing and the develo pment of
completely new products and processes, and sometimes new services as well. Companies
often experiment with multiple applications at the same time, many of which are still in the
research phase.
– Nanotechnology may best be described as a "science-based and demand-driven field".
While all of the case study companies undertake in-house R&D, collaboration with
universities and "star scientists" are also important sources of innovation and knowledge,
especially for small companies. Larger companies in relatively mature nanotechnology
subareas appear to focus more on applications which are driven by market demand and
tend to collaborate with a broader range of organizations to leverage their in -house R&D.
– Nanotechnology mainly affects the R&D and production activities of the case study
companies. Many of the smaller companies focus exclusively on nanotechnology, while the
larger ones typically blend nanotechnology with a range of other technologies. In the larger
companies it is thus difficult to single out the share of nanotechnology in total labor costs,
R&D expenditure, production costs, capital spending and sales.

– The larger companies in the sample have typically been involved in nanotechnology for
many years and seem well placed to assimilate nanotechnology due to their established
Course Module
critical mass in R&D and production, their ability to acquire and operate expensive
instrumentation and to access and use external knowledge. The relative strength of larger
companies in the early phases of nanotechnology developments runs counter to what the
traditional model of company dynamics and technology lifecycles would predict where
smaller, younger companies are generally considered more innovative.
–The case studies illustrate that nanotechnology is a complex field owing to its dependency
on various scientific disciplines, research/engineering approaches and advanced
instrumentation. Further, many nanotechnology sub-areas are in an early, immature, phase
of development. These features of nanotechnology can often create barriers to entry
especially for smaller companies which have limited human and other resources. They also
contribute to the poor process scalability of nanoscale engineering during the transition
from R&D to pilot and industrial scale production.
– Difficulties arise for recruiting human resources, especially for R&D and production
activities. The need for employees, or so-called gatekeepers, who combine specialist and
general knowledge (knowledge integration) and can manage interdisciplinary teams is also
a challenge.
– Challenges to funding R&D and related activities are often mentioned, especially by
business start-ups. The poor process scalability of R&D, which raises costs and prolongs
new product development times, can make nanotechnology less attractive to investors.
Uncertain regulatory environments and public perceptions of nanotechnology's
environmental, health and safety (EHS) risks can also influence R&D funding.
– The novelty of nanotechnology, the established interests of stakeholders, and difficulties
that companies can have in communicating the value proposition of applications to
potential customers (e.g. other companies), makes their entry and positioning in value
chains harder. The challenge is even greater for smaller companies th at experiment with
multiple applications and have to monitor many different industries and business
environments.
– Intellectual property rights (IPR) may become an issue as commercialization progresses
and nanotechnology matures as there is already a very wide range of patent claims, and the
possible formation of patent thickets (interrelated and overlapping patents), which could
contribute to barriers to entry for companies.
– The potential for overreaction to both actual and perceived EHS uncertainties a nd risks,
combined with regulatory uncertainties, complicates the business environment for
companies. Global harmonization of future EHS regulations is considered important.
A similar project was conducted by dandolopartners with their study of business’
understanding of and attitudes towards nanotechnology.
The report contains findings from a component of that research base – in-depth interviews
with 15 representatives from the business community. Businesses interviewed ranged
from small businesses to multinational companies, industry associations and local
government.
Key Findings
1. Companies are generally aware of nanotechnology and positive about its
potential benefits.
 2. Overall, businesses have few concerns about nanotechnology, but are wary of
unknown health and safety side-effects.
3. For most companies, nanotechnology is a ‘watching brief’: they believe its impact
will not be felt in the short term, except perhaps in ICT (Information and
Communications Technology) and electronics. It is seen as offering a particularly
strong competitive advantage for companies operating in highly competitive and
mature markets.
4. Local companies see themselves predominantly as users of nanotechnology,
rather than developers of nanotechnology
5. Companies believe there is a clear role for government to support
nanotechnology development
The full details of the study are in the report that can be accessed through this link:
https://industry.gov.au/industry/IndustrySectors/nanotechnology/Publications/Docume
nts/Nanotechnologyandthebusinesscommunity2005.pdf

Effects of Nanotechnology on Economy

A recent review article in Environmental Health ("Opportunities and challenges of
nanotechnology in the green economy") examines opportunities and practical challenges
that nanotechnology applications pose in addressing the guiding principles for a green
economy.
The authors provide examples of the potential for nanotechnology applications to address
social and environmental challenges, particularly in energy production and storage thus
reducing pressure on raw materials, clean-up technologies as well as in fostering
sustainable manufactured products. The areas covered include:
 nanomaterials for energy conversion (photovoltaics, fuel cells, hydrogen storage
and transportation)
 nanomaterials for energy storage
 nanomaterials for water clean-up technologies
 nanomaterials for the construction industry
These solutions may offer the opportunities to reduce pressure on raw materials trading
on renewable energy, to improve power delivery systems to be more reliable, efficient and
safe as well as to use unconventional water sources or nano -enabled construction products
therefore providing better ecosystem and livelihood conditions.
Conflicting with this positive message is the growing body of research that raises questions
about the potentially negative effects of engineered nanoparticles on human health and the
environment. This area includes the actual processes of manufacturing nanomaterials and
the environmental footprint they create, in absolute terms and in comparison with existing
industrial manufacturing processes.
Consequently, the review aims to critically assess the impact that green nanotechnology
may have on the health and safety of workers involved in this innovative sector and
proposes action strategies for the management of emerging occupational risks.

Course Module
 The authors propose action strategies for the assessment, management and
communication of risks aimed to precautionary adopt preventive measures including full
lifecycle assessment of nanomaterials, formation and training of employees, collective and
personal protective equipment, health surveillance programs to protect the health and
safety of nano-workers.
Concluding, the scientists emphasize that green nanotechnology should not only provide
green solutions, but should also 'become green' in terms of the attention paid to
occupational safety and health. In this context, a full democratic discussion between
expertise should be pursued to carefully balance the benefits of green nanotechnology and
the potential costs for the society, particularly in terms of environmental, public and
occupational health. This careful consideration will maximize environmental and societal
benefits, health gains and cost savings and will increase the likelihood of further
investment and sustainable development of this promising technological field.

References and Supplementary Materials

Online Supplementary Reading Materials
1. The Strategic Impact of Nanotechnology on the Future of Business and Economics ;
http://www.globalfuturist.com/dr-james-canton/insights-and-future-
forecasts/stratigic-impact-of-nanotechnology-on-business-and-economics.html;
November 7, 2017
2. Nanotechnology business – The impact of nanotechnology on companies;
https://www.nanowerk.com/spotlight/spotid=19620.php; November 7, 2017
3. Nanotechnology and business opportunities: scenarios as awareness instrument;
http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.93.5222&rep=rep1&type
=pdf; November 7, 2017
4. Nanotechnology and the business community;
https://industry.gov.au/industry/IndustrySectors/nanotechnology/Publications/Doc
uments/Nanotechnologyandthebusinesscommunity2005.pdf; November 7, 2017
5. Nanotechnology in the ‘green’ economy – opportunities and risks;
https://www.nanowerk.com/spotlight/spotid=38141.php; November 7, 2017
6. Assessing the Economic Impact of Nanotechnology: The Role of Nanomanufacturing;
http://www.internano.org/node/580; November 7, 2017
7. Social and economic aspects of nanotechnology;
http://www.softmachines.org/wordpress/?cat=5; November 7, 2017
8. The Social and Economic Impacts of Nanotechnologies: A Literature Review;
https://industry.gov.au/industry/IndustrySectors/nanotechnology/Publications/Doc
uments/SocialandEconomicImpacts_LiteratureReview.pdf; November 7, 2017