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If manufacturing or distributing your own
label Class II or higher device, do you have your ISO 13485
QS in place? It has been required since 2006. |
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Robotic lab makes heart proceedures safer
Toronto’s Sunnybrook Health Science Centre recently announced the
opening of the GTA’s first robotic arrhythmia invasive lab. The lab
will allow patients with irregular heart beats to receive minimally
invasive treatment to restore normal heart function.
The new lab is home to a cutting-edge system from Stereotaxis. The
system uses computerized, magnet-guided technology to enhance the
precision and safety of heart procedures. According to Sunnybrook’s
Dr. Eugene Crystal, the system is one of only three such suites in
Canada and it will revolutionize how hospitals treat patients with
cardiac arrhythmias and perform other cardiovascular interventions.
A cardiac arrhythmia occurs when the electricity that flows through
the heart to trigger the pumping action "short circuits" or gets
blocked - disturbing the heart's normal rhythm. In many patients,
this development can cause symptoms like heart palpitations,
fatigue, dizziness, chest pain and shortness of breath. Such
symptoms can severely affect quality of life. If left untreated,
they can also lead to heart attack and stroke. The goal of treatment
is to ablate - or destroy - damaged heart tissue that causes the
electrical malfunction and restore a regular heart rhythm.
During a procedure in a robotic arrhythmia invasive suite, powerful
magnets are positioned near the patient while a cardiologist
operates the system from an adjoining control room, away from the
x-ray field. A sophisticated GPS technology maps a pathway through a
patient's blood vessels and heart to the diseased heart tissue. The
system’s magnets lead a soft catheter gently along this pathway by
guiding its magnetic tip.
The new suite is part of a $25 million redevelopment project to
create a world-class, technologically advanced Schulich Heart Centre
at Sunnybrook.

A
virtual brain is predicting how aging impacts us all
Located at
Baycrest, a world leading academic health science centre, RRI
(Rothman Research Institute) is at the forefront of the quest to
understand how the brain ages and mitigate factors surrounding the
development of diseases such as Alzheimer’s and problems such as
stroke. By bringing together world-renowned researchers in a broad
spectrum of disciplines, from cognitive neuro-pyschologists to
computer scientists, RRI is able to tackle its goal of understanding
the workings of memory and the functions of the brain.
According to Dr.
Randy McIntosh, senior scientist and director of RRI, the focus of
the research at the Institute is to understand both the aging brain
and age-related diseases and disorders. A leader in the CNS field,
Dr McIntosh has been working on developing a unified theory of brain
operation that emphasizes the integrative capacity of the brain.
“The idea is to understand how different kinds of mental functions
change as we age, how these functions can be worse if they’re
accompanying disease but also understand ways to try and stave off
these changes,” he explains.
The research
focuses on understanding the neuro-basis of those changes in terms
of cognitive theories for memory and attention. “We aim to use
information obtained from neuro-imaging technology to develop more
effective ways of staving off the declines. We strive to develop
cognitive rehabilitation strategies and try to remediate the more
protracted kind of decline that comes with things like mild
cognitive impairment, dementia and/or stroke. We also focus on
tracking the efficacy of those therapies by once again using neuro-imaging
technology as a way of validating that those therapies have direct
benefit.”
The benefit of
working at an institution such as RRI is that it brings together a
group of researchers from a divers range of disciplines, all devoted
to solving a common problem. The varied backgrounds of the
scientific staff at RRI allows for unique solutions to be
engineered. “If you address that problem form a number of different
perspectives, the solutions to that problem end up being much more
innovative than they would be if they were addressed from only one
discipline,” says MacIntosh.
In trying to
understand memory, he explains, the typical approach has been to let
psychologists address it in a traditional environment such as a
university. But the idea behind RRI has a much broader scope. A
diverse group of psychologist, engineers, neurologists,
physiologists and computer scientists, all approach memory from
different avenues with their contrasting back grounds allowing them
to foster new solutions.
“Addressing a
challenge from different perspectives brings different ideas to the
table. You come up with solutions that would not be possible if you
focused on only one particular way of looking at the world, says
McIntosh. At RRI, perhaps the best example of this process
incorporates a combination of strong cognitive theory and modern
neuro-imaging technologies while looking at the computational or
informatics aspects and trying to merge theory with data to develop
large-scale computational models of the brain and how it changes as
we age.
“Our next step is
to develop what’s been called the virtual brain which is actually a
model of the human brain that allows us to understand not only how
the brain functions in a normal state but also how the brain
functions as we age, “ said McIntosh. “You can make a virtual brain
that actually ages, a virtual brain that gets Alzheimer’s disease, a
virtual brain that gets a stroke and develops the algorithms that
help explain how the brain tries to adapt to age and adapt to damage
and disease.”
McInstosh
explains that the virtual brain is built from structural information
collected from neuro-imaging at RRI in combination with functional
information and brought together with high-level mathematics to
model the brain in action.
“We’re really
merging the math with the ‘wet-brain’. This allows us to include the
necessary dynamics captured in the math that drive the model,” said
McIntosh. “You get structural MRI, for example, that you can use to
image the connections in the brain. You then use that as your
architecture and then impose the dynamics on top of that using the
neuro-network theory. The virtual brain actually ends up being an
amalgamation of both normative data but also the clinical that we
have access to as well.” he says.
Bringing the
research back to its real-world applications and the looming
concerns of an aging population, the end-goal of the research, is
prediction. People generally associate Alzheimer’s with the aging
brain but what about those individuals who develop these diseases in
their 40’s? The idea is to use the virtual brain as a way of testing
whether that person is showing some kind of random abnormality, over
and above what you can see with the regular clinical imaging.”
Using the
information gathered from the neuro-imaging technologies, one can
then apply a specific person’s characteristics to the virtual brain.
From this, researchers can then compare brain functions in the
virtual environment to see how the virtual brain’s patterns show
similarities to someone who has, for example, dementia.
“It ends up being
a sort of diagnostic tool and a prognostic tool” says McIntosh. “In
theory, you could use that virtual brain to help guide the course of
therapy. This could help a physician decide what potential pathways
one can stimulate to help the brain recover after a stroke for
instance.”
Recovery is
definitely what they’re after. Previously, it was thought that the
brain didn’t change after the first 20 to 25 years of life. RRI is
leading the charge to reshape that theory.
“The most
significant work coming out of Rotman is the recognition that the
aging brain is in fact… malleable,” says McIntosh. “For a number of
years, the assumption was that once you’re were 20 to 25, your brain
didn’t change anymore. What we’ve shown is that the brain does
change the way it does things pretty much across its lifespan. There
is this idea of plasticity or adaptability that’s in brain function
throughout life, and what that does is actually improve the
potential. It give us hope that one can make use of that
flexibility, then potentially remediate cognitive function.”
It truly is hope
to the millions that are affected by these problems, a fact that
certainly isn’t lost on McIntosh. The translation from research to
reality can be long and arduous both these problems are fast
becoming some of the most pressing concerns of life sciences.
“There’s been a
difficulty, I think with that translational aspect. Part of it is
structural, in that a lot of research is done without a direct link
into the clinical domain part of it is sociological as well: ocne
this stuff gets published it take a while for it to filter down to
the applied into things,” he says.
"There
are models developing. That’s one thing we’re trying to do at Rotman,
it’s trying to make sure that the clinical research and the
translational component is actually part of the way the Institute is
structured. So that when there is the potential for translating the
basic findings into a clinical or applied domain, we can do that
in-house and actually get the validation part of it done much more
quickly.”
With baby boomers
now reaching their “golden years” there is an urgent need for new
treatment options for the unprecedented large proportion of older
Canadians. It makes the CNS field and particularly RRIs
groundbreaking research very timely. In the past, McIntosh, says
that neuroscience has been about explaining a condition after it was
too far-gone. Now a shift is occurring where trying to pick up the
warning signs early is taking over as the dominant point of view.
“As people age,
the number of these core morbidities are going to factor into
quality of life and become more difficult to manage so the more we
can get it early, the better off we all are,” says Dr. McIntosh.
“That why I think it’s important to not only understand the diseased
brain but also what keeps the brain healthy for longer period of
time. And that’s why this research into the brain and aging is so
important. We can understand not just the bad parts about aging and
the brain but also the good parts and how to make the good parts
more prevalent for the boomers”.
This article
was edited from the May 2010 issue of Biotechnology Focus.

Nuclear physics
delivers
ScienceDaily (Mar. 4, 2010)
— Time taken to detect brain tumours could soon be significantly
reduced thanks to an ongoing pioneering project led by the
University of Liverpool with the Nuclear Physics Group and
Technology departments at the Science and Technology Facilities
Council (STFC) at Daresbury Laboratory. Project ProSPECTus is
developing the technology for next generation SPECT (single
photon emission computed tomography) imaging that is set to
revolutionise the medical imaging process, improving future
diagnosis of cancer and the probability of successful cancer
therapy whilst enabling a higher throughput of patients in
hospitals.
Project ProSPECTus is based on a form of imaging
known as SPECT which detects gamma rays emitted by a tiny amount
of a radioactive pharmaceutical which is injected into the body.
SPECT is a widely used method of imaging in many areas of
medicine providing 3D functional information about the body,
which is typically presented as cross-sectional slices through
the patient. It is most commonly used to test the functioning of
the heart or for the detection of tumours. Conventionally, SPECT
imaging uses what is known as an 'Anger Camera' which relies on
a collimator, a filtering device with many small holes, which
lets just some gamma rays through and relies on geometry to
identify exactly where they are coming from in order to build a
picture of a biological process happening inside the patient.
However,
ProSPECTus has taken a fundamentally different approach and has
developed its technology based on what is known as the 'Compton
Camera'. This identifies the origin of the gamma rays without
the use of a collimator, meaning that much less of the radiation
used in the process is wasted, so the radiation is used more
efficiently. It has not been possible to do this successfully
before. However, using brand new, cutting edge detector systems,
ProSPECTus is now building a prototype SPECT imaging system,
using the Compton Camera principle, that is one hundred times
more sensitive than existing clinical SPECT systems. This
increased sensitivity offers two benefits- either the dose of
radiation administered to the patient could be reduced or
alternatively more patients could be scanned by one machine in a
day if the current dose is used.
These new
cutting edge detector systems, designed by the University of
Liverpool's Nuclear Physics research group alongside the Nuclear
Physics Group at STFC Daresbury Laboratory, are a direct spin
out of AGATA (Advanced Gamma Tracking Array), a nuclear physics
research and development project with the aim of building the
next generation gamma-ray spectrometer. ProSPECTus is funded
from STFC's Particle and Nuclear Physics Applied Systems (PNPAS)
programme, a scheme aimed at exploiting techniques developed in
blue-skies basic research projects like AGATA so as to generate
knowledge exchange into the areas of health, security and energy
applications.
Dr Andy
Boston, the project spokesperson, at the University of Liverpool
said: "Not only is ProSPECTus' technology a hundred times more
sensitive than that of the traditional Compton camera, it is
unique in that it will also be possible to operate it
simultaneously with MRI (Magnetic resonance Imaging), which has
never been an option due to the MRI's strong magnetic field. In
fact, it will be possible to fit this SPECT system
retrospectively to the 350 or so existing MRI scanners across
the UK. For patients this means fewer appointments, earlier and
more effective diagnosis of tumours, which means higher
probability of effective treatment.
The higher
sensitivity camera also offers the scope for shorter imaging
time and lower doses of radiation, which is highly beneficial
for patients who require frequent scanning. For clinicians, this
means that more patients can be seen in a day. This is a truly
collaborative effort between the Nuclear Physics Groups both at
the University of Liverpool and STFC Daresbury Laboratory,
working with STFC's Technology teams who will design and build
the detector cryostat and with the essential support from
Liverpool's Magnetic Resonance & Image Analysis Research Centre
(MARIARC) who provide the MRI expertise."
Ian Lazarus of STFC's Nuclear Physics team at
Daresbury Laboratory said: "ProSPECTus has taken the abilities
of the Compton imager to a new level. This is a particularly
exciting example of how technology emerging from one nuclear
physics project, in this case, AGATA, can have a direct and
positive impact on the future wellbeing of our society."
Article taken from http://www.sciencedaily.com/releases/2010/03/100303113956.htm

Do you work in an Intrapreneurial Company? Take the
1-Minute Test.
Neil Seeman
Is
your organization 'intrapreneurial'?
Gifford Pinchot III invented the term "intrapreneur" to describe
employees of large corporations hired on to think and act as
entrepreneurs.
Definitions are important here. Let's not confuse an 'intrapreneur'
with a change agent (e.g., someone who circulates a
company-wide petition for bigger cubicle space to force the boss to
comply with workplace health regulations) or an entrepreneur
- someone who takes on extraordinary personal, financial and social
risk to build a new organization with his own sweat and unrelenting
passion.
Companies such as IBM, 3M and Google boast that they nurture a
culture of intrapreneurs by protecting funds, and employee time, for
basic research and development. (The most-cited example is the "Skunk
Works" group at
Lockheed Martin). Other companies have tried to adopt processes
that protect a proportion, say one day a week, of employees' time
for intrapreneurial invention. But an official policy or process
manual for intrapreneurialism does not make for an intrapreneurial
culture.
This
logic flaw - the idea that innovation policy will conjure up an
innovation culture - operates at a national level too; the
Conference Board of Canada recently gave the
country a "D" on innovation, ranking the nation poorly on
measures such as published scientific articles and international
trademarks per capita. To improve our grade, many observers have
recommended that more corporate money be poured into R&D, and that
Canada needs an integrated innovation strategy to focus on select
industries, like clean energy technology, as opposed to spreading
investments thinly across diverse sectors.
In my
opinion, celebrating a culture of workplace intrapreneurialism would
deliver a far greater return on investment for companies - and for
this country.
Intrapreneurialism is the route to innovation inside organizations,
and in healthcare organizations in particular. A culture of
intrapreneurialism is what enables a graduate student scientist in a
University lab, or a policy analyst in a government department, to
launch a magical product or service to market.
Business writers and
certain
academics - some of the latter have gold start-up experience;
others are tenured, with no entrepreneurial scars - have designed
personality tests to determine if someone is a 'natural'
entrepreneur. (I
have argued that all such tests are absurd, statistically flawed and
offensive). Yet a culture of corporate intrapreneurialism is
easier to determine and track. Knowing whether your organization
nurtures intrapreneurialism can signal its capacity to commercialize
ideas into action.
Do
you work in an intrapreneurial organization? Take my 1-minute test.
('Yes' or 'No' answers only)
-
If your boss knew that you were acting in the best interests of
the company to succeed on a project that you started and drove
forward with company funds - and you failed - would
your investment of time, money and effort be recognized as
providing value for the company?
-
If your boss knew that you were acting in the best interests of
the company to succeed on a self-initiated project, and your
work was later widely recognized as a success, would your boss
give you 100 percent of the credit for the initiation of
the project?
-
If you were instrumental in initiating a company product or
service that successfully made it to market, would you receive a
financial bonus in excess of one year's salary?
-
If potential employees said in an interview that their career goal
was to run their own company after two years, would they
still be considered for the job?
-
If you had a new, potentially commercializable idea that you
developed while at the company, would all of your colleagues
say it was safe to share the idea with the company brass?
If
you answered 'no' to all of these questions, then your organization
is in danger of being irrelevant to innovation - and possibly a
toxic place to work. If you answered 'yes' to one or two questions,
then your organization has the potential for intrapreneurialism. If
you answered 'yes' to three or four questions, then your
organization enjoys an intrapreneurial culture; it's going places.
If you answered 'yes' to five out of five, you may be deluding
yourself ... or your organization really is an innovation lion.
A
courageous manager would send an anonymous survey with these
questions to all her staff and track the results over time.
Otherwise she might lose all her company's best ideas - and so will
we all.
About the Author
Neil Seeman is a writer, and Director and Primary Investigator of
the
Health Strategy Innovation Cell at Massey College in the
University of Toronto.
Life cycle assessment as an
ecodesign tool

Life cycle
assessment is a useful tool for manufacturers as they become more
accountable for the effect they have on the environment.
This column is
based on an article which appeared as
Designing sustainable medical devices
in the July 2009
issue (volume 31, number 7) of MDDI, the magazine of the Medical
Device & Diagnostic Industry.
Stakeholders in
the medical device manufacturing industry are becoming more
concerned about the environmental impact of their products and
processes. These effects range from the potential negative effects
of substances such as phthalate plasticizers leached from plastic
products to emissions resulting from the incineration of disposed
products. In addition, consumers are also becoming more aware of the
negative impact that manufacturers can have on the environment. To
combat such effects, consumer advocacy groups are demanding products
that are more sustainable.
Sustainability
as a competitive advantage
Government
initiatives continue to increase environmental awareness through the
development of new policy and legislation. This in turn is
encouraging industry to become more accountable for the
environmental impact of their products and operations. For example,
the Waste Electrical & Electronic Equipment (WEEE) Directive and the
Producer Responsibility Obligations (Packaging Waste) regulations of
2008 have set precedents regarding end-of-life disposal of products
involved in their industries. It is only a matter of time before
regulatory bodies start initiating changes in policy for other
manufacturing sectors. Such regulations could well make it more
difficult for companies to develop new products, at least in the
short term.
In such
competitive environments, new product development can no longer rely
solely on traditional criteria such as cost, quality and delivery.
Effective environmentally sensitive product design enables
manufacturers to gain a prominent competitive advantage in the
development of “green” products. As a result, more and more
businesses are adopting environmental management systems to organize
and assess environmental effects, and meet the growing demand from
consumers and legislation for green products.
The ISO 14001
standard, “Environmental Management Systems–Requirements with
Guidance for Use” sets guidelines to enable businesses to recognize
the environmental effects of their products and processes. In order
to qualify for ISO 14001 accreditation, a company must identify its
overall environmental impact and determine the significant effects
of its various products, while also demonstrating continual
improvement in its manufacturing processes.
Life cycle assessment
Life cycle
assessment (LCA) is a useful technique to evaluate the environmental
impact of products, identify problem areas, and make improvements at
the most effective stage of a product’s life cycle. Various studies
have shown the benefits of performing a LCA at the product design
stage to effectively lower a product’s overall negative
environmental effect.
One tool used to
make such an assessment is a LCA software packaged called SimaPro.
It uses Eco-Indicator LCA methodology to aid manufacturers in
selecting the most environmentally suitable materials for its
products. The Eco-Indicator method provides impact assessment and
ecodesign scoring. While there is no doubt that a detailed LCA is an
extremely useful method for environmental impact evaluation, it can
be costly and time-consuming, and the results can be difficult to
convey to nonexperts such as consumer and environmental advocacy
groups.
In-house web-based tool
Although there
are various LCA software available, they can be difficult to use on
a large range of products. The user must have prior knowledge of LCA
inventory databases and internal product details before starting an
LCA. The information needs to be entered manually into the program
for each each product. The process is time-consuming and usually
needs to be carried out by an experienced LCA practitioner. In some
cases, materials used in a given product may or may not be present
in the LCA inventory. This means the assessor now has to choose the
closest substitute. This can introduce error into the results of the
assessment.
Some companies
are working their way around these challenges by innovating new
approaches. For instance, a manufacturer of a single-use
respiratory-care device has developed an in-house tool that performs
a streamlined LCA on products using existing company data to obtain
an immediate environmental impact score for any product it
manufactures. Internally, although the tool was developed to aid in
the design process, it also has value in other departments, because
the system provides a baseline score that enables product
comparisons.
Departments can
use the tool to set targets to lower a specific product’s
environmental impact and identify areas of high environmental
concern when designing, purchasing, and marketing products. Once
widespread, such a tool would aid manufacturers in the
decision-making process. The following example is a real-lfie
scenario of how manufacturers can develop a similar tool to aid
designers in developing more sustainable products.
One company
stored information relating to its products in standard structure
query language databases managed by Efacs, an electronic database
and software program. The Efacs system was used to organize the
company’s data and contained features such as the bill of material (BOM)
for each product. Each product BOM provided detailed information on
the product and was organized in a hierachical structure.
Information included all components, subcomponents, and even
specified packaging in terms of weights and materials involved.
Gathering environmental data
The
company used LCA software to collect the environmental data for the
scoring tool and chose the EcoIndicator 99 methodology. The process
involved creating a project within the scoring tool that calculated
an environmental impact score for all materials and processes. It
also incorporated the required disposal scenarios of landfill or
incineration. The figures were stored in a separate material scores
table.
The first step
involved collecting a list of all the materials and finding them (or
the most appropriate substitutes) within the scoring tool databases.
The next step involved calculating the environmental impact using
Edo-Indicator 99 methodology.
Because the scoring tool is Web based, users have easy access to the
data. The user can type any component part or product code that the
company manufactures into the tool. Once the part code is entered,
the scoring tool must read data from the BOM. The results of the BOM
is dsiplayed in the table, showing part number, description of the
part, material number, description of the material, generic material
type, and weight of the material. The system then calculates the
total quantity of each material used for each part (if more than one
is used). The tool displays a dropdown menu for each material so
that materials can be changed, and the button to calculate the score
is activated only once all the fields are completed.
When calculating
the score, the tool gets information from the populated scores table
by multiplying quantities with score values. The results are then
summed for each selected product and displayed in a report for
landfill and incineration disposal scenarios.
The
simple-to-use Web-based tool enables the streamlined LCA of a
product to be carried out in as little as two steps. This is
important, because in order to design a more sustainable product,
the designer needs to benchmark the existing product. New product
designs are usually based on products already in production. The
first use of the tool is to score the existing product to provide a
benchmark. Once a benchmark is set, targets can be determined and
improvements can be recognized. Because the products are made of
components and subcomponents, the tool can change the materials and
weights based on these. Any changes are reflected in the scores that
can be compared side-by-side with the benchmark.
The tool also
has dynamic features that allow designers to change and compare
products in five steps. The designer can also view product BOMs, add
new components or remove existing components, change materials alter
the weights involved, and compare the environmental impact of
designs side-by-side. All the design ideas can be saved to a file
for future reference.
Challenges remain but the course
is set
The
environmental scoring tool achieved the objective of quick and
accurate impact scores for existing products, setting the benchmark
to design more-sustainable products. Error is greatly reduced when
comparing products because the environmental impact scores for
selected materials have already been decided. Having access to such
data precludes the need for the user to have prior knowledge of the
environmental effects of different materials and products. These
features mean the tool can be used by nonexperts of environmental
LCA and provide accurate results, unlike traditional LCA software.
The scoring tool also runs from a live database that eliminates
error associated with incorrect data input, and products can be
scored in seconds rather than hours.
As is often the
case when it comes to manufacturing considerations, the medical
device industry poses special challenges with regards to
environmental issues. Medical devices involve additional
environmental factors that have not yet been taken into account in
generating an environmental impact score at this early assessment
stage. For example, the additional environmental impact associated
with the leaching of phthalate plasticizers from plastics. There are
also the effects of product sterilization (of which a variety of
techniques are used) before and after use, which have not yet been
included. These processes and others like them will have to be added
at a later stage
Another important
limitation is the lack of available environmental data for
thermoplastics elastomers and biopolymer materials, which may end up
being used in future products. Estimates, however can be made by
manually performing an LCA using existing data on raw materials and
processes. Research in these areas will be used to develop the
environmental scoring tool to aid in designing future sustainable
medical devices. The process has really only just begun. A whole new
generation of greener, more environmentally benign products will
definitely see the light of day.

That crunching
noise you hear is the sound of endoscopes shrinking. Medical
diagnostic and therapeutic procedures are growing smaller, from
neurology to podiatry. Minimally invasive surgery (MIS) is shrinking
to the point that incisions can heal without sutures, and the new
words of the day are “endoluminal” and “NOTES” (natural orifice
transluminal endoscopic surgery), both implying procedures done via
natural body openings, with no external incisions.
Endoscope remains
the workhorse
But
how do the doctors performing these miracles see inside their
patients? Various new and experimental technologies seek to five
doctors with now direct visual access the equivalent of x-ray
vision. But for most of these new procedures, the workhorse of
visualization remains the endoscope.
Direct
visualization via endoscopy provides the clearest image for doctors.
It is the gold standard against which other technologies are
weighted for effectiveness. For example, in comparison between MRS
and spectroscopy systems, arthroscopy has been used to judge the
performance of each. According to the literature available,
endoscopy demonstrates the following attributes:
-
-
Offers a track record of procedural success.
-
-
Enables real-time visualization to precisely guide placement, as
well as use of intruments, vastly reducing potential for
malpositioning or damage.
-
-
Also enable doctors to see as a patient is manipulated (e.g. as a
shoulder is rotated during surgery, via arthroscopy)
-
-
Provides greater portability than other similar technologies.
Together, these
factors mean endoscopy offers accuracy, flexibility, and breadth of
use, particularly in therapeutic applications, Many studies bear out
this claim. Magnetic resonance images (MRI) of musculoskeletal
joints including soft tissue, for instance, are notoriously
problematic. Estimates of false positives for pathological knee MRIs
reach as high as 20%, creating complications for patients and adding
costs for insurance providers. In some studies, MRIS barely
outperformed clinical examinations. In other areas, such as
diagnosis of scapholunate ligament injury, MRI failures have been
severe enough that studies have concluded they simply should not be
used.
Despite these
studies, endoscoppy has historically been underused in many
applications. MRIs still dominate advance diagnosis of knee and
shoulder pain. Why? Because traditional arthroscopy has been
perceived as highly invasive, requiring fairly large scopes
(2.7-4mm. diameter), and thus full anesthesia in a hospital or
surgical centre. Conversely, MRIs are noninvasive. Given the
perception that arthroscopy requires hospitalization or at least an
advanced surgical centre, doctors have not traditionally viewed
arthroscopy as a comparable potential of office revenue.
The perception of
endoscopy as highly invasive is changing as technology improves.
However, there are still challenges that must be met.
Nonsurgical
endoscopy has been hampered somewhat by technological challenges.
When endoscopic systems are shrunk beyond traditional endoscopy
(say, to sizes below 1.5 mm OD) pixelization and brittleness can
occur. Microdiameters limit fiber size and the ability to carry
light. Smaller systems mean less room for everything: light fiber,
image fiber, coatings, and other materials that increase durability.
There are also
challenges in trying to connect microendoscopes to the cameras that
doctors use, and ultimately to the endscope tower that offer video
image display and capture options. Working with scopes in the 1mm
range has been likened to trying to control a strand of cooked
spaghetti.
In addition,
microendoscope systems can be difficult to manufacture reliably and
with cost stability. Making a small number of experimental prototype
microendoscopes that sell in the $7,000 range is one thing. Finding
reliable, repeatable manufacturing technologies that allow
production runs in the thousands and affordable scope prices is a
challenge. But it’s the mass-produced scoope that can benefit
doctors, patients and insurance companies.
All the
difficulties associated with designing and manufacturing
microendoscope systems must be resolved in an integrated way that
provides seamlesss end-to-end imaging and service.
Several
visualization options other than traditional endoscopy are in use or
under development to support minimally invasive procedures. Some of
the most promising include the following.
Capsule endoscopy:
This integrated endoscopic camera, relay lenses, and transmission
system is the size of a large multi-vitamin. Patients swallow the
device, which enables clear and continuous transmission of images
that, in many cases, can replace gastroscopy and colonoscopy. There
have been issues with capsules not being eliminated requiring
further medical attention. A limitation of capsule endoscopy is that
the doctor cannot control the capsule’s movement. Nonetheless,
capsule endoscopes have been used in diagnostic procedures.
Nanotechnology cameras:
Several nanotechnology camera systems exist or are under
development, including some potentially small enough to travel
through the circulatory system. These exciting systems are for
diagnostics, but they do not yet enable manipulation and thus have
no immediate therapeutic value.
Single-fiber
endoscopes:
Hair-thin single-fiber endoscopes break out visible light by color
and use spectrographs to generate virtual 3-D images. These offer
interesting possibilities for extremely small incisions, if inherent
issues of fragility and brittleness can be addressed. The clarity
and procedural usefulness of images generated via spectrography also
require further study.
Robotic
image-guided systems:
Robotic image guidance systems use microcameras isnerted with
surgical instruments and electromagnetic devices to track location,
overlaying the information using fast 3-D visualization to generate
real-time live images, some in high definition. Such systems are
being used in pioneering forms, for example, Intuitive Surgical’s
daVinci robotic surgical system.
Virtual imaging:
Potential real-time visualization systems are emerging from virtual
image technologies. These devices fuse images generated by different
noninvasive technologies (such as MRI and ultrasound) to form
composites that combine the best of each technology.
The new
procedures enabled by non-surgical endoscopy offer the potential for
a paradign shift away from large traditional glass endoscopes.
Innovative diagnostic and therapeutic applications will reduce costs
for insurers, ease patient pain, and speed healing, while also
increasing revenue for doctors and device manufacturers alike.
This text is
based on an article which appeared in the July 2009 issue (volume
31, number 7) of MDDI, the magazine of the Medical Device &
Diagnostic Industry
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Synthetic
life has been created in the laboratory in a feat of ingenuity that
pushes the boundaries of humanity’s ability to manipulate the
natural world.
Craig Venter, the biologist who
led the effort to map the human genome, said yesterday that the
first cell controlled entirely by man-made genetic instructions had
been produced.
The synthetic bacterium,
nicknamed Synthia, has been hailed as a step change in biological
engineering, allowing the creation of organisms with specialised
functions that could never have evolved in nature. The team at the
J. Craig Venter Institute in Rockville, Maryland, is investigating
how the technology could yield microbes that make vaccines, and
algae that turn carbon dioxide into hydrocarbon biofuels.
The
achievement has, however, stirred ethical concerns. Critics called
for tighter regulation, citing the potential for bioterror or
“bioerror” that could endanger health or the environment.
Dr Venter,
who has been working on synthetic life for a decade, told The Times:
“It is our final triumph. This is the first synthetic cell. It’s the
first time we have started with information in a computer, used four
bottles of chemicals to write up a million letters of DNA software,
and actually got it to boot up in a living organism.
“Though this is a baby step, it
enables a change in philosophy, a change in thinking, a change in
the tools we have. This cell we’ve made is not a miracle cell that’s
useful for anything, it is a proof of concept. But the proof of
concept was key, otherwise it is just speculation and science
fiction. This takes us across that border, into a new world.”
Julian Savulescu, Professor of
Practical Ethics at the University of Oxford, said: “Venter is
creaking open the most profound door in humanity’s history,
potentially peeking into its destiny. He is going towards the role
of a god: creating artificial life that could never have existed
naturally. The potential is in the far future, but real and
significant. But the risks are also unparalleled.”
In the research, published in the
journal Science, scientists made a synthetic copy of the genome of a
bacterium, Mycoplasma mycoides. Several inert DNA “watermarks” were
added to distinguish the synthetic genome from the natural version.
The man-made genome was then
transplanted into a related bacterium, Mycoplasma capricolum. This
“rebooted” the cell so that it was controlled by the synthetic
genome, transforming it into another species. The cell has since
divided more than a billion times.
Paul Freemont, of the Centre for
Synthetic Biology at Imperial College London, described the
achievement as a “step change advance”. He said: “The applications
of this enabling technology are enormous.”
Others, however, are unconvinced.
Ben Davis, who works on synthetic biology at the University of
Oxford, said: “I still think we are quite a long way away from
artificial life. “You could take this synthetic genome and write in
new genes with known functions, but that is not so different from
molecular biology at the moment.”
David King, of
the pressure group Human Genetics Alert, called for a moratorium on
similar research and Pat Mooney, of the ETC Group, which campaigns
against biotechnology, said: “This is a Pandora’s box moment. We’ll
all have to deal with the fallout from this
This item was
adapted from the May 21, 210 issue of the Times

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