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The Gen
News from Sagentia
Summer 2013
	Utility underground
asset mapping
technology
	Algorithms enable low
cost 3D visualisation
in surgery
	How information
systems are reshaping
healthcare delivery
	Device powered
chemistry in personal
care – greater than
the sum of its parts?
ContentsContents
Introduction
02 Introduction
03 News
03 Update
04 Feature
Algorithms enable low
cost 3D visualisation
in surgery
06 Feature
How information
systems are reshaping
healthcare delivery
08 Technology insight
Wireless communications
systems – improving the
way medical devices work
09 Case study
OXEMS – Utility
underground asset
mapping technology
10 Focus on
Device powered chemistry
in personal care – greater
than the sum of its parts?
11 Focus on
The industrial design
revolution
W
elcome to the
Summer 2013 Gen!
It’s a privilege to be
addressing the front
page of The Gen as Sagentia’s
Managing Director; I’ve been
writing articles and reading
colleagues' contributions for
eight years. During these years
I’ve come to know our customers,
capabilities and opportunities well
and am proud to be introducing
our work to you. MickWithers and
I took up the reigns from Brent
Hudson who resigned at the end of
October last year after three great
years leading the company.With
positive year-end financial results
recently announced, we are both
working hard, along with the rest
of our great team at Sagentia, to
grow and expand the value of our
services to you, our clients.
To be successful in our business,
we need to stay on top of science
and technology breakthroughs
coming out of academia
and industry and we need to
understand the challenges and
drivers affecting our clients’
markets. This means that our
consultants often have interesting
and diverse perspectives that
we like to capture and share
where possible. In this issue,
we have articles including a
mathematician opining the
future of surgical imaging (p4),
a life scientist challenging the
status quo in healthcare thinking
(p6) and a physicist/chemist
inviting the consumer industry
to bring formulation science and
devices together in the pursuit
of innovation (p10). These are
all written by individuals who
have strong opinions on how
technology can be made to
serve the markets they work
across. Elsewhere in this issue,
on p9 we highlight how our
work with OXEMS helped them
turn academic output into a
commercially viable, market ready
product for underground asset
mapping, and on p8 we discuss
wireless communication systems
in medical devices.
The first few months of 2013 have
been very busy for us and in our
largest market – North America
– there is significant anecdotal
and empirical evidence that
corporate cash reserves are strong;
operational mandates to control
fixed cost remain tight and RD
drive is healthy. These three
factors are building the case for
deeper and longer term RD
partnerships with some of our
clients. If the notion of having
a specialist RD team ‘on-call’
sounds appealing – let us know!
Mick and I would welcome the
opportunity to visit you.
Dan Edwards
Managing Director
News
Sagentia grows expertise in
industrial design and usability
agentia recently acquired Quadro Design
and has invested in its usability capabilities.
Quadro works with clients to improve the
effectiveness of their product design, making
sure they go to market with the confidence of
achieving commercial success. The company is
now operating as an independent but integrated
division of the Sagentia Group.
With industrial design and usability
fundamental, and increasingly essential
ingredients in innovation and product
development, this acquisition demonstrates
our desire to grow Sagentia’s share of the global
product development market.
Dan Edwards, Managing Director at Sagentia,
comments:“We have enjoyed collaborating with
Quadro for several years, and are delighted to
formally welcome them into our team.The value
this brings – having design and technology staff
co-located – is clear to our clients. Equally, as the
medical/healthcare industry increasingly focuses
on usability of medical devices we know the time
is right to invest in human factors and strategic
design capability.”
With Quadro and new usability experts, Sagentia
is able to take a unique approach to industrial
design, focusing not just on the product but on
designing the user experience.
S Sagentia's
Boston office
We've now settled into
our larger Boston based
US headquarters.
Our contact details are:
One Beacon Street
Suite 2300
Boston
MA 02108
T:+1 617 896 0213
agentia recently announced
that we have completed initial
alpha prototype development of the
RESOLUTION™ Microbial Genotyping
System that we are developing for
PathoGenetix.
As PathoGenetix’s technology and
product development partner, we’re
working with them across the full product
development lifecycle:helping to take two
initial bread board systems and combining
them into an intuitive and usable system
with a smaller footprint, as well as a lower
per unit cost base.
Our involvement initially focused on
concept validation and voice of the
customer analysis across worldwide
sites. The output of this effort helped
PathoGenetix’s management to determine
and define the company’s go-to-market
strategy. Subsequently, the focus has
been on developing the architecture and
delivering the electro-mechanical and
electro-optical aspects that enable the
GSS technology to be taken to market.
This has included the detailed design and
development of state-of-the-art custom
optics, robotics, fluidics, pneumatics, and
embedded and application software.
“Sagentia has been a great product
development partner.Working with
them has allowed us to get to market
faster with concept to delivery of the new
RESOLUTION™ System in 18 months,”said
PathoGenetix CEO Ann Merrifield. “This
exciting technology has a lot of potential
in food safety and we look forward to
demonstrating its potential as we take it
forward to commercial launch.”
Take a look at our Introduction to Sagentia video on YouTube.
It gives a great overview of who we are and what we do.
Sagentia and MIT
Technology Review: 10
Breakthrough Technologies
agentia and MIT Technology Review
recently co-hosted a special event
to present and discuss 10 Breakthrough
Technologies for 2013.
The event saw Jason Pontin, Editor in
Chief at MIT Technology Review, explaining
the selection process and how the
technologies could expand the scope of
human possibilities. Dr Robin Lee, Chief
Technology Officer at Sagentia, then
discussed how these technologies could
be used in a broader product development
context, specifically highlighting
technical challenges and market-focused
opportunities.
The technologies selected by MIT
Technology Review range across industries
from energy, materials and biomedicine
to communications and IT, and include
additive manufacturing, Baxter the Blue
Collar Robot, supergrids, ultra-efficient
solar power and smart watches.
Read our analysis on the technologies
here:www.sagentia.com/
10breakthroughtechnologies
S
S
Sagentia delivers alpha prototype of new
Microbial Genotyping System for
PathoGenetix Inc
Summer 2013 The Gen 03
Feature
Algorithms enable low cost 3D
visualisation in surgery
By Ross Jones
T
he 3D interpretation of 2D images is now
commonplace. Double-click on a spot down the road
in Streetview and Google will transport you there.
Cars in TV adverts are realistically superimposed
on mountaintops. Harry Potter is seen on a broomstick
swooping around a castle that only exists in a computer.
The mathematics and algorithms behind this trickery have
the potential to transform medical imaging and should
complement the recent advances in minimally invasive and
robotic assisted surgery, but have yet to find acceptance in
the operating theatre. Nonetheless, researchers are making
impressive progress with the more complex problems that
arise in surgical visualisation and navigation. There is a gap
between theory and practice that should be explored.
People are naturally good at
3D interpretation. If you were
to walk through a building,
you should develop a good
sense of its 3D structure and
overall layout. Furthermore,
you should also have a good
idea of the path you took. The
fact that you have stereo vision
is not sufficient to explain this
capability – you could achieve
the same feat with one eye
closed. Instead, it relies on
synthesising 2D images taken
from multiple viewpoints.
In theory, if you were to carry
a video camera with you, it
should be possible to hand the
footage over to a computer and
have it perform the same task:
reconstruct the 3D geometry of
the building and retrace your
path through it. This is known
as ‘Structure from Motion’(SfM).
If a robot is performing the task
for its own benefit, it’s known as
‘Simultaneous Localisation and
Mapping’, or SLAM.
The mathematical feasibility
of SfM is simple to demonstrate,
but it’s difficult to find an
efficient algorithm. That
problem is due to perspective,
which makes the equations
for imaging highly non-linear.
Tomasi and Kanade realised that
if perspective is eliminated, for
example by using cameras with
telephoto lenses, then SfM can
be solved using simple matrix
algebra. Their 1992 paper on
the ‘factorisation method’laid
the foundation for modern
approaches to SfM.
Subsequent research quickly
built up the capabilities of
the method. Iterative versions
of factorisation allowed
for increasing amounts
of perspective. Different
approaches were developed for
handling ‘missing data’, ie the
(very common) case that not
every point appears in every
image. Different types of data
were able to be incorporated,
eg prior knowledge that
points lie on a line or a plane,
or observations of an object’s
shadow.
Streamlined algorithms and
advances in hardware enabled
‘real-time’SfM. As an early
example of near-real-time
reconstruction, Takeo Kanade’s
‘Virtualised Reality™’system
was used in the 2001 SuperBowl
by CBS to create action replays
from novel viewpoints. State-of-
the-art systems can now track
around 100 features at frame
rates of 30Hz.
Current research is focused on
tracking deformable objects.
With enough cameras, a
dynamic scene could be treated
as a sequence of static scenes,
each reconstructed using basic
SfM methods. If the objects in
the view are assumed to deform
in simple (but unknown) ways,
fewer cameras can be used and
SfM methods can be used to
determine the modes of
deformation as well as 3D
structure and motion.
All of these developments
have been trialled for surgical
applications. For example, the
author developed a system for
reconstructing the geometry of
the ear canal from endoscope
images, to assist the fitting
of hearing aids. SfM has been
used to provide off-line 3D
reconstructions of surgical
procedures for training
purposes. In laparascopic chest
or bowel surgery, with the lungs
deflated or the abdominal cavity
inflated, multiple endoscopic
cameras could be used to
present the surgeon with a wide
field 3D view of the anatomy,
equivalent to what might be
seen with the patient fully
‘opened up’.
Challenges
SfM has yet to make it into
commercial systems that are
used regularly in the operating
theatre.The key obstacle
according to Danail Stoyanov,
a leading researcher in SfM at
University College London, is
demonstrating a real clinical
benefit.This seems odd, given
the capabilities of SfM, but
there are two important
aspects to this.
Firstly, it is difficult to validate
an SfM system and thereby
demonstrate that it is safe.
04 The Gen Summer 2013
Feature
SfM software is complex
and difficult to make robust:
features may be mismatched
between images, iterative
algorithms may fail to converge
properly, small measurement
errors may lead to large errors
in the reconstruction. Surgical
companies are comfortable with
mechanics and still learning
to embrace electronics and
software:SfM takes them well
beyond their comfort zone.
Secondly, existing optical
systems provide similar
functionality. Calibrated
tracking systems allow
real-time registration of
surgical instruments with
pre-operative MRI and CAT
images. They involve an
expensive setup and have
limited accuracy when
attempting to infer the
position of distal end of a
long instrument from a view
of its proximal end, but are
relatively simple to validate.
Stereo endoscopes also provide
the surgeon with a real-time
3D view without the need for
any computer trickery. In the
simple case, where the surgeon
directly looks through the
endoscope, he obtains a narrow
field of view and/or limited
depth cues. In robotic systems,
notably the da Vinci system by
Intuitive Surgical, the surgeon
views multiple endoscopic
images on a monitor and
effectively performs the SfM
task in his head.
Routes to adoption
There are two likely routes
to the adoption of SfM. Firstly,
SfM could be used to augment
other systems in a way that
poses no risk. Danail Stoyanov
is using SfM to provide
automatic registration of
multispectral images of tissue.
A number of groups at Johns
Hopkins University are working
on surgical vision systems, and
one project that could provide a
safe, demonstrable benefit uses
SfM post-surgery to evaluate
the skill with which a surgeon
has managed a robotic surgical
system.
The other route is to piggy-back
on advanced systems like the
da Vinci robot. This has proven
to be an effective platform
for putting state-of-the-art
technologies in the hands of
the surgeon. In the case of SfM,
the system already works with
multiple endoscopic views and
tracks instruments through
encoders. This information
could be used to ‘pre-condition’
the SfM calculations and
check for errors in the 3D
reconstruction, mitigating the
complex problems of robustness
that a vision-only system is
faced with.
Conclusion
The irony then, is that a low-
cost vision technology which
consumers will soon use on
their smart phones and iPads is
likely to find its way into the
operating theatre via a multi-
million dollar robotic surgery
system. The academic research
in SfM is now very sophisticated;
someone with the art of Steve
Jobs may be required to create
an implementation that is
simple, robust and has obvious
clinical benefits.
Interested to know more? Contact Ross.Jones@sagentia.com
Summer 2013 The Gen 05
Feature
How information systems are
reshaping healthcare delivery
By Niall Mottram  David Pettigrew
With continuing revelations in
connectivity, data handling and
micro processing, information
has never been so plentiful.
While some have viewed this
plethora of information as
dangerous (see the increasing
rates of patient self-diagnosis
thanks toWeb MD etc), it
is more commonly being
embraced as an enabler.
An enabler because of the
possibilities to push diagnosis
and treatment away from
traditional centralised points
of care and into domestic
environments. An enabler
because of the possibilities
for new business models.
An enabler because of the
potential to give the physician
unprecedented visibility of
their patient’s progress, while
at the same time empowering
the patients themselves to take
more responsibility for their
own care.
But if your business is built
on designing, developing
and manufacturing medical
devices, how do you leverage
information? You can clearly
use user feedback, crowd
sourcing and focus groups
to improve your products,
but isn’t there a bigger
opportunity out there?
Large medtech companies
certainly believe so and many
of the big names have already
publicly announced that
they want to integrate real
time data management and
decision support into their
next generation products to
facilitate the move into remote
diagnosis and monitoring.
This has been facilitated by
a move from standalone
products to entire ecosystems
of ‘smart’connected
devices. Diabetes
management
is in the
vanguard
of this new
trend, with
companies like
Medtronic, Roche
and Dexcom
moving away from
standalone Point
of Care devices to
networked systems
consisting of devices
like wearable patches for
monitoring glucose, insulin
pumps and mobile apps. These
systems are set to become the
gold standard for diabetes
care. In hospitals, devices are
increasingly being networked
and connected into hospital
information systems (HIS’s) to
ensure relevant clinical data
are received by the attending
physician at critical points in
the care pathway. An example
of this at the ward level may
include networked bedside
monitors linked into a central
hub, which utilises Clinical
Decision Support Algorithms
to alert nurses of a critical
event. In addition, the use of
centralised servers which log
anonymised patient data from
a number of sites and use
these data to train algorithms
which support diagnosis is
also an increasing trend in
fields like cardiology and image
analysis.
These ‘connected health’
systems are designed to
address several unmet needs
(see Table 1). Through mobile
medical apps at one end of
this spectrum and bespoke
treatment devices at the other,
these companies are utilising
years of valuable user insights
to produce devices which blur
the boundary between medical
and consumer products.
While consumer/patient
acceptance is important,
particularly for home care
devices, these user insights
are also crucial for developing
devices which minimise
the risk of patient harm
through user error. If these
considerations are navigated
successfully, these systems
will become increasingly
important for physicians
who wish to monitor their
patient’s progress between
consultations and for payers
who wish to receive evidence
of treatment compliance.
“Healthcare is changing”how many times have you
heard that? Probably more than you can remember.
But it really is and now there is increasing consensus
on exactly how. Five years ago the messages centred
on incremental innovations and preserving margins.
Last year it was ‘Obamacare’and the huge implications
on reimbursement mechanisms and cost pressures.
Now the hot topic isn’t products or legislation, it's
information. But why is this the case and what does
it mean to the 2nd
largest US business industry?
06 The Gen Summer 2013
Feature
Ultimately, they may also
support the patient’s decision
making by providing automated
advice on the management
of their condition. These
tools will eventually pull
certain responsibilities away
from physicians to patients,
transforming regulation in the
process. The functionality of
these devices will vary based on
their technical sophistication,
but the end goals are the same:
support the clinician’s decision
making and empower the
patient.
Manufacturers are facing
a number of unfamiliar
challenges around developing
these ‘connected health’devices,
particularly for those that
blur the boundary between
medical and consumer devices.
For example, while the rising
prominence of smartphone
apps at first glance provides
an easy route to a ‘consumer
friendly’user experience for
their connected systems,
the regulatory landscape,
particularly in the US,
remains highly uncertain.
Manufacturers and regulators
are increasingly concerned
about:
•	How rapid changes in
smartphone hardware and
operating systems will affect
the intended function of their
medical devices;
•	A lack of clarification on
how the FDA will determine
which health apps require
regulation;
•	The challenges of protecting
the privacy and security of
personal health information;
and
•	The development cost/time
that the medical app could
incur if their products require
FDA approval.
Depending on the level of risk of
the intended connected health
system, when faced with these
issues manufacturers often
conclude that it is still cheaper
and less risky in the long run to
develop a bespoke connected
hardware and software that
they can control entirely. There
is, however, a middle ground.
Smart devices developed by
the manufacturer (containing
sophisticated embedded
algorithms) can perform the
‘high risk’data processing
functions, and they can in
turn transmit the result to the
smartphone which displays the
data to the user. In this way,
the power of a smartphone
interface is brought to bear
without adding in the extra
risk of using the ‘unregulated’
smartphone processor itself to
generate the data.
Looking further into the future,
‘connected health’systems will
give medtech companies the
opportunity to leverage the
information acquired from
them to build new services
and solutions in addition to
new devices. This information
will place them ideally to
develop an unparalleled
vision of the care pathway
for a particular disease.
These companies will use
these new clinical information
services to make patient
data and related information
available throughout the
patient care continuum –
during diagnosis upstream
on the clinical environment,
through to disease
management downstream
in post-operative care. By
employing this methodology
for specific diseases, medtech
companies can ‘own the
disease’from inception,
greatly expanding patient
interaction points and ‘locking
in’treatment along the care
continuum.
The opportunity to ‘own’a
disease by managing treatment
along the patient care
continuum is one that offers
potentially great returns, a
point not lost on big medtech
as they jockey for position
across a myriad of disease
states. Ultimately no one
organisation will ‘win’this
race, but the benefits for us all
as users of healthcare services
promise to be great—the
information revolution 2.0 has
begun.
Interested to know more? Contact
Niall.Mottram@sagentia.com or
David.Pettigrew@sagentia.com
'The opportunity
to 'own' a disease
by managing
treatment along
the patient care
continuum is
one that offers
potentially great
returns'
Table 1: Benefits of ‘connected health’systems include:
Improved healthcare access
in remote settings
Increased access to specialist
knowledge
Easier collection of clinically
relevant data outside clinical
settings
Improved patient compliance
with treatment
Alerts for acute events Greater patient mobility
Management of lifestyle to
reduce disease progression
and/or prevent co-morbidities
Improved infection control
with less requirement for
surface cleaning
Incentivising consumer fitness
and wellness market
Evidence of compliance linked
to reimbursement
Summer 2013 The Gen 07
Technology insight
Wireless communications systems –
improving the way medical devices work
By Mark Tuckwell
There has been growing interest in the use
of wireless technology in medical devices,
also called ‘Connected Health’, over the
last few years. And although there are still
a number of technical and commercial
challenges, we are seeing positive signs
that this market might finally be taking off.
So what are the opportunities and how
do we approach the technical development
aspects at this stage of the market and
technology maturity?
Areas of opportunity
There are significant economic and
market drivers for monitoring patients at
a distance. Importantly, connected health
promises to deliver against two of the hot
topic areas in the industry:improved health
effectiveness and better cost efficiency.
So although connected health has
been known as an area with opaque
reimbursement guidelines, products
that can demonstrate against cost and
effectiveness should have market and
reimbursement appeal.
From an application perspective, we see a
number of interesting opportunities for
remote monitoring between the home
and clinics, within a clinic or even between
clinics, in areas including:
•	 Vital signs monitoring
•	 Respiration monitoring
•	 Sleep management
•	 Drug compliance monitoring
•	 Diabetes management
•	 Wellness monitoring
Product development  technical realities
Some of the initial barriers to adoption of
wireless technology in healthcare include
concerns over data security and reliability,
lack of dedicated spectrum availability,
limited availability of commercial medical
hardware solutions, burdens of regulatory
approval and uncertain commercial viability
of the end products. However, many of
these concerns are now being addressed
and although they remain important
discussion points in any development path
most can be solved by prudent spectrum
selection for the medical device and the
appropriate level of customisation.
There are two distinct ways in which to
approach wireless connectivity of medical
devices. The first is to use a mature
technology which utilises one of the
ISM bands. This portion of the spectrum
is shared by many commercial wireless
devices including wireless computer
networks. Using wifi has the advantage
that the medical device can be connected
to a backbone of wireless hotspots,
eg using an existing hospital network, and
the investment will be relatively low from
a technology perspective. The drawback of
this approach is that it is power hungry and
cannot be used if you have very small size
requirements.Where direct connection to
a hospital network is not required, the
use of bluetooth low energy devices is a
possibility. These enable smaller, lower
power, lower data rate when compared
with wifi, making them suitable for
personal health monitoring.
But while the use ofWifi and Bluetooth
might be off the shelf, there are still a
number of customisation options you
can make to optimise this approach. For
example there are considerable benefits
to be had by paying careful attention to
areas such as architecture design, choice
of bands and spectrum, antenna design,
data and power consumption and
emissions standards.
The second approach is to use a custom
transmitter and receiver operating in
the spectrum set aside for medical use.
Using a less crowded spectrum can result
in a more robust solution. This approach
would meet very demanding requirements
(eg extremely low power, high data rates
and/or very small size) and could be
designed exactly to your specific needs, but
will also involve significant development
time, and therefore spend, as the maturity
of chip sets and solutions to make use of
dedicated medical bands are not yet readily
available. Again you will need to clearly
define your architecture, antenna design,
data and power requirements, emissions
requirements and perhaps most notably
need to pay particular attention to meeting
the required industry standards.
Looking to the future
The recent introduction of the Medical Area
Body Networks (MBAN) spectrum, operating
at 2.4 GHz, aims to introduce a step change
in the use of small, low power, moderate
data rate and robust bodyworn transceivers.
Philips, Zarlink and Texas Instruments
are all proponents of the wireless MBAN
spectrum so expect to see semiconductor
solutions for this band soon. An alternative
to wireless MBAN is to consider the
human body as the transmission medium.
Using the body provides a stable, reliable
communication channel with few radiated
emissions. Body coupled communications
would enable low power, high reliability
and secure transmission of data. Even
while waiting for these developments to
happen, we see a number of opportunities
in this space and there is a large choice of
communication technologies which are
suitable for enabling wireless connectivity
on a medical device. The key is defining
the opportunity and customising your
development approach so that your end
product appropriately fits your strategic
market objectives.
Interested to know more? Contact
Mark.Tuckwell@sagentia.com
08 The Gen Summer 2013
Case study
OXEMS is a University of Oxford start-
up which offers a fully integrated
underground asset management
system that gives utilities full visibility
of their network. They needed to
determine how best to optimise the
system for manufacture and worked
with Sagentia to design the core RF
elements of the OXEMS solution and
turn an academic concept into a
commercially viable product.
OXEMS: Utility underground asset
mapping technology
Challenge
The OXEMS rFINDGoTo™ solution
includes tags, detectors and a database
with automatic data logging and instant
recall, allowing utility assets to be mapped,
located and identified with precision. This
is important when utility companies or
local councils need to update or repair their
assets and want to avoid costly and often
error prone underground interventions.
In 2010, OXEMS had just been spun out of
the University of Oxford by Isis Innovation.
The start-up had rights to an initial tagging
technology that had been developed by
Professor David Edwards at the University
of Oxford as part of the Engineering and
Physical Sciences Research Council’s (EPSRC)
Mapping the Underworld challenge.
Although proven at a concept level, OXEMS
needed to determine how best to optimise
the system for manufacturing.
This included needing to identify the
appropriate number of tag IDs that should
be used and how to optimally allocate that
spectrum within realistic manufacturing
tolerances.
Approach
Sagentia was brought into the project as
a technology and product development
partner to conduct a feasibility study and
help turn the academic output into a
commercially viable product.
Working closely with OXEMS, the Sagentia
team looked at cost models, evaluated
system performance and ranges and
undertook a technology assessment of
the tags and accompanying equipment.
Having determined the best approach,
we then worked with OXEMS to develop
manufacturing tolerances, electromagnetic
models and electronic prototypes.
Benefit
OXEMS now has a fully developed
technology that is technically sound,
market ready and commercially attractive
for the UK utility market. The company has
gone on to complete field trials with fully
functioning equipment at customer sites
around the country.
Kevin Gooding, CEO at OXEMS, comments:
At last utility companies have the one
tool needed to transform the economics of
underground asset management. OXEMS’
ability to tag, register, map and pinpoint
each buried asset is the 21st
century digital
toolkit of the future. Sagentia was a key
partner in helping us progress our solution
from the university research environment
to the market.
Through the use of advanced sensor
technologies and data fusion models,
companies like OXEMS are delivering
‘smarter infrastructure’.
Summer 2013 The Gen 09
Device powered chemistry in personal care
- greater than the sum of its parts?
By Lucy Mullice  Peter Luebcke
D
evice assisted chemistry
provides innovation
headroom for personal
care companies that are
in a highly competitive industry
worth over $300bn globally.
Devices offer new opportunities
for intellectual property creation
and a much-welcomed distinction
from the crowd through greater
efficacy. But how do you make this
happen?
In the case of skincare, application
of a topical formulation to the skin
is straightforward, so use of a device
requiring extra expense to do the same
thing is difficult to justify. For a device to
be attractive and worthwhile it needs to
add additional therapeutic benefit and
demonstrate market differentiation.
Similarly in haircare, consumers are
unlikely to invest in a passive implement
to apply a hair serum when their fingers
or even a comb would suffice. A more
compelling approach requires investment
in the development of a device with
greater functionality which can give truly
breakthrough performance – an approach
regularly adopted in the medical industry.
So why can’t we do the same in the
consumer sector?
The main challenge is to choose the
right enabling technologies that can be
exploited to demonstrably increase efficacy.
Top of this list are technologies such as
light (eg photodynamic therapy), heat,
microwave, friction-release encapsulation,
iontophoresis and sonophoresis, amongst
others. Typically when combined with a
formulation, these technologies, embedded
as part of a device, will do one or more of
the following:
1.	Deliver the ‘active’substance more deeply
or in a more targeted fashion than could
be achieved topically;
2.	Release the active from a stabilised
formulation ‘activating’it in situ only
when and where required;
3.	Trigger a chemical change (eg
photochemical) from an inert to a
biochemically reactive state to have an
effect on the surrounding physiology;
4.	Measure the current condition (eg hair
damage, skin colour etc) and use this
measurement to tailor the treatment.
The range of possible combinations of
biochemical actives and device/energy
modalities is vast. Some examples of
potential innovative device-formulation
combinations could include concepts
such as:
•	A device where substances are delivered
through the epidermis to the dermis (eg
ultrasonically) and then activated with
LEDs photodynamically to form a collagen
expression stimulating active in situ to
target anti-ageing;
•	An iontophoretic device that delivers
anionic or polar active molecules to a
depth within the epidermis to enhance
or suppress melanogenesis depending
on the desired outcome (ie tanning vs.
lightening respectively);
•	A device in which a keratin modifying
active is evenly spread over the hair and
fused (eg by RF heating) to the outer
cuticle forming a smooth outer layer,
therefore adding shine and strength.
Importantly, the traditional formulation-
only company considering a move to device
powered chemistry will need to consider
the resulting mode of action and the claims
it intends to make about the product to
abide by the regulatory guidelines around
cosmetics, drugs and medical devices.
In addition, the development dynamic
that characterises device innovation
and formulation chemistry innovation is
very different so this will also need to be
managed carefully.
The device element combined with
formulation can bring great additional
value by increasing efficacy, enhancing
safety claims and/or reducing the
quantities of expensive active components
through more efficient targeting. But for
consumer companies to get it right, they
need to both exploit the right technologies
and fine-tune the synergy between the
device and the chemistry. If they get that
right, chemistry in devices can become a key
enabler to gaining greater market appeal in
this field.
The ‘brand bundle’
One of the key opportunities offered by a
device assisted chemistry approach is the
offer of a ‘brand bundle’, providing brand
lock-in to consumables and therefore
driving core product revenues. Clarisonic’s
Opal Sonic Infusion anti-aging sonic ‘micro-
massage’system and NUSKIN’s ageLOC™
Galvanic Spa iontophoretic system both
incorporate a device and an associated
serum and claim to deliver the active
deeper than manual application. Brand
bundling not only enhances revenues from
a product line, it also conveys a message
of a deep scientific understanding of the
target problem, whether it is a therapeutic
device that enhances efficacy of the
chemistry or a diagnostic in-store device
that can assess an individual’s condition
and personalise the product to them.
Need help with your device strategy?
Contact Peter.Luebcke@sagentia.com
Focus on
10 The Gen Summer 2013
Focus on
The industrial design
revolution By Prof Phil Gray
I
ndustrial design and its role
in the business context has
changed radically over the last
decade. Its practice spans a
wider range of skills including
service design, user interaction
design and corporate branding,
and its role has become a
powerful business tool – enabling
governments and enterprises to
adopt game changing approaches
to creating new products, services
and environments.
Industrial design is becoming an agent of
change, in a similar way to the IT revolution
of the 80s, which forced companies to
evaluate how they operated and gave them
an opportunity to streamline their business
processes. By emphasising the consumer
experience, as well as providing a common
language that binds organisations together
to meet their future needs, industrial
design has become an effective way to
break down silos, encourage more lateral
collaboration across the business, and
respond smarter and quicker to market
changes. Design is now a key strategic
business tool as opposed to its traditional
place as a ‘nice to have’that sits outside the
core thrust of the business.
So why should you ensure your company
is design led? Technology alone will no
longer satisfy the increasingly savvy buyer,
whether it’s a teenager looking for the latest
entertainment device or an industrial buyer
purchasing expensive instrumentation.
Function and performance are not enough.
Technology has to deliver benefits – both
real and perceived. A product needs to be
attractive, deliver on the brand promise, be
delightful to use, and be safe, reliable and
easy to dispose of. To deliver these things
you need to understand ‘good design’in all
aspects – usability, beauty, inclusive design,
cost reduction, design for assembly and
design for manufacture.
Beyond this, the stereotype of a ‘typical
consumer’no longer exists. Consumers
behave differently depending on the time
of day, what they are doing and who they
are with. It’s naïve to believe or assume
that people know what they want, other
than something that’s better and cheaper
than they already have.Working closely
with consumers and users as part of their
creative processes enables companies to get
a unique understanding of customer ‘care
abouts’, which are critical to the success
of new products and services. There is no
doubt that the companies that really pay
attention to understanding customer
behaviours, future needs and aspirations
are going to be the winners.
Designers also provide creative and
visualisation skills to help clarify the
thinking behind project requirements and
to bridge communication gaps between
market researchers and consumers,
engineering and marketing departments
or senior executives and project teams.
This, coupled with better customer insights,
creates a lower risk and a more confident
platform for serious product and service
creation and development.
This shift can bring significant benefits to
businesses.With organisations frequently
structured as silos of knowledge, this
new approach breaks down barriers,
improves communication and builds well-
constructed definitions.
Designing the experience has now become
more important than designing the
product. Have you adapted your business?
Quadro Design is a division of the
Sagentia Group, focused on integrating
user experience into the product
development process through the power
of design. For more information visit
www.quadrodesign.com or email
Phil@quadrodesign.com
Summer 2013 The Gen 11
© Sagentia June 2013
Sagentia
Sagentia is a global innovation, technology and product
development company. We provide outsourced RD consultancy
services to start ups through to global market leaders in the medical,
industrial and consumer sectors.
With global headquarters in Cambridge, UK, and US headquarters
in Boston, Massachusetts, Sagentia works with clients from
opportunity discovery through to concept generation and full
product development and transfer to manufacture. We deliver
science and technology innovation and work with clients to develop
next generation products and services that provide commercial
value and market advantage.
Further information can be found at www.sagentia.com
Sagentia Ltd | Harston Mill | Harston | Cambridge | CB22 7GG | UK	 T. +44 1223 875200
Sagentia Inc | One Beacon Street | Suite 2300 | Boston | MA 02108 | USA	 T. +1 617 896 0213
Quadro Design Ltd | Harston Mill | Harston | Cambridge | CB22 7GG | UK	 T. +44 1223 875181
info@sagentia.com
www.sagentia.com
www.quadrodesign.com

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The Gen - Summer 2013

  • 1. The Gen News from Sagentia Summer 2013  Utility underground asset mapping technology  Algorithms enable low cost 3D visualisation in surgery  How information systems are reshaping healthcare delivery  Device powered chemistry in personal care – greater than the sum of its parts?
  • 2. ContentsContents Introduction 02 Introduction 03 News 03 Update 04 Feature Algorithms enable low cost 3D visualisation in surgery 06 Feature How information systems are reshaping healthcare delivery 08 Technology insight Wireless communications systems – improving the way medical devices work 09 Case study OXEMS – Utility underground asset mapping technology 10 Focus on Device powered chemistry in personal care – greater than the sum of its parts? 11 Focus on The industrial design revolution W elcome to the Summer 2013 Gen! It’s a privilege to be addressing the front page of The Gen as Sagentia’s Managing Director; I’ve been writing articles and reading colleagues' contributions for eight years. During these years I’ve come to know our customers, capabilities and opportunities well and am proud to be introducing our work to you. MickWithers and I took up the reigns from Brent Hudson who resigned at the end of October last year after three great years leading the company.With positive year-end financial results recently announced, we are both working hard, along with the rest of our great team at Sagentia, to grow and expand the value of our services to you, our clients. To be successful in our business, we need to stay on top of science and technology breakthroughs coming out of academia and industry and we need to understand the challenges and drivers affecting our clients’ markets. This means that our consultants often have interesting and diverse perspectives that we like to capture and share where possible. In this issue, we have articles including a mathematician opining the future of surgical imaging (p4), a life scientist challenging the status quo in healthcare thinking (p6) and a physicist/chemist inviting the consumer industry to bring formulation science and devices together in the pursuit of innovation (p10). These are all written by individuals who have strong opinions on how technology can be made to serve the markets they work across. Elsewhere in this issue, on p9 we highlight how our work with OXEMS helped them turn academic output into a commercially viable, market ready product for underground asset mapping, and on p8 we discuss wireless communication systems in medical devices. The first few months of 2013 have been very busy for us and in our largest market – North America – there is significant anecdotal and empirical evidence that corporate cash reserves are strong; operational mandates to control fixed cost remain tight and RD drive is healthy. These three factors are building the case for deeper and longer term RD partnerships with some of our clients. If the notion of having a specialist RD team ‘on-call’ sounds appealing – let us know! Mick and I would welcome the opportunity to visit you. Dan Edwards Managing Director
  • 3. News Sagentia grows expertise in industrial design and usability agentia recently acquired Quadro Design and has invested in its usability capabilities. Quadro works with clients to improve the effectiveness of their product design, making sure they go to market with the confidence of achieving commercial success. The company is now operating as an independent but integrated division of the Sagentia Group. With industrial design and usability fundamental, and increasingly essential ingredients in innovation and product development, this acquisition demonstrates our desire to grow Sagentia’s share of the global product development market. Dan Edwards, Managing Director at Sagentia, comments:“We have enjoyed collaborating with Quadro for several years, and are delighted to formally welcome them into our team.The value this brings – having design and technology staff co-located – is clear to our clients. Equally, as the medical/healthcare industry increasingly focuses on usability of medical devices we know the time is right to invest in human factors and strategic design capability.” With Quadro and new usability experts, Sagentia is able to take a unique approach to industrial design, focusing not just on the product but on designing the user experience. S Sagentia's Boston office We've now settled into our larger Boston based US headquarters. Our contact details are: One Beacon Street Suite 2300 Boston MA 02108 T:+1 617 896 0213 agentia recently announced that we have completed initial alpha prototype development of the RESOLUTION™ Microbial Genotyping System that we are developing for PathoGenetix. As PathoGenetix’s technology and product development partner, we’re working with them across the full product development lifecycle:helping to take two initial bread board systems and combining them into an intuitive and usable system with a smaller footprint, as well as a lower per unit cost base. Our involvement initially focused on concept validation and voice of the customer analysis across worldwide sites. The output of this effort helped PathoGenetix’s management to determine and define the company’s go-to-market strategy. Subsequently, the focus has been on developing the architecture and delivering the electro-mechanical and electro-optical aspects that enable the GSS technology to be taken to market. This has included the detailed design and development of state-of-the-art custom optics, robotics, fluidics, pneumatics, and embedded and application software. “Sagentia has been a great product development partner.Working with them has allowed us to get to market faster with concept to delivery of the new RESOLUTION™ System in 18 months,”said PathoGenetix CEO Ann Merrifield. “This exciting technology has a lot of potential in food safety and we look forward to demonstrating its potential as we take it forward to commercial launch.” Take a look at our Introduction to Sagentia video on YouTube. It gives a great overview of who we are and what we do. Sagentia and MIT Technology Review: 10 Breakthrough Technologies agentia and MIT Technology Review recently co-hosted a special event to present and discuss 10 Breakthrough Technologies for 2013. The event saw Jason Pontin, Editor in Chief at MIT Technology Review, explaining the selection process and how the technologies could expand the scope of human possibilities. Dr Robin Lee, Chief Technology Officer at Sagentia, then discussed how these technologies could be used in a broader product development context, specifically highlighting technical challenges and market-focused opportunities. The technologies selected by MIT Technology Review range across industries from energy, materials and biomedicine to communications and IT, and include additive manufacturing, Baxter the Blue Collar Robot, supergrids, ultra-efficient solar power and smart watches. Read our analysis on the technologies here:www.sagentia.com/ 10breakthroughtechnologies S S Sagentia delivers alpha prototype of new Microbial Genotyping System for PathoGenetix Inc Summer 2013 The Gen 03
  • 4. Feature Algorithms enable low cost 3D visualisation in surgery By Ross Jones T he 3D interpretation of 2D images is now commonplace. Double-click on a spot down the road in Streetview and Google will transport you there. Cars in TV adverts are realistically superimposed on mountaintops. Harry Potter is seen on a broomstick swooping around a castle that only exists in a computer. The mathematics and algorithms behind this trickery have the potential to transform medical imaging and should complement the recent advances in minimally invasive and robotic assisted surgery, but have yet to find acceptance in the operating theatre. Nonetheless, researchers are making impressive progress with the more complex problems that arise in surgical visualisation and navigation. There is a gap between theory and practice that should be explored. People are naturally good at 3D interpretation. If you were to walk through a building, you should develop a good sense of its 3D structure and overall layout. Furthermore, you should also have a good idea of the path you took. The fact that you have stereo vision is not sufficient to explain this capability – you could achieve the same feat with one eye closed. Instead, it relies on synthesising 2D images taken from multiple viewpoints. In theory, if you were to carry a video camera with you, it should be possible to hand the footage over to a computer and have it perform the same task: reconstruct the 3D geometry of the building and retrace your path through it. This is known as ‘Structure from Motion’(SfM). If a robot is performing the task for its own benefit, it’s known as ‘Simultaneous Localisation and Mapping’, or SLAM. The mathematical feasibility of SfM is simple to demonstrate, but it’s difficult to find an efficient algorithm. That problem is due to perspective, which makes the equations for imaging highly non-linear. Tomasi and Kanade realised that if perspective is eliminated, for example by using cameras with telephoto lenses, then SfM can be solved using simple matrix algebra. Their 1992 paper on the ‘factorisation method’laid the foundation for modern approaches to SfM. Subsequent research quickly built up the capabilities of the method. Iterative versions of factorisation allowed for increasing amounts of perspective. Different approaches were developed for handling ‘missing data’, ie the (very common) case that not every point appears in every image. Different types of data were able to be incorporated, eg prior knowledge that points lie on a line or a plane, or observations of an object’s shadow. Streamlined algorithms and advances in hardware enabled ‘real-time’SfM. As an early example of near-real-time reconstruction, Takeo Kanade’s ‘Virtualised Reality™’system was used in the 2001 SuperBowl by CBS to create action replays from novel viewpoints. State-of- the-art systems can now track around 100 features at frame rates of 30Hz. Current research is focused on tracking deformable objects. With enough cameras, a dynamic scene could be treated as a sequence of static scenes, each reconstructed using basic SfM methods. If the objects in the view are assumed to deform in simple (but unknown) ways, fewer cameras can be used and SfM methods can be used to determine the modes of deformation as well as 3D structure and motion. All of these developments have been trialled for surgical applications. For example, the author developed a system for reconstructing the geometry of the ear canal from endoscope images, to assist the fitting of hearing aids. SfM has been used to provide off-line 3D reconstructions of surgical procedures for training purposes. In laparascopic chest or bowel surgery, with the lungs deflated or the abdominal cavity inflated, multiple endoscopic cameras could be used to present the surgeon with a wide field 3D view of the anatomy, equivalent to what might be seen with the patient fully ‘opened up’. Challenges SfM has yet to make it into commercial systems that are used regularly in the operating theatre.The key obstacle according to Danail Stoyanov, a leading researcher in SfM at University College London, is demonstrating a real clinical benefit.This seems odd, given the capabilities of SfM, but there are two important aspects to this. Firstly, it is difficult to validate an SfM system and thereby demonstrate that it is safe. 04 The Gen Summer 2013
  • 5. Feature SfM software is complex and difficult to make robust: features may be mismatched between images, iterative algorithms may fail to converge properly, small measurement errors may lead to large errors in the reconstruction. Surgical companies are comfortable with mechanics and still learning to embrace electronics and software:SfM takes them well beyond their comfort zone. Secondly, existing optical systems provide similar functionality. Calibrated tracking systems allow real-time registration of surgical instruments with pre-operative MRI and CAT images. They involve an expensive setup and have limited accuracy when attempting to infer the position of distal end of a long instrument from a view of its proximal end, but are relatively simple to validate. Stereo endoscopes also provide the surgeon with a real-time 3D view without the need for any computer trickery. In the simple case, where the surgeon directly looks through the endoscope, he obtains a narrow field of view and/or limited depth cues. In robotic systems, notably the da Vinci system by Intuitive Surgical, the surgeon views multiple endoscopic images on a monitor and effectively performs the SfM task in his head. Routes to adoption There are two likely routes to the adoption of SfM. Firstly, SfM could be used to augment other systems in a way that poses no risk. Danail Stoyanov is using SfM to provide automatic registration of multispectral images of tissue. A number of groups at Johns Hopkins University are working on surgical vision systems, and one project that could provide a safe, demonstrable benefit uses SfM post-surgery to evaluate the skill with which a surgeon has managed a robotic surgical system. The other route is to piggy-back on advanced systems like the da Vinci robot. This has proven to be an effective platform for putting state-of-the-art technologies in the hands of the surgeon. In the case of SfM, the system already works with multiple endoscopic views and tracks instruments through encoders. This information could be used to ‘pre-condition’ the SfM calculations and check for errors in the 3D reconstruction, mitigating the complex problems of robustness that a vision-only system is faced with. Conclusion The irony then, is that a low- cost vision technology which consumers will soon use on their smart phones and iPads is likely to find its way into the operating theatre via a multi- million dollar robotic surgery system. The academic research in SfM is now very sophisticated; someone with the art of Steve Jobs may be required to create an implementation that is simple, robust and has obvious clinical benefits. Interested to know more? Contact Ross.Jones@sagentia.com Summer 2013 The Gen 05
  • 6. Feature How information systems are reshaping healthcare delivery By Niall Mottram David Pettigrew With continuing revelations in connectivity, data handling and micro processing, information has never been so plentiful. While some have viewed this plethora of information as dangerous (see the increasing rates of patient self-diagnosis thanks toWeb MD etc), it is more commonly being embraced as an enabler. An enabler because of the possibilities to push diagnosis and treatment away from traditional centralised points of care and into domestic environments. An enabler because of the possibilities for new business models. An enabler because of the potential to give the physician unprecedented visibility of their patient’s progress, while at the same time empowering the patients themselves to take more responsibility for their own care. But if your business is built on designing, developing and manufacturing medical devices, how do you leverage information? You can clearly use user feedback, crowd sourcing and focus groups to improve your products, but isn’t there a bigger opportunity out there? Large medtech companies certainly believe so and many of the big names have already publicly announced that they want to integrate real time data management and decision support into their next generation products to facilitate the move into remote diagnosis and monitoring. This has been facilitated by a move from standalone products to entire ecosystems of ‘smart’connected devices. Diabetes management is in the vanguard of this new trend, with companies like Medtronic, Roche and Dexcom moving away from standalone Point of Care devices to networked systems consisting of devices like wearable patches for monitoring glucose, insulin pumps and mobile apps. These systems are set to become the gold standard for diabetes care. In hospitals, devices are increasingly being networked and connected into hospital information systems (HIS’s) to ensure relevant clinical data are received by the attending physician at critical points in the care pathway. An example of this at the ward level may include networked bedside monitors linked into a central hub, which utilises Clinical Decision Support Algorithms to alert nurses of a critical event. In addition, the use of centralised servers which log anonymised patient data from a number of sites and use these data to train algorithms which support diagnosis is also an increasing trend in fields like cardiology and image analysis. These ‘connected health’ systems are designed to address several unmet needs (see Table 1). Through mobile medical apps at one end of this spectrum and bespoke treatment devices at the other, these companies are utilising years of valuable user insights to produce devices which blur the boundary between medical and consumer products. While consumer/patient acceptance is important, particularly for home care devices, these user insights are also crucial for developing devices which minimise the risk of patient harm through user error. If these considerations are navigated successfully, these systems will become increasingly important for physicians who wish to monitor their patient’s progress between consultations and for payers who wish to receive evidence of treatment compliance. “Healthcare is changing”how many times have you heard that? Probably more than you can remember. But it really is and now there is increasing consensus on exactly how. Five years ago the messages centred on incremental innovations and preserving margins. Last year it was ‘Obamacare’and the huge implications on reimbursement mechanisms and cost pressures. Now the hot topic isn’t products or legislation, it's information. But why is this the case and what does it mean to the 2nd largest US business industry? 06 The Gen Summer 2013
  • 7. Feature Ultimately, they may also support the patient’s decision making by providing automated advice on the management of their condition. These tools will eventually pull certain responsibilities away from physicians to patients, transforming regulation in the process. The functionality of these devices will vary based on their technical sophistication, but the end goals are the same: support the clinician’s decision making and empower the patient. Manufacturers are facing a number of unfamiliar challenges around developing these ‘connected health’devices, particularly for those that blur the boundary between medical and consumer devices. For example, while the rising prominence of smartphone apps at first glance provides an easy route to a ‘consumer friendly’user experience for their connected systems, the regulatory landscape, particularly in the US, remains highly uncertain. Manufacturers and regulators are increasingly concerned about: • How rapid changes in smartphone hardware and operating systems will affect the intended function of their medical devices; • A lack of clarification on how the FDA will determine which health apps require regulation; • The challenges of protecting the privacy and security of personal health information; and • The development cost/time that the medical app could incur if their products require FDA approval. Depending on the level of risk of the intended connected health system, when faced with these issues manufacturers often conclude that it is still cheaper and less risky in the long run to develop a bespoke connected hardware and software that they can control entirely. There is, however, a middle ground. Smart devices developed by the manufacturer (containing sophisticated embedded algorithms) can perform the ‘high risk’data processing functions, and they can in turn transmit the result to the smartphone which displays the data to the user. In this way, the power of a smartphone interface is brought to bear without adding in the extra risk of using the ‘unregulated’ smartphone processor itself to generate the data. Looking further into the future, ‘connected health’systems will give medtech companies the opportunity to leverage the information acquired from them to build new services and solutions in addition to new devices. This information will place them ideally to develop an unparalleled vision of the care pathway for a particular disease. These companies will use these new clinical information services to make patient data and related information available throughout the patient care continuum – during diagnosis upstream on the clinical environment, through to disease management downstream in post-operative care. By employing this methodology for specific diseases, medtech companies can ‘own the disease’from inception, greatly expanding patient interaction points and ‘locking in’treatment along the care continuum. The opportunity to ‘own’a disease by managing treatment along the patient care continuum is one that offers potentially great returns, a point not lost on big medtech as they jockey for position across a myriad of disease states. Ultimately no one organisation will ‘win’this race, but the benefits for us all as users of healthcare services promise to be great—the information revolution 2.0 has begun. Interested to know more? Contact Niall.Mottram@sagentia.com or David.Pettigrew@sagentia.com 'The opportunity to 'own' a disease by managing treatment along the patient care continuum is one that offers potentially great returns' Table 1: Benefits of ‘connected health’systems include: Improved healthcare access in remote settings Increased access to specialist knowledge Easier collection of clinically relevant data outside clinical settings Improved patient compliance with treatment Alerts for acute events Greater patient mobility Management of lifestyle to reduce disease progression and/or prevent co-morbidities Improved infection control with less requirement for surface cleaning Incentivising consumer fitness and wellness market Evidence of compliance linked to reimbursement Summer 2013 The Gen 07
  • 8. Technology insight Wireless communications systems – improving the way medical devices work By Mark Tuckwell There has been growing interest in the use of wireless technology in medical devices, also called ‘Connected Health’, over the last few years. And although there are still a number of technical and commercial challenges, we are seeing positive signs that this market might finally be taking off. So what are the opportunities and how do we approach the technical development aspects at this stage of the market and technology maturity? Areas of opportunity There are significant economic and market drivers for monitoring patients at a distance. Importantly, connected health promises to deliver against two of the hot topic areas in the industry:improved health effectiveness and better cost efficiency. So although connected health has been known as an area with opaque reimbursement guidelines, products that can demonstrate against cost and effectiveness should have market and reimbursement appeal. From an application perspective, we see a number of interesting opportunities for remote monitoring between the home and clinics, within a clinic or even between clinics, in areas including: • Vital signs monitoring • Respiration monitoring • Sleep management • Drug compliance monitoring • Diabetes management • Wellness monitoring Product development technical realities Some of the initial barriers to adoption of wireless technology in healthcare include concerns over data security and reliability, lack of dedicated spectrum availability, limited availability of commercial medical hardware solutions, burdens of regulatory approval and uncertain commercial viability of the end products. However, many of these concerns are now being addressed and although they remain important discussion points in any development path most can be solved by prudent spectrum selection for the medical device and the appropriate level of customisation. There are two distinct ways in which to approach wireless connectivity of medical devices. The first is to use a mature technology which utilises one of the ISM bands. This portion of the spectrum is shared by many commercial wireless devices including wireless computer networks. Using wifi has the advantage that the medical device can be connected to a backbone of wireless hotspots, eg using an existing hospital network, and the investment will be relatively low from a technology perspective. The drawback of this approach is that it is power hungry and cannot be used if you have very small size requirements.Where direct connection to a hospital network is not required, the use of bluetooth low energy devices is a possibility. These enable smaller, lower power, lower data rate when compared with wifi, making them suitable for personal health monitoring. But while the use ofWifi and Bluetooth might be off the shelf, there are still a number of customisation options you can make to optimise this approach. For example there are considerable benefits to be had by paying careful attention to areas such as architecture design, choice of bands and spectrum, antenna design, data and power consumption and emissions standards. The second approach is to use a custom transmitter and receiver operating in the spectrum set aside for medical use. Using a less crowded spectrum can result in a more robust solution. This approach would meet very demanding requirements (eg extremely low power, high data rates and/or very small size) and could be designed exactly to your specific needs, but will also involve significant development time, and therefore spend, as the maturity of chip sets and solutions to make use of dedicated medical bands are not yet readily available. Again you will need to clearly define your architecture, antenna design, data and power requirements, emissions requirements and perhaps most notably need to pay particular attention to meeting the required industry standards. Looking to the future The recent introduction of the Medical Area Body Networks (MBAN) spectrum, operating at 2.4 GHz, aims to introduce a step change in the use of small, low power, moderate data rate and robust bodyworn transceivers. Philips, Zarlink and Texas Instruments are all proponents of the wireless MBAN spectrum so expect to see semiconductor solutions for this band soon. An alternative to wireless MBAN is to consider the human body as the transmission medium. Using the body provides a stable, reliable communication channel with few radiated emissions. Body coupled communications would enable low power, high reliability and secure transmission of data. Even while waiting for these developments to happen, we see a number of opportunities in this space and there is a large choice of communication technologies which are suitable for enabling wireless connectivity on a medical device. The key is defining the opportunity and customising your development approach so that your end product appropriately fits your strategic market objectives. Interested to know more? Contact Mark.Tuckwell@sagentia.com 08 The Gen Summer 2013
  • 9. Case study OXEMS is a University of Oxford start- up which offers a fully integrated underground asset management system that gives utilities full visibility of their network. They needed to determine how best to optimise the system for manufacture and worked with Sagentia to design the core RF elements of the OXEMS solution and turn an academic concept into a commercially viable product. OXEMS: Utility underground asset mapping technology Challenge The OXEMS rFINDGoTo™ solution includes tags, detectors and a database with automatic data logging and instant recall, allowing utility assets to be mapped, located and identified with precision. This is important when utility companies or local councils need to update or repair their assets and want to avoid costly and often error prone underground interventions. In 2010, OXEMS had just been spun out of the University of Oxford by Isis Innovation. The start-up had rights to an initial tagging technology that had been developed by Professor David Edwards at the University of Oxford as part of the Engineering and Physical Sciences Research Council’s (EPSRC) Mapping the Underworld challenge. Although proven at a concept level, OXEMS needed to determine how best to optimise the system for manufacturing. This included needing to identify the appropriate number of tag IDs that should be used and how to optimally allocate that spectrum within realistic manufacturing tolerances. Approach Sagentia was brought into the project as a technology and product development partner to conduct a feasibility study and help turn the academic output into a commercially viable product. Working closely with OXEMS, the Sagentia team looked at cost models, evaluated system performance and ranges and undertook a technology assessment of the tags and accompanying equipment. Having determined the best approach, we then worked with OXEMS to develop manufacturing tolerances, electromagnetic models and electronic prototypes. Benefit OXEMS now has a fully developed technology that is technically sound, market ready and commercially attractive for the UK utility market. The company has gone on to complete field trials with fully functioning equipment at customer sites around the country. Kevin Gooding, CEO at OXEMS, comments: At last utility companies have the one tool needed to transform the economics of underground asset management. OXEMS’ ability to tag, register, map and pinpoint each buried asset is the 21st century digital toolkit of the future. Sagentia was a key partner in helping us progress our solution from the university research environment to the market. Through the use of advanced sensor technologies and data fusion models, companies like OXEMS are delivering ‘smarter infrastructure’. Summer 2013 The Gen 09
  • 10. Device powered chemistry in personal care - greater than the sum of its parts? By Lucy Mullice Peter Luebcke D evice assisted chemistry provides innovation headroom for personal care companies that are in a highly competitive industry worth over $300bn globally. Devices offer new opportunities for intellectual property creation and a much-welcomed distinction from the crowd through greater efficacy. But how do you make this happen? In the case of skincare, application of a topical formulation to the skin is straightforward, so use of a device requiring extra expense to do the same thing is difficult to justify. For a device to be attractive and worthwhile it needs to add additional therapeutic benefit and demonstrate market differentiation. Similarly in haircare, consumers are unlikely to invest in a passive implement to apply a hair serum when their fingers or even a comb would suffice. A more compelling approach requires investment in the development of a device with greater functionality which can give truly breakthrough performance – an approach regularly adopted in the medical industry. So why can’t we do the same in the consumer sector? The main challenge is to choose the right enabling technologies that can be exploited to demonstrably increase efficacy. Top of this list are technologies such as light (eg photodynamic therapy), heat, microwave, friction-release encapsulation, iontophoresis and sonophoresis, amongst others. Typically when combined with a formulation, these technologies, embedded as part of a device, will do one or more of the following: 1. Deliver the ‘active’substance more deeply or in a more targeted fashion than could be achieved topically; 2. Release the active from a stabilised formulation ‘activating’it in situ only when and where required; 3. Trigger a chemical change (eg photochemical) from an inert to a biochemically reactive state to have an effect on the surrounding physiology; 4. Measure the current condition (eg hair damage, skin colour etc) and use this measurement to tailor the treatment. The range of possible combinations of biochemical actives and device/energy modalities is vast. Some examples of potential innovative device-formulation combinations could include concepts such as: • A device where substances are delivered through the epidermis to the dermis (eg ultrasonically) and then activated with LEDs photodynamically to form a collagen expression stimulating active in situ to target anti-ageing; • An iontophoretic device that delivers anionic or polar active molecules to a depth within the epidermis to enhance or suppress melanogenesis depending on the desired outcome (ie tanning vs. lightening respectively); • A device in which a keratin modifying active is evenly spread over the hair and fused (eg by RF heating) to the outer cuticle forming a smooth outer layer, therefore adding shine and strength. Importantly, the traditional formulation- only company considering a move to device powered chemistry will need to consider the resulting mode of action and the claims it intends to make about the product to abide by the regulatory guidelines around cosmetics, drugs and medical devices. In addition, the development dynamic that characterises device innovation and formulation chemistry innovation is very different so this will also need to be managed carefully. The device element combined with formulation can bring great additional value by increasing efficacy, enhancing safety claims and/or reducing the quantities of expensive active components through more efficient targeting. But for consumer companies to get it right, they need to both exploit the right technologies and fine-tune the synergy between the device and the chemistry. If they get that right, chemistry in devices can become a key enabler to gaining greater market appeal in this field. The ‘brand bundle’ One of the key opportunities offered by a device assisted chemistry approach is the offer of a ‘brand bundle’, providing brand lock-in to consumables and therefore driving core product revenues. Clarisonic’s Opal Sonic Infusion anti-aging sonic ‘micro- massage’system and NUSKIN’s ageLOC™ Galvanic Spa iontophoretic system both incorporate a device and an associated serum and claim to deliver the active deeper than manual application. Brand bundling not only enhances revenues from a product line, it also conveys a message of a deep scientific understanding of the target problem, whether it is a therapeutic device that enhances efficacy of the chemistry or a diagnostic in-store device that can assess an individual’s condition and personalise the product to them. Need help with your device strategy? Contact Peter.Luebcke@sagentia.com Focus on 10 The Gen Summer 2013
  • 11. Focus on The industrial design revolution By Prof Phil Gray I ndustrial design and its role in the business context has changed radically over the last decade. Its practice spans a wider range of skills including service design, user interaction design and corporate branding, and its role has become a powerful business tool – enabling governments and enterprises to adopt game changing approaches to creating new products, services and environments. Industrial design is becoming an agent of change, in a similar way to the IT revolution of the 80s, which forced companies to evaluate how they operated and gave them an opportunity to streamline their business processes. By emphasising the consumer experience, as well as providing a common language that binds organisations together to meet their future needs, industrial design has become an effective way to break down silos, encourage more lateral collaboration across the business, and respond smarter and quicker to market changes. Design is now a key strategic business tool as opposed to its traditional place as a ‘nice to have’that sits outside the core thrust of the business. So why should you ensure your company is design led? Technology alone will no longer satisfy the increasingly savvy buyer, whether it’s a teenager looking for the latest entertainment device or an industrial buyer purchasing expensive instrumentation. Function and performance are not enough. Technology has to deliver benefits – both real and perceived. A product needs to be attractive, deliver on the brand promise, be delightful to use, and be safe, reliable and easy to dispose of. To deliver these things you need to understand ‘good design’in all aspects – usability, beauty, inclusive design, cost reduction, design for assembly and design for manufacture. Beyond this, the stereotype of a ‘typical consumer’no longer exists. Consumers behave differently depending on the time of day, what they are doing and who they are with. It’s naïve to believe or assume that people know what they want, other than something that’s better and cheaper than they already have.Working closely with consumers and users as part of their creative processes enables companies to get a unique understanding of customer ‘care abouts’, which are critical to the success of new products and services. There is no doubt that the companies that really pay attention to understanding customer behaviours, future needs and aspirations are going to be the winners. Designers also provide creative and visualisation skills to help clarify the thinking behind project requirements and to bridge communication gaps between market researchers and consumers, engineering and marketing departments or senior executives and project teams. This, coupled with better customer insights, creates a lower risk and a more confident platform for serious product and service creation and development. This shift can bring significant benefits to businesses.With organisations frequently structured as silos of knowledge, this new approach breaks down barriers, improves communication and builds well- constructed definitions. Designing the experience has now become more important than designing the product. Have you adapted your business? Quadro Design is a division of the Sagentia Group, focused on integrating user experience into the product development process through the power of design. For more information visit www.quadrodesign.com or email Phil@quadrodesign.com Summer 2013 The Gen 11
  • 12. © Sagentia June 2013 Sagentia Sagentia is a global innovation, technology and product development company. We provide outsourced RD consultancy services to start ups through to global market leaders in the medical, industrial and consumer sectors. With global headquarters in Cambridge, UK, and US headquarters in Boston, Massachusetts, Sagentia works with clients from opportunity discovery through to concept generation and full product development and transfer to manufacture. We deliver science and technology innovation and work with clients to develop next generation products and services that provide commercial value and market advantage. Further information can be found at www.sagentia.com Sagentia Ltd | Harston Mill | Harston | Cambridge | CB22 7GG | UK T. +44 1223 875200 Sagentia Inc | One Beacon Street | Suite 2300 | Boston | MA 02108 | USA T. +1 617 896 0213 Quadro Design Ltd | Harston Mill | Harston | Cambridge | CB22 7GG | UK T. +44 1223 875181 info@sagentia.com www.sagentia.com www.quadrodesign.com