The advantages of a connected device can be explored through the different categories of needs, by trialling a range of solutions and considering a framework of manageable steps.

1. 38
Connected Devices
November 2018
Charlotte Harris, Tom Etheridge,
and Paul Greenhalgh at
Team Consulting
The advantages of a connected device can be explored
through the different categories of needs, by trialling a
range of solutions and considering a framework of
manageable steps
To Connect,or Not to Connect?
Billions of dollars are wasted each
year due to healthcare solutions
noncompliance. With the challenges
healthcare budgets face (an ageing
population and an increasing number of
chronic conditions to name a few), how
can patients better manage their health?
While making a device connected is not a
magic bullet to improve compliance and
health, they present some clear benefits.
How does one decide if a device should
be smart, connected, or neither? Clear
questions must be asked before deciding
if a device should be connected or not.
The categories of needs which define
this include: engagement, competence,
onboarding, re-onboarding, and more.
These should be identified by exploring
both connected and non-connected
solutions, after which, the solutions to
whether a product is connected or not
becomes clearer.
In the regulated world of healthcare, the
true cost of a connected solution is high
and not just financially. Patient attitudes
around sharing their health data must
be considered, and the benefits they
receive should be worthwhile for
providing that information.
Understanding the Problem
Many stakeholders are involved
in delivering and managing a
patient’s therapy. These range
from the patient, the caregivers,
and healthcare professionals
who deliver the care, through
to the pharmacist who dispenses
the therapy, the payer who funds it,
and, not forgetting, the pharmaceutical
company that developed it. Each of
these stakeholders has different needs
and desires, which may or may not be
satisfied through the use of a connected
medical device. For example, a pharma
company may want to ensure that
their clinical trials run smoothly so
that the therapy is successful, effective,
and meets the needs of the regulators.
Healthcare professionals want better
clinical outcomes for patients, and,
ultimately, the patient wants to
have their therapy funded and
to be able to manage their
condition successfully.
Considering these stakeholder needs,
why might a connected device be
helpful? What are the drivers and
where are the opportunities for
‘going connected’? A connected
device could be helpful in monitoring
adherence, learning about patient
behaviour, or helping patients
engage with their therapy – all
of which are linked to attaining
better clinical outcomes (see Figure
1a). In contrast to this, several barriers
are met when ‘going connected’,
including high costs, lengthy
development time, and the
unwillingness of some patients
to share their data (see Figure 1b).
With all of these factors to consider, how
can it be decided whether a connected
device is right or not, and where is the
real value in developing one?
Necessitating
Connected Devices
‘Connected’is a term that is used freely
in the industry these days, but what is
meant by a connected device? When
identifying solutions to stakeholder
needs, they could be thought of as
being classified into three categories:
• Dumb – These are solutions that
do not incorporate any sensing or
communication functionality into
the medical device itself. The system
may still allow one- or two-way
communication with the patient (ie,
through email, text prompts, and
advice) but the device itself is‘dumb’
• Smart – These solutions incorporate
sensing functionality into the device,
but the data from these sensors remains
on the device and is visible only to the
user. For example, sensing functionality
may be embedded within the device
to monitor certain interactions. This
might be teamed with visual, audible,
and haptic feedback, perhaps including
a simple on-board liquid crystal display
to record events and provide feedback.
The key to this category of solution is
that this information is not shared
any further
Possible opportunities
Competence Communicate
therapy benefits
Diagnostics of
disease progression
Disease self-
management
Competitor
differentiation
Learning about
patient behaviour
Patient
engagement
Clinical
trial support
Adherence
support
Figure 1a: Reasons for a connected device

2. www.samedanltd.com 39
• Connected – These solutions
incorporate sensing and
communications functionality
into the device. Data is logged or
transferred in real time to the Cloud
(normally incorporating connectivity
with a smartphone app) and the data
is visible to anyone with permission
and the means to access it (healthcare
provider, payer, pharma company, etc)
Ultimately, the ideal solution to a
stakeholder need may be in any one
of these categories, or it could
be a combination of solutions
from each of them. Exploring
solutions across all categories
and weighing them up against
the reasons for and against
a connected device will
help identify whether
‘going connected’is
indeed the optimum
solution or whether
the needs could be
addressed just as
effectively with
a simpler solution.
Matching Solutions to Needs
Broadly speaking, needs can be
categorised into five key themes:
• Competence: the ability to complete
the task correctly
• Adherence: compliance with specified
medication regimen
• Engagement: actively encouraging use
• Differentiation: standing out from
the competition
• Clinical trial support: confidence in
clinical results and the three previously
mentioned classifications of solution
with which to address them
To see whether a connected solution
is, indeed, the optimal solution, the
opportunity space can be mapped
and ideas for solutions explored in
Competence
Dumb
Smart
Connected
Figure 2: Opportunity space map
Competence Technical complexity
and risk
Potential increase
in device size
Negative patient
attitudes to sharing data
Potential wastefulness High cost and long
development time
Increased BOM/unit price Could add burden to user
Potential barriers against
a connected solution
Figure 1b: Reasons against a connected device

3. each square of the map (see Figure
2, page 39). By assessing each idea
against how well they meet the need
and weighing this up against the
technical and commercial implications
of implementing it, making a judgement
on the advantages of going connected
is possible. For example, if the need for
competence in device use is looked at,
a possible‘dumb’solution could be to
redesign the packaging and information
so that it clearly steps the user through
the use of the device.
Similarly, if the need for engagement is
looked at, an indicator on the device to
show when it was last used could be a
smart way of providing the information
needed to better engage a user. With
the need for adherence support, a fully
connected solution which takes data
from the device and transmits this to
the Cloud for the HCP to view could
help. Any of these solutions could be
viable, and the most suitable will depend
heavily on attitude to risk, technical, and
commercial constraints, and, ultimately,
the likely financial cost or savings that
could be achieved by a connected
solution. Certainly, in the case of
improving competence, a well-thought-
out piece of packaging and information
design could go a long way towards
guiding the patient through using the
device without the lengthy outlay and
risk involved in developing a connected
solution. However, when monitoring
adherence, a smart or connected
solution might be more appropriate.
Taking a Punt
If it has been decided that a connected
solution is the best way to meet the
identified needs, the next challenge is to
prototype and test it. Deciding what to
sense is key: ‘just because you can, does
not mean you should’. While adding clever
technology is a good way of ensuring a
device has maximum sensing potential, it
also runs the risk of generating needless
data and increasing power budgets, size,
and device cost.
The time to develop a quick and dirty
prototype has been significantly
reduced thanks to the array of readily
available development boards, such
as those by Nordic Semiconductor, ST
Microelectronics,Texas Instruments, or
Diolan, to name but a few (see Figure 3).
For just a few dollars, these boards can
measure multiple parameters, such
as sound, temperature, orientation,
acceleration, and humidity, etc.They come
paired with a communication module
that allows data transfer to accompanying
software.With such boards, creating and
testing the technical feasibility of early
concepts, without having to embark on
a lengthy development path, is easy.
However, the most important thing that
early prototyping provides is the ability to
test concepts with people.This allows for
40 www.samedanltd.com
Image:©TeamConsulting
Figure 3: Off-the-shelf development boards

4. About the authors
Charlotte Harris is a
Senior Consultant at
Team Consulting whose
work typically focusses
on managing the
strategic and creative
‘front-end’ of the product development
process. She has over 20 years’
experience in the medical device
industry and has worked in clinical,
start-up, and consultancy environments.
Charlotte studied medical engineering
and has a BEng from Cardiff University,
UK, and an MSc from Kings College
London, UK.
Email: charlotte.harris@team-
consulting.com
Tom Etheridge is an
Industrial Design
Consultant at Team
Consulting who uses
his experience to
deliver holistic support
to design, engineering, and human
factors groups. He has a degree in
industrial design technology from Brunel
University, UK, and has worked in a
design consultancy environment since
graduating in 2010. Tom has been the
lead industrial designer on several
projects ranging from medical devices
to consumer electronics.
Email: tom.etheridge@team-
consulting.com
Paul Greenhalgh heads
Team Consulting’s
design group. He is a
passionate advocate
of the importance
of ‘good design’ and
is involved in all stages of product
development, from front-end
innovation to detailed design
for manufacture.
Email: paul.greenhalgh@team-
consulting.com
carrot or stick that encourages adoption?
That question can be answered once a
larger number of connected devices are
on the market that deliver real and holistic
benefit to patients, payers, prescribers,
and manufacturers.
www.samedanltd.com 41
stakeholder input at an early stage and
the option to assess which features are
useful and will add most value. Getting this
information early on in the process is key
to informing the design and feature set of
the device. Not only does the connected
solution have to address a need, but its
implementation will be key to getting
users to engage with it (as well as its
ultimate success).
The Human Factor
The importance of motivating the user
cannot be ignored.What will make them
engage with the system?Without that
motivation, even the‘smartest’solution
may fail.This is where something may be
learnt from the consumer world.Think
about the many apps that essentially do
the same thing – what makes one of them
the blockbuster? Often, it is not about the
amount of functionality in the app – it
is more about its implementation and
usefulness: the way it provides the service
you want, and how digestible it makes the
information. In this instance, less is often
more.The design of the user experience
(UX) will be key, as following a user-centric
development approach will be essential
to understand what details or nuances
engage users to help them onboard and
stay with this new technology.
The users of these connected solutions
are likely being asked to give up a certain
amount of privacy and control, so,
understandably, they will feel they need
something in return – and feeling‘better’
might not be enough.
Leaving the huge topic of payment by
results to one side, how the systems
provided get the balance right between
user input and useful output (for the user)
needs to be considered.What can make
it instantly easier for the user to manage
their condition? Is it reminders, access
to additional information and support,
or something else? All of this might be
possible if smartphone connectivity
had already been introduced into the
system.This is particularly important if the
connected element is an add-on to the
device rather than integrated, where the
user is asked to do an extra job in addition
to what they are used to.
In summary, it is a complex question
(and unlikely to be a‘no-brainer’to go
connected for some time yet). However,
the opportunities a connected system
offers may reach way beyond the practical
issues of sensing and confirming correct
use.This article presents some ways of
breaking down the question into more
manageable chunks, which should help
to assess the full breadth of opportunities.
Creating early, low-cost mock-ups to gain
user input on the effectiveness of an
idea is important, so that solutions
are introduced that meet a real need
and the importance that UX design
will likely play in achieving success is
highlighted. However, maybe the only
way to truly answer the question is to ask
how confident one is feeling.
While most of the big players in
the industry are currently tooling
up for this brave new world, it is
still too early to be able understand
how consumers will react.Will it be