Development of DVTech – a novel wearable medical device for the detection of Deep Vein Thrombosis caused due to orthopaedic implants, using Pugh’s total design model

1. BIOC40130 Medical Device Technology
April 2019
Title: Proposal for the Development of DVTech -
a novel wearable sensor for the detection of DVT blood clots
Group members:
Bisola Aloba 18203764, Orla Dunne 14411742, Sarah Hill 18204017,
Eric Hubbard 18202468, Malavika Sankararaman 18200405
Declaration of Authorship: We declare that all material in this assessment is
our own work except where there is clear acknowledgement and appropriate
reference to the work of others.

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INDEX
1. Executive Summary
2. Background
i. Deep Vein Thrombosis (DVT)
ii. Current Problems and Market Need
iii. Related Products on the Market
iv. Essential Design Requirements
3. Design Concept
i. Stocking
ii. DVT Monitor
iii. Future Directions of Technology
4. Regulatory Pathway
i. Classification
ii. Conformity Assessment
iii. Preclinical Studies
iv. Clinical Studies
5. Intellectual Property
i. Background to the Invention
ii. General Data Protection Regulation (GDPR)
6. Market Strategy
i. Market Analysis
ii. Market Segmentation & Targeting
iii. Value Proposition
iv. Marketing Plan
v. Distribution Channel
vi. Branding & Positioning
7. Product Differentiation
i. Market Forecast
ii. Brexit & our Product
iii. Future Expansion
8. References
Summary of contributions:
All group members participated in the development of the product concept as well as editing the final report
1. Background (2(i) to 2(iii)) - Sarah Hill
2. Design concept and Essential design requirements (2(iv)) - Eric Hubbard
3. Regulatory Pathway, Intellectual Property and Data Compliance - Orla Dunne
4. Market Strategy - Malavika Sankararaman
5. Product Differentiation - Bisola Aloba

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1. EXECUTIVE SUMMARY
We propose the design, development and market strategy of a novel detection solution for
Deep Vein Thrombosis (DVT), a common complication associated with orthopaedic surgeries.
This product has the potential to target the total joint replacement market valued at €16.96mn
as well as the wearable technology market valued at €6.26bn. Upon further clinical validation,
this next generation product will significantly improve patient lifestyle, post-operative care
and rehabilitation among those who have undergone or are undergoing joint replacement
surgeries in the knee or hip regions.
DVTech, is a wearable sensor technology that (i) utilises doppler ultrasound waves to measure the diameter and
blood flow of major veins for the early detection of DVT, as well as (ii) provides sufficient compression to reduce
the likelihood of clot formation within the deep veins of the legs. This device worn from the ankle to the upper
thigh will be easy to put-on and take-off and will be wirelessly connected to a smartphone application as well as
the GPs database to provide instant information and feedback.
DVTech addresses the unmet needs of the existing thrombotic technologies by providing an affordable, at home,
highly accurate and rapid detection and prevention tool. The primary market for this device are individuals who
have undergone or will be undergoing joint replacement surgeries across the Europe. Due an increase in the ageing
population in European countries, the popularity of joint replacement surgeries are significantly growing.
DVTech’s market plan will span from 2019-2021 gradually targeting key leaders in the business industry,
healthcare professionals, medical device manufacturers, health insurance companies and patients. Annually,
160,000 hip and knee replacements are performed in the UK across 400 hospitals and 762,341 procedures are
performed in Europe. Calculating from this incidence size, DVTech has estimated to project a revenue of €4.8
million within the first 3 years, assuming 10% market penetration. Therefore, it is believed that DVTech will
be invaluable in the wearable diagnostic market and will become an indispensable tool among the worldwide
healthcare service providers and patients.

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2. BACKGROUND
2(i) Deep Vein Thrombosis (DVT)
1 in 4 people worldwide die from conditions caused by blood clots. In Europe, there are approximately 544,000
clot-related deaths annually, which is more than AIDs, breast cancer, prostate cancer and car crash related deaths
combined (WorldThrombosisDay.org, 2019). Deep vein thrombosis (DVT) is the formation of a blood clot in a
deep vein and most commonly occurs in the leg. This can cause pain and swelling in the leg and may lead to serious
consequences such as pulmonary embolism (PE). PE occurs when a piece of the blood clot breaks off into the
bloodstream and blocks the blood vessels in the lungs. DVT and PE together are termed venous thromboembolism
(VTE) (nhs.uk, 2019). Figure 1 outlines the common symptoms of DVT and PE. However, in approximately 50%
of VTE cases there are no clinical symptoms. VTE is often underdiagnosed and can lead to serious but preventable
medical complications (Centers for Disease Control and Prevention, 2019).
Figure 1: Symptoms of VTE (nhs.uk, 2019)
Anyone can develop VTE, but there are number of risk factors that increase an individual’s chance of developing
a clot (Figure 2). This chance increases greatly for someone who has several of these risk factors e.g. an elderly
person. VTE is more prevalent in the aging population, reaching 1 in 100 in those over the age of 80 (nhs.uk, 2019).
Furthermore, the elderly are more likely to have extended hospital stays, need total hip or total knee replacement
surgery and are, in general less mobile than the wider population. It is likely that with advancing years there are
increasing risks for the development of VTE (Centers for Disease Control and Prevention, 2019).
Figure 2: Factors and situations that increase the risk of developing VTE (worldthrombosisday, 2019).
DVTs are diagnosed using several techniques such as D-dimer blood test, Venogram or Ultrasound (Blood Clots,
2019). DVTs are highly treatable after they have been detected. Many cases of DVT will spontaneously resolve
themselves, however, initial hospital treatment is required. Current standard of treatment uses anticoagulants (e.g.
Heparin, Warfarin and Apixaban), although in severe cases the clot might need to be removed surgically. PEs
require immediate medical attention as they can be life-threatening. Thrombolytics are used to dissolve the clot or
anticoagulants are prescribed to prevent further clot formation (Centers for Disease Control and Prevention, 2019).
Prophylaxis has also been shown to be highly effective in the prevention of blood clots, for example, moving around
and avoiding sitting for extended periods of time. However, in the elderly or infirmed this can be an issue.
Anticoagulants prescribed prior to long hospital stays or orthopaedic surgeries are popular, however, some doctors

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are more reluctant to prescribe these to geriatric patients given the risks of adverse bleeding events (Minno and
Tufano, 2004). Otherwise, medical professionals sometimes recommend the use of compression stockings.
Compression stockings generally go from the ankle to the calf and increase blood flow out of the lower extremities
and back to the heart. These may also reduce the pain and swelling associated with damaged blood vessels in post-
thrombotic syndrome patients. Compression stockings for DVT use graduated pressure, where the highest pressure
is at the ankle and the lowest in the upper region of the stocking. These are often professionally measured to ensure
appropriate fit and should ideally be worn as much as possible (North American Thrombosis Forum, 2019).
2(ii) Current Problems and the Market Need
According to recent projections, the world’s elderly population (aged 60 or over) is expected to more than double
by 2050, rising from 962 million globally in 2017 to 2.1 billion in 2050 (UN.org, 2019). VTE is an age-associated
illness (e.g. over 65s account for 60% of VTE events) and incidence rates are likely to rise with the growing aging
population (Minno and Tufano, 2004). However, novel VTE devices can be applied to the wider population as DVT
can occur in anyone regardless of age, sex or ethnicity.
Despite compression therapy providing improved circulation and reducing the risk of blood clot formation, there
remains problems with compliance and comfort. There is a need for achieving effective compression (30-40 mmHg)
while retaining comfort as well as improving compliance with discrete or attractive designs. It has also been noted
that elderly patients with arthritis or mobility problems struggle to pull on compression stockings (North American
Thrombosis Forum, 2019). Therefore, a design with easy application is preferable.
DVT requires multiple diagnostic tests, treatments, prolonged hospital stays and, when certain anticoagulants are
used e.g. Warfarin, need extensive monitoring. This type of care is very costly and currently VTE is costing the
NHS €640 million per year (worldthrombosisday, 2019). There is a need for an at home detection device that can
allow the monitoring of clot development without the need to prolong hospital stays.
2(iii) Related Products on the Market
There are several lower leg compression devices currently available to VTE consumers. Pneumatic compression
devices use an inflatable sleeve to mimic rhythmic calf muscle contractions. However, these pumps are expensive,
bulky, noisy and not suitable for mobile use (Johns Hopkins Medicine Health Library, 2019). ElastiMed is
developing a smart compression stocking constructed from a low-cost electro active polymer that uses an electric
pulse to stretch and contract stimulating blood flow. This product is a mobile, active compression device designed
to wear with a comfortable fit (Elastimed.com, 2019).
There has been a rise in portable ultrasound technology from pocket sized hand-held imaging such as the Vscan
from GE healthcare to flexible ultrasound skin patches that track blood pressure 1 inch below the skin
(GEhealthcare, 2019; Wang et al., 2018). Other wearable ultrasound devices on the market include SamSport that
reduces pain associated with tendonitis and muscle injury using continuous ultrasound waves (Zetroz.com, 2019).
Novioscan is an adhesive patch ultrasound sensor for incontinence management. Its wireless function allows
notification to be sent to the user via smartphone (Novioscan, 2019).
2(iv) Essential Design Requirements
DVTech will target the post orthopaedic surgery rehabilitation market by providing a wearable stocking which will
not only help to prevent, but also actively identify DVT during post-op recovery. The design requirements of this
technology will be twofold: first, to provide sufficient compression over the lower and upper regions of the leg to
help prevent DVT following surgery, and second to utilize doppler ultrasound technology to regularly measure the
diameter and blood flow of major veins leading from the surgery site. This device can then alert the patient and
physician when there are significant changes which may signify a DVT event.

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3. DESIGN CONCEPT
One of the problems with the development of DVT is that it commonly presents no symptoms and the disorder
often goes untreated. This is dangerous in that an untreated blood clot could detach and cause a potentially fatal
embolism (NHS, 2016). When symptoms do present, the two most common ones are inflammation in the lining of
the vein, and slower blood flow in many of the major veins leading from the site of thrombosis. Our device will
monitor both symptoms. Through the longitudinal monitoring of the blood flow of the major veins leading from
the surgery site, any decreases in blood flow or increases in inflammation, picked up by changes in vein diameter,
caused by a DVT can be immediately detected and acted upon by the patient’s physician.
3. (i) Stocking
The stocking attached to this device will utilize a graduated compression stocking technology to help prevent DVT
as has been suggested in literature previously. The typical pressures for the stocking are 30mmHg, with the highest
pressure a patient can tolerate generally being the most effective (20–60 mm Hg) (Lim & Davies 2014). Therefore,
the design of this sleeve will utilize a graduated pressure gradient as demonstrated in figure 3. This sleeve will also
allow patients to strap it on rather than having to slide the leg through the entirety of the sleeve, this should help
alleviate the compliance issues which commonly occur with this type of device and make it easier for elderly
individuals with arthritis or weakness in the hands to use the stocking. The stockings can also come in multiple
colors and designs to make wearing the sleeve more desirable.
Figure 3: Shows the varying compression of the graduated compression sleeve over the entirety of the leg. The
maximum compression is located at the ankle with decreasing pressure exerted as it comes closer to the thigh.
3. (ii) DVT Monitor
The other, and more innovative part of this design is the utilisation of ultrasound technology to constantly monitor
for symptoms of DVT in the patient by collecting time point data about the diameter and blood flow rate of the
major venous groups which are most likely to be affected by DVT following orthopaedic surgery. This product will
require the licensing of a variety of previously discovered technologies which will be uniquely combined to allow
us to provide an effective preventative device for the aging orthopaedic rehabilitation sector.
This device will utilize technology developed by the University of British Columbia which demonstrated an
ultrasound device capable of being run on 10v of electricity, and small enough to be easily worn. This device costs
roughly €200-€300 to produce currently (with scale this could be brought down)(Gerardo et al. 2018). Additionally,
in order to actually implement this small transducer this device will utilise the scanning system and programming
initially designed at the university of Florida to detect changes in arterial diameter (Shomaji et al. 2016).

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Figure 4: Shows the approximate size of the ultrasound transducer.
This technology will utilize a 7.5MHz transducer with B mode ultrasound to image at a depth of roughly 4cm which
will be sufficient for the purposes of this product, as most of the major veins come within that distance of the
surface. Our technology allows for the sleeve to be fully customized for each patient by giving physicians the ability
to identify the points where these deep veins travel through the muscle and surface to become peripheral veins, also
known as perforator veins. The emerging points of these veins are perfect points to strategically monitor the blood
flow of the deep veins.
Figure 5: Shows the various perforator veins that can be monitored to measure the activity of the deep veins.
Once the sensors are appropriately placed, the device will regularly monitor the blood flow rate and diameter of the
vein in 10-minute increments to build up a reliable estimation of the baseline for the patient. If the device finds that
these values have deviated significantly for a sustained period, it will then notify the patient and physician through
the linked app.
Fig 6: DVTech prototype

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3. (iii) Future Directions of Technology
In the future we hope to develop this device into the only device necessary to monitor the patient following extensive
leg surgery. We would like to implement the ability to monitor for on-site infection via scanning for biofilms and
local inflammation, as well as to regulate blood pressure and surgery damage recovery.
4. REGULATORY PATHWAY
4 (i) Classification
The wearable ultrasound device falls under Medical Device Regulation 2017/745 and will be classed as an active
medical device intended to administer energy for use in the long term, with body contact for approximately 90 days
postoperatively following joint replacement in the knee or hip (HPRA, 2009). The device will only come into direct
contact with intact skin on the leg, does not intend to come into contact with direct wounds and will store data for
eventual administration by healthcare professionals (HPRA, 2009). The ultrasound device will be used for direct
monitoring of vital physiological processes in the legs. The device is intended to monitor veins of the leg
postoperatively following hip and knee joint replacement for the development of deep vein thrombosis (DVT), with
a built in compression stocking to reduce the incidence of DVT in patients. Therefore, the device is classified in
the Class IIa medium risk category consistent with Directive 93/42/EEC (HPRA, 2009).
4 (ii) Conformity assessment
To obtain CE marking, a full quality assurance audit will be conducted of the device by the NSAI in accordance
with ISO 13485:2003 quality management system requirements in which the quality of the device is assessed and
monitored. Clinical evaluations are conducted following guidelines of ISO 14155:2011. A technical file will be
composed containing details of the design, intended use, composition, claims and clinical evaluation of the device.
A declaration of conformity will be produced to accompany the CE marked product for EU marketing.
4 (iii) Preclinical studies
Preclinical studies will be key in the development, evaluation and marketing of the device and will be conducted
in accordance with HPRA guidelines. The design will be set during this stage, including the functionality, safety
and validation of materials and processes (Shafer et al, 2015). Once the device materials have been chosen,
performance will be evaluated in preclinical designs in which the purpose, objective and primary endpoints of the
study will include efficacy of the device against DVT development, patient safety and functionality of the device
to achieve the desired effect including both men and women in the study. This stage will include feasibility, proof
of concept, model development and good laboratory practice studies to cover various aspects of the device
development (Shafer et al, 2015). The device materials are a plastic outer coating, internal wiring composed of
copper and plastic and elastic fibre for the stocking, categorised consistent with the devices use. Toxicological,
physical, chemical and mechanical areas will be examined during the preclinical stage referencing previous
literature on Doppler ultrasound and available data in which, biocompatibility of raw materials, standard testing
and purity data is reviewed (Shafer et al, 2015). Available data will be crucial during this stage to reduce company
resources and time spent on complete assessment of the HPRA’s requirements. There will be no novel materials
implemented in the design therefore there will be no additional impact on timelines (Shafer et al, 2015).
The safety and performance of the device will be incorporated during manufacturing procedures. Manufacturing
will be conducted in accordance with previous data obtained during clinical evaluations for similar devices (Shafer
et al, 2015). Changes or modifications to manufacturing will be recorded in accordance with regulation.
Additionally, indirect components of the device will be analysed during this stage, including storage instructions,
packing, sterilisation, shelf-life, proposed use, intended population, transport etc (Shafer et al, 2015). Packaging
and sterilisation will also be considered during this stage based on the integrity and functionality of the product and
method of sterilisation. The objective is to produce a packaging system enabling ease of access by the user while
protecting the product from sterility breaches (Shafer et al, 2015). Robust materials will be chosen to protect the

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product during shipping and temperature conditions. The integrity of the product will be key to avoid
compromising the product which may result in unintentional functionality and safety effects (Shafer et al, 2015).
4(iv) Clinical studies
Clinical investigations will be conducted in accordance with ISO standard 14155:2011 “Clinical Investigations of
Medical Devices for Human Subjects”. Following on from preclinical results, a detailed protocol will be established
including detailed and reproducible outlines and parameters for the search terms included in literature searches
(Laufer, 2017). Time will be spent designing studies creating document which clearly state intentions to patients
involved in the study and to the notified body. During this time the relevant literature will be reviewed to aid in
study designs and objectively define which peer reviewed journals and databases will be searched (Laufer, 2017).
Relevant articles will be harvested for analysis and compose a safety and performance review. Based on data
obtained from relevant journals pertaining to risk analysis, clinical methods and comparative devices, endpoints,
parameters and criteria are defined to meet and exceed the criteria for safety and performance (Laufer, 2017). A
data management system will be implemented to determine the best practice for data collection during the study.
Statistical input will also be addressed along with the primary and secondary safety and efficacy endpoints coupled
with an explanation of what statistical methods will be employed at appropriate times during the study duration
(Drake, 2015). Biostaticians will also work with the data management system to ensure information obtained from
the device will be evaluated in compliance to GDPR and a consent form will be produced (Drake, 2015).
During clinical evaluation in human subjects the following will be assessed: verification under normal conditions
of use that the device performance conforms to the intended use of DVT detection in the leg region following joint
replacement in the knee and hip and the design, manufacture process and packaging is such that proves suitable for
these conditions (EC, 1993). Additionally, any undesirable side effects associated with the device under normal
conditions of use will be assessed along with whether such side effects constitute risk when weighed against the
proposed performance of the device (EC, 1993).
A risk analysis will be conducted on the device in which the intended use of the device is outlined, potential sources
of harm associated with the device are assessed, and the risk of each hazard is estimated (EC, 1993). It is expected
that the risk associated with this device is minor, indicating that any defaults could result in a small amount of
patient inconvenience with slight or no effect on device performance indicating a non-vital fault in the device (EC,
1993). The likelihood of such risk occurring is very remote, approximately 1 in 100,000 patients. All clinical
investigations will be conducted in a manner that reflects the relevant literature obtained during analysis, all
procedures will be consistent with normal conditions of use of the ultrasound device and appropriate to the device
classification (EC, 1993). Safety and performance effects on patients will be assessed with regard to any serious
adverse events reported to the notified body. Investigations will be conducted under the responsibility of a medical
practitioner. Following this, a technical file will be composed including all relevant data pertaining to the clinical
investigation for submission to the HPRA (EC, 1993).
5. INTELLECTUAL PROPERTY
5(i) Patent
Background to the invention:
The present invention relates to a method of blood flow monitoring in blood vessels through utilisation of ultrasonic
technology, involving methods employable to monitor blood flow following joint replacement surgery in the hip
and knee. It is of substantial importance following joint replacement surgery to monitor the surgery region in order
to ensure a desired level of blood flow is maintained and that no problems with deep vein thrombosis (DVT) will
occur. Should thrombosis manifest, post thrombotic syndrome can develop causing chronic swelling, calf pain,
fatigue, heaviness, along with skin discolouration and venous ulcers. This device employs ultrasound technology
in which an ultrasonic transducer has been fixed to a compression stocking. The present invention meets the need
described at the beginning of this report. The device involves both pulsed energy to the transducer and receive

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returned signals from the transducer and process this data which is fed back to an app accessible by patients and to
the GP for analysis.
5 (i) Claims
1. A method for diagnosis of the occurrence/non-occurrence of deep vein thrombosis blood vessel
blockage composed of non-invasively applying ultrasound to lower leg locations on the
patient's body.
- Providing an ultrasonic transducer operatively linked with with an ultrasonic processor
through connection with electric conductive wiring.
- The assembly of the ultrasonic transducer-conductor wire is fixed to a strip of absorbable or
biologically inert material (Swartz, 1993).
- Wrapping this material into contacting surrounding relationship with the external surface of
the blood vessel and locked into position to create a cuff.
- The cuff is fixed into the surrounding relationship (Swartz, 1993).
- The assembly of the ultrasonic transducer wire is utilised to observe blood flow within blood
vessels.
- The cuff for monitoring is positioned downstream consistent with that of blood flow of an
anastomosis in blood vessels.
- Following completion of the monitoring period, the ultrasound transducer wire is removed
from the patient but the cuff remains acting as a compression stocking to prevent thrombosis
(Swartz, 1993).
5 (ii) General Data Protection Regulation (GDPR)
Data Compliance:
The patient will be supplied with a consent form in order to acknowledge their rights and consent in terms of
processing and use of their information obtained from the ultrasound device. Explicit consent must be obtained
from patients due to sensitive data regarding health. Consent forms will be tailored in terms of patient age,
nationality, ethnicity, health conditions etc (Barchie, 2018). Data generated from this device will connect with an
app connected to the patients smartphone or tablet and database controlled by the patients GP, only the patient and
the GP will have access to information generated regarding the patients health, thereby the GP will be considered
as the controller, unless in certain circumstances the GP contracts out data processing to another service provider,
known as the processor (Barchie, 2018). In either circumstance the processing of this data will be covered under
GDPR regulations. The device shall be configured to the app protect patient information and shall be processed
according to specified consent by the patient. Each practitioner using the device must indicate that the patient
understands and approves processing of data that will occur using the ultrasound device (Barchie, 2018). Patient
data obtained from this device includes time point data of the diameter and blood flow rate of the deep veins of the
leg, name, age, condition, type of joint replacement and prior health conditions. When using this device patients
will have the right to be informed regarding the type of processing their data will undergo, access and review data
obtained and make decisions based on the data subject, wipe their data from the system once the service is complete,
and data portability, in which the GP must make patient data available in electronic format (Barchie, 2018).
6. MARKET STRATEGY
6(i) Market Analysis
DVT is one of the most severe complications arising after a total knee or hip replacement, thus DVTech will utilise
the rapidly growing market of clot management and joint replacement surgeries, across the globe. A market survey
has estimated that the number of people affected by DVT is higher than AIDS, road accidents and cancer put
together. In spite of the medications given to lower clot risk, 2 out of every 10 patients who have undergone knee/hip
replacement tend to develop DVT and, 33% of this population will have a recurrence within 10 years of treatment

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(ahra.gov, 2012). Annually, in Europe, 140 per 100,000 DVT cases have been reported and every year, 544,000
deaths due to DVT have been recorded (Luzia M, 2018; Heit, 2008).
Figure 6: Graph depicts that the highest no. of surgeries has been performed in Switzerland
It is estimated that the worldwide market size, for both knee and hip replacements will reach USD 31.89mn, by the
year 2024, with a compound annual growth rate rate of 7.7% (Globenewswire.com, 2018). More specifically,
Europe’s TKR/THR and DVT market size is the second largest, after North America and is followed by the Asia-
Pacific region, due to the huge ageing population, as depicted in the graph and unhealthy lifestyle, which as
indicated by the Eurostat report, indicates that 1 in 6 adults in Europe are obese and 28% consume tobacco regularly
(Helpage.org, 2015). In recent times, in addition to an ageing population, 15% of the >25 age group have started to
undergo joint replacements. Increased healthcare expenditure, advances in treatments including robotic surgery,
joint replacements lasting for longer and a desire to maintain active lifestyles are also market drivers. Among the
European countries, Germany, Switzerland and the United Kingdom account for the highest number of surgeries
performed (OECD/European Union, 2016).
The growth in disease and technological advancements has resulted in the wearable sensor market expanding to an
incredible USD7.07bn in 2018 (Globenewswire.com, 2019). Within the sector of wearable devices for patient
rehabilitation, those designed and specifically aimed towards individuals who have undergone elective orthopaedic
surgeries are of particular interest and value. Thus, as orthopaedic-based wearable technologies make up a huge
part of this market, due to prevalence of chronic joint diseases in aging populations coupled with the ever-increasing
demand for user-friendly, painless, post-operative monitoring, the annual growth rate for DVTech should correlate
with the overall wearable device market size and generate substantial rates of revenue.

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Figure 7: These maps show the proportion of population aged >60 in 2014 and 2050
[Global AgeWatch Index 2015]
6(ii) Market Segmentation & Targeting
Through analysis of statistical reports, DVTech will be targeted in:
● The European region, due to its increasingly ageing population.
● Primarily, individuals over 45 years of age, since comparatively this group will be performing less activity
(Cushman, 2007)
● Patients that have undergone TKR/THR
● Over 7,077 hospitals in Europe (hospitals.webometrics.info, 2015)
Figure 8: DVTech Target Population – Europe (indexmundi.com, 2018)
6(iii) Value Proposition
Our 2-in-1 wearable non-invasive sensor - DVTech will address the unmet needs among the three age segments of
the population, by providing DVT detection, and clot prevention, by applying ultrasonic waves. On average,
existing techniques to detect DVT includes Doppler Ultrasound charged at 150 Euros, MRI Scans for 250
Euros and Venography for 77 Euros. In contrary to the current detection techniques, DVTech has been proven to
produce 99% error free results, and detection at a very early stage even before symptoms arise.

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Benefits for Patients Benefits for Hospitals/Laboratories
Painless procedure Bed availability
Non-invasive Staff and Nurse availability
At home wearable sensor –
High comfort level & easy to use
Instant transfer of result to the lab/doctor
through smartphone app.
Reduction in Societal costs
→ Cost per DVT hospitalisation
accounts to $8764
→ Scanning fee can be eliminated
Scanners, on an average cost $300,000, which can
be reduced
Wirelessly connected to smartphone Reduction in machine operation costs, and technician costs
Faster recovery from surgery
Thus, owing to the benefits, and high sensitivity of our device, our 2-in-1 DVTech will be priced at €150. Annually,
160,000 hip and knee replacements are performed in United Kingdom across 400 hospitals and 762, 341
procedures are performed in Europe. Calculating from this incidence size, our firm has estimated to project a
revenue of €4.8 million within the first 3 years, assuming 10% market penetration (Alliedmarketresearch.com,
2016; njrcentre.org.uk).
6(iv) Marketing Plan
DVTech will be marketed through a 3-phase approach, that covers the next 3 years.
Phase 1 [0-8 months]: Approach Early Adopters.
● Approach academic teaching hospitals, since they would be well aware of the latest innovations through
journals and publications.
● Participate in trade shows to build network contacts.
● Approach medical device firms to license out DVTech.
● Build relationships with key opinion leaders i.e. physicians, and medical device firms.
Phase 2 [9-16 Months]: End users and Health Insurance Companies.
● Approach insurance companies for coverage, thus enabling access to consumers.
● Reach out to consumers through campaigns, email marketing, and free check-up camps.
Phase 3 [17-36 Months]: Mass Expansion.
● Mass market coverage.
● Expansion into new areas of health conditions that can addressed by DVTech.
6(v) Distribution Channel
Distribution of DVTech across Europe will be conducted through Selective B2B channels.
Figure 9: Distribution channel of DVTech

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6(vi) Branding & Positioning
● Awareness workshops and campaigns on diagnosis, prevention and treatment methods of DVT, pulmonary
embolism, and TKR/THR.
● Education on the functional and unique benefits of DVTech to nurses, doctors and technicians, through hospital
and laboratory tie-ups.
● Active business blog with short videos and pictorial content on DVT, TKR, THR.
● Regular emails, video releases, journal publications, webinars, and white papers about DVTech to get the
attention of key stakeholders.
● Testimonial marketing by gathering feedback from doctors, healthcare representatives and other end users.
7. PRODUCT DIFFERENTIATION
Careful analysis of current ultrasound-based compression devices, as well as wearable health technologies presently
available on the market, has guided the design and development of DVTech. By outlining the major sources of
limitations hindering the widespread success of these products, this knowledge has been applied to the design
process of DVTech the manufacture of a novel, highly-effective device has followed, which will greatly improve
the quality of life of the intended users.
● Clinician-Independent Detection and Treatment of DVT – A significant amount of remote patient
monitoring ultrasound devices currently available do very little to reduce the number of hospital visits which
patients must endure. Many often require the assistance of a clinician to interpret the data generated by the
ultrasound before the next course of action can be taken. This prolongs the length of time in which patients are
afflicted with the condition and may lead to re-hospitalisation in the long-run.
The DVTech ultrasound system has proven to successfully avert this issue, and can effectively analyse blood
flow, detect any blood clots e.g. unusual expansion of blood vein, and activate the commencement of gradual
compression to alleviate the clots.
● Consumer Input for Product Design – Patient-based outcome measures were used to identify a vast number
of factors which often negatively affect product success. Many find current compression devices to be bulky,
non-aesthetically pleasing and uncomfortable for daily use (Chung Sim Lim., 2014). DVTech will incorporate a
wearable mini-sensor within a ‘smart’ breathable, lightweight elastic fibre material, with an in-built graduated
compression rating system. DVTech will also provide users with the opportunity to decide between a selected
range of materials, colours and styles to increase patient satisfaction. Additionally, many elderly patients with
reduced mobility have reported difficulty with putting on and taking off compression devices, such as stockings
(Chung Sim Lim., 2014). As the target users are older populations, DVTech has to be designed with these patients
in mind. As of right now, a wrap-around wearable product has been developed which is far easier to use in
comparison to competitor products.
7 (i) Market Forecast
Within the sector of wearable devices for patient rehabilitation, those designed and specifically aimed towards
individuals who have undergone elective orthopaedic surgeries are of particular interest and value. According to
Reports and Data released in early 2019, the global market for wearable medical devices is expected to shift from
$6,414.43 Million in 2018 to over $16,228.95 Million by 2023, with a compound annual growth rate (CAGR) of
18.51%. Furthermore, products like DVTech, which ensure remote patient monitoring is anticipated to exhibit the
fastest growth rate over sports/fitness and home healthcare product applications during this forecast period. Thus,
as orthopaedic-based wearable technologies make up a huge part of this market, due to increased prevalence of
chronic joint diseases in aging populations coupled with the ever-increasing demand for user-friendly, remote,
patient, post-operative monitoring - the annual growth rate for our product should correlate nicely with the overall
wearable device market growth.
Market forecast predictions based on geography, healthcare infrastructure and rapid uptake of medical technologies,
alongside the high incidence rates of total/partial knee replacement procedures in this region, it is expected that in
the future North America will be the highest market group for this novel device, holding an estimated 40% of
potential product consumers (Hilal Maradit Kremers et al., 2015). This will be closely followed by Europe and
Asia-Pacific, with the Asia-Pacific market predicted to rapidly expand over the next couple of years. DVTech’s
market is driven by the growing incidence of age-related disorders, particularly osteoarthritis, which greatly
increases the risk of deep vein thrombosis (DVT). In the US alone, about 30 million adults suffer with osteoarthritis,

15. 15
with the majority of these patients over the age of 60 (Tuhina Neogi., 2013). As a result of advanced surgical
procedures and implant designs, more and more patients are opting to undergo elective knee replacement surgeries
to alleviate osteoarthritis symptoms. Regardless of this, the incidence rates of DVT within this cohort remains high.
A 2010 survey concluded that 4.7 million people (3.0 million women & 1.7 million men) live with total knee
replacement (TKR) in the US, with similar figures seen in the UK also. Taking these data into account, we can
estimate an addition of about 1 million TKR patients to this list per annum, by the year 2035. To establish DVTech
within this target population, DVTech will be marketed to patients worldwide who have been diagnosed with DVT,
osteoarthritis and those who have recently undergone TKR surgery, as a method of detecting and treating the
potential onset of DVT. With a projected competitive value of about €200-300 per product, as well as our large
target audience, high revenue generation is to be expected.
7(ii) Brexit and DVTech
As the UK is Ireland’s primary trading partner in many aspects, including health technologies, the occurrence of
Brexit, regardless of its outcome, will greatly impact DVTech. In particular, introduction of DVTech into the UK
could be complicated as EU regulatory systems will no longer apply and new custom barriers may present between
the EU and the UK (Lexology.com). Notably, the UK government have recently advocated for the possibility of a
post-Brexit trade agreement, which would cover most goods and services, in exchange for payments to the European
Union. This is particularly beneficial for products like DVTech in the health technologies industry, as both parties
involved understand the importance of facilitating easy access to medical device products for UK/EU patients
without major limitations (Lexology.com). Essentially, the goal is to maintain the current standard of movement
for medical products coming in and out of the UK and the EU.
Irrespective of all of this, it crucial to stay alert and ready for all possible outcomes, to ensure widespread success
of our product. To counteract all plausible negative consequences of Brexit, DVTech will be designed with a
number of key factors in mind. In particular:
● Supply Chain: In order to mitigate the most unfavourable effect of Brexit, and essentially ensure the success of
our product, an in-depth understanding of our supply chains will be central. From the import of raw materials
for manufacturing the product, to the export of the end-product out of Ireland, and into the hands of the intended
target patients globally. Can we avoid transit of the raw materials through the UK? Do we require the supply of
materials from any UK manufacturers or facilities? What are the potential post-Brexit customs procedures we
need to be aware of? (Prepareforbrexit.com)
● EU Product Certification: All novel medical device products must be certified by one of over 50 notified
bodies in the EU, with approximately 40% of all medical device products currently being certified in the UK.
According to the European Commission, these UK-based product certifications will no longer be valid post-No
Deal Brexit. Thus, in order to avoid this issue, we have explored all options available, and have identified
suitable alternative certifying bodies within the EU. Alternatively, in the event that UK bodies reach an
agreement and establish their presence within the EU, DVTech will be presented with a straightforward path for
export into the EU market. (Prepareforbrexit.com)
7(iii) Future Expansion
DVTech is designed and will be marketed towards those at risk of developing knee/leg-related deep vein
thrombosis, as this is a common clinical manifestation of the condition. However, the incidence rates for deep vein
thrombosis in patients who have undergone a variety of other surgeries, including total hip replacement (THR),
pelvic surgery and a major abdominal procedure are almost on par with knee replacement incidence rates. For
example, of the 30 million Americans, and 8.5 million adults in the UK with osteoarthritis, osteoarthritis of the hip
is as commonly observed as knee arthritis in these populations, thus the possibility of developing DVT is increased
in these patients also (Tuhina Neogi., 2013). As similarly projected for total knee replacements, THR procedures
per annum, are expected to reach a count of 439,097 by 2035. Accordingly, future product designs may take the
form of a hip compression wrap or a target-specific abdominal compression wrap. This expansion will be feasible,
as the underlying technology for DVTech can be easily manipulated to suit alternative placements of the product.
Additionally, these future designs will also have the potential for personalisation, allowing patients to decide
product colour, style, and size while also maintaining high standards of compression, comfortability and compliance
with regulatory guidelines.

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