Internship Summary

By: Diego Solio Fernndez.

Period: from June till September 2016.
Contact:
-Email: diego.sf.vigo@gmail.com
-Linkedin: https://es.linkedin.com/in/diegosolinho

This work is licensed under the Creative Commons CC BY-SA License. To view a copy of the license, visit https://creativecommons.org/licenses/bysa/4.0/legalcode ; or click the image below:

- Literature review about Parkinsons disease and telemedicine based on sensors.

A- Selected articles.
1. About PERFORM project.
2. Other articles.
3. Other topics about PD and telemedicine.
B- Appendix.
C-References.
- Legislation and certification process for wearables.

A- EU law relevant to Totem's sensors:

-DIRECTIVE 93/42/EEC and DIRECTIVE 2007/47/EC.
B-Additional information about:
-Selling the device in other EU countries.
-Circumvent EU law based on the product's purpose set by the manufacturer.
-Pros and cons CE vs FDA approval.
-Importance of second valley of death to scale.
-Insights from interviews with DevKit users.

A. Interviews.
1. Respondents.
2. Introduction.
3. Summary of users' main problems.
1. Lack of information from Totem Open Health.
2. Technical problems with the sensor.
3. Support from TOH.
4. Solutions they would like to have.
5. Conclusion.
B. Short term improvements.

1. Website.
2. Support.
3. Mailing list.
C. Value proposition for researchers and health funds.
- Business model proposal.
1. Introduction.
2. Free users.
3. Premium users.
4. Potential premium services and products.
5. General strategy.

- Literature review about Parkinsons disease and telemedicine based on sensors.

Methods:

Database

Equation

Results

Pubmed

("Telemedici 93

Last 5 years Not related

No access

Selected

40

23

ne"[Mesh])
AND
"Movement
Disorders"[
Mesh]

A- Selected articles:
1. About PERFORM project (intro video)
1.1. Article (Tzallas et al. 2014)
Problem:
Parkinson disease (PD) symptoms caused by lack of dopamine so the treatment basically increases
that substance by different means. The problem is that in the long run is very hard to adjust the
correct dose of treatment and the patient experiences additional symptoms if it is too much or too
less. For instance:
-Low dose: tremor, bradykinesia and freezing of gait.
-Over-dose: dyskinesia.
On top of that, for the clinician neurologist is very hard to figure out the right dose of treatment in
Parkinson patients because it varies from one case to another.
Solution: Accelerometers and gyroscopes can evaluate and quantify PD motor symptoms
(determine if it is a low dose or over-dose symptom) so the specialist can adjust the dose better.
They can also monitor activities determine body postures. In the case of PERFORM they showed
4

around 80% accuracy distinguishing tremor, bradykinesia, freezing of gait and dyskinesia.
Other use cases: neurodegenerative diseases such as Huntington disease, Tourette syndrom and
idiopathic dystonia.
Other existing projects: see Annex 1 and 2.
1.2. Article (Cancela et al. 2014) (Cancela et al. 2013)
Goal: Assess wearability of PERFORM wearable sensors (see measures of comfort in annex 3).
Results: Overall, good acceptance and good performance of the sensors.
NOTES:
-Patients concerned about privacy and having the device in public spaces (wrist sensors could
imitate bracelets and should be waterproof).
-Straps lead to unpleasant feelings.
-The use of these systems can be highly intrusive and uncomfortable for the patients and this could
lead the application to fail, even when it has been proven that it benefits patients health. Therefore,
compliance must be taken into account during the development of any wearable system in order to
identify potential weak points in the adoption of the systems by the final users.
2. Other articles:
2.1. Article (Piro et al. 2014)
Usability: involve Parkinson patients and neurologists during the design process of the sensors.
Interoperability of the system: use recommendations of Continua Health Alliance.
In PD the monitoring of data does not need to be in real time.
2.2. Article (Yang et al. 2011)
One tri-axial accelerometer on the waist can measure several gait cycle parameters, including
cadence, step regularity, stride regularity and step symmetry (in real-time and by using an
autocorrelation procedure).

Other uses of accelerometers: movement classification, fall detection, estimation of energy

expenditure and gait analysis.
2.3. Article (Achey et al. 2014)
The implementation of telemedidine is shooting up and, next to stroke, movement disorders is one
of the most common applications.
In the Netherlands, ParkinsonNet infrastructure (health professionals who use ehealth solutions).
Reimbursement is the main limitation of telemedicine now but in the future it will be privacy.
2.4. Articles (Rasooly & Herold 2015)
2.4.1.Article in pages 335358
Wireless accelerometers for real-time biofeedback for gait rehabilitation. Uses:
Neuroreabilitation: A single wireless triaxial accelerometer could differentiate between
healthy gait and hemiplegic gait. Also for balance training, to evaluate postural control as a measure
of fatigue status.
Musculoskeletal conditions: Gait symmetry and step duration cycle for subjects with
osteoarthritis and amputees.
PD: classification of on and off states, gait and tremor.
All these use cases were with accelerometers, they say gyroscopes may offer new benefits but do
not expand on that.
2.4.2.Article in pages 359374
Tremor assessment for PD using smartphone sensors.
Alternative solutions:
-In laboratory with accelerometers or laser displacement sensors: reliable but require specialized

equipment and trainer personnel.

-Clinical scales: no specialized equipment but require trained personnel and are not adequate to
track variations over time.
Both solutions require patient to go to the healthcare facility.
2.4.3. Article (Wagner & Ganz 2012)
Gait analysis uses: in the treatment of neurological and musculoskeletal conditions and to monitor
rehabilitation progress after leg injuries.
PD can be detect by using gait analysis alone (source 3 of this article)
accelerometer-based systems are not the standard method of measuring gait, and are not as
accurate in recording gait metrics as footswitch based systems (source 4 of this article)
3. Other topics about PD and telemedicine:
-Online cognitive behavioral therapy to for depression associated to PD.
-Use of the Internet and videos to diagnose PD.
-Many telephone follow-up programs in movement disorders.
-Social networks to report PD symptoms.
-Telemedicine as a mean to get more participants for randomized control trials.
4. Summary:
4.1. Context
Much more than sensors: In the case or Parkinson disease (PD), sensors play a key role but are
part of a bigger and much more complex process, which includes additional devices or hardware,
mobile applications or software and machine learning.
Telemedicine: major trend and with a huge potential for PD.
Lack of standardization: PERFORM seems to be the most prominent project in the EU but there
7

are many others and they use different processes and devices. Most of them use accelerometers but
few gyroscopes.
Lack of robust evidence: no meta-analysis about state of the art and best practice models nor costeffectiveness analysis or health technology evaluation yet.

4.2. Applications and uses of accelerometers (and gyroscopes):

For PD in particular: detect different movements to adjust medication, for cueing during on-off
periods and as a complement of telemedicine.
Gait cycle parameters: cadence, step regularity, stride regularity and step symmetry in real-time.
To differentiate between normal and abnormal gaits and monitor progress in rehabilitation (useful
for neuroreabilitation and musculoskeletal conditions).
Other: movement classification, fall detection, estimation of energy expenditure, balance training,
evaluate postural control (and then measure fatigue status),.
4.3. Conclusion and recommendations:
Focus on usability: involve Parkinson patients and neurologists during the design process of the
sensors.
Focus on interoperability: design the totem sensor in a way that different stakeholders can use it.
Given the current messy state of the art, the complexity of the whole process and the multiple
stakeholders involved; researchers, organizations and startups could be very good early adopters.
-Researchers: not just for future research but those who have already done projects. For
instance, in PERFORM they use sensors (accelerometers and sensors) from ANCO S.A. (Athens,
Greece) and Totem sensor could compete in that field. On top of that, working closely with
researcher would help to improve the product and validate it according to real needs.

-Organizations: specially of neurologists and PD patients because they are very aware of the
uses and can influence a bigger change from bottom-up.
-Startups: health and tech enthusiast which can expand and apply uses in different ways.

B-Appendix:
ANNEX 1: Projects PD motor symptoms

ANNEX 2: Systems for PD motor symptoms

ANNEX 3: Measures of comfort

EmotionConcerns about appearance and relaxation.
AttachmentComfort related to non-harmful physical sensation of the device on the body
(e.g. the feel of the device either directly as pressing on the body or indirectly as it pulls on
clothing or moves in relation to the body).
HarmPhysical sensation conveying pain.
Perceived changeNon-harmful indirect physical sensation making the wearer feel different
overall with perceptions such as being awkward or uncoordinated, may result in making
conscious compensations to movement or actions.
MovementConscious awareness of modification to posture or movement due to direct
impedance or inhibition by the device.
AnxietyWorries as to the safety of wearing the device and concerns as to whether the
wearer is using it correctly or it is working appropriately.
C-References
Achey, M. et al., 2014. The Past, Present, and Future of Telemedicine for Parkinsons Disease. , 29(7), pp.871883.
Cancela, J. et al., 2013. A telehealth system for remote monitoring. The PERFORM approach. , pp.74927495.
Cancela, J. et al., 2014. Wearability Assessment of a Wearable System for Parkinsons Disease Remote Monitoring
Based on a Body Area Network of Sensors. , pp.1723517255.
Piro, N.E. et al., 2014. Telemonitoring of patients with Par - kin sons disease using inertia sensors. , pp.503511.
Rasooly, A. & Herold, K.E., 2015. Mobile Health Technologies. In pp. 335358, 359374.
Tzallas, A.T. et al., 2014. PERFORM: A System for Monitoring, Assessment and Management of Patients with
Parkinsons Disease. , (October), pp.2132921357.
Wagner, R. & Ganz, A., 2012. PAGAS: Portable and Accurate Gait Analysis System. , pp.280283.
Yang, C. et al., 2011. Real-Time Gait Cycle Parameter Recognition Using a Wearable Accelerometry System. ,
pp.73147326.

10

- Legislation and certification process for wearables.

A- EU law relevant to Totem's sensors:

Comment: They legislation in this area consists of directives. This means that the EU sets the
general rules at the EU level but the countries transpose those rules to national law so there might
be slight differences from country to country (but it can not go against the directive because in such
case the directive always prevails). With regards to medical devices it is tricky because the EU rules
in terms of internal market but it as a mere advisory role regarding provision of healthcare.
1. COUNCIL DIRECTIVE 93/42/EEC (1993) concerning medical devices:
Article 1
(b) 'accessory' means an article which whilst not being a device is intended specifically by its
manufacturer to be used together with a device to enable it to be used in accordance with the use of
the device intended by the manufacturer of the device;
Comment: An example could be the Totem Open sensor as part of Cue2walk or other medical
device.
(e) 'device intended for clinical investigation' means any device intended for use by a duly
qualified medical practitioner when conducting investigations as referred to in Section 2.1 of Annex
X in an adequate human clinical environment. For the purpose of conducting clinical investigation,
any other person who, by virtue of his professional qualifications, is authorized to carry out such
investigation shall be accepted as equivalent to a duly qualified medical practitioner;
Comment: Example, relationship between Totem and researchers.
(f) 'manufacturer' means the natural or legal person with responsibility for the design,
manufacture, packaging and labelling of a device before it is placed on the market under his own
name, regardless of whether these operations are carried out by that person himself or on his behalf
by a third party. The obligations of this Directive to be met by manufacturers also apply to the
natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or
11

more ready-made products and/or assigns to them their intended purpose as a device with a view to
their being placed on the market under his own name.
This subparagraph does not apply to the person who, while not a manufacturer within the meaning
of the first subparagraph, assembles or adapts devices already on the market to their intended
purpose for an individual patient;
Comment: The ones who make the sensors for Totem, Totem Ope Health and those who use the
sensor for a specific use case are all considered as manufacturers.
(g) 'intended purpose' means the use for which the device is intended according to the data
supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials;
Comment: the requirements in terms of if it is a medical device or not vary not just due to the
product as such but depending on the use or purpose that the manufacturer assigns to the product.
Article 4
Member States shall not create any obstacle to the placing on the market or the putting into
service within their territory of devices bearing the CE marking provided for in Article 17 which
indicate that they have been the subject of an assessment of their conformity in accordance with the
provisions of Article 11 .
Comment: This is true for general devices but trickier for medical devices. Overall, it seems like
member states have to accept the CE of medical devices too but they might want to do a double
check. In theory member states could be able to restrict free movement of goods to their country if
the measure is justified and proportional (if you want I can expand a on that on a future update).
Annex IX, section 3.2.
Active devices intended for diagnosis are in Class Ila:
if they are intended to allow direct diagnosis or monitoring of vital physiological processes,
unless they are specifically intended for monitoring of vital physiological parameters, where the
nature of variations is such that it could result in immediate danger to the patient, for instance
variations in cardiac performance, respiration, activity of central nervous system in which case they
12

are in Class IIb.

Comment: The Totem sensor with ECG could fall in one or another depending on the use. For
example, if its purpose is to measure just the heart rate it could be II a but if it detects trends that
show a potential heart attach it will be II b . If its main purpose its not health but sports or
something similar it might be possible to circumvent the CE marking or go for class I.
Annex I
Section 10. Devices with a measuring function:
10.1 . Devices with a measuring function must be designed and manufactured in such a way as to
provide sufficient accuracy and stability within appropriate limits of accuracy and taking account of
the intended purpose of the device. The limits of accuracy must be indicated by the manufacturer.
10.2. The measurement, monitoring and display scale must be designed in line with ergonomic
principles, taking account of the intended purpose of the device.
10.3. The measurements made by devices with a measuring function must be expressed in legal
units conforming to the provisions of Council Directive 80/181/EEC ( 1 ).
Section 12. Requirements for medical devices connected to or equipped with an energy source:
Requirements such as 12.2., Devices where the safety of the patients depends on an internal power
supply must be equipped with a means of determining the state of the power supply.
Comment: Basically the requirements Totem sensor should fulfill.
2. DIRECTIVE 2007/47/EC :
Comment: It is an update of the previous directive.
- Medical device means any instrument, apparatus, appliance, software, material or
other article, whether used alone or in combination, together with any accessories, including the
software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic
13

purposes and necessary for its proper application, intended by the manufacturer to be used
for human beings for the purpose of:
diagnosis, prevention, monitoring, treatment or alleviation of disease,
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
investigation, replacement or modification of the anatomy or of a physiological process,
control of conception, and which does not achieve its principal intended action in or on
the human body by pharmacological, immunological or metabolic means, but which may be
assisted in its function by such means.
Comment: The key here is the main purpose of the device set by the manufacturer so there is
flexibility regarding to that.
-Stand alone software is considered to be an active medical device.
Comment: Just keep that in mind.
-Member States shall not create any obstacles to:
devices intended for clinical investigations being made available to duly qualified medical
practitioners or authorised persons for that purpose if they satisfy the conditions laid down
in Article 10 and in Annex 6.
Comment: Basically, if some conditions are fulfilled it is possible to investigate with the device
without the CE mark (it can not be put on the market though).
3. More information and resources on EU law concerning medical devices:
Certification process
Main portal
14

Regulatory framework
Legal documents
B-Additional information.
Source UK Government certification agency
The CE marking means that the product can be freely marketed anywhere in the EU (27
member states of the EU and EFTA countries, Iceland, Norway and Liechtenstein). You are not
required to comply with any national schemes when exporting these devices to other countries.
However, CE marked medical devices are subject to inspection by the market surveillance
authorities of the relevant member states.
Comment: It seems like CE marking allows medical devices to be sold all around the EU but
member states can double check them.
CE VS FDA approval (Souces: 1 , 2 and 3. Futher information: 1 and 2.)
CE MARK

Main function is to assess the safety of new devices. European CE Mark only requires
proof of safety and that the device performs in a manner consistent with the manufacturers
intended use.

Certification results are more predictable, less bureaucratic and efficient.

Obtained through a clinical evaluation (requirement is that the manufacturer conduct a

postmarket clinical follow-up study once the CE Mark is obtained. However, this type of
study is much easier to get approval for and therefore much less expensive to conduct than
a clinical trial) of published data for existing equivalent devices.

Requires a postmarket clinical follow-up study once the CE Mark is obtained.

Valid in all EU countries (EU: 30 percent worldwide market share) and recognized almost
globally.

15

Puts more onus on and endues a greater amount of trust to the manufacturer and to the
physician compared with the FDA approval system.

Allows new technology to more quickly become available to patients compared with the
FDA approval system (1-3 years quicker to launch a new medical device into general
clinical practice compared to the US).

Leaves safety and efficacy of the surgical procedure that is performed by the device to the
responsibility of the physicians and surgeons who use the device.

No guarantee that the device will be widely accepted by physicians or reimbursable by the
government in each European country (specially Class III devices). Additional clinical
studies might be required in each country to show the efficacy of the device from a
marketing perspective. However, once a device is CE Marked, subsequent approvals are
much quicker.

Class I and II devices have a global advantage in obtaining CE mark certification first.
Although US uses non-government reviewers for the preliminary assessment of Class I
and Class II devices, the government retains final authority over device approval while in
the EU for class I and II, EU governments do represent a limitation.

FDA APPROVAL

Main function is to assess the safety and efficacy of new devices. Efficacy is indirectly but
ultimately linked to healthcare reimbursements (CE does not relate to reimbursements).

Requires a full clinical trial or trials. Regulatory process is currently unpredictable and the
approval timeline is longer due to required clinical data showing efficacy.

Medical device companies can expect more consistent reimbursement, better intellectual
property protection, and less competition.

Narrow approved range of parameters.

Valid only in the United States (50 percent of the worldwide market share).

More expensive to obtain compared with CE Mark, as the documentation required from
investigators is much less efficient, the review cycle is about three times longer, and there

16

are almost always more rounds of questions.

Indicates that strict criteria have been met, signifying that clinical application of a drug or
device will be safe and effective.

Class III devices have a global advantage in obtaining FDA mark certification first. Even
though lass III devices require Premarket Approval (PMA) from the FDA with the CE,
given all EU countries have their own healthcare administration, a company marketing a
Class III device needs to gain approval from every European countrys regulatory body
independently (need to claim reimbursement for every single country) while FDA approval
is applicable in all 50 states. To summarize, once a device has received FDA clearance,
companies can start marketing their product in the entire U.S. On top of that,
reimbursement in the U.S., such as Medicare, is also more consistent than in the EU since
there is only a single government.

Source 2: Comments on current state of EU legislation and ways to go

Implantables and apps that claim to diagnose, treat, prevent or monitor disease and injury are are
considered medical devices. However, sports and other wellness kits only need regulation if they
were specifically designed to measure heart rate and other biometrics as opposed to other sport
metrics such as laps, repetitions...

There's something of a wearables gap in legislation - one that no one is looking to fill. Harry
Quilter-Pinner, analyst at UK thinktank IPPR.

One important reason that there's no regulations at the moment is that it's very hard to test how
effective and what the risks of these actually products are.

If would be key to get healthcare professionals to trust, understand and ultimately prescribe certain
gold-standard wearables.

"What happens if the device is linked to your doctor but the doctor isn't watching or you make a

17

decision based on what the app says? If it's tied into the NHS, it's provided by the NHS and linked
to the NHS, then it's almost as if the decision it comes to is sanctioned by the NHS. So, who is
responsible if something goes wrong?"

Source 3: The second valley of death

Many novel entrepreneurs in medical technology consider CE marking and/or FDA approval as
their primary endpoint (Phase D), unaware of the time and costs needed to establish proper
(clinical) evidence to convince clinicians (Phase E) and health insurers (Phase F), even though these
phases must be completed in order to successfully market the device (Phase G). The gap between
clinical evidence needed for regulatory approval on the one hand and reimbursement on the other
can be surprisingly wide. As a result, the planned time-to-market and development costs of the
device are often excessively exceeded. We are convinced that understanding and estimating the
level of clinical evidence needed for clinical acceptation and reimbursement at an early
development stage is crucial for strategic planning and can prevent the occurrence of the second
valley of death.
Comment: Second valley of death seems like a long shot but there is definitely a gap between the
fact that the device is approved and its scalability, specially since health technology evaluation
18

plays a key role regarding governments reimbursement. For example, the device migth have the CE
marking, it could even have studies that prove that it is more effective than other solutions but if it
is not cost-effective enough the government will no reimburse it the and scalability of the product
will be very limited (unless if focuses on private insurers or users).

-Insights from interviews with DevKit users.

A. Interviews
1. Respondents:
Interviews done:

7
6

-Erwin van Wegen from VU University Medical

Center.

-Hamza Jrad from HumediQ.

3
2

-Levi van Dam from Spirit.

-Simon Hoogveld van der Meer from Cue2Walk.

-Tom Frissen from Qwiek.

Interviews
done
Pending due
to vacations
No reply

Respondents

-Yannick Brouwer from Totem POP.

Interviews pending due to vacations:
-Norbert Schmidt from DDQ.
-Yuan Lu from Eindhoven University of Technology.

2. Introduction:
Overall, all the users were at a very early stage. Some did not even start developing the sensor
because did not know what to do with it, others tried it and quited because it was too complicated
and time consuming, others tried a lot but could not make it work and a few could measure useful
parameters with it.
19

The teams had a multidisciplinary background. In general they consisted on health experts,
designers, software developers, industrial designers and motion scientists. However, many of the
teams did not have all these skillsets so they lacked key knowledge to develop the sensor. These are
the specific backgrounds encountered: industrial engineering, industrial design (many!),
engineering informatics, psychology, data science, biomedicine, movement science, physiotherapy
and software developers.
3. Summary of users' main problems:
3.1. Lack of information from Totem Open Health (TOH):
This is something all agreed on. Lack of information regarding the mission of TOH, what it is, how
is works and what can be done with it.
E.g.
Do not know what the sensor can do.
Do not really know how to develop the sensor.
Did not know that Totem had a Forum, mailing list.
Did not know how much can they change of the sensor (design and features).
Website too technical, few use cases.
DevKit documentation not clear.
Totem website not clear about what they can do.
3.2. Technical problems with the sensor:
Some users where aware of the early stage of the sensor are were fine with it, others found it too
inconvenient and stopped using it or changed it for another sensor.
E.g.
Totem sensor not stable and hard to develop.
The firmware is not working and he can't write it himself.
Difficulties login to the SD card and if it works its very inconvenient to use.
The content of the DevKit is not enough to develop sensor, need additional software (jlinkedu
programmer)
20

They can not see what the sensor is measuring in a convenient way or even if the sensor is really
working.
He quit because he could not fix the sensor.
He wants to work with Totem app but has troubles with adjusting the parameters and the app does
not seem to work in tablets. He could install the app but can not make it work nor change the
predefined values of 10 second data storage.

3.3. Support from TOH:

Some were satisfied with the support from TOH, others were not satisfied at all and others did not
even know that TOH has support channels such as the forum or the mailing list.
E.g.
Bad support from Totem: not easy to find information in forum.
Did not know forum even existed.
Support from mailing list not useful, forum too slow.
Made a Skype call with somebody from TOH, it was extremely useful.
Emailed TOH with doubts, the reply was quick and my problems solved.

4. Solutions they would like to have:

-All would like to have a basic product that already measures things, that works form the beginning
and gives actionable data; and then once they see what it can measure, develop it further.
-One common theme was that they wanted to have something to see directly what data they were
obtaining. They would also appreciate to have filters regarding this data to know roughly how noisy
it is, its overall quality or how is varies. E.g. an app or an online dashboard.
-Some would like to have support regarding data analysis and others did not because they wanted to
have access to raw data, own it and develop it further.
-Just a few wanted support regarding design, many were industrial designers and would like to do
21

that on their own. However, they all wanted to know how much could they personalize the design
and TOH adapt to it.
-One mentioned that it would be very valuable to have a online platform where medical experts
meet technical experts so they can work together, share ideas about use cases together and
eventually create a team that develops to sensor for a new use case.
-One mentioned that he would like to know how much battery the sensor has left.
5. Conclusion: value proposition validated
Open data is very valuable for them because it allows them to develop their own solutions. That is
essential for them. One interviewee said that they stopped using well functioning wearables (Fitbit,
Garmin and Withings) because they did not have access to raw data, and used TOH's sensor.
However, TOH's sensor is not stable and as a consequence many stopped using it. Overall, they are
very keen on the open data and would like to continue using TOH in the future when it is more
stable, specially the ECG sensor.

B. Short term improvements:

Engage customers! Do not let them go!
1. TOH's website:
1.1. Explain REAL use cases. Many of the interviewees would be happy to share what they
are working on with the sensor and that can be added as examples in the website. Something like:
ongoing projects, A, B ,C...
1.2. Add basic information about what the sensor can measure, things like: stride length,
tremor, gait speed, cadence, rotation, balance....(I can send websites that can be used as benchmark).
1.3. Add the main steps to develop the sensor and put a link to the forum. Simple steps and
tools they can use.
22

1.4. Add a short Q&A to the website: it does not need to and should not be as comprehensive
and as technical as the forum, just solve general doubts like, how much can the design and features
or the sensor be personalized? What does one need to develop the sensor on top of the DevKit?
What backgrounds are needed to develop it? ()
1.5. OPEN DATA or OWN YOUR DATA should be one of the first things one sees in the
website. All the interviewees agree that why they like from Totem is that the other wearables do not
give them the raw data, Totem should explain that 1,2 or 20 times, it's a key value proposition.
1.6. What does the DevKit contain? How many do I need to develop something? How much
does it cost (if it's free why not tell it?)? ()
1.7. Explain the premium services and products TOH has, and what they can expect from
TOH regarding support.

2. Support:
2.1. Explain the channels they can use: for technical issues email us here, mailing list and
forum (maybe they can also Skype with someone from Totem).
2.2. Explain what information they can find and where they can find it. How should they use
the channels? Use cases here, technical issues there, questions about Devkit here...
2.3. Explain what can they do if they want a premium service or product. The differences
between them.
3. Mailing list newsletter:
The mailing list could be converted to a weekly newsletter with updates regarding TOH status and
improvements in order to keep customers and users engaged. E.g. Now TOH has a new app to see
what you are tracking, Now TOH has a forum for technical issues, now X team is working on Y use
case with the sensor...
23

C. Value proposition for researchers and health funds.

The interview with Erwin van Wegen from VU University Medical Center gave a piece of
information that can be very valuable.
Basically, in order to get funds for a research project one needs to propose one or several research
questions and then a health fund or a similar organization decides whether to fund it or not based on
how relevant they consider a certain topic. The process similar to the following:
Basic research---->find research question---->Apply for funds. Therefore, they need to generate
initial data in order to find a good research question and do a decent proposal. Nonetheless,
researchers do not have the money yet so their resources are very limited. This is particularly
noteworthy in student projects because they do NOT have funding available at all and for them is
essential to generate pilot data to apply for funding later on. As a consequence, this niche really
needs a low cost solution which allows them to have access to raw data, they need TOH.
With this niche market in mind, TOH would be at a very good position if it was a middle man
between researchers and health funds. For instance, if the health funds subsidize TOH sensors,
many young researchers will be able to create high quality proposals and innovate more, so the fund
will have a greater impact. On top of that, given the openness of the sensor it will be easier to
spread the discoveries they make along the way.
In spite of the facts mentioned above, it is noteworthy that researchers, specially senior researchers,
need to deliver results quick so as to maintain their funding. For example, Erwin mentioned that
they really wanted to use TOH sensor but they could not make it work as they wanted to and they
eventually changed to a different sensor.

- Business model proposal.

1. Introduction:
WHY focus on creating a big community:

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Totem Open Health's (TOH) impact and sustainability directly related to its community, so the
bigger it is the better.
HOW to increase TOH's community and be economically sustainable:
Increase supply of open sensors in order to increase demand of complementary products / services
around it.
WHAT business model fits this strategy: Freemium.

*Image from: http://www.freemium.org/wp-content/ebook-101.pdf

2. Free users:
Strategy: provide them with just enough tools to develop the sensor, no more no less and at a very
lost cost for TOH (ideally cost extra free user =0).
E.g.: they can get X amount of free sensors to start off (but they pay shipping costs) or sensors at a
very low price.
They have free information from website, forum and mailing list.
What TOH gets:
Free users can become premium users.
Free users can improve free platforms such as the forum and exemplify use cases, they are an added
value.
Free users can talk about TOP to others (word of mouth marketing) or be part of a viral marketing
campaign (get free extra sensors, 6 month free premium subscription... if you share a video of you
developing the sensor, write about your use case...)
3. Premium users:
Strategy: Up-selling and cross-selling
Persuade customers to purchase more expensive items, add-ons or upgrades .
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E.g. They can get the sensor for free / low cost BUT they are charged for additional services or
products that are very profitable for TOH.
Considerations
Even if just 5-10% of all users are premium users, TOH must get enough money from premium
users to sustain free users and be profitable.
TOH's focus is on the premium users' needs, they are the real customers.
4. Potential premium services and products:
4.1. Services:
-Complement the skills they lack
-Design.
-Data analysis.
-Firmware.
-Premium technical support:
-Support from TOH via
Skype or hotline.
-Additional material such as webinars.
-Consulting:
-Dual-licensing.
-Certification process.
-Open technologies

4.2. Products:
-Additional sensors:
First sensors free then low cost for massive production once they completed development.
-Additional features:
Change certain features of the sensor according to the specific needs of the customer.
-Third party products:

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Purchase external products that might be needed for developing the sensor via TOH so TOH gets a
% of those sales.
E.g. Jlink programmer.
5. General strategy:
5.1. Initial phase: focus on growing the community.
-Sensors at a very low cost so users can start development.
-Charge premium users for premium services an products to validate which they need the
most.
-Revenue mostly from premium technical support, complementing stills they do not have
in their teams.
5.2. Mature phase: focus on manufacturing more sensors.
-Some premium customers will succeed with their use cases and will need mass
production because they want to launch or sell their product.
-Engage those key customers with complementary services and products.
-Revenue mostly from selling more sensors, consulting and dual licensing.

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