SMARTASTHMA

MADE IN

EUROPE
BRITISH
TECHNOLOGY

How Smart Asthma

can help fight against

Covid-19
Future role for Smart Asthma as a
Telemedicine platform
Company Overview SMARTASTHMA

• Smart Respiratory Products was founded in

2014 by Dr Thomas Antalffy with HQ at Imperial
College London and factory in Budapest
• Smart Peak Flow was launched in 2018, the
world’s first peak flow meter to use
smartphone technology. Smart Asthma was
launched in 2020
• Mission to help asthmatics manage their
condition by predicting their lung function
through AI
• CE certified, FDA approval mid 2020,
Class IIa Medical Device, ISO 13485

MADE IN

EUROPE
BRITISH
TECHNOLOGY
Asthma and Covid-19 SMARTASTHMA

Covid-19 Risk to Asthmatics

Managing Asthma during
During the rapid spread of coronavirus, much attention has Lockdowns and Self-Isolation
been paid to vulnerable groups with existing respiratory
diseases, including asthma. The U.S. Center for Disease At present, self-isolation is the widely suggested solution for
Control and Prevention has listed asthma as one of the reducing the spread of Covid-19. Many people who contract
Covid-19, including those with asthma, will not be able to be
chronic illnesses that may increase the chance of a severe admitted to a hospital unless their condition deteriorates
case of Covid-19. Leading immunologists explain that people significantly. Getting your asthma under control through
with asthma are not generally at a higher risk of becoming the use of medications and using peak flow meters is vital
infected but they have an increased risk of a more serious to give you the best chance of fighting off Covid-19 if you
case if they become infected with Covid-19. contract it and asthmatics should be proactive in managing
their condition. This can be successfully done by monitoring
peak expiratory flow on a daily basis. Asthma UK advises,
‘Start a peak flow diary if you have a peak flow meter as
Recovering from Covid-19 it can be a good way of tracking your asthma. If you don’t
have a peak flow meter, think about getting one from your
There is no recognised method of monitoring a patient’s doctor or pharmacist to help to tell the difference between
lung condition whilst recovering from Covid-19 after being your asthma symptoms and coronavirus.‘ National Health
discharged from hospital. Many international hospital groups services worldwide are under increased pressure to cope
with coronavirus and patients with respiratory conditions are
are using peak flow meters to remotely monitor the lung being encouraged to self-manage. The NHS in the UK works
conditions of recovering patients, both asthmatics and non- closely with ORCHA, the world’s leading health app evaluator
asthmatics, as patients can’t visit hospitals for spirometry and Smart Peak Flow was listed as one of the leading apps
tests and home spirometry tests are complex and costly. for self-management. https://wwww.orcha.co.uk/news/
Smart Asthma is an ideal solution. coronavirus-apps-to-help-self-management/

The Bluetooth connection offers hygiene benefits as well as a

better user experience.
Asthma and Covid-19 SMARTASTHMA

Telemedicine
• Covid-19 has increased the recognition of the value of • Artificial Intelligence (Machine Learning) is now widely
telemedicine care where patients in self isolation can’t used in cardiology and moving into respiratory/pulmonary
physically visit doctors and hospitals are overloaded. sectors. Smart Respiratory Products aims to be at the
Telemedicine to manage your diabetes, blood pressure, cutting edge and to become the leading asthma solution
heart condition is more recognised but Covid-19 is through telemedicine solutions.
accelerating the need for the self-management of
respiratory conditions and all you need is a smartphone
and app.
• ‘Artificial Intelligence is moving out of the computer labs
and into the real world of healthcare, carrying out some
Ecommerce
tasks better than doctors could do alone.’
(British Heart Foundation) • Panic Buying – patients usually receive peak flow
• ’Todays medical professionals must be masters of different meters from doctors or pharmacies but due to self-
skills that are related to digital devices or online solutions isolation they are increasingly ordering online to take
and mastering those skills is now a crucial skill set that all control of their medical condition in case they contract
medical professionals require.’ Covid-19. This is likely to accelerate the boom in
(Canadian Medical Association) ecommerce once the pandemic is over.
• ’Telemedicine is amongst the essential services in
strengthening the Health Systems Response to Covid-19
policy and should be one of the alternative models for
clinical services and clinical decision support.'
(World Health Organisation - WHO}
Asthma SMARTASTHMA

• Variable disease – ups and downs

• Lifelong chronic condition, prevalence rising
• Worldwide – 350m asthmatics, 250,000 deaths
annually, millions of hospital visits
• UK – 5.4m asthmatics (8% of adults, 9% of
children), 3 deaths a day, many could be avoided
• Costly – $500b p.a. in USA – low medication
adherence compared with diabetes, cholesterol
• Onset before age of 12 – mainly genetic
• Onset after age of 12 – mainly environmental
• Environmental factors – allergens (dust mites,
animal dander, air pollution), environmental
chemicals, smoking, respiratory infections
Medication Adherence SMARTASTHMA
Comparison
Peak Flow (PEF) Overview SMARTASTHMA

• Spirometry – gold standard for doctors to diagnose asthma

• Peak Flow – gold standard to monitor asthma at home
– Patient Action Plan (PAP)
• Alerts you to worsening symptoms or conditions
• Determines severity of asthma and enables patient to decide
whether to use medication or seek emergency care
• Peak flow meters have been around since the late 1950s
when Dr Martin Wright introduced the very first mechanical device

1950s 1970s 2000s

Dr. Martin Wright invented the The Mini Wright, a portable and Electronic meters of higher accuracy
first peak flow meter. The original inexpensive device, was introduced. began to replace the old, mechanical
instrument was a large, heavy, clock- Doctors realised that the instrument models. With the ability to record up
shaped device and was too expensive could be useful in home treatments. to a few hundred readings they quickly
for the common person to have The meter came complete with a set became a popular alternative to the
at home. It was generally used of disposable cardboard mouthpieces. handwritten peak flow diaries.
in hospitals to assess patients.
1. PEF Self-Monitoring SMARTASTHMA

Peak Flow Sensor Patient App

Patented Symptom Logging
CE marked Asthma status prediction
FDA expected in 2020 40% adherence rate
Distributed in 16 countries beyond 6 months
Co-branding available Available in 25 languages
Traffic Light system SMARTASTHMA
in association with
the America Lung Institute

ZONE READING DESCRIPTION

80 to 100 percent of the usual or A peak flow reading in the

normal peak flow readings are green zone indicates that the
Green Zone
clear asthma is under good control.

50 to 79 percent of the usual or Indicates caution. It may mean

normal peak flow readings respiratory airways are
Amber Zone narrowing and additional
medication may be required

Less than 50 percent of the usu- Indicates a medical

al or normal peak flow readings emergency.
Severe airway narrowing may
Red Zone be occurring and immediate
action needs to be taken.
This would usually involve
contacting a doctor or hospital
App Traffic Light System SMARTASTHMA

Green Zone Amber Zone Red Zone

Awesome job! Awesome job!

What a great result! What a great result!

%63
489 L/min
%43
489 L/min

My note My note
Write some notes for this blow! Write some notes for this blow!
I'm sick, I just ran, etc. I'm sick, I just ran, etc.

Claim my quote Claim my quote

I'm done for now

I'm done for now

Discard
Discard
Peak Flow Measurements SMARTASTHMA

Peak Flow Graph giving a visual description

of the patient’s peak flow measurements
when used on a regular basis

The data produced

by SPF can be
sent via either a
CSV or PDF file to
their health care
practitioner

Peak flow chart indicating:

• Peak expiratory flow
• Personal Best for the 3 blows
• Personal Best percentage (%)
Smart Peak Flow (SPF) SMARTASTHMA

SPF Charts
brings peak flow measurement into 21st century weekly, monthly, annual, Personal Best – share with
doctor or family by e mail – PFD/Excel (see slide)
App
free download – Google Play/iOS Store, Accuracy
25+ languages, smartphone automatically selects awarded Class IIa CE certification but doctors prefer
language medical publications. BMC White Paper compares
Peak Flow meters and only two pass, one of which
Connectivity is SPF (see slides)
audio jack, lightning adapter for iOS, Bluetooth Adapter,
no batteries as charges from phone How does it work?
Light enters window and is chopped up by propeller.
How to use
Resultant flicker is picked up by photodiode and data
onboarding, check lighting (not fluorescent),
is transmitted digitally to smartphone and Cloud as
calibration, blow 3 times, saves highest blow
sound file
How often should you measure PEF?
Durability
Twice a day
tested to 20,000 blows in bench test which equals
Traffic Light zones 9 years’ use. 2 year warranty. More likely to break or lose
Green 80%+, Amber 50-79%, Red 50% or lower device than mechanical failure
– American Lung Institute System (see slide)
SPF costs more than mechanical device, why?
Both measure PEF but SPF offers benefits before and
after (see slide)
Smart Peak Flow (SPF) SMARTASTHMA

Can several patients use one SPF device? Adherence

No, it is for one person use and not multi person use 90% of SPF users still use it after 60 days, 70% of
them use it at least twice a week, 30% less than twice
Privacy a week. Much higher adherence than mechanical
data is anonymised/de-identified and stored in the device. Patients using mechanical PEF meter forget to
Cloud - we can’t identify individuals measure or record peak flow 90% of the time whereas
those using SPF save measurements automatically to
Can you clean SPF? PDF or Excel files
Device and mouthpiece can be washed with warm
water and mild detergent but not soapy water. Circuit API – can we integrate SPF into our system?
board is waterproof and there are no batteries in the PEF measurement requires user cooperation (blowing
device. Dry naturally 3 times) with a user interface instructing the user what
to do and showing the result.
Does SPF come with a mouthpiece? We have 3 options:
One mouthpiece is included, disposable mouthpieces Apple Health – users share PEF data there and you
also work retrieve it but no Android equivalent
Software Library – use it to take PEF measurements
in your app and provides seamless user experience
but you need to write user interface to go with it
Smart Peak Flow service – we are developing
service which you call from your app. Will invoke
SPF app solely to take a measurement and return
the value to your app
 Remote SMARTASTHMA
Patient Monitoring

Peak Flow Sensor Patient App HCP Console

Patented Symptom Logging Secure cloud storage
CE marked Asthma status prediction Remote Patient
FDA expected in 2020 40% adherence rate Monitoring Asthma
beyond 6 months control status CompEx
Distributed in 16 countries
event detection GDPR and
Co-branding available Available in 25 languages
HIPAA compliant
 SMARTASTHMA

++++

CompEx
– Compound Exacerbation Score

Priorities:

• 1st Predicter is “Peak Expiratory Flow”

• 2nd Predicter is “Rescue Inhaler use”

• 3rd Predicter is “Symptoms”

Smart Peak Flow CompEx Score

 SMARTASTHMA
++++

Once the data from the three outcomes

has been collected, Smart Asthma will
grade the level of asthma control into:
• well controlled
• poorly controlled
P+R+S • very poorly controlled
AI
Based on this, the likelihood of having
an asthma attack (exacerbation)
increases.
Smart Asthma Console SMARTASTHMA
— features

• Smart Asthma Console video — watch our new, remote • Smart Rescue Inhaler – monitor inhaler use where
patient monitoring console demo fluctuations mean need to amend medication or see
• https://smartasthma-console.web.app —check out the doctor
console using the following test login details: Clinic ID: • Inhaler Technique app – incorrect usage means patients
I679LU (letter I not number 1)⁄ Password: RPM2020 don’t fully benefit from medication.
• CompEx (Compound Exacerbation Score) — algorithm App enables patient to optimise inhaler use
created by Astra Zeneca, using P+R+S (Peak Expiratory • Predicting Peak Flow for tomorrow – unique AI-based
Flow + Rescue Inhaler + Symptoms). Smart Asthma feature that forecasts the probability
app uses this algorithm to detect ‘CompEx events’, of asthma sufferers being in the red, amber or green zone
which are milder but more frequent than potentially life- the following day, giving them
threatening asthma exacerbations, and are considered a chance to prepare
an ‘early warning’ of poor asthma control • Asthma Action Plan – can now be tailored to reflect the
• Remote Patient Monitoring – console using P+R+S to policies of clinics
allow doctors and nurses to monitor patients’ asthma • Online Consultation – if your country has online medical
remotely. If the doctor has registered for the Smart consultation providers, we can
Asthma Console, they receive a QR code which the add a button to connect patients. Eg. in the UK we use
patient can scan, enabling the patient to share their https://thegpservice.co.uk/
data with the doctor. Data sharing can be revoked at
any time by the patient
Smart Asthma Console SMARTASTHMA
— benefits

PATIENTS • Usually have annual asthma appointment with doctor. Smart Asthma monitors patients 24/7

DOCTORS • After adjusting asthma patientʼs medication, donʼt adjust until next consultation in 12
months. Smart Asthma offers dashboard where can access patientʼs records on a daily
basis
• Usually assess asthma patients once a year. Do they attend when they have symptoms
or asthma exacerbation or just on an annual basis at a fixed date? Smart Asthma Console
enables doctors to see patients when their asthma is active
• When doctors see patients, how do they assess the patientʼs asthma control?
A questionnaire or a few questions? Smart Asthma Console shows reliable
data regarding patientsʼ asthma control

PAYERS • Doctors are the most expensive resource. Are they seeing the patients who need to
be seen or wasting clinical time on non-essential check-ups? Smart Asthma Console
ensures only asthma patients with active symptoms visit the doctor
• Asthma attacks are expensive to the payer, and stressful for the patient. Preventing
attacks is not always a case of more medication or better adherence. The AI technology
of Smart Asthma Console detects early signs of worsening asthma and allows patients
to be seen before an attack
Smart Asthma SMARTASTHMA
Console Summary

Steps to sign up on the Console

WHAT YOU 1. Install the Smart Asthma app on your smartphone

NEED?
2. Complete the onboarding process
3. Measure your Peak Flow and record your Rescue Inhaler use
and Symptoms. Ensure they appear on your Chart
• Smart Peak Flow device 4. On your computer go to http://smartasthma-console.web.app
and click on the Register button
• Smart Asthma app from Google Play or Apple Appstore
5.  egister yourself for free.
R
• A computer You will receive your login details in an email
6. Log in to your console. Your patient list will be empty.
7. Add yourself as a patient. On the console tap your profile
(your name next to the patient list) to reveal your QR code
8.  n your Smart Asthma app go to Profile / Health Centre /
O
Data Sharing and scroll down to the Scan QR code button.Tap
on the button and scan the QR code on your computer screen
9. That’s it, your app has enabled data sharing with your console
10. Tap on the Patient list on your console and you should see
your asthma diary card on the screen. Click on the card for
a more detailed Patient Overview. Click View Details at the
bottom of the overview to see even more detail
11. You can withdraw data sharing from the Smart Asthma app
at any time by going to Profile/Health Centre/Data Sharing
 Inhaler Technique SMARTASTHMA
Training (coming soon)

Adjustable Patient App

Resistance Advising on inhale
technique
6 different resistance
Peak Flow Sensor - Duration
levels, mimicking all
inhaler types - Strength
- Attack
 Durable, ultra-lightweight and easy to use

Accurate, precise and designed for children and adults

Integrated PAP (Patient Action Plan) Download the Smart Peak Flow
app on your smartphone

Meets all international ISO standards Asthma Control

in your Pocket
for portable Peak Flow Meters

Bluetooth connectivity

SRP/SPF/2018/0006
Download Blow Track Share

© 2014-2019. Smart Respiratory Products Limited. All rights reserved. www.smartpeakflow.com SMART PEAK FLOW
All information, specifications and illustrations contained in this document are
based on the latest product information available at the time of publication.
[email protected] 
Digital Peak Flow Meter
Errors and omissions excepted. Smart Respiratory Products Limited reserves the
Smart Respiratory Products Ltd.
right to change specifications and design at any time without prior notice.
Imperial White City Incubator, (I-HUB) PRODUCT DATA SHEET
80 Wood Lane, London W12 0BZ, United Kingdom Version ENGv03 Date of Release: 29/11/2019
 SMART
The Gold Standard in Smart technology
HOME ASTHMA MANAGEMENT THAT FITS IN THE PALM OF YOUR HAND

PEAK FLOW
Peak flow monitoring is recognised as the Whilst the ergonomic and light-weight design makes
gold standard in asthma management. Keeping Smart Peak Flow comfortable to hold and easy to carry
accurate peak flow records manually has proven around, the user-friendly interface of the app makes it
to be difficult, if not impossible. With Smart Peak remarkably easy and intuitive to use. The device does not
Flow’s automatic recording and visual charting, even require additional batteries
is a compact digital users and healthcare professionals can finally to operate.
peak expiratory flow meter (PEFM) say goodbye to unreliable data and paper charts.
that connects to any Android The app will ask the user to perform three blows and will
and iOS smartphones. Smart Peak Flow has simplified asthma homecare save the highest of the three values as the result. After the
by bringing it directly into the hands of patients test is complete, the user is able to manually save notes
Using the Smart Peak Flow app, users can take across the world. Using exactly the same about their symptoms. Test results are then shown in a
and record their peak flow measurement in technology as a diagnostic spirometer, the small Chart view, where users can get an excellent overview of
the comfort of their own home and share the device guarantees more accurate peak flow the progress of their condition.
results with their healthcare professional. measurements than mechanical peak flow meters.

The smartphone enabled Technical specifications

device is designed to be used
as a self-monitoring tool Device category: Digital peak expiratory flow meter (PEFM)
Key Features Measurement principle: Light interruption
for those with a Applicable source of light: Volfram-, halogen-, LED and natural light
Universal 60-800 L/min range
respiratory condition (asthma). Easy to set up Required strength
Min. 100 lux
of illuminance:
Android and iOS compatible
Communication interface: Bluetooth technology – 3.5mm audio jack
Simple to use
Power source: Connected smartphone’s battery
Traffic light health indicator
Voltage supply: Max. 5V DC
No paper charts
Track progress over time Measurement range: 60-800 L/min

Set reminders Accuracy: ± 10%

Share results Dimensions: Turbine: 54x32x39mm | Mouthpiece: 39x33x33mm

Smart Respiratory Products Ltd. Ergonomically designed IP protection level: IP21

www.smartpeakflow.com  detachable mouthpiece Temperature: min. 0° C, max. 50° C

Operating conditions:
[email protected] Humidity: min. 10% RH; max. 95% RH
Bluetooth technology
 VanZeller et al. BMC Pulmonary Medicine (2019)
https://doi.org/10.1186/s12890-019-0837-3

RESEARCH ARTICLE OPEN ACCESS

ABSTRACT

originally published in:

Background: The study evaluates and compares the accuracy of nine peak flow meters (“PFMs”)
VanZeller et al. BMC Pulmonary Medicine (2019) 19:74 and spirometers that are currently available in Europe and have Conformité Européene (“CE”) mark-
https://doi.org/10.1186/s12890-019-0837-3 ing. The CE marking is a manufacturer’s declaration that their product complies with European health
regulations and it is a requirement for marketing medical devices in Europe.

Methods: The nine devices were selected as they all had received or were in the process of receiv-
ing CE approval in Europe and were readily obtainable. The devices were bench tested following
the ISO 23747:2015 accuracy guidelines for medical devices measuring peak flow. All standards,
including accuracy, from these guidelines must be met to obtain CE marking.

This study was performed with a certified piston pump testing apparatus. The apparatus chosen was
Cristiano VanZeller 1, Andrew Williams 2 and Ian Pollock 3 * the pulmonary waveform generator manufactured by Piston Medical Ltd. Using predefined flow (time)
* Correspondence: [email protected]
and volume (time) waveforms, peak flow meters and spirometers were tested for validation and cali-

Comparison
bration. Three CE guideline tests were utilised, and standards require that all three tests are passed
for the device to obtain certification.

Results: Of the nine devices that were tested, two passed and seven failed. The devices that passed

of bench test results the tests were the Smart Peak Flow® and the Mini Wright®.

Conclusions: A high percentage of devices failed accuracy testing in this study. This is a concern

measuring the accuracy

as the CE marking is a manufacturer’s certification documenting the accuracy, reliability and safety
of devices. Of the seven devices that failed all have the CE marking. All tested devices are on the
market in Europe based upon studies conducted by each of the manufacturers. The data used to

of peak flow meters

obtain CE certification of these devices, however, are not in the public domain.

Keywords: Peak flow meter, Accuracy, CE, Asthma

3 St Mary’s Hospital, London, UK

Full list of author information is available at the end of the article

© The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International
License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium,
provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate
if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/)
applies to the data made available in this article, unless otherwise stated.
Accuracy of Smart Peak Flow SMARTASTHMA
– BMC White Paper
• Comparison of bench test results measuring the accuracy of peak flow meters
• Of the nine devices tested only 2 devices passed the standard T1, T2 and T3 “Piston” mechanical lung test

Air Smart Spirometer® MIR Smart One® Vitalograph®

Pond Healthcare Innovation AB MIR Medical International Research Srl. Vitalograph (Ireland) Ltd.
Spirometer digital Spirometer digital Peak flow meter mechanical
CE 0598 LOT: B010 CE 0476 SERIAL: A23-A000485 CE 0086 LOT: 1408
T1:  PASS  T2:  PASS  T3:  FAIL  T1:  PASS  T2:  PASS  T3:  FAIL  T1:  FAIL  T2:  FAIL  T3:  FAIL 
overall result –  FAIL  overall result –  FAIL  overall result –  FAIL 

AirZone® Philips PersonalBest® Medi®

Clement Clarke International Ltd. Respironics Respiratory Drug Delivery Ltd Medicareplus International Ltd.
Peak flow meter mechanical Peak flow meter mechanical Peak flow meter mechanical
CE 0120 LOT: M4200020K LOT: 16A005 CE 0598 LOT: 1342
T1:  FAIL  T2:  PASS  T3:  FAIL  T1:  PASS  T2:  PASS  T3:  FAIL  T1:  FAIL  T2:  FAIL  T3:  FAIL 
overall result –  FAIL  overall result –  FAIL  overall result –  FAIL 

eMini Wright® Smart Peak Flow® Mini Wright®

Clement Clarke International Ltd. Smart Respiratory Products Ltd. Clement Clarke International Ltd.
Peak flow meter digital Peak flow meter digital - prototype Peak flow meter mechanical
CE 0120 SERIAL: SN00500 T1:  PASS  T2:  PASS  T3:  PASS  CE 0120 LOT: M004151K
T1:  PASS  T2:  PASS  T3:  FAIL  overall result –  PASS  T1:  PASS  T2:  PASS  T3:  PASS 
overall result –  FAIL  overall result –  PASS 
Competitor Products SMARTASTHMA

Product Manufacturer PEF FEV1 FEV6

Airzone EU Scale Clement Clarke Ltd 3 0 0

Asma-1 (Adult Version) Vitalograph (Ireland) Ltd 3 3 0

Asma-1 (Child Version) Vitalograph (Ireland) Ltd 3 3 0

• Mechanical peak flow meters Datospir Peak-10 Sibelmed 3 0 0

– low price eMini-Wright Clement Clarke Ltd 3 0 0

• Digital peak flow meters Mini-Wright Clement Clarke Ltd 3 0 0

Mini-Wright (Low) Clement Clarke Ltd 3 0 0

• Spirometers – home use
MIR SmartOne MIR 3 3 1
• Digital devices to manage diabetes,
MIR Spirobank II MIR 3 3 1
ECG, blood pressure
NuvoAir NuvoAir AB 3 3 1
• Inhalers and drugs
PersonalBest Respironics 3 0 0
– used instead of PEF
Pinnacle Sibelmed 3 0 0

Smart Peak Flow Smart Respiratory Products Ltd 3 0 0

SP10 Spirometer Contec Medical Systems 3 3 3 1

Vitalograph
Vitalograph (Ireland) Ltd 3 3 0 0
(Adult Version)

Vitalograph MyPEF Vitalograph (Ireland) Ltd 3 3 0 0

Sales & Marketing SMARTASTHMA

• Roadmap – distributor journey (see slide) • Pricing/MOQs – high volume/low margin product so
distributor prices linked to volume (see slide)
• Distributor Presentation & Sales & Marketing Plan
• Distributor Contract – standard 3 year contract with
• Routes to Market – best practices in other markets –
annual MOQs for Q1, Q2, Q3 and Q4
Europe, Asia-Pacific, South America, Middle East
• Training for distributor sales team – by video conference
» hospitals/doctors – private and public – reimbursement
or at London HQ
» pharmacies
• Digital Sales & Marketing folder – access to regulatory
» pharmas and marketing documents, brochures, images
» B2C • Apps/Website – translate apps and working on local
language landing page for website
» OEM/dual branding – subject to MOQs and app
development costs • Brochures – digital versions available in key languages
for distributor to print out
» clinical trials/research projects – Novartis/Sandoz,
Harvard Medical School • Exhibitions & Congresses – we exhibit at international
events and distributor exhibits at domestic events
» occupational asthma – 10% of adult onset asthma is
work related • Social Media & PR – active on social media and featured
in Red Bull campaign, BBC World
• Regulatory Process – CE/FDA, local requirements, cost,
leadtime, documents, in SRP name or distributor name? • Testimonials (doctors) and Reviews (customers)
• Evaluation Packs – samples to give to KOLs (see slide) • Future – initial offering is SPF but hope to work with
distributor to become a leading player in the Smart
Asthma market where we provide AI solutions for
patients with respiratory conditions
How Smart Peak Flow Video call
review
Can Help Grow Evaluation
Your Business Stage 2
(2 months)
Smart COPD solutions

Explore routes to market: Investigate local Order Premium or Classic Evaluation Pack
clinicians, re-imbursement, regulatory requirements: (50-100 samples)
B2C, clinical trials, pharmacies is it CE accepted, lead times,
cost etc.
Remote Patient Monitoring
for clinicians
Attend training session,
Demo SPF internally and to KOLs London HQ or via video
conference call AI based asthma
prediction

SRP translate app

Evaluation Smart Inhaler
into local language
Stage 1
(2 weeks)

Video Call Give Evaluation Pack samples

product demo • to KOLs and clinicians Expand your
benefits of SPF • mHealth
Sample evaluation • Respiratory
regulatory process • Portfolio
Distributor starts regulatory
routes to market • application. SRP to provide
regulatory documents
9-month
Complete SRP provide review
Distribution Distributor to create sales On Boarding to discuss
Questionnaire and marketing plan for years 1-3 Distributor following
Pack year

Intro Stage
(2 weeks) Distribution

Initial contact Complimentary SPF sample Monthly Quarterly

• exhibition • exhibition Sign contract
Skype review
• email • courier • agree MOQ for years 1-3
call
• place opening stock order
[email protected] +44 (0)7950 941 084
Clinical Studies SMARTASTHMA

We are currently working worldwide with

the above renowned hospitals and pharma
companies to conduct clinical research and
pilot studies. Exhibit at leading congresses
including European Respiratory Society
and European Academy of Allergy and
Clinical Immunology.
Social Media SMARTASTHMA

Various different social media platforms

are being used to engage with our followers
as well as media campaigns and television
appearances. We would be interested in
such opportunities in your country.
SPF Training Questions SMARTASTHMA
for Distributors

Does SPF work with iPhones?

Does SPF measure FEV1?
Can several patients use one SPF device?
What happens to patients’ PEF data?
Is SPF accurate?
Can I use SPF while watching TV?
SPF costs more than a mechanical PEF meter!
How much does the app cost?
How do you select the app language?
How often should you take your PEF?
How can a patient send the PEF diary to a doctor?
How can you clean SPF?
How many times can you use SPF?
Does the device come in different colours?
 QUALITY MANAGEMENT'
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Smart Respiratory Products Ltd.
33 Riding House Street, London W1W 7DZ
VAT ID: GB 243369501│Company No. 09239984 Smart
Telephone: 0203 7692204│Email: [email protected]
Respiratory
Products Ltd.

EC DECLARATION OF CONFORMITY

Manufacturer: Smart Respiratory Products Ltd.

Registered Office: 33 Riding House Street, W1W 7DZ London, United Kingdom
Product Description: Peak expiratory flow meter with software application
Product Name: Smart Peak Flow

is in conformity with provisions of the applied 93/42/EEC directive concerning medical devices (amended by
2007/47/EC of the European Parliament), as a class II. a medical device.

EC Certificate Registration Number: 144797-18-11-08

Issued: 08 November 2018
Expires: 07 November 2021

Harmonised standards applied:

EN 60601-1:2015;
EN 60601-1-2:2015;
EN 60601-1-6:2010;
IEC 62366-1:2015;
EN ISO 10993-1:2018;
EN ISO 23747:2015;
EN 62304:2006;
EN ISO 13485:2016;
EN ISO 14971:2013

Name of Notified Body: CE CERTISO Kft

Address of Notified Body: Gyár u. 2, 2040 Budaörs, Hungary
Notified Body Number: NB2409

Quality Management System Certificate Registration Number: 14796-18-11-08

Issued: 08 November 2018
Expires: 07 November 2021

Thomas Antalffy
Managing Director

www.smartpeakflow.com
Smart Respiratory Products Ltd. 33 Riding House St, London W1W 7DZ. Tel: 0203 7692204