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#DIGITAL #DEVICES #SUCCESS #LEARNINGS:
LEARNINGS AND KEY SUCCESS FACTORS
FOR THE ADOPTION AND CONTINUOUS USE
OF DIGITAL MEDICAL DEVICES
Milena Saleh, Director Digital Health, Sanofi Primary Care
June 4th, 2019, Digital Pharma Europe, Rome
MilenaSaleh2019©Allrightsreserved
DISCLOSURES
 This presentation is based on publicly available data from Sanofi and Onduo
 All clinical data is published
 I am an employee of Sanofi, and am not affiliated with Onduo
2
#Digital #Devices #Success #Learnings: Digital Medical Devices –
Milena Saleh, June 4th, 2019 Digital Pharma Europe
Milena Saleh 2019 © All rights reserved
3
#Digital #Devices #Success #Learnings: Digital Medical Devices –
Milena Saleh, June 4th, 2019 Digital Pharma Europe
Milena Saleh 2019 © All rights reserved
Disruption vs.
Transformation
QUESTIONS I WILL ADDRESS TODAY
4
Diabetes in the era of technology-enabled care
Overview of two digital diabetes programs
Learnings and key success factors
1
2
3
#Digital #Devices #Success #Learnings: Digital Medical Devices –
Milena Saleh, June 4th, 2019 Digital Pharma Europe
Milena Saleh 2019 © All rights reserved
1 IN 10 ADULTS HAS DIABETES; A SIGNIFICANT INCREASE IS
EXPECTED, ESPECIALLY IN LOW-/MIDDLE-INCOME REGIONS
5
Source: IDF Diabetes Atlas, 8th Edition
Global prevalence of diabetes
among adults has risen / is rising
significantly
Nr people with diabetes (m)
Low/middle income regions show
the higher growth rates
Growth in number of patients 2017-
2045 (%)
425
151
2017
629
20452000
+3%
WP
35
1516
48
62
84
110
156
NACMENA SACA EURAFR SEA Avg
High incidence of diabetes
in global population
Nr people with diabetes (%)
90%
10%
Without diabetes
With diabetes
1
#Digital #Devices #Success #Learnings: Digital Medical Devices –
Milena Saleh, June 4th, 2019 Digital Pharma Europe
Milena Saleh 2019 © All rights reserved
LESS THAN 1 IN 10 PEOPLE WITH DIABETES ACHIEVE
SATISFACTORY CLINICAL OUTCOMES (“RULE OF THE HALVES”)
6
https://www.novonordisk.com/content/dam/cities-changing-diabetes/Toolbox/RULE%20OF%20HALVES_INTRO%20MANUAL_200920171.pdf
1
#Digital #Devices #Success #Learnings: Digital Medical Devices –
Milena Saleh, June 4th, 2019 Digital Pharma Europe
Milena Saleh 2019 © All rights reserved
DIABETES MANAGEMENT IS COMPLEX AND REQUIRES
CONTINUOUS MOTIVATION & SUPPORT
7
AADE.org.
Healthy eating
Being active
Taking medication
Healthy coping
Problem-solving
Reducing risks
Monitoring
?
1
+ +
+ +
+ +
+
#Digital #Devices #Success #Learnings: Digital Medical Devices –
Milena Saleh, June 4th, 2019 Digital Pharma Europe
Milena Saleh 2019 © All rights reserved
EFFECTIVE DIABETES MANAGEMENT REQUIRES A NEW CARE MODEL
8
Visit
to doctor
Self-care
(BG-monitoring, medication, food, etc)
Visit
to doctor
Visit
to doctor
Virtual/F2F
Visit to Visit to Visit to Visit
to doctor
Virtual/F2F
Supported self-care + ongoing Rx modification
Intervention / coach
+ feedback loop
Intervention / coach
+ feedback loop
Intervention / coach
+ feedback loop
Traditional
Technology
-enabled
Care model How it looks like
Contacts with
doctor / care team
1 in 3
months
Weekly or
more
FUTU
Smart devices & apps
• Real-time BG & insulin
data
• Enable Rx modi-
fication remotely
Data analytics & algorithms
• Identify which patient require
high-intensity follow-up
Social networking
• In-between visits,
patients (educators)
coach each other
#Digital #Devices #Success #Learnings: Digital Medical Devices –
Milena Saleh, June 4th, 2019 Digital Pharma Europe
Milena Saleh 2019 © All rights reserved
Educational Content
1
THE TECHNOLOGY ENABLED PATIENT ACTION MODEL SUPPORTS DESIGN
AND IMPLEMENTATION OF EFFECTIVE DISEASE MANAGEMENT PROGRAMS
9
#Digital #Devices #Success #Learnings: Digital Medical Devices –
Milena Saleh, June 4th, 2019 Digital Pharma Europe
Milena Saleh 2019 © All rights reserved
Adapted from: Developing a Technology Enabled Model to Support Medication Taking Behaviors, Poster at the DTS 2018, Greenwood et al.
Initiation Toolkit:
Assessment
Clinical Inertia
Toolkit
Self-care Toolkit
“…Toolkits, designed to support
healthcare provider’s actions and
patient behavior changes, during
three phases of medication taking
behaviors (initiation, implementation,
persistence) are driven by the TES
engine. The proposed outcomes are
increased engagement, improved
experience and empowerment….”
1
MY DOSE COACH OVERVIEW
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#Digital #Devices #Success #Learnings: Digital Medical Devices –
Milena Saleh, June 4th, 2019 Digital Pharma Europe
Milena Saleh 2019 © All rights reserved
1
2
Sanofi internal
MY DOSE COACH WORKFLOW
11
#Digital #Devices #Success #Learnings: Digital Medical Devices –
Milena Saleh, June 4th, 2019 Digital Pharma Europe
Milena Saleh 2019 © All rights reserved
HCPs: prescribe
and send a custom
dose plan to their
patients
Patients: record daily
fasting blood glucose in
the MDC app to start
getting insulin dose
recommendations.
1
2
Sanofi internal
MY DOSE COACH APP
12
#Digital #Devices #Success #Learnings: Digital Medical Devices –
Milena Saleh, June 4th, 2019 Digital Pharma Europe
Milena Saleh 2019 © All rights reserved
1
2
Enter blood glucose Get dose reco Confirm dose taken Review progress
Sanofi internal
KEY RESULTS INDIA PILOT
13
#Digital #Devices #Success #Learnings: Digital Medical Devices –
Milena Saleh, June 4th, 2019 Digital Pharma Europe
Milena Saleh 2019 © All rights reserved
 Conducted in Apollo Sugar Clinics, in 2017
 137 patients, 12-weeks; HCP prescribed dose plan, patient used app to adjust dose
APP-based Approach to Basal Insulin Titration: Initial Results of the MyDoseCoach Pilot in India, Poster at the IDF 2018, Shah et al.
“Conclusions:
…This current 12-week pilot project
conducted in India, demonstrates
that the MDC app-aided titration of
basal insulin is an effective, safe,
and user-friendly technology-
enabled option for optimizing basal
insulin dose in patients with T2D…”
1
2
OVERVIEW ONDUO VIRTUAL DIABETES CLINIC
14
#Digital #Devices #Success #Learnings: Digital Medical Devices –
Milena Saleh, June 4th, 2019 Digital Pharma Europe
Milena Saleh 2019 © All rights reserved
Onduo is a virtual diabetes clinic designed to bring the best, most up-to-date care to
people with diabetes – anytime, anywhere. Onduo is a joint venture of Sanofi and Verily
Onduo.com, accessed May 2019
1
2
WORKFLOW ONDUO
15
#Digital #Devices #Success #Learnings: Digital Medical Devices –
Milena Saleh, June 4th, 2019 Digital Pharma Europe
Milena Saleh 2019 © All rights reserved
Patient
signs up,
gets
Welcome
Kit
Patient is
paired with
Coach
(app, text,
phone)
Patient logs
meals, BG,
medication
Patient gets
targeted
advice to
improve
self-care
Coach may
loop in
patient’s
HCP for Rx
change
1
2
Adapted from Onduo.com, accessed May 2019
ONDUO APP
16
#Digital #Devices #Success #Learnings: Digital Medical Devices –
Milena Saleh, June 4th, 2019 Digital Pharma Europe
Milena Saleh 2019 © All rights reserved
1
2
Onduo.com, accessed May 2019
KEY RESULTS US PILOTS
17
#Digital #Devices #Success #Learnings: Digital Medical Devices –
Milena Saleh, June 4th, 2019 Digital Pharma Europe
Milena Saleh 2019 © All rights reserved
 Data from 2018
 769 patients, enrolled in early pilots; patients logged meals, BG, meds and exchanged
messages with coach
“Conclusions (Close Concerns):
… the need for high-touch,
technology-driven care in diabetes,
specifically as a means of making
care more continuous (rather than
episodic), scaling experts, and
assisting the over-burdened PCPs
who deliver ~80% of outpatient
diabetes care.”
Glytec and Onduo Webinar, Virtual Diabetes Care: Unlocking the Keys to Real Results, May 2019, https://www.himsslearn.org/virtual-diabetes-care-unlocking-keys-real-results
1
2
INSIGHTS PATIENTS
18
 Eligible patient vs. activated patient
 Simplicity & ease of use
 High satisfaction
 Demonstrated clinical effectiveness
 Improved disease perception & engagement
 Patient support for repeated use
 Long term use is challenging
 Data analytics for continuous engagement
#Digital #Devices #Success #Learnings: Digital Medical Devices –
Milena Saleh, June 4th, 2019 Digital Pharma Europe
Milena Saleh 2019 © All rights reserved
1
2
3
INSIGHTS HCPS
19
 High interest vs. product adoption
 Customer prioritization: early adopters, advocacy
 Fit to/improvement of current workflow
 Time constraints: easy to learn & easy to teach
 Multi-point HCP engagement & support
 Help HCP identify best patient profiles
#Digital #Devices #Success #Learnings: Digital Medical Devices –
Milena Saleh, June 4th, 2019 Digital Pharma Europe
Milena Saleh 2019 © All rights reserved
1
2
3
INSIGHTS PAYERS
20
 High interest for innovation
 Limited / non-existing reimbursement
 Long lead time for reimbursement
 Payer “co-design” solution & metrics
 Reimbursement does not drive adoption
 Clinical data vs. real-life tool validation
#Digital #Devices #Success #Learnings: Digital Medical Devices –
Milena Saleh, June 4th, 2019 Digital Pharma Europe
Milena Saleh 2019 © All rights reserved
1
2
3
IMPLICATIONS: WHAT
21
 Prioritize: HCP vs. DTC-driven
 Digital is a product in its own right
 Pilot vs. full-scale launch: resources
 Regulatory framework: co-promotion possible?
 Doctor-patient relationship transformation
 You are NOT alone – ecosystem fit
 AI & algorithms at the core
 Product scale-up: design and resources
#Digital #Devices #Success #Learnings: Digital Medical Devices –
Milena Saleh, June 4th, 2019 Digital Pharma Europe
Milena Saleh 2019 © All rights reserved
1
2
3
IMPLICATIONS: HOW
22
 Execution: pharma or partner?
 Overall resource investment vs. engagement rate by channel
(HCP/DTC)
 Alternative activation channels?
 HCP usage model and frequency
 Sales force vs. dedicated experts, Training via MCE
 Customer-service mindset & capabilities
 Continuous patient enrollment improvement
 No IMS: new metrics
#Digital #Devices #Success #Learnings: Digital Medical Devices –
Milena Saleh, June 4th, 2019 Digital Pharma Europe
Milena Saleh 2019 © All rights reserved
1
2
3
#
MilenaSaleh2019©Allrightsreserved

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2019-06-04 Learnings and key success factors digital medical devices Milena Saleh

  • 1. #DIGITAL #DEVICES #SUCCESS #LEARNINGS: LEARNINGS AND KEY SUCCESS FACTORS FOR THE ADOPTION AND CONTINUOUS USE OF DIGITAL MEDICAL DEVICES Milena Saleh, Director Digital Health, Sanofi Primary Care June 4th, 2019, Digital Pharma Europe, Rome MilenaSaleh2019©Allrightsreserved
  • 2. DISCLOSURES  This presentation is based on publicly available data from Sanofi and Onduo  All clinical data is published  I am an employee of Sanofi, and am not affiliated with Onduo 2 #Digital #Devices #Success #Learnings: Digital Medical Devices – Milena Saleh, June 4th, 2019 Digital Pharma Europe Milena Saleh 2019 © All rights reserved
  • 3. 3 #Digital #Devices #Success #Learnings: Digital Medical Devices – Milena Saleh, June 4th, 2019 Digital Pharma Europe Milena Saleh 2019 © All rights reserved Disruption vs. Transformation
  • 4. QUESTIONS I WILL ADDRESS TODAY 4 Diabetes in the era of technology-enabled care Overview of two digital diabetes programs Learnings and key success factors 1 2 3 #Digital #Devices #Success #Learnings: Digital Medical Devices – Milena Saleh, June 4th, 2019 Digital Pharma Europe Milena Saleh 2019 © All rights reserved
  • 5. 1 IN 10 ADULTS HAS DIABETES; A SIGNIFICANT INCREASE IS EXPECTED, ESPECIALLY IN LOW-/MIDDLE-INCOME REGIONS 5 Source: IDF Diabetes Atlas, 8th Edition Global prevalence of diabetes among adults has risen / is rising significantly Nr people with diabetes (m) Low/middle income regions show the higher growth rates Growth in number of patients 2017- 2045 (%) 425 151 2017 629 20452000 +3% WP 35 1516 48 62 84 110 156 NACMENA SACA EURAFR SEA Avg High incidence of diabetes in global population Nr people with diabetes (%) 90% 10% Without diabetes With diabetes 1 #Digital #Devices #Success #Learnings: Digital Medical Devices – Milena Saleh, June 4th, 2019 Digital Pharma Europe Milena Saleh 2019 © All rights reserved
  • 6. LESS THAN 1 IN 10 PEOPLE WITH DIABETES ACHIEVE SATISFACTORY CLINICAL OUTCOMES (“RULE OF THE HALVES”) 6 https://www.novonordisk.com/content/dam/cities-changing-diabetes/Toolbox/RULE%20OF%20HALVES_INTRO%20MANUAL_200920171.pdf 1 #Digital #Devices #Success #Learnings: Digital Medical Devices – Milena Saleh, June 4th, 2019 Digital Pharma Europe Milena Saleh 2019 © All rights reserved
  • 7. DIABETES MANAGEMENT IS COMPLEX AND REQUIRES CONTINUOUS MOTIVATION & SUPPORT 7 AADE.org. Healthy eating Being active Taking medication Healthy coping Problem-solving Reducing risks Monitoring ? 1 + + + + + + + #Digital #Devices #Success #Learnings: Digital Medical Devices – Milena Saleh, June 4th, 2019 Digital Pharma Europe Milena Saleh 2019 © All rights reserved
  • 8. EFFECTIVE DIABETES MANAGEMENT REQUIRES A NEW CARE MODEL 8 Visit to doctor Self-care (BG-monitoring, medication, food, etc) Visit to doctor Visit to doctor Virtual/F2F Visit to Visit to Visit to Visit to doctor Virtual/F2F Supported self-care + ongoing Rx modification Intervention / coach + feedback loop Intervention / coach + feedback loop Intervention / coach + feedback loop Traditional Technology -enabled Care model How it looks like Contacts with doctor / care team 1 in 3 months Weekly or more FUTU Smart devices & apps • Real-time BG & insulin data • Enable Rx modi- fication remotely Data analytics & algorithms • Identify which patient require high-intensity follow-up Social networking • In-between visits, patients (educators) coach each other #Digital #Devices #Success #Learnings: Digital Medical Devices – Milena Saleh, June 4th, 2019 Digital Pharma Europe Milena Saleh 2019 © All rights reserved Educational Content 1
  • 9. THE TECHNOLOGY ENABLED PATIENT ACTION MODEL SUPPORTS DESIGN AND IMPLEMENTATION OF EFFECTIVE DISEASE MANAGEMENT PROGRAMS 9 #Digital #Devices #Success #Learnings: Digital Medical Devices – Milena Saleh, June 4th, 2019 Digital Pharma Europe Milena Saleh 2019 © All rights reserved Adapted from: Developing a Technology Enabled Model to Support Medication Taking Behaviors, Poster at the DTS 2018, Greenwood et al. Initiation Toolkit: Assessment Clinical Inertia Toolkit Self-care Toolkit “…Toolkits, designed to support healthcare provider’s actions and patient behavior changes, during three phases of medication taking behaviors (initiation, implementation, persistence) are driven by the TES engine. The proposed outcomes are increased engagement, improved experience and empowerment….” 1
  • 10. MY DOSE COACH OVERVIEW 10 #Digital #Devices #Success #Learnings: Digital Medical Devices – Milena Saleh, June 4th, 2019 Digital Pharma Europe Milena Saleh 2019 © All rights reserved 1 2 Sanofi internal
  • 11. MY DOSE COACH WORKFLOW 11 #Digital #Devices #Success #Learnings: Digital Medical Devices – Milena Saleh, June 4th, 2019 Digital Pharma Europe Milena Saleh 2019 © All rights reserved HCPs: prescribe and send a custom dose plan to their patients Patients: record daily fasting blood glucose in the MDC app to start getting insulin dose recommendations. 1 2 Sanofi internal
  • 12. MY DOSE COACH APP 12 #Digital #Devices #Success #Learnings: Digital Medical Devices – Milena Saleh, June 4th, 2019 Digital Pharma Europe Milena Saleh 2019 © All rights reserved 1 2 Enter blood glucose Get dose reco Confirm dose taken Review progress Sanofi internal
  • 13. KEY RESULTS INDIA PILOT 13 #Digital #Devices #Success #Learnings: Digital Medical Devices – Milena Saleh, June 4th, 2019 Digital Pharma Europe Milena Saleh 2019 © All rights reserved  Conducted in Apollo Sugar Clinics, in 2017  137 patients, 12-weeks; HCP prescribed dose plan, patient used app to adjust dose APP-based Approach to Basal Insulin Titration: Initial Results of the MyDoseCoach Pilot in India, Poster at the IDF 2018, Shah et al. “Conclusions: …This current 12-week pilot project conducted in India, demonstrates that the MDC app-aided titration of basal insulin is an effective, safe, and user-friendly technology- enabled option for optimizing basal insulin dose in patients with T2D…” 1 2
  • 14. OVERVIEW ONDUO VIRTUAL DIABETES CLINIC 14 #Digital #Devices #Success #Learnings: Digital Medical Devices – Milena Saleh, June 4th, 2019 Digital Pharma Europe Milena Saleh 2019 © All rights reserved Onduo is a virtual diabetes clinic designed to bring the best, most up-to-date care to people with diabetes – anytime, anywhere. Onduo is a joint venture of Sanofi and Verily Onduo.com, accessed May 2019 1 2
  • 15. WORKFLOW ONDUO 15 #Digital #Devices #Success #Learnings: Digital Medical Devices – Milena Saleh, June 4th, 2019 Digital Pharma Europe Milena Saleh 2019 © All rights reserved Patient signs up, gets Welcome Kit Patient is paired with Coach (app, text, phone) Patient logs meals, BG, medication Patient gets targeted advice to improve self-care Coach may loop in patient’s HCP for Rx change 1 2 Adapted from Onduo.com, accessed May 2019
  • 16. ONDUO APP 16 #Digital #Devices #Success #Learnings: Digital Medical Devices – Milena Saleh, June 4th, 2019 Digital Pharma Europe Milena Saleh 2019 © All rights reserved 1 2 Onduo.com, accessed May 2019
  • 17. KEY RESULTS US PILOTS 17 #Digital #Devices #Success #Learnings: Digital Medical Devices – Milena Saleh, June 4th, 2019 Digital Pharma Europe Milena Saleh 2019 © All rights reserved  Data from 2018  769 patients, enrolled in early pilots; patients logged meals, BG, meds and exchanged messages with coach “Conclusions (Close Concerns): … the need for high-touch, technology-driven care in diabetes, specifically as a means of making care more continuous (rather than episodic), scaling experts, and assisting the over-burdened PCPs who deliver ~80% of outpatient diabetes care.” Glytec and Onduo Webinar, Virtual Diabetes Care: Unlocking the Keys to Real Results, May 2019, https://www.himsslearn.org/virtual-diabetes-care-unlocking-keys-real-results 1 2
  • 18. INSIGHTS PATIENTS 18  Eligible patient vs. activated patient  Simplicity & ease of use  High satisfaction  Demonstrated clinical effectiveness  Improved disease perception & engagement  Patient support for repeated use  Long term use is challenging  Data analytics for continuous engagement #Digital #Devices #Success #Learnings: Digital Medical Devices – Milena Saleh, June 4th, 2019 Digital Pharma Europe Milena Saleh 2019 © All rights reserved 1 2 3
  • 19. INSIGHTS HCPS 19  High interest vs. product adoption  Customer prioritization: early adopters, advocacy  Fit to/improvement of current workflow  Time constraints: easy to learn & easy to teach  Multi-point HCP engagement & support  Help HCP identify best patient profiles #Digital #Devices #Success #Learnings: Digital Medical Devices – Milena Saleh, June 4th, 2019 Digital Pharma Europe Milena Saleh 2019 © All rights reserved 1 2 3
  • 20. INSIGHTS PAYERS 20  High interest for innovation  Limited / non-existing reimbursement  Long lead time for reimbursement  Payer “co-design” solution & metrics  Reimbursement does not drive adoption  Clinical data vs. real-life tool validation #Digital #Devices #Success #Learnings: Digital Medical Devices – Milena Saleh, June 4th, 2019 Digital Pharma Europe Milena Saleh 2019 © All rights reserved 1 2 3
  • 21. IMPLICATIONS: WHAT 21  Prioritize: HCP vs. DTC-driven  Digital is a product in its own right  Pilot vs. full-scale launch: resources  Regulatory framework: co-promotion possible?  Doctor-patient relationship transformation  You are NOT alone – ecosystem fit  AI & algorithms at the core  Product scale-up: design and resources #Digital #Devices #Success #Learnings: Digital Medical Devices – Milena Saleh, June 4th, 2019 Digital Pharma Europe Milena Saleh 2019 © All rights reserved 1 2 3
  • 22. IMPLICATIONS: HOW 22  Execution: pharma or partner?  Overall resource investment vs. engagement rate by channel (HCP/DTC)  Alternative activation channels?  HCP usage model and frequency  Sales force vs. dedicated experts, Training via MCE  Customer-service mindset & capabilities  Continuous patient enrollment improvement  No IMS: new metrics #Digital #Devices #Success #Learnings: Digital Medical Devices – Milena Saleh, June 4th, 2019 Digital Pharma Europe Milena Saleh 2019 © All rights reserved 1 2 3