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Presentation for SEMICON Europe 2016, Copyright EVEON1/17
SEMICON EUROPE, OCT 25, 2016
Remy VOMSCHEID, Director of Development, EVEON
Automation & Connectivity
applied to Medical Devices –
Benefits for the patients
Presentation for SEMICON Europe 2016, Copyright EVEON2/17
• Medtech headquartered in Grenoble France
with an office in Boston
• Mission : To develop and manufacture medical devices that address unmet need of patients, doctors
and nurses by automating the preparation of treatments, facilitating their administration and enabling the
patients to stay connected to healthcare professionals.
• Customers : Pharmaceutical Industries
• ISO 13485 and ISO 9001
• Proprietary technology : 13 patent families,
worldwide extensions
Core competencies
EVEON at a glance
Headquarter:
Grenoble,
FRANCE
Office in
Cambridge,
MA, USA
Presentation for SEMICON Europe 2016, Copyright EVEON3/17
EVEON platform
Automated preparation and administration
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• Oncology
• Urology
• Cell therapy
• Curietherapy
• Radiotherapy
• Hematology
• On-going
negotiations in
Ophthalmology,
Immunology and
Inflammatory
Simple solutions for complex treatments
Confidential
partners
Strategic partnerships
Cell
therapy
Viscous
PEG
mAbs
Lyo
Mono /
multivials
Suspension
Emulsion
On-going co-developments (therapies)
Presentation for SEMICON Europe 2016, Copyright EVEON5/17
Intuity® Mix – Automated Preparation/Mixing
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Illustration of a complex drug’s preparation
Manual
Intuity®
Mix
Intuity® Mix: Up to 5 times less handling
1. Remove the two caps from the vials2. Connect the needle on the sampling syringe3. Pump air in the syringe4. Puncture the vial of diluent and inject air in the vial5. Flip-off the vial of diluent and sample the diluent with
the syringe 6. Inject the diluent in the Lyo vial7. Mix8. Sample the reconstituted solution with the syringe9. Remove the needled from the syringe 10. Connect the needle for injection
The all-in-one automated preparation solution!
(1) (2) (3) (5)(4) (6) (7) (8) (9) (10)
Vials containing diluent and Lyo product
Product user manual
EASY TO USE AND SECURED SOLUTION FOR PATIENTS AND HEALTHCARE PROFESSIONALS
10 Steps
2Steps
(1) Load the cassette (2) Press reco button
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Data tracking
Automatic recording
No overdosage
Alarm
Programmable calendar
Data sharing
Connectable solutions to improve compliance
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Automation
+
Connectivity
Patient Benefits Safety
Reliability
Quality of Life
Adherence
Benefits of automated & connected medical devices
Presentation for SEMICON Europe 2016, Copyright EVEON9/17
• Health
25% to 50% patients are non-adherent
10% of hospitalizations in older adults may be caused by medication nonadherence
• Cost for the Community
3% to 10% of total US health care cost attributed to nonadherence ($100 to $300 billion)
Sources :
Luga A., Maura J., Adherence and health care costs, Risk Management and Healthcare Policy 2014:7 35–44
Image : www.adherium.com
Why is patient adherence so important ?
Presentation for SEMICON Europe 2016, Copyright EVEON10/17
• Pillboxes & Medication Dispensers
• Inhalers
• Auto-injectors
• Blood-glucose monitors & Insulin pumps
Examples of « Smart » products in the healthcare market
Presentation for SEMICON Europe 2016, Copyright EVEON11/17
• Adheretech*
Twist of the cap : medication taken
Blue light & alarm when not taken
Cell phone technology -> used WW
• Other products (not exhaustive)**:
Vitality GlowCap®
WestRock MEMSCap™
Philips Lifeline® Medication Dispenser System
Balda Medical App-controlled Smart Dispenser
Sources : * www.adheretech.com
** www.vitality.net, www.mwvaardex.com/index.php/our-adherence-solutions-data-
collection/memscap-tm, www.lifeline.philips.com/health-solutions/health-mdp.html,
www.balda-group.com/markets-solutions/healthcare/pharma.html
Pillboxes & Medication Dispensers
Presentation for SEMICON Europe 2016, Copyright EVEON12/17
• Novartis Onbrez Breezhaler™ for COPD patients*
Next generation in development, with Qualcomm
Will detect usage and wirelessly send relevant data (e.g.
time) to patients & healthcare professionals.
• Other products (not exhaustive)**
Adherium Smartinhaler
Cohero Health
Sources : * www.novartis.com/news/media-releases/novartis-
pharmaceuticals-collaborates-qualcomm-digital-innovation-breezhalertm
** www.adherium.com, www.coherohealth.com
Inhalers
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• Merck Serono RebiSmart™ for multiple sclerosis
patients*
Launched in 2009
Self-administration of Rebif® multidose
3-step injection procedure guided by on-screen instructions
Smart safety features -> make mis-administration unlikely
On-screen electronic dose-log enabling assessment of
adherence to treatment
• Other products (not exhaustive)**
Merck Serono Easypod™
Bayer BETACONNECT™
Unilife Teneo Touch
Biocorp DataPen
West Pharma SmartDose Electronic Wearable Injector
Sources : * www.rebismart.com, www.magazine.emerck/
** www.betaferon.com/betaconnect/features.php, www.unilife.com,
www.biocorp.fr, www.westpharma.com
Auto-injectors
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• Medtronic Minimed Insulin pump & Enlite® Sensor*
Continuous Blood Glucose Monitoring
Alerts / trends high or low
Pump worn on the body
Connect App
• Other products (not exhaustive)**
OmniPod Insulin patch pump
LifeScan OneTouch Verio Flex®
Sanofi iBGStar®
Sources : * www.medtronic-diabete.com/
** www.omnipod.com, www.onetouch.com, www.mystarsanofi.com,
Blood-glucose monitors & Insulin pumps
Presentation for SEMICON Europe 2016, Copyright EVEON15/17
• Council Directive 93/42/EEC concerning medical devices
• EN ISO 13485
specifies requirements for a quality management system where an organization needs to
demonstrate its ability to provide medical devices and related services
US : 21 CFR Part 820, harmonized with ISO 13485
• IEC 62304
specifies life cycle requirements for the development of medical software and software within
medical devices
• EN ISO 14971
specifies a process for a manufacturer to identify the hazards associated with medical devices
to estimate and evaluate the associated risks, to control these risks, and to monitor the
effectiveness of the controls.
• IEC 60601 series
technical standards for the safety and effectiveness of medical electrical equipments
covers electromagnetic disturbances, usability, environment, etc.
Automated & Connected Medical Device Development : key standards
Presentation for SEMICON Europe 2016, Copyright EVEON16/17
Smart, connected products offer exponentially expanding opportunities for new
functionality, far greater reliability, much higher product utilization, and capabilities that
cut across and transcend traditional product boundaries (…)
They are reshaping industry boundaries and creating entirely new industries. In many
companies, smart, connected products fill force the fundamental question, « what
business am I in »
Michael E. Porter & James E. Heppelmann*
* Porter, M., Heppelmann, E., How smart, connected products are transforming competition, Harvard Business
Review, November 2014.
Conclusion
Presentation for SEMICON Europe 2016, Copyright EVEON17/17
www.eveon.eu
