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MedicalDeviceDevelopment–
Trends,ChallengesandRisks
Dina Sifri
CEO
Med-Dev Design
Medicine
&Technology
Riddle
Medicine
&Technology
Lifecycle
Unmet
medical
need
Innovation
Development
Clinical
trials /
Validation
Change in
medical
practice
Medicine
&Technology
Advancement
Agenda
www.meddev-design.com
Agenda
MedicalTrends
MedicalTrends
Today
• Customer tailored medicine - Personal
Medicine
• Repair, restore, replace organs, tissues, cells
• Global and instant access to medical info
• Homecare health
• Mobile medicine
• Prevention
• Healthcare & Wellness
Medical Health
Trends
Medical
TrendsShift
Today:
Detect &Treat
Tomorrow:
Predict & Prevent
Technological /
Science
Advantage
Biomedical
Science
• Genomics
• Stem Cells
• Vaccines
• Pharmaceutical
• Diagnosis
Computer /
Engineering
• Devices: Small, powerful
• Imaging: not just X-Ray
• OR of the future
• Medical Info managing
• Telemedicine
• Mobile technology
• Robotics
• 3D printing of organs
• Nanotechnology
• Brain-computer interface
Sciences
Trends
Digital Medicine Robotic Surgery Nanomedicine
Genomics Neuro Connected Health
Global Medical
Challenges
Global Medical
Challenges
• Chronic diseases
• Baby boom generation
• Live longer
• Life style
• Physicians/patient ratio
• Regulation of Innovation
• Healthcare reforms
• Healthcare costs
• World wide environment
Global Medical
Challenges
Cost Demographics Access Variation in clinical practice
Insufficient Use of
information
Fragmented care versus
integrated care
Duplication, defensive medicine &
waste
Protracted Adoption of
Innovation
Thechnological
Challenges
Technological
Challenges
• Electronics
• Mechanics
• Software
• IT networking
• Cyber security
• Multimodality
• Maintenance
• Usability
Software
Strengths
• Operation system
• Powerful computing
• Smartphones
• Embedded
• Graphical cards
• Open source
• Libraries
• Knowledge sharing
Software
Strengths
Risks:
Medical/
Technological/
Regulation
• R&D hurdles/technology
• Time to market
• Competition
• IPs
• Costs/Revenue
• Reimbursement
• Payers: customers
• Risks from payers to providers
• Global crisis
www.meddev-design.com
Medical Devices Lifecycle
Healthcare
Delivery Process
Treatment
Rehabilitatio
n
Diagnosis
Prevention
Use of Medical
Device
Knowledge
Creation
Medical
Device -
Lifecycle
SWOT
AboutUs
Thank you
We welcome you
to visit our
company booth

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