Medical Device Development - Trends, Challenges and Risks
-
Upload
dina-sifri -
Category
Software
-
view
152 -
download
1
Transcript of Medical Device Development - Trends, Challenges and Risks
Medicine &Technology Lifecycle
Unmet medical
need
Innovation
Development
Clinical trials /
Validation
Change in medical practice
Medical Trends 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
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
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
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
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
Rehabilitation
Diagnosis
Prevention
Use of Medical Device
Knowledge Creation
Medical Device - Lifecycle