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Medical Device Development - Trends, Challenges and Risks

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Dina Sifri
Dina Sifri

This document discusses trends, challenges, and risks in medical device development. Some key trends include a shift towards personalized medicine, replacing organs and tissues, increased mobile access to healthcare information, and a focus on prevention over treatment. Technological advances are enabling smaller, more powerful devices for imaging, surgery, and managing medical information. However, medical device development faces challenges such as high costs, lengthy regulatory processes, reimbursement uncertainties, and ensuring cybersecurity. The document also outlines strengths and weaknesses in software for medical devices as well as risks at different stages of the medical device lifecycle.

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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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