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Medical Device Development - Trends, Challenges and Risks
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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Medical Device Development - Trends, Challenges and Risks
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- 7. MedicalTrends Today • Customer tailoredmedicine - Personal Medicine • Repair, restore, replace organs, tissues, cells • Global and instant access to medical info • Homecare health • Mobile medicine • Prevention • Healthcare & Wellness
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- 11. Biomedical Science • Genomics • StemCells • Vaccines • Pharmaceutical • Diagnosis
- 12. 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
- 13. Sciences Trends Digital Medicine RoboticSurgery Nanomedicine Genomics Neuro Connected Health
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- 15. Global Medical Challenges • Chronicdiseases • Baby boom generation • Live longer • Life style • Physicians/patient ratio • Regulation of Innovation • Healthcare reforms • Healthcare costs • World wide environment
- 16. Global Medical Challenges Cost DemographicsAccess Variation in clinical practice Insufficient Use of information Fragmented care versus integrated care Duplication, defensive medicine & waste Protracted Adoption of Innovation
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- 18. Technological Challenges • Electronics • Mechanics •Software • IT networking • Cyber security • Multimodality • Maintenance • Usability
- 19. Software Strengths • Operation system •Powerful computing • Smartphones • Embedded • Graphical cards • Open source • Libraries • Knowledge sharing
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- 21. 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
- 22. www.meddev-design.com Medical Devices Lifecycle Healthcare DeliveryProcess Treatment Rehabilitatio n Diagnosis Prevention Use of Medical Device Knowledge Creation Medical Device - Lifecycle
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