January 4, 2010 – The U.S. Food and Drug Administration (FDA) has released an update of what medical devices it expects to be developed and brought to market within the next 10 years.

The FDA this week released its “Future Trends in Medical Device Technologies” from the William A. Herman and Gilbert B. Devey Center for Devices and Radiological Health (CDRH). The forecast reflects the inputs of many participants, including senior CDRH technical managers and 15 non-FDA experts, including physicians, engineers, healthcare policymakers, manufacturers and technology analysts.

The study found the following technologies have a high likelihood of being developed and making it to market in the next decade:

• Computerized devices and medical IT systems
- Integrated electronic patient medical records
- Computer-assisted diagnostic systems
- Internet-based medical device systems
- Virtual reality systems for immersive training and other applications
- Networks and systems of devices

• Robotic products and systems
- Robotic surgical systems
- Robotic prosthetics

• Wireless products and systems
- Advanced radiofrequency identification (RFID) systems

• Artificial organs and organ-assistive products
- Tissue engineered products
- Neuro-sensory devices
- Glucose monitoring products
- Electrostimulation products
- New types of insulin pumps and delivery systems
- Advanced prosthetic limbs
- New types of stents
- Joint replacements

• Combination device and drug/biological products
- New (non-eluting) drug delivery systems

• Imaging devices and systems
- Image-guided therapy systems
- Advanced ultrasound imaging systems
- Advanced optical imaging systems
- Advanced magnetic resonance (MR) imaging systems

• Photonic products
- Optical diagnostic products
- Optical therapeutic devices

• Minimally invasive therapeutic products
- Minimally invasive implants (e.g., percutaneous or natural orifice delivery)
- Minimally invasive radiotherapy systems

• Home- and self-care products
- New types of home sensors
- Smart homes

• Aging-related products

• Genomic, proteomic, metabolomic, and epigenomic technologies
- Genetic diagnostic products

• Sensor technologies
- New sensors

• Patient monitoring systems
- Remote patient monitoring systems

• Other
- Point-of-care products
- MEMS/MOTES devices

The primary purpose of the forecast is to help CDRH (and other medical device stakeholders) prepare for pioneering products that will pose new scientific questions and regulatory issues during the next decade. This preview it provides is intended to help CDRH develop initiatives to identify key scientific issues, collect basic information and set clear regulatory strategies for responding to a flow of new products. To these ends, the forecast identifies emerging medical device technologies and types of devices that manufacturers are highly likely to submit to CDRH for premarket decision making.

For a copy of the complete report: www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM23852…


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