"The Artificial Pancreas" by Alicia Graham

"The Artificial Pancreas" by Alicia Graham https://padlet.com/algraham0316/artificial_pancreas Medtronic's- MiniMed 670G en-us 2018-12-03 20:15:06 UTC 2023-08-15 20:56:15 UTC hello@padlet.com " The Artificial Pancreas"-MiniMed 670 algraham0316 https://padlet.com/algraham0316/artificial_pancreas/wish/310638655
* Small Wearable Device
*Continuous Monitoring levels
*Delivering System
* Timely- (i.e. every 5 minutes)

]]> 2018-12-03 20:21:46 UTC https://padlet.com/algraham0316/artificial_pancreas/wish/310638655 Target Market and Need algraham0316 https://padlet.com/algraham0316/artificial_pancreas/wish/310641859
* Diabetic Community
1. 29.1 million Americans diagnosed, 8.1 million un-diagnosed

*Business Sector
1. Self-Diagnostic Medical Device
a. Standalone continuous glucose monitoring (CGM) system
a1. Competitive edge ( i.e revenue) uncrowded market

Need

This device provide a continuous monitoring and delivery system that ensures the patients level of blood glucose or insulin remain optimal. ]]> 2018-12-03 20:29:10 UTC https://padlet.com/algraham0316/artificial_pancreas/wish/310641859 Attributes and Function Overview algraham0316 https://padlet.com/algraham0316/artificial_pancreas/wish/310645443 https://youtu.be/h4a3f5RWg-o

]]> 2018-12-03 20:36:59 UTC https://padlet.com/algraham0316/artificial_pancreas/wish/310645443 Safety and Efficacy algraham0316 https://padlet.com/algraham0316/artificial_pancreas/wish/310646487 The device is not suitable for
1. pregnant patients
2.Children under 7 years of age, or
3. Patients who require less than 8 units of insulin daily.

These warning notes are apparent because the way the device is designed and clinic trials have not been completed for these age groups, they will not benefit from this device.Testing in quality, safety, and efficacy standards must be met prior to this group of patients using the device.]]> 2018-12-03 20:39:35 UTC https://padlet.com/algraham0316/artificial_pancreas/wish/310646487 Regulatory Pathways for Development algraham0316 https://padlet.com/algraham0316/artificial_pancreas/wish/310648835 1. The National Institute of Health (NIH)

a. Small Business Innovation Research (SBIR)

b. Small Business Technology Transfer (SBTT)

2. The Food and Drug Administration (FDA)

a. Clinical Trials

b. Pre-Market Approvals

c. Approvals for usage

d. Devices registration

3. North American Industry Classification System

a. Industry and market code

4. United States Patent and Trade Office

5. World Intellectual Property Organization

]]> 2018-12-03 20:45:40 UTC https://padlet.com/algraham0316/artificial_pancreas/wish/310648835 References algraham0316 https://padlet.com/algraham0316/artificial_pancreas/wish/310649983 https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm600603.htm

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160017

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?start_search=1&establishmentName=&StateName=&CountryName=&RegistrationNumber=&OwnerOperatorNumber=&OwnerOperatorName=&ProductCode=OZP&DeviceName=&ProprietaryName=&establishmentType=&PAGENUM=5&SortColumn=

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=156599

https://www.clinicaltrials.gov/ct2/show/results/NCT02130284?term=NCT02130284&rank=1

https://www.ncbi.nlm.nih.gov/pubmed/28221823?dopt=Abstract

https://www.clinicaltrials.gov/ct2/show/results/NCT02246582?term=NCT02246582&rank=1

https://www.ncbi.nlm.nih.gov/pubmed/28700272?dopt=Abstract

https://www.clinicaltrials.gov/ct2/show/results/NCT02463097?term=NCT02463097&rank=1

https://www.ncbi.nlm.nih.gov/pubmed/29148821?dopt=Abstract

https://www.ncbi.nlm.nih.gov/pubmed/28134564?dopt=Abstract

https://www.wipo.int/edocs/plrdocs/en/self_diagnostic_medical_device.pdf

https://www.medtronic.com/us-en/about/news/Tia-minimed-670g.html