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* Small Wearable Device
*Continuous Monitoring levels
*Delivering System
* Timely- (i.e. every 5 minutes)

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* 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.

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https://youtu.be/h4a3f5RWg-o

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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

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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

https://www.medtronicdiabetes.com/download-library/minimed-670g-system

https://www.medtronicdiabetes.com/patents

https://www.medtronicdiabetes.com/search?t=8&cq=What%20is%20the%20MiniMed%E2%84%A2%20670G%20system?

https://www.medtronicdiabetes.com/res/img/670g/670GCoverageToolkit.pdf

https://www.medtronic.com/us-en/about/corporate-governance/suppliers.html

https://www.medtronic.com/us-en/about/mission.html

https://www.medtronic.com/us-en/healthcare-professionals/therapies-procedures/stroke-care/partnerships-professional-societies.html

https://www.medtronicdiabetes.com/blog/preparing-minimed-670g-system-launch/

http://professional.medtronicdiabetes.com/para/competitive-matrix1

http://www.strokeassociation.org/STROKEORG/AboutStroke/TogethertoEndStroke/Together-to-End-Stroke_UCM_448718_SubHomePage.jsp

https://www.adwdiabetes.com/product/20721/minimed-670g-pump-system?utm_source=google&utm_medium=cpc&utm_campaign=shopping&gclid=EAIaIQobChMIla-zten_3gIVBdbACh3OxQrsEAQYASABEgJy0PD_BwE

https://qz.com/795716/the-fda-has-approved-the-medtronic-minimed-670g-which-brings-type-1-diabetes-patients-closer-to-having-an-artificial-pancreas/

http://www.ipwatchdog.com/2016/08/22/artificial-pancreas-technology-probable-fda-approval/id=72004/

https://www.contournext.com/siteassets/products/cnl24/cr_85587269_cntrnextlink_2_4_ug_en_v5_c.pdf

http://www.freepatentsonline.com/6809653.html

https://medcitynews.com/2018/09/should-medtronics-return-to-standalone-continuous-glucose-monitoring-market-worry-competitors/?rf=1

https://seekingalpha.com/symbol/MDT

https://seekingalpha.com/filing/4156317

https://seekingalpha.com/symbol/MDT/earnings

https://www.owler.com/company/medtronicdiabetes

https://www.naics.com/sic-industry-description/?code=5047

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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.